注射用兰索拉唑说明书(美国)

O N H N

S CH 2 N H 3C

2CF 3 (No. 3954)

PRV0509 R6

May 2009

PREVACID ? I.V.

(lansoprazole)

for Injection

30 mg/vial

R x only

DESCRIPTION

The active ingredient in PREVACID I.V. (lansoprazole) for Injection is a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C 16H 14F 3N 3O 2S with a molecular weight of 369.37. PREVACID has the following structure:

Lansoprazole is a white to brownish-white odorless crystalline powder which melts with

decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water.

Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH.

PREVACID I.V. for Injection contains 30 mg of the active ingredient lansoprazole, 60 mg

mannitol, 10 mg meglumine, and 3.45 mg sodium hydroxide and is supplied as a sterile, lyophilized powder for I.V. (intravenous) use. The solution of PREVACID I.V. for Injection has a pH of

approximately 11 following the first reconstitution with Sterile Water for Injection, USP, and

approximately 10.2, 10.0, or 9.5 after further dilution with either 0.9% Sodium Chloride Injection, USP, Lactated Ringer’s Injection, USP, or 5% Dextrose Injection, USP, respectively.

CLINICAL PHARMACOLOGY

Pharmacokinetics and Metabolism

Following the administration of 30 mg of lansoprazole by intravenous infusion over 30 minutes to healthy subjects, plasma concentrations of lansoprazole declined exponentially with a mean (+ standard deviation) terminal elimination half-life of 1.3 (± 0.5) hours. The mean peak plasma concentration of lansoprazole (C max) was 1705 (± 292) ng/mL and the mean area under the plasma concentration versus time curve (AUC) was 3192 (± 1745) ng?h/mL. The absolute bioavailability of lansoprazole following oral administration is over 80%, and C max and AUC of lansoprazole are approximately proportional in doses from 15 mg to 60 mg after single oral administration. The pharmacokinetics of lansoprazole did not change with time after 7-day once daily repeated oral or intravenous administration of 30 mg lansoprazole.

Distribution

The apparent volume of distribution of lansoprazole is approximately 15.7 (± 1.9) L, distributing mainly in extracellular fluid. Lansoprazole is 97% bound to plasma proteins. Plasma protein binding is constant over the concentration range of 0.05 to 5.0 μg/mL.

Metabolism

Lansoprazole is extensively metabolized in the liver. Two metabolites have been identified in measurable quantities in plasma (the hydroxylated sulfinyl and sulfone derivatives of lansoprazole). These metabolites have very little or no antisecretory activity. Lansoprazole is thought to be transformed into two active species which inhibit acid secretion by blocking the proton pump [(H+,

K+)-ATPase enzyme system] at the secretory surface of the gastric parietal cell. The two active species are not present in the systemic circulation. The plasma elimination half-life of lansoprazole is less than 2 hours while the acid inhibitory effect lasts more than 24 hours. Therefore, the plasma elimination half-life of lansoprazole does not reflect its duration of suppression of gastric acid secretion. Elimination

Following an intravenous dose of lansoprazole, the mean clearance was 11.1 (± 3.8) L/h. Following single-dose oral administration of lansoprazole, virtually no unchanged lansoprazole was excreted in the urine. In one study, after a single oral dose of 14C-lansoprazole, approximately one-third of the administered radiation was excreted in the urine and two-thirds was recovered in the feces. This implies a significant biliary excretion of the lansoprazole metabolites.

Special Populations

Geriatric Use

Following oral administration, the clearance of lansoprazole is decreased in the elderly, with elimination half-life increased approximately 50% to 100%. Because the mean half-life in the elderly remains between 1.9 to 2.9 hours, repeated once daily dosing does not result in accumulation of lansoprazole. Peak plasma levels were not increased in the elderly. No intravenous dosage adjustment is needed.

Pediatric Use

The pharmacokinetics of intravenous lansoprazole have not been studied in pediatric patients. For further information, please see the PREVACID package insert for the oral formulations.

Gender

The pharmacokinetic data of intravenous lansoprazole in females is limited; however, in a study with oral lansoprazole comparing 12 male and 6 female human subjects who received lansoprazole, no gender differences were found in pharmacokinetics and intragastric pH results. No intravenous dosage adjustment is needed (also refer to Use in Women).

Renal Insufficiency

In patients with severe renal insufficiency, plasma protein binding decreased by 1.0%-1.5% after oral administration of 60 mg of lansoprazole. Patients with renal insufficiency had a shortened elimination half-life and decreased total AUC (free and bound). The AUC for free lansoprazole in plasma, however, was not related to the degree of renal impairment; and the C max and T max (time to reach the maximum concentration) were not different than the C max and T max from subjects with normal renal function. No intravenous dosage adjustment is necessary in patients with renal insufficiency. Hepatic Insufficiency

In patients with various degrees of chronic hepatic disease, the mean plasma half-life of lansoprazole was prolonged from 1.5 hours to 3.2-7.2 hours after oral administration. An increase in the mean AUC of up to 500% was observed at steady state in hepatically-impaired patients compared to healthy subjects. Intravenous dose reduction in patients with severe hepatic disease should be considered. Race

The pooled mean pharmacokinetic parameters of orally administered lansoprazole from twelve U.S. Phase 1 studies (N=513) were compared to the mean pharmacokinetic parameters from two Asian

studies (N=20). The mean AUCs of lansoprazole in Asian subjects were approximately twice those seen in pooled U.S. data; however, the inter-individual variability was high. The C max values were comparable. Information for intravenous dosing is not available.

Pharmacodynamics

Mechanism of Action

PREVACID (lansoprazole) belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H+, K+) -ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the parietal cell, lansoprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated gastric acid secretion for at least 24 hours irrespective of the stimulus. Lansoprazole does not exhibit anticholinergic or histamine type-2 antagonist activity.

Antisecretory Activity

Acid Output

An open-label, single-center, two period study was conducted to evaluate the pharmacodynamics of 30 mg of intravenous lansoprazole and 30 mg of oral lansoprazole in 29 healthy subjects. The primary pharmacodynamic endpoints were pentagastrin stimulated maximum acid output (MAO) and basal acid output (BAO). Subjects received oral lansoprazole for 7 days in Period 1 and then were immediately switched to intravenous lansoprazole for 7 days in Period 2. MAO and BAO were measured at baseline and 21 hours following the last oral dose and the last intravenous dose of lansoprazole. This study demonstrated that 7 days of oral lansoprazole followed by 7 days of intravenous lansoprazole administration significantly suppressed gastric acid output as compared with baseline. Seven days of 30 mg of intravenous lansoprazole was equivalent to 30 mg of oral lansoprazole in the ability to maintain gastric acid output suppression (Table 1).

