2016年英语四级考试报名

?一、主要β-内酰胺酶及β-内酰胺酶抑制剂

β-内酰胺类抗生素因其优良的特点而成为临床治疗各种细菌感染应用最广泛的药物，

但细菌对其耐药的问题也日益严重。细菌通过产生β内酰胺酶催化水解β-内酰胺环致使β-内酰胺类抗生素的抗菌效力大大削减或丧失。β内酰胺酶抑制剂能可逆或不可逆地抑制β-内酰胺酶，避免β内酰胺抗生素被水解，从而维持或增强后者的抗菌效能。临床上常用的β-内酰胺酶抑制剂主要有：克拉维酸、舒巴坦、他唑巴坦，三者均含有β-内酰

胺环结构，为不可逆竞争抑制剂。[1]Drawz SM,Bonomo RA. Three decades of beta-lactamase inhibitors[J].Clin Micriobiol Rev .2010.23(1).160-201.

β-内酰胺酶种类繁多，有多种分类方法，最主要的分类方法有根据β-内酰胺酶的底物、生化特效及是否被酶抑制剂所抑制的功能分类法，将β-内酰胺酶分为青霉素酶、广谱酶、超广谱β-内酰胺酶、头孢菌素酶和碳青霉烯酶等。根据β-内酰胺酶末端的氨基酸

序列特征将β-内酰胺酶分为丝氨酸酶和金属酶。目前引用较多的是基于上述两种方法

建立的分类方法。[2] Queenan AM,Bush K.Carbapenemases:the versatile beta-lactamases[J].Clin Microbiol Rev,2007,20(3)：440-458.

根据1995年Bush提出的分类方法[3]。Medeiros AA.Evolution and dissemination

ofB-lactamases accelerated by generations ofB-lactam antibiotics1[J].ClinInfect

Dis,1997,24:19 B-内酰胺酶按照底物和抑制物轮廓分为4组(其中第2组和第3组又

可分成许多亚组)。Ambler等则根据它们的氨基酸序列,把之分为A、B、C、D 4种类别。TEM、SHV、CTX-M型等ESBLs,能被B-内酰胺酶抑制剂克拉维酸等抑制,不被EDTA抑制,归于2be、A类;IMP型ESBLs不被克拉维酸抑制,被EDTA抑制,归于3a、B 类;MOX、CMY等种类少的ESBLs不被克拉维酸、EDTA抑制,归于1、C类;OXA型ESBLs部分类型被克拉维酸抑制,不被EDTA抑制,归于2d、D类。IRT不被克拉维酸抑制,对第三代头孢菌素敏感,归于2dr、A类。

二、β-内酰胺类抗生素/β-内酰胺酶抑制剂合剂的组成原则

β-内酰胺类抗生素/β-内酰胺酶抑制剂合剂的组成合剂必须考虑组方和配方的合理性。基本组成原则如下：（1）β-内酰胺类抗生素与β-内酰胺酶抑制剂的药代动力学特征基本吻合，如消除半衰期相近和分布相似，两者在体内的有效浓度能共同维持足够的作用时间，以发挥更好的协同杀菌效果。（2）β-内酰胺类抗生素与酶抑制剂组方后毒理学试验表明合剂与单药相比毒性未显著增加。（3）母体和酶抑制剂均需适当剂量。在已上市的β-内酰胺类抗生素/酶抑制剂合剂基础上增加新配比的品种，必须有充足理由说明现有配比不能完全满足临床需要，临床前和临床研究结果证明新配比合剂与已上市配比合剂相比，在有效性或安全性上具有临床价值的明显优势和新配比合剂有特殊适应征范围等。目前国内外临床上应用的主要β-内酰胺类抗生素/β-内酰胺酶抑制剂合剂包括：（1）阿莫西林/克拉维酸钾（针剂5:1，口服4:1或2:1）；(2)替卡西林/克拉维酸（15:1）；（3）氨苄西林/舒巴坦（2:1）；（4）头孢哌酮/舒巴坦（2:1或1:1）；（5）哌拉西林/他唑巴坦(8:1)。此5种复合制剂的配方符合抑制剂合剂的组成原则、有详细的药物代谢动力学数据（表2）、详实的体外药敏监测数据及丰富的临床使用数据，成为临床抗感染治疗的重要选择。

