摘要
目的:探讨尿通卡克乃其片治疗淋证-下焦湿热证(下尿路感染)的有效性与安全性。方法:进行分层区组随机、双盲双模拟、阳性药对照、多中心临床试验。将入选病例分为2组,治疗组(尿通卡克乃其片组)336例、对照组(三金片组)112例;治疗组脱落14例、剔除3例,对照组脱落2例、剔除3例;2组疗程均为7 d。结果:尿通卡克乃其片治疗下尿路感染的有效率达99.69%,高于同类产品三金片的93.46%;尿通卡克乃其片对淋证-下焦湿热证的中医症候方面有效率为97.49%,明显高于三金片的78.50%;治疗组与对照组在临床试验中均未出现不良不良反应,也未出现不良事件。结论:尿通卡克乃其片治疗淋证-下焦湿热证(下尿路感染)安全、有效,在临床试验中未出现不良事件,具有明显的治疗优势。
OBJECTIVE：To evaluate the efficacy and safety of Niaotongkakenaiqi tablets for gonorrhea dampness- heat in lower jiao （lower urinary tract infection）. METHODS： By stratified blocked randomization, a double-blind, double-dummy, positive control, multi-center clinical trial was conducted. The patients included were assigned to receive either Niaotongkakenaiqi tablets （ treatment group, n = 336 ） or Sanjin tablets （ control, n = 112 ） for 7 days. 14 cases lost contact and 3 were excluded in the treatment group versus 2 lost contact and 3 were excluded in the control group. RESULTS： The effective rate in lower urinary tract infection in the treatment group was higher than in the control group （99.69% vs. 93.46% ）; the effective rate in the syndrome of traditional Chinese medicine for gonorrhea dampness-heat in lower jiao （lower urinary tract infection）was significantly higher in the treatment group than in the control group （97.49% vs. 78.50% ）. Neither adverse drug reactions nor adverse events occurred in both groups during clinical trial. CONCLUSION： Niaotongkakenaiqi tablet turned out to be safe and effective for gonorrhea dampness-heat in lower jiao（ lower urinary tract infection）without presence of adverse events in clinical trial and it has noticeable therapeutic advantage.
出处
《中国医院用药评价与分析》
2014年第1期70-72,共3页
Evaluation and Analysis of Drug-use in Hospitals of China
关键词
尿通卡克乃其片
三金片
淋证-下焦湿热证
下尿路感染
Niaotongkakenaiqi tablets
Sanjin tablets
Gonorrhea dampness-heat in lower jiao
Lower urinary tractinfection
