苏黄止咳胶囊治疗感冒后咳嗽的随机对照研究

摘要 目的观察苏黄止咳胶囊治疗感冒后咳嗽的临床有效性及安全性。方法 以止咳宁嗽胶囊为阳性对照药，采用随机、双盲、多中心、阳性药平行对照临床试验。选择符合研究标准的感冒后咳嗽患者280例，治疗组210例（剔除2例），服用苏黄止咳胶囊3粒/次，3次/天；对照组70例（剔除1例），服用止咳宁嗽胶囊3粒/次，3次/天；7天为1个疗程。观察患者咳嗽次数、咳嗽程度、咽痒程度、咯痰情况。结果 治疗组完成204例，对照组完成67例。咳嗽症状疗效PP分析: 治疗组愈显率58.82%，总有效率87.75 %；对照组愈显率34.33%，总有效率76.12%；治疗组优于对照组（P<0.05）。全分析集（ITT分析）: 治疗组愈显率57.42%，总有效率87.02 %；对照组愈显率35.71%，总有效率75.36 %，治疗组优于对照组（P<0.05）。总疗效符合方案集（PP分析）:治疗组愈显率60.29%，总有效率9216%；对照组愈显率31.34%，总有效率86.57%，愈显率治疗组优于对照组（P<0.05），总有效率两组差异无统计学意义（P>0.05）。ITT分析: 治疗组愈显率59.62%，总有效率91.35%；对照组愈显率30.43%，总有效率85.51%，愈显率治疗组优于对照组（P<0.05），总有效率两组差异无统计学意义（P>0.05）。结论 苏黄止咳胶囊治疗感冒后咳嗽安全、有效。

Randomized Controlled Study on Suhuang Zhike Capsule for Treatment of Post-cold Cough

OBJECTIVE: To observe the effect and safety of Suhuang Zhike Capsule (SZC) on post-cold cough. METHODS: The multi-centered randomized double-blinded clinical trial was adopted, and Zhike Ningsuo Capsule (ZNC) as the positive control drug, 280 patients were enrolled and assigned to two groups, the 210 patients (2 dropped out) in the treatment group were treated with SZC, and the 70 (1 dropped out) in the control group treated with ZNC, both at the daily dose of 3 capsules for three times, and the course for all patients was 7 days. The frequency, degree of cough as well as the condition of throat itching and expectoration were observed. RESULTS: The program was completed in 204 patients of the treatment group and 67 in the control group. per-protocol (PP) analysis on cough showed the total effective rate and the cured-effective rate was 87.75 % and 58.82% in the treatment group respectively, which was superior to that in the control group, 76.12% and 34.33%, respectively (P < 0.05). intention-to-treat (ITT) analysis on cough also showed the similar results 87.02 % vs 75.36% for total effective rate, 57.42% vs 35.71% for the cured-effective rate (P < 0.05). The two indexes of effectiveness on disease analyzed by PP were 92.16 % and 60.29% in the treatment group, and 86.57% and 31.34% in the control group respectively (P < 0.05), and by ITT were 91.35 % and 59.62%, 85.51% and 30.43%, respectively (P < 0.05), both showed significant difference between groups only in cured-effective rate but not in the total effective rate (P > 0.05). CONCLUSION: SZC is effective and safe in treating post-cold cough.