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目的以美罗培南为对照,评价比阿培南治疗呼吸系统和泌尿系统急性细菌性感染的安全性和有效性。方法采用多中心、双盲、随机、阳性药平行对照研究方法,将288例病例随机分为治疗组和对照组,各144例。对照组用美罗培南治疗,治疗组用比阿培南治疗,两组疗程7~14 d,视病情和病种而异,比较两组疗效。结果治疗组和对照组的临床总痊愈率分别为68.31%和72.92%,总有效率分别为95.77%和92.36%,总细菌清除率分别为89.71%和87.95%。PPS分析和FAS分析一致。总不良反应发生率分别为7.04%和5.56%。以上结果组间比较差异均无统计学意义。结论比阿培南治疗呼吸系统和泌尿系统急性细菌性感染,不良反应少,安全性好。
Objective To compare the efficacy and safety of meropenem in the treatment of acute bacterial infections of respiratory and urinary systems by biapenem. Methods A total of 288 cases were randomly divided into treatment group and control group with 144 cases in each group. The control group with Meropenem treatment, the treatment group with biapenem treatment, two courses of treatment 7 ~ 14 d, depending on the disease and disease-specific, compared the two groups. Results The total cure rates of the treatment group and the control group were 68.31% and 72.92%, respectively. The total effective rates were 95.77% and 92.36% respectively. The total bacterial clearance rate was 89.71% and 87.95% respectively. PPS analysis is consistent with FAS analysis. The total incidence of adverse reactions were 7.04% and 5.56% respectively. The above results were no significant difference between groups. Conclusion Biapenem treatment of respiratory and urinary tract bacterial infections, less adverse reactions, good safety.