咳速宁颗粒剂治疗慢性支气管炎急性发作的临床观察

目的：验证咳速宁颗粒剂对慢性支气管炎急性发作期（痰热证）的疗效，并对其安全性作出客观评价。方法：采用双盲双模拟随机对照试验，选择慢性支气管炎急性发作（痰热证）患者120例，随机分为咳速宁颗粒剂组（治疗组）60例，金贝痰咳清颗粒剂组（对照组）60例，治疗组给予咳速宁颗粒剂，每日3次，次8g，对照组给予金贝痰咳清颗粒剂，每日3次，每次7g，疗程均为6天。结果：临床总体疗效；治疗组显效率58．33％，有效率93．33％，对照组显效率51．67％，有效率91．67％。两组临床总体疗效比较差异无显著性（P＞0．05）。中医证候疗效；治疗组显效率68．33％，有效率93．33％，对照组显效率66．67％，有效率90．00％。两组中医证候疗效比较差异亦无显著性（P＞0．05）。两组平均起效时间比较治疗组显著优于对照组（P＜0．05）。临床观察中，未发现明显不良反应。结论：咳速宁颗粒剂临床疗效确切，未发现明显毒副反应。

Clinical Observation on Effect of Kesuning Granule in Treating Acute Onset of Chronic Bronchitis

Objective: To prove the effect of Kesuning Granule (KSNG) in treating chronic bronchitis in exacerbation (Phlegm Heat syndrome) and objectively evaluate its safety. Methods: The double blinded, double dummy and randomized controlled method was adopted to observe 120 patients, who were divided into the treated group (n=60, treated with KSNG 8g, three times a day) and the control group (n=60, treated with Jinbei Tankeqing Granule (JBTKQ) 7g, three times a day). The therapeutic course for both groups was 6 days. Results: In the treated group, the markedly effective rate was 58.33% and effective rate was 93.33%, while in the control group, they were 51.67% and 91.67% respectively, no significant difference was found between the two groups. For therapeutic effects on TCM syndromes, the markedly effective rate and effective rate in the treated group was 68.33% and 93.33% respectively and in the control group, 66.67% and 90.00% respectively, also showed insignificant difference. The effect initiative time was earlier in the treated group than that in the control group significantly (P<0 05). No adverse effect was found in the observation. Conclusion: KSNG shows a definite clinical effect with no obvious toxic adverse effects.