Gummadi Tejaswi, Harave Virupaksha Shanmugam, Aiyar Lakshmi Narayan, RajaLekshmi Saraswathy Ganesan, Kunnavil Radhika
Department of Pharmacy Practice, M S Ramaiah University of Applied Sciences, Bengaluru, Karnataka, India.
Department of Psychiatry, M.S. Ramaiah Medical College, Bengaluru, Karnataka, India.
Indian J Psychol Med. 2017 May-Jun;39(3):306-311. doi: 10.4103/0253-7176.207328.
Psychotropic medications are the mainstay of treatment in psychiatric disorders and are associated with ADRs which affect the compliance and treatment course. Previous studies have looked at the frequency, profile of ADRs and their management aspects. However, the systematic comparison between IP and OP was lacking even though there is a prescription pattern difference. Hence this study was aimed to compare the proportion, pattern, severity and resolution of ADRs once detected.
This is a hospital based, prospective follow up study done in the psychiatry ward and outpatient setting for a period of 6 months. A total of 491 patients (200 IP, 291 OP) who received psychotropics were monitored in the study. UKU side effect rating scale was used to detect ADRs, WHO - UMC scale for causality, Modified Hartwig and Siegel Scale to assess severity of ADR and CDSCO suspected ADR form for reporting it.
Out of 491 patients who were recruited for the study, 83 patients developed ADRs (34 IP, 49 OP, = 0.963). The mean number of ADRs per patient was found to be higher in IP (IP-2.17±1.14, OP-1.65±1.12, -0.01). Severe ADRs were observed to be higher IP (IP-67.64%, OP-38.7%, -0.014) which was statistically significant. There is no statistically significant difference in distribution of ADRs across all age groups (-0.475).
The study results emphasises the need for active pharmacovigilance so that ADRs are detected and managed at the earliest, hence reducing the morbidity and improving compliance. There is also need for systematic long term, multicentric study to further examine and correlatethe observations of our study.
精神药物是精神疾病治疗的主要手段，且与影响依从性和治疗过程的不良反应相关。既往研究关注了不良反应的发生率、特征及其管理方面。然而，尽管存在处方模式差异，但住院患者和门诊患者之间的系统比较仍很缺乏。因此，本研究旨在比较一旦检测到不良反应后的比例、模式、严重程度及缓解情况。
这是一项基于医院的前瞻性随访研究，在精神科病房和门诊进行，为期6个月。本研究共监测了491例接受精神药物治疗的患者（200例住院患者，291例门诊患者）。使用乌普萨拉监测中心（UKU）副作用评定量表检测不良反应，采用世界卫生组织药物不良反应因果关系评价量表（WHO-UMC）评估因果关系，使用改良的哈特维希和西格尔量表评估不良反应的严重程度，并使用国家药品不良反应监测中心（CDSCO）可疑不良反应报告表进行报告。
在纳入本研究的491例患者中，83例出现了不良反应（34例住院患者，49例门诊患者，P = 0.963）。发现住院患者中每位患者的平均不良反应数量更高（住院患者-2.17±1.14，门诊患者-1.65±1.12，P = -0.01）。观察到严重不良反应在住院患者中更高（住院患者-67.64%，门诊患者-38.7%，P = -0.014），具有统计学意义。各年龄组不良反应分布无统计学差异（P = -0.475）。
研究结果强调了积极开展药物警戒的必要性，以便尽早发现和管理不良反应，从而降低发病率并提高依从性。还需要进行系统的长期多中心研究，以进一步检验和关联我们的研究观察结果。
