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目的:对文献进行Meta分析,评价树突状细胞疫苗(DC疫苗)治疗前列腺癌的安全性及临床有效性,探讨疫苗临床获益率相关性的因素。方法:根据Cochran协作网制定的策略,使用Medline数据库进行英文检索,根据纳入和排除标准,收集前列腺癌DC疫苗治疗的随机对照试验(RCT),对符合检索条件的文献进行系统评价,文献质量评价和数据提取由2名评价员独立完成,使用RevMan 5.0和SPSS17.0软件进行分析。结果:共有10篇RCT的文献共179例前列腺癌患者临床资料纳入Meta分析,前列腺癌DC疫苗临床获益率(CBR)为54.2%,客观缓解率(完全缓解+部分缓解+混合疗效)为7.7%;仅有轻微不良反应,多为注射部位的局部反应、发热、流感样症状等。分析结果显示:前列腺癌患者给予DC疫苗后出现细胞免疫反应(OR=31.12,95%CI=5.52～175.6,P<0.01)和PSA对数斜率降低(OR=4.38,95%CI=1.17～16.35,P=0.03)与临床获益呈正相关,疫苗剂量(OR=5.98,95%CI=1.45～24.62,P=0.01)对临床获益率有显著影响;患者年龄(P=0.53)与临床获益无相关性。此外,密度富集法获得的DC临床获益率更高;给药途径与临床获益率无相关性。结论:前列腺癌DC疫苗是治疗前列腺癌的有效手段,安全性高,耐受性良好。研究发现前列腺癌DC疫苗介导的细胞免疫反应对临床获益率有显著影响,免疫反应可作为疫苗疗效评价的主要指标。但由于可纳入研究的文献数较少,需要大样本多中心、研究质量高的RCT以明确更好的循证证据。
OBJECTIVE: To evaluate the safety and clinical efficacy of dendritic cell vaccine (DC vaccine) in the treatment of prostate cancer by meta-analysis of the literature and to explore the factors related to the clinical benefit rate of the vaccine. METHODS: According to the strategy of Cochrane Collaboration, the Medline database was used to carry out English search. According to inclusion and exclusion criteria, randomized controlled trials (RCTs) of prostate cancer DC vaccines were collected to systematically evaluate the literatures eligible for retrieval, Data extraction was done independently by two reviewers and analyzed using RevMan 5.0 and SPSS17.0 software. Results: A total of 179 RCT articles were included in the Meta-analysis. Prostate cancer DC vaccine clinical benefit rate (CBR) was 54.2%. The objective response rate (complete response + partial response + combined effect) was 7.7 %; Only mild adverse reactions, mostly local injection site reactions, fever, flu-like symptoms. The results showed that the cellular immune response (OR = 31.12, 95% CI = 5.52-175.6, P <0.01) and the logarithm slope of PSA decreased after DC vaccination in prostate cancer patients (OR = 4.38,95% CI = 1.17-16.35 , P = 0.03) was positively correlated with clinical benefit. The vaccine dose (OR = 5.98, 95% CI = 1.45-24.62, P = 0.01) had a significant effect on the clinical benefit rate; No relevant benefits. In addition, the DC clinical benefit rate obtained by density-enrichment method is higher; the route of administration has no correlation with the clinical benefit rate. Conclusion: Prostate cancer DC vaccine is an effective treatment for prostate cancer, which is safe and well tolerated. The study found that DC vaccine-mediated cellular immune response to prostate cancer has a significant impact on the clinical benefit rate, immune response can be used as a major indicator of vaccine efficacy evaluation. However, due to the small number of articles that can be included in the study, large sample multicentre studies of RCTs of high quality are needed to identify better evidence-based evidence.