Tamang Ramisa, Bharati Laxman, Khatiwada Asmita Priyadarshini, Ozaki Akihiko, Shrestha Sunil
Department of Pharmacy, Maharajgunj Medical Campus, Institute of Medicine, Tribhuvan University, Kathmandu, Nepal.
Department of Pharmaceutical and Health Service Research, Nepal Health Research and Innovation Foundation, Lalitpur, Nepal.
JMA J. 2022 Oct 17;5(4):416-426. doi: 10.31662/jmaj.2021-0015. Epub 2022 Sep 26.
Adverse drug reactions (ADRs) are among the leading causes of morbidity and mortality worldwide. ADRs of anticancer drugs are ubiquitous. However, in Nepal, studies on chemotherapy-induced ADRs are scarce. Thus, this study aimed to assess the ADRs associated with the use of anticancer drugs and their management along with causality assessment and severity of ADRs.
A prospective cross-sectional observational and single-center study was conducted at Bhaktapur Cancer Hospital, Nepal, for 6 months. All the patients who fulfilled the study criteria were analyzed to identify ADRs occurring daily. In addition, all collected data were recorded and analyzed using descriptive statistics.
A total of 861 ADRs were detected among 102 cancer patients. The mean ± S.D. age of the patients was 49.93 ± 14.27 years, and each enrolled patient experienced one or more ADRs with a mean ± S.D. of 8.44 ± 3.27. The common ADRs observed were fatigue, anorexia, alopecia, constipation, nausea, vomiting, and neuropathy. Cyclophosphamide, either alone or in combination with other chemotherapeutic agents, was responsible for most ADRs. According to Naranjo's causality assessment algorithm, most of the ADRs belonged to the probable (47.1%) category. Majority (54.9%) of the ADRs were moderate in their severity. Proton pump inhibitors, antiemetic, mouth gargle, protein powders, iron tablets, and multivitamin and mineral tablets were commonly used for ADR management.
The occurrence of chemotherapy-related ADRs in each enrolled patient is a crucial concern. The present study highlights the need for active monitoring of the patients to identify and manage ADRs promptly.
药物不良反应（ADR）是全球发病和死亡的主要原因之一。抗癌药物的不良反应普遍存在。然而，在尼泊尔，关于化疗引起的ADR的研究很少。因此，本研究旨在评估与抗癌药物使用相关的ADR及其管理，同时进行因果关系评估和ADR的严重程度评估。
在尼泊尔巴克塔普尔癌症医院进行了一项为期6个月的前瞻性横断面观察性单中心研究。对所有符合研究标准的患者进行分析，以确定每日发生的ADR。此外，所有收集的数据均使用描述性统计进行记录和分析。
在102名癌症患者中共检测到861例ADR。患者的平均年龄±标准差为49.93±14.27岁，每位入选患者经历了一种或多种ADR，平均±标准差为8.44±3.27。观察到的常见ADR包括疲劳、厌食、脱发、便秘、恶心、呕吐和神经病变。环磷酰胺单独或与其他化疗药物联合使用导致了大多数ADR。根据纳伦霍因果关系评估算法，大多数ADR属于可能（47.1%）类别。大多数（54.9%）ADR的严重程度为中度。质子泵抑制剂、止吐药、漱口水、蛋白粉、铁片以及多种维生素和矿物质片常用于ADR的管理。
每位入选患者中化疗相关ADR的发生是一个关键问题。本研究强调需要对患者进行积极监测，以便及时识别和管理ADR。