Table 1: Acid Output (mEq/hr)

PREVACID 30 mg

Baseline After 7 Days of

Oral Dosing After 7 Days of I.V. Dosing

Maximum Acid Output (Median) 11.26

n=27 4.76*

n=28

5.13*

n=28

Basal Acid Output (Median) 1.42

n=28 0.42*

n=28

0.27*

n=28

* Significantly (p ≤ 0.05) less acid output as compared to baseline.

24-Hour Intragastric pH

A multiple-dose study was conducted in 36 healthy subjects comparing the pharmacokinetics and pharmacodynamics of lansoprazole after intravenous administration and oral administration. During the first-hour post-dosing interval, intravenous lansoprazole resulted in significantly higher mean intragastric pH than did oral lansoprazole. There were no statistically significant differences between oral and intravenous regimens in 24-hour mean intragastric pH for the percentage of time that the intragastric pH was above 3 and 4 after 1-day or 5-day once daily repeated administration of 30 mg lansoprazole. Gastric acid suppression was maintained throughout each treatment period. The pharmacodynamic results are summarized in Table 2.

Table 2: Mean Antisecretory Effects after Single and Multiple Daily Dosing

Parameter Baseline

Value

PREVACID

30 mg daily Orally

x 5 days

30 mg I.V. Infusion daily x

5 Days

Day 1 Day 5 Day 1 Day 5

Mean 24-Hour pH Mean first hour pH % Time Gastric pH>3 % Time Gastric pH>4 3.33

4.44

45.27

31.07

4.75

2.74

74.08

67.18

5.25

4.79

83.92

77.61

4.86

4.64*

78.36

70.51

5.36

5.91*

85.54

79.68

*Significantly (p≤ 0.05) higher than the oral lansoprazole

Refer to CLINICAL PHARMACOLOGY for pharmacokinetic results.

Enterochromaffin-like (ECL) Cell Effects

During lifetime exposure of rats with up to 150 mg/kg/day of lansoprazole dosed orally seven days per week, marked hypergastrinemia was observed followed by ECL cell proliferation and formation of carcinoid tumors, especially in female rats (refer to PRECAUTIONS, Carcinogenesis, Mutagenesis, Impairment of Fertility).

Gastric biopsy specimens from the body of the stomach from approximately 150 patients treated continuously with lansoprazole for at least one year did not show evidence of ECL cell effects similar to those seen in rat studies. Longer term data are needed to rule out the possibility of an increased risk of the development of gastric tumors in patients receiving long-term therapy with lansoprazole. Other Gastric Effects In Humans

Lansoprazole did not significantly affect mucosal blood flow in the fundus of the stomach. Due to the normal physiologic effect caused by the inhibition of gastric acid secretion, a decrease of about 17% in blood flow in the antrum, pylorus, and duodenal bulb was seen. Lansoprazole significantly slowed the gastric emptying of digestible solids. Lansoprazole increased serum pepsinogen levels and decreased pepsin activity under basal conditions and in response to meal stimulation or insulin injection. As with other agents that elevate intragastric pH, increases in gastric pH were associated with increases in nitrate-reducing bacteria and elevation of nitrite concentration in gastric juice in patients with gastric ulcer. No significant increase in nitrosamine concentrations was observed.

Serum Gastrin Effects

In over 2,100 patients, median fasting serum gastrin levels increased 50% to 100% from baseline but remained within normal range after treatment with 15 to 60 mg of oral lansoprazole. These elevations reached a plateau within two months of therapy and returned to pretreatment levels within four weeks after discontinuation of therapy.

Endocrine Effects

Human studies for up to one year have not detected any clinically significant effects on the endocrine system. Hormones studied include testosterone, luteinizing hormone (LH), follicle stimulating hormone (FSH), sex hormone binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEA-S), prolactin, cortisol, estradiol, insulin, aldosterone, parathormone, glucagon, thyroid stimulating hormone (TSH), triiodothyronine (T3), thyroxine (T4), and somatotropic hormone (STH). Lansoprazole in oral doses of 15 to 60 mg for up to one year had no clinically significant effect on sexual function. In addition, lansoprazole in oral doses of 15 to 60 mg for two to eight weeks had no clinically significant effect on thyroid function.

In 24-month carcinogenicity studies in Sprague-Dawley rats with daily lansoprazole dosages up to 150 mg/kg, proliferative changes in the Leydig cells of the testes, including benign neoplasm, were increased compared to control rates; these findings are rat specific.

Other Effects

No systemic effects of lansoprazole on the central nervous system, lymphoid, hematopoietic, renal, hepatic, cardiovascular or respiratory systems have been found in humans. Among 56 patients who had extensive baseline eye evaluations, no visual toxicity was observed after lansoprazole treatment (up to 180 mg/day) for up to 58 months.

After lifetime lansoprazole exposure in rats, focal pancreatic atrophy, diffuse lymphoid hyperplasia in the thymus and spontaneous retinal atrophy were seen.

CLINICAL STUDIES

Erosive Esophagitis

A multicenter, double-blind, two-period placebo-controlled, pharmacodynamic study was conducted

to assess the ability of PREVACID I.V. for Injection to maintain gastric acid suppression in patients switched from the oral dosage form of lansoprazole to the intravenous dosage form. Erosive esophagitis patients (n=87; 18 to 78 years of age; 28 female; 69 Caucasian/non-Hispanic, 14 Hispanic, 3 African-American, and 1 Native American) received 30 mg of oral lansoprazole for 7 days in Period 1. Patients were then immediately switched to receive either 30 mg of intravenous lansoprazole or intravenous placebo (normal saline) for 7 days in Period 2. MAO and BAO were determined 21 hours following the last dose of oral medication and the last dose of intravenous administration. MAO was calculated from two hours of continuous collection of gastric contents following a subcutaneous injection of 6.0 μg/kg of pentagastrin. BAO was calculated from one hour of continuous collection of gastric contents.

This study demonstrated that, after seven days of repeated oral administration followed by 7 days of intravenous administration, the oral and intravenous dosage forms of PREVACID were similar in their ability to suppress MAO and BAO in patients with erosive esophagitis (refer to Table 3). Also, patients receiving oral PREVACID, who were switched to intravenous placebo, experienced a significant increase in acid output within 48 hours of their last oral dose.

Table 3: Acid Output (mEq/h) in Erosive Esophagitis Patients

PREVACID Oral PREVACID I.V. Placebo I.V.

