疏风解毒胶囊治疗急性上呼吸道感染风热证随机对照双盲试验

Clinical Observation on Treatment of Acute Upper Respiratory Infection of Wind-heat Syndrome with Shufeng Jiedu Capsules(疏风解毒胶囊):A Randomize-Controlled Double-Blind Test

目的观察疏风解毒胶囊对急性上呼吸道感染风热证患者的临床疗效。方法将240例急性上呼吸道感染风热证患者随机分为治疗组和对照组各120例。治疗组与对照组分别口服疏风解毒胶囊和模拟剂,每次2.08 g,每日3次,餐后0.5 h服用,两组疗程均为3天。观察两组治疗前后疾病总积分、中医证候积分,观察体温起效及解热时间,判定疾病疗效、中医证候疗效、体温疗效并进行安全性评价。结果治疗后两组患者疾病总积分及中医证候积分均明显下降(P<0.05),治疗组均明显低于对照组(P<0.05)。治疗组体温起效时间及解热时间均明显低于对照组(P<0.05)。治疗组疾病疗效、中医证候疗效、体温疗效总有效率分别为91.67%、93.33%、86.67%,对照组分别为36.44%、35.59%、43.22%,治疗组均优于对照组(P<0.05)。结论疏风解毒胶囊治疗急性上呼吸道感染风热证,可快速降低体温、改善临床症状,安全性好。

Objective To explore the clinical effect of Shufeng Jiedu Capsules on patients with acute upper respiratory infection with wind-heat syndrome. Method 240 patients with upper respiratory infection with windheat syndrome were randomly divided into treatment group（120 cases） and control group（120 cases）. Treatment group was given Shufeng Jiedu Capsules and control group took placebo,both orally 2. 08 g each time 0. 5 h after meals,3 times a day for three days. Total scores of disease and Traditional Chinese Medicine（ TCM） symptom scores before and after treatment were calculated for two groups. Time spent that body temperature dropped 0. 5 C and temperature became normal were recorded. Therapeutic effects on disease,TCM syndromes and temperature,as well as the safety of treatment were evaluated. Results After treatment,total scores of disease and TCM symptom scores were significantly decreased in both groups（ P 0. 05）,especially in treatment group（ P 0. 05）. Time spent that body temperature dropped 0. 5 C and temperature became normal in treatment group were both evidently shorter than that in control group（ P 0. 05）. Total effective rates of the effect on disease,TCM syndrome and temperature were91. 67%,93. 33% and 86. 67%,respectively in treatment group,and 36. 44%,35. 59% and 43. 22% respectively in control group. Treatment group was superior to control group（ P 0. 05）. Conclusion In treating acute upper respiratory infection of wind-heat syndrome,Shufeng Jiedu Capsules could lower body temperature quickly and improv clinical symptoms with good safety.