铜绿假单胞菌制剂辅助治疗恶性肿瘤疗效的系统评价

Systematic review of efficacy of pseudomonas aeruginosa-mannose sensitive hemagglutinin for tumor

摘要:

目的：系统评估铜绿假单胞菌制剂（pseudomonas aeruginosa-mannose sensitive，PA-MSHA）辅助治疗恶性肿瘤的疗效。方法：计算机检索PubMed、Sciverse、Cochrone Library、中国知网、CBM、VIP及万方数据库，检索时间均从建库至2014年11月。收集关于PA-MSHA辅助治疗恶性肿瘤的随机对照研究（RCTs），2名研究者根据纳入排除标准独立筛选文献，应用Revman 5.3进行Meta分析。结果：通过筛选纳入10个RCTs，共计611例。在治疗效果方面，实验组完全缓解率（complete remission，CR）（RR=1.95，95%CI=1.37～2.79，P=0.000 2）、总有效率（overall response rate，RR）（RR=1.34，95%CI=1.06～1.69，P=0.01）明显高于对照组，对照组进展率（progressive rate of disease，PD）（P=0.001）高于实验组，而２组部分缓解率（partial remission，PR）和稳定率（stable rate of disease，SD）无统计学差异；在免疫学指标方面，实验组CD3（SMD=0.93，95%CI=0.16～1.70，P=0.02）、NK细胞（SMD=1.40，95%CI=0.26，2.53，P=0.02）和IFN-γ（MD=16.92，95%CI=12.88～20.96，P＝0.000）高于对照组，而2组CD4、CD8水平及CD4/CD8无统计学差异；同时实验组Karnofsky评分（P＝0.000）高于对照组。亚组分析后显示，实验组肺癌患者CR（P=0.006）、PD（P=0.04）及NK细胞（P＝0.000）明显高于对照组，乳腺癌患者RR（P=0.01）、Karnofsky评分（P<0.000 01）高于对照组；新辅助化疗联合PA-MSHA能够提高Karnofsky评分（P=0.000 2），化疗联合PA-MSHA能够提高患者CR（P=0.000 2）、PD（P=0.003）、Karnof－sky评分（P＝0.000），而对PR、SD无影响。结论：PA-MSHA辅助治疗恶性肿瘤，能够提高机体抗肿瘤效应，值得临床推广。

Abstract:

Objective：To systematically evaluate the efficacy of pseudomonas aeruginosa-mannose sensitive（PA-MSHA） for tumor. Methods：Randomized controlled trials（RCTs） about the efficacy of PA-MSHA on tumor were retrieved in Pubmed，Sciverse，Cochrone Library，CNKI，CBM，VIP and WanFang databases up to November，2014. According to the inclusion and exclusion criteria，two reviewers independently screened the trials，extracted the data，assessed the quality，conducted the Meta-analysis with Revman 5.3 finally. Results：A total of 10 RCTs were eligible for the study including 611 cases. The pooled results showed that complete re－mission（CR）（RR=1.95，95%CI=1.37 to 2.79，P=0.000 2） and overall response rate（RR）（RR=1.95，95%CI=1.37 to 2.79，P=0.000 2）were increased and progression rate of disease（PD） RR=0.42，95%CI=0.24 to 0.71，P=0.001）was decreased in experiment groups，however，partial response rate（PR） and stability rate of disease（SD） were not different in both two groups. Meanwhile，the count of CD3（SMD=0.93，95%CI=0.16 to 1.70），P=0.02），NK cell（SMD=1.40，95%CI=0.26 to 2.53，P=0.02），IFN-γ（MD=16.92，95%CI=12.88 to 20.96，P=0.000）was higher in experiment group than in control group. There was no statically difference in the number of CD4，CD8 and between two groups. Karnofsky scores were also higher in experiment group than in control group. The pooled results of subgroup analysis indicated that CR（P=0.006），PD（P=0.04） and NK cell（P=0.000） were increased in experiment group in lung cancer patients. RR（P=0.01） and Karnofsky scores（P=0.000） were also increased in experiment group in breast cancer patients. The results also showed that neo-adjuvant chemother－apy with PA-MSHA could improve Karnofsky scores（P=0.000 2）. Chemotherapy with PA-MSHA could improve CR（P=0.000 2），PD（P=0.003） and Karnofsky scores（P=0.000），oppositely，there was no difference in PR（P=0.73） and SD（P=0.39） between the two groups. Conclusion：PA-MSHA can effectively increase treat the tumor and enhance host anti-tumor function. PA-MSHA should be widely used in tumor administration in clinical application.