中药注射液辅助治疗前列腺癌随机对照试验的系统综述

Systematic Review of Randomized Controlled Trials for Adjuvant Therapy of Prostate Cancer with Chinese Medicine Injection

目的评价中药注射液辅助治疗前列腺癌的临床疗效及安全性。方法检索中国知网数据库(CNKI)、中国生物医学文献数据库(Sino Med)、重庆维普中文科技期刊数据库(VIP)、万方数据库(Wanfang Data),Pub Med、Cochrane Library英文数据库以及美国临床试验注册系统,截止时间2016年1月31日,将纳入的文献采用Cochrane偏倚风险评估,并使用Rev Man 5.3软件进行Meta分析。结果最终纳入14项随机对照研究共计804例患者。苦参注射液联合西医治疗对生活质量的改善优于单纯西医治疗(P<0.0001);参芪扶正注射液联合化疗在化疗毒性反应各项分级中发生不良事件人数较单纯化疗少(P<0.05);苦参注射液在白细胞减少方面具有一定作用(P<0.05);鸦胆子注射液、肿节风注射液联合内分泌治疗较单纯内分泌治疗对前列腺特异性抗原水平改善具有统计意义(P<0.0001)。Meta分析显示,中药注射液联合内分泌治疗对卡氏评分改善率是单纯内分泌治疗的1.77倍(RR=1.77,95%CI[1.34,2.35],I2=0%,4项研究);参芪扶正注射液联合内分泌治疗对前列腺体积改善较单纯内分泌治疗明显(MD=-5.73,95%CI[-7.44,-4.02],2项研究)。结论中药注射液辅助治疗对改善前列腺癌患者生活质量、前列腺特异性抗原水平、卡氏评分、国际前列腺症状评分、血清睾酮、前列腺体积水平,降低化疗后毒副反应等可能具有一定疗效,但由于现有证据质量较低,该结论有待于高质量的研究加以证实。

Objective To evaluate the efficacy and safety of adjuvant therapy of prostate cancer with Chinese medicine injection. Methods Literature in CNKI, SinoMed, China science and technology journal database of Chongqing VIP Information Co. , Ltd. （VIP） , Wangfang Data, PubMed, Cochrane Library and Clinical Trials was retrieved up to Jan. 31st, 2016. The risk of bias of the literature screened was assessed through Cochrane Criteria, and the meta-analysis was conducted by RevMan 5.3 software. Results There were 14 RCTs eventually selected, including 804 patients totally. Kushen Injection （苦参注射液） combined with western medicine improved the quality of life significantly better than western medicine alone （P 〈 0. 0001 ）. In each grade of National Cancer Institute Common Terminology Criteria for Adverse Events （ NCI-CTCAE）, the number of patients with adverse reactions was smaller if they were treated by Shenqi Fuzheng Injection （参芪扶正注射液） combined with chemotherapy instead of chemotherapy alone （P 〈 0.05 ）. The Kushen Injection could ameliorate leukopenia （P 〈 0. 05 ）. Yadanzi Injection （鸦胆子注射液） or Zhongjiefeng Injection （肿节风注射液） combined with endocrine therapy showed significant difference in reducing the level of prostate specific antigen （PSA） （ P 〈 0. 0001 ）. Meta-analysis showed that Chinese medicine injection combined with endocrine therapy could improve Karnofsky Score 1.77 times compared with endocrine thera- py alone （ RR = 1.77, 95% CI [ 1.34, 2.35 ], 12 = 0%, 4 studies involved）. Shenqi Fuzheng Injection combined with endocrine therapy could reduce the prostate volume （PV） more significantly than endocrine therapy alone （ MD = -5.73, 95% CI [ -7.44, -4.02 ], 2 studies involved）. Conclusion As an adjuvant therapy, Chinese medi- cine injection could improve the quality of life of patients with prostate cancer and reduce PSA level, Karnofsky Score, international prostate symptom score （IPSS）, the level of serum testosterone and PV. It may also reduce the adverse effects. But these evidences are of low-quality till now, and more supportive studies of high-quality are expected.