摘要
目的:评价复方苦参注射液联合经导管动脉化疗栓塞术(Transcatheter Arterial Chemoembolization,TACE)治疗原发性肝癌的临床疗效及安全性。方法:通过计算机检索中国知网数据库、万方数据库、维普数据库、中国生物医学文献服务系统、PubMed、the Cochrane Library、EMbase中关于复方苦参注射液联合TACE治疗原发性肝癌的相关文献,检索时间从数据库建库至2021年2月。由两位研究者独立纳入文献,进行文献偏倚风险评价,数据资料由RevMan 5.3提取并进行数据分析。结果:最终共纳入文献15篇,总样本量1470例。Meta分析结果显示与单纯TACE治疗相比,复方苦参注射联合TACE治疗能提高原发性肝癌患者的客观缓解率(RR=1.32,95%CI[1.19,1.46],P<0.00001)、Karnofsky功能状态评分法(Karnofsky Performance Status,KPS)评分(RR=1.77,95%CI[1.33,2.37];P=0.0001,MD=12.27;95%CI[9.15,15.40];P<0.00001)、6个月生存率(RR=1.16,95%CI[1.01,1.34];P=0.04)、1年生存率(RR=1.24,95%CI[1.07,1.44];P=0.004)、CD3+水平(MD=9.30,95%CI[1.37,17.23];P=0.02)、CD4+水平(MD=9.33,95%CI[7.11,11.54];P<0.00001)、CD4+/CD8+(MD=0.50,95%CI[0.45,0.54];P<0.00001),降低患者的甲胎蛋白(Alpha-fetoprotein,AFP)值(RR=1.80,95%CI[1.12,2.90];P=0.02)、不良反应发生率(RR=0.59,95%CI[0.45,0.78];P=0.0002)。结论:复方苦参注射液治疗原发性肝癌安全性好,具有一定的疗效。但由于纳入研究样本量有限、文献质量偏低,仍需大样本、多中心、严格的随机对照试验进一步证实。
Objective:To evaluate the clinical efficacy and safety of the Fufang Kushen injection(复方苦参注射液)plus transcatheter arterial chemoembolization surgery on primary liver cancer.Methods:The relevant literature on treating primary liver cancer from database construction to February 2021 was retrieved in CNKI,WANFANG,VIP,SinoMed,PubMed,the Cochrane Library,and EMbase by computer.Data extraction and bias risk assessment of included literature was performed independently by two investigators.A Meta-analysis was performed by RevMan 5.3 software.Results:A total of 15 articles were finally included,with a total sample size of 1180 cases.The Meta-analysis result showed that compared with TACE treatment alone,the Fufang Kushen injection plus TACE treatment could improve the patients’objective response rate(RR=1.32,95%CI[1.19,1.46],P<0.00001),KPS score(RR=1.77,95%CI[1.33,2.37];P=0.0001,MD=12.27;95%CI[9.15,15.40];P<0.00001),6-month survival rate(RR=1.16,95%CI[1.01,1.34];P=0.04),1-year survival rate(RR=1.24,95%CI[1.07,1.44];P=0.004),CD3+Level(MD=9.30,95%CI[1.37,17.23];P=0.02),CD4+Level(MD=9.33,95%CI[7.11,11.54];P<0.00001),CD4+/CD8+(MD=0.50,95%CI[0.45,0.54];P<0.00001),and can reduce AFP value(RR=1.80,95%CI[1.12,2.90];P=0.02)and the incidence of adverse reactions(RR=0.59,95%CI[0.45,0.78];P=0.0002)in patients with primary liver cancer.Conclusion:The Fufang Kushen injection on primary liver cancer was safe and had a certain efficacy.However,due to the limited sample size and low quality of the included studies,the Meta-analysis result still needs to be further confirmed by large sample size,multicenter and rigorous RCTs.
出处
《中医临床研究》
2021年第28期126-131,共6页
Clinical Journal Of Chinese Medicine
基金
河南省中医管理局(2018JDZX109)
河南省中医拔尖人才培养项目(豫中医科教函【2019】21号)。
关键词
复方苦参注射液
原发性肝癌
随机对照试验
系统评价
META分析
The Fufang Kushen injection
Primary liver cancer
Randomized controlled trial
Systematic review
Meta-analysis
