Objective To evaluate the safety and efficacy of Xuanfei Zhisou(宣肺止剂)for acute bronchitis of wind evil invading lung type.Methods Randomized,controlled and placebo-controlled parallel trial design was adopted,the observation was conducted in 19 parallel centers,and 240 cases were randomly divided into trial group and control group,with 120 cases in each group.The trial group was administered with Xuanfei Zhisou Mixture,while the control group was given Xuanfei Zhisou Mix-ture simulation agent.The treatment course was 7 days.The cough visual analogue scale(VAS),cough relief and disappearance,clinical efficacy and safety were compared.Results There were 232 cases completed this trial,including 118 cases in the trial group and 114 cases in the control group.After treatment,cough VAS decreased in both groups,and the VAS score of the trial group decreased greatly than that of the control group(P＜0.05 or P＜0.01).The differences between the 4th day after treatment and baseline,and differences between within 3 days after treatment and baseline of VAS score showed statistical significance(P＜0.05 or P＜0.01).The cough relief rate and disappearance rate in the trial group was higher than those in the control group(P＜0.01),and the results of per protocol set(PPS)and full analysis set(FAS)were similar.The treatment efficiency in the trial group was 97.44％(FAS)and 97.37％(PPS),respectively,both were higher than those in control group[81.42％(FAS)and 81.25％(PPS)](P＜0.001).There was no significant difference in general vital signs or laboratory test indexes between the two groups before and after treatment(P＞0.05).In the trial group,there was 11 adverse events occurred in 7 subjects,4 adverse e-vents occurred in 4 subjects in the control group,and there were no statistical difference between two groups(P＞0.05).After a-nalysis,the above adverse events may not be related to the test drug.Conclusion Xuanfei Zhisou Mixture is effective and safe in treating acute bronchitis(wind evil invading lung type),which can effectively improve the cough symptoms of patients with a good safety profile.
维普
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