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

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

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（Wanfang）、中国生物医学文献数据库（CBM）、中国期刊全文数据库（CNKI）、中国科技期刊全文数据库（VIP）、PubMed、EMBASE、the Co-chrane Library，检索时间均从建库开始截至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项研究，共371例患者。 Meta 分析结果显示：①生活质量：两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）和生活质量降低（OR =0．29，95％CI：0．16～0．54，P ＜0．00001）方面的差异均有统计学意义；②治疗前后的 PSA 水平变化：两组患者 PSA 水平治疗一个月后（OR =-3．49，95％CI：-15．03～8．05，P =0．55）、治疗3个月后（OR =-5．99，95％CI：-17．06～5．08，P =0．29）和治疗6个月后（OR =-3．25，95％CI：-16．89～10．38，P =0．64）PSA 的变化均无统计学意义；③血清睾酮的变化：两组患者血清睾酮水平在治疗1个月后的差异有统计学意义（OR =1．92，95％CI：-0．10～3．74，P =0．04），在治疗3个月后（OR =-0．09，95％CI：-1．83～1．65，P =0．92）和治疗6个月后（OR =-0．15，95％CI：-1．85～1．55，P =0．86）的差异均无统计学意义；④不良反应：两组患者发生不良反应的人数差异无统计学意义（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，在降低患者不良反应发生率方面不具优势，但结论尚需更多高质量、大样本的随机对照试验加以验证。

Objective： 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 emul-sion 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： ① the quality of life： there were statistical significant differences in improving KPS scores （OR =3.57, 95%CI： 2.24 ~5.67, P 〈0.00001）, stabilizing KPS scores （OR =0.58,95%CI：0.37 ~0.92,P =0.02） and inducing KPS scores （OR =0.29,95%CI： 0.16 ~0.54, P 〈0.00001）.②The change of the level of ser-um 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 ser-um 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.More high quality and large sample RCTs are needed to verify the validity.