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瑞得治疗类风湿关节炎的多中心双盲前瞻性研究

[A multi-center double blind prospective study of ridaura in the treatment of rheumatoid arthritis].

作者信息

Zhang N Z

机构信息

Ridaura Collaborative Study Group, Peking Union Medical College Hospital, Beijing.

出版信息

Zhonghua Nei Ke Za Zhi. 1992 Jul;31(7):394-7, 443.

PMID:1298591
Abstract

223 cases of definite rheumatoid arthritis were studied which were divided into ridaura treatment group and placebo group. Observations were made double-blind and prospectively. Judging from the comparison of therapeutic results of each treatment group on each clinical and laboratory parameters and of effective rate of each treatment group on the parameters and by comparing the physicians' and patients' assessments to the ridaura or placebo treatment, it was evident that the ridaura was much superior than placebo, possessing statistical significance. In physicians' assessment 14.2% failed to improve in the ridaura group but being 52% in the placebo group. Ridaura was a slow-acting drug, the earliest time for it to show clinical improvements being 2-4 months after medication. Adverse effects of ridaura were limited; incidence of loose bowel movements was much lower than that reported in the western countries. Among the 148 cases of the ridaura group, only two cases failed to complete the six months treatment course because of untoward reactions.

摘要

对223例确诊的类风湿性关节炎患者进行了研究,这些患者被分为金诺芬治疗组和安慰剂组。采用双盲前瞻性观察。从各治疗组在各项临床和实验室参数上的治疗结果比较,以及各治疗组在这些参数上的有效率比较,并通过比较医生和患者对金诺芬或安慰剂治疗的评估来看,显然金诺芬比安慰剂优越得多,具有统计学意义。在医生的评估中,金诺芬组有14.2%没有改善,而安慰剂组为52%。金诺芬是一种起效缓慢的药物,用药后最早2至4个月才出现临床改善。金诺芬的不良反应有限;腹泻的发生率远低于西方国家报告的发生率。在金诺芬组的148例患者中,只有两例因不良反应未能完成六个月的治疗疗程。

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