治咳川贝枇杷滴丸治疗普通感冒后咳嗽(痰热郁肺证)的随机对照多中心临床研究

A Randomized Controlled, Multi-center Clinical Study on Zhike Chuanbei Pipa Dropping Pills in the Treatment of Cough After Common Cold (Phlegm-heat Stagnating in Lung Syndrome)

目的 评价治咳川贝枇杷滴丸治疗普通感冒后咳嗽(痰热郁肺证)的有效性和安全性。方法 采用随机、双盲、对照、多中心的试验方法,纳入160例患者,按3∶1的比例随机分为试验组120例和对照组40例。试验组口服治咳川贝枇杷滴丸和复方瓜子金颗粒模拟剂,对照组口服复方瓜子金颗粒和治咳川贝枇杷滴丸模拟剂,疗程均为5 d。比较两组患者治疗前后日间咳嗽症状积分、夜间咳嗽症状积分、中医证候积分的变化,评价治咳川贝枇杷滴丸治疗的临床疗效和安全性。结果 治疗后,试验组愈显率为85%(102/120),高于对照组的60.00%(24/40),差异有统计学意义(χ^(2)=11.20,P<0.01);试验组总有效率为92.50%(111/120),高于对照组的75.00%(30/40),差异有统计学意义(χ^(2)=7.19,P<0.01)。治疗后,两组患者日间咳嗽症状积分、夜间咳嗽症状积分较治疗前均显著减少(P<0.01);试验组日间咳嗽症状积分相对于基线差值为(-1.63±0.64),对照组为(-1.26±0.68),两组差值比较有统计学意义(P<0.01);试验组夜间咳嗽症状积分相对于基线差值为(-1.44±0.66),对照组为(-1.08±0.74),两组差值比较有统计学意义(P<0.01)。治疗后,两组患者中医证候积分较治疗前均显著减少(P<0.01);试验组中医证候积分相对于基线差值为(-10.10±3.55),对照组为(-7.73±4.01),两组差值比较有统计学意义(P<0.01)。试验组和对照组不良反应发生率均为2.50%,组间比较差异无统计学意义(P>0.05)。结论 治咳川贝枇杷滴丸治疗普通感冒后咳嗽(痰热郁肺证)临床疗效确切,可有效改善患者的咳嗽症状,改善中医证候,安全性较好。

Objective To evaluate the efficacy and safety of treating cough after common cold(phlegm-heat stagnating in lung syndrome)by Zhike Chuanbei Pipa Dropping Pills. Methods A randomized,double-blinded,double-simulation,parallel control of positive drugs and multi-center clinical trial was conducted in 160 patients who were randomly divided into trial group and control group at a ratio of 3∶1. The trial group was given Zhike Chuanbei Pipa Dropping Pills and the simulator of Compound Guazijin Granules. The control group was given Compound Guazijin Granules and the simulator of Zhike Chuanbei Pipa Dropping Pills. The course was 5 days. To evaluate the clinical efficacy and safety of Zhike Chuanbei Pipa Dropping Pills by comparing the changes of symptom scores of daytime cough,nocturnal cough and TCM syndrome scores of the two groups of patients before and after treatment. Results 160 cases were actually enrolled,including 120 cases in the trial group and 40 cases in the control group. After treatment,the recovery rate between the trial group and the control groups were 85%(102/120)and 60%(24/40)respectively,and the differences were statistically significant(χ^(2)=11.20,P<0.01);the total effective rate between the trial group and the control group were 92.50%(111/120)and 75.00%(30/40),and the differences were statistically significant(χ^(2)=7.19,P<0.01). The clinical effect of the trial group was superior to that of the control group. After treatment,the daytime cough symptom scores and nocturnal cough symptom scores in two groups were significantly lower than those before treatment(P<0.01). The differences of daytime cough symptom scores between the trial group and the control group relative to the baseline were(-1.63±0.64)and(-1.26±0.68) with statistically significant difference between each other(P<0.01). The differences of nocturnal cough symptom scores between the trial group and the control group relative to the baseline were(-1.44±0.66)and(-1.08±0.74)with statistically significant difference(P<0.01). After treatment,the scores of TCM syndromes in the two groups were significantly lower than those before treatment(P<0.01). The differences of TCM syndromes scores between the trial group and the control group relative to the baseline were(-10.10±3.55)and(-7.73±4.01)with statistically significant difference(P<0.01). The incidence of adverse reactions in the two groups were both 2.50% with no statistically significant difference(P<0.05). Conclusion Zhike Chuanbei Pipa Dropping Pills are effective and safe in treating cough after common cold(phlegm-heatstagnating in lung syndrome), which can effectively improve the cough and TCM symptoms of patients with a good safety profile.