(last oral dose) (last I.V. dose) (last I.V. dose)

Maximum Acid Output (Median) 7.16

n=80

7.64

n=56

26.90**

n=17

Basal Acid Output (Median) 0.77

n=81

0.51

n=55

3.19*

n=16

*, ** Significantly different from PREVACID I.V. at p=0.005 and p<0.001 levels, respectively

INDICATIONS AND USAGE

When patients are unable to take the oral formulations, PREVACID I.V. for Injection is indicated as an alternative for the short-term treatment (up to 7 days) of all grades of erosive esophagitis. Once the patient is able to take medications orally, therapy can be switched to an oral formulation of PREVACID for a total of 6 to 8 weeks. The safety and efficacy of PREVACID I.V. for Injection as an initial treatment of erosive esophagitis have not been demonstrated. Refer to full prescribing information for the oral formulations of PREVACID.

CONTRAINDICATIONS

PREVACID I.V. for Injection is contraindicated in patients with known severe hypersensitivity to any component of the formulation.

PRECAUTIONS

General

Symptomatic response to therapy with lansoprazole does not preclude the presence of gastric malignancy.

Treatment with PREVACID I.V. for Injection should be discontinued as soon as the patient is able to resume treatment with PREVACID oral formulations.

Drug Interactions

Lansoprazole is metabolized through the cytochrome P450 system, specifically through the CYP3A and CYP2C19 isozymes. Studies have shown that lansoprazole does not have clinically significant interactions with other drugs metabolized by the cytochrome P450 system, such as warfarin, antipyrine, indomethacin, ibuprofen, phenytoin, propranolol, prednisone, diazepam, or clarithromycin in healthy subjects. These compounds are metabolized through various cytochrome P450 isozymes including CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A. When lansoprazole was administered concomitantly with theophylline (CYP1A2, CYP3A), a minor increase (10%) in the clearance of theophylline was seen. Because of the small magnitude and the direction of the effect on theophylline clearance, this interaction is unlikely to be of clinical concern. Nonetheless, individual patients may require additional titration of their theophylline dosage when lansoprazole is started or stopped to ensure clinically effective blood levels.

In a study of healthy subjects neither the pharmacokinetics of warfarin enantiomers nor prothrombin time were affected following single or multiple 60 mg doses of lansoprazole. However, there have been reports of increased International Normalized Ratio (INR) and prothrombin time in patients receiving proton pump inhibitors, including lansoprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with proton pump inhibitors and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time.

Concomitant administration of lansoprazole and tacrolimus may increase whole blood levels of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19.

Lansoprazole causes a profound and long-lasting inhibition of gastric acid secretion; therefore, it is theoretically possible that lansoprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, ampicillin esters, iron salts, digoxin). Carcinogenesis, Mutagenesis, Impairment of Fertility

In two 24-month carcinogenicity studies, Sprague-Dawley rats were treated with oral lansoprazole doses of 5 to 150 mg/kg/day - about 1 to 40 times the exposure on a body surface (mg/m2) basis of a 50-kg person of average height [1.46 m2 body surface area (BSA)] given the recommended human dose of 30 mg/day. Lansoprazole produced dose-related gastric enterochromaffin-like (ECL) cell hyperplasia and ECL cell carcinoids in both male and female rats. It also increased the incidence of intestinal metaplasia of the gastric epithelium in both sexes. In male rats, lansoprazole produced a dose-related increase of testicular interstitial cell adenomas. The incidence of these adenomas in rats receiving doses of 15 to 150 mg/kg/day (4 to 40 times the recommended human dose based on BSA) exceeded the low background incidence (range = 1.4 to 10%) for this strain of rat.

In a 24-month carcinogenicity study, CD-1 mice were treated orally with doses of 15 to

600 mg/kg/day, 2 to 80 times the recommended human dose based on BSA. Lansoprazole produced a dose-related increased incidence of gastric ECL cell hyperplasia. It also produced an increased incidence of liver tumors (hepatocellular adenoma plus carcinoma). The tumor incidences in male mice treated with 300 and 600 mg/kg/day (40 to 80 times the recommended human dose based on BSA) and female mice treated with 150 to 600 mg/kg/day (20 to 80 times the recommended human dose based on BSA) exceeded the ranges of background incidences in historical controls for this strain

of mice. Lansoprazole treatment produced adenoma of rete testis in male mice receiving 75 to

600 mg/kg/day (10 to 80 times the recommended human dose based on BSA).

A 26-week p53 (+/-) transgenic mouse carcinogenicity study was not positive.

Lansoprazole was not genotoxic in the Ames test, the ex vivo rat hepatocyte unscheduled DNA synthesis (UDS) test, the in vivo mouse micronucleus test, or the rat bone marrow cell chromosomal aberration test. It was positive in in vitro human lymphocyte chromosomal aberration assays.

Lansoprazole at intravenous doses of up to 30 mg/kg/day (approximately 8 times the recommended human dose based on BSA) was found to have no effect on fertility and reproductive performance in male and female rats.

Pregnancy: Teratogenic Effects

Pregnancy Category B

Teratology studies have been conducted in rats and rabbits using intravenous lansoprazole doses of up to 30 mg/kg/day (approximately 8 times in rats and 16 times in rabbits of the recommended human dose based on BSA). Treatment with lansoprazole did not result in any impairment of fertility or harm to the fetus.

However, there are no adequate and well-controlled studies in pregnant women using the intravenous route. Because animal reproduction studies are not always predicative of human response, PREVACID I.V. for Injection should be used during pregnancy only if clearly needed.

Nursing Mothers

Lansoprazole or its metabolites are excreted in the milk of rats. It is not known whether lansoprazole is excreted in human milk. Because many drugs are excreted in human milk, because of the potential for serious adverse reactions in nursing infants from lansoprazole, and because of the potential for tumorigenicity shown for lansoprazole in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue PREVACID I.V. for Injection, taking into account

the importance of PREVACID I.V. for Injection to the mother.

Pediatric Use

The safety and effectiveness of PREVACID I.V. for Injection have not been established for pediatric patients. For further information, please see the PREVACID package insert for the oral formulations.

Use in Women

Among intravenous PREVACID treated subjects, similar percentages of adverse events were reported in males and females.

Over 4,000 women were treated with oral PREVACID. Ulcer healing rates in females were similar to those in males. The incidence rates of adverse events in females were also similar to those seen in males.

