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目的评价国产阿莫西林/克拉维酸钾(16∶1)缓释片治疗急性细菌性感染的有效性和安全性。方法采用多中心随机、双盲双模拟、平行对照临床试验设计方法,对入组的286例病例进行观察分析,其中纳入临床疗效FAS人群分析的病例数为284例,试验组和对照组分别为141例和143例;纳入PPS人群分析的病例数为266例,试验组和对照组各133例。试验组口服阿莫西林/克拉维酸钾(16∶1)缓释片每次500mg/31.25mg,对照组口服阿莫西林/克拉维酸钾(4∶1)每次500mg/125mg,用法均为2次/d,疗程均为5～10d。结果疗程结束时,试验组和对照组的总临床痊愈率、总有效率、总细菌清除率、不良事件发生率、药物相关不良反应发生率相比较,均无统计学差异(P>0.05)。结论国产阿莫西林/克拉维酸钾(16∶1)缓释片治疗急性细菌性感染的临床疗效和安全性与进口阿莫西林/克拉维酸钾(4∶1)普通片相当。
Objective To evaluate the efficacy and safety of domestic amoxicillin / clavulanate potassium (16:1) sustained release tablets in the treatment of acute bacterial infections. Methods A multicenter randomized, double-blind, double-dummy, parallel-controlled, clinical trial design was used to analyze 286 patients enrolled in the study. The number of patients enrolled in the FAS population for clinical efficacy was 284, and the experimental and control groups were 141 cases and 143 cases; 266 cases were included in the PPS population analysis, 133 cases in the test group and the control group. The experimental group was orally given amoxicillin / clavulanate potassium (16: 1) sustained-release tablets each 500mg / 31.25mg, the control group was orally administered amoxicillin / clavulanate potassium (4: 1) each 500mg / 125mg, 2 times / d, treatment are 5 ~ 10d. Results At the end of the course of treatment, there was no significant difference in the total clinical cure rate, total effective rate, total bacterial clearance rate, incidence of adverse events and the incidence of drug-related adverse reactions between the experimental group and the control group (P> 0.05). Conclusion The clinical efficacy and safety of domestic amoxicillin / clavulanate potassium (16: 1) sustained-release tablets in the treatment of acute bacterial infections are comparable to those of imported amoxicillin / clavulanate potassium (4: 1) tablets.