目的 觀察治咳川貝枇杷滴丸治療慢性支氣管炎（單純型）急性發(fā)作（痰熱郁肺證）有效性和安全性。方法 160例西醫(yī)診斷為慢性支氣管炎（單純型）急性發(fā)作、中醫(yī)辨證痰熱郁肺證患者隨機分為試驗組120例和對照組40例。試驗組口服治咳川貝枇杷滴丸，6丸/次，3次/d；對照組口服枇杷止咳膠囊，2粒/次，3次/d；兩組療程均為10 d。以臨床療效為主要觀察指標。結(jié)果 治療后試驗組咳嗽、咯痰癥狀減輕的起效中位時間為102.0 h（FAS數(shù)據(jù)集，下同）、對照組為123.5 h，試驗組咳嗽、咯痰癥狀痊愈中位時間為199.0 h、對照組為未痊愈，兩組比較差異均具有統(tǒng)計學(xué)意義（P<0.05）；兩組治療后中醫(yī)證候評分均較治療前均明顯減少，組內(nèi)治療前后比較，差異均具有統(tǒng)計學(xué)意義（P<0.01），但治療后中醫(yī)證候評分與基線差值的組間比較無統(tǒng)計學(xué)差異（P>0.05）；治療滿10 d，試驗組總愈顯率為64.17%，對照組為45.00%，兩組比較，差異具有統(tǒng)計學(xué)意義（P<0.05）；試驗組發(fā)生不良事件10例（6.67%），對照組發(fā)生不良事件3例（7.50%），兩組比較差異無統(tǒng)計學(xué)意義（P>0.05）；試驗期間無嚴重不良事件發(fā)生。結(jié)論 治咳川貝枇杷滴丸治療慢性支氣管炎（單純型）急性發(fā)作（痰熱郁肺證）的臨床療效確切，安全性較好，具有較好的臨床應(yīng)用前景。

Objective To observe the efficacy and safety of Zhikechuanbeipipa Dropping Pills in treating acute attack of chronic bronchitis (simple type) with phlegm heat stagnation lung syndrome. Methods A total of 160 patients with acute attack of chronic bronchitis (simple type) diagnosed with western medicine and syndrome of phlegm, heat and stagnation of lung based on traditional Chinese medicine (TCM) syndrome differentiation were randomly divided into experimental group (120 cases) and control group (40 cases). In the experimental group, 6 pills of Zhikechuanbeipipa Dropping Pills were taken orally to treat cough, three times a day. The control group took loquat cough relieving capsule orally, 2 pills once, 3 times a day. The course of treatment in both groups was 10 days. Clinical efficacy was the main observation index. Results The median effective time for relieving cough and sputum symptoms in the experimental group was 102.0 hours (FAS data set, the same below), and 123.5 hours in the control group, respectively; the median recovery time of cough and sputum symptoms in the experimental group was 199.0 hours and that in the control group was not cured, the differences between the two groups were statistically significant (P<0.05); The TCM syndrome score of the two groups after treatment was significantly reduced compared with that before treatment, and the difference was statistically significant before and after treatment in the group (P<0.01), but there was no statistical difference in the TCM syndrome score between groups after treatment (P>0.05). After 10 days of treatment, the total recovery rate of the experimental group was 64.17% and that of the control group was 45.00%, the difference between the two groups was statistically significant (P>0.05). There were 10 cases (6.67%) adverse events in the experimental group and 3 cases (7.50%) in the control group. The difference between the two groups was not statistically significant (P>0.05). No serious adverse events occurred during the whole test period. Conclusion The curative effect and safety of treating acute attack of chronic bronchitis (with phlegm heat stagnation lung syndrome) is definite and has a good clinical application prospect.

R286.4;R974

“重大新藥創(chuàng)制”科技重大專項（2018ZX09734-002-004）；黑龍江中醫(yī)藥大學(xué)工程中心建設(shè)資助項目（2017SEC01）