Use in Geriatric Patients

Data in elderly patients administered intravenous lansoprazole is limited; however, with oral lansoprazole, ulcer healing rates in elderly patients are similar to those in a younger age group. The incidence rates of PREVACID-associated adverse events and laboratory test abnormalities are similar to those seen in younger patients. For geriatric patients, dosage and administration of PREVACID need not be altered for a particular indication.

ADVERSE REACTIONS

Clinical Safety Experience with PREVACID I.V. for Injection

More than 1,000 patients and subjects have participated in domestic and foreign clinical trials. Treatment with PREVACID I.V. for Injection was well-tolerated.

In four U.S. trials involving 161 subjects exposed to PREVACID I.V. for Injection, the following treatment-related adverse events were reported in >1% of subjects: headache (1.0%), injection site pain (1.0%), injection site reaction (1.0%) and nausea (1.3%). Treatment-related adverse events occurring in less than 1% of subjects included abdominal pain, vasodilatation, diarrhea, dyspepsia, vomiting, dizziness, paresthesia, rash, and taste perversion. No additional adverse drug reactions were reported with the intravenous formulation that had not been reported previously with the oral formulations.

Clinical Safety Experience with Oral Formulations of PREVACID

Worldwide, over 10,000 patients have been treated with oral PREVACID in Phase 2 or Phase

3 clinical trials involving various dosages and durations of treatment. In general, PREVACID treatment has been well-tolerated in both short-term and long-term trials.

The following adverse events were reported by the treating physician to have a possible or probable relationship to drug in 1% or more of PREVACID-treated patients and occurred at a greater rate in PREVACID-treated patients than placebo-treated patients in Table 4.

Table 4: Incidence of Possibly or Probably Treatment-Related Adverse Events in Short-Term,

Placebo-Controlled PREVACID Studies

Body System/Adverse Event PREVACID

Oral

(N= 2768)

%

Placebo

(N= 1023)

%

Body as a Whole

Abdominal Pain Digestive System

Constipation Diarrhea

Nausea 2.1

1.0

3.8

1.3

1.2

0.4

2.3

1.2

Headache was also seen at greater than 1% incidence but was more common on placebo. The incidence of diarrhea was similar between patients who received placebo and patients who received 15 mg and 30 mg of PREVACID, but higher in the patients who received 60 mg of PREVACID (2.9%, 1.4%, 4.2%, and 7.4%, respectively).

Additional adverse experiences occurring in less than 1% of patients or subjects who received PREVACID in domestic trials are shown below:

Body as a Whole - abdomen enlarged, allergic reaction, asthenia, back pain, candidiasis, carcinoma, chest pain (not otherwise specified), chills, edema, fever, flu syndrome, halitosis, infection (not otherwise specified), malaise, neck pain, neck rigidity, pain, pelvic pain; Cardiovascular System - angina, arrhythmia, bradycardia, cerebrovascular accident/cerebral infarction, hypertension/ hypotension, migraine, myocardial infarction, palpitations, shock (circulatory failure), syncope, tachycardia, vasodilation; Digestive System - abnormal stools, anorexia, bezoar, cardiospasm, cholelithiasis, colitis, dry mouth, dyspepsia, dysphagia, enteritis, eructation, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastric nodules/fundic gland polyps, gastritis, gastroenteritis, gastrointestinal anomaly, gastrointestinal disorder, gastrointestinal hemorrhage, glossitis, gum hemorrhage, hematemesis, increased appetite, increased salivation, melena, mouth ulceration, nausea and vomiting, nausea and vomiting and diarrhea, gastrointestinal moniliasis, rectal disorder, rectal hemorrhage, stomatitis, tenesmus, thirst, tongue disorder, ulcerative colitis, ulcerative stomatitis; Endocrine System - diabetes mellitus, goiter, hypothyroidism; Hemic and Lymphatic System - anemia, hemolysis, lymphadenopathy; Metabolic and Nutritional Disorders -avitaminosis, gout, dehydration, hyperglycemia/hypoglycemia, peripheral edema, weight gain/loss; Musculoskeletal System - arthralgia, arthritis, bone disorder, joint disorder, leg cramps,

musculoskeletal pain, myalgia, myasthenia, ptosis, synovitis; Nervous System - abnormal dreams, agitation, amnesia, anxiety, apathy, confusion, convulsion, dementia, depersonalization, depression, diplopia, dizziness, emotional lability, hallucinations, hemiplegia, hostility aggravated, hyperkinesia, hypertonia, hypesthesia, insomnia, libido decreased/increased, nervousness, neurosis, paresthesia, sleep disorder, somnolence, thinking abnormality, tremor, vertigo; Respiratory System - asthma, bronchitis, cough increased, dyspnea, epistaxis, hemoptysis, hiccup, laryngeal neoplasia, lung fibrosis, pharyngitis, pleural disorder, pneumonia, respiratory disorder, upper respiratory

inflammation/infection, rhinitis, sinusitis, stridor; Skin and Appendages -acne, alopecia, contact dermatitis, dry skin, fixed eruption, hair disorder, maculopapular rash, nail disorder, pruritus, rash, skin carcinoma, skin disorder, sweating, urticaria; Special Senses -abnormal vision, amblyopia, blepharitis, blurred vision, cataract, conjunctivitis, deafness, dry eyes, ear/eye disorder, eye pain, glaucoma, otitis media, parosmia, photophobia, retinal degeneration/disorder, taste loss, taste perversion, tinnitus, visual field defect; Urogenital System - abnormal menses, breast enlargement, breast pain, breast tenderness, dysmenorrhea, dysuria, gynecomastia, impotence, kidney calculus, kidney pain, leukorrhea, menorrhagia, menstrual disorder, penis disorder, polyuria, testis disorder, urethral pain, urinary frequency, urinary retention, urinary tract infection, urinary urgency, urination impaired, vaginitis.

Postmarketing

Additional adverse experiences have been reported since oral PREVACID has been marketed. The majority of these cases are foreign-sourced and a relationship to PREVACID has not been established. Because these events were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events are listed below by COSTART body system.

Body as a Whole –anaphylactic/anaphylactoid reactions; Digestive System - hepatotoxicity, pancreatitis, vomiting; Hemic and Lymphatic System - agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic purpura; Musculoskeletal System – myositis; Skin and Appendages – severe dermatologic reactions including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal); Special Senses -speech disorder; Urogenital System – interstitial nephritis, urinary retention.

Laboratory Values

There were no clinically important changes identified in any laboratory parameter with PREVACID I.V. for Injection.

