参一胶囊辅助治疗原发性肝癌的系统评价

Systematic Evaluation of Adjuvant Treatment of Primary Liver Cancer with Shenyi Capsules

目的系统评价参一胶囊辅助治疗原发性肝癌的临床疗效及安全性。方法计算机检索中国知识资源总库(CNKI)、中国学术期刊数据库(Wanfang Data)、中国生物医学文献数据库(CBM)、中文科技期刊数据库(VIP)、PubMed、Cochrane Library、Embase、Web of Science自建库至2020年12月参一胶囊辅助治疗原发性肝癌的临床随机对照试验。由2名研究者独立筛选文献,进行有效资料提取,并根据Cochrane偏倚风险评估工具进行质量评估。采用RevMan 5.3进行Meta分析。结果共纳入9篇文献,涉及患者788例。Meta分析结果显示,参一胶囊联合西医治疗在客观缓解率(OR=2.51,95%CI[1.65,3.83],P<0.0001)、疾病控制率(OR=2.76,95%CI[1.88,4.07],P<0.00001)、甲胎蛋白下降率(OR=2.60,95%CI[1.01,6.69],P=0.05)、1年生存率(OR=2.34,95%CI[1.53,3.58],P<0.0001)、2年生存率(OR=2.33,95%CI[1.28,4.27],P=0.006)、Karnofsky功能状态评分提高率(OR=2.91,95%CI[1.62,5.23],P=0.0004)、骨髓抑制发生率(OR=0.40,95%CI[0.23,0.68],P=0.0009)方面均显著优于单纯西医治疗。结论参一胶囊辅助治疗原发性肝癌可提高临床疗效、患者生存率,改善患者生存质量,降低骨髓抑制发生率,但尚需大样本、多中心、高质量的临床随机对照试验进一步验证。

Objective To systematically evaluate the efficacy and safety of Shenyi Capsules in the adjuvant treatment of primary liver cancer.Methods RCTs of Shenyi Capsules combined with Western medicine in the treatment of primary liver cancer in CNKI,Wanfang Data,CBM,VIP,PubMed,Cochrane Library,Embase,and Web of Science were retrieved by computer from the establishment of databases to December 2020.Two investigators independently screened the literature,extracted valid data,and assessed the quality according to the Cochrane risk of bias assessment tool.Meta-analysis was conducted with RevMan 5.3 software.Results A total of 9 articles were included,involving 788 cases.Meta-analysis showed that compared with Western medicine,Shenyi Capsules combined with Western medicine could improve the objective remission rate(OR=2.51,95%CI[1.65,3.83],P<0.0001),disease control rate(OR=2.76,95%CI[1.88,4.07],P<0.00001),AFP decline rate(OR=2.60,95%CI[1.01,6.69],P=0.05),and 1-year survival rate(OR=2.34,95%CI[1.53,3.58],P<0.0001),2-year survival rate(OR=2.33,95%CI[1.28,4.27],P=0.006),the improvement rate of KPS score(OR=2.91,95%CI[1.62,5.23],P=0.0004),and bone marrow suppression rate(OR=0.40,95%CI[0.23,0.68],P=0.0009).Conclusion Shenyi Capsules combined with Western medicine in the treatment of primary liver cancer can improve clinical efficacy,increase survival rate,improve life quality,and reduce bone marrow suppression rate.However,more large-scale,multi-center,and high-quality clinical RCTs are needed for further verification.