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中华乳腺病杂志(电子版)

中华乳腺病杂志(电子版) ›› 2019, Vol. 13 ›› Issue (03) : 150 -158. doi: 10.3877/cma.j.issn.1674-0807.2019.03.004

所属专题： 文献；

论著

乳腺癌保留乳房手术中放射治疗有效性和安全性的Meta分析
薛玉1, 徐晓帆2, 顾军2,†()   
  1. 1. 210009　南京，东南大学医学院临床医学系
    2. 210002　南京，解放军东部战区总医院普通外科研究所
  • 收稿日期:2018-12-28 出版日期:2019-06-01
  • 通信作者: 顾军
  • 基金资助:
    南京军区南京总医院课题资助项目(2015021); 江苏省社会发展基金资助项目(BE2017726)

Efficacy and safety of intraoperative radiotherapy in breast conservative surgery for breast cancer patients: a meta-analysis

Yu Xue1, Xiaofan Xu2, Jun Gu2,†()   

  1. 1. Department of Clinic Medicine, School of Medicine, Southeast University, Nanjing 210009, China
    2. Research Institute of General Surgery, General Hospital of Eastern Military Command of PLA, Nanjing 210002, China
  • Received:2018-12-28 Published:2019-06-01
  • Corresponding author: Jun Gu
  • About author:
    Corresponding author: Gu Jun, Email:
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引用本文：

薛玉, 徐晓帆, 顾军. 乳腺癌保留乳房手术中放射治疗有效性和安全性的Meta分析[J]. 中华乳腺病杂志(电子版), 2019, 13(03): 150-158.

Yu Xue, Xiaofan Xu, Jun Gu. Efficacy and safety of intraoperative radiotherapy in breast conservative surgery for breast cancer patients: a meta-analysis[J]. Chinese Journal of Breast Disease(Electronic Edition), 2019, 13(03): 150-158.

目的

评价乳腺癌保留乳房手术中放射治疗的有效性和安全性。

方法

用计算机检索中国知网、维普、万方、PubMed、Cochrane、Web of Science和Embase数据库，检索时限为建库至2018年12月20日，收集有关乳腺癌保留乳房手术中放射治疗有效性和安全性的临床试验研究。由2名研究者独立按照纳入及排除标准进行文献筛选、资料提取、方法学质量评价后，采用RevMan 5.3软件对纳入研究进行Meta分析。

结果

共纳入12项研究，包括8项随机对照研究(RCT)和4项非RCT，共6 277例患者。与术后放射治疗者比较，术中放射治疗患者的局部复发率更高(RR＝2.78，95%CI: 1.25～6.19，P＝0.01)，切口愈合时间更长[均数差(MD)＝5.92，95%CI: 5.46～6.37，P<0.01]，但在远处转移率和OS率方面与术后放射治疗者比较，差异均无统计学意义(RR＝0.92，95%CI: 0.62～1.37，P＝0.68；RR＝1.01，95%CI: 1.00～1.01，P＝0.26)。术中放射治疗患者的美容优良率高于术后放射治疗(RR＝1.17，95%CI: 1.05～1.31，P<0.01)。术中放射治疗患者的脂肪液化率和渗出率与术后放射治疗患者比较，差异均无统计学意义(RR＝2.18，95%CI: 0.71～6.72，P＝0.18；RR＝1.55，95%CI: 0.36～6.68，P＝0.56)。

结论

术中放射治疗在远处转移率、总生存率及不良反应方面与术后放射治疗相似，且有更好的美容效果，但其局部复发率可能更高，应选择复发风险较低的患者。

关键词: 乳腺肿瘤, Meta分析, 放射疗法, 保留乳房手术
Objective

To evaluate the clinical efficacy and safety of intraoperative radiotherapy in breast conservative surgery for breast cancer patients.

Methods

The databases including CNKI, VIP, Wanfang, PubMed, Cochrane, Web of Science, Embase were retrieved to identify clinical trials which investigated the efficacy and safety of intraoperative radiotherapy in breast conservative surgery from the date of establishment to December 20, 2018. Two researchers independently performed literature screening, data extraction, and methodological quality evaluation according to the inclusion and exclusion criteria. An meta-analysis of the included studies was performed using RevMan 5.3 software.

