复方中药赫章颗粒治疗急性痛风性关节炎的有效性和安全性:双盲随机对照试验。

IF 4.2 2区 医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE
Hao Wang , Si-ting Chen , Xiao-jie Ding , Le Kuai , Liang Hua , Xin Li , Yi-fei Wang , Ming Zhang , Bin Li , Rui-ping Wang , Mi Zhou
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引用次数: 0

摘要

背景:急性痛风性关节炎(AGA)是一种发病率很高的关节炎性疾病。包括非甾体抗炎药、秋水仙碱和糖皮质激素在内的典型医疗干预措施可能会产生严重的不良反应。复方中药赫章颗粒(HZG)用于治疗 AGA 已有 30 多年的历史,疗效满意,无明显不良反应。然而,HZG 对 AGA 患者的疗效和安全性仍然未知:本研究旨在探讨HZG治疗AGA患者的疗效和安全性:本研究是一项非劣效性随机对照临床试验,共有180名符合条件的参与者参加。参与者被随机分配到HZG组和依托考昔组。治疗时间为5天,在此期间,HZG组接受HZG和安慰剂依托考昔,而依托考昔组按相同比例(1:1)接受依托考昔和安慰剂HZG:主要结果是患者在治疗窗口期的第2天至第5天感到痛风引起的关节疼痛。疼痛程度通过视觉模拟量表测量,范围从0毫米到100毫米。次要结果包括关节触痛和肿胀、炎症生物标志物的减少以及患者和研究人员对治疗反应的总体评价:HZG组的疼痛平均减轻幅度为-51.22毫米(95%置信区间[CI]为[-53.42, -49.03]毫米),依托考昔组的疼痛平均减轻幅度为-52.00毫米(95%置信区间[CI]为[-54.06, -49.94]毫米)。两组之间的平均差异为0.78毫米(95% CI,[-2.25,3.81]毫米)。所有其他疗效终点,包括炎症减轻和疼痛缓解,都有力地证明了非劣效性。与依托考昔组相比,HZG组患者的不良反应发生率相对较低(4.44% vs 13.33%; P ≤ 0.05):结论:HZG组和依托考昔组的镇痛效果相似。试验登记:试验注册:中国临床试验注册中心(ChiCTR2000036970)。本文引用如前:Wang H, Chen ST, Ding XJ, Kuai L, Hua L, Li X, Wang YF, Zhang M, Li B, Wang RP, Zhou M. Huzhang Granule, a compound Chinese herbal medicine, for acute gouty arthritis:双盲随机对照试验。J Integr Med.2024; Epub ahead of print.
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy and safety of Huzhang Granule, a compound Chinese herbal medicine, for acute gouty arthritis: A double-blind, randomized controlled trial

Background

Acute gouty arthritis (AGA) is an inflammatory joint disease with a high prevalence. Typical medical interventions, including nonsteroidal anti-inflammatory drugs, colchicine and glucocorticoids, can have serious adverse reactions. Huzhang Granule (HZG), a compound Chinese herbal medicine, has been used to treat AGA for more than 30 years with satisfactory effects and no significant adverse reactions. However, the efficacy and safety of HZG in AGA patients remains unknown.

Objective

The present investigation was designed to examine the efficacy and safety profile of HZG in managing AGA patients.

Design, setting, participants and interventions

The current study was conducted as a noninferiority, randomized controlled clinical trial on 180 eligible enrolled participants. Participants were randomly assigned into the HZG and etoricoxib groups. Treatments were administered for 5 d, during which the HZG group received HZG and placebo etoricoxib, while the etoricoxib group received etoricoxib and placebo HZG in the same ratio (1:1).

Main outcome measures

The primary outcome was pain experienced by the patient in the gout-afflicted joint from days 2 to 5 of the treatment window. The pain level was measured via a visual analogue scale, ranging from 0 mm to 100 mm. The secondary outcomes comprised joint tenderness and swelling, reduction of inflammatory biomarkers, and the patient’s and investigator’s global evaluations of therapeutic response.

Results

The mean reduction in pain was −51.22 mm (95% confidence interval [CI], [−53.42, −49.03] mm) for the HZG and −52.00 mm (95% CI, [−54.06, −49.94] mm) for the etoricoxib groups. The mean difference between the two groups was 0.78 mm (95% CI, [−2.25, 3.81] mm). All additional efficacy endpoints, covering decreased inflammation and pain relief, yielded compelling proof of noninferiority. Patients in the HZG group exhibited a comparatively lower rate of adverse events compared to those in the etoricoxib group (4.44% vs 13.33%; P ≤ 0.05).

Conclusion

HZG and etoricoxib groups demonstrated similar levels of analgesic effectiveness. The safety and efficacy of HZG indicates that it can be used as a potential therapeutic option for treating AGA.

Trial registration

Chinese Clinical Trial Registry (ChiCTR2000036970).

Please cite this article as: Wang H, Chen ST, Ding XJ, Kuai L, Hua L, Li X, Wang YF, Zhang M, Li B, Wang RP, Zhou M. Efficacy and safety of Huzhang Granule, a compound Chinese herbal medicine, for acute gouty arthritis: A double-blind, randomized controlled trial. J Integr Med. 2024; 22(3): 270–278.

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来源期刊
Journal of Integrative Medicine-Jim
Journal of Integrative Medicine-Jim Medicine-Complementary and Alternative Medicine
CiteScore
9.20
自引率
4.20%
发文量
3319
期刊介绍: The predecessor of JIM is the Journal of Chinese Integrative Medicine (Zhong Xi Yi Jie He Xue Bao). With this new, English-language publication, we are committed to make JIM an international platform for publishing high-quality papers on complementary and alternative medicine (CAM) and an open forum in which the different professions and international scholarly communities can exchange views, share research and their clinical experience, discuss CAM education, and confer about issues and problems in our various disciplines and in CAM as a whole in order to promote integrative medicine. JIM is indexed/abstracted in: MEDLINE/PubMed, ScienceDirect, Emerging Sources Citation Index (ESCI), Scopus, Embase, Chemical Abstracts (CA), CAB Abstracts, EBSCO, WPRIM, JST China, Chinese Science Citation Database (CSCD), and China National Knowledge Infrastructure (CNKI). JIM Editorial Office uses ThomsonReuters ScholarOne Manuscripts as submitting and review system (submission link: http://mc03.manuscriptcentral.com/jcim-en). JIM is published bimonthly. Manuscripts submitted to JIM should be written in English. Article types include but are not limited to randomized controlled and pragmatic trials, translational and patient-centered effectiveness outcome studies, case series and reports, clinical trial protocols, preclinical and basic science studies, systematic reviews and meta-analyses, papers on methodology and CAM history or education, conference proceedings, editorials, commentaries, short communications, book reviews, and letters to the editor. Our purpose is to publish a prestigious international journal for studies in integrative medicine. To achieve this aim, we seek to publish high-quality papers on any aspects of integrative medicine, such as acupuncture and traditional Chinese medicine, Ayurveda medicine, herbal medicine, homeopathy, nutrition, chiropractic, mind-body medicine, taichi, qigong, meditation, and any other modalities of CAM; our commitment to international scope ensures that research and progress from all regions of the world are widely covered. These ensure that articles published in JIM have the maximum exposure to the international scholarly community. JIM can help its authors let their papers reach the widest possible range of readers, and let all those who share an interest in their research field be concerned with their study.
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