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碳青霉烯类药物在重症感染儿童中的延长或持续输注:一项系统评价与叙述性综合分析

Extended or Continuous Infusion of Carbapenems in Children with Severe Infections: A Systematic Review and Narrative Synthesis.

作者信息

Zhou Pengxiang, Zhang Yahui, Wang Zhenhuan, Ying Yingqiu, Xing Yan, Tong Xiaomei, Zhai Suodi

机构信息

Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China.

Institute for Drug Evaluation, Peking University Health Science Center, Beijing 100191, China.

出版信息

Antibiotics (Basel). 2021 Sep 9;10(9):1088. doi: 10.3390/antibiotics10091088.

Abstract

We systematically reviewed the efficacy and safety of an extended or continuous infusion (EI/CI) versus short-term infusion (STI) of carbapenems in children with severe infections. Databases, including PubMed, Embase, the Cochrane Library, Clinicaltrials.gov, China National Knowledge Infrastructure, WanFang Data, and SinoMed, were systematically searched from their inceptions to 10 August 2020, for all types of studies (such as randomized controlled trials (RCTs), retrospective studies, and pharmacokinetic or population pharmacokinetic (PK/PPK) studies) comparing EI/CI versus STI in children with severe infection. There was no limitation on language, and a manual search was also conducted. The data were screened, evaluated, extracted, and reviewed by two researchers independently. Quantitative (meta-analysis) or qualitative analyses of the included studies were performed. Twenty studies (including two RCTs, one case series, six case reports, and 11 PK/PPK studies) were included in this review (CRD42020162845). The RCTs' quality evaluation results revealed a risk of selection and concealment bias. Qualitative analysis of RCTs demonstrated that, compared with STI, an EI (3 to 4 h) of meropenem in late-onset neonatal sepsis could improve the clinical effectiveness and microbial clearance rates, and reduce the rates of mortality; however, the differences in the incidence of other adverse events were not statistically significant. Retrospective studies showed that children undergoing an EI of meropenem experienced satisfactory clinical improvement. In addition, the results of the PK/PPK study showed that an EI (3 or 4 h)/CI of carbapenems in severely infected children was associated with a more satisfactory goal achievement rate (probability of target attainment) and a cumulative fraction of response than STI therapy. In summary, the EI/CI of carbapenems in children with severe infection has a relatively sufficient PK or pharmacodynamic (PD) basis and satisfactory efficacy and safety. However, due to the limited quantity and quality of studies, the EI/CI therapy should not be used routinely in severely infected children. This conclusion should be further verified by more high-quality controlled clinical trials or observational studies based on PK/PD theories.

摘要

我们系统回顾了碳青霉烯类药物延长输注或持续输注(EI/CI)与短期输注(STI)用于重症感染儿童的疗效和安全性。对包括PubMed、Embase、Cochrane图书馆、Clinicaltrials.gov、中国知网、万方数据和中国生物医学文献数据库在内的数据库,从建库至2020年8月10日进行系统检索,查找比较EI/CI与STI用于重症感染儿童的各类研究(如随机对照试验(RCT)、回顾性研究以及药代动力学或群体药代动力学(PK/PPK)研究)。不限语言,并进行了手工检索。由两名研究人员独立对数据进行筛选、评估、提取和审查。对纳入研究进行定量(荟萃分析)或定性分析。本综述纳入了20项研究(包括2项RCT、1项病例系列、6项病例报告和11项PK/PPK研究)(CRD42020162845)。RCT的质量评估结果显示存在选择和隐匿偏倚风险。RCT的定性分析表明,与STI相比,美罗培南在晚发型新生儿败血症中进行3至4小时的EI可提高临床疗效和微生物清除率,并降低死亡率;然而,其他不良事件发生率的差异无统计学意义。回顾性研究表明,接受美罗培南EI的儿童临床改善情况良好。此外,PK/PPK研究结果显示,碳青霉烯类药物在重症感染儿童中进行3或4小时的EI/CI与比STI治疗更令人满意的目标达成率(目标达成概率)和反应累积分数相关。总之,碳青霉烯类药物在重症感染儿童中进行EI/CI具有相对充分的药代动力学或药效学(PD)基础,疗效和安全性良好。然而,由于研究数量和质量有限,EI/CI疗法不应在重症感染儿童中常规使用。这一结论应通过更多基于PK/PD理论的高质量对照临床试验或观察性研究进一步验证。

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