丹龙口服液治疗儿童支气管哮喘急性发作期(热哮证)的多中心临床研究

A multicenter clinical study of Danlong Oral Liquid in treatment of acute attack of bronchial asthma(heat wheezing syndrome) in children

目的评价丹龙口服液缓解儿童支气管哮喘急性发作期症状、改善热哮证证候的作用,并评价其临床应用的安全性。方法采用随机、阳性药平行对照、双盲、多中心临床研究的方法,2001年5月-2002年10月由4家临床评价中心共同完成。观察病例284例,随机分为2组,其中治疗组口服丹龙口服液,对照组口服咳喘宁口服液,2组均治疗7 d,选用近期疗效、中医证候疗效、肺功能指标等有效性评价指标。结果共收集病例284例,其中试验组204例、对照组80例。试验组、对照组的近期疗效总有效率分别为87.25%、73.75%,中医证候疗效总有效率分别为88.23%、78.75%,两指标各疗效等级的组间比较差异均有统计学意义(P<0.05),且试验组优于对照组(P<0.05)。试验组报告临床不良事件(皮疹)1例次,经研究者判断,与试验用药无关。结论丹龙口服液对儿童支气管哮喘急性发作期(热哮证)的近期疗效和中医证候疗效均优于对照药,临床应用安全性较好。

Objective To evaluate the efficacy and safety of Danlong Oral Liquid in the treatment of acute bronchial asthma exacerbation in children with the syndrome of heat wheezing. Methods This was a multicenter, randomized, double-blinded,positive parallel controlled study, conducted from May 2001 to October 2002 in four clinical centers. Participants in the treatment group were given Danlong Oral Liquid, while those in the control group were offered Kechuanning Oral Liquid instead. All the patients in the two groups underwent a seven-day course of treatment. The outcomes of short-term therapeutic effects, TCM symptom scores and pulmonary function ware adopted to assess the validity. Outcomes A total of 284 patients were included in this study with 204 in the treatment group, 80 in the control group. The recovery rate was 87.25% in the treatment group, higher than73.75% of control group with statistical significance(P < 0.05). The total effectiveness calculated by TCM symptom scores was88.23% in the treatment group, 78.75% in the control group with statistical significance(P < 0.05). There was an adverse event reported by treatment group, presented as rash,which was judged to be irrelevant with experimental drug by researchers. Conclusion As for short-term therapeutic effects, TCM symptom scores and clinical safety, Danlong Oral Liquid worked better than control drug in the treatment of acute bronchial asthma exacerbation in children with the syndrome of heat wheezing.