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Safety Evaluation Of Antitubercular Therapy Under Revised National Tuberculosis Control Programme In India

机译:经修订的印度国家结核病控制计划下抗结核治疗的安全性评估

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Introduction: The World Health Organization declared tuberculosis (TB) as a global emergency in 1993. To intensify the efforts to control TB, the Government of India gradually replaced the National Tuberculosis Programme by the Directly Observed Short Course Therapy (DOTS) programme which is now known as the Revised National Tuberculosis Programme (RNTCP). Objectives: The present study was carried out to evaluate the safety of the DOTS therapy by monitoring adverse drug reactions (ADRs). Methodology: All the TB patients admitted at the DOTS centre Kasturba Hospital, Manipal, and at the DOTS Centre, Udupi, were enrolled as per the study criteria and were monitored for ADRs. The data were evaluated for patient demography, types of TB, types of DOTS treatment, incidence of ADRs, predisposing factors for developing ADRs and the types, onset, management and outcome of the ADRs. ADRs were also assessed for their causality and severity as per the standard algorithms. Results: Out of 94 TB patients, a majority of them were males (70%) and belonged to the age group of 18-40 years (52%). The incidence of ADRs was 17.02%. Gastritis was the most common ADR and multiple drug therapy was the major predisposing factor. We found that 28.51% of the total ADRs belonged to Type-A ADRs. In 87.1% of the cases, the suspected drug was continued in spite of the ADR, without any complications. On evaluation of the causality of ADRs, a majority of them were found to be ?possible? by both WHO and Naranjo?s scales. The severity assessment of ADRs showed that 31(51%) reactions were moderate and 30 (49%) were of the ?mild? nature. Conclusion: We found DOTS therapy to be safer. But regular monitoring is required for ADRs, so that certain percentage of ADRs can be prevented.
机译:简介:世界卫生组织于1993年宣布结核病为全球紧急情况。为了加强控制结核病的努力,印度政府逐渐将国家结核病计划替换为直接观察短程疗法(DOTS)计划。被称为国家结核病修订计划(RNTCP)。目的:本研究旨在通过监测药物不良反应(ADR)来评估DOTS治疗的安全性。方法:按照研究标准招募了在马尼帕尔卡特斯巴医院DOTS中心和乌杜皮DOTS中心收治的所有结核病患者,并进行了ADR监测。对数据进行了患者人口统计学,结核病类型,DOTS治疗类型,ADR发生率,发展ADR的诱发因素以及ADR的类型,发作,治疗和结局的评估。还根据标准算法评估了ADR的因果关系和严重性。结果:在94例TB患者中,大多数为男性(70%),属于18至40岁的年龄组(52%)。 ADR的发生率为17.02%。胃炎是最常见的ADR,多种药物治疗是主要诱因。我们发现,全部ADR中有28.51%属于A型ADR。在87.1%的病例中,尽管有ADR,但仍继续使用可疑药物,没有任何并发​​症。在评估ADR的因果关系时,发现其中大多数是“可能的”吗?根据WHO和Naranjo的量表。 ADR的严重程度评估显示,中度反应为31(51%),轻度反应为30(49%)。性质。结论:我们发现DOTS疗法更安全。但是需要对ADR进行定期监控,以便可以防止某些百分比的ADR。

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