国产和进口甘草酸制剂治疗116例慢性乙型肝炎的药物经济学分析
【摘要】 目的 针对不同病情程度，观察分析国产及进口甘草酸制剂(甘利欣和美能)护肝治疗方案的临床疗效及成本效果。方法 116例慢性乙型肝炎患者，分为甘利欣组和美能组，各58例，依据病情从轻中度和重度两方面分别观察肝功能指标变化、临床症状与体征改善，并做成本-效果分析。结果 轻中度病例,两组有效率分别为90.3%和90.0%,差异无显著性(P>0.05),从成本-效果比看，甘利欣组占优。重度病例，美能组在有效率及周期治疗时间上均优于甘利欣组，ALT的降低作用也优于甘利欣组，差异有显著性(P<0.05);从成本-效果比看，美能组占优。结论 依据药物经济学分析结果，慢乙肝轻中度病例宜选用甘利欣护肝，重度病例宜选择美能护肝。
【关键词】 慢性乙型肝炎;甘草酸制剂;临床疗效;成本-效果分析
Abstract:Objective To observe and analyze the clinical efficacy and cost effectiveness of two therapeutic regimes with domestic and imported glycyrrhizin preparations (diammonium glycyrrhizinate and compound glycyrrhizin) for chronic hepatitis B. Methods 116 cases of patients with chronic hepatitis B were divided into two groups. Two groups were separately treated with diammonium glycyrrhizinate (58 cases) and compound glycyrrhizin (58 cases). Variations of liver function parameters, clinical manifestation, and physical symptoms were observed according to different severity degrees of chronic hepatitis B. The results were compared by pharmacoeconomic costeffectiveness analysis.Results The effective rates of two groups of mild to moderate severities were 90.3% and 90.0% (P>0.05) respectively; By the costeffectiveness ratios, the expenses in the group treated with diammonium glycyrrhizinate reaching the similar effect was 1owest. For severe cases, the group treated with compound glycyrrhizin was superior to that in the group treated with diammonium glycyrrhizinate at effective rates and duration of treatment cycle. Conclusions According to the results of pharmacoeconomic costeffectiveness analysis, cases of chronic hepatitis B with mild to moderate severities should be treated with diammonium glycyrrhizinate as the first choice. Compound glycyrrhizi should be used at first in the treatment of serious chronic hepatitis B.
Key words:chronic hepatitis B; glycyrrhizin; clinical efficacy; costeffectiveness analysis
目前，国内对于慢性乙型肝炎的药物经济学研究主要集中在抗病毒治疗方面。由于抗病毒药物使用适应证的限制，以及经济条件等原因，能够系统接受抗病毒治疗的患者还比较有限，而绝大多数慢性乙型肝炎患者还需通过抗炎保肝、抗纤维化等综合治疗修复肝脏的损伤。现阶段医院常用的护肝药物多为甘草酸制剂，有国产的甘利欣针和进口的美能针，一些研究报道显示进口美能在疗效方面优于甘利欣[1]。
本文对我院2005～2008年收治的116例慢性乙肝患者住院期间分别应用甘利欣、美能两类护肝降酶方案治疗的情况作回顾性分析，进行不同病情程度条件下两种制剂的药物经济学评价分析，现报道如下。
1 资料与方法
1.1 临床资料
116例患者系本院住院病人，全部病例均符合《病毒性肝炎防治方案》和相关文献《病毒性肝炎防治方案》中的诊断标准[2]。血清HbsAg和HbeAg持续阳性6个月以上，HBVDNA阳性，血清丙氨酸转氨酶(ALT)在正常值上限2倍以上者，排除合并其他病毒性肝炎感染、失代偿性肝病、肝硬化、肝癌患者。随机分为两组，甘利欣组58例，男41例，女17例，其中重度27例，中度23例，轻度8例，年龄20～58岁，平均(37.11±12.57)岁;美能组 58例，男39例，女19例，其中重度28例，中度24例，轻度6例，年龄21～57岁，平均(40.75±11.41)岁。各组在性别、年龄、分型等方面差异均无显著性意义(P>0.05)，具有可比性。
1.2 治疗方法
两组均采用基础护肝治疗(肝泰乐、能量合剂、维生素C等)。甘利欣组使用国产甘草酸制剂(江苏正大天晴药业股份有限公司);美能组使用进口甘草酸制剂(日本米诺发源制药株式会社)。
观测项目及疗程：观察两组治疗前后主要临床症状及体征、肝功能(如：TBiL、ALT、AST)指标的变化值。疗程以患者实际住院时间计算，并计算住院总费用及平均费用。
1.3 临床评判标准[3]
显效:症状明显减轻或消失，血清总胆红素、血清丙氨酸转氨酶降至正常;有效:症状明显减轻，血清总胆红素、血清丙氨酸转氨酶下降>50%;无效:未达到有效标准或血清总胆红素不降反升者。