盐酸安妥沙星片与左氧氟沙星片双盲双模拟随机对照治疗急性细菌性感染临床研究

A multi-center, randomized, controlled, double blind and double dummy clinical trial of antofloxacin hydrochloride tablet versus levofloxacin tablet for the treatment of acute bacterial infections

目的 评价盐酸安妥沙星片治疗呼吸道、泌尿道和皮肤软组织感染的安全性和有效性。方法 采用区组随机化、双盲双模拟、多中心、平行对照的临床试验设计方法，选用左氧氟沙星片为对照药物，疗程7～14d。结果 719例患者入选，其中安妥沙星组359例，左氧氟沙星组360例，分别有330与337例完成研究，进入符合方案集（PPS）分析人群；安妥沙星组和左氧氟沙星组PPS人群治疗结束后第1天临床痊愈率分别为79．7％与77．4％，有效率分别为95．2％和96．7％，细菌清除率分别为96．7％与97．5％。呼吸道、泌尿道、皮肤软组织感染患者分别为239、240与240例，两组临床疗效差异没有统计学意义。左氧氟沙星组与盐酸安妥沙星组分别有357例和356例进行了安全性评价，不良事件发生率均为10．1％，不良反应发生率分别为7．8％和7．9％，主要以轻度消化道反庸为主。没有发现心电图QTc延长患者，两组各有1例患者治疗结束时血糖轮度增加，随访均恢复正常；两组临床、细菌学疗效以及不良反心发生情况差异无统计学意义（P〉0．05）。结论 盐酸安妥沙星片治疗急性细菌性呼吸道、泌尿道和皮肤软组织感染疗效确切，安全性良好。

Objective To evaluate the clinical efficacy and safety of antofloxacin hydrochloride tablet for tire treatment of acute bacterial infections. Methods A muhi-eenter randomized control, double blind and double dummy clinical trial was conducted; levotloxaein tablet was ehnsed as controlled drug. The duration of treahnent was 7-14 days in both groups. Results A total of 719 patients were enrolled in the study, in which 359 patients treated with antofloxacin and 360 patients treated with levofloxaein were included. Three hundred and thirty and 337 patients completed the study and met with all the criteria for perprotocol analysis, respectively. By the end of chemotherapy, the cured rates in per protocol set （PPS） population were 79.7% and 77.4%, the effeetive rates were 95.2% and 96. 7%, and the bacterial clearance were 96. 7% and 97.5% for the treating and control group, respectively. The clinical and Bacterial efficacy of antofloxacin and levofloxaein was comparable by the analysis of infectious sites. Three hundred and fifty-seven and 356 patients in antofloxaein and levofloxacin groups were evaluated the safety. The drug adverse events occrred both in 10. 1% , and drug adverse reactions aceurred in 7.8% and 7.9% patients in the two groups. The most common drug adverse reactions were mild gastroenteric symptoms. No QTc prologation was detected in all the patients. One patient in each group had mild blood glucose increase at the end of therapy, but the glucose returned to normal level without any intervention. No statistic significant difference between the two groups in clinical efficacy and safety was detected （ P 〉 0. 05 ） . Conclusions Antofloxacin hydrochloride tablet was effective and safe for the treatment of acute bacterial infections.