美罗培南与亚胺培南/西司他汀治疗重症感染疗效与安全性的Meta分析

目的 评价碳青霉烯类抗生素美罗培南与亚胺培南/西司他汀在重症感染治疗中的疗效和安全性.方法 利用计算机检索EMBASE、MEDLINE、Cochrane library和CNKI等数据库,纳入比较美罗培南与亚胺培南/西司他汀在相同给药剂量、给药方案下治疗重症感染疗效和安全性的随机对照试验(RCTs),采用RevMan 5.2.6软件对入选试验进行Meta分析.结果 共纳入16个随机对照试验,包括3055例重症感染患者.Meta分析结果显示,美罗培南相比亚胺培南/西司他汀在治疗重症感染中的临床有效率高[RR=1.03,95％CI(1.00,1.06)].在临床治愈率[RR=1.04,95％CI(1.00,1.10)]与细菌清除率[RR=1.02,95％CI(0.97,1.07)]方面,美罗培南与亚胺培南/西司他汀相当.美罗培南组与药物相关不良反应发生率为11.6％,相比于亚胺培南/西司他汀组的13.6％[RR=0.85,95％CI(0.70,1.02)],但中枢神经系统不良反应在亚胺培南/西司他汀组发生率较高(P＜0.01).结论 现有证据表明,美罗培南在重症感染治疗中的临床有效率略优于亚胺培南/西司他汀,中枢神经系统不良反应发生率显著低于亚胺培南/西司他汀.     

美罗培南和亚胺培南/西司他丁治疗新生儿重度呼吸道感染的疗效观察

目的:与亚胺培南/西司他丁对比,观察美罗培南对新生儿重度呼吸道感染的临床疗效。方法:将66例重度呼吸道感染的新生儿随机分为试验组和对照组,试验组用美罗培南治疗,对照组用亚胺培南/西司他丁治疗。结果:试验组和对照组的治疗有效率分别为81.82%和78.79%,细菌清除率分别为88.46%和85.71%,不良反应发生率分别为3.03%和6.06%,两组间无明显差异(P>0.05)。结论:美罗培南治疗新生儿重度呼吸道感染的效果与亚胺培南/西司他丁相当,是一种有效、安全的抗菌药物。     

美罗培南与亚胺培南/西司他丁治疗医院获得性下呼吸道感染

目的比较国产美罗培南与亚胺培南／西司他丁治疗医院获得性下呼吸道感染的有效性和安全性。方法采用随机对照平行试验设计进行研究，治疗组31例，给予美罗培南0．5g，q8h，静脉滴注；对照组32例，给予亚胺培南／西司他丁1．0g，q8h，静脉滴注。两药疗程均为7～10d。结果美罗培南组和亚胺培南／西司他丁组的临床痊愈率分别为45．2％和43．8％；临床有效率分别为74．2％和78．1％；细菌清除率分别为82．6％和78．3％；不良反应发生率分别为6．5％和6．3％。以上指标差异均无显著性（P〉0．05）。结论国产美罗培南治疗医院获得性下呼吸道感染是有效和安全的，与亚胺培南／西司他丁相比无显著性差异。     

临床药师参与1例疑似亚胺培南/西司他丁致幻觉患者的药学监护

目的 探讨亚胺培南/西司他丁在急性胰腺炎患者使用后诱发幻觉的关联性评价、机制、影响因素、处理措施与药学监护.方法 1例重症急性胰腺炎患者发生幻觉时,临床药师及时分析和判断幻觉与亚胺培南/西司他丁的相关性,予以换用美罗培南及相关对症治疗.结果 经过治疗后患者神志清醒、幻觉逐渐消失.结论 对于存在肾功能不全、高龄等危险因素的患者,在应用亚胺培南/西司他丁时,应严密监测其精神状态.一旦出现幻觉及其他不适主诉,临床药师及临床医师应充分权衡利弊;如必须应用碳青霉烯类药物,可选择美罗培南以确保临床用药的安全性和有效性.     

