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研究背景:对于两性霉素B治疗真菌感染.如果将所有的治疗成本和治疗收益都纳入考虑,那么该药物不同脂质剂型之间安全性、有效性和经济性等方面的差异依然是模糊不清的。研究设计:对于两性霉素B的两种剂型,两性霉素B脂质复合物(amphotericin B lipid complex,ABLC)和两性霉素B脂质体(liposomal amphotericin B,L-AMB),采用回顾性最小成本法进行比较分析,研究角度采用医疗机构角度。治疗成本(以美元计数,2001年的水平)被分成3个层次,第一为只有药品费用,第二为包括相关医疗措施的成本,第三为包括全部住院治疗的相关成本。结果:两组研究对象的社会人口学情况和治疗时间均没有显著性差异。两组的临床有效率比较接近(ABLC为53%,L-AMB为60%,P=0.68),所以本经济学评估采用了最小成本法。ABLC组47%的研究对象血清肌酸酐(SCr)出现上升,而L-AMB组只有10%,P值为0.025。对于3个层次的总治疗成本,两组间均没有明显差异。但当校正了治疗时间因素后,L-AMB组的治疗成本显著地高于ABLC组(第一层次,ABLC为340美元,L-AMB为435美元,P=0.002;第二层次,ABLC为361美元,L-AMB为454美元,P=0.027)。预防或治疗不良事件(adverse events)的成本在两组间并无差异。敏感性分析表明,经济学评估结果对药品价格和用药剂量敏感。二维敏感性分析显示,只要L-AMB的价格高于ABLC的135%,ABLC的经济性优势就可以保持。结论:这两种药品的总院内治疗成本并无差别。但校正了治疗时间因素后,ABLC的治疗成本明显低于L-AMB。治疗成本的计算包括了药品费用、相关治疗费用、不良反应的预防和治疗费用。研究提示药品价格是治疗成本的重要影响因素。
Research Background: For fungal infections with amphotericin B. If all the costs of treatment and benefits of treatment are taken into account, the differences in safety, efficacy, and economy between the different lipid formulations remain vague Clear. Study Design: For both amphotericin B dosage forms, amphotericin B lipid complex (ABLC) and liposomal amphotericin B (L-AMB), a retrospective The comparative analysis of the minimum cost method, the research perspective of the medical institutions. The costs of treatment (in US $, 2001 levels) are broken down into three levels, the first being drug costs only, the second being the cost of the related medical treatment and the third being the cost of including all hospitalizations. Results: There was no significant difference in the socio-demographic status and treatment time between the two groups. The clinical efficacy was similar between the two groups (ABLC, 53%, L-AMB, 60%, P = 0.68), so this economic assessment uses the least cost method. Serum creatinine (SCr) increased in 47% of the study participants in the ABLC group compared with only 10% in the L-AMB group, with a P value of 0.025. For the three levels of total cost of treatment, there was no significant difference between the two groups. However, when the treatment time was adjusted, the cost of treatment in the L-AMB group was significantly higher than in the ABLC group (ABLC was $ 340 for the first level and $ 435 for the L-AMB, P = 0.002; for the second level, ABLC was 361 US $, L-AMB was US $ 454, P = 0.027). The cost of preventing or treating adverse events did not differ between the two groups. Sensitivity analysis shows that the economic assessment results are sensitive to drug prices and dosage. Two-dimensional sensitivity analysis shows that ABLC’s economic advantage can be maintained as long as L-AMB is priced above 135% of ABLC. Conclusion: There is no difference in total hospital treatment costs between the two drugs. However, after adjusting for treatment time, the cost of treatment for ABLC was significantly lower than for L-AMB. The cost of treatment includes drug costs, related treatment costs, prevention and treatment of adverse events. Research suggests that drug prices are an important factor in the cost of treatment.