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茵栀黄注射液作为新生儿高胆红素血症的辅助治疗:一项随机临床试验的系统评价和荟萃分析

Yinzhihuang injection as adjuvant treatment for neonatal hyperbilirubinemia: a systematic review and meta-analysis of randomized clinical trials.

作者信息

Li Junqiang, Zhang Liyu, Chen Zhongguo, Qin Min

机构信息

Department of Neonatology, Lincang Maternity and Child Health Hospital, Lincang, Yunnan, China.

Administrative Department of Lincang Maternity and Child Health Hospital, Lincang, Yunnan, China.

出版信息

Front Pharmacol. 2024 Dec 5;15:1467325. doi: 10.3389/fphar.2024.1467325. eCollection 2024.

Abstract

BACKGROUND

Neonatal hyperbilirubinemia (NH) is a common phenomenon for neonate inpatients, and Yinzhihuang (YZH) injection is a well-known Chinese herbal formula for the treatment of NH. This study aims to evaluate the efficacy of YZH injection on NH.

METHODS

A comprehensive literature search was performed in four Chinese databases [China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature (CBM), China Science Journal Database (VIP), and Wan Fang ] and four English language databases (PubMed, Web of Science, EMbase and the Cochrane Library) from inception to 16 April 2024. Randomized controlled trials on YZH injection for NH were collected. Review Manager 5.4 software was used for meta-analysis and bias risk assessment.

RESULT

Twenty-two trials involving 2,714 neonates were included. Significant differences were detected between YZH injection group and control group for total effective rate (RR = 1.15, 95%CI: 1.11 to 1.20, < 0.00001), serum bilirubin level (the third day, MD = -36.80, 95%CI: -52.07 to -21.53; the fifth day, MD = -4.18, 95%CI: -7.50 to -0.86, < 0.00001), and time to jaundice resolution (MD = -2.46, 95%CI -2.81 to -2.10, < 0.00001). Adverse effects of YZH injection were described in four trials, with an incidence of 8.60%.

CONCLUSION

The use of YZH injection as an adjuvant to NH appears to be safe and may offer superior benefits compared to routine treatment alone for NH. However, these potential benefits require confirmation in future trials employing rigorous methodology. The current evidence is not enough to recommend YZH injection as a routine treatment for NH.

SYSTEMATIC REVIEW REGISTRATION

PROSPERO (https://www.crd.york.ac.uk/prospero/), identifier, CRD42024556811.

摘要

背景

新生儿高胆红素血症(NH)是新生儿住院患者中的常见现象,茵栀黄(YZH)注射液是治疗NH的一种知名中药配方。本研究旨在评估YZH注射液治疗NH的疗效。

方法

从建库至2024年4月16日,在中国的四个数据库[中国知网(CNKI)、中国生物医学文献数据库(CBM)、维普中文科技期刊数据库(VIP)和万方数据库]以及四个英文数据库[PubMed、科学引文索引(Web of Science)、荷兰医学文摘数据库(EMbase)和考克兰图书馆]中进行了全面的文献检索。收集了关于YZH注射液治疗NH的随机对照试验。使用Review Manager 5.4软件进行荟萃分析和偏倚风险评估。

结果

纳入了22项涉及2714例新生儿的试验。YZH注射液组与对照组在总有效率(RR = 1.15,95%CI:1.11至1.20,P < 0.00001)、血清胆红素水平(第3天,MD = -36.80,95%CI:-52.07至-21.53;第5天,MD = -4.18,95%CI:-7.50至-0.86,P < 0.00001)以及黄疸消退时间(MD = -2.46,95%CI -2.81至-2.10,P < 0.00001)方面存在显著差异。四项试验描述了YZH注射液的不良反应,发生率为8.60%。

结论

YZH注射液作为NH的辅助治疗似乎是安全的,与单独的常规治疗相比,可能具有更大的益处。然而,这些潜在益处需要在未来采用严格方法的试验中得到证实。目前的证据不足以推荐YZH注射液作为NH的常规治疗方法。

系统评价注册

国际前瞻性系统评价注册库(PROSPERO,https://www.crd.york.ac.uk/prospero/),标识符,CRD42024556811。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4fa5/11655195/2af5ed19e785/fphar-15-1467325-g001.jpg

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