阿奇霉素注射液治疗急性细菌性感染的随机对照临床研究

目的:考察阿奇霉素注射液对急性细菌性感染的临床疗效与安全性。方法:采用随机对照性临床研究方法,治疗组(100例),药物为阿奇霉素注射液,200mg/d,qd,静脉滴注3~5d;对照组(60例),药物为注射用乳糖酸红霉素,1000mg/d,bid,静脉滴注5d。观察药物对全身性细菌性感染的临床疗效,细菌清除率与安全性。结果:随机对照试验结果显示:治疗组和对照组临床痊愈率分别为66.67%和48.33%。两组的临床有效率分别为91.67%和78.33%,均显示有显著的统计学差异(P<0.05),细菌清除率分别为89.19%和78.95%。99株临床分离致病菌体外抗菌活性测定结果表明:阿奇霉素注射液对绝大部份细菌的MICs值均远远低于乳糖酸红霉素。治疗组和对照组的不良反应发生率分别为6.67%及39.34%,两者有显著的统计学差异(P<0.01)。结论:阿奇霉素注射液对急性细菌性感染的临床疗效确切,不良反应少,是一安全、有效的抗感染药物。

A Randomized Controlled Clinical Trial of Azithromycin Injection in the Treatment of Acute Bacterial Infection

Objective:To assess the clinical efficacy and safety of azithromycin injection in the treatment of acute bacterial infections. Methods: A randomized controlled clinical trial was conducted for the treatment of patients with acute bacterial infections. The dose of azithromycin injection (azithromycin-treated group, 100 cases) is 200 mg as a single daily dose by the intravenous route for 3~5 days and the daily dose of erythromycin (erythromycin-treated group ,60 cases)is 1 000 mg given in a b.i.d regimen for 5 days. The clinical efficacy, bacterial clearance and safety of these two agents in the treatment of acute bacterial infections were investigated. Results:The results of the randomized controlled clinical trial showed that the clinical cure and the efficacy rates were from 66.67 % to 48.33 % and from 91.67 % to 78.33 % in treatment group and control group, respectively. It showed that there was statistical significant difference between the two groups (P < 0.05). The bacterial clearance rates were 89.19 % and 78.95 %. The data of in vitro antibiotic susceptibility tests showed that the MICs value was lower for most of isolated bacteria in azithromycin group than in erythromycin group. The incidence of adverse reaction were 6.67 % and 39.34 % in treatment and control groups, respectively: The difference was highly significant compared within these groups(P < 0.01). Conclusion: Azithromycin injection is proved to possess convinced efficacy in the treatment of acute bacterial infections with low adverse responses and it is a safe and effective antibiotic agent.