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美罗培南与头孢他啶联合阿米卡星用于严重医院感染的多中心开放性随机试验

[Multicenter open randomized trial of meropenem in comparison to ceftazidime and amikacin used in combination in severe hospital infections].

作者信息

Iakovlev S V, Iakovlev V P, Derevianko I I, Kira E F

机构信息

I.M. Sechenov Moscow Medical Academy, A.V. Vishnevsky Institute of Surgery, Moscow.

出版信息

Antibiot Khimioter. 1998;43(1):15-23.

PMID:9532327
Abstract

Clinical efficacy and tolerance of meropenem were estimated by comparison with those of ceftazidime and amikacin used in combination in the therapy of hospital infections of the lower respiratory tract, skin and soft tissues, intraabdominal and gynecologic infections, urinary tract infection and sepsis. 48 patients were given meropenem in a dose of 1 g every 8 hours for 3-14 days (the average of 9 days). 47 patients were subjected to the routine combined therapy: ceftazidime in a dose of 1 g every 8 hours and amikacin in a dose of 0.5 g every 12 hours for 2-14 days (the average of 9 days). The patient groups were comparable by the age, nature and severity of the infection and the condition (the mean APACHE II of 9.1 and 8.9). By the end of the treatment a positive clinical effect (recovery and improvement) was observed in 47 patients (97.9 per cent) treated with meropenem and in 41 patients (89.1 per cent) subjected to the combined therapy. The infection relapse within 4 weeks after the treatment completion was recorded in 3 patients in every group. Before the treatment 133 microbial strains were isolated from the patients. 121 of them were susceptible to meropenem (91.1 per cent), 111 to amikacin (83.4 per cent) and 90 to ceftazidime (67.7 per cent). The difference between meropenem and ceftazidime was significant (p = 0.0005). Eradication of the primary pathogens at the background of the meropenem therapy was stated in 41 out of 44 patients (93.2 per cent) and that of the combined therapy in 38 out of 43 patients (88.4 per cent). The microbiological relapse after the treatment completion was recorded in 3 and 2 patients, respectively. Side effects were observed in 8.3 per cent of the patients treated with meropenem and in 10.6 per cent of the patients subjected to the combined therapy. The trial results were indicative of the meropenem high efficacy and good tolerance and of the possible use of the drug in the monotherapy as an alternative of the routine combined therapy of severe hospital infections.

摘要

通过与头孢他啶和阿米卡星联合用于治疗下呼吸道、皮肤和软组织、腹腔和妇科感染、尿路感染及败血症的疗效及耐受性进行比较,评估美罗培南的临床疗效及耐受性。48例患者接受美罗培南治疗,剂量为每8小时1g,疗程3 - 14天(平均9天)。47例患者接受常规联合治疗:头孢他啶剂量为每8小时1g,阿米卡星剂量为每12小时0.5g,疗程2 - 14天(平均9天)。两组患者在年龄、感染性质和严重程度及病情方面具有可比性(平均急性生理与慢性健康状况评分系统II分别为9.1和8.9)。治疗结束时,接受美罗培南治疗的47例患者(97.9%)出现了积极的临床效果(康复和改善),接受联合治疗的41例患者(89.1%)出现了积极的临床效果。每组均有3例患者在治疗完成后4周内出现感染复发。治疗前从患者中分离出133株微生物菌株。其中121株对美罗培南敏感(91.1%),111株对阿米卡星敏感(83.4%),90株对头孢他啶敏感(67.7%)。美罗培南与头孢他啶之间的差异具有显著性(p = 0.0005)。在接受美罗培南治疗的44例患者中有41例(93.2%)根除了主要病原体,在接受联合治疗的43例患者中有38例(88.4%)根除了主要病原体。治疗完成后,分别有3例和2例患者出现微生物复发。接受美罗培南治疗的患者中有8.3%出现了副作用,接受联合治疗的患者中有10.6%出现了副作用。试验结果表明美罗培南具有高效和良好的耐受性,并且可能作为严重医院感染常规联合治疗的替代方案用于单一疗法。

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