2.4 不同β- 内酰胺类抗生素和β- 内酰胺酶抑制剂的组合[22]

许多实验室尝试了不同β- 内酰胺类抗生素和β-内酰胺酶抑制剂的组合，获得了大量数据。体外试验显示，8 ∶ 1 配比的头孢哌酮 / 他唑巴坦的抗菌活性与头孢哌酮 / 舒巴坦（1：1）和哌拉西林 / 他唑巴坦（8：1）相似[23]。头孢曲松 / 他唑巴坦对产酶的金黄色葡萄球菌、大肠埃希菌和铜绿假单胞菌感染的小鼠有明显保护作用，且明显优于头孢曲松和头孢曲松 /舒巴坦[24]。另有体外试验显示，头孢他啶 / 舒巴坦对革兰阴性菌有较好的抗菌效果，其作用与头孢哌酮 / 舒巴坦相当，但优于哌拉西林 / 他唑巴坦和阿莫西林 / 克拉维酸。尤其对大肠埃希菌、阴沟肠杆菌、柠檬酸菌属和不动杆菌属，加入舒巴坦明显提高了头孢他啶对其耐药菌的抗菌效果[25]。还有体外试验显示，头孢噻肟 / 他唑巴坦 (8：1) 的 MIC50值是头孢噻肟的 1/2 ～ 1/128、MIC90值是头孢噻肟的 1/2 ～ 1/64，即加入他唑巴坦明显提高了头孢噻肟的抗菌活性[26]。

2.5 不同配比的β- 内酰胺类抗生素 /β- 内酰胺酶抑制剂复合制剂

体外试验显示，哌拉西林 / 舒巴坦（1：1、2：1 和 4：1）是一种有效的β- 内酰胺类抗生素 /β- 内酰胺酶抑制剂复合制剂，3 种配比的哌拉西林 / 舒巴坦的体外抗菌活性

相似[27]。当哌拉西林 / 他唑巴坦配比为 4：1 时，相对水解率较配比为 8：1 的显著降低，说明他唑巴坦起到了增强哌拉西林对β- 内酰胺酶的稳定性和抑酶作用的保护作

用[28]。但继续增加他唑巴坦剂量，不仅增加成本，且无显著效果[29]。对不同配比的头孢他啶 / 他唑巴坦体外抗菌活性及抑酶作用保护率的测定结果均表明，头孢他啶 / 他唑巴坦各配比复合制剂均具有抑酶增效作用，且此作用随他唑巴坦含量增加而增强

[30]。国外某教学医院对产 ESBL 的肠杆菌属菌株做检测，从中筛选出 361 株同时携带 AmpC 酶的菌株，然后检测联用β- 内酰胺类抗生素和β- 内酰胺酶抑制剂的 MIC，

结果发现舒巴坦联用头孢曲松、头孢泊肟或头孢噻肟使MIC 降低了 8 倍；克拉维酸联用全部第三代头孢菌素类药物的 MIC 均降低 8 倍；舒巴坦和克拉维酸联用氨曲南

的 MIC 下降程度更大[31]。

[22] 张永信 . 开发新抗生素的又一新思路——β- 内酰胺酶抑制剂复合制剂［J］．上海医药，2001，22(3) ：116-117.

[23] 张扣兴，唐英春，朱家馨，等 . 头孢哌酮钠 / 他唑巴坦钠体外抗菌活性和影响因素［J］．中国临床药理学杂志，2001，17(3) ：195-198.

[24] 符健，曾祥周，邢桂兰 . 头孢曲松钠 / 他唑巴坦钠的体内抗菌作用研究［J］．海南大学学报 ( 自然科学版 )，2001，19(4) ：370-372.

[25] 王睿，王中，孝柴栋，等 . 哌拉西林 / 舒巴坦体外抗菌活性研究［J］．中国临床药理学杂志，2001，17(4) ：272-276.

[26] 李耘，刘健，钟巍，等 . 头孢他啶 / 舒巴坦体外抗菌作用研究［J］．中国临床药理学杂志，2002，18(4) ：251-258.

[27] 丁力，刘爱英，王进，等 . 头孢噻肟钠与他唑巴坦联用对112 株临床菌株的体外抗菌活性［J］．中国医院药学杂志，2003，23(10) ：613-615.

