金钱草片治疗尿路结石的多中心随机对照临床研究  

Lysimachia Christinae Hance tablet in treating urinary calculus:A randomized,multicenter,controlled clinical study

作　　者：彭波[1] 刘琦[1] 邹升产[1] 

机构地区：[1]四川省泸州医学院附属医院肾内科,四川泸州646000

出　　处：《实用临床医药杂志》2011年第11期71-73,共3页Journal of Clinical Medicine in Practice

摘　　要：目的评价金钱草片治疗尿路结石的有效性与安全性。方法采用多中心、随机对照试验设计,以八正合剂为对照药,金钱草片组6片/次,3次/d,八正合剂组20 mL/次,3次/d,疗程均为4周。结果本研究共纳入病例230例,其中金钱草片组178例,八正合剂组52例,八正合剂组全分析集(FAS集)和有效病例分析集(PPS集)FAS集/PPS集的临床痊愈率分别为40.00%/40.82%,有效率分别为70.00%/71.43%,金钱草片组FAS集/PPS集的临床痊愈率分别为44.97%/45.23%,有效率分别为75.15%/75.60%,经统计学检验,2组的临床疗效无显著性差异。2组患者的治疗后中医证候疗效比较比较结果(FAS集/PPS集)表明:八正合剂组FAS集/PPS集的临床痊愈率分别为16.00%/16.33%,有效率分别为98.00%/100.00%,金钱草片组FAS集/PPS集的临床痊愈率分别为37.87%/38.10%,有效率分别为99.41%/99.40%,FAS和PPS分析结果均表明2组中医证侯疗效痊愈率差别有统计学意义,试验组的痊愈率较对照组高,2组不良事件和不良反应发生率无显著性差异。结论金钱草片与八正合剂疗效相当,不良反应发生率,安全性好,是一种治疗尿路结石的安全有效的药物。Objective To evaluate the clinical efficacy and safety of Lysimachia Christinae Hance tablet for the treatment of urinary calculus.Methods Two hundred thirty patients with urinary calculus were randomly divided into two groups： the treatment group in which 178 cases were treated with Lysimachia Christinae Hance tablet,6 tablets,three times daily,and the other 52 cases as the control group were treated with Bazheng mixture,20 mL three times daily.They were treated for four weeks.Results After four weeks,the clinical recovery rates of Bazheng mixture in FAS and PPS were 40.00% and 40.82% respectively.The response rates were 70.00% and 71.43% respectively.The clinical recovery rates of Lysimachia Christinae Hance tablet in FAS/PPS were 44.97% and 45.23% respectively.The response rates were 75.15% and 75.60% 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 symptom in FAS/PPS showed that the clinical recovery rates of Bazheng mixture in FAS and PPS were 16.00% and 16.33% respectively,and the clinical recovery rates of Lysimachia Christinae Hance tablet in FAS/PPS were 99.41% and 99.40% respectively.The result of statistical analysis in FAS/PPS showed that the clinical recovery rate of two groups was significantly different in TCM symptom,the clinical recovery rate of test group was higher than control group and adverse events of two groups had no difference（P0.05）.Conclusion The efficacy of Lysimachia Christinae Hance tablet in treating urinary calculus is similar to that of Bazheng mixture,Lysimachia Christinae Hance tablet is highly safe and has few side effects,which is an effective and safe method for treating urinary calculus.

关 键 词：金钱草片 八正合剂 尿路结石 多中心临床试验 

分 类 号：R692.4[医药卫生—泌尿科学]