治咳川贝枇杷滴丸治疗慢性支气管炎(单纯型)急性发作(痰热郁肺证)的多中心随机双盲对照研究

A multicenter randomized and double-blind controlled study on Zhikechuanbeipipa Dropping Pills treatment of acute attack of chronic bronchitis(simple type)with phlegm heat stagnation lung syndrome

目的观察治咳川贝枇杷滴丸治疗慢性支气管炎(单纯型)急性发作(痰热郁肺证)有效性和安全性。方法160例西医诊断为慢性支气管炎(单纯型)急性发作、中医辨证痰热郁肺证患者随机分为试验组120例和对照组40例。试验组口服治咳川贝枇杷滴丸,6丸/次,3次/d;对照组口服枇杷止咳胶囊,2粒/次,3次/d;两组疗程均为10 d。以临床疗效为主要观察指标。结果治疗后试验组咳嗽、咯痰症状减轻的起效中位时间为102.0 h(FAS数据集,下同)、对照组为123.5 h,试验组咳嗽、咯痰症状痊愈中位时间为199.0 h、对照组为未痊愈,两组比较差异均具有统计学意义(P<0.05);两组治疗后中医证候评分均较治疗前均明显减少,组内治疗前后比较,差异均具有统计学意义(P<0.01),但治疗后中医证候评分与基线差值的组间比较无统计学差异(P>0.05);治疗满10 d,试验组总愈显率为64.17%,对照组为45.00%,两组比较,差异具有统计学意义(P<0.05);试验组发生不良事件10例(6.67%),对照组发生不良事件3例(7.50%),两组比较差异无统计学意义(P>0.05);试验期间无严重不良事件发生。结论治咳川贝枇杷滴丸治疗慢性支气管炎(单纯型)急性发作(痰热郁肺证)的临床疗效确切,安全性较好,具有较好的临床应用前景。

Objective To observe the efficacy and safety of Zhikechuanbeipipa Dropping Pills in treating acute attack of chronic bronchitis(simple type)with phlegm heat stagnation lung syndrome.Methods A total of 160 patients with acute attack of chronic bronchitis(simple type)diagnosed with western medicine and syndrome of phlegm,heat and stagnation of lung based on traditional Chinese medicine(TCM)syndrome differentiation were randomly divided into experimental group(120 cases)and control group(40 cases).In the experimental group,6 pills of Zhikechuanbeipipa Dropping Pills were taken orally to treat cough,three times a day.The control group took loquat cough relieving capsule orally,2 pills once,3 times a day.The course of treatment in both groups was 10 days.Clinical efficacy was the main observation index.Results The median effective time for relieving cough and sputum symptoms in the experimental group was 102.0 hours(FAS data set,the same below),and 123.5 hours in the control group,respectively;the median recovery time of cough and sputum symptoms in the experimental group was 199.0 hours and that in the control group was not cured,the differences between the two groups were statistically significant(P<0.05);The TCM syndrome score of the two groups after treatment was significantly reduced compared with that before treatment,and the difference was statistically significant before and after treatment in the group(P<0.01),but there was no statistical difference in the TCM syndrome score between groups after treatment(P>0.05).After 10 days of treatment,the total recovery rate of the experimental group was 64.17%and that of the control group was 45.00%,the difference between the two groups was statistically significant(P>0.05).There were 10 cases(6.67%)adverse events in the experimental group and 3 cases(7.50%)in the control group.The difference between the two groups was not statistically significant(P>0.05).No serious adverse events occurred during the whole test period.Conclusion The curative effect and safety of treating acute attack of chronic bronchitis(with phlegm heat stagnation lung syndrome)is definite and has a good clinical application prospect.