妊娠期药物治疗药物使用对新生儿健康潜在影响的回顾性评估

K. Podolská, D. Mazánková, M. Göböová
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引用次数: 1

摘要

摘要本研究的重点是临床药师在优化药物治疗的情况下,在怀孕期间的病人和其在斯洛伐克医院部门的重要性的作用。回顾性评价药物治疗的孕妇,重点是致畸性和适当的药物选择。在24个月内收集22名女性患者的医院数据。主要观察结果是新生儿的健康状况,表示为健康新生儿、新生儿疾病、任何先天性缺陷或畸形、自然流产或未明确的新生儿信息。根据产品特性总结(SmPC)、基础胎儿和新生儿风险评估(Briggs等,2017)中使用的治疗药物的胎儿风险评估,以及建议和相关的人类过去报告和支持证据研究,将药物分为两组:确认的胎儿风险药物和阴性(未确认)胎儿风险药物。共有36.3%的患者同时使用两种药物。患者在妊娠早期使用药物最多(81.8%)。妊娠期用药最多的是神经系统(25.5%)、抗感染(23.6%)和呼吸系统(14.5%)。在22例患者中,尽管使用了不同胎儿风险变异的治疗药物,但16例(73%)的新生儿健康。在已确认有风险的药物组中,部分药物对新生儿健康的负面影响已在临床表现出来。应用醋酸去甲睾酮和丙戊酸后出现自然流产;使用干扰素β-1a和琥珀酸甲基强的松龙钠后出现出生缺陷(未指明)。使用甲硝唑一水钠盐后出现心脏杂音。使用布地奈德后出现另一种疾病(Wilm肿瘤)。在使用强的松、别嘌呤醇、钠黄嘌呤和氟伐他汀后,观察到4例新生儿未明确的信息。
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Retrospective Assessment of the Use of Pharmacotherapeutic Agents in Pregnancy with Potential Impact on Neonatal Health
Abstract This study focuses on the role of a clinical pharmacist in the optimisation of pharmacotherapy in the case of patients during pregnancy and its importance within the hospital sector in Slovakia. Retrospective evaluation of pharmacotherapy in pregnant patients with a focus on teratogenicity and appropriate drug selection was used. The hospital data were collected during 24 months from 22 female patients. The main observed outcome was health condition of the newborn, and it was expressed as healthy newborn, illness of the newborn, any congenital defect or malformation, spontaneous abortion, or unspecified information about the newborn. Based on a foetal risk assessment of used therapeutic agents from the Summary of Product Characteristics (SmPC), basal foetal and neonatal risk assessment (Briggs et al., 2017), and recommendations and related human past reports and supporting evidence studies, drugs were divided into two groups: confirmed foetal risk drugs and negative (nonconfirmed) foetal risk drugs. A total of 36.3% of the patients used two drugs. Patients most frequently used drugs during the first trimester (81.8%). During pregnancy, the most used drugs were for the nervous system (25.5%), anti-infective agents (23.6%), and respiratory therapeutic agents (14.5%). Of the 22 patients, 16 (73%) had healthy newborns, despite the use of therapeutic agents with different foetal-risk variations. In the group of therapeutic agents with confirmed risk, in some, negative effect on the newborn's health was clinically manifested. Spontaneous abortion was present after using norethisterone acetate and valproic acid; birth defect (unspecified) was present after usage of interferon β-1a and methylprednisolone sodium succinate. An illness (heart murmur) was present after the use of monohydrate sodium salt of metamizole. Another illness (Wilm's tumour) was present after the use of budesonide. Unspecified information about the newborn was observed in four cases after the use of prednisone, allopurinol, nadroparin, and fluvastatin.
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来源期刊
European Pharmaceutical Journal
European Pharmaceutical Journal Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)
CiteScore
0.60
自引率
0.00%
发文量
16
期刊介绍: European Pharmaceutical Journal publishes only original articles not previously published and articles that are not being considered or have not been submitted for publication elsewhere. If parts of the results have been published as conference abstract or elsewhere, it should be stated in references. The ethical standards of the Helsinki-Tokio Declaration should be kept. This should be mentioned in the Methods of manuscript. Reviews are published only on request. Authors, whose submitted research work was performed with the support of a company, should indicate this in Conflict of Interest.
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