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美罗培南仿制药的真实世界使用情况:一项观察性研究的结果

Real-World Use of Generic Meropenem: Results of an Observational Study.

作者信息

Garnica-Velandia Santiago, Aristizábal-Ruiz Luz Adriana, Alvarez-Moreno Carlos Arturo

机构信息

Vitalis SACI, Bogota 111121, Colombia.

Internal Medicine, Department Facultad de Medicina, Universidad Nacional de Colombia, Bogota 111176, Colombia.

出版信息

Antibiotics (Basel). 2021 Jan 11;10(1):62. doi: 10.3390/antibiotics10010062.

Abstract

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, = 0.000), tachycardia (13% vs. 47%, = 0.049), and leukocytosis (39% vs. 15% at the beginning, = 0.008) were evidenced. The improvement in the indicator that combines all the Systemic Inflammatory Response Syndrome (SIRS) criteria was also significant ( = 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.

摘要

背景

为了从临床和微生物学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

对2015年10月至2016年3月期间在布卡拉曼加(哥伦比亚)一家大学医院接受美罗培南治疗的所有患者进行了一项真实世界、观察性、描述性、纵向研究,并每日监测临床病史记录。

结果

该研究评估了84例平均年龄为63.2岁的患者,大多数为患有多种合并症的老年人,其中54.8%为男性。98.8%的患者获得了阳性临床或微生物学反应。在治疗结束时,体温异常(开始时为0% vs. 29%,P = 0.000)、心动过速(13% vs. 47%,P = 0.049)和白细胞增多(开始时为39% vs. 15%,P = 0.008)有显著改善。综合所有全身炎症反应综合征(SIRS)标准的指标也有显著改善(P = 0.000)。该治疗耐受性良好,尽管我们发现了一些非严重且预期的不良反应。

结论

在常规临床实践中,通用型美罗培南对不同类型的感染证明是有效且耐受性良好的。结果与创新药物的临床研究结果一致。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/51c6/7827234/d516a07187c8/antibiotics-10-00062-g001.jpg

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