首页 / 院系成果 / 成果详情页

A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Tong Luo Hua Shi capsule, a modernized Tibetan medicine, in patients with rheumatoid arthritis 期刊论文

编号：

77fe9953-bc26-4653-8c21-274171c9bf06
作者：

Liu, Wei#*^[1]Wu, YuanHao#^[1]Hu, SiYuan^[1];Zhong, ChengLiang^[1];Gao, MingLi^[2];Liu, DongWu^[2];Wang, HaiYun^[3];Chen, MuZhi^[3];Song, YueJin^[4];Yang, BenZhaXi^[5];Zheng, QingShan(郑青山)^[6]Yao, Hua^[7];Qi, XueBing^[8];Li, Gang^[8];
语种：

英文
期刊：

TRIALS ISSN：1745-6215 2016 年 17 卷 ; JUL 27
收录：
关键词：

Rheumatoid arthritis Tibetan medicine Antirheumatic therapy Tong Luo Hua Shi capsules Wu-weigan-lu decoction
摘要：

Background: Tong Luo Hua Shi (TLHS) is a new formulation of the traditional Tibetan medicine Wu-wei-gan-lu that has been used for the treatment of rheumatoid arthritis (RA) for hundreds of years in China. This study aimed to evaluate the efficacy and safety of TLHS in patients with RA.
Methods: This was a randomized, double-blind, placebo-controlled, dose-finding study performed in patients with active RA from five medical centers. Patients received three doses (4.8, 3.6, or 2.4 g/day po) of TLHS or placebo (tid po) for 8 weeks. Blood sampling, physical examination, and assessment of the American College of Rheumatology (ACR) 20 % improvement (ACR20) criteria were performed before and every 2 weeks after starting treatment. The primary endpoint was the ACR20. The secondary endpoints included safety.
Results: A total of 240 participants were screened and 236 patients were randomized (n = 59/group); 20 dropped out. After 8 weeks, ACR20 improvements in the TLHS 4.8 g and 3.6 g groups were significantly higher than in the placebo group (P < 0.01 and P < 0.05, respectively). ACR50 improvement in the TLHS 4.8 g group was significantly higher compared with the placebo group (P < 0.01). Symptoms of RA were significantly relieved in the TLHS groups. In the TLHS groups, insomnia (n = 1), gastroenteric reactions (n = 2), arrhythmia (n = 1), and minor hepatic lesion (n = 1) were reported; in the placebo group, hepatic dysfunction (n = 1) was reported (P = 0.878).
Conclusions: TLHS improved the symptoms of patients with RA according to the ACR20. Moreover, TLHS was safe.
推荐引用方式
GB/T 7714：

Liu Wei,Wu Yuan-Hao,Hu Si-Yuan, et al. A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Tong Luo Hua Shi capsule, a modernized Tibetan medicine, in patients with rheumatoid arthritis [J].TRIALS,2016,17.
APA：

Liu Wei,Wu Yuan-Hao,Hu Si-Yuan,Zhong Cheng-Liang,&Li Gang.(2016).A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Tong Luo Hua Shi capsule, a modernized Tibetan medicine, in patients with rheumatoid arthritis .TRIALS,17.
MLA：

Liu Wei, et al. "A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Tong Luo Hua Shi capsule, a modernized Tibetan medicine, in patients with rheumatoid arthritis" .TRIALS 17(2016).
条目包含文件：

文件类型：PDF,文件大小：

正在加载全文

未找到全文

浏览次数：40  下载次数：0

分享到：

浏览次数：40

下载次数：0

打印次数：0