金钱草片治疗尿路感染的多中心随机对照临床观察  

Lysimachia Christinae Hance Tablet in treatment of urinary tract infection:a randomized,multicenter,controlled clinical study

作　　者：彭波[1] 刘琦[1] 侯静[1] 邹升产 

机构地区：[1]泸州医学院附属医院肾内科,四川泸州646000 [2]四川珍珠制药有限公司,四川安岳642350

出　　处：《现代医药卫生》2011年第11期1615-1617,共3页Journal of Modern Medicine & Health

摘　　要：目的:观察金钱草片治疗尿路感染的有效性与安全性。方法:采用多中心、随机对照试验设计,以八正合剂为对照药,观察组金钱草片6片/次,3次/d,对照组八正合剂20 mL/d,3次/d,疗程均为两周。结果:本研究共纳入病例233例(其中对照组66例,观察组167例),进入PPS分析147例,进入安全性分析164例。对照组FAS集/PPS集的临床痊愈率分别为61.02%、61.02%,有效率分别为98.31%、98.31%,观察组FAS集/PPS集的临床痊愈率分别为63.82%、65.31%,有效率分别为98.68%、99.32%,两组的临床疗效差异无显著性(P>0.05)。两组患者治疗后中医证候疗效比较结果(FAS集/PPS集)表明:对照组FAS集/PPS集的临床痊愈率分别为54.24%、54.24%,有效率分别为96.61%、96.61%;观察组FAS集/PPS集的临床痊愈率分别为55.92%、57.14%,有效率分别为100.00%、100.00%,两组临床疗效差异无显著性(P>0.05)。结论:金钱草片与八正合剂疗效相似,不良反应发生率低,安全性好,是一种治疗尿路感染的安全有效的药物。Objective：To evaluate the clinical efficacy and safety of Lysimachia Christinae Hance Tablet for treating urinary tract infections.Methods：The randomized,multicenter,controlled experiment design was adopted.233 patients with urinary tract infection were randomly divided into two groups： the test group（167 cases） treated with Lysimachia Christinae Hance Tablet,6 tablets each time,three times daily,and the control group（66 cases） treated with Bazheng Mixture,20 mL/d,three times daily.The treatment courses all were two weeks.Results：After two weeks,the clinical recovery rates of Bazheng Mixture in FAS and PPS were 61.02% and 61.02% respectively,the response rates were 98.31% and 98.31% respectively.The clinical recovery rates of Lysimachia Christinae Hance Tablet in FAS/PPS were 63.82% and 65.31% respectively,the response rates were 98.68% and 99.32% respectively.The clinical recovery rate and the response rate of two groups had no difference（P0.05）.The clinical efficacy of two groups in TCM symptoms in FAS /PPS showed： the clinical recovery rates of Bazheng Mixture in FAS and PPS were 54.24% and 54.24% respectively,the response rates were 96.61% and 96.61% respectively.The clinical recovery rates of Lysimachia Christinae Hance Tablet in FAS /PPS were 55.92% and 57.14% respectively.The response rates were 100.00% and 100.00% respectively.The result of statistical analysis in FAS/PPS showed that the clinical recovery rate of two groups was significant different in TCM symptoms,the clinical recovery rate of test group was higher than that of control group and the adverse events of two groups had no statistical difference（P0.05）.Conclusion：The efficacy of Lysimachia Christinae Hance Tablet in treating urinary tract infection is similar to that of Bazheng Mixture with high safety and low occurrence rate of adverse reactions,which is an effective and safe method for treating urinary tract infection.

关 键 词：金钱草片 八正合剂 尿路感染 多中心临床试验 

分 类 号：R25[医药卫生—中医内科学]