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基于“异病同治”临床应用的桂枝茯苓胶囊临床试验整合证据链研究

[Study of integrative evidence chain in clinical trial of Guizhi Fuling Capsules based on "Yibing Tongzhi" in clinical applications].

作者信息

Gao Yang, Wang Gui-Qian, Xie Yan-Ming, Wei Rui-Li, Liu Fu-Mei

机构信息

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University Beijing 100010, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2020 May;45(10):2304-2309. doi: 10.19540/j.cnki.cjcmm.20200211.504.

DOI:10.19540/j.cnki.cjcmm.20200211.504
PMID:32495585
Abstract

Guizhi Fuling Capsules is a new-type traditional Chinese medicine preparation made by modern process method. It was widely used to treat uterine fibroids, pelvic inflammation, dysmenorrhea, endometriosis, mammary gland hyperplasia and other gynecological diseases. Under the combination of disease and syndrome, the diagnosis and treatment model of "Yizheng Tongbing, Yibing Tongzhi" with Chinese patent medicine has been widely used in clinical practice. Meanwhile, the effectiveness and safety have been given more and more attention. Based on the effectiveness of Guizhi Fuling Capsules, this paper preliminarily summarized the dominant diseases in randomized controlled trials and systematic reviews of Guizhi Fuling Capsules. On the basis of the basic theory of traditional Chinese medicine and modern pharmacological mechanism, the clinical efficacy and mechanism of Guizhi Fuling Capsules were explored. Finally, according to the traditional Chinese medicine theory of "Yizheng Tongbing, Yibing Tongzhi", all the clinical evidences were integrated to form an integrated evidence chain, so as to provide guidance for the safe and rational use of Guizhi Fuling Capsules.

摘要

桂枝茯苓胶囊是采用现代工艺方法制成的新型中药制剂。它被广泛用于治疗子宫肌瘤、盆腔炎、痛经、子宫内膜异位症、乳腺增生等妇科疾病。在病证结合的情况下,中成药“异病同治,同病异治”的诊疗模式已在临床实践中广泛应用。同时,其有效性和安全性也越来越受到关注。基于桂枝茯苓胶囊的有效性,本文初步总结了桂枝茯苓胶囊随机对照试验和系统评价中的优势病种。在中医基础理论和现代药理机制的基础上,探讨了桂枝茯苓胶囊的临床疗效及作用机制。最后,根据中医“异病同治,同病异治”理论,整合所有临床证据形成完整的证据链,为桂枝茯苓胶囊的安全合理应用提供指导。

相似文献

1
[Study of integrative evidence chain in clinical trial of Guizhi Fuling Capsules based on "Yibing Tongzhi" in clinical applications].基于“异病同治”临床应用的桂枝茯苓胶囊临床试验整合证据链研究
Zhongguo Zhong Yao Za Zhi. 2020 May;45(10):2304-2309. doi: 10.19540/j.cnki.cjcmm.20200211.504.
2
[Literature research and status analysis on clinical application of Guizhi Fuling Formula].桂枝茯苓方临床应用的文献研究与现状分析
Zhongguo Zhong Yao Za Zhi. 2020 Dec;45(23):5789-5796. doi: 10.19540/j.cnki.cjcmm.20200615.501.
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[Guizhi Fuling capsule / pill treatment for chronic pelvic inflammatory disease:a systematic review of randomized clinical trials].桂枝茯苓胶囊/丸治疗慢性盆腔炎:随机临床试验的系统评价
Zhongguo Zhong Yao Za Zhi. 2017 Apr;42(8):1500-1509. doi: 10.19540/j.cnki.cjcmm.2017.0048.
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Metabolomics Study of Guizhi Fuling Capsules in Rats With Cold Coagulation Dysmenorrhea.桂枝茯苓胶囊对寒凝血瘀型痛经大鼠的代谢组学研究
Front Pharmacol. 2021 Oct 28;12:764904. doi: 10.3389/fphar.2021.764904. eCollection 2021.
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Guizhi Fuling Formulation: A review on chemical constituents, quality control, pharmacokinetic studies, pharmacological properties, adverse reactions and clinical applications.桂枝茯苓配方:化学成分、质量控制、药代动力学研究、药理作用、不良反应及临床应用综述。
J Ethnopharmacol. 2024 Jan 30;319(Pt 2):117277. doi: 10.1016/j.jep.2023.117277. Epub 2023 Oct 5.
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Chinese herbal medicine Guizhi Fuling Formula for treatment of uterine fibroids: a systematic review of randomised clinical trials.中药桂枝茯苓方治疗子宫肌瘤:随机临床试验的系统评价
BMC Complement Altern Med. 2014 Jan 2;14:2. doi: 10.1186/1472-6882-14-2.
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[Main progress on studies of pharmacological activities and clinical applications of Guizhi Fuling capsule].[桂枝茯苓胶囊药理活性与临床应用研究的主要进展]
Zhongguo Zhong Yao Za Zhi. 2015 Mar;40(6):989-92.
8
Randomized double-blind trial comparing low dose and conventional dose of a modified traditional herbal formula Guizhi Fuling Wan in women with symptomatic uterine fibroids.随机双盲试验比较低剂量和常规剂量改良传统中药方剂桂枝茯苓丸治疗有症状子宫肌瘤的女性。
J Ethnopharmacol. 2022 Jan 30;283:114676. doi: 10.1016/j.jep.2021.114676. Epub 2021 Sep 22.
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[Monitor on influence of quality standard improvement upon Guizhi Fuling capsules efficacy].[质量标准提高对桂枝茯苓胶囊疗效影响的监测]
Zhongguo Zhong Yao Za Zhi. 2015 Oct;40(19):3786-93.
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[Dissolution test and evaluation of Guizhi Fuling Capsules].桂枝茯苓胶囊的溶出度试验与评价
Zhongguo Zhong Yao Za Zhi. 2022 Oct;47(19):5256-5263. doi: 10.19540/j.cnki.cjcmm.20220127.301.

引用本文的文献

1
Complementary authentication of Chinese herbal products to treat endometriosis using DNA metabarcoding and HPTLC shows a high level of variability.使用DNA宏条形码和高效薄层层析法对治疗子宫内膜异位症的中草药产品进行补充鉴定,结果显示出高度的变异性。
Front Pharmacol. 2023 Dec 5;14:1305410. doi: 10.3389/fphar.2023.1305410. eCollection 2023.
2
Efficacy of Guizhi Fuling Wan for primary dysmenorrhea: protocol for a randomized controlled trial.桂枝茯苓丸治疗原发性痛经的疗效:一项随机对照试验方案。
Trials. 2021 Dec 18;22(1):933. doi: 10.1186/s13063-021-05834-0.