Piparva Kiran G, Buch J G, Chandrani Kalpesh V
Department of Pharmacology, P.D.U. Medical College, Rajkot, India.
Indian J Psychol Med. 2011 Jul;33(2):153-7. doi: 10.4103/0253-7176.92067.
Novel atypical antipsychotics are superior to conventional antipsychotics as they significantly reduce both positive and negative symptoms of schizophrenia and have lower risk of extrapyramidal symptoms (EPS). However, these drugs have separate set of adverse drug reactions (ADRs). Therefore, this study was carried out to assess these ADRs, which can have impact on long-term compliance and achieving successful treatment.
A prospective study of analysis of ADR of atypical antipsychotic drugs was carried out in the psychiatry outpatient department. Patients of psychotic disorder (any age, either sex), who were prescribed atypical antipsychotic drugs, were included. Those who were prescribed conventional antipsychotics or combinations of antipsychotics were excluded from the study. Apart from spontaneously reported ADRs, a questionnaire related to the likely ADR was used and patients' responses were recorded in the case record form.
Totally 93 ADRs were recorded from 84 prescriptions. Majority of the ADRs (82 out of 93) were seen with risperidone and olanzepine, as they were the commonly prescribed drugs. Weight gain, dizziness, sleep disturbance and appetite disturbance accounted for nearly 78% of the total events. With risperidone (at 4-6 mg/day) and olanzepine (at 10-15 mg/day), gastrointestinal and sleep disturbance were observed in the initial (within 7 days to 2-3 months after treatment) course of treatment, while EPS, fatigue, seizure, increased frequency of micturition and dizziness were observed after long-term (3-9 months) use.
The present study adds to the existing information on the prevalence of adverse effects of atypical antipsychotic drugs. Role of active surveillance in post-marketing phase is also emphasized.
新型非典型抗精神病药物优于传统抗精神病药物，因为它们能显著减轻精神分裂症的阳性和阴性症状，且锥体外系症状（EPS）风险较低。然而，这些药物有各自不同的药物不良反应（ADR）。因此，开展本研究以评估这些可能影响长期依从性和治疗成功的药物不良反应。
在精神科门诊对非典型抗精神病药物的药物不良反应进行前瞻性分析研究。纳入开具了非典型抗精神病药物的精神障碍患者（任何年龄、性别）。开具传统抗精神病药物或抗精神病药物联合用药的患者被排除在研究之外。除了自发报告的药物不良反应外，还使用了一份与可能的药物不良反应相关的问卷，并将患者的回答记录在病例记录表中。
共从84份处方中记录到93例药物不良反应。大多数药物不良反应（93例中的82例）见于利培酮和奥氮平，因为它们是常用药物。体重增加、头晕、睡眠障碍和食欲障碍占总事件的近78%。使用利培酮（4 - 6毫克/天）和奥氮平（10 - 15毫克/天）时，在治疗初期（治疗后7天至2 - 3个月内）观察到胃肠道和睡眠障碍，而在长期（3 - 9个月）使用后观察到锥体外系症状、疲劳、癫痫发作、尿频和头晕。
本研究补充了关于非典型抗精神病药物不良反应发生率的现有信息。还强调了上市后阶段主动监测的作用。
