肾苓颗粒治疗下尿路感染(下焦湿热证)的临床随机对照试验

目的评价肾苓颗粒治疗下尿路感染(下焦湿热证)的有效性和安全性,并与阳性对照药尿感灵作等效性分析。方法选择下尿路感染(下焦湿热证)患者96例进行随机、双盲双模拟、阳性药平行对照的临床试验。其中试验组72例,给予肾苓颗粒每日3次,每次1袋口服;对照组24例,给予尿感灵冲剂每日3次,每次1袋口服。治疗1周后,评价临床有效性和安全性。结果意向性治疗(ITT)分析显示,治疗1周后试验组和对照组在下尿路感染综合疗效的总有效率方面分别为92·43%和91·31%;符合方案(PP)分析显示,试验组和对照组的总有效率分别为92·31%和90·91%,两组差异无统计学意义(P均>0·05)。在中医证候有效率方面,ITT分析显示试验组和对照组分别为93·94%和95·65%,PP分析为95·38%和95·45%,两组差异无统计学意义(P均>0·05)。临床试验中未发现明显不良反应。结论肾苓颗粒与尿感灵治疗下尿路感染(下焦湿热证)的疗效差异无统计学意义,未发现不良反应。

Shenling Granule for Lower Urinary Tract Infection (Damp-heat in Lower-JIAO): A Randomized Controlled Trial

Objective To assess the effectiveness and safety of Shenling granule for lower urinary tract infection (damp-heat in lower-Jiao) in comparison with Niaoganling Chongji. Methods A double-blind, double-dummy, randomized controlled trial was conducted. A total of 96 patients (damp-heat in lower-Jiao) were randomized to the treatment group (n=72, Shenling granule, 1 bag, tid) and the control group (n=24, Niaoganling Chongji, 1 bag, tid). The therapeutic course for both groups was 1 week. Results ITT (intention-to-treatment) analysis showed that the total effective rates of the treatment group and the controlled group were 92.43% and 91.31%, respectively (P>0.05). PP (per-protocol-population) analysis showed that they were 92.31% and 90.91%, respectively (P>0.05). The effective rates on Chinese medicine symptom of the treatment group and the controlled group were 93.43% and 95.65% respectively by ITT analysis (P>0.05), 95.38% and 94.45% respectively by PP analysis (P>0.05). No significant difference between the two groups was detected. No adverse effect was found. Conclusions There is no significant difference between Shenling granule and Niaoganling Chongji in the treatment of patients with lower urinary tract infection. No adverse effect was found.