紫花温肺止嗽方治疗风寒恋肺证感冒后咳嗽的随机对照研究

Randomized controlled trial of Zihua Wenfei Zhisou Formula in treating cough after cold differentiated as syndrome of wind-cold retention in lung

目的:评价紫花温肺止嗽方治疗风寒恋肺证感冒后咳嗽的疗效及安全性。方法:采用优效性试验设计,以随机、双盲对照研究方法将144例风寒恋肺证的感冒后咳嗽患者以随机信封法分为治疗组、对照组,各72例,治疗组服用紫花温肺止嗽方,对照组服用安慰剂,疗程均为7d。治疗前及治疗第7天行实验室检查,通过访视结合患者填写日志卡方式记录咳嗽及咽部不适等症状,累计症状积分并依此统计出紫花温肺止嗽方的疗效并评价其安全性。结果:治疗后治疗组咳嗽症状缓解程度优于对照组(P<0.05)。伴随症状:疗程结束治疗组较对照组咽痒症状好转明显(P<0.05)。完成疗程后治疗组总有效率为81.4%,对照组为45.7%,差异具有统计学意义(P<0.05)。结论:紫花温肺止嗽方临床治疗风寒恋肺证感冒后咳嗽安全有效,未见明显不良事件。

Objective:To evaluate the efficacy and safety of Zihua Wenfei Zhisou Formula in treating post-infectious cough differentiated as syndrome of wind-cold retention in lung.Methods:A randomized,double blind placebo-controlled study was conducted in a design of a superiority trial.One hundred and forty-four patients of post-infectious cough differentiated as syndrome of wind-cold retention in lung were randomly divided into the treatment group and the control group(72 cases)in each group.The treatment group took Zihua Wenfei Zhisou Formula,and the control group took placebo for 7 days.Laboratory examination was conducted before the treatment and on the seventh day of treatment.The symptoms of cough and pharyngeal discomfort were recorded by visiting patients and filling in a log card.The symptom scores were accumulated and the efficacy and safety of Zihua Wenfei Zhisou Formula were evaluated.Results:After treatment,the relief degree of cough symptoms in the treatment group was better than that in the control group(P<0.05).Accompanied symptoms:at the end of the course of treatment,the symptoms of pharyngeal itching in the treatment group were significantly better than those in the control group(P<0.05).The treatment group had a total effective rate of 81.4%,and the placebo group was 45.7%,and the difference in efficacy was statistically significant(P<0.05).Conclusion:Zihua Wenfei Zhisou Formula is safe and effective in the treatment of postinfectious cough differentiated as syndrome of wind-cold retention in lung with no obvious adverse events.