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降低曲妥珠单抗使用时间对HER-2阳性乳腺癌患者影响的系统评价
Effectiveness of Reducing Trastuzumab Use Time on HER-2 Positive Breast Cancer Patients: A Systematic Review
  
DOI:
中文关键词:  曲妥珠单抗  乳腺癌  随机对照试验  系统评价
英文关键词:Trastuzumab  Breast cancer  Randomized controlled trial  Systematic review
基金项目:中国药学会医院处方分析合作项目(编号:312120242)
作者单位
田方圆 张莹 陈昭燕 徐珽 四川大学华西医院临床药学部 成都 610041 
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中文摘要:
      摘 要 目的:系统评价降低曲妥珠单抗使用时间对人类表皮生长因子受体2(HER-2)阳性乳腺癌患者的影响。方法:计算机检索PubMed、Embase、the Cochrane Library(2018年5期)、Clinicaltrial.gov、SinoMed、CNKI、WanFang Data和VIP数据库,搜集曲妥珠单抗不同给药疗程治疗HER-2阳性乳腺癌患者的随机对照试验(RCTs),检索时限均为建库至2018年5月。由两位研究人员独立进行文献筛选、数据提取和偏倚风险评价后,采用RevMan 5.3软件进行Meta分析。 结果:共纳入4个RCTs,包括9 466例患者,Meta分析结果显示,与对照组(6个月组)相比,试验组(12个月组)因心脏毒性提前停药[Peto OR=2.49,95%CI(1.83,3.39),P<0.000 01]、心功能障碍[Peto OR=1.50,95%CI(1.23,1.83),P<0.000 1]、LVEF<50% [Peto OR=1.39,95%CI(1.14,1.70),P=0.001]的发生率更高,差异有统计学意义。两组在有效率与死亡率方面的差异无统计学意义(P>0.05)。结论:当前证据表明,缩短曲妥珠单抗的使用时间,并未降低治疗效果,但却可以降低心脏毒性。受纳入研究数量和质量的影响,上述结论尚需大样本高质量临床研究予以证实。
英文摘要:
      ABSTRACT Objective: To systematically evaluate the effect of reducing trastuzumab use time on HER-2 positive breast cancer patients. Methods:PubMed, EMBase, The Cochrane Library (Issue 5, 2018), Clinicaltrial.gov, SinoMed, CNKI, WanFang Data and VIP databases were electronically searched to collect randomized controlled trials (RCTs) of reducing trastuzumab use time on HER-2 positive breast cancer patients from inception to May 2018. Two reviewers independently screened literatures, extracted data and assessed risk of bias of included studies. Then Meta analysis was performed by RevMan 5.3 software. Results:A total of 4 RCTs involving 9 466 patients were included. The results of Meta analysis showed that: compared with control group (6 months group), the early cardiac discontinuation due to cardiotoxicity (Peto OR=2.49, 95%CI 1.83 to 3.39, P<0.000 01), the cardiac function obstacle (Peto OR=1.50, 95%CI 1.23 to 1.83, P<0.000 1), LVEF<50% (Peto OR=1.39, 95%CI 1.14 to 1.70, P=0.001) of experimental group (12 months group) was higher, the difference was statistically significant. There was no significant difference between the two groups in the efficiency and mortality rate (P>0.05). Conclusion: Current evidence showed that shortening the use of trastuzumab didn’t reduce the effect, but it could reduce cardiotoxicity. Due to the limited quality of included studies, the above conclusion still needed to be verified by more high quality studies.
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