摘要
目的评价金莲清热胶囊治疗急性上呼吸道感染(感冒风热证)的安全性及有效性。方法试验采用随机、双盲双模拟、多中心阳性药平行对照试验设计,共纳入226例受试者,随机分为试验组(金莲清热胶囊+金莲清热颗粒模拟剂)116例和对照组(金莲清热颗粒+金莲清热胶囊模拟剂)110例,疗程3天。结果急性上呼吸道感染疗效:试验组总显效率66.38%,总有效率95.69%;对照组总显效率60.91%,总有效率95.45%;两组比较差异无统计学意义(P>0.05),说明两组疗效相当。中医症状疗效:试验组总显效率70.69%,总有效率97.41%;对照组总显效率69.09%,总有效率93.64%;两组比较差异无统计学意义(P>0.05),说明两组疗效相当。两组体温降低起效时间比较差异有统计学意义(P<0.05),说明试验组体温降低起效时间优于对照组。在用药过程中,未发现该药的不良反应。结论金莲清热胶囊治疗急性上呼吸道感染(感冒风热证)安全有效。
Objective To evaluate the safety and efficacy of Jinlianqingre capsule in treatment of acute upper respiratory tract infection （external wind-heat syndrome）. Methods A multi center, double-blind, double dummy, randomized controlled trial was conducted. A total of 226 patients with acute upper respiratory tract infection were randomized into two groups： the trial group （116 patients） received Jinlianqingre capsule and the control group （110 patients） received Jinlianqingre granule. The therapeutic courses of both groups were 3 days. Results The total significant effective rates and the total effective rates of acute upper respiratory tract infection were 66.38 % and 95.69% in the trial group respectively, and 60.91% and 95.45% in the control group respectively. There were no statistical differences between the two groups （P 〉0.05）. The total significant effective rates and the total effective rates of Chinese medicine symptoms were 70.69% and 97.41% in the trial group respectively, and 69.09% and 93.64% in the control group respectively. There were no statistical differences between the two groups （P 〉0.05）. Besides, the efficacy of Jinlianqingre capsule was better than that of Jinlianqingre granule with respect to fever duration after treatment; there were statistical differences between the two groups （ P 〈0. 05 ）. No adverse effects were found in the trial group. Conclusions Jinlianqingre capsule is effective and safe in treatment of acute upper respiratory tract infection （external wind-heat syndrome）.
出处
《中国循证医学杂志》
CSCD
2005年第8期593-598,共6页
Chinese Journal of Evidence-based Medicine
基金
国家药品临床研究基地资助课题。
关键词
金莲清热胶囊
随机对照试验
急性上呼吸道感染
感冒风热证
Jinlianqingre（金莲清热） capsule
Randomized controlled trial
Double-blind
Acute upper respira tory tract infection
External wind-heat syndrome
