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[中药临床试验质量:对314篇已发表论文的综述]

[Quality of clinical trials of Chinese herbal drugs, a review of 314 published papers].

作者信息

Yu G P, Gao S W

机构信息

Shanghai Medical University.

出版信息

Zhongguo Zhong Xi Yi Jie He Za Zhi. 1994 Jan;14(1):50-2.

PMID:8044004
Abstract

The study was based on a review of clinical trials for herbal drugs published in various journals. Three journals selected were Chinese Journal of Integrated Traditional and Western Medicine (JITWM), Journal of Traditional Chinese Medicine (JTCM), and a provincial Journal of Traditional Medicine (JTM). In order to reflect different levels of the journal, each paper of the clinical trials of herbal drugs in the above-mentioned journals during the survey years, 1991, 1987 and 1980 (or 1981) was reviewed using a standard checklist and quantified through a score system. A total of 314 paper were reviewed, in which 179 in 1991, 82 in 1987, and 53 in 1980 and 1981. Controlled trials were found in 86% of JITWM, 40.8% of JTCM, and 26.8% of JTM in 1991. Although there was an increased trend in the use or randomized trials, it still showed a lower proportion, respectively 52.9% in JITWM, 36.0% in JTCM, and 11.1% in JTM. We found that the quality of clinical trials in JITWM was the first, JTCM the second, JTM the third and showed a gradually improved trend with time.

摘要

该研究基于对发表于各类期刊上的草药临床试验的综述。所选的三本期刊分别是《中国中西医结合杂志》(JITWM)、《中医杂志》(JTCM)以及一本省级《传统医学杂志》(JTM)。为反映期刊的不同水平,在调查年份1991年、1987年和1980年(或1981年)期间,使用标准清单对上述期刊中有关草药临床试验的每篇论文进行综述,并通过评分系统进行量化。共综述了314篇论文,其中1991年有179篇,1987年有82篇,1980年和1981年有53篇。1991年,《中国中西医结合杂志》中86%的论文为对照试验,《中医杂志》为40.8%,《传统医学杂志》为26.8%。尽管随机试验的使用呈上升趋势,但比例仍较低,在《中国中西医结合杂志》中分别为52.9%,在《中医杂志》中为36.0%,在《传统医学杂志》中为11.1%。我们发现,《中国中西医结合杂志》的临床试验质量最高,其次是《中医杂志》,《传统医学杂志》最低,且随时间呈逐渐改善的趋势。

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引用本文的文献

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J R Soc Med. 2025 May 23:1410768251337693. doi: 10.1177/01410768251337693.
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Astragalus-containing Chinese herbal combinations for advanced non-small-cell lung cancer: a meta-analysis of 65 clinical trials enrolling 4751 patients.含黄芪的中药复方治疗晚期非小细胞肺癌:纳入4751例患者的65项临床试验的荟萃分析
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Review of randomised controlled trials of traditional Chinese medicine.
中医药随机对照试验综述
BMJ. 1999 Jul 17;319(7203):160-1. doi: 10.1136/bmj.319.7203.160.