国产美罗培南与进口亚胺培南/西司他丁预防重症急性胰腺炎腹腔感染的随机对照研究

目的:评价国产美罗培南对重症急性胰腺炎患者腹腔感染预防的有效性和安全性。方法:采用随机、双盲、对照开放试验。临床确诊重症急性胰腺炎的患者随机分为试验组与对照组,试验组应用国产美罗培南500mg,tid,对照组应用进口亚胺培南/西司他丁500mg,tid,疗程均为7～14d。记录2组患者生命体征、急性生理学与慢性健康状况评分Ⅱ(APACHEⅡ)评分、血常规、肝肾功能以及恶心、呕吐、腹痛、腹胀等,统计患者感染发生率及死亡率。结果:试验组与对照组均有28例患者纳入本研究,各有27、25例可进行疗效评价,各组有25例可进行安全性评价。腹腔感染发生率试验组为14.8%,对照组为16.0%(P>0.05);不良反应发生率试验组为20.0%,对照组为24.0%(P>0.05)。结论:在重症急性胰腺炎预防性应用抗菌药物治疗中,单用国产美罗培南可达到进口亚胺培南/西司他丁同样的效果。     

帕尼培南/倍他米隆与亚胺培南/西司他丁治疗细菌感染疗效与安全性的Meta分析

目的评价碳青霉烯类抗菌药物帕尼培南/倍他米隆与亚胺培南/西司他丁在细菌感染治疗中的疗效和安全性。方法利用计算机检索Pub Med、Medline、Cochrane library、中国期刊全文数据库、万方数据库和维普数据库等。2名研究员背对背提取资料,并对其方法学质量进行评价。纳入比较帕尼培南/倍他米隆与亚胺培南/西司他丁在相同给药剂量、给药方案下治疗细菌感染的疗效和安全性的随机对照试验(RCTs),采用Rev Man 5.2软件对入选试验进行Meta分析。结果共纳入12个随机对照试验,包括1261例细菌感染患者。Meta分析结果显示,帕尼培南/倍他米隆相比亚胺培南/西司他丁在治疗细菌感染中,临床有效率[OR=1.14,95%CI(0.85,1.53),P=0.38]与细菌清除率[OR=0.85,95%CI(0.60,1.20),P=0.36]差异均没有统计学意义。帕尼培南/倍他米隆与药物相关不良反应发生率为6.7%,亚胺培南/西司他丁为11.1%,两者差异[OR=0.59,95%CI(0.39,0.88),P=0.01<0.05]具有统计学意义。结论现有证据表明,帕尼培南/倍他米隆与亚胺培南/西司他丁在治疗细菌感染中疗效相当,前者安全性更高。     

美罗培南与亚胺培南／西司他丁钠治疗细菌感染有效性和安全性的Meta分析

目的运用Meta分析的方法综合比较评价美罗培南与亚胺培南／西司他丁钠治疗细菌感染的有效性和安全性。方法制定原始文献的纳入和排除标准及检索策略,检索文献数据库,收集有关美罗培南与亚胺培南／西司他丁钠治疗细菌感染的随机对照试验研究报告,剔除不符合要求的文献后,纳入文献17篇,提取文献数据进行定量综合分析。结果综合分析显示,美罗培南和亚胺培南／西司他丁钠治疗细菌感染痊愈率计算OR值（95％cI）为1．07（0．85～1．34）,有效率OR值（95％CI）为0．90（O．67～1．22）,不良反应发生率OR值（95％CI）为0．84（0．56～1．26）。结论美罗培南与亚胺培南／西司他丁钠在治疗细菌感染时有效性和安全性相当。     

美罗培南治疗腹腔内感染的临床有效性及安全性评价Δ

目的:系统评价美罗培南治疗腹腔内感染的临床有效性及安全性。方法:根据纳入及排除标准,计算机检索Medline、Cochrane图书馆、PubMed、Embase、中国期刊全文数据库(CNKI)、中文科技期刊全文数据库(VIP)和中华医学会数字化期刊(Wanfang),纳入美罗培南治疗腹腔内感染的随机对照试验(RCT)。根据Cochrane手册对纳入的RCT进行治疗评价,并通过RevMan 5.2软件进行Meta分析。结果:本研究共纳入19个RCT,纳入的总样本量为2 486例。Meta分析结果显示,美罗培南的临床有效率优于亚胺培南/西司他丁[RR=1.01,95%CI(0.98,1.04),P=0.61],低于头孢噻肟与甲硝唑联用[RR=0.95,95%CI(0.90,0.99),P=0.01];美罗培南的厌氧菌清除率优于头孢噻肟与甲硝唑联用[RR=1.02,95%CI(0.89,1.17),P=0.78];美罗培南的大肠埃希菌清除率低于亚胺培南/西司他丁[RR=0.96,95%CI(0.88,1.05),P=0.39],优于头孢噻肟与甲硝唑联用[RR=1.04,95%CI(0.83,1.31),P=0.73]以及妥布霉素与克林霉素联用[RR=1.09,95%CI(1.02,1.17),P=0.01];美罗培南的安全性优于亚胺培南/西司他丁[RR=0.89,95%CI(0.69,1.15),P=0.37]及头孢噻肟与甲硝唑联用[RR=0.63,95%CI(0.40,0.97),P=0.04]。除美罗培南临床有效率低于头孢噻肟与甲硝唑联用、大肠埃希菌清除率优于妥布霉素与克林霉素联用、安全性优于头孢噻肟与甲硝唑联用的结果差异有统计学意义(P<0.05)以外,其余结果差异均无统计学意义(P>0.05)。结论:在治疗腹腔感染时,美罗培南的临床有效率和安全性与亚胺培南/西司他丁相当;而美罗培南的临床有效率比头孢噻肟与甲硝唑联用低,但安全性更高。     