The following changes in laboratory parameters in patients who received PREVACID were reported as adverse events:

Abnormal liver function tests, increased SGOT (AST), increased SGPT (ALT), increased creatinine, increased alkaline phosphatase, increased globulins, increased GGTP, increased/decreased/abnormal WBC, abnormal AG ratio, abnormal RBC, bilirubinemia, eosinophilia, hyperlipemia,

increased/decreased electrolytes, increased/decreased cholesterol, increased glucocorticoids, increased LDH, increased/decreased/abnormal platelets, and increased gastrin levels. Urine abnormalities such as albuminuria, glycosuria, and hematuria were also reported. Additional isolated laboratory abnormalities were reported.

In the placebo controlled studies, when SGOT (AST) and SGPT (ALT) were evaluated, 0.4%

(4/978) and 0.4% (11/2677) patients, who received placebo and PREVACID, respectively, had enzyme elevations greater than three times the upper limit of normal range at the final treatment visit. None of these patients who received PREVACID reported jaundice at any time during the study. OVERDOSAGE

Single intravenous doses of PREVACID at 218 mg/kg in mice (approximately 30 times the recommended human dose based on BSA) and 167 mg/kg in rats (approximately 46 times the recommended human dose based on BSA) were lethal. The symptoms of acute toxicity were decreased locomotor response, ataxia, ptosis and tonic convulsions.

PREVACID is not removed from the circulation by hemodialysis.

DOSAGE AND ADMINISTRATION

PREVACID I.V. for Injection admixtures should be administered intravenously using the in-line filter provided. The filter must be used to remove precipitate that may form when the reconstituted drug product is mixed with I.V. solutions. Studies have shown that filtration does not alter the amount of lansoprazole that is available for administration. Read the following instructions carefully.

There are two methods for preparing PREVACID I.V. for Injection:

1. Reconstitution in Vial and Preparation of Admixture.

OR

2. Direct reconstitution with Baxter’s MINI-BAG Plus Container.

1. Reconstitution in Vial and Preparation of Admixture

There are two steps for preparing PREVACID I.V. for Injection.

STEP ONE - Reconstitution in Vial

-First PREVACID I.V. MUST be reconstituted with Sterile Water for Injection, USP.

-Inject 5 mL of ONLY Sterile Water for Injection, USP into a 30 mg vial of

PREVACID I.V. for Injection. The resulting solution will contain lansoprazole

6 mg/mL (30 mg/5 mL).

-Failure to reconstitute with Sterile Water may result in formation of

precipitation/particulates.

-Mix gently until the powder is dissolved.

The pH of this reconstituted solution is approximately 11. The reconstituted solution can be

held for 1 hour when stored at 25oC (77oF) prior to further dilution.

STEP TWO - Preparation of Admixture

-Dilute the reconstituted solution in either 50 mL of 0.9% Sodium Chloride Injection, USP, Lactated Ringer’s Injection, USP, or 5% Dextrose Injection, USP.

-The admixture should be stored at 25oC (77oF) and should be administered within the designated time period as listed in Table 5. No refrigeration is required.

Diluent pH

within:

Administer

0.9% Sodium Chloride

Approximately 10.2 24 hours

Injection, USP

Lactated Ringer’s

Approximately 10.0 24 hours

Injection, USP

Approximately 9.5 12 hours

5% Dextrose Injection,

USP

-Once the admixture is prepared, proceed to Instructions for Priming and Use of Filter.

2. Reconstitution with Baxter’s MINI-BAG Plus Container

-PREVACID I.V. for Injection can be reconstituted directly into 50 mL of 0.9% Sodium Chloride for Injection, USP or 5% Dextrose Injection, USP utilizing Baxter’s MINI-

BAG Plus Container.

-Refer to separate instructions that are provided with Baxter’s MINI-BAG Plus

Container.

-Once the admixture is prepared, proceed to Instructions for Priming and Use of

Filter.

The admixture should be stored at 25oC (77oF) and should be administered within the

designated time period as listed in Table 6. No refrigeration is required.

Diluent pH

within:

Administer

Approximately 10.2 24 hours

0.9% Sodium Chloride

Injection, USP

Approximately 9.5 8 hours

5% Dextrose Injection,

USP

Instructions for Priming and Use of Filter

TO PRIME FILTER

-Prime administration set in usual manner and close administration set clamp.

-Connect luer adapter of administration set to filter inlet using a twisting motion. Over-tightening should be avoided.

-Hold filter below the level of solution container.

-Open administration set clamp and slowly prime filter.

-Close administration set clamp. Verify no air bubbles are present on patient side of filter.

-If air bubbles are observed, open set clamp slightly to re-establish flow then gently tap filter housing. Observe that no air bubbles are present and close clamp.

-Connect to patient and regulate flow. Filter may be primed using a syringe and saline.

-The administration set can then be connected to inlet of filter.

PRECAUTIONS WITH USE OF FILTER

Follow instructions carefully:

-Use Aseptic technique. For single use only. Do not resterilize or reuse. Do not use if package is damaged.

-If repositioning of filter is required, loosen luer locking collar, reposition, then retighten locking collar firmly.

-Maximum working pressure is 1500 mmHg (30 psi, 2 bar). When the working limits of the filter are exceeded, causes of the added resistance should be investigated and corrected.

- The internal volume of the filter is approx. 0.7 mL.

- The administration set clamp should be closed during solution container change.

- Pumps should not be used downstream of filter.

Administration

Do not administer with other drugs or diluents as this may cause incompatibilities.

IN-LINE FILTER THAT IS PROVIDED MUST BE USED when administering PREVACID I.V. for Injection via an administration set.

Follow these steps:

1. Flush the PREVACID I.V. for Injection administration port before administration of

PREVACID I.V. for Injection with at least 5 cc of either:

? 0.9% Sodium Chloride Injection, USP,

? Lactated Ringer’s Injection, USP, or

? 5% Dextrose Injection, USP.

2. Attach the filter and administration set.

3. Administer PREVACID I.V. for Injection over 30 minutes.

4. Remove and discard the administration set, including the filter, used for PREVACID I.V.

for Injection.

5. Flush the administration port with at least 5 cc of above mentioned solutions.

If the administration port is not flushed and the administration set is not removed, lansoprazole degradation may occur with time, and black or brown particulate may be observed in the tubing or on the filter.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Treatment of Erosive Esophagitis

The recommended adult dose (when patients are unable to take the oral therapy) is 30 mg of lansoprazole (1 vial of PREVACID I.V. for Injection) per day administered by I.V. infusion over 30 minutes for up to 7 days. Once the patient is able to take medications orally, therapy can be switched to an oral PREVACID formulation for a total of 6 to 8 weeks. Refer to full prescribing information for the oral formulations of PREVACID.

