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【关键词】抗肿瘤药物；食管癌；药物经济学
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【中图分类号】R73.5【文献标识码】A【文章编号】1008-6455（2011）10-0010-02Clinical Evaluation and Cost-Effectiveness Analysis of Three Kinds of Plant Antineoplastic Drug in the treatment of Advanced Esophageal Cancer
Zhang Weichun1Zhang Jingfu2
【Abstract】Objective:To explore the clinical evaluation and cost-effectiveness analysis of three kinds of plant antineoplastic drug in the treatment of the advanced esophageal cancer. Methods:The 71 patients with advanced esophageal cancer were randomly divided into three treating groups. The Ⅰ group was NP which was given NVB and DDP. The Ⅱ group was TD which was given TAXOL and DDP .The Ⅲ group was EAP which was given ADM and VP-16 and DDP. The three groups were assessed by clinical evaluation of pharmacoepidemiology and cost effectiveness analysis of pharmacoeconomics. Results:There were no significant differences in clinical effects among three groups(P>0.05);There were significant differences in abnormal white cells, neurotoxicity, and KPS?R10 increase among three groups(P60分，未接受过放疗，近60天内未用过其他药物[2]。依据不同的化疗方案将所选患者分为3组：Ⅰ组NP方案（长春瑞滨NVB+顺铂DDP）；Ⅱ组TD方案（紫杉醇TAXOL+顺铂DDP）；Ⅲ组EAP方案（多柔比星ADM+依托泊苷VP-16+顺铂DDP）。3组患者的年龄分别为49.2、48.1和50.3岁。
1.2治疗方案:各组患者治疗方案中的药物剂量根据患者个体体表面积或体重以及药物剂型等计算，疗程和周期也根据循证医学的原则结合患者具体情况实施。Ⅰ组NP方案，长春瑞滨25mg/m2静注，d1, d8, q21d; 顺铂30mg/m2静滴，d1~3, q21d.。 Ⅱ组TD方案，紫杉醇135mg/m2静滴，d1，q21d; 顺铂20mg/m2静滴，d1~3, q21d; Ⅲ组EAP方案，多柔比星20mg/m2静滴，d1~7, q28d; 依托泊苷70mg/m2静滴，d4~6, q28d; 顺铂50mg/m2静滴，d2~8, q28d。每组患者一般进行2个治疗周期，一个治疗周期一般为3周~4周。
1.3临床观察指标
1.3.1疗效指标:按有效和无效区分，以WHO实体瘤疗效标准中的CR（完全缓解）和PR（部分缓解）为有效；以NC(无变化)和PD（病变进展）为无效。
1.3.2不良反应指标:化疗后检测血红蛋白、白细胞数、血小板、胃肠道功能异常和神经毒性等，并详细记录不良反应。毒副反应的评价参照WHO制定的抗癌药物急性与亚急性毒副反应分度标准，分为0-Ⅳ度，本研究只计出Ⅰ-Ⅳ度的总数。
1.3.3生活质量指标:按WHO推荐的KPS评分标准对患者治疗前后生活质量进行评估，增加?R10分者为改善，减少?R10分者为降低，增加或减少统计学方法:成本均数用Newman-Keuls进行检验，有效率和例数用X2检验，以P0.05)。
2.2不良反应和生活质量指标:3组患者白细胞异常、神经毒性、KPS?R10分增加人数间差别有显著性意义（P0.05）,见表1.组间比较：Ⅲ组和Ⅰ组、Ⅱ组骨髓抑制指标间差别有显著性意义（P
2.5各组敏感度:依据药物流行病学和药物经济学的原理进行敏感度分析。具体方法是假设药物费用均下降10%，计算出C/E。结果发现Ⅲ组比Ⅰ组、Ⅱ组的C/E值明显高，Ⅰ组和Ⅱ组间无显著性意义。以成本最低的方案为参照，其他两组与其进行比较，以观察△C/△E,结果发现Ⅰ组明显低于Ⅱ组，见表4。
0 3讨论
本研究表明，不良反应发生率主要表现为骨髓抑制和胃肠道反应等。NP方案的不良反应可能与长春瑞滨联用顺铂有关[4]。TD方案的不良反应主要由于紫杉醇有剂量依赖性的骨髓抑制和神经毒性[5]。EAP方案的不良反应可能与VP-16的骨髓抑制等有限剂量毒性有关[6]。
在成本指标方面，总成本由高到低分别为Ⅱ组、Ⅰ组、Ⅲ组。但是从经济学角度，不能认为成本越低就越经济，还应进行C/E和其他相对增量△C/△E的比较。从表3可以看出Ⅰ组和Ⅱ组差别不大，他们的C/E最小，Ⅲ组的C/E最大。这说明疗效每提高一个百分点所需成本Ⅰ参考文献
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发表于 2018-7-16 20:15:38