我国尘肺病治疗药物的临床疗效研究分析  

Research on the therapeutic effects of drugs on patients with pneumoconiosis in China

作　　者：王焕强[1] 李涛[1] 

机构地区：[1]中国疾病预防控制中心职业卫生与中毒控制所,北京100050

出　　处：《中华劳动卫生职业病杂志》2016年第7期510-516,共7页Chinese Journal of Industrial Hygiene and Occupational Diseases

基　　金：十二五国家科技支撑计划课题（2014BA112801）

摘　　要：目的回顾我国治疗尘肺病的主要药物的临床研究，评价分析其疗效，提出尘肺病治疗研究建议。方法通过查阅我国尘肺病临床治疗的科研课题档案，检索2016年1月1日前中国知网、万方数据库中关于克矽平、汉防己甲素、磷酸哌喹、磷酸羟基哌喹、柠檬酸铝、矽宁、矽肺宁和N-乙酰半胱氨酸（NAC）等八种主要药物治疗尘肺的临床疗效研究，对符合质量标准的随机对照试验（RCT），提取包括咳嗽、咳痰、胸痛和呼吸困难等呼吸系统症状改善率、呼吸系统感染率下降、肺功能指标中FEV。扬改变量（△FEV1.0％）、X线胸片稳定率和好转率以及不良反应等5类指标以及描述性疗效总结等进行系统分析。结果15篇文献中的9个RCT研究人选，共有2097名尘肺病患者，其中治疗组1215例，对照组882例。将用药方式分单药（如克矽平、磷酸羟基哌喹、矽肺宁和矽宁）、汉防己甲素和其他药物配伍（简称汉甲配伍）、磷酸羟基哌喹和柠檬酸铝（简称羟哌柠铝）、肺灌洗（含加用药物）四类，分析表明治疗组患者呼吸系统症状改善率、呼吸道感染下降率、△FEV1.0%、X线胸片阴影好转率和稳定率等指标均明显优于对照组（P〈0．01），减去对照组均值后，尘肺病患者在治疗期内呼吸系统症状改善率（％）平均提高34．6（95％CI32．9，36．3），呼吸道感染率（％）下降均值26．0（95CI％24．0，28．0），△FEV1.0％均值4．08（95％CI3．56，4．60），x线胸片好转率（％）平均提高8．80（95％CI8．55，9．05），x线胸片稳定率（％）平均提高10．6（95％CI9．18，12．0）；单因素方差分析表明4类用药方式的疗效差异有统计学意义（F呼吸系统症状改善率=482．2，P〈0．01；F呼吸道感染率F降=72．01，P〈0．01；F△FEV1.0％=246．6，P〈0．01；Fx线胸片稳定率=212．9，P〈0．01；RX线胸片好转经=466Objective To review the clinical research on the main drugs which are used to treat pneumoconiosis in China, evaluate and analyze the efficacy, and give the suggestions on the study of pneumoeoniosis treatment. Methods The data of researches on the therapeutic effects of eight main drugs on patients with pneumoconiosis in China were retrieved from CNKI and Wanfang database before Jan. 1, 2016 including polyvinylpyridine, tetrandrine, piperaquine phosphate, hydroxypiperaquine phosphate, aluminium citrate, Xinin, Xifeining and N-acetyl eysteine （NAC） after consulting the related project files on the clinical treatment on the patients with pneumoconiosis, and a systematic analysis was made on the random control test （RCT） which conformed to the quality criteria in terms of five indices such as the improvement rate of respiratory system symptoms such as cough, expectoration, chest pain and dyspnea, the decrease of the respiratory system infection rate, the changes in FEV 1.0% （forced expired volume in one second to forced vital capacity ratio） （△FEV1.0%）, index of stability and improvement rate of chest X-ray, and adverse reactions as well as the summary of descriptive efficacy. Results Nine RCTs in the 15 papers were included; 2 097 patients with pneumoconiosis were included with 1215 in the treatment group and 882 in the control group. The medication modes were divided into four categories, monotherapy （such as polyvinylpyridine, hydroxypiperaquine phosphate, Xifeining and Xinin）, combination of tetrandfine with other drugs, hydroxypiperaquine phosphate and aluminium citrate, and lung lavage （added medications）; the analysis indicated that the patients in the treatment group were obviously superior to those in the control group in terms of the improvement rate of respiratory system symptoms, the decrease rate of the respiratory tract infection, △FEV1.0%, the improvement rate of shadows as indicated in the X-ray chest film and the index of stability （P〈 0.01 ） ; after the mean value

关 键 词：尘肺 克矽平 汉防己甲素 磷酸哌喹 磷酸羟基哌喹 柠檬酸铝 矽宁 矽肺宁 N-乙酰半胱氨酸 

分 类 号：R135.2[医药卫生—劳动卫生]