No dosage adjustment is necessary in patients with renal insufficiency or the elderly. For patients with severe liver disease, dosage adjustment should be considered.

HOW SUPPLIED

PREVACID I.V. for Injection contains 30 mg of lansoprazole as white to pale yellow friable masses and powder in a vial and is available as follows:

NDC 64764-954-25 Tray containing 10 single dose vial packs: Each pack

containing one 30-mg single dose vial of PREVACID

I.V. for Injection and 1 required in-line filter (1.2 μm

pore size).

Store PREVACID I.V. for Injection at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from light. Use carton to protect contents from light.

U.S. Patent No. 4,628,098.

Distributed by

Takeda Pharmaceuticals America, Inc.

Deerfield, IL 60015

PREVACID?is a registered trademark of Takeda Pharmaceuticals North America, Inc. and used under license by Takeda Pharmaceuticals America, Inc.

MINI-BAG is a trademark of Baxter International Inc.

All other trademark names are the property of their respective owners.

? 2004 - 2009 Takeda Pharmaceuticals America, Inc.

PRV0509 R6, May 2009

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【成份】 分子式：C16H14F3N3O2S 分子量：369.37 【性状】该品为肠溶片，除去包衣后显白色或类白色。 【适应症/功能主治】胃溃疡、十二指肠溃疡、反流性食管炎、佐-艾（Zollinger-Ellison）综合征（胃泌素瘤）。 【规格型号】15mg*14s 【用法用量】治疗胃溃疡和十二指肠溃疡，每日清晨口服1次，一次15~30mg。或遵医嘱。 【不良反应】本品副作用轻微，主要表现为口干、头晕、恶心。 【禁忌】孕妇、哺乳期妇女忌用。 【注意事项】1、治疗过程中应注意观察，因长期使用的经验不足，暂不推荐用于维持治疗。2、本品服用时请不要嚼碎，应整

片用水吞服。3、下列患者慎重用药。（1）曾发生药物过敏症的患者。（2）肝肾功能障碍的患者。4、因本药会掩盖胃癌的症状，所以须先排除胃癌，方可给药。 【儿童用药】遵医嘱。 【老年患者用药】遵医嘱。 【孕妇及哺乳期妇女用药】孕妇、哺乳期妇女忌用。 【药物相互作用】如与其他药物同时使用可能会发生药物相互作用，详情请咨询医师或药师。 【药物过量】尚不明确。 【药理毒理】该品为新型的抑制胃酸分泌的药物，它作用于胃壁细胞的H+-K+-ATP酶，使壁细胞的H+不能转运到胃中去，以致胃液中胃酸量大为减少，临床上用于十二指肠溃疡、胃溃疡、反流性食管炎，佐-艾（Zollinger-Ellison）综合征（胃泌素瘤）的治疗，疗效显著，对幽门螺杆菌有抑制作用。 【药代动力学】该品口服后1小时左右可在血中检出，达峰时间

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【药物名称】兰索拉唑 Lansoprazole [国家基本药物] 【药物类别】抗消化性溃疡药 其结构式为： 分子式：C16H14F3N3O2S 分子量：369.37【性状】 【性状】略带褐色的白色结晶性粉末。熔点（分解）166℃；易溶于二甲基甲酰胺，可溶于甲醇，难溶于无水乙醇，极难溶于乙醚，几乎不溶于水。 【药物别名】达克普隆，兰素拉唑 Takepron、Prevacid 【分子式成分】2-[3-甲基-4-(2,2,2-村氟乙氧基)-2-吡啶基]亚磺酰]-1H-苯并咪唑。本品为结 晶,M.P.178-182℃。 【制剂规格】胶囊：15mg、30mg。 【药理毒理】本药转移到胃粘膜壁细胞的酸分泌细管后，在酸性条件下，转变为活性体结构，此种活性物与质子泵((H+＋K+)-ATPase)的SH基结合，从而抑制该酶的活性，故能抑制胃酸的分泌。 1.(H+＋K+)-ATPase活性抑制作用兰索拉唑可抑制狗胃粘膜内微粒体的(H+＋K+)-ATPase活性(体外实验)。 2.壁细胞酸生成抑制作用兰索拉唑对狗胃粘膜离体壁细胞由组胺、乙酰胆碱及胃泌素的刺激所产生的酸分泌，皆具有抑制作用(体外实验)。 3.胃酸分泌抑制作用1)对胃泌素刺激引起的酸分泌：于健康成人，1天1次兰索拉唑30mg口服给药，连续7天，可明显地抑制由胃泌素引起的酸分泌，且此作用能持续24小时。2)对胰岛素刺激引起的酸分泌：于健康成人，1天1次兰索拉唑30mg口服给药，连续7天，可明显地抑制由胰岛素引起的酸分泌。3)对夜间的酸分泌：于健康成人，1天1次兰索拉唑30mg口服给药，连续7天，具有明显地抑制夜间胃酸分泌的作用。4)对24小时的酸分泌：于健康成人24小时胃液采样试验，以1天1次兰索拉唑30mg口服给药连续7天，24小时的胃酸分泌明显地受到抑制。5)24小时胃内pH值的监测：对健康成人以及十二指肠溃疡患者，以1天1次兰索拉唑30mg口服给药连续7天，24小时的胃酸分泌皆明显地受到抑制。6)24小时下部食道pH值的监测：于反流性食管炎患者，以1天1次兰索拉唑30mg口服给药连续7天～9天，对胃食管反流现象，有明显地抑制作用。7)对大白鼠及胃pouch狗的胃酸分泌：本药对于大白鼠的基础酸分泌和因组胺、胃泌素、氨基甲酰基胆碱、2-脱氧-D-葡萄糖或水浸应激试验(water immersion stress)所引起的酸分泌均能明显且持续地抑制(在十二指肠内)。对胃pouch狗因各种刺激

