{"title":"评估单克隆抗体在2020年印度班加罗尔三级医院乳腺癌治疗中的不良反应","authors":"F. Najari, A. Setayesh, E. Gopinath, S. Mirzaei","doi":"10.30699/jambs.31.146.255","DOIUrl":null,"url":null,"abstract":"10.30699/jambs.31.146.255 Background & Objective: Breast cancer (BC) is the leading cause of cancer mortality among women in different countries around the world, including India. Monoclonal antibodies (MoAbs) have emerged as a promising targeted treatment for BC, improving the survival rate of these patients with minimum adverse effects. This study aimed to investigate the severity of the adverse effects of MoAbs in an Indian population. Materials & Methods: This longitudinal descriptive study was conducted on 120 BC patients over six months in a tertiary care hospital in Bangalore, India, in 2020. A data collection form was used to gather relevant data. The collected data were analyzed by SPSS Version 21, using Chi-square and Fisher’s exact tests. A P-value less than 0.05 was considered statistically significant. Results: Among 97 patients evaluated in this study (including 29 patients in the non-exposed group), the adverse effects of BC were observed in all age groups. Most adverse effects were attributed to trastuzumab (37.50%; CI: 31.6-44) and bevacizumab (26.78%; CI: 20.9-31.8). The MoAbs were well tolerated by the patients, causing minimum adverse effects that were manageable by supportive therapy. Anemia was the most prevalent adverse effect. Evaluation of the null hypothesis indicated that the adverse effects of MoAbs depended on their amount and composition. The results of analysis using the Naranjo scale revealed that most of the adverse effects were probable (67%) and possible (32%), respectively. Also, according to the WHO scale, most of the adverse effects were under the categories of probable (61.20%) and possible (38.14%), respectively. Conclusion: Based on the present results, the adverse effects of MoAbs were manageable by supportive care. Anemia was found to be the most prevalent adverse effect. Meanwhile, no potential adverse cardiovascular event was observed in patients on trastuzumab, except one case of dilated cardiomyopathy.","PeriodicalId":36550,"journal":{"name":"Journal of Advances in Medical and Biomedical Research","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Evaluation of the Adverse Effects of Monoclonal Antibodies in Breast Cancer Treatment in a Tertiary Care Hospital in Bengaluru, India, in 2020\",\"authors\":\"F. Najari, A. Setayesh, E. Gopinath, S. Mirzaei\",\"doi\":\"10.30699/jambs.31.146.255\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"10.30699/jambs.31.146.255 Background & Objective: Breast cancer (BC) is the leading cause of cancer mortality among women in different countries around the world, including India. Monoclonal antibodies (MoAbs) have emerged as a promising targeted treatment for BC, improving the survival rate of these patients with minimum adverse effects. This study aimed to investigate the severity of the adverse effects of MoAbs in an Indian population. Materials & Methods: This longitudinal descriptive study was conducted on 120 BC patients over six months in a tertiary care hospital in Bangalore, India, in 2020. A data collection form was used to gather relevant data. The collected data were analyzed by SPSS Version 21, using Chi-square and Fisher’s exact tests. A P-value less than 0.05 was considered statistically significant. Results: Among 97 patients evaluated in this study (including 29 patients in the non-exposed group), the adverse effects of BC were observed in all age groups. Most adverse effects were attributed to trastuzumab (37.50%; CI: 31.6-44) and bevacizumab (26.78%; CI: 20.9-31.8). The MoAbs were well tolerated by the patients, causing minimum adverse effects that were manageable by supportive therapy. Anemia was the most prevalent adverse effect. Evaluation of the null hypothesis indicated that the