[28] 李耘，郝凤兰，李家泰 . 不同配比哌拉西林、他唑巴坦对β- 内酰胺酶稳定性与抑酶增效作用研究［J］．中国临床药理学杂志，1998，14(2) ：113-120.

[29] 赵彩云，李耘，李家泰 . 哌拉西林及三唑巴坦对β- 内酰胺酶稳定性研究［J］．中国抗生素杂志，2000，25(1) ：28-32.

[30] 汪辉，陈景勇，张石楠，等 . 头孢他啶 / 他唑巴坦复方对产β- 内酰胺酶耐药菌株的增效作用研究［J］．药物生物技术，2004，11(6) ：364-367.

[31] Bhattacharjee A，Sen MR，Prakash P，et al. Role of beta-lactamase inhibitors in enterobacterial isolates producingextended-spectrum beta-lactamases［J］．J Antimicrob Chemother，2008，61(2) ：309-314.

三、主要β- 内酰胺类抗生素 /β- 内酰胺酶抑制剂合剂的共同特点

（1）除舒巴坦对不动杆菌属具有很强的抗菌活性外，其他β- 内酰胺酶抑制剂仅具有微弱的抗菌作用；（2）β- 内酰胺酶抑制剂对多数质粒介导的β- 内酰胺酶有较强抑制作用，与阿莫西林、氨苄西林、哌拉西林、替卡西林、头孢哌酮等联合后可保护上述抗生素不被细菌产生的灭活酶水解；（3）β- 内酰胺酶抑制剂不增强与其配伍药物对敏感细菌或非产β- 内酰胺酶的耐药细菌的抗菌活性；（4）β- 内酰胺酶抑制剂合剂的

抗菌作用主要取决于其β- 内酰胺类抗生素的抗菌谱和抗菌活性；（5）β- 内酰胺类抗

生素和β- 内酰胺酶抑制剂合剂中两药的药代动力学性质相近，具协同抗菌作用；（6）两药联合应用后不良反应无明显增加。

β- 内酰胺类抗生素 /β- 内酰胺酶抑制剂合剂的抗菌活性有一定差异：

四、β- 内酰胺酶抑制剂和耐药菌的关系

面对细菌耐药性越来越强的局面，β- 内酰胺酶抑制剂仍然是临床使用最广的药物之一。从 2008 年 1 月 1日 -12 月 31 日对我国 89 家医院临床分离细菌的耐药资料看，89

家医院按照监测方案共获得 157 813 株临床分离菌株，其中革兰阴性菌 106 957 株（占 68.3%），包括大肠埃希菌 26 957 株、铜绿假单胞菌 18 347 株和肺炎克雷伯菌16 396 株。对大肠埃希菌作用最强的药物依次为厄他培南 (100%)、亚胺培南(99.4%)、呋喃妥因、哌拉西林 / 他唑巴坦 (78.4%) 和阿米卡星、头孢哌酮 / 舒巴坦 (75.8%) ；对铜绿假单胞菌作用最强的药物依次为多黏菌素 (94.4%)、阿米卡星、美罗培南、头

孢他啶和哌拉西林 / 他唑巴坦 (70.0%) ；对肺炎克雷伯菌作用最强的药物依次为厄他培南 (98.9%)、亚胺培南 (98.7%)、阿米卡星、头孢哌酮 / 舒巴坦 (75.4%)、头孢西

丁和哌拉西林 / 他唑巴坦 (67.7%) ；对鲍曼不动杆菌作用最强的药物为多黏菌素

(85.0%)、米诺环素和头孢哌酮 / 舒巴坦 (61.2%)[20]。从以上数据可以作出看出：

虽然β- 内酰胺类抗生素 /β-内酰胺酶抑制剂复合制剂的抑菌率并非最高，但对常见

革兰阴性菌都有良好的抗菌作用。β- 内酰胺类抗生素 /β- 内酰胺酶抑制剂复合制剂在

临床占有重要地位，其中口服制剂多用于产β- 内酰胺酶敏感菌所致的呼吸道、泌尿生殖道和皮肤软组织等轻、中度感染治疗，而静脉制剂可用于治疗更为严重的产β- 内酰胺酶耐药菌感染、院内感染和混合感染，包括腹腔和盆腔感染、感染性心内膜炎、菌

血症和败血症等[21]。

[20] 肖永红，王进，朱燕，等 . Mohnarin 2008 年度全国细菌耐药监测［J］．中华医院感染学杂志，2010，20(16) ：2377-2383.

