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目的评价注射用比阿培南治疗呼吸系统和泌尿系统细菌感染的疗效和安全性。方法采用多中心、随机、盲法、阳性药物平行对照试验方法,共入选288例呼吸系统和泌尿系统感染患者,随机分别接受比阿培南(试验组,144例)或美罗培南(对照组,144例)的治疗,统计两组的临床治愈率、细菌学疗效和不良反应发生率并进行比较。结果试验组和对照组临床治愈率分别为95.10%(136/143)和92.25%(131/142),呼吸系统感染治愈率分别为93.06%(67/72)和94.29%(66/70),泌尿系统感染治愈率分别为97.18%(69/71)和90.28%(65/72);试验组和对照组细菌清除率分别为88.00%(66/75)和92.65%(63/68),呼吸系统感染细菌清除率分别为83.33%(30/36)和90.62%(29/32),泌尿系统感染细菌清除率分别为92.31%(36/39)和94.44%(34/36);两组间临床治愈率、细菌学疗效比较差异无统计学意义(P>0.05);试验组不良反应发生率为2.08%(3/144),对照组为8.33%(12/144),两组间比较差异有统计学意义(P=0.030 6)。非劣效性检验结果显示,试验组的细菌清除率和综合疗效非劣于对照组成立。结论比阿培南治疗呼吸系统感染和泌尿系统感染的疗效与美罗培南相仿,安全性更好。
Objective To evaluate the efficacy and safety of biapenem in the treatment of respiratory infections and urinary tract bacterial infections. Methods A total of 288 patients with respiratory and urinary tract infections were enrolled in this study. The patients were randomly assigned to receive either biapenem (n = 144) or meropenem (n = 144 cases). The clinical cure rate, bacteriological efficacy and incidence of adverse reactions were compared between the two groups. Results The clinical cure rates of the experimental group and the control group were 95.10% (136/143) and 92.25% (131/142), respectively. The cure rates of respiratory infections were 93.06% (67/72) and 94.29% (66/70) respectively, The cure rates of urinary tract infection were 97.18% (69/71) and 90.28% (65/72), respectively. The bacterial clearance rate in the test group and the control group were 88.00% (66/75) and 92.65% (63/68) respectively, The bacterial clearance rates of systemic infection were 83.33% (30/36) and 90.62% (29/32) respectively, and the bacterial clearance rate of urinary tract infection was 92.31% (36/39) and 94.44% (34/36) respectively. There was no significant difference in clinical cure rate and bacteriological efficacy (P> 0.05). The incidence of adverse reactions was 2.08% (3/144) in the test group and 8.33% (12/144) in the control group, with significant differences between the two groups There was statistical significance (P = 0.030 6). Non-inferiority test results showed that the bacterial clearance rate and comprehensive efficacy of the test group were not worse than that of the control group. Conclusions Biapenem has similar efficacy and safety to meropenem in the treatment of respiratory and urinary tract infections.