Efficacy and safety of Yiqi Peiyuan granules for improving the short-term prognosis of patients with acute kidney injury: A multicenter, double-blind, placebo-controlled, randomized trial

IF 4.2 2区 医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE
Jia-jia Wu , Tian-yi Zhang , Ying-hui Qi , Min-yan Zhu , Yan Fang , Chao-jun Qi , Li-ou Cao , Ji-fang Lu , Bo-han Lu , Lu-min Tang , Jian-xiao Shen , Shan Mou
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引用次数: 0

Abstract

Background

Yiqi Peiyuan (YQPY) prescription, a composite prescription of traditional Chinese medicine, has been used to prevent or delay the continued deterioration of renal function after acute kidney injury (AKI) in some institutions and has shown considerable efficacy.

Objective

This is the first randomized controlled trial to assess efficacy and safety of YQPY for improving short-term prognosis in adult patients with AKI.

Design, setting, participants and interventions

This is a prospective, double-blind, multicenter, randomized, and placebo-controlled clinical trial. A total of 144 enrolled participants were randomly allocated to two groups according to a randomization schedule. Participants, caregivers and investigators assessing the outcomes were blinded to group assignment. Patients in the YQPY group received 36 g YQPY granules twice a day for 28 days. Patients in the placebo group received a placebo in the same dose as the YQPY granules.

Main outcome measures

The primary outcome was the change in the estimated glomerular filtration rate (eGFR) between baseline and after 4 and 24 weeks of treatment. The secondary outcomes were the change of serum creatinine (Scr) level between baseline and after treatment, and the incidence of endpoint events, defined as eGFR increasing by more than 25% above baseline, eGFR >75 mL/min per 1.73 m2 or the composite endpoint, which was defined as the sum of patients meeting either of the above criteria.

Results

Data from a total of 114 patients (59 in the YQPY group and 55 in the control group) were analyzed. The mean changes in eGFR and Scr in weeks 4 and 24 had no difference between the two groups. In further subgroup analysis (22 in the YQPY group and 31 in the control group), the mean change in eGFR after treatment for 4 weeks was 27.39 mL/min per 1.73 m2 in the YQPY group and 5.78 mL/min per 1.73 m2 in the placebo group, and the mean difference between groups was 21.61 mL/min per 1.73 m2 (P < 0.001). Thirteen (59.1%) patients in the YQPY group and 5 (16.1%) in the placebo group reached the composite endpoints (P = 0.002). During the intervention, 2 and 4 severe adverse events were reported in the YQPY and placebo groups, respectively.

Conclusion

The YQPY granules can effectively improve the renal function of patients 4 weeks after the onset of AKI, indicating that it has good efficacy for improving short-term renal outcomes in patients with AKI. The YQPY granules may be a promising therapy for adults with AKI.

Trial Registration

Chinese Clinical Trial Registry ChiCTR2100051723.

Please cite this article as: Wu JJ, Zhang TY, Qi YH, Zhu MY, Fang Y, Qi CJ, Cao LO, Lu JF, Lu BH, Tang LM, Shen JX, Mou S. Efficacy and safety of Yiqi Peiyuan granules for improving the short-term prognosis of patients with acute kidney injury: a multicenter, double-blind, placebo-controlled, randomized trial. J Integr Med. 2024; 22(3): 279–285.

益气培元颗粒改善急性肾损伤患者短期预后的有效性和安全性:一项多中心、双盲、安慰剂对照随机试验
背景益气培元方是一种中药复方制剂,在一些机构已被用于预防或延缓急性肾损伤(AKI)后肾功能的持续恶化,并显示出相当的疗效。共有 144 名参加者按照随机分配表被随机分配到两组。参试者、护理人员和评估结果的研究人员对组别分配进行盲测。YQPY组患者服用36克YQPY颗粒,每天两次,连续服用28天。主要结果测量主要结果是基线与治疗 4 周和 24 周后估计肾小球滤过率(eGFR)的变化。次要结果是基线与治疗后血清肌酐(Scr)水平的变化,以及终点事件的发生率,终点事件定义为 eGFR 比基线增加 25% 以上、eGFR >75 mL/min per 1.73 m2 或复合终点,复合终点定义为符合上述任一标准的患者总和。结果共分析了 114 名患者(YQPY 组 59 人,对照组 55 人)的数据。两组患者在第 4 周和第 24 周的 eGFR 和 Scr 平均值变化没有差异。在进一步的亚组分析中(YQPY 组 22 人,对照组 31 人),治疗 4 周后,YQPY 组的 eGFR 平均变化为 27.39 mL/min 每 1.73 m2,安慰剂组为 5.78 mL/min 每 1.73 m2,组间平均差异为 21.61 mL/min 每 1.73 m2(P < 0.001)。YQPY 组中有 13 名(59.1%)患者达到了综合终点,安慰剂组中有 5 名(16.1%)患者达到了综合终点(P = 0.002)。结论YQPY颗粒能在AKI发生4周后有效改善患者的肾功能,这表明它对改善AKI患者的短期肾脏预后具有良好的疗效。试验注册中国临床试验注册中心 ChiCTR2100051723.Please cite this article as:Wu JJ, Zhang TY, Qi YH, Zhu MY, Fang Y, Qi CJ, Cao LO, Lu JF, Lu BH, Tang LM, Shen JX, Mou S. Efficacy and safety of Yiqi Peiyuan granules for improving the short-term prognosis of patients with acute kidney injury: a multicenter, double-blind, placebo-controlled, randomized trial.J Integr Med.2024; 22(3):279-285.
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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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