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七种中成药治疗早期糖尿病肾病的疗效比较:一项贝叶斯网络荟萃分析。

Comparative efficacy of seven Chinese patent medicines for early diabetic kidney disease: A Bayesian network meta-analysis.

作者信息

Zhao Jie, Ai Jun, Mo Chao, Shi Wei, Meng LiFeng

机构信息

Graduate School, Hunan University of Chinese Medicine, Changsha, Hunan 410208, PR China.

Basic Medicine School, Guangxi University of Chinese Medicine, Nanning, Guangxi 530200, PR China.

出版信息

Complement Ther Med. 2022 Aug;67:102831. doi: 10.1016/j.ctim.2022.102831. Epub 2022 Apr 7.

Abstract

BACKGROUND

Bailing Capsule (BLC), Jinshuibao (JSB), Huangkui Capsule (HKC), Uremic Clearance Granule (UCG), Tripterygium glycosides (TG), Compound Xueshuantong Capsule (CXC), and Shenyan Kangfu Tablet (SYKFT) as classic Chinese patent medicines (CPMs), have been widely used and shown beneficial effects on the treatment of early diabetic kidney disease (DKD). However, the comparative efficacy of seven CPMs in the treatment of early DKD remains unknown.

OBJECTIVE

To evaluate and compare the efficacy of seven CPMs (BLC, JSB, HKC, UCG, TG, CXC, SYKFT) combined with angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) on early DKD by a Bayesian network meta-analysis (NMA) of randomized controlled trials (RCTs).

METHODS

A comprehensive and systematic literature search was performed in PubMed, Embase, Cochrane Library, Web of Science, Clinical Trials.gov, China Biology Medicine, Chinese National Knowledge Infrastructure, Chinese Scientific Journal, and Wanfang databases from inception to March 14, 2021, for full-text RCTs that evaluated the efficacy of seven CPMs combined with ACEI/ARB on patients with early DKD. Two reviewers independently screened studies for eligibility, extracted data, and assessed the risk of bias. Agreement between reviewers was measured using kappa statistics. Mean difference (MD) and odds ratio (OR) were calculated to evaluate continuous variables and dichotomous, respectively. The random effect modeling NMA was performed and the ranking probability of interventions in various outcomes was also conducted based on the surface under the cumulative ranking curve (SUCRA). Begg's and Egger's tests were used to evaluate publication bias. The certainty of the evidence for outcomes was evaluated according to the GRADE system.

RESULTS

A total of 62 RCTs with 5362 patients with early DKD were identified. The value of Kappa calculated for the various parameters extracted by the two investigators was 0.821 (P < 0.001). Among these CPMs, UCG + ACEI/ARB showed the best effectiveness for urinary albumin excretion rate (UAER) (MD 32.25, 95% CrI 19.11-45.67, low certainty) with SUCRA 92%. JSB + ACEI/ARB showed the highest effectiveness for 24-h urinary total protein (24-h UTP) (MD 76.92, 95% CrI 53.54-100.58, low certainty) with SUCRA 97%. CXC + ACEI/ARB showed the highest effectiveness for serum creatinine (SCr) (MD 26.02, 95% CrI 6.10-45.95, low certainty) with SUCRA 96%. HKC + ACEI/ARB showed the highest effectiveness for blood urea nitrogen (BUN) (MD 1.46, 95% CrI 0.42-2.54, very low certainty) with SUCRA 86%. BLC + ACEI/ARB showed significant differences in triglyceride (TRIG) (MD - 1.17, 95% CrI - 1.93 to - 0.43, low certainty) with SUCRA 90%, total cholesterol (TC) (MD - 1.17, 95% CrI - 1.97 to - 0.39, very low certainty) with SUCRA 90%, and C-reaction protein (CRP) (MD - 0.90, 95% CrI - 1.51 to - 0.32, very low certainty) with SUCRA 76%.

