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鸦胆子油乳联合内分泌治疗中晚期前列腺癌有效性和安全性的Meta分析

石芳毓,李金龙,张明霞,马继春,田金徽   

  1. 兰州大学循证医学中心兰州,兰州大学第一临床医学院,兰州大学第二临床医学院,兰州大学第一临床医学院,兰州大学循证医学中心
  • 收稿日期:2014-08-24 修回日期:2014-09-19 出版日期:2014-10-25 发布日期:2014-10-25

Effectiveness and Safety of Fructus Brucea Oil Emulsion plus Endocrine Drugs in the Treatment of Advanced Prostate Cancer: A Meta-Analysis

  1. Evidence based medicine center of Lanzhou University,,,,
  • Received:2014-08-24 Revised:2014-09-19 Online:2014-10-25 Published:2014-10-25

摘要: 目的:系统评价鸦胆子油乳联合内分泌治疗前列腺癌的有效性与安全性。方法:计算机检索万方数据库、中国生物医学文献数据库、中国知网、维普数据库、PubMed、EMBASE、the Cochrane Library,检索时间均从建库开始截止2014年7月,语种不限。纳入鸦胆子油乳联合内分泌对比内分泌治疗前列腺癌的随机对照试验,采用ReVMan5.2软件进行Meta分析。结果:最终纳入7个研究,共371例患者。Meta分析结果显示:①2组患者在生活质量改善(OR=3.57, 95%CI: 2.24-5.67, P<0.00001)、生活质量稳定(OR=0.58, 95%CI: 0.37-0.92, P=0.02)方面的差异有统计学意义;②2组患者PSA水平治疗1个月(MD=-3.49, 95%CI: -15.03-8.05, P=0.55)、3个后(MD=-5.99, 95%CI: -17.06-5.08, P=0.29)和6个月(MD=-3.25, 95%CI: -16.89-10.38, P=0.64)的变化均无统计学意义;③2组患者血清睾酮水平在治疗1个月的差异有统计学意义(MD=1.92, 95%CI: -0.10-3.74, P=0.04),在治疗3个月(MD=-0.09, 95%CI: -1.83-1.65, P=0.92)和6个月(MD=-0.15, 95%CI: -1.85-1.55, P=0.86)的差异均无统计学意义;④2组患者不良反应发生情况方面差异无统计学意义(OR=0.87, 95%CI: 0.37-2.07, P=0.76)。结论:鸦胆子油乳联合内分泌治疗前列腺癌的疗效优于单独内分泌治疗,并不能降低患者不良反应的发生率。

Abstract: Objectives: To evaluate the efficacy and safety of the combination of Fructus Brucea Oil Emulsion and endocrine drugs for advanced prostate cancer. Methods: Databases including WanFang, CBM, CNKI, VIP, PubMed, EMBASE, and the Cochrane Library were systematically searched through inception to July 2014 to include the randomized controlled trials (RCTs) of fructus brucea oil emulsion plus endocrine drugs for advanced prostate cancer. Meta-analysis was performed using RevMan5.2 software. Results: A total of 7 RCTs involving 371 patients were analyzed. The results of meta-analysis indicated: ①there was statistical significant differences in improving KPS scores (OR=3.57, 95%CI: 2.24-5.67, P<<0.00001). ②The change of the level of serum prostate specific antigen (PSA): There were no statistical significant differences in the change of the level of PSA after one month (MD=-3.49,95%CI: -15.03-8.05,P=0.55), three months (MD=-5.99,95%CI; -17.06-5.08,P=0.29), six months (MD=-3.25,95%CI: -16.89-10.38,P=0.64). ③The change of the level of serum testosterone: The change of the level of serum testosterone after one month (MD=1.92,95%CI: -0.10-3.74,P=0.04) have significant difference. The change of the level of serum testosterone after three months (MD=-0.09,95%CI: -1.83-1.65,P=0.92) and six months (MD=-0.15,95%CI: -1.85-1.55,P=0.86) have insignificant differences. ④Adverse events: there were no statistical significant differences in adverse events (MD=0.87,95%CI: 0.37-2.07,P=0.76). Conclusion: Fructus brucea oil Emulsion plus endocrine drugs has better efficacy, and the incidence of adverse events were similar in the treatment of advanced prostate cancer when compared to endocrine drugs alone.