绿脓杆菌注射液辅助治疗恶性肿瘤的安全性和疗效的系统评价

目的 评价绿脓杆菌注射液(pseudomonas aeruginosa injection，PAI)辅助治疗恶性肿瘤的临床疗效和安全性。方法 通过检索Cochrane Library、PubMed、Embase、CBM、CNKI、VIP和万方数据库，纳入相关的随机对照试验(randomized controlledtrail，RCT)。采用Jadad评分评价文献质量，使用Revman 5.3进行数据合并和分析。结果 纳入14项RCT，合计1 036例患者，其中PAI组526例，对照组510例。PAI组在疾病完全缓解率RR=1.64，95%CI(1.34，2.00)，P<0.000 1]、疾病部分缓解率RR=1.31，95%CI(1.12，1.53)，P=0.000 6]、疾病稳定率RR=0.35，95%CI (0.26，0.48)，P<0.000 1]和疾病进展(PD)率RR=0.45，95%CI (0.27，0.74)，P<0.000 1]方面与对照组有显著性差异。在不良反应方面，PAI显著增加了发热和皮肤局部反应的发生率，而2组在胸痛方面无显著性差异。结论 在常规手术和放化疗的基础上加用绿脓杆菌注射液辅助治疗恶性肿瘤时，虽然其增加了发热和皮肤局部反应的风险，但并无严重不良反应存在，同时可在一定程度上改善临床相关的指标。

Meta-analysis of Additional Pseudomonas Aeruginosa Injection for Malignant Tumor

OBJECTIVE To evaluate the efficacy and safety of pseudomonas aeruginosa injection (PAI) for malignant tumor. METHODS Online databases including Cochrane Library, PubMed, Embase, CBM, CNKI, VIP and WANFANG were searched, and relevant randomized controlled trials (RCTs) investigating PAI for malignant tumor were included. Jadad scale was used to assess literature quality and Revman 5.3 was used to analyze data. RESULTS Fourteen RCTs with 1 036 patients were included (PAI group, 526 cases; control group, 510 cases). Compared with control group, PAI achieved better results in aspects of complete remission(CR) RR=1.64, 95%CI=1.34~2.00, P<0.000 1], partial remission(PR) RR=1.31, 95%CI=1.12~1.53, P=0.000 6], stable disease(SD) RR=0.35, 95%CI=0.26~0.48, P<0.000 1] and progressive disease(PD) RR=0.45, 95%CI=0.27~ 0.74, P<0.000 1]. While it increased the risk of fever and skin reaction, and there was no significant difference in chest pain incidence. CONCLUSION Additional PAI increases the incidence of fever and skin reaction, while there are no severe events existed. Meanwhile, it also can to some extend improve relevant clinical index.