CONCLUSIONS

CPMs + ACEI/ARB might be positive efficacious interventions from which patients with DKD will derive benefit. UCG + ACEI/ARB, JSB + ACEI/ARB, CXC + ACEI/ARB, and HKC + ACEI/ARB might be potentially the preferred intervention for reducing UAER, 24-h UTP, SCr, and BUN levels, respectively. BLC + ACEI/ARB has a better impact on lowing TRIG, TC, and CRP levels in patients with early DKD. However, more high-quality, large-scale, multi-center RCTs and stronger head-to-head trials are required to confirm these findings.

摘要

背景

百令胶囊(BLC)、金水宝(JSB)、黄葵胶囊(HKC)、尿毒清颗粒(UCG)、雷公藤多苷(TG)、复方血栓通胶囊(CXC)和肾炎康复片(SYKFT)作为经典中成药,已被广泛应用,并在早期糖尿病肾病(DKD)的治疗中显示出有益效果。然而,七种中成药在早期DKD治疗中的疗效比较仍不清楚。

目的

通过对随机对照试验(RCT)的贝叶斯网络Meta分析(NMA),评估和比较七种中成药(BLC、JSB、HKC、UCG、TG、CXC、SYKFT)联合血管紧张素转换酶抑制剂(ACEI)或血管紧张素受体阻滞剂(ARB)治疗早期DKD的疗效。

方法

从建库至2021年3月14日,在PubMed、Embase、Cochrane图书馆、Web of Science、ClinicalTrials.gov、中国生物医学文献数据库、中国知网、中国科学期刊全文数据库和万方数据库中进行全面系统的文献检索,以获取评估七种中成药联合ACEI/ARB治疗早期DKD患者疗效的全文RCT。两名研究者独立筛选研究的纳入资格、提取数据并评估偏倚风险。使用kappa统计量衡量研究者之间的一致性。计算均数差(MD)和比值比(OR)分别评估连续变量和二分变量。进行随机效应模型NMA,并基于累积排序曲线下面积(SUCRA)对各种结局的干预措施进行排序概率分析。使用Begg检验和Egger检验评估发表偏倚。根据GRADE系统评估结局证据的确定性。

结果

共纳入62项RCT,涉及5362例早期DKD患者。两位研究者提取的各项参数的kappa值为0.821(P<0.001)。在这些中成药中,UCG+ACEI/ARB对尿白蛋白排泄率(UAER)显示出最佳疗效(MD 32.25,95% CrI 19.11 - 45.67,低确定性),SUCRA为92%。JSB+ACEI/ARB对24小时尿总蛋白(24-h UTP)显示出最高疗效(MD 76.92,95% CrI 53.54 - 100.58,低确定性),SUCRA为97%。CXC+ACEI/ARB对血清肌酐(SCr)显示出最高疗效(MD 26.02,95% CrI 6.10 - 45.95,低确定性),SUCRA为96%。HKC+ACEI/ARB对血尿素氮(BUN)显示出最高疗效(MD 1.46,95% CrI 0.42 - 2.54,极低确定性),SUCRA为86%。BLC+ACEI/ARB在甘油三酯(TRIG)方面有显著差异(MD -1.17,95% CrI -1.93至-0.43,低确定性),SUCRA为90%;在总胆固醇(TC)方面(MD -1.17,95% CrI -1.97至-0.39,极低确定性),SUCRA为90%;在C反应蛋白(CRP)方面(MD -0.90,95% CrI -1.51至-0.32,极低确定性),SUCRA为76%。

结论

中成药+ACEI/ARB可能是对DKD患者有益的有效干预措施。UCG+ACEI/ARB、JSB+ACEI/ARB、CXC+ACEI/ARB和HKC+ACEI/ARB可能分别是降低UAER、24-h UTP、SCr和BUN水平的潜在首选干预措施。BLC+ACEI/ARB对降低早期DKD患者的TRIG、TC和CRP水平有较好影响。然而,需要更多高质量、大规模、多中心的RCT和更强的头对头试验来证实这些发现。

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