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与放射性药物使用相关的不良事件:来自一家三级医疗机构的前瞻性研究。

Adverse events associated with the use of radiopharmaceuticals: A prospective study from a tertiary care institute.

作者信息

Agrawal Kanhaiyalal, Meher Bikash Ranjan, Baranwal Abhinav, Kumar Navneet

机构信息

Department of Nuclear Medicine, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.

Department of Pharmacology, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.

出版信息

Perspect Clin Res. 2025 Apr-Jun;16(2):87-91. doi: 10.4103/picr.picr_89_24. Epub 2024 Sep 10.

Abstract

INTRODUCTION

Radiopharmaceuticals (RPs) are used in the diagnosis and management of various cancer and noncancerous conditions. Like those of conventional drugs, the use of RPs may also be associated with the development of various adverse events (AEs). The information obtained from patients about these AEs may empower medical professionals to identify, evaluate, and manage them more efficiently to ensure the safe use of RPs.

OBJECTIVE

The objective of our study was to assess the type, timing, and frequency of the reported AEs associated with the use of RPs and to establish their causal association as well as to evaluate the outcome of these AEs from the perspective of patients.

METHODS

This study was a prospective cohort study conducted on 315 patients who underwent nuclear medicine examination in a tertiary care center for various indications. Relevant data were collected from the participants regarding suspected AEs associated with the use of various RPs. The collected data were objectively analyzed and assessed.

RESULTS

Of 315 patients, 39 (12.3%) developed 59 AEs. All the reported AEs were mild in nature and neither required hospitalization nor caused death of any participants. 37.2% of the reported AEs occurred within 1 h of administration of the RPs and spontaneously resolved within a few hours. Of these 59 AEs, 10 had causal associations (possible or probable) with RPs and were considered adverse drug reaction (ADR). The incidence of ADR in our study was 2.2%.

CONCLUSION

RPs can cause ADRs though it is less in comparison to conventional drugs. We expect that our study will increase the awareness of AEs associated with the use of RPs among patients and health-care professionals and encourage its reporting.

摘要

引言

放射性药物(RPs)用于各种癌症和非癌症疾病的诊断和治疗。与传统药物一样,放射性药物的使用也可能与各种不良事件(AE)的发生有关。从患者那里获得的有关这些不良事件的信息可以使医疗专业人员更有效地识别、评估和管理它们,以确保放射性药物的安全使用。

目的

我们研究的目的是评估与放射性药物使用相关的报告不良事件的类型、时间和频率,确定其因果关系,并从患者的角度评估这些不良事件的结果。

方法

本研究是一项前瞻性队列研究,对在一家三级护理中心因各种适应症接受核医学检查的315名患者进行。从参与者那里收集了与各种放射性药物使用相关的疑似不良事件的相关数据。对收集到的数据进行客观分析和评估。

结果

在315名患者中,39名(12.3%)出现了59起不良事件。所有报告的不良事件性质均为轻度,既不需要住院治疗,也没有导致任何参与者死亡。37.2%的报告不良事件发生在放射性药物给药后1小时内,并在数小时内自行缓解。在这59起不良事件中,10起与放射性药物有因果关系(可能或很可能),被认为是药物不良反应(ADR)。我们研究中药物不良反应的发生率为2.2%。

结论

放射性药物可引起药物不良反应,尽管与传统药物相比发生率较低。我们希望我们的研究将提高患者和医疗保健专业人员对与放射性药物使用相关不良事件的认识,并鼓励报告此类事件。

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