adverse effects of MoAbs depended on their amount and composition. The results of analysis using the Naranjo scale revealed that most of the adverse effects were probable (67%) and possible (32%), respectively. Also, according to the WHO scale, most of the adverse effects were under the categories of probable (61.20%) and possible (38.14%), respectively. Conclusion: Based on the present results, the adverse effects of MoAbs were manageable by supportive care. Anemia was found to be the most prevalent adverse effect. Meanwhile, no potential adverse cardiovascular event was observed in patients on trastuzumab, except one case of dilated cardiomyopathy.\",\"PeriodicalId\":36550,\"journal\":{\"name\":\"Journal of Advances in Medical and Biomedical Research\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Advances in Medical and Biomedical Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.30699/jambs.31.146.255\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Advances in Medical and Biomedical Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.30699/jambs.31.146.255","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0
摘要
10.30699/jamms.31.46.255背景与目的:癌症(BC)是包括印度在内的世界各国癌症妇女死亡的主要原因。单克隆抗体(MoAbs)已成为BC的一种很有前途的靶向治疗方法,可以提高这些患者的生存率,并将不良反应降至最低。本研究旨在调查MoAbs在印度人群中不良反应的严重程度。材料与方法:这项纵向描述性研究于2020年在印度班加罗尔的一家三级护理医院对120名BC患者进行了为期六个月的研究。数据收集表用于收集相关数据。收集的数据采用SPSS Version 21进行分析,采用卡方检验和Fisher精确检验。P值小于0.05被认为具有统计学意义。结果:在本研究评估的97名患者中(包括29名非暴露组患者),所有年龄组都观察到BC的不良反应。大多数不良反应归因于曲妥珠单抗(37.50%;CI:31.6-44)和贝伐单抗(26.78%;CI:20.9-31.8)。MoAbs患者耐受性良好,造成的不良反应最小,可通过支持性治疗进行控制。贫血是最常见的不良反应。对无效假设的评估表明,MoAbs的不良影响取决于其数量和成分。使用Naranjo量表的分析结果显示,大多数不良反应分别是可能的(67%)和可能的(32%)。此外,根据世界卫生组织的量表,大多数不良反应分别属于可能(61.20%)和可能(38.14%)两类。结论:根据目前的结果,MoAbs的不良反应可以通过支持性护理来控制。贫血被发现是最普遍的不良反应。同时,除了一例扩张型心肌病外,在服用曲妥珠单抗的患者中未观察到潜在的心血管不良事件。
Evaluation of the Adverse Effects of Monoclonal Antibodies in Breast Cancer Treatment in a Tertiary Care Hospital in Bengaluru, India, in 2020
10.30699/jambs.31.146.255 Background & Objective: Breast cancer (BC) is the leading cause of cancer mortality among women in different countries around the world, including India. Monoclonal antibodies (MoAbs) have emerged as a promising targeted treatment for BC, improving the survival rate of these patients with minimum adverse effects. This study aimed to investigate the severity of the adverse effects of MoAbs in an Indian population. Materials & Methods: This longitudinal descriptive study was conducted on 120 BC patients over six months in a tertiary care hospital in Bangalore, India, in 2020. A data collection form was used to gather relevant data. The collected data were analyzed by SPSS Version 21, using Chi-square and Fisher’s exact tests. A P-value less than 0.05 was considered statistically significant. Results: Among 97 patients evaluated in this study (including 29 patients in the non-exposed group), the adverse effects of BC were observed in all age groups. Most adverse effects were attributed to trastuzumab (37.50%; CI: 31.6-44) and bevacizumab (26.78%; CI: 20.9-31.8). The MoAbs were well tolerated by the patients, causing minimum adverse effects that were manageable by supportive therapy. Anemia was the most prevalent adverse effect. Evaluation of the null hypothesis indicated that the adverse effects of MoAbs depended on their amount and composition. The results of analysis using the Naranjo scale revealed that most of the adverse effects were probable (67%) and possible (32%), respectively. Also, according to the WHO scale, most of the adverse effects were under the categories of probable (61.20%) and possible (38.14%), respectively. Conclusion: Based on the present results, the adverse effects of MoAbs were manageable by supportive care. Anemia was found to be the most prevalent adverse effect. Meanwhile, no potential adverse cardiovascular event was observed in patients on trastuzumab, except one case of dilated cardiomyopathy.