| 黄葵制剂治疗糖尿病肾病剂量疗效的Meta分析 |
| 投稿时间：2024-08-24 修订日期：2024-09-12 点此下载全文 |
| 引用本文：李佳,刘苏.黄葵制剂治疗糖尿病肾病剂量疗效的Meta分析[J].医学研究杂志,2025,54(2):48-57 |
| DOI：
10.11969/j.issn.1673-548X.2025.02.009 |
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| 基金项目:国家自然科学基金青年科学基金资助项目(81804027)；江苏省卫生健康委员会科研项目(M2022053) |
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| 中文摘要:目的 基于Meta分析,从疾病分期、药物干预剂量及疗程角度评价黄葵制剂治疗糖尿病肾病(diabetic kidney disease, DKD)的有效性及安全性。方法 检索多个中英文数据库,搜集自建库至2024年6月24日有关黄葵制剂治疗糖尿病肾病的随机对照试验(randomized controlled trial, RCT)。使用Endnote 21软件进行文件的管理与筛选,使用Cocharane风险偏倚评估工具和RevMan5.4软件进行系统评价。结果 本研究共检索到1386篇文献,经过筛选后最终纳入28篇文献,总样本量为2631例；纳入黄葵制剂4种,分别为黄葵胶囊、芪葵颗粒、甲花片和六黄糖肾康。Meta分析结果显示,黄葵制剂可降低DKD患者血肌酐(SMD=-0.38,95%CI:-0.55~-0.21,P<0.0001)、血清胱抑素C(MD=-0.48,95%CI:-0.63~-0.33,P<0.00001)、尿白蛋白/肌酐比值(SMD=-0.74,95%CI:-1.10~-0.38,P<0.0001)、尿白蛋白排泄率(SMD=-1.58,95%CI:-1.93~-1.24,P<0.00001)、24h尿蛋白定量(SMD=-1.00,95%CI:-1.34~-0.66,P<0.00001)等多项指标,临床总有效率高于对照组(OR=4.57,95%CI:3.12~6.70,P<0.00001)。纳入研究显示,黄葵制剂治疗对象为DKD Ⅰ～Ⅳ期患者；黄葵制剂剂量区间为3~42g,以30g为主,临床亦有使用大剂量如90g者,均可有效治疗DKD；干预疗程以短期(8~12周)为主,亦有长疗程者(≥6个月),各疗程区间总体疗效均优于常规治疗组；亚组分析结果显示,较短疗程干预对降低尿白蛋白排泄率、24h尿蛋白定量效果最优,提示黄葵制剂在短期内即可发挥积极作用。黄葵制剂3~42g剂量区间均无明显不良反应,大剂量黄葵制剂的文献量不足,安全性有待于进一步考证。结论 黄葵制剂适用于DKD Ⅰ～Ⅳ期患者,剂量区间在3~90g,临床以30g为主,常用剂型包括代茶饮、中成药及中药水煎剂,规律服用黄葵制剂有助于降低尿蛋白,延缓肾功能衰退,且药物不良反应少,值得临床广泛应用。 |
| 中文关键词:黄葵 黄蜀葵花 糖尿病肾病 Meta分析 |
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| Meta-analysis of Dose-related Efficacy of Abelmoschus Moschatus Preparations in the Treatment of Diabetic Kidney Disease. |
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| Abstract:Objective Using a Meta-analysis, the efficacy and safety of Abelmoschus moschatus preparations for treating diabetic kidney disease (DKD) were evaluated from the perspectives of disease stage, drug dosage, and course of intervention. Methods Both Chinese and English databases were searched from their inception to June 24,2024, for relevant randomized controlled trial (RCT) on Abelmoschus moschatus preparations in DKD treatment. Endnote 21software was applied for reference management and filtering, while Cochrane risk of bias assessment tool and RevMan 5.4 were used for systematic evaluation. Results Initially, a total of 1386 literatures were retrieved in this study, and 28 literatures were finally included after further screening, encompassing a total sample size of 2631 patients. Four types of Abelmoschus moschatus preparations were included:Huangkui capsules, Qikui granules, Jiahua tablets, and Liuhuang Tangshenkang decoction. The Meta-analysis results showed that Abelmoschus moschatus preparations could reduce multiple indicators, such as serum creatinine (SMD= -0.38,95%CI:-0.55--0.21, P<0.0001)、cystatin C (MD=-0.48,95%CI:-0.63--0.33, P<0.00001), urinary albumin/creatinine ratio (SMD=-0.74,95%CI:-1.10 - -0.38, P<0.0001), urinary albumin excretion rate (SMD=-1.58,95%CI:-1.93--1.24, P<0.00001) and 24h urine total protein (SMD= -1.00,95%CI:-1.34 - -0.66, P<0.00001) in DKD patients, the total clinical effective rate was higher than that of the control group (OR=4.57,95%CI:3.12-6.70, P<0.00001). The included literatures show that the treatment object of Abelmoschus moschatus preparations was DKD patients at Ⅰ-Ⅳ stage. The dosage of Abelmoschus moschatus preparations ranged from 3-42g, with 30g being the most common, and exceptions as high as 90g in clinical practice, all of which could effectively treat DKD. The course of intervention in the included literatures was mainly short-term (8-12 weeks), and there were also patients with long-term intervention (≥ 6months). The overall efficacy of each course of intervention was higher compared with the conventional treatment group. The results of subgroup analysis showed that short-term interventio had the best efficacy on reducing urinary albumin excretion rate and 24h urine total protein, suggesting that Abelmoschus moschatus preparations can play a positive role in the short term. No significant adverse reactions were observed in intervention with Abelmoschus moschatus preparations at a dosage range of 3-42g. However, due to the scarcity of literature references on the application of high-dose Abelmoschus moschatus preparations, their safety needs further investigation. Conclusion Abelmoschus moschatus preparations can be used for the indication of DKD stages Ⅰ-Ⅳ at a common clinical dosage of 30g (dosage range:3-90g) in common dosage forms of substitutional tea, Chinese patent drug, and decoction of Chinese medicine. Regular administration of Abelmoschus moschatus preparations can not only help to reduce urine protein, delay renal function decline, but also show fewer adverse reactions of drug, which makes them worthy of being popularized for clinical practices. |
| keywords:Abelmoschus moschatus Abelmoschus manihot Diabetic kidney disease Meta-analysis |
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