亚胺培南／西司他丁不良反应文献分析

目的分析近年来亚胺培南／西司他丁在临床上用于治疗各类疾病时发生的不良反应及处理方法,为临床合理使用该药物提供有用的信息。方法通过中国期刊全文数据库检索自1995年以来关于亚胺培南／西司他丁不良反应的文献并进行分析和统计,总结亚胺培南／西司他丁不良反应的特点与相应治疗方法。结果临床上使用亚胺培南／西司他丁时,不良反应发生率有所上升,且不良反应涉及许多体内系统的损害,根据不良反应实际情况给予吸氧,调整用药剂量和给药间隔时间,停药等处理;神经系统损害患者,给予镇静剂或少量抗精神病药,心血管系统损害患者给予营养心肌的药物,肾功能异常患者给予血液透析等治疗,可获得较佳的临床效果。结论合理使用亚胺培南／西司他丁是避免不良反应的发生的关键。     

亚胺培南 /西司他丁与美罗培南在中重度肺部感染人群中的成本效果分析

目的 探讨亚胺培南/西司他丁和美罗培南治疗中重度肺部感染人群的药物经济学评价.方法 通过"PASS合理用药监测系统"收集福建省立医院2016年1月至2019年6月55例临床诊断为肺部感染且使用亚胺培南/西司他丁(亚西组)或美罗培南(美罗组)抗感染治疗的病人的病历资料,比较两组病人治疗前后炎症指标及临床疗效,观察不良反应发生情况,并采用成本效果分析法评价两组方案.结果 亚西组与美罗组总有效率比较[23例(92.00％)比28例(93.33％)],差异无统计学意义(P>0.05).除去治疗无效的病人,两组总有效病人经治疗后白细胞计数、中性比、降钙素原和C反应蛋白显著低于治疗前,且差异有统计学意义(P<0.05);上述指标组间比较,差异无统计学意义(P>0.05).亚西组与美罗组药品不良反应发生率分别为8.00％、3.33％,差异无统计学意义(P>0.05).成本效果分析显示,亚西组病人的成本高于美罗组[(4298.89±2161.21)元比(3121.60±1292.81)元,P<0.05].结论 两组治疗中重度肺部感染的有效性、安全性相当;但经济性方面,美罗培南优于亚胺培南/西司他丁.     

美罗培南治疗耐药菌感染的临床研究

目的：评价美罗培南在治疗耐药菌感染时的临床疗效和安全性.方法：观察本院426例住院患者给予美罗培南和亚胺培南/西司他丁后的治疗效果和不良反应.美罗培南组每日给予美罗培南0.5～1g,分2～3次给药,每次经30min静脉滴注;亚胺培南/西司他丁组每日给予亚胺培南/西司他丁0.5～1g,分2～3次,每次经30min静脉滴注.结果：美罗培南组的治愈率为77.65％,有效率为87.67％,细菌清除率87.87％;亚胺培南/西司他丁组治愈率为77.04％,有效率为87.09％,细菌清除率85.26％.两组药物结果无统计学差异.结论：美罗培南治疗耐药细菌感染有良好的临床疗效,且安全性良好.     