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【性状】本品为白色至淡黄色结晶或结晶性粉末 【适应症】适用于头孢甲肟敏感的链球菌、肺炎链球菌、消化球菌属，大肠杆菌等引起的下述感染症： 1、肺炎、支气管炎、支气管扩张合并感染、慢性呼吸系统疾病的继发感染;肺脓肿、脓胸; 2、肾盂肾炎、膀胱炎;前庭大腺炎、子宫内膜炎、子宫附件炎、盆腔炎、子宫旁组织炎; 3、胆管炎、胆囊炎、肝脓肿;腹膜炎; 4、烧伤、手术创伤的继发感染; 5、败血症; 6、脑脊膜炎。 【规格】⑴0.5g ⑵1.0g 【用法用量】 用法：该品溶于0.9%氯化钠注射液或葡萄糖注射液中，静脉滴注。 用量： 1、成人： 轻度感染：1日1-2g，分2次静脉滴注； 中.重度感染：可增至一日4g，分2-4次静脉滴注，也可根据临床情况进行剂量调整。 2、小儿： 轻度感染：一日每公斤体重40-80mg，分3-4次静脉滴注； 中、重度感染：可增至一日每公斤体重160mg，分3-4次静脉滴注； 脑脊膜炎：可增量至至一日每公体重200mg，分3-4次静脉滴注 【不良反应】 1、不良反应 休克（小于0.1%），故要仔细观察，若出现感觉不适，口内异常感、喘、眩晕、排便感、耳鸣、出汗等异常症状时，应停止给药，并进行适当处理。 偶有急性肾功能不全等严重肾功能障碍（小于0.1%），故要定期检查肾功能，仔细观察，如异常时，要停止给药.并进行适当的处理。 2、良反应 过敏症：皮疹、荨麻疹、红斑、瘙痒、淋巴腺肿大、关节痛； 禁忌对该品及头孢菌素类有过敏反应史者禁用 【注意事项】对青霉素类抗生素有过敏史的患者 【贮藏】遮光，密闭，在阴凉处保存 【有效期】24个月 1

评价注射用兰索拉唑治疗十二指肠溃疡出血疗效及安全性

评价注射用兰索拉唑治疗十二指肠溃疡出血疗效及安全性 发表时间：2016-10-12T16:48:18.083Z 来源：《心理医生》2016年16期作者：刘成吾 [导读] 十二指肠溃疡是临床上的常见消化系统疾病，该病可导致患者出现胃肠道不适。 （洛宁县中医院脑病科河南洛宁 471700） 【摘要】目的：探讨注射用兰索拉唑治疗十二指肠溃疡出血的临床效果及治疗安全性。方法：自2015年1月至12月期间，我院收治十二指肠溃疡出血患者共100例。按照随机数字法对患者作分组处理。观察组50例患者，以注射液兰索拉唑进行治疗；对照组50例患者，以注射用奥美拉唑进行治疗。比较两组患者的临床治疗效果及治疗安全性。结果：（1）治疗总有效率：观察组患者的治疗总有效率为94%，明显高于对照组患者的治疗总有效率68%，两组患者的治疗总有效率比较存在统计学差异（P＜0.05）。（2）止血时间：观察组患者平均止血时间为（27.2±2.3）h、对照组患者平均止血时间为（38.3±1.8）h。观察组患者的止血时间明显短于对照组，组间存在统计学差异（P ＜0.05）。（3）安全性分析：两组患者的不良反应发生率比较无统计学差异（P＞0.05）。结论：注射液兰索拉唑治疗十二指肠溃疡出血效果显著，安全性高，可在临床上进行推广应用。 【关键词】兰索拉唑；十二指肠溃疡；出血；安全性 【中图分类号】R453 【文献标识码】A 【文章编号】1007-8231（2016）16-0058-02 十二指肠溃疡是临床上的常见消化系统疾病，该病可导致患者出现胃肠道不适。若不加以重视，还可诱发出血，加重病情[1]。而胃酸腐蚀是导致患者出血的重要因素，因此抑制胃酸是该病治疗的关键[2]。奥美拉唑及兰索拉唑均是临床上用于抑制胃酸的药物。传统治疗中，一直以奥美拉唑为主，但效果较为一般，患者溃疡面愈合较慢。兰索拉唑为一苯并咪唑衍生物，可获得更强的治疗效果。在本次调查中，笔者即对注射液兰索拉唑及奥美拉唑治疗十二指肠溃疡出血的效果及安全性进行分析，现作下述报道： 1.资料及方法 1.1 一般资料 本次调查时间为2015年1月至12月，调查对象为我院收治的100例十二指肠溃疡患者。按照随机数字法对患者进行分组处理，观察组及对照组患者各为50例。观察组中，男女人数分别为22例、28例，患者最小20岁，最大65岁，平均年龄为（54.3±2.3）岁；对照组中，男女人数分别为23例、27例，患者最小22岁，最大64岁，平均年龄为（55.0±2.1）岁。两组患者的一般资料分析比较无统计学差异（P＞ 0.05），可进行对比参照。 1.2 方法 观察组患者以药物兰索拉唑进行治疗，具体如下：注射液兰索拉唑（生产企业：江苏奥赛康药业股份有限公司；批准文号：国药准字H20080336）30mg+0.9%生理盐水100ml，静脉滴注给药，每日2次。 对照组患者以药物奥美拉唑进行治疗，具体如下：注射液奥美拉唑（生产企业：AstraZeneca AB；批准文号：国药准字J20090010）40mg+0.9%生理盐水100ml，静脉滴注给药，每日1次。 两组患者均连续治疗5d。 1.3 观察治疗及疗效判定 观察指标：比较两组患者的平均止血时间与不良反应发生情况。 疗效判定：（1）治愈：患者出血症状消除；（2）显效：患者出血量明显减少，并呈持续减少趋势；（3）有效：患者出血量逐渐减少；（4）无效：患者治疗前后出血量无变化，甚至病症更为严重。总有效率%=治愈率%+显效率%+有效率%。 1.4 统计学分析 所得数据经SPSS 18.0统计学软件作分析，对于计数资料，以百分比形式表示，并行χ2检验；对于计量资料，以（均数±标准差）形式表示，并行t检验。对于P＜0.05，提示存在统计学差异。 2.结果 2.1 治疗效果比较 治疗后对两组患者的效果进行评定，其中观察组患者的治疗总有效率为94%，明显高于对照组患者的治疗总有效率68%，两组患者的治疗总有效率比较存在统计学差异（P＜0.05）。具体见表1。 2.2 止血时间分析 观察组患者平均止血时间为（27.2±2.3）h、对照组患者平均止血时间为（38.3±1.8）h。观察组患者的平均止血时间明显低于对照组患者，组间差异存在统计学意义（P＜0.05）。 2.3 不良反应发生情况 观察组患者不良反应3例，其不良反应发生率为6%，主要表现为皮疹1例，恶心2例；对照组患者不良反应2例，其不良反应发生率为4%，主要表现为恶心呕吐。两组患者的不良反应发生率比较无统计学差异（P＞0.05）。 3.讨论 十二指肠溃疡是临床上的常见胃肠道疾病，近年来随着人们饮食习惯、生活习惯的改变，使得该病发病率呈明显上升趋势。十二指肠溃疡可造成患者胃肠道不适，若不进行治疗，还可诱发出血症状。对于十二指肠溃疡出血患者，其治疗难度增加，患者生理机能也将受到影响，甚至威胁生命[3]。临床上主要以质子泵抑制剂对患者进行治疗。其作用机理为通过抑制胃酸的分泌，促进溃疡面愈合，继而改善出血症状。 奥美拉唑与兰索拉唑均是常用的质子泵抑制剂。传统治疗中，一直以药物奥美拉唑治疗为主，但效果较为一般，许多患者病情未得到

