中药联合索拉菲尼治疗原发性肝癌的Meta分析

Meta-analysis of Traditional Chinese Medicine Combined with Sorafenib in Treatment of Primary Liver Cancer

目的通过Meta分析系统评价中药联合索拉菲尼的方法在临床中治疗原发性肝癌的有效性和安全性。方法通过检索Cochrane图书馆、Pub Med、EMbase数据库、中国学术期刊全文数据库(CNKI)、维普中文科技期刊数据库(VIP)、万方数据知识服务平台等数据库中所有关于中药联合索拉菲尼的方法治疗原发性肝癌的临床随机对照试验的文章,检索日期截至2019年3月。使用统一资料提取表提取患者一般资料、干预措施、观察指标等相关信息,采用Cochrane协作网提供的偏倚风险评估工具对纳入研究进行方法学质量评价,采用Revman 5.3软件对患者临床有效率、KPS评分改善率、疼痛缓解情况和发生不良反应率进行Meta分析。结果共纳入12项研究,共计848例患者,其中治疗组426例,对照组422例。文献均为中文文献,但文献质量偏低,均为低质量文献。Meta分析结果显示,与单用索拉菲尼或其他化疗方案进行比较,中药联合索拉菲尼的治疗方法可提高原发性肝癌患者近期有效率[RR=1.32,95%CI(1.21,1.44),P<0.01]、生活质量(以KPS评分为标准)改善率[RR=1.12,95%CI(1.01,1.25),P<0.05],并且能够降低化疗的不良反应发生率[RR=0.56,RR=0.68,95%CI(0.57,0.81),P<0.01],但疼痛缓解情况无明显差异[RR=1.11,95%CI(0.72,1.73),P>0.05]。但这一结果是建立在纳入文献可能存在偏倚性和低质量研究的定量综合分析的基础上的。结论中药联合索拉菲尼的治疗方法相比单纯使用索拉菲尼等化疗的方案,近期疗效较好,能够有效提高患者的近期有效率,提高患者KPS评分改善率,并能降低化疗所带来的不良反应率,但患者的疼痛缓解情况无明显差异,而且此种治疗方法相对简便可行,较适宜于临床广泛应用。但由于纳入文献的质量普遍偏低,仍需要高质量、大样本的临床随机对照试验提供更可靠的证据支持。

Objective To systematically evaluate the efficacy and safety of traditional Chinese medicine(TCM)combined with Sorafenib in the treatment of primary liver cancer(PLC)by meta-analysis.Methods All articles about randomized clinical trials of TCM combined with Sorafenib in the treatment of primary liver cancer were retrieved from Cochrane Library,PubMed,EMbase database,CNKI,VIPand Wanfang Data Knowledge Service Platform.The date of retrieval was up to March 2019.Revman 5.3 software was used to analyze the clinical efficiency,KPS scoreimprovement rate,pain relief and adverse reaction rate of patients.Results A total of 848 patients were enrolled in 12 studies,including 426 in the treatment group and 422 in the control group.The literature is all Chinese literature,but all of which are of low quality.Meta-analysis showed that the short-term response rate[RR=1.32,95%CI(1.21,1.44),P<0.01],quality of life(based on KPS score)improvement rate[RR=1.12,95%CI(1.01,1.25),P<0.05]of patients with primary liver cancer could be improved by traditional Chinese medicine combined with Sorafenib or other chemotherapy regimens,and the adverse effects of chemotherapy could be reduced the incidence of stress[RR=0.56,RR=0.68,95%CI(0.57,0.81)P<0.01],but there was no significant difference in pain relief[RR=1.11,95%CI(0.72,1.73),P>0.05].However,this result is based on a quantitative and comprehensive analysis of the possible bias and low-quality studies included in the literature.Conclusion The short-term curative effect of TCM combined with Sorafenib is better than that of s using Sorafenib and other therapies alone.It can effectively improve the short-term effective rate of patients,improve the KPS score of patients,and reduce the rate of adverse reactions caused by radiotherapy.However,there is no significant difference in the pain relief of patients,and this method is relatively simple and feasible,and more appropriate.It is widely used in clinic.However,because the quality of the included literature is generally low,it still needs high quality,large sample of RCTsto provide more reliable evidence support.