中国循证医学杂志

中国循证医学杂志

TE 方案与 CEF 方案比较治疗中国女性 TNM 分期ⅡA~ⅢC 乳腺癌的有效性和安全性的 Meta 分析

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目的 系统评价 TE 方案(多西紫杉醇或紫杉醇联合表柔比星治疗方案)和 CEF 方案(5-氟脲嘧啶、表柔比星、环磷酰胺联合治疗方案)治疗中国女性乳腺癌患者(TNM 分期ⅡA~ⅢC)的有效性和安全性。 方法 计算机检索 PubMed、EMbase、VIP、CNKI、WanFang Data 和 CBM 数据库,搜集关 TE 与 CEF 治疗中国女性乳腺癌的随机对照试验(RCT),检索时限均为建库至 2016 年 12 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 RevMan 5.3 软件进行 Meta 分析。 结果 共纳入 14 个 RCT。Meta 分析结果显示:TE 组的完全缓解率(CR)[OR=2.03,95%CI(1.48,2.79),P<0.001]和总有效率(RR)[OR=2.70,95%CI(2.06,3.55),P<0.001]优于 CEF 组;但两组在在心脏毒性、骨髓抑制、胃肠道反应发生率方面差异无统计学意义。 结论 与 CEF 方案相比,TE 方案治疗中国女性ⅡA~ⅢC 乳腺癌患者疗效更好,且安全性相当。受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。

Objective To systematically review the efficacy and safety of TE regimen versus CEF regimen for Chinese women with ⅡA to ⅢC stage breast cancer. Methods Databases including PubMed, EMbase, CBM, CNKI, VIP and WanFang Data databases were electronically searched from inception to December 2016 to collect randomized controlled trials about TE regimen versus CEF regimen for Chinese women with ⅡA to ⅢC stage breast cancer. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed by using RevMan 5.3 software. Results A total of 14 RCTs were included. The results of meta-analysis showed that: the complete remission rate (CR) (OR=2.03, 95%CI 1.48 to 2.79, P<0.001) and clinical efficacy rate (RR) (OR=2.70, 95%CI 2.06 to 3.55,P<0.001) in TE group were superior to the CEF group. But there were no differences between two groups in cardiac toxicity, myelosuppression and gastrointestinal reactions. Conclusion TE regimen is superior to CEF in terms of efficacy for the Chinese women with ⅡA to ⅢC stage breast cancer, and there is no differences between the incidence of adverse reactions. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify above conclusion.

关键词: 乳腺癌; 新辅助化疗; TE 方案; CEF 方案; 中国女性; 随机对照试验; 系统评价; Meta 分析

Key words: Breast cancer; Neoadjuvant chemotherapy; TE regimen; CEF regimen; Chinese women; Randomized controlled trial; Systematic review; Meta-analysis

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