平消胶囊治疗乳腺癌的系统评价

Systematic Review of Pingxiao Capsules in Adjuvant Treatment of Breast Cancer

目的:系统评价平消胶囊治疗乳腺癌的疗效及安全性。方法:检索建库至2022年7月国内外数据库(中国知网、万方医学数据库、维普资讯、中国生物医学文献数据库、PubMed等)公开发表的相关文献,搜集平消胶囊辅助治疗乳腺癌的随机对照试验,分别由3名研究员进行独立的文献筛选,并对信息进行提取,然后对纳入研究的资料进行偏倚风险评估,最后使用RevMan 5.3软件进行Meta分析,并对结局指标进行证据质量评价。结果:共纳入15篇文献,总样本量1402例。Meta分析结果显示,平消胶囊能够提高乳腺癌患者的客观缓解率[RR=1.21,95%CI(1.09,1.35),P=0.0004],提高疾病控制率[RR=1.15,95%CI(1.01,1.31),P=0.03],改善中医证候疗效[RR=1.27,95%CI(1.06,1.53),P=0.01],降低不良反应发生率[MD=0.42,95%CI(0.28,0.56),P<00001]、[RR=0.53,95%CI(0.30,0.93),P=0.03]、[RR=0.43,95%CI(0.19,0.97),P=0.04];提高患者生活质量[MD=11.03,95%CI(0.90,21.16),P<03],改善患者的免疫功能CD3+[MD=1.42,95%CI(0.75,2.09),P<0.0001]、CD4+[MD=6.02,95%CI(3.55,8.55),P<0.0001]、CD8+[MD=-2.34,95%CI(-13.62,8.94),P=0.68]、CD4+/CD8+[MD=1.19,95%CI(0.28,2.11),P=0.01]。结论:平消胶囊治疗乳腺癌疗效确切,能降低不良反应发生率,提高实体瘤的客观缓解率,改善免疫功能。

Objective:To systematically evaluate the efficacy and safety of Pingxiao Capsules in the treatment of breast cancer.Methods:Relevant literature published in domestic and foreign databases(CNKI,Wanfang Medical Database,VIP Information,China Biomedical Literature Database,PubMed,etc.)from the establishment of the database to July 2022 was searched,and randomized controlled trials(RCTs)of Pingxiao Capsules in the adjuvant treatment of breast cancer were collected.Three researchers independently screened the literature and extracted information,then assessed the risk of bias of the included studies,and finally performed Meta-analysis using RevMan 5.3 software,and evaluated the quality of evidence for the outcome indicators.Results:A total of 15 articles were included,with a total sample size of 1402 cases.Meta-analysis results showed that Pingxiao Capsules could improve the objective response rate(RR=1.21,95%CI[1.09,1.35],P=0.0004),improve disease control rate(RR=1.15,95%CI[1.01,1.31],P=0.03),improve the efficacy of TCM syndromes(RR=1.27,95%CI[1.06,1.53],P=0.01),and reduce the incidence of adverse reactions(MD=0.42,95%CI[0.28,0.56],P<00001),(RR=0.53,95%CI[0.30,0.93],P=0.03),(RR=0.43,95%CI[0.19,0.97],P=0.04).It also could improve the quality of life of patients(MD=11.03,95%CI[0.90,21.16],P<0.3),and improve the immune function of patients CD3+(MD=1.42,95%CI[0.75,2.09],P<0.0001),CD4+(MD=6.02,95%CI[3.55,8.55],P<0.0001),CD8+(MD=-2.34,95%CI[-13.62,8.94],P=0.68),CD4+/CD8+(MD=1.19,95%CI[0.28,2.11],P=0.01).Conclusion:Pingxiao Capsule is effective in treating breast cancer,can reduce the incidence of adverse reactions,increase the objective response rate of solid tumors,and improve immune function.