Results

Totally 12 clinical trials (6 277 subjects) including 8 randomized controlled trials (RCT) and 4 non-RCT were enrolled. Meta-analysis showed that the local recurrence rate in patients with intraoperative radiotherapy was significantly higher than that in patients with postoperative radiotherapy (RR=2.78, 95%CI: 1.25-6.19, P=0.01), and the wound healing time was significantly longer [mean difference (MD)=5.92, 95%CI: 5.46-6.37, P<0.01]. There was no significant difference in distant metastasis rate and overall survival between intraoperative radiotherapy group and postoperative radiotherapy group (RR=0.92, 95%CI: 0.62-1.37, P=0.68; RR=1.01, 95%CI: 1.00-1.01, P=0.26). The patients undergoing intraoperative radiotherapy had significantly better cosmetic effect compared with the patients with postoperative radiotherapy (RR=1.17, 95%CI: 1.05-1.31, P<0.01). The fat liquefaction rate and exudation rate presented no significant difference between intraoperative radiotherapy group and postoperative radiotherapy group(RR=2.18, 95%CI: 0.71-6.72, P=0.18; RR=1.55, 95%CI: 0.36-6.68, P=0.56).

Conclusion

Intraoperative radiotherapy is not inferior to postoperative radiotherapy in distant metastasis rate, overall survival and adverse reaction, but with better cosmetic effect and a higher local recurrence rate, so the patients with low risk of recurrence are recommended.

Key words: Breast neoplasms, Meta-analysis, Radiotherapy, Breast conservative surgery
图1 文献筛选流程及结果
表1 纳入研究的基本情况
纳入研究 年份 研究设计 例数(T/C) 年龄(岁) 肿瘤直径(cm) 随访时间(月) 干预措施 结局指标 质量评分
Vaidya[3] 2016 RCT 1 721/1 730 ≥45 ≤3.5 29 T:术中20 Gy 50 kV X线；C:体外放射治疗 ①②③⑦ 5b
Veronesi[4] 2013 RCT 651/654 48～75 ≤2.5 70 T:术中21 Gy；C:全乳放射治疗 ①②③⑦ 5b
孙春雷[8] 2010 非RCT 36/41 35～69 ≤2.5 30 T:术中21 Gy 9 MeV电子线3～5 min；C:全乳放射治疗50～60 Gy，5～6周(全乳50 Gy，瘤床加量至60 Gy) ①②④⑤ 18a
Zhou[9] 2012 非RCT 72/71 ≥40 ≤2.5 32 T:术中21 Gy 9/12 MeV电子线3～5 min；C:术后传统放射治疗 ①②③④⑥ 20a
Cracco[10] 2015 非RCT 81/105 38～81 ≤3.0 17 T:术中21 Gy；C:体外放射治疗 ④⑥⑦ 21a
Sorrentino[11] 2018 非RCT 223/220 ≥50 ≤3.0 ≥12 T:术中21 Gy 2～4 min；C:体外放射治疗 ①②③⑥ 22a
Sperk[12] 2012 RCT 54/55 T:中位64.4;C:中位69.0 ≤3.5 40 T:术中20 Gy；C:全乳放射治疗46～50 Gy ①②③ 4b
肖海燕[13] 2013 RCT 70/70 33～68 未提及 8～24 T:术中21 Gy 9/12 MeV电子线3～5 min；C:全乳放射治疗 ①②③④⑤ 2b
彭宗玉[14] 2013 RCT 60/60 29～68 ≤2.5 8～24 T:术中21 Gy 9/12 MeV电子线3～5 min；C:全乳放射治疗 ①②③④⑤⑥ 3b
董世亮[15] 2016 RCT 44/44 30～68 ≤2.5 12 T:术中21 Gy 9/12 MeV电子线3～5 min；C:全乳放射治疗 ④⑥⑦ 2b
刘军[16] 2017 RCT 54/55 30～68 ≤3.0 12 T:术中21 Gy 9 MeV电子线5 min；C: 21 Gy全乳放射治疗 ②④⑥⑦ 2b
宋艾红[17] 2018 RCT 53/53 45～71 ≤3.0 60 T：术中9 Gy 9/12 MeV电子线3～5 min；C:全乳放射治疗 ②③④⑤⑥ 5b
图2 术中放射治疗组与术后放射治疗组乳腺癌患者局部复发率的森林图及异质性检验结果
图3 术中放射治疗组与术后放射治疗组乳腺癌患者远处转移率的森林图及异质性检验结果
图4 术中放射治疗组与术后放射治疗组乳腺癌患者总生存率的森林图及异质性检验结果
图5 术中放射治疗组与术后放射治疗组乳腺癌患者美容优良率的森林图及异质性检验结果
图6 术中放射治疗组与术后放射治疗组乳腺癌患者切口愈合时间的森林图及异质性检验结果
图7 术中放射治疗组与术后放射治疗组乳腺癌患者脂肪液化率的森林图及异质性检验结果
图8 术中放射治疗组与术后放射治疗组乳腺癌患者渗出率的森林图及异质性检验结果
图9 术中放射治疗组与术后放射治疗组乳腺癌患者远处转移率比较的论文发表偏倚漏斗图
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