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

Q2 Medicine
Perspectives in Clinical Research Pub Date : 2025-04-01 Epub Date: 2024-09-10 DOI:10.4103/picr.picr_89_24
Kanhaiyalal Agrawal, Bikash Ranjan Meher, Abhinav Baranwal, Navneet Kumar
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引用次数: 0

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.

与使用放射性药物相关的不良事件:一项来自三级保健机构的前瞻性研究。
简介:放射性药物(RPs)用于各种癌症和非癌性疾病的诊断和治疗。与常规药物一样,rp的使用也可能与各种不良事件(ae)的发生有关。从患者那里获得的关于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rp的安全使用。目的:本研究的目的是评估与rp使用相关的不良事件的类型、时间和频率,建立它们之间的因果关系,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315例在三级保健中心接受各种适应症核医学检查的患者进行研究。从参与者收集了与使用各种rp相关的疑似ae的相关数据。对收集到的数据进行客观分析和评价。结果:315例患者中,39例(12.3%)发生59例ae。所有报告的不良事件都是轻微的,既不需要住院治疗,也没有导致任何参与者死亡。37.2%报告的不良反应发生在给药后1小时内,并在几小时内自行消退。在这59例ae中,10例与rp有因果关系(可能或可能),被认为是药物不良反应(ADR)。在我们的研究中,不良反应的发生率为2.2%。结论:与常规药物相比,rp可引起不良反应,但发生率较低。我们期望我们的研究将提高患者和卫生保健专业人员对与rp使用相关的ae的认识,并鼓励其报告。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Perspectives in Clinical Research
Perspectives in Clinical Research Medicine-Medicine (all)
CiteScore
2.90
自引率
0.00%
发文量
41
审稿时长
36 weeks
期刊介绍: This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.
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