{"title":"埃塞俄比亚西北部阿姆哈拉综合专科医院以多路替格雷韦为基础的抗逆转录病毒药物治疗方案的成人免疫病毒感染患者药物不良事件的流行和模式:一项多中心回顾性随访研究。","authors":"Alemu Birara Zemariam, Yabibal Berie Tadesse, Abebe Tarekegn Kassaw","doi":"10.2147/HIV.S411948","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Antiretroviral therapy (ART) refers to any HIV treatment that uses a combination of two or more drugs to suppress viral load and preserve immunofunction. Despite the success of ART, adverse events persist, in particular in patients with baseline viral loads >100,000 copies/mL. Apart from premarketing surveillance, the safety and risk profile of dolutegravir has not been thoroughly researched in Ethiopia. Therefore, this study aimed to assess the prevalence and patterns of adverse drug events among HIV-infected adult patients on dolutegravir-based ART regimens at Amhara comprehensive specialized hospitals, northwest Ethiopia.</p><p><strong>Methods: </strong>A retrospective follow-up study was conducted from January 1, 2019 to December 31, 2021 at Amhara comprehensive specialized hospitals, with a sample size of 423. Simple random sampling was employed and data collected using kobo tool box software by four trained BSc nurses from March to April, 2022. SPSS 25 was used for analysis. Descriptive summary statistics are used and data presented using tables and text.</p><p><strong>Results: </strong>A total of 372 patient charts were included in the final analysis, and the prevalence of adverse events associated with dolutegravir was found to be 37.6% (95% CI 32.1%-42.1%). Nearly two-thirds (60.7%) of the participants had neuropsychiatric symptoms, followed by gastrointestinal symptoms (23.6%) and hepatic problems (7.14%). All recorded adverse events were mild.</p><p><strong>Conclusion: </strong>Dolutegravir adverse events were relatively low compared to previous studies. Common adverse events reported were neuropsychiatric symptoms and gastrointestinal symptoms, followed by hepatic and renal events. All adverse events were mild and none was severe or life-threatening events. Therefore, we recommend the use of dolutegravir in clinical settings.</p>","PeriodicalId":46555,"journal":{"name":"HIV AIDS-Research and Palliative Care","volume":"15 ","pages":"271-278"},"PeriodicalIF":1.5000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/7b/a6/hiv-15-271.PMC10241189.pdf","citationCount":"0","resultStr":"{\"title\":\"Prevalence and Patterns of Adverse Drug Events Among Adult Patients with Human Immune Virus Infection on Dolutegravir-Based Antiretroviral Drug Regimens in Amhara Comprehensive Specialized Hospitals, Northwest Ethiopia: A Multicenter Retrospective Follow-Up Study.\",\"authors\":\"Alemu Birara Zemariam, Yabibal Berie Tadesse, Abebe Tarekegn Kassaw\",\"doi\":\"10.2147/HIV.S411948\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Antiretroviral therapy (ART) refers to any HIV treatment that uses a combination of two or more drugs to suppress viral load and preserve immunofunction. Despite the success of ART, adverse events persist, in particular in patients with baseline viral loads >100,000 copies/mL. Apart from premarketing surveillance, the safety and risk profile of dolutegravir has not been thoroughly researched in Ethiopia. Therefore, this study aimed to assess the prevalence and patterns of adverse drug events among HIV-infected adult patients on dolutegravir-based ART regimens at Amhara comprehensive specialized hospitals, northwest Ethiopia.</p><p><strong>Methods: </strong>A retrospective follow-up study was conducted from January 1, 2019 to December 31, 2021 at Amhara comprehensive specialized hospitals, with a sample size of 423. Simple random sampling was employed and data collected using kobo tool box software by four trained BSc nurses from March to April, 2022. SPSS 25 was used for analysis. 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引用次数: 0
摘要
背景:抗逆转录病毒治疗(ART)是指使用两种或两种以上药物的组合来抑制病毒载量和保持免疫功能的任何HIV治疗。尽管抗逆转录病毒治疗取得了成功，但不良事件持续存在，特别是在基线病毒载量>100,000拷贝/mL的患者中。除了上市前的监测外，在埃塞俄比亚还没有对多鲁特韦的安全性和风险概况进行彻底的研究。因此，本研究旨在评估埃塞俄比亚西北部阿姆哈拉综合专科医院接受以盐酸孕酮为基础的抗逆转录病毒治疗方案的艾滋病毒感染成年患者中药物不良事件的发生率和模式。方法:于2019年1月1日至2021年12月31日在阿姆哈拉综合专科医院进行回顾性随访研究，样本量为423人。于2022年3 - 4月对4名经过培训的BSc护士进行简单随机抽样，使用kobo工具箱软件进行数据采集。采用SPSS 25进行分析。使用描述性汇总统计，并使用表格和文本呈现数据。结果:最终分析共纳入372例患者病历，发现与多替格拉韦相关的不良事件发生率为37.6% (95% CI 32.1% ~ 42.1%)。近三分之二(60.7%)的参与者有神经精神症状，其次是胃肠道症状(23.6%)和肝脏问题(7.14%)。所有记录的不良事件均为轻度。结论:与以往的研究相比，多来替韦的不良事件相对较低。报告的常见不良事件是神经精神症状和胃肠道症状，其次是肝脏和肾脏事件。所有的不良事件都是轻微的，没有严重或危及生命的事件。因此，我们建议在临床环境中使用多替格雷韦。
Prevalence and Patterns of Adverse Drug Events Among Adult Patients with Human Immune Virus Infection on Dolutegravir-Based Antiretroviral Drug Regimens in Amhara Comprehensive Specialized Hospitals, Northwest Ethiopia: A Multicenter Retrospective Follow-Up Study.
Background: Antiretroviral therapy (ART) refers to any HIV treatment that uses a combination of two or more drugs to suppress viral load and preserve immunofunction. Despite the success of ART, adverse events persist, in particular in patients with baseline viral loads >100,000 copies/mL. Apart from premarketing surveillance, the safety and risk profile of dolutegravir has not been thoroughly researched in Ethiopia. Therefore, this study aimed to assess the prevalence and patterns of adverse drug events among HIV-infected adult patients on dolutegravir-based ART regimens at Amhara comprehensive specialized hospitals, northwest Ethiopia.
Methods: A retrospective follow-up study was conducted from January 1, 2019 to December 31, 2021 at Amhara comprehensive specialized hospitals, with a sample size of 423. Simple random sampling was employed and data collected using kobo tool box software by four trained BSc nurses from March to April, 2022. SPSS 25 was used for analysis. Descriptive summary statistics are used and data presented using tables and text.
Results: A total of 372 patient charts were included in the final analysis, and the prevalence of adverse events associated with dolutegravir was found to be 37.6% (95% CI 32.1%-42.1%). Nearly two-thirds (60.7%) of the participants had neuropsychiatric symptoms, followed by gastrointestinal symptoms (23.6%) and hepatic problems (7.14%). All recorded adverse events were mild.
Conclusion: Dolutegravir adverse events were relatively low compared to previous studies. Common adverse events reported were neuropsychiatric symptoms and gastrointestinal symptoms, followed by hepatic and renal events. All adverse events were mild and none was severe or life-threatening events. Therefore, we recommend the use of dolutegravir in clinical settings.
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