参果老年感冒颗粒治疗老年体虚感冒(气虚肺热证)的多中心、随机、双盲、对照试验

中国临床药理学与治疗学 ›› 2013, Vol. 18 ›› Issue (9): 1019-1024.

参果老年感冒颗粒治疗老年体虚感冒(气虚肺热证)的多中心、随机、双盲、对照试验

张琼, 苗青, 张燕萍, 樊茂蓉

中国中医科学院西苑医院呼吸科,北京 100091

收稿日期:2012-10-24 修回日期:2012-12-03 发布日期:2013-09-07
通讯作者: 樊茂蓉,女,硕士,副主任医师,研究方向:中西医结合呼吸病学。Tel: 13621077946 E-mail: fanmaorong1025@yahoo.cn
作者简介:张琼,女,博士,主任医师,研究方向:中西医结合呼吸病学。Tel: 13311296665 E-mail: zhangq810@263.net
基金资助:
中国中医科学院第三批优势病项目(CACMS08Y0033);国家中医药管理局全国名老中医药专家传承工作室建设项目——许建中工作室

A mutli-center randomized double-blind controlled trial of Shenguolaonianganmao Granules in the treatment of elderly and fragile patients with common cold(Qi-deficiency and Lung-heat Syndrome)

ZHANG Qiong, MIAO Qing, ZHANG Yan-ping, FAN Mao-rong

Xiyuan Hospital of China Academy of Chinese Medical Sciences the Pneumology Department, Beijing 100091,China

Received:2012-10-24 Revised:2012-12-03 Published:2013-09-07

摘要/Abstract

摘要： 目的: 评价参果老年感冒颗粒治疗老年体虚感冒(气虚肺热证)的临床疗效与安全性。方法: 采用随机、双盲、阳性药平行对照、多中心的临床试验方法,将240例患者随机分为治疗组与对照组(1∶1),治疗组采用参果老年感冒颗粒治疗,对照组采用银翘解毒颗粒治疗,治疗 5 d 后比较疗效。结果: 共有228例患者完成试验,其中治疗组115例,对照组113例,治疗组疾病疗效总有效率为 97.39%,对照组为 91.15%,治疗组优于对照组(P<0.05);治疗组愈显率为 80.00%,对照组为 67.26%,治疗组优于对照组(P<0.05);单项症状比较中,两组治疗后所有的单项症状均较治疗前好转,治疗组对懒言和肢节酸痛的疗效明显优于对照组(P<0.05), 治疗组对发热、头痛、咽干痛、汗出、咳嗽、恶风恶寒、乏力的疗效有优于对照组的趋势,但无统计学差异。试验期间,对照组无不良事件,治疗组有1例不良事件(患者右手指檫皮伤),与试验药物无关。结论: 参果老年感冒颗粒可安全有效地治疗老年体虚感冒(气虚肺热证)。

关键词: 参果老年感冒颗粒, 老年体虚感冒, 随机对照试验, 双盲, 多中心

Abstract: AIM: To evaluate the therapeutic effect, safty and tolerance of Shenguolaonianganmao Granules in the treatment of elderly and fragile patients suffering from common cold(Qi-deficiency and Lung-heat Syndrome).METHODS: The clinical trial was designed multicentered, double blind, randomized and parallel. A total of 240 elderly and fragile patients with common cold were randomly divided into two groups: a trial group (120 patients) were treated with Shenguolaonianganmao Granules, while a control group (120 patients) were treated with Yinqiaojiedu Granules. The therapeutic course of both groups was 3 days.RESULTS: The clinical trial include 228 patients was completed,105 in trial group and 104 in control group. The total effective rate of the trial group were 97.39%, while it of the control group were 91.15%,the comparison showed that the trial group achieved better therapeutic effect than the control group; The marked effective rate of the trial group were 80%, while it of the control group were 67.26%, the comparison showed that the trial group achieved better therapeutic effect than the control group (P<0.05). Each symptom was improved after treatment. The trial group received better effect than control group in relieving inactive talking and extremities soreness symptom(P<0.05). The trial group received better effect than control group in relieving fever, headache, sore throat, sweating, cough, fatigue, aversion of wind and coldness symptom, but there was no significant statistical difference in both groups(P>0.05). Only one patient in trial group had an adverse event(bruises of the right hand) during the treatment, but it is not caused by Shenguolaonianganmao Granules.CONCLUSION: The results show that Shenguolaonianganmao Granules has a definite effect on elderly and fragile patients with common cold (Qi-deficiency and Lung-heat Syndrome) with good safety.

Key words: Shenguolaonianganmao Granules, Elderly and fragile patients with common cold, Randomize controlled trial, Double blinded, Multi-centre

中图分类号:

张琼, 苗青, 张燕萍, 樊茂蓉. 参果老年感冒颗粒治疗老年体虚感冒(气虚肺热证)的多中心、随机、双盲、对照试验[J]. 中国临床药理学与治疗学, 2013, 18(9): 1019-1024.

ZHANG Qiong, MIAO Qing, ZHANG Yan-ping, FAN Mao-rong. A mutli-center randomized double-blind controlled trial of Shenguolaonianganmao Granules in the treatment of elderly and fragile patients with common cold(Qi-deficiency and Lung-heat Syndrome)[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2013, 18(9): 1019-1024.

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