目的 評價丹龍口服液緩解兒童支氣管哮喘急性發(fā)作期癥狀、改善熱哮證證候的作用，并評價其臨床應用的安全性。方法 采用隨機、陽性藥平行對照、雙盲、多中心臨床研究的方法，2001年5月—2002年10月由4家臨床評價中心共同完成。觀察病例284例，隨機分為2組，其中治療組口服丹龍口服液，對照組口服咳喘寧口服液，2組均治療7 d，選用近期療效、中醫(yī)證候療效、肺功能指標等有效性評價指標。結(jié)果 共收集病例284例，其中試驗組204例、對照組80例。試驗組、對照組的近期療效總有效率分別為87.25%、73.75%，中醫(yī)證候療效總有效率分別為88.23%、78.75%，兩指標各療效等級的組間比較差異均有統(tǒng)計學意義（P<0.05），且試驗組優(yōu)于對照組（P<0.05）。試驗組報告臨床不良事件（皮疹）1例次，經(jīng)研究者判斷，與試驗用藥無關。結(jié)論 丹龍口服液對兒童支氣管哮喘急性發(fā)作期（熱哮證）的近期療效和中醫(yī)證候療效均優(yōu)于對照藥，臨床應用安全性較好。

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 than 73.75% of control group with statistical significance (P<0.05). The total effectiveness calculated by TCM symptom scores was 88.23% 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.