谷春华等

摘要：目的 初步評价连花急支片治疗急性气管-支气管炎痰热壅肺证的有效性和安全性。方法 采用随机双盲、安慰剂对照、多中心临床试验的设计方法，将240例患者随机分为试验组和对照组各120例，纳入全分析集237例，试验组服用连花急支片，对照组服用安慰剂，均12片/d，疗程7 d。观察2组对急性气管-支气管炎的疾病疗效、中医证候疗效、咳嗽与咯痰症状积分及曲线下面积（AUC）、咳嗽症状消失疗效，并进行安全性评价。结果 疾病疗效的愈显率试验组与对照组分别为66.67%（78/117）和29.17%（35/120），中医证候疗效的愈显率试验组与对照组分别为68.38%（80/117）和27.50%（33/120），咳嗽与咯痰症状积分曲线下面积2组比较差异有统计学意义（P<0.01），日间咳嗽消失率（痊愈）试验组与对照组分别为52.99%（62/117）和13.33%（16/120），夜间咳嗽消失率（痊愈）试验组与对照组分别为76.52%（88/115）和31.90%（37/116）。试验组未见不良反应。结论 连花急支片治疗急性支气管-支气管炎能明显缓解临床症状，具有良好的临床疗效与安全性。

关键词：连花急支片；急性气管-支气管炎；中医药疗法；痰热壅肺；随机对照临床试验

DOI：10.3969/j.issn.1005-5304.2015.09.006

中图分类号：R259.62 文献标识码：A 文章编号：1005-5304（2015）09-0018-04

Randomized Double-blind and Multi-center Clinical Trial of Lianhua Jizhi Tablets in Treatment of Acute Trachitis and Bronchitis with Syndrome of Phlegm-Heat Obstructing Lung GU Chun-hua1， REN Jun-xia1， YANG Li-bo1， TIAN Ye1， SUN Li1， GAO Xue-dong1， LIU Gui-ying2， HU Si-yuan2， SHI Li-qing3， WANG Tan4， QU Ni-ni5， ZHU Wen-xiang6 （1.Hebei Yiling Medicine Research Institute， Shijiazhuang 050035， China；2.First Teaching Hospital of Tianjin University of TCM， Tianjin 300193， China；3.Dongfang Hospital， the Second Clinical Medical College of Beijing University of Chinese Medicine， Beijing 100078， China；4.The Affiliated Hospital of Changchun University of Chinese Medicine， Changchun 130103， China；5.The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine， Shenyang 110033， China；6.Hubei Provincial Hospital of TCM， Wuhan 430060， China）

Abstract：Objective To evaluated the effectiveness and safety of Lianhua Jizhi Tablets for acute trachitis and bronchitis with syndrome of phlegm-heat obstructing. Methods A randomized double-blind， placebo-controlled and multi-center clinical trial design was selected. Totally 240 cases were randomly divided into experimental group and control group， 120 cases in each group， of which 237 cases were included in the analysis of FAS. Experimental group was given Lianhua Jizhi Tablets， while control group was given placebo， 12 tablets/day， 7 days for a course. Curative effect of acute trachitis and bronchitis， TCM syndrome and disappearance of cough， cough and sputum symptom scores and area under the curve （AUC） were observed. The safety was evaluated. Results The cure rates of disease in experimental group and control group were 66.67% （78/117） and 29.17% （35/120）， respectively；cure rates of TCM syndrome in experimental group and the control group were 68.38% （80/117） and 27.50% （33/120）， respectively；there was statistically

基金项目：北京市科技计划“十病十药”中药专项（Z121102001112002）

significant difference in area under the curve of cough and sputum symptom score between the two groups （P<0.01）. Disappearance rates （cure） of daytime cough in experimental group and control group were 52.99% （62/117） and 13.33% （16/120）， respectively；disappearance rates （cure） of nocturnal cough in experimental group and control group were 76.52% （88/115） and 31.90% （37/116）， respectively；there were no side effects in experimental group. Conclusion Lianhua Jizhi Tablets can significantly relieve clinic symptoms in the treatment of acute trachitis and bronchitis， and have good clinical efficacy and safety.

Key words：Lianhua Jizhi Tablets；acute trachitis and bronchitis；traditional Chinese medicine therapy；phlegm-heat obstructing lung；randomized controlled clinical trial

急性气管-支气管炎是由于病毒和细菌感染、物理化学性刺激或过敏因素对气管黏膜所造成的急性下呼吸道炎症，主要临床特征为持久和严重的咳嗽，可发生于肺部正常的人群。随着大气污染的日益严重及细菌性耐药的增加，本病的发病呈现增加趋势，在门诊中该病发病率为肺炎的20倍、支气管哮喘的10倍[1]。病毒、肺炎衣原体、支原体为呼吸道感染重要的病原体，细菌的致病作用不肯定。

急性气管-支气管炎治疗不当可以发展为肺炎、哮喘或慢性支气管炎等疾病，对患者的健康造成严重威胁。连花急支片为临床经验方，作为河北以岭医院院内制剂在临床应用多年，前期药理毒理研究显示，该制剂有止咳、平喘、化痰、解痉、抗炎、解热、抗菌抗病毒作用，起效快，无明显不良反应[2]。……