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平消胶囊辅助治疗乳腺癌的有效性和安全性:系统评价和 Meta 分析。

Effectiveness and safety of Pingxiao capsule as adjuvant therapy in treatment of breast cancer: a systematic review and Meta-analysis.

机构信息

Henan University of Chinese Medicine, Zhengzhou 450046, China.

Department of Pharmacy, the First Affiliated Hospital of Henan University of Chinese Medicine.

出版信息

J Tradit Chin Med. 2023 Oct;43(5):851-859. doi: 10.19852/j.cnki.jtcm.20230713.001.

Abstract

OBJECTIVE

To systematically review the effectiveness and safety of Pingxiao capsule adjuvant chemotherapy in the treatment of breast cancer.

METHODS

A total of 8 databases including the Cochrane Library, PubMed, EMBASE, Engineering Index, Chinese Biomedical Literature Database, Wanfang database, China National Knowledge Infrastructure Database, and China Science and Technology Journal Database were searched for the Randomized Controlled Trials (RCTs) of Pingxiao capsule combined with chemotherapy in the treatment of breast cancer published before June 2022. Two researchers independently screened the literature, extracted data, and evaluated the risk of bias. R language was used for estimating risks of bias of included studies, data analysis, and plotting.

RESULTS

A total of 15 RCTs involving 1272 patients were included in this study. Meta-analysis results indicated that compared with chemotherapy alone, Pingxiao capsule combined with chemotherapy could significantly improve breast cancer patients' objective response rate of breast cancer patients [rate ratio () = 1.35, 95% confidence interval () (1.12, 1.63), = 0.0017], the disease control rate [=1.16, 95% (1.08, 1.25), < 0.0001], the quality of life [ =1.42, 95% (1.16, 1.74), = 0.007], and the level of the immune cells [CD3+: standardized mean difference () =1.42, 95% (0.76, 2.09), < 0.001; CD4+: =1.18, 95% (0.70, 1.66), < 0.001]. In addition, Pingxiao capsule combined with chemotherapy can also significantly reduce CD8+ level ( < 0.0001) and reduce the symptoms of decreased white blood cell count [ = 0.62, 95% (0.39, 0.85), < 0.0001], and the occurrence of adverse reactions such as gastrointestinal adverse reactions and limb pain ( < 0.05).

CONCLUSIONS

Pingxiao capsule can significantly improve the efficacy of chemotherapy, the quality of life and immune function of patients, and reduce the clinical side effects caused by chemotherapy. However, high-quality randomized clinical trials with large samples are required for further verification of these results.

摘要

目的

系统评价平消胶囊辅助化疗治疗乳腺癌的有效性和安全性。

方法

计算机检索 Cochrane 图书馆、PubMed、EMBASE、Engineering Index、中国生物医学文献数据库、万方数据库、中国知网数据库和中国科技期刊数据库,搜集平消胶囊联合化疗治疗乳腺癌的随机对照试验(RCT),检索时限均为建库至 2022 年 6 月。由 2 位研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用 R 语言进行估计纳入研究的偏倚风险、数据合并及绘制森林图。

结果

共纳入 15 项 RCT,总计 1272 例患者。Meta 分析结果显示,与单纯化疗相比,平消胶囊联合化疗可显著提高乳腺癌患者的客观缓解率[率比(RR)=1.35,95%置信区间(CI)(1.12,1.63),=0.0017]、疾病控制率[RR=1.16,95%CI(1.08,1.25),<0.0001]、生活质量[RR=1.42,95%CI(1.16,1.74),=0.007],以及免疫细胞水平[CD3+:标准化均数差(SMD)=1.42,95%CI(0.76,2.09),<0.001;CD4+:RR=1.18,95%CI(0.70,1.66),<0.001]。此外,平消胶囊联合化疗还可显著降低 CD8+水平[RR=-0.38,95%CI(-0.25,-0.56),<0.0001],减少白细胞减少等化疗相关不良反应症状[RR=0.62,95%CI(0.39,0.85),<0.0001]及胃肠道不良反应和手足痛等不良反应的发生(<0.05)。

结论

平消胶囊能显著提高化疗疗效,改善患者的生活质量和免疫功能,降低化疗所致的临床毒副反应。但仍需开展更多高质量、大样本的随机临床对照试验进一步验证上述结果。

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