Adis, Auckland, New Zealand.
Drugs R D. 2012 Dec 1;12(4):239-44. doi: 10.2165/11208130-000000000-00000.
The most common cause of severe diarrhea in infants and young children is rotavirus gastroenteritis (RVGE), which is associated with significant morbidity, healthcare resource use, and direct and indirect costs in industrialized nations. The monovalent rotavirus vaccine RIX4414 (Rotarix™) is administered as a two-dose oral series in infants and has demonstrated protective efficacy against RVGE in clinical trials conducted in developed countries. In addition, various naturalistic studies have demonstrated 'real-world' effectiveness after the introduction of widespread rotavirus vaccination programs in the community setting. Numerous cost-effectiveness analyses have been conducted in developed countries in which a universal rotavirus vaccination program using RIX4414 was compared with no universal rotavirus vaccination program. There was a high degree of variability in base-case results across studies even when the studies were conducted in the same country, often reflecting differences in the selection of data sources or assumptions used to populate the models. In addition, results were sensitive to plausible changes in a number of key input parameters. As such, it is not possible to definitively state whether a universal rotavirus vaccination program with RIX4414 is cost effective in developed countries, although results of some analyses in some countries suggest this is the case. In addition, international guidelines advocate universal vaccination of infants and children against rotavirus. It is also difficult to draw conclusions regarding the cost effectiveness of rotavirus vaccine RIX4414 relative to that of the pentavalent rotavirus vaccine, which is administered as a three-dose oral series. Although indirect comparisons in cost-effectiveness analyses indicate that RIX4414 provided more favorable incremental cost-effectiveness ratios when each vaccine was compared with no universal rotavirus vaccination program, results were generally sensitive to vaccine costs. Actual tender prices of a full vaccination course for each vaccine were not known at the time of the analyses and therefore had to be estimated.
婴幼儿中最常见的严重腹泻病因是轮状病毒胃肠炎（RVGE），这种疾病在工业化国家会导致较高的发病率、医疗资源利用和直接及间接成本。单价轮状病毒疫苗 RIX4414（Rotarix）以两剂口服系列的形式用于婴儿，并且在发达国家开展的临床试验中显示出对 RVGE 的保护效力。此外，在社区环境中广泛开展轮状病毒疫苗接种计划后，各种自然主义研究已经证明了“真实世界”的有效性。在发达国家进行了许多成本效益分析，其中使用 RIX4414 的普遍轮状病毒疫苗接种计划与没有普遍轮状病毒疫苗接种计划进行了比较。即使在同一国家进行的研究中，基础病例结果也存在很大的可变性，这通常反映了数据来源的选择或用于填充模型的假设的差异。此外，结果对许多关键输入参数的合理变化很敏感。因此，无法明确说明使用 RIX4414 进行普遍轮状病毒疫苗接种计划是否在发达国家具有成本效益，尽管一些国家的某些分析结果表明情况确实如此。此外，国际指南主张普遍为婴儿和儿童接种轮状病毒疫苗。相对于五价轮状病毒疫苗，也难以得出关于 RIX4414 相对于五价轮状病毒疫苗的成本效益的结论，后者以三剂口服系列的形式进行管理。尽管成本效益分析中的间接比较表明，当每种疫苗与没有普遍轮状病毒疫苗接种计划进行比较时，RIX4414 提供了更有利的增量成本效益比，但结果通常对疫苗成本很敏感。在进行分析时，不知道每种疫苗完整接种疗程的实际招标价格，因此必须进行估计。
