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中成药康莱特注射液治疗非小细胞肺癌:系统评价概述

Chinese patent medicine Kanglaite injection for non-small-cell lung cancer: An overview of systematic reviews.

作者信息

Lu Taicheng, Yu Jingwen, Gao Ruike, Wang Jia, Wang Heping, Wang Xinmiao, Xu Bowen, Cao Luchang, Wu Jingyuan, Ni Baoyi, Li Shixin, Li Jie

机构信息

Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China; Graduate School, Beijing University of Chinese Medicine, Beijing, China.

Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.

出版信息

J Ethnopharmacol. 2023 Feb 10;302(Pt A):115814. doi: 10.1016/j.jep.2022.115814. Epub 2022 Oct 12.

Abstract

ETHNOPHARMACOLOGICAL RELEVANCE

Kanglaite injection (KLTi), a Chinese herbal medicine, is used as an adjuvant treatment for non-small-cell lung cancer (NSCLC).

AIMS OF THE STUDY

To provide an evidence-based endorsement for the clinical application and selection of KLTi by evaluating the reporting quality, methodological quality, risk of bias, and evidence quality of systemic reviews (SRs).

MATERIALS AND METHODS

SRs of KLTi adjuvant therapy of NSCLC were searched by using 12 databases, consulting experts, and retrieving relevant conference papers until 2022.03.24. The treatment group received KLTi in combination with other therapies, regardless of dosage, duration, or the therapy combined. Network meta-analyses and SRs using repeated data were excluded. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines 2009, A MeaSurement Tool to Assess systematic Reviews, Risk of Bias in Systematic Review, and the Grading of Recommendations Assessment, Development and Evaluation were used to assess the quality of reports, methodological quality, risk of bias, and level of evidence; R was used for visual analysis of the relevant contents.

RESULTS

Twenty SRs (13 Chinese and 7 English articles), all authored by Chinese authors as the first author, were included. The reporting information of most included studies was relatively complete (21-27 points), accounting for three-fourths of the total literature. The quality of the methods used in all studies was critically low. The risk of bias was mostly high. Results of the evidence summary showed that among the "moderate" evidence, KLTi combined with chemotherapy had benefits of 9.7-16.4% for objective response rate (ORR) (11 SRs), 8.1-14% for disease control rate (four SRs), and 20.1-28.6% for quality of life (12 SRs) compared with those of chemotherapy alone. The incidence of gastrointestinal symptoms (five SRs) was reduced by 11.5%-23.2%, while that of leukopenia (four SRs) improved by 19.5-29.2%. Combined radiotherapy and targeted therapy had benefits of 25.9% and 16.8%, respectively, in ORR and 31.3% and 22.8%, respectively, in quality of life (the quality of evidence was "low"). The results depicted that treatment with two courses of KLTi produce the best results.

CONCLUSION

Our results suggest that KLTi, whether combined with chemotherapy, radiotherapy, or targeted therapy, has an effect on ORR and quality of life and induces adverse reactions, such as leukopenia, nausea, and vomiting. It may improve patient survival; however, the impact of its low-grade quality on the immune function remains undetermined. Owing to the low reporting quality and methodological quality and high risk of bias of the SRs and the included studies, clinical application of KLTi remains unelucidated; higher-quality SRs and randomized controlled trials are necessary in the future.

摘要

民族药理学相关性

康莱特注射液(KLTi)是一种中药,用作非小细胞肺癌(NSCLC)的辅助治疗药物。

研究目的

通过评估系统评价(SRs)的报告质量、方法学质量、偏倚风险和证据质量,为KLTi的临床应用和选择提供循证支持。

材料与方法

截至2022年3月24日,通过检索12个数据库、咨询专家以及检索相关会议论文,对KLTi辅助治疗NSCLC的SRs进行检索。治疗组接受KLTi联合其他疗法,无论剂量、疗程或联合的疗法如何。排除使用重复数据的网络荟萃分析和SRs。使用《系统评价和荟萃分析的首选报告项目》2009版、评估系统评价的测量工具、系统评价中的偏倚风险以及推荐分级评估、制定和评价方法来评估报告质量、方法学质量、偏倚风险和证据水平;使用R软件对相关内容进行可视化分析。

结果

纳入20篇SRs(13篇中文和7篇英文文章),所有文章的第一作者均为中国作者。大多数纳入研究的报告信息相对完整(21 - 27分),占文献总数的四分之三。所有研究中使用的方法质量极低。偏倚风险大多较高。证据总结结果显示,在“中等”证据中,与单纯化疗相比,KLTi联合化疗在客观缓解率(ORR)方面有9.7 - 16.4%的获益(11篇SRs),疾病控制率方面有8.1 - 14%的获益(4篇SRs),生活质量方面有20.1 - 28.6%的获益(12篇SRs)。胃肠道症状的发生率(5篇SRs)降低了11.5% - 23.%, 而白细胞减少症的发生率(4篇SRs)改善了19.5 - 29.2%。联合放疗和靶向治疗在ORR方面分别有25.9%和16.8%的获益,在生活质量方面分别有31.3%和22.8%的获益(证据质量为“低”)。结果表明,两个疗程的KLTi治疗效果最佳。

结论

我们的结果表明,KLTi无论与化疗、放疗还是靶向治疗联合使用,对ORR和生活质量都有影响,并会引发白细胞减少、恶心和呕吐等不良反应。它可能会提高患者生存率;然而,其低质量对免疫功能的影响仍未确定。由于SRs及纳入研究的报告质量和方法学质量较低,偏倚风险较高,KLTi的临床应用仍不明确;未来需要更高质量的SRs和随机对照试验。

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