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热感糖浆治疗普通感冒(风热证)的随机、双盲、多中心临床疗效评价
A randomized,double-blind and multi-centered clinical efficacy evaluation of Regan Tangjiang in the treatment of common cold( wind heat syndrome)
【摘要】 目的评价热感糖浆治疗普通感冒(风热证)的临床疗效及安全性。方法本研究采用随机、双盲、安慰剂对照、多中心的设计方法,随机分为3组。A组78例(小剂量组)口服热感糖浆+热感糖浆模拟剂30 m L/次(含热感糖浆20 m L);B组76例(大剂量组)口服热感糖浆30 m L/次;C组79例(安慰剂组)口服热感糖浆模拟剂30 m L/次,每日4次,疗程为5 d。结果 A组和B组在中医证候疗效、症状消失时间、体温起效时间及解热时间上明显优于C组,其中B组在咽痛单项症状消失率、体温累积起效率、解热率等方面优于A组,在体温低于38℃时A,B组解热时间明显优于C组。在研究过程中,未发生严重不良事件。结论热感糖浆是治疗普通感冒(风热证)安全有效的药物。
【Abstract】 Objective To evaluate the clinical effect and safety of Regan Tangjiang in the treatment of common cold( wind heat syndrome). Methods A randomized,double-blind,placebo-controlled and multi-center design method was used in this study. The patients were randomly divided into 3 groups.Group A( low-dose group,n = 78) was given oral Regan Tangjiang and Regan Tangjiang simulation regent,30 m L every time( including 20 m L Regan Tangjiang); group B( high-dose group n = 76) was given oral Regan Tangjiang,30 m L every time; group C( placebo group n = 79) was given oral Regan Tangjiang simulation regent,30 m L every time,4 times per day,the treatment course was 5 d. Results Group A and B were superior to group C in terms of TCM syndrome,symptom disappearance time,temperature onset time and antipyretic time. Pharyngalgia elimination coefficient,accumulated temperature efficiency and antipyretic rate of group B was superior to group A. When the body temperature was lower than38 ℃,antipyretic time of group B was superior to group C. No serious adverse event happened during the study. Conclusion Regan Tangjiang is an effective and safe medicine for common cold( wind heat syndrome).
【Key words】 wind heat cold; efficacy evaluation; randomized and double-blind; control; traditional Chinese meidicine;
- 【文献出处】 现代中医临床 ,Modern Chinese Clinical Medicine , 编辑部邮箱 ,2015年06期
- 【分类号】R259
- 【被引频次】4
- 【下载频次】251