比阿培南与亚胺培南/西司他丁治疗中、重度下呼吸道感染的Meta分析

目的:系统评价比阿培南与亚胺培南/西司他丁治疗中、重度下呼吸道感染(LRTIs)的有效性和安全性。方法:计算机检索截至2011年12月Pubmed、Science Direct、中国期刊全文数据库(CNKI)、万方数据库、维普数据库和中国生物医学文献数据库中关于比阿培南与亚胺培南/西司他丁随机对照治疗中、重度LRTIs的文献,对检索文献进行质量评价及筛选,采用Rev Man 5.1软件对最终纳入文献的研究结果进行Meta分析。结果:共纳入10项随机对照试验,总共949例患者。Meta分析结果显示,比阿培南在中、重度LRTIs治疗中的临床有效率显著高于亚胺培南/西司他丁[OR=1.53,95%CI(1.09,2.14),P=0.01],细菌清除率亦显著高于亚胺培南/西司他丁[OR=2.05,95%CI(1.31,3.23),P=0.002];二者临床痊愈率[OR=1.19,95%CI(0.90,1.59),P=0.22]及总不良反应发生率[OR=0.70,95%C(I0.41,1.18),P=0.18]比较差异无统计学意义,但亚胺培南/西司他丁中枢神经系统不良反应发生率较高(P<0.05)。结论:比阿培南在中、重度LRTIs治疗中的临床有效率和细菌清除率均优于亚胺培南/西司他丁,且中枢神经系统不良反应发生率低于亚胺培南/西司他丁。     

Meropenem: a review of its use in patients in intensive care

Meropenem is a carbapenem antibacterial agent that has antimicrobial activity against gram-negative, gram-positive and anaerobic micro-organisms. In vitro studies involving isolates from patients in intensive care units (ICUs) indicate that meropenem is more active against most gram-negative pathogens than other comparators (including imipenem), although, compared with imipenem, meropenem is less active against most gram-positive organisms. Resistance to meropenem is uncommon in most bacteria. Treatment with meropenem as initial empirical monotherapy was effective in a range of serious infections in adult and paediatric ICU patients. Meropenem monotherapy was as effective as imipenem/cilastatin in 4 comparative trials in terms of satisfactory clinical and bacteriological responses. Meropenem monotherapy was significantly more effective than ceftazidime-based combination treatments in 2 trials in patients with nosocomial lower respiratory tract infections (LRTIs) in terms of both clinical and bacteriological responses. Meropenem was also more active than ceftazidime-based treatments against both gram-positive and gram-negative organisms. However, 2 studies in patients with a range of serious infections found no significant differences between meropenem and cephalosporin-based treatments in terms of clinical or bacteriological response. Meropenem was also as effective as cephalosporin-based treatments in comparative trials in children with serious infections. Meropenem is well tolerated as either a bolus or an infusion, and clinical trials have shown similar incidences of adverse events to those observed with cephalosporin-based treatments. It is well tolerated by the CNS, with seizures reported infrequently, and can therefore be used at high doses and in patients with meningitis. The incidence of drug-related nausea and vomiting is low and, in contrast to imipenem/cilastatin, does not increase with dose or speed of administration. Conclusions: Meropenem is a well tolerated broad spectrum antibacterial agent that, when used as initial empirical monotherapy, is as effective as imipenem/cilastatin in the treatment of a range of serious infections (including nosocomial) in adults and children in ICUs. Compared with cephalosporin-based combination treatments, meropenem monotherapy may be more effective in the treatment of nosocomial LRTIs and can be used as monotherapy. Meropenem has an important role in the empirical treatment of serious infections in adults and children in ICUs.     

美罗培南和亚胺培南西司他丁钠临床副反应的对比研究

目的对比研究美罗培南和亚胺培南西司他丁钠的临床副反应。方法100例炎症患者,随机分为美罗培南组和亚胺培南组,每组50例。美罗培南患者采用美罗培南治疗,亚胺培南组患者采用亚胺培南西司他丁钠治疗。对比两组患者临床副反应(肠胃道反应、局部过敏反应、白细胞减少、肝功能障碍)发生情况。结果亚胺培南组患者临床副反应发生率为4.00%(2/50),与美罗培南组的6.00%(3/50)对比差异无统计学意义(P>0.05)。结论美罗培南和亚胺培南西司他丁钠用于治疗炎症患者的临床副反应无明显差异,发生率均较低,安全性较高。     

Meropenem: an updated review of its use in the management of intra-abdominal infections

