Department of Pharmacology, Institute of Postgraduate Medical Education & Research (IPGME&R), 244B, Acharya J. C. Bose Road, Kolkata - 700 020, India.
Indian J Pharmacol. 2011 Feb;43(1):36-9. doi: 10.4103/0253-7613.75664.
Adverse drug reactions (ADRs) to psychotropic agents are common and can lead to noncompliance or even discontinuation of therapy. There is paucity of such data in the Indian context. We deemed it worthwhile to assess the suspected ADR profile of psychotropic drugs in an ambulatory setting in a public teaching hospital in Kolkata.
A longitudinal observational study was conducted in the outpatient department (OPD) of the concerned psychiatry unit. Twenty consecutive patients per day, irrespective of their psychiatric diagnosis, were screened for suspected ADRs, 2 days in a week, over 15 months. Adverse event history, medication history and other relevant details were captured in a format as adopted in the Indian National Pharmacovigilance Programme. Causality was assessed by criteria of World Health Organization-Uppsala Monitoring Center (WHO-UPC).
We screened 2000 patients (68.69% males, median age 34.4 years), of whom 429 were suspected of having at least one ADR; 84 cases had insufficient evidence about causality (WHO-UMC causality status "unlikely") and were excluded from further analysis. Thus, 17.25% (95% confidence interval: 15.59-18.91%) of our study population reported ADRs with at least "possible" causality. Of 352 events recorded, 327 (92.90%) were "probable" and the rest "possible". None was labeled "certain" as rechallenge was not performed. Patients received a median of 3.2 psychotropic drugs each. Thirty-three different kinds of ADRs were noted, including tremor (19.60%), weight gain (15.34%) and constipation (14.49%). Among the incriminated drugs, antipsychotics represented the majority (57.10%), with olanzapine topping the list.
This study offers a representative profile of ADRs to be expected in psychiatry out-patients in an Indian public hospital. Establishment of a psychotropic drug ADR database can be a worthy long-term goal in the Indian context.
精神类药物的不良反应（ADR）很常见，可能导致患者不遵医嘱，甚至停药。印度目前缺少此类数据。因此，我们认为在加尔各答的一家公立医院的门诊环境中评估精神类药物的可疑 ADR 情况是很有价值的。
在相关精神科病房的门诊部门进行了一项纵向观察性研究。在 15 个月的时间里，每周两天，每天筛查 20 名连续就诊的患者，无论其精神诊断如何，以筛查可疑的 ADR。采用印度国家药物警戒计划采用的格式记录不良事件史、用药史和其他相关细节。通过世界卫生组织-乌普萨拉监测中心（WHO-UPC）的标准评估因果关系。
我们筛查了 2000 名患者（68.69%为男性，中位年龄 34.4 岁），其中 429 名患者至少有一种可疑的 ADR；84 例因果关系证据不足（WHO-UMC 因果关系状态“不太可能”），被排除在进一步分析之外。因此，我们的研究人群中有 17.25%（95%置信区间：15.59-18.91%）报告了至少“可能”因果关系的 ADR。记录的 352 个事件中，327 个（92.90%）为“很可能”，其余为“可能”。由于未进行再挑战，因此没有一个被标记为“肯定”。每位患者平均接受 3.2 种精神类药物。共观察到 33 种不同类型的 ADR，包括震颤（19.60%）、体重增加（15.34%）和便秘（14.49%）。在被怀疑的药物中，抗精神病药占大多数（57.10%），其中奥氮平位居榜首。
本研究提供了印度公立医院门诊精神科患者 ADR 的代表性概况。在印度，建立精神类药物 ADR 数据库可以是一个值得长期追求的目标。