[21] 汪复 . 感染性疾病与抗微生物治疗［M］．第 3 版 . 上海：复旦大学出版社，2008 ：137-143.

五、近年来随着第三代B-内酰胺类抗生素和酶抑制剂克拉维酸、舒巴坦、三唑巴坦等

的联用,细菌面临双重选择压力。在较短的时间内细菌的B-内酰胺酶发生了进化突变,

突变后酶结构发生改变,酶要么能水解B-内酰胺类抗生素,要么能逃避酶抑制剂的作用。前者成为超广谱B-内酰胺酶(Extended-spectrumB-lactamases,ESBLs),后者就成为耐酶抑制剂B-内酰胺酶(Inhibitor-resistantB-lactamases)。绝大部分耐酶抑制剂B-内酰胺

酶都属于TEM型,称为耐酶抑制剂TEM型B-内酰胺酶(Inhibitor-resistant TEMB-lactamases,IRT)。

产生B-内酰胺酶是B-内酰胺抗生素耐药的主要机制之一,特别是由质粒介导的超广谱

B-内酰胺酶(Extended SpectrumB-lactamases, ESBLs),由于其底物谱相当广泛,对所有

B-内酰胺类抗生素均有较强的灭活能力,给临床抗感染治疗带来极大的麻烦。近年来,B-内酰胺类抗生素与B-内酰胺酶抑制剂组成的复合制剂的出现给此类感染的治疗提供了

有效的手段。本文采用聚合酶链反应(Polymerase Chain Reac-tion, PCR)对细菌所产ESBLs进行分型,利用体外药敏试验的方法对哌拉西林P他唑巴坦、头孢哌酮P舒巴

坦、阿莫西林P克拉维酸、替卡西林P克拉维酸和氨苄西林P舒巴坦5种B-内酰胺酶抑制剂复合制剂对产ESBLs菌株的抗菌活性以及对产不同型别ESBLs菌株的抗菌活性

作一比较。5种复合制剂对154例菌株的药敏结果见表1,154株ESBLs阳性菌株对TIA、AMS、AOA、SPZ、PIP等5种酶抑制复合制剂的敏感率分别为3.2%、1.3%、7.1%、38.3%和95.5%。5种复合制剂对154株ESBL阳性菌株的药敏试验结果见下表:

154例产ESBLs菌株对哌拉西林P他唑巴坦(PIP)、头孢哌酮P舒巴坦(SPZ)、阿莫西林P克拉维酸(AOA)、替卡西林P克拉维酸(TIA)和氨苄西林P舒巴坦(AMS)的敏感率分别是95.5%、38.3%、7.14%、3.2%和1.3%,产TEM及SHV型ESBLs菌株对PIP的敏感率分别是100%和89.7%,对SPZ的敏感率分别为39.4%和27.6%。抗菌活性有极显著差异(P<0.005)。PIP和SPZ对产TEM和SHV型ESBLs菌株的抗菌活性无明显区别(P>0.05)。结论 PIP对产ESBLs菌株的抗菌活性明显强于SPZ、AOA、TIA以及AMS等其它酶抑制剂复合制剂。

六、不同酶抑制剂的耐药情况分析—做表格？

抗生素耐药性及其耐药机制

抗生素（antibiotic）是生物在其生命活动过程中产生的（以及用化学、生物、生物化学方法衍生的），能在低微浓度下有选择性抑制或影响它种生物功能的有机化合物。细菌耐药性（antibiotic resistance）是指细菌对抗生素不敏感的现象，又可分为固有耐药（intrinsic resistance）和获得性耐药（acquired resistance）。固有耐药是由细菌染色体基因决定、代代相传，不会改变的。如链球菌对氨基糖苷类抗生素天然耐药。获得性耐药是由于细菌与抗生素接触后，通过改变自身的代谢途径，使其不被抗生素杀灭。如本文将重点讨论的细菌对β-内酰胺酶的耐药性。

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