复方石韦片治疗尿路感染的临床观察

目的观察复方石韦片治疗中医辨证为湿热下注证尿路感染的安全性和有效性。方法采用多中心、随机、开放、阳性药物（三金片，下简称对照组）平行对照临床研究方法，观察疾病综合疗效、中医症候积分及尿白细胞疗效，并记录不良反应情况。结果上尿路感染患者治疗组110例，下尿路感染患者治疗组206例，总有效率均优于对照组（37例和106例，P〈0．05和P〈0．01）。治疗后两组中医症候积分和尿白细胞均较治疗前显著减少（P〈0．01）；临床观察过程中未见明显不良反应发生。结论复方石韦片治疗尿路感染疗效确切，临床使用安全。

Clinical Observation on Effect of Compound Shiwei Tablet in Treating Urinary Tract Infection

OBJECTIVE: To evaluate the safety and efficacy of Compound Shiwei Tablet (CST) in treating upper and lower urinary tract infection (UTI, pyretic stranguria of dampness-heat of the Lower-jiao type in 'TCM). METHODS: A multi-center, randomized, and opened clinical trial was conducted in the UTI patients with Sanjin Tablet (ST) as the parallel positive control medicine. The comprehensive efficacy, effect on TCM syndrome score, and change of urinary leukocyte count were observed, and the adverse reaction was recorded. RESULTS: In the 147 upper UTI cases and the 312 lower UTI cases after treatment, the comprehensive effect was higher and urinary leukocyte was less in the CST treated patients than in the ST treated patients (P < 0.05); but significant difference in the improvement of TCM symptoms was found between them only in the lower UTI cases ( P < 0.05); and no adverse reaction was observed during the treatment course. CONCLUSION: CST has definite therapeutic efficacy on UTI and is safe in clinical application.