复方苦参注射液联合放疗治疗恶性肿瘤骨转移的循证药物经济学分析

Evidence-based Pharmacoeconomic Analysis of Compound Kushen Injection Combined with Radiotherapy in Treating Bone Metastasis of Malignant Tumor

目的基于Meta分析评价复方苦参注射液联合放疗治疗恶性肿瘤骨转移的安全性、有效性和经济性。方法计算机系统检索PubMed、Embase和中国知网(CNKI)、维普(VIP)、万方数据库,检索复方苦参注射液联合放疗治疗恶性肿瘤骨转移的随机对照试验(randomized controlled trial,RCT),以疼痛缓解率为临床疗效指标,利用RevMan5.3软件进行Meta分析,采用成本-效果分析进行经济学评价。结果共纳入11篇文献,总计783例患者,其中复方苦参注射液联合放疗治疗组395例,单纯放疗组388例。Meta分析结果显示:联合放疗组的疼痛缓解率和单纯放疗组相比具有显著优势[OR=2.27,95%CI(1.58,3.26),P<0.000 01],。单纯放疗组致白细胞减少、血小板减少的发生率高于联合放疗组,但胃肠道反应的发生率低于联合放疗组。构建决策树模型,采用成本—效果分析法,结果显示联合放疗组(C/E=264.06)比单纯放疗组(C/E=285.39)更具有经济性,敏感性分析结果证明该结论具有稳定性。结论复方苦参注射液联合放疗治疗恶性肿瘤骨转移有较好疗效、较低的不良反应和更好的经济性,值得临床推广应用。

Objective To evaluate the safety,efficacy and economy about Compound Kushen injection combined with radiotherapy in the treatment of bone metastasis of malignant tumor based on Meta-analysis. Methods The data were collected from the PubMed, Embase and CNKI, VIP, Wangfang databases by computer retrieval.Randomized controlled trials of Compound Kushen Injection combined radiotherapy vs radiotherapy alone for bone metastasis of malignant tumor were searched. With pain-relief rate as the clinical efficacy index,Meta-analysis of clinical efficacy and safety was performed by RevMan 5.3 software,while cost-effectiveness analysis was used for economic evaluation. Results A total of 11 RCTs involving 783 patients were included in the analysis,387 cases in the group of Compound Kushen injection combined with radiotherapy(combination group)and 379 in the group of radiotherapy alone(radiotherapy group). Meta-analysis results showed that the combination group is more effective on improving pain-relief rate than the radiotherapy group [OR=2.27,95%CI(1.58,3.26),P<0.00001],and the radiotherapy group had higher incidence of leukopenia and thrombocytopenia and lower incidence of gastrointestinal reaction than the combination group. The decision tree model was constructed for the costeffectiveness analysis. The results showed that the combination group(C/E = 264.06)was more economical than the radiotherapy group(C/E = 285.39). The sensitivity analysis results showed that the conclusion was stable.Conclusion Compound Kushen Injection combined with radiotherapy has stronger curative effect, lower adverse reaction and higher economy in the treatment of bone metastasis of malignant tumor.