复方龙星片联合西医常规治疗慢性阻塞性肺疾病稳定期痰热蕴肺证临床研究

徐贵华 史苗颜 张炜 宋秀明 张艺宝

摘要：目的 觀察复方龙星片联合西医常规治疗慢性阻塞性肺疾病（COPD）稳定期痰热蕴肺证的临床疗效。方法 采用随机数字表法将120例中重度COPD稳定期患者随机分为治疗组和对照组各60例。对照组予西医常规治疗；治疗组在对照组基础上予复方龙星片，每次5粒，每日3次，口服。均4周为1个疗程，连续治疗2个疗程，随访8周。观察治疗前后及随访时中医症状积分、肺功能、6 min步行距离（6MWD）和COPD评估测试（CAT）评分。监测不良反应及安全性。结果 治疗组总有效率为88.33%（53/60），对照组为73.33%（44/60），治疗组明显优于对照组（P<0.05）。与本组治疗前比较，2组治疗后、随访时中医症状积分及CAT评分明显降低，差异有统计学意义（P<0.05）；治疗组治疗后、随访时中医症状积分、CAT评分低于对照组，差异有统计学意义（P<0.05）。与本组治疗前比较，治疗组随访时FEV1%、FEV1/FVC、6MWD明显改善（P<0.05），对照组6MWD明显改善（P<0.05）；治疗组治疗后、随访时同一时点肺功能和6MWD改善情况优于对照组（P<0.05）。2组均未见肝肾功能、血尿常规、心电图异常，2组不良反应各1例。结论 复方龙星片联合西医常规治疗COPD稳定期痰热蕴肺证可有效改善患者持续呼吸道症状、肺功能及CAT评分。

关键词：慢性阻塞性肺疾病；痰热蕴肺证；复方龙星片；肺功能

DOI：10.3969/j.issn.1005-5304.2018.05.006

中图分类号：R259.63 文献标识码：A 文章编号：1005-5304（2018）05-0023-04

Clinical Study on Compound Longxing Tablets in Treatment of Chronic Obstructive Pulmonary Disease with Syndrome of Phlegm-heat Obstructing Lung

XU Gui-hua， SHI Miao-yan， ZHANG Wei， SONG Xiu-ming， ZHANG Yi-bao

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine， Shanghai 201203， China

Abstract： Objective To observe the clinical efficacy of Longxing Tablets in treating chronic obstructive pulmonary disease （COPD） with syndrome of phlegm-heat obstructing lung. Methods Totally 120 patients with COPD were randomly divided into the treatment group and the control group， with 60 cases in each group. The control group was treated with the conventional Western medicine， while the treatment group was additionally treated with compound Longxing Tablets based on routine therapy with Western medicine， five tablets per day， three times a day， orally. Four weeks was one treatment course， for two courses， with follow-up for eight weeks. The scores of TCM syndrome， pulmonary function， 6MWD and CAT questionnaire were observed before and after treatment. Adverse reactions and safety were observed. Results The clinical total effective rate were 88.33% （53/60） in the treatment group and 73.33% （44/60） in the control group， and the treatment group was better than control group （P<0.05）. Compared with before treatment， TCM syndrome scores and CAT scores after treatment and at the follow-up were significantly lower in the two groups， with statistical significance （P<0.05）. After treatment， the scores of TCM syndromes and CAT in the treatment group were lower than those in the control group after treatment and at follow-up， with statistical significance （P<0.05）. Compared with before treatment， FEV1%， FEV1/FVC and 6MWD

基金项目：上海市科委基金（14401970600）；上海市中医临床重点实验室（14DZ2273200）；上海市进一步加快中医药事业发展三年行动计划（ZY3-JSFC-2-1032）

通讯作者：史苗颜，E-mail：yan03117@sina.com

in the treatment group were significantly improved （P<0.05）， and 6MWD in the control group were significantly improved （P<0.05）. After treatment， the improvement of lung function and 6MWD at the same time point in the treatment group were better than those in the control group （P<0.05）. No liver and kidney function， hematuria and electrocardiogram were abnormal in the 2 groups， with 1 adverse reaction in each group. Conclusion Compound Longxing Tablets can effectively improve the patient's persistent respiratory symptoms， pulmonary function and CAT score.

Keywords： chronic obstructive pulmonary disease； syndrome of phlegm-heat obstructing lung； Compound Longxing Tablets； lung function

慢性阻塞性肺疾病（chronic obstructive pulmonary disease，COPD）以持续存在的呼吸道症状和气流受限为特征，通常由有害颗粒或气体暴露引起的气道和/或肺泡异常导致[1]，我国40岁以上人群患病率高达8.2%[2]。目前，西医治疗主要采用支气管扩张剂、糖皮质激素、抗生素、祛痰剂、控制性氧疗及机械通气等，但易反复发作。复方龙星片及相关地龙制剂治疗COPD临床疗效显著[3-4]。本研究采用复方龙星片联合西医常规治疗COPD痰热蕴肺证患者，观察其对持续呼吸道症状、肺功能及COPD评估测试（CAT）评分的影响，现报道如下。

1 資料与方法

1.1 一般资料

选择2015年11月-2016年12月本院肺病科门诊及住院部中重度稳定期COPD患者120例，采用随机数字表法分为对照组和治疗组各60例。……