国产盐酸丙卡特罗片治疗支气管哮喘及喘息性支气管炎临床评价  

CLINICAL EVALUATION OF DOMESTIC PROCATEROL IN TREATMENT OF BRONCHIAL ASTHMA AND ASTHMATIC BRONCHITIS

作　　者：王选锭[1] 刘富光[1] 卞如濂[1] 杜文彬[1] 陈先瑾 李学敏[1] 吴洪范[1] 马树林[1] 

机构地区：[1]浙江医科大学临床药理研究所,天津医科大学总医院呼吸科,天津胸科医院,天津医科大学第二医院内科

出　　处：《中国临床药理学杂志》1996年第2期75-80,共6页The Chinese Journal of Clinical Pharmacology

摘　　要：本文报告国产盐酸丙卡特罗片治疗支气管哮喘及喘息性支气管炎的多中心Ⅱ期临床研究结果，选用合资产品（商品名美喘清）随机对照。试验分两部分，第一部分单剂量给药（５０μｇ）平喘作用起效时间、达峰时间、持续时间以及作用强度，试验组和对照组各３０例；第二部分考察５０μｇｂｉｄ给药一周的临床疗效及其安全性，其中随机对照试验１２７例（试验组、对照组分别６５例和６２例），无对照开放试验３７例。结果显示，国产丙卡特罗片５０μｇ顿服后０．５ｈ起效，于２ｈ左右临床评分降至最低，ＰＥＦ达峰，作用持续８ｈ以上，与美喘清相近；按５０μｇｂｉｄ连续给药一周，国产丙卡特罗片剂的总有效率为７２．５％，也与美喘清相近，其中对支气管哮喘有效率８０．６％，高于喘支的５７．１％，两药治疗后ＰＥＦ均较治疗前明显增高，两药比较无显著差异。国产丙卡特罗一周给药的不良反应发生率为１３．５％，主要为轻度心悸、手颤，美喘清组为２１％，无显著差异。结果表明，国产盐酸丙卡特罗片治疗支气管哮喘及喘息性气管炎疗效确切、安全。This trial was designed to evaluate the clinical efficacy and safety of domestic procaterol in treatment of bronchial asthma and asthmatic bronchitis controlled with Meptin.The study progressed by two steps,the first step was designed to investigate its onset time,peak time and duration of antiasthmatic effect after a single dose of 50μg,with 30 cases in each groups;The second step was designed to evaluate its clinical efficacy and safety when patients received 50μg twice daily for 1 week,with 65 cases of randomized controlled test and 37 cases of open test.The result sindicated that domestic procaterol showed antiasthmatic effect at 0.5 h and the effect peaked 2 h after administration.Its effect sustained more than 8 h.Its clinical efficacy rate of 50μg twice daily for l week was 72.5%,which was not significantly different from that of meptin,and was showed more effective on bronchial asthma than asthmatic bronchitis.The adverse drug reactions of both drugs were mild with the rates of l3.5% and 21 % respectively,The results indicated that domestic procaterol was effective and safe in the treatment of bronchial asthma and asthmatic bronchitis.It is as good as the control drug meptin.

关 键 词：丙卡特罗 支气管炎 哮喘性 

分 类 号：R562.05[医药卫生—呼吸系统]