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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、Pub Med、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。
Objective To evaluate the clinical efficacy and safety of pseudomonas aeruginosa injection (PAI) in adjuvant treatment of malignant tumors. Methods Randomized controlled trials (RCTs) were included in the Cochrane Library, Pub Med, Embase, CBM, CNKI, VIP and Wanfang databases. The quality of the literature was assessed using the Jadad score and the data was combined and analyzed using Revman 5.3. Results The RCTs included 14 RCTs, totaling 1 036 patients, of which 526 were in the PAI group and 510 in the control group. PAI patients had significantly lower disease response rates (RR = 1.31, 95% CI (1.12, 1.53), P = 0.0006] , Disease stability [RR = 0.35, 95% CI (0.26, 0.48), P <0.000 1], and disease progression (PD) rates [RR = 0.45,95% CI (0.27,0.74), P <0.0001] Significant difference with the control group. In adverse reactions, PAI significantly increased the incidence of fever and local skin reactions, while there was no significant difference in chest pain between the two groups. Conclusions The addition of Pseudomonas aeruginosa injection to adjuvant treatment of malignant tumors based on conventional surgery and chemoradiotherapy, although it increases the risk of fever and local skin reactions, does not result in serious adverse reactions and improves to a certain extent Clinical related indicators.