Efficacy and safety of Abelmoschus manihot capsule combined with ACEI/ARB on diabetic kidney disease: a systematic review and meta analysis.
Efficacy and safety of Abelmoschus manihot capsule combined with ACEI/ARB on diabetic kidney disease: a systematic review and meta analysis.
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DOI：
10.3389/fphar.2023.1288159
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发表时间：
2023
影响因子：
5.6
通讯作者：
Yu, Jiangyi
中科院分区：
文献类型：
--
作者：
Tan, Ying;Zhang, Ziqi;Zhou, Peipei;Zhang, Qiling;Li, Nan;Yan, Qianhua;Huang, Liji;Yu, Jiangyi
关键词：
背景资料：糖尿病肾病（Diabetic kidney disease，DKD）是糖尿病最严重的微血管并发症之一，发病率逐年上升，是慢性肾脏病（chronic kidney disease，CKD）和终末期肾脏病的主要病因。黄蜀葵胶囊是一种中成药，在我国被广泛用于治疗慢性肾脏病。目前，黄蜀葵（AM）胶囊和肾素-血管紧张素-醛固酮系统抑制剂（RASI）联合治疗DKD已成为一种流行的治疗选择，越来越多的随机对照试验（RCT）正在进行中。然而，支持其在DKD中应用的高质量临床证据仍然不足。 目的：全面系统地评价黄芪胶囊联合黄芪注射液治疗DKD的疗效和安全性。 材料与方法：检索Pubmed、科克伦图书馆、Embase、CNKI、SinoMed、WF、VIP等中英文数据库，收集AM胶囊治疗DKD的随机对照试验。然后由两名研究者独立审查并提取符合纳入标准的RCT数据。采用科克伦偏倚风险评估工具对数据质量进行评估，采用RevMan 5.4软件进行Meta分析。 结果：纳入了32项RCT，共2，881例DKD患者（治疗组1，442例，对照组1，439例）。研究结果表明，AM胶囊联合RASI可更有效地降低24 h-UTP [MD =-442.05，95%CI（-609.72，-274.38），p < 0.00001]，UAER [MD =-30.53，95%CI（−39.10，−21.96），p < 0.00001]，UACR [MD = −157.93，95% CI（−288.60，−27.25），p < 0.00001]、Scr [MD = −6.80，95%CI（−9.85，−3.74），p < 0.0001]和BUN [MD = −0.59，95%CI（−1.07，−0.12），p = 0.01]。亚组分析显示，AM联合ARB降低UAER的效果优于ACEI，且对24 h-UTP>2 g或Scr>110-133 μmol/L和>133 μ mol/L的DKD患者，AM联合ARB降低Scr的效果更显著。此外，联合用药组未观察到其他不良反应[OR = 1.06; 95%CI：（0.66，1.69），p = 0.82]。 结论：AM联合RASI治疗DKD可能优于RASI单药治疗，是一种上级策略。但由于存在显著的异质性，对结果的解释应十分谨慎，未来仍需更多多中心、不同阶段、大样本量、长随访期的高质量RCT，以提高AM治疗DKD的证据质量。 系统综述注册：https：//www.crd.york.ac.uk/PROSPERO/#recordDetails;标识符CRD 42022351422
Background: Diabetic kidney disease (DKD) is one of the most serious microvascular complications of diabetes, with the incidence rate increasing yearly, which is the leading cause of chronic kidney disease (CKD) and end-stage kidney disease. Abelmoschus Manihot capsule, as a proprietary Chinese patent medicine, is widely used for treating CKD in China. Currently, the combination of Abelmoschus Manihot (AM) capsule and renin-angiotensin-aldosterone system inhibitor (RASI) has gained popularity as a treatment option for DKD, with more and more randomized control trials (RCTs) in progress. However, the high-quality clinical evidence supporting its application in DKD is still insufficient. Aim of the study: To comprehensively and systematically evaluate the efficacy and safety of AM capsule combined with RASI in the treatment of DKD. Materials and methods: English and Chinese databases such as Pubmed, Cochrane Library, Embase, CNKI, SinoMed, WF, and VIP were searched to collect the RCTs of AM capsule in treatment of DKD. Then Two investigators independently reviewed and extracted data from the RCTs which met the inclusion criteria. The quality of the data was assessed using the Cochrane risk of bias assessment tool, and meta-analysis was performed using RevMan 5.4 software. Results: 32 RCTs with a total of 2,881 DKD patients (1,442 in the treatment group and 1,439 in the control group) were included. The study results showed that AM capsule combined with RASI could be more effective in decreasing 24h-UTP [MD = −442.05, 95% CI (−609.72, −274.38), p < 0.00001], UAER [MD = −30.53, 95% CI (−39.10, −21.96), p < 0.00001], UACR [MD = −157.93, 95% CI (−288.60, −27.25), p < 0.00001], Scr [MD = −6.80, 95% CI (−9.85, −3.74), p < 0.0001], and BUN [MD = −0.59, 95% CI (−1.07, −0.12), p = 0.01], compared to using RASI alone. According to the subgroup analyses, the combination of AM and ARB seems to be more effective in reducing UAER than the combination of ACEI, and the addition of AM may achieve a more significant clinical effect on decreasing Scr for DKD patients with 24h-UTP>2 g or Scr>110–133 μmol/L and >133 μmol/L. Furthermore, no additional adverse reactions were observed in the combination group [OR = 1.06; 95%CI: (0.66, 1.69), p = 0.82]. Conclusion: Combining AM with RASI may be a superior strategy for DKD treatment compared to RASI monotherapy. However, due to significant heterogeneity, the results should be interpreted with great caution, and more high-quality RCTs with multi-centers, different stages of DKD, large sample sizes, and long follow-up periods are still needed to improve the evidence quality of AM for DKD in the future. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/#recordDetails; Identifier CRD42022351422
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DOI：
10.1002/ptr.6818
发表时间：
2021-01
期刊：
Phytotherapy research : PTR
影响因子：
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作者：
Li N;Tang H;Wu L;Ge H;Wang Y;Yu H;Zhang X;Ma J;Gu HF
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Gembillo G;Ingrasciotta Y;Crisafulli S;Luxi N;Siligato R;Santoro D;Trifirò G
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