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阿扑西林与哌拉西林治疗严重腹部感染的比较——一项III期对照研究。

Aspoxicillin versus piperacillin in severe abdominal infections--a comparative phase III study.

作者信息

Scheinin H, Havia T, Pekkala E, Huovinen P, Klossner J, Lehto H, Niinikoski J

机构信息

Department of Surgery, Turku University Central Hospital, Finland.

出版信息

J Antimicrob Chemother. 1994 Nov;34(5):813-7. doi: 10.1093/jac/34.5.813.

DOI:10.1093/jac/34.5.813
PMID:7706179
Abstract

We compared aspoxicillin, a new broad-spectrum penicillin derivative, with piperacillin in severe abdominal infection. Aspoxicillin 4 g administered tds (n = 52) or piperacillin 4 g qds (n = 53) usually as monotherapy were randomly given to patients suffering from perforated appendicitis, acute cholecystitis, ulcer or colon perforation, or intra-abdominal abscess. Blood, tissue and exudate cultures were obtained when applicable for pathogen identification and susceptibility testing. The efficacy rates were similar in the two study groups. Of the 50 evaluable aspoxicillin patients 45 (90%) were considered as treatment responders compared with 48 patients out of 53 (91%) in the piperacillin group (NS). The 95% confidence interval for the efficacy difference was -12% to +11% thus showing no difference between the two drugs. Both drugs were generally well tolerated and no serious drug-related adverse events were noted. However, five patients died because of their illness and one patient had a fatal myocardial infarction. In conclusion, aspoxicillin 4 g tds was shown to be equal to piperacillin 4 g qds in severe abdominal infections.

摘要

我们将新型广谱青霉素衍生物阿扑西林与哌拉西林用于严重腹部感染的治疗进行了比较。将通常作为单一疗法使用的阿扑西林4克每日三次(n = 52)或哌拉西林4克每日四次(n = 53)随机给予患有穿孔性阑尾炎、急性胆囊炎、溃疡或结肠穿孔或腹腔脓肿的患者。在适用时获取血液、组织和渗出物培养物,以进行病原体鉴定和药敏试验。两个研究组的有效率相似。在50例可评估的阿扑西林患者中,45例(90%)被视为治疗有效者,而哌拉西林组53例中有48例(91%)(无显著性差异)。疗效差异的95%置信区间为-12%至+11%,因此表明两种药物之间无差异。两种药物总体耐受性良好,未观察到严重的药物相关不良事件。然而,有5例患者因病死亡,1例患者发生致命性心肌梗死。总之,在严重腹部感染中,阿扑西林4克每日三次与哌拉西林4克每日四次疗效相当。

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