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复方苦参注射液联合化疗对乳腺癌术后患者的疗效及安全性:一项随机对照试验的Meta分析

Efficacy and safety of compound Kushen injection combined with chemotherapy on postoperative Patients with breast cancer: A meta-analysis of randomized controlled trials.

作者信息

Ao Man, Xiao Xu, Li Qingshan

机构信息

Oncology Department.

Pharmacology Department, Affiliated Hospital of Chengde Medical School of Hebei Province, China.

出版信息

Medicine (Baltimore). 2019 Jan;98(3):e14024. doi: 10.1097/MD.0000000000014024.

Abstract

BACKGROUND

This meta-analysis aimed to assess efficacy and safety of combination of Kushen and chemotherapy or chemotherapy alone among postoperative patients with breast cancer receiving.

METHODS

A systematic literature search was conducted for relevant randomized controlled trials from 2000 to July 2017. Primary outcomes were clinical response rate (CRR) and performance status improvement by Karnofsky performance scale score (KPSS); secondary outcomes were adverse drug reactions (ADRs) rate and tumor marker decrease rate. Quality assessment and data analysis were performed with Review Manager 5.3.

RESULTS

A total of 16 studies with 1315 participants were included in the analysis. Compared with chemotherapy alone, compound Kushen injection (CKI or KI) combined with chemotherapy did not significant increase CRR. However, performance status improvement rate was significantly higher among patients given Kushen injection combined with chemotherapy (relative risk 1.25, 95% confidence interval 1.09-1.42, P = .001). In the analysis of ADRs, combination of Kushen and chemotherapy was indicated to significantly reduce the rate liver dysfunction, kidney dysfunction, nausea and vomiting, diarrhea, hair loss, platelet decrease, and oral mucositis.

CONCLUSION

Using CKI on the basis of chemotherapy might improve performance status and reduce ADRs among postoperative patients with breast cancer.

摘要

背景

本荟萃分析旨在评估在接受治疗的乳腺癌术后患者中,苦参与化疗联合应用或单纯化疗的疗效和安全性。

方法

对2000年至2017年7月的相关随机对照试验进行系统文献检索。主要结局指标为临床缓解率(CRR)和卡诺夫斯基功能状态量表评分(KPSS)所反映的功能状态改善情况;次要结局指标为药物不良反应(ADR)发生率和肿瘤标志物降低率。使用Review Manager 5.3进行质量评估和数据分析。

结果

共有16项研究、1315名参与者纳入分析。与单纯化疗相比,复方苦参注射液(CKI或KI)联合化疗并未显著提高CRR。然而,接受苦参注射液联合化疗的患者功能状态改善率显著更高(相对危险度1.25,95%置信区间1.09 - 1.42,P = 0.001)。在药物不良反应分析中,苦参与化疗联合应用显示可显著降低肝功能障碍、肾功能障碍、恶心呕吐、腹泻、脱发、血小板减少及口腔黏膜炎的发生率。

结论

在化疗基础上使用CKI可能改善乳腺癌术后患者的功能状态并降低药物不良反应。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7085/6370033/1683a0a02aca/medi-98-e14024-g001.jpg

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