E.S.E. Hospital Universitario San Jorge, Pereira, Colombia.
Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia; Case Western Reserve University, Cleveland, United States; Grupo de Investigación en Resistencia Antimicrobiana y Epidemiología Hospitalaria, Universidad El Bosque, Bogotá, Colombia..
Braz J Infect Dis. 2019 Jul-Aug;23(4):237-245. doi: 10.1016/j.bjid.2019.06.010. Epub 2019 Jul 22.
Recent studies suggest that sustained use of generic antibiotics may be associated with clinical failure and emergence of antibacterial resistance. The present study was designed to determine the clinical outcome between the use of generic meropenem (GM) and brand-name meropenem (BNM). Additionally, this study evaluated the economic impact of GM and BNM to determine if the former represents a cost-effective alternative to the latter.
Patients treated between January 2011 and May 2014 received GM while patients treated between June 2014 and March 2017 received BNM. Mortality was compared between groups. Total infection cost was defined by the cost of antimicrobial consumption, length of stay, and laboratory and imaging exams until infection resolution.
A total of 168 patients were included; survival rate for the 68 patients treated with GM was 38% compared to 59% in the patients treated with BNM. Multivariate analysis showed that the variables most strongly-associated with mortality were cardiovascular disease (OR 18.18, 95% CI 1.25-262.3, p = 0.033) and treatment with generic meropenem (OR 18.45, 95% CI 1.45-232.32, p = 0.024). On the other hand, total infection cost did not show a significant difference between groups (BNM $10,771 vs. GM $11,343; p = 0.91).
The present study suggests that patients treated with GM have a risk of death 18 times higher compared to those treated with BNM. Furthermore, economic analysis shows that GM is not more cost effective than BNM.
More studies measuring clinical outcomes are needed to confirm the clinical equivalence of brand-name versus generic antibiotics, not only for meropenem but also for other molecules.
最近的研究表明,长期使用仿制药抗生素可能与临床治疗失败和抗菌药物耐药性的出现有关。本研究旨在确定使用美罗培南仿制药(GM)和品牌美罗培南(BNM)的临床结果。此外,本研究还评估了 GM 和 BNM 的经济影响,以确定前者是否是后者的具有成本效益的替代方案。
2011 年 1 月至 2014 年 5 月期间接受 GM 治疗的患者为一组,2014 年 6 月至 2017 年 3 月期间接受 BNM 治疗的患者为另一组。比较两组患者的死亡率。总感染成本定义为抗菌药物消耗、住院时间、实验室和影像学检查费用之和,直至感染得到解决。
共纳入 168 例患者;GM 治疗的 68 例患者的生存率为 38%,而 BNM 治疗的患者的生存率为 59%。多变量分析显示,与死亡率最密切相关的变量是心血管疾病(OR 18.18,95%CI 1.25-262.3,p=0.033)和 GM 治疗(OR 18.45,95%CI 1.45-232.32,p=0.024)。另一方面,两组的总感染成本无显著差异(BNM 为 10771 美元,GM 为 11343 美元;p=0.91)。
本研究表明,与接受 BNM 治疗的患者相比,接受 GM 治疗的患者的死亡风险高 18 倍。此外,经济分析表明 GM 并不比 BNM 更具成本效益。
需要进行更多的临床结果测量研究来证实品牌与仿制药抗生素的临床等效性,不仅针对美罗培南,还针对其他分子。