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Real-World Use of Generic Meropenem: Results of an Observational Study
Antibiotics ( IF 4.3 ) Pub Date : 2021-01-11 , DOI: 10.3390/antibiotics10010062
Santiago Garnica-Velandia , Luz Adriana Aristizábal-Ruiz , Carlos Arturo Alvarez-Moreno

Background: To determine the therapeutic effect and tolerability of meropenem in routine clinical practice, in terms of clinical and microbiological response. Methods: A real-world, observational, descriptive, longitudinal study with daily monitoring of clinical history records was conducted on all patients who were medically prescribed meropenem during a period between October 2015 and March 2016 at a university hospital in Bucaramanga (Colombia). Results: The study evaluated 84 patients with an average age of 63.2 years, mostly older adults with multiple comorbidities, of whom 54.8% were men. A positive clinical or microbiological response was obtained in 98.8% of the patients. At the end of the treatments, significant improvements in dysthermia (0% vs. 29% at the beginning, p = 0.000), tachycardia (13% vs. 47%, p = 0.049), and leukocytosis (39% vs. 15% at the beginning, p = 0.008) were evidenced. The improvement in the indicator that combines all the Systemic Inflammatory Response Syndrome (SIRS) criteria was also significant (p = 0.000). The treatment was well tolerated, although we identified some non-serious and expected adverse reactions. Conclusions: Generic meropenem proved to be effective and well tolerated for different types of infection in routine clinical practice. The results are consistent with the findings of the clinical studies with the innovator drug.

中文翻译:

通用美罗培南在现实世界中的使用:一项观察性研究的结果

背景:从临床和微生物反应方面,确定美罗培南在常规临床实践中的治疗效果和耐受性。方法:在2015年10月至2016年3月期间,在布卡拉曼加(哥伦比亚)的一家大学医院对所有接受美罗培南药物处方治疗的患者进行了实时观察,描述性纵向研究,并每天监测临床病历。结果:该研究评估了84例平均年龄为63.2岁的患者,其中多数为患有多种合并症的老年人,其中54.8%为男性。98.8%的患者获得了积极的临床或微生物反应。在治疗结束时,体温异常明显改善(0%比开始时的29%,p= 0.000),心动过速(13%比47%,p = 0.049)和白细胞增多(开始时39%比15%,p = 0.008)被证明。结合所有系统性炎症反应综合征(SIRS)标准的指标的改善也很显着(p = 0.000)。尽管我们发现了一些非严重和预期的不良反应,但治疗耐受性良好。结论:在常规临床实践中,通用美罗培南被证明对不同类型的感染有效且耐受性良好。结果与创新药物的临床研究结果一致。
更新日期:2021-01-11
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