Sagar Anubha, Sharma Taruna
Department of Pharmacology, Himalayan Institute of Medical Sciences, Dehradun, IND.
Cureus. 2023 Jul 13;15(7):e41819. doi: 10.7759/cureus.41819. eCollection 2023 Jul.
Introduction The absence of a common National Treatment Guideline during the second wave of the COVID-19 pandemic in India resulted in different treatment strategies, and the use of "off-label drugs" (OfLDs) was one of them. Aims This study aimed to assess the proportion of doctors who prescribed OfLDs, their perceived appropriateness, and the factors leading to their use. Settings and design This is an undergraduate student research project, in which a web-based cross-sectional survey was conducted on doctors who delivered care to COVID-19 patients during the second wave of the pandemic in Uttarakhand, India. Materials and methods The minimum sample size was 370 (for a 95% confidence level, an alpha error of 0.5, and a power of 80%). Data were collected electronically using a validated questionnaire after institutional ethical clearance and the participants' consent. Statistical analysis This is a descriptive-analytical study. Results We received 419 completed responses; all specialties had seen COVID-19 patients, and 91.4% (383) of the doctors had provided care to COVID-19 patients in some way or the other. About 90.7% (380) of the doctors used OfLDs; 62.5% (262) agreed that OfLDs were beneficial, and 78.9% (331) disagreed on universal steroid use. Only 34.1% (143) felt that using OfLDs was ethical. About 16.9% (71) of the doctors believed that alternative medicine was a useful treatment adjunct, and 20% (84) of doctors prescribed OfLDs under duress. About 21.2% (89) believed that Remdesivir was the main treatment for the disease, and 18.6% (78) believed that Tocilizumab was the main treatment for the disease. Personal experience, conviction, or advice from peers were among the various reasons that were put forward for using OfLDs. Conclusions The use of OfLDs during the COVID-19 pandemic in India was extensive. It was done sometimes under pressure and was largely based on confusion (multiplicity of guidelines, many times at variance with each other) as well as on a personal or low level of scientific evidence forwarded to support the use.
引言 在印度第二波新冠疫情期间，由于缺乏通用的国家治疗指南，导致出现了不同的治疗策略，使用“超说明书用药”（OfLDs）就是其中之一。
目的 本研究旨在评估开具超说明书用药的医生比例、他们对其适用性的认知以及导致使用超说明书用药的因素。
设置与设计 这是一个本科生研究项目，对印度北阿坎德邦第二波疫情期间为新冠患者提供治疗的医生进行了基于网络的横断面调查。
材料与方法 最小样本量为370（95%置信水平、0.5的α错误率和80%的检验效能）。在获得机构伦理批准和参与者同意后，使用经过验证的问卷以电子方式收集数据。
统计分析 这是一项描述性分析研究。
结果 我们收到了419份完整回复；所有专科都诊治过新冠患者，91.4%（383名）医生曾以某种方式为新冠患者提供过治疗。约90.7%（380名）医生使用过超说明书用药；62.5%（262名）认为超说明书用药有益，78.9%（331名）不同意普遍使用类固醇。只有34.1%（143名）认为使用超说明书用药符合伦理。约16.9%（71名）医生认为替代医学是一种有用的治疗辅助手段，20%（84名）医生在压力下开具超说明书用药。约21.2%（89名）认为瑞德西韦是该疾病的主要治疗方法，18.6%（78名）认为托珠单抗是该疾病的主要治疗方法。个人经验、信念或同行建议是提出的使用超说明书用药的各种原因之一。
结论 在印度新冠疫情期间，超说明书用药的使用很广泛。有时是在压力下进行的，很大程度上是基于困惑（指南繁多，且很多时候相互矛盾）以及个人或低水平的科学证据来支持其使用。
