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

苦参注射液联合化疗治疗乳腺癌术后患者的疗效和安全性:一项随机对照试验的荟萃分析

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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.

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