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参芪扶正注射液联合化疗治疗癌症的疗效与安全性:系统评价概述

Efficacy and safety of Shenqi Fuzheng injection combined with chemotherapy for cancer: An overview of systematic reviews.

作者信息

Chen Guang, Lu Jiawei, Li Boyao, Zhao Mengsha, Liu Di, Yang Zongyu, Liu Fei

机构信息

Hebei Province Cangzhou Hospital of Integrated Traditional and Western Medicine, No. 31, West Huanghe Road, Yunhe District, Cangzhou, Hebei 061012, China; College of Traditional Chinese Medicine, Hebei University, Baoding, Hebei 071000, China.

Hebei Province Cangzhou Hospital of Integrated Traditional and Western Medicine, No. 31, West Huanghe Road, Yunhe District, Cangzhou, Hebei 061012, China; Graduate School, Hebei University of Chinese Medicine, Shijiazhuang, Hebei 050091, China.

出版信息

Phytomedicine. 2024 Mar;125:155293. doi: 10.1016/j.phymed.2023.155293. Epub 2023 Dec 23.

Abstract

BACKGROUND

In China, Shenqi Fuzheng injection (SFI) has been used as an adjuvant therapy to treat all kinds of cancer for many years. A large number of systematic reviews or meta-analyses (SRs/MAs) were published to assess its efficacy and safety in the past few years. However, the quality of SRs/MAs was unclear and did not generate high-quality clinical evidence.

OBJECTIVE

We conducted an overview to integrate relevant SRs/MAs published in the past with the aim of providing new clinical evidence for SFI in combination with chemotherapy in the treatment of cancer.

OBJECTIVE

We conducted an overview to integrate relevant SRs/MAs published in the past with the aim of providing new clinical evidence for SFI in combination with chemotherapy in the treatment of cancer.

METHODS

A comprehensive search of PubMed, Web of Science, Embase, the Cochrane Library, CNKI, VIP, WanFang, and CBM was performed from the database inception to September 30, 2023. SRs/MAs of randomized controlled trials (RCTs) on SFI combined with chemotherapy for cancer were included. Four reviewers screened the literature and extracted relevant information. Five reviewers assessed the quality of reporting, methodological quality, risk of bias, and quality of evidence for SRs/MAs. We used corrected covered area (CCA) to assess the degree of overlap among the RCTs included in SRs/MAs. We performed a descriptive analysis for the results of the included SRs/MAs.

RESULTS

A total of 32 SRs/MAs of SFI combined with chemotherapy for cancer were included. We assessed the reporting quality of SRs/MAs using the PRISMA 2020 statement. 1 SR/MA had relatively complete reports, 20 SRs/MAs had some deficiencies in reporting, and 11 SRs/MAs had serious deficiencies in reporting. We assessed the methodological quality of SRs/MAs using the AMSTAR 2 tool. The methodological quality of all SRs/MAs was very low. We assessed the risk of bias for SRs/MAs using the ROBIS tool. The risk of bias was low for 19 SRs/MAs and unclear for 13 SRs/MAs. We assessed the quality of evidence for SRs/MAs using the GRADE evidence quality evaluation system. 50 items were moderate quality, 46 items were low quality, 27 items were very low quality, and 85 items were unclear. SFI combined with chemotherapy played a role in increasing efficacy and decreasing toxicities in all kinds of cancer, including clinical efficacy (except liver cancer), quality of life, immune function (except CD8+), leukopenia, thrombocytopenia, hemoglobinopenia, nausea and vomiting, liver damage, kidney damage, neurotoxicity, alopecia, and diarrhea.

CONCLUSION

The overview showed that SFI combined with chemotherapy may improve clinical efficacy (except for liver cancer), quality of life, and immune (except for CD8+) function in all types of cancer, as well as adverse events (AEs) such as leukopenia, thrombocytopenia, etc. Since most of the clinical evidence was low, higher quality clinical trials will be expected to improve the reliability of the above conclusions in the future.

摘要

背景

在中国,参芪扶正注射液(SFI)多年来一直被用作辅助治疗各种癌症。在过去几年中,发表了大量的系统评价或荟萃分析(SRs/MAs)来评估其疗效和安全性。然而,SRs/MAs的质量尚不清楚,并未产生高质量的临床证据。

目的

我们进行了一项综述,整合过去发表的相关SRs/MAs,旨在为SFI联合化疗治疗癌症提供新的临床证据。

方法

从数据库建立至2023年9月30日,对PubMed、Web of Science、Embase、Cochrane图书馆、中国知网、维普、万方和中国生物医学文献数据库进行全面检索。纳入SFI联合化疗治疗癌症的随机对照试验(RCTs)的SRs/MAs。四位评审员筛选文献并提取相关信息。五位评审员评估SRs/MAs的报告质量、方法学质量、偏倚风险和证据质量。我们使用校正覆盖面积(CCA)来评估SRs/MAs中纳入的RCTs之间的重叠程度。我们对纳入的SRs/MAs的结果进行了描述性分析。

结果

共纳入32篇SFI联合化疗治疗癌症的SRs/MAs。我们使用PRISMA 2020声明评估SRs/MAs的报告质量。1篇SR/MA报告相对完整,20篇SRs/MAs报告存在一些缺陷,11篇SRs/MAs报告存在严重缺陷。我们使用AMSTAR 2工具评估SRs/MAs的方法学质量。所有SRs/MAs的方法学质量都非常低。我们使用ROBIS工具评估SRs/MAs的偏倚风险。19篇SRs/MAs的偏倚风险较低,13篇SRs/MAs的偏倚风险不明确。我们使用GRADE证据质量评估系统评估SRs/MAs的证据质量。50项为中等质量证据,46项为低质量证据,27项为极低质量证据,85项不明确。SFI联合化疗在提高各种癌症的疗效和降低毒性方面发挥了作用,包括临床疗效(肝癌除外)、生活质量、免疫功能(CD8+除外)、白细胞减少、血小板减少、血红蛋白减少、恶心呕吐、肝损伤、肾损伤、神经毒性、脱发和腹泻。

结论

综述表明,SFI联合化疗可能改善所有类型癌症的临床疗效(肝癌除外)、生活质量和免疫(CD8+除外)功能,以及白细胞减少、血小板减少等不良事件(AEs)。由于大多数临床证据质量较低,未来预计将进行更高质量的临床试验以提高上述结论的可靠性。

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