藿香正气滴丸治疗感冒风寒兼湿滞证的随机对照试验

Huo Xiang Zhengqi Dropping Pill in Treating Wind Cold and Dampness Stagnation Pattern of Common Cold: A Randomized Controlled Trial

目的评价藿香正气滴丸治疗感冒风寒兼湿滞证(普通感冒)的有效性和安全性。方法试验采用随机、双盲双模拟、阳性药物平行对照、多中心临床再评价试验设计,共纳入480例受试者,随机分为试验组(藿香正气滴丸+藿香祛暑软胶囊模拟剂)360例和对照组(藿香祛暑软胶囊+藿香正气滴丸模拟剂)120例,疗程3天。结果中医主症泄泻疗效:试验组愈显率86.1%,总有效率96.1%,对照组愈显率69.2%,总有效率84.6%;中医证候疗效:试验组愈显率87.5%,总有效率98.5%,对照组愈显率69.2%,总有效率91.5%。两组间比较其差异均有统计学意义(P<0.05),说明藿香正气滴丸治疗感冒风寒兼湿滞证(普通感冒)的疗效优于藿香祛暑软胶囊。在用药过程中未发现该药的不良反应。结论藿香正气滴丸治疗感冒风寒兼湿滞证(普通感冒)安全有效。

Objective To evaluate the efficacy and safety of Huo Xiang Zhengqi dropping pill in treating wind cold and dampness stagnation pattern of common cold. Methods A multicenter, randomlyized, double blind, double dum- my, controlled trial was conducted. A total of 480 patients with common cold were randomly divided into two groups： a trial group （360 patients） were treated with Huo Xiang Zhengqi Dropping Pill and Huo Xiang Summer-heat Eliminating Soft Capsule analogue, while a control group （120 patients） were treated with Huo Xiang Summer-heat Eliminating Soft Capsule and Huo Xiang Zhengqi Dropping Pill analogue. The therapeutic course of both groups was 3 days. Results The therapeutic effectiveness of diarrhea as the main symptom： the marked effective rate and total effective rate of the trial group were 86.1% and 96.1%, respectively, while those of the control group were 69.2% and 84.6%, respectively; the thera- peutic effectiveness of traditional Chinese medicine （TCM） pattern： the marked effective rate and total effective rate of the trial group were 87.5% and 98.5%, respectively, while those of the control group were 69.2% and 91.5%, respectively. There were significant differences between the two groups in terms of the above two indicators （P〈0.05）, which indicated Huo Xiang Zhengqi Dropping Pill was superior to Huo Xiang Summer-heat Eliminating Soft Capsule in treating wind cold and dampness stagnation pattern of common cold. No adverse effects were found in the trial group. Conclusion Huo Xiang Zhengqi Dropping Pill is effective and safe in treating wind cold and dampness stagnation pattern of common cold.