Meropenem is a carbapenem antibacterial agent with a broad spectrum of activity which encompasses gram-negative, gram-positive and anaerobic bacteria. Like other carbapenems, meropenem is stable against chromosomal and extended-spectrum beta-lactamases. In patients with moderate to severe intra-abdominal infections, empirical monotherapy with meropenem achieved clinical response rates ranging from 91 to 100% in 7 randomised comparative trials. Efficacy rates were similar to those of imipenem/cilastatin (94 to 97%), clindamycin plus tobramycin (93%) and, overall, to cefotaxime plus metronidazole (75 to 100%), although there were differences between trials versus this combination regimen. According to limited data, meropenem also achieved clinical response rates of over 80% in patients with severe intra-abdominal infections. Meropenem is well tolerated, the most common adverse events being diarrhoea, rash, nausea/vomiting and inflammation at the injection site which are reported in <2.5% of patients each. Meropenem also has an improved CNS tolerability profile compared with imipenem/cilastatin. Conclusions: Extensive comparative clinical data demonstrate that meropenem can be used effectively as empirical monotherapy in moderate to severe intra-abdominal infections. It also shows potential in the most severe forms of infection, although experience in this infection type remains limited. Compared with standard combination regimens, meropenem offers the benefits of ease of administration without the need for monitoring. It also offers improved CNS tolerability compared with imipenem/cilastatin with the option of a higher maximum dosage, which may be a particular advantage in patients with severe intra-abdominal infections.     

Meropenem. A pharmacoeconomic review of its use in serious infections

Meropenem is a carbapenem antibiotic which is active against the majority of aerobic and anaerobic bacteria implicated in serious infections. Its therapeutic efficacy in a wide range of serious infections is similar to that of imipenem/cilastatin and standard combination drug regimens. Hence, meropenem is suitable for use as monotherapy. Although the acquisition cost of meropenem is likely to be higher than that of aminoglycoside- and metronidazole-containing combination regimens, the latter incur additional drug administration costs and potentially higher costs for treatment of adverse effects. In addition, aminoglycoside-containing regimens also incur assay and toxicity monitoring costs. Economic analyses are required to compare overall treatment costs with combination therapy and meropenem. Cost analyses indicate that the ability to give meropenem, but not imipenem/cilastatin, by rapid intravenous bolus injection results in lower drug administration costs than with the standard infusion method. More comprehensive pharmacoeconomic data on meropenem are required. However, assuming that meropenem and imipenem/cilastatin have similar acquisition costs, the option of administering meropenem by bolus injection and its lower epileptogenic potential at high dosages (thus permitting its use in meningitis) should be considered potentially important attributes when choosing a carbapenem antibiotic for inclusion in a hospital formulary.     

Safety profile of meropenem: an updated review of over 6,000 patients treated with meropenem.

Meropenem is a broad-spectrum carbapenem antibacterial with potent antimicrobial activity against a broad range of Gram-negative, Gram-positive and anaerobic bacteria. The second parenteral carbapenem to be introduced worldwide, meropenem has been in clinical use since 1994. Two previous safety reviews have established that meropenem has a favourable and acceptable safety profile. This new review was conducted after the approval of meropenem in the US in 2005 for the treatment of patients with complicated skin and skin-structure infections, in addition to the previously approved indications of intra-abdominal infections and paediatric bacterial meningitis. The analysis includes the clinical trial data from the previous safety reviews, updated with expanded experience across a number of serious bacterial infections, including a large international study in patients with skin or skin-structure infections and further experience in patients with intra-abdominal infections and bacterial meningitis. A total of 6154 patients with 6308 meropenem exposures were compared with 4483 patients treated with comparator agents (4593 exposures), and the paediatric population base for which safety data are available has doubled to over 1000 patients. The data presented reinforce the favourable safety profile of meropenem. In general, the incidence and pattern of adverse events occurring with meropenem were similar to those of the first carbapenem, imipenem/cilastatin, and to those of the cephalosporin- and clindamycin-based regimens to which it had been compared. The most common adverse events reported for meropenem were diarrhoea (2.5%), rash (1.4%) and nausea/vomiting (1.2%). No adverse event occurred in more than 3% of patient exposures to meropenem, indicating a low overall frequency of adverse events as well as excellent gastrointestinal tolerability. Furthermore, no unexpected adverse events were identified, and the very low incidence of seizures in patients with meningitis was not considered to be drug related. In infections other than meningitis, the incidence of seizures considered by investigators to be related to meropenem treatment was 0.07%. In the new studies that updated the earlier safety data, no new cases of drug-related seizure were reported for any treatment or patient group (meningitis/non-meningitis infections). In conclusion, meropenem is well tolerated and has good CNS and gastrointestinal tolerability when used for the treatment of serious bacterial infections in a wide range of adult and paediatric patient populations.