复方五指柑胶囊治疗风热感冒多中心随机双盲平行对照临床试验  

Randomized,double-blind,multi-center,positive parallel control clinical trial of compound Wuzhigan capsules on anemopyretic cold

作　　者：陈晓媚[1] 曹晖 孙虹[1] 温静[1] 黄文华[3] 胡雅静[3] 林琳[4] 汤翠英[4] 许睿[1] 胡海棠[1] 

机构地区：[1]丽珠集团医学临床研究中心,广东珠海519020 [2]国家中药现代化工程技术研究中心,广东珠海519020 [3]丽珠集团利民制药厂,广东韶关512028 [4]广东省中医院,广东广州510120

出　　处：《中国中药杂志》2014年第3期531-535,共5页China Journal of Chinese Materia Medica

基　　金：广东省经贸委2006年省级挖潜改造资金重点产业技术创新项目(2006855007)

摘　　要：复方五指柑胶囊是由五指柑、十大功劳、岗梅、山芝麻等中成药组成的复方制剂,采用多中心随机双盲阳性平行对照设计来评价复方五指柑胶囊治疗风热感冒临床疗效和安全性。试验组120例口服复方五指柑胶囊,每次2粒,每天3次;对照组119例口服复方五指柑片,每次4片,每天3次。治疗3 d后经统计分析得到,试验组综合临床疗效愈显率为63.3%,总有效率为80.0%;对照组愈显率为72.5%,总有效率为80.7%。2组疗效无统计学差异。复方五指柑胶囊服药量小,依从性好。Compound Wuzhigan capsules is a compound preparation composed of Wuzhigan, Shidagonglao, Gangmei, Shanzhima. A Randomized, double-blind, multi-center, positive parallel control designed to evaluate the clinical efficacy and safety of compound Wuzhigan capsules on anemopyretic cold. One hundred and twenty anemopyretic cold patients were given compound Wuzhi- gan capsules （test group）, 2 capsules one time, three times a day, 119 patients were given compound Wuzhigan tablets （control group） ,4 tablets one time, three times a day; three days of treatment. The study showed, the markedly effective rate and total effective rate respectively were 63.3% and 80% of the test group. For the control group, the markedly effective rate and total effective rate respectively were 72.5% and 80. 7%. The difference was not statistically significant. Compound Wuzhigan capsules can reduce the dosage, and get better patient compliance.

关 键 词：随机双盲对照临床试验 复方五指柑胶囊 风热感冒 

分 类 号：R259[医药卫生—中西医结合]