胃苏颗粒、兰索拉唑联合治疗胃溃疡(活动性)效果观察

胃苏颗粒、兰索拉唑联合治疗胃溃疡（活动性）效果观察 发表时间：2018-07-16T13:16:57.790Z 来源：《中国误诊学杂志》2018年第12期作者：司道平 [导读] 目的：研究分析胃苏颗粒、兰索拉唑联合治疗胃溃疡（活动性）的效果。 北京市丰台区南苑医院内科 100076 摘要：目的：研究分析胃苏颗粒、兰索拉唑联合治疗胃溃疡（活动性）的效果。方法：在2016年2月到2017年2月之间，随机选取60例我院收治的胃溃疡（活动性）患者，采用双盲法分为两组，对照组进行常规治疗（兰索拉唑），观察组采用兰索拉唑+胃苏颗粒治疗，分析临床效果。结果：观察组和对照组患者的治疗总有效率、不良反应发生率对比，差异显著，且P＜0.05，具有统计学意义。结论：对胃溃疡（活动性）患者采用胃苏颗粒联合兰索拉唑治疗，效果显著，具有推广价值。 关键词：胃溃疡；胃苏颗粒；兰索拉唑；效果 胃溃疡是一种常见的消化系统疾病，主要指胃粘膜被消化液自身消化而造成的超过黏膜的组织损伤。临床症状主要表现为嗳酸、出血、背部压痛及上腹部疼痛[1]。活动性胃溃疡是指胃溃疡还在发展，并有可能进一步恶化。为了提高临床治疗效果，本次研究分析胃苏颗粒、兰索拉唑联合治疗胃溃疡（活动性）的效果，详细内容现汇报如下。 1、资料与方法 1.1一般资料 在2016年2月到2017年2月之间，随机选取60例我院收治的胃溃疡（活动性）患者，采用双盲法分为两组，对照组男女比例为17：13，年龄分布在19~71岁，平均（51.2±3.6）岁；观察组男女比例为19：11，年龄分布在18~69岁，平均（50.9±3.8）岁。经内镜检查，溃疡基底部有白色或黄白色厚苔，周围黏膜充血、水肿。且两组患者均符合《中医胃病诊疗指南》，对比；两组患者的临床资料，差异不显著，且P＞0.05，无统计学意义。 1.2方法 对照组进行常规治疗（兰索拉唑），静脉滴注注射用兰索拉唑，30mg/次，用0.9%氯化钠注射液100ml溶解后，2次/d，推荐静滴时间30min，疗程不超过7天。观察组采用兰索拉唑+胃苏颗粒治疗，兰索拉唑用法用量同对照组，选用胃苏颗粒，5g/袋，一次1袋，一日3次。用适量开水冲服，搅拌至全溶。两组患者连续治疗7d，对比治疗效果[2]。 1.3判定标准 根据《中医胃病诊疗指南》，及胃镜检查情况本次治疗效果判定如下，显效：嗳酸、出血及上腹部疼痛等症状消失，胃镜检查检查黏膜充血、水肿面积减小＞90%；有效：嗳酸、出血及上腹部疼痛等症状明显改善，胃镜检查检查黏膜充血、水肿面积减小50~90%；无效：嗳酸、出血及上腹部疼痛等症状无变化，胃镜检查检查黏膜充血、水肿面积减小＞50%。记录两组患者服药后，不良反应发生情况，如头痛、腹泻、消化不良等。 1.4统计学方法 本次研究中出现的对比数据，采用“统计产品与服务解决方案”软件进行分析，版本为SPSS20.0。当P＜0.05，说明对比有差异，具有统计学意义。采用t检验计量资料“”，采用2检验计数资料“[n（%）]”。 2．结果 2.1两组患者治疗效果对比 结果见表1，观察组患者的治疗效果高于对照组，对比差异显著，同时满足P＜0.05，具有统计学意义。 表1 两组患者治疗总有效率对比 2.2两组患者不良反应发生情况对比 服药后，对照组出现2例头痛、1例腹泻、1例消化不良，不良反应发生率为13.3%，观察组出现1例头痛、不良反应发生率为3.3%，对比有差异，且P＜0.05，具有统计学意义。 3．讨论 胃溃疡是位于贲门至幽门之间的慢性溃疡，指胃黏膜被胃消化液自身消化而造成的粘膜肌层的组织损伤。临床常见病因有幽门螺杆菌感染、胃酸和胃蛋白酶、遗传因素和胃运动异常。嗳酸是临床常见的症状，在心窝部或者剑突部感觉到疼痛[3]。出血也是患者最常见的症状，会伴有呕血、大便出血。临床主要进行内镜检查，可诊断患者的病期。主要分为活动期、愈合期和瘢痕期，活动期指患者的病情正在发展。临床治疗主要制酸剂、抗胆碱能药物、H2受体拮抗药，并给予患者胃黏膜保护的药物。传统的西医治疗胃溃疡，起效虽然快，但是容易复发。中医治疗活动性胃溃疡根据症候辨证施治，中医将胃溃疡分为实证和虚症，实证为血瘀阻络证、肝肺郁热证，虚证为肝胃气滞证、脾胃虚寒证。随着中药内服治疗溃疡病及生肌收敛取得良好的作用，对于活动性胃溃疡应以清热化瘀、温络活血为主，若患者出现胃粘膜血流，应选用促进溃疡愈合的药物[4]。 兰索拉唑是一种抑制胃酸分泌的药物，主要作用于胃壁细胞质子泵，对于基础胃酸分泌（促胃液素、组胺）等和食物激发的胃酸分泌具有显著的作用。能够作用于H+-K+ATP酶，使H+不能被转运到胃中去，因而使胃液中的胃酸减少。临床相关研究表明，兰索拉唑居具有长效抑制胃酸分泌的效果，持续时间长达24h[5]。胃苏颗粒的主要成分为紫苏梗、香附、香橼等，紫苏梗可用于用于脾胃气滞，胸闷呕

注射用兰索拉唑治疗十二指肠溃疡出血的临床效果分析

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