蟾酥制剂辅助治疗肿瘤的疗效及安全性系统综述和Meta分析  

Effectiveness and Safety of Bufalin Praeparatum in the Adjuvant Therapy of Tumor: A Systematic Review and Meta-analysis

作　　者：张洲姬[1] 杨云柯[1] 

机构地区：[1]复旦大学附属中山医院中医/中西医结合科,上海200032

出　　处：《上海中医药大学学报》2013年第5期35-40,共6页Academic Journal of Shanghai University of Traditional Chinese Medicine

基　　金：国家"十一五"科技支持计划重大疑难疾病中医防治研究项目(2006BAI0)

摘　　要：目的:系统评价肿瘤患者进行化疗或放疗时,采用蟾酥制剂进行辅助治疗的有效性和安全性。方法:采取Cochrane系统综述方法,检索Cochrane图书馆及其对照试验注册资料库(CENTRAL)、PubMed、Nature、EMbase、CNKI、万方数据库、VIP以及手工检索《中华肿瘤杂志》等。按照纳入排除标准选择文献、提取资料和进行质量评价后,采用Cochrane协作网提供的RevMan 5.0.24软件进行Meta分析。结果:共纳入6篇研究文献,包括369例患者(治疗组192例,对照组177例)。Meta分析结果表明:蟾酥制剂中的有效成分对肿瘤患者KPS功能状态评分增加率影响的效应统计量风险比(risk ratio,RR)及其95%可信区间(CI)为1.92[1.29,2.85]、临床证候改善率影响的效应统计量RR及其5%CI为1.43[1.08,1.89],放化疗毒性作用影响的效应统计量RR及其95%CI为0.35[0.24,0.52],上述各指标比较,差异均有统计学意义。但肿瘤患者的疾病缓解率影响的效应统计量RR及其95%CI为1.25[0.97,1.63],此差异无统计学意义。治疗期间,该药调整了抑制性和辅助性T淋巴细胞使趋向合理比例,并提高了NK细胞活性、免疫球蛋白及补体等指标,以上次要指标的差异均有统计学意义。该药物相关不良反应报道较少,仅存在2例心律失常及1例皮疹,且两者皆无统计学意义。结论:蟾酥制剂作为辅助治疗肿瘤的药物,对提高患者KPS功能状态评分增加率、改善临床证候、减轻化疗放疗毒性、增强机体免疫功能具有一定效果,但鉴于纳入研究样本量小且质量受限,上述结论尚需更多高质量的研究来加以证实。Objective： To evaluate the efficacy and safety of Bufalin Praeparatum as an adjuvant therapy for the tumor patients underwent chemotherapy or radiotherapy. Methods： The databases such as Cochrane Library, Coohrane Central Register of Controlled Trails, PubMod, Nature, EMbase, CNKI, WanFang Data and VIP were searched by taking the Cochrane＇ s systematic review method, and Chinese Journal of Oncology was searched by a manual retrieva! operation. The data were extracted, the quality was assessed, and meta-analysis was conducted by using Revman 5.0.24 soft ware. Results： Six research literatures involving 369 participants （192 participants in treatment group and 177 participants in control group）were included. The meta analysis showed that active constituents in Bufalin Praeparatum for tumor patients＇ increasing rate of KPS function scored of the effect of statistic risk ratio （RR） and 95% confidence interval （CI） being 1.9211.29,2.85 ] , clinical symptoms to improve the rate of impact the effect of statistics of RR and its 95% CI being 1.43 [ 1.08,1.89 ]. The effects of the toxic effects of statistic RR and 95% CI caused by chemotherapy or radiotherapy are 0.35 [ 0.24, 0.52 ]. Influences on these three outcome indicators were statistically significant. While there was no significant difference in tumor remission rate of the effect of statistic RR and 95%CI being 1.25 [0.97, 1.63~. During the period of treatment, this medicine adjusted helper T lymphocytes and suppressor T lymphooytes to tend to become a reasonable ratio remarkably and enhanced NK cell＇ s viability, imrnunoglobnlin, and complement in blood serum and so on. These secondary indicators of the differences were statistically significant. In addition, fewer reports of adverse events were associated with Bufalin Praeparatum. Only two cases with arrhythmia and one case with a rash existed, while without significant difference in the two symptoms. Conclusion： The existing evidence reveals that the Bufalin Praeparatum, as neoadjuvant

关 键 词：蟾酥制剂 肿瘤 辅助治疗 随机对照试验 系统评价 META分析 

分 类 号：R730.5[医药卫生—肿瘤]