Shah Aashal, Yadav Preeti P, Chaudhari Mayur, Vataliya Ankit, Kantharia N D, Mehta Ritambhara
Resident, Department of Pharmacology, Government Medical College, Surat, Gujarat, India.
Associate Professor, Department of Pharmacology, Government Medical College, Surat, Gujarat, India.
J Clin Diagn Res. 2017 May;11(5):FC24-FC28. doi: 10.7860/JCDR/2017/24009.9873. Epub 2017 May 1.
Bipolar disorder is a chronic, debilitating psychiatric disorder. Mood stabilizers and atypical antipsychotics are first line drugs for bipolar disorder. They have significant adverse effects.
The study was conducted with an aim to evaluate the pattern of occurrence of Adverse Drug Reactions (ADRs) in the patients with bipolar disorder and to assess their causality, severity and preventability.
A prospective and observational study - carried out in the psychiatry outpatient department of New Civil Hospital, Surat for 15 months. All patients diagnosed with bipolar disorder and receiving pharmacotherapy were included. Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale and Abnormal Involuntary Movement Scale (AIMS) were used for documenting ADRs and tardive dyskinesia, respectively. Assessment of causality, severity and preventability of recorded ADRs was done using Naranjo's algorithm and WHO-UMC scale, modified Hartwig and Seigel Scale and modified Schumock and Thornton scale, respectively. Descriptive statistics was used (percentage, mean±standard deviation) for presentation of demographics and other numerical data; Chi Square test and Fisher's exact test were used to assess association between variables. A p-value < 0.05 was considered significant.
A total of 703 ADRs were recorded from 175 patients. The most common ADRs observed were asthenia (11.95%) and sedation (10.24%). Majority of ADRs were mild on assessment with UKU scale. Mood stabilizers (59.46%) were most frequently associated with ADRs and lithium was most common single drug responsible. Upon causality assessment, majority of the reactions were probable (54.77% with WHO-UMC scale, and 56.33% with Naranjo's algorithm). The association of results between the two scales was statistically significant (p<0.001). Majority of ADRs (70.27%) were assessed as mild and 64.30% of the ADRs were not preventable.
ADRs are a frequent occurrence in patients with bipolar disorder which are mild in most cases. Incidence of ADRs can be decreased and compliance as well as quality of life of patient can be improved by early detection and management.
双相情感障碍是一种慢性、使人衰弱的精神疾病。心境稳定剂和非典型抗精神病药物是双相情感障碍的一线用药。它们有显著的不良反应。
本研究旨在评估双相情感障碍患者药物不良反应（ADR）的发生模式，并评估其因果关系、严重程度和可预防性。
在苏拉特新公民医院精神科门诊进行了一项为期15个月的前瞻性观察研究。纳入所有诊断为双相情感障碍并接受药物治疗的患者。分别使用临床研究不良反应量表（UKU）和异常不自主运动量表（AIMS）记录ADR和迟发性运动障碍。分别使用纳伦霍算法、世界卫生组织药物不良反应因果关系评价量表（WHO-UMC）、改良的哈特维希和西格尔量表以及改良的舒莫克和桑顿量表评估所记录ADR的因果关系、严重程度和可预防性。使用描述性统计（百分比、均值±标准差）呈现人口统计学和其他数值数据；使用卡方检验和费舍尔精确检验评估变量之间的关联。p值<0.05被认为具有统计学意义。
共记录了来自175名患者的703例ADR。观察到的最常见ADR是乏力（11.95%）和镇静（10.24%）。根据UKU量表评估，大多数ADR为轻度。心境稳定剂（59.46%）与ADR的关联最为频繁，锂盐是最常见的单一责任药物。经因果关系评估，大多数反应为很可能（WHO-UMC量表为54.77%，纳伦霍算法为56.33%）。两种量表结果之间的关联具有统计学意义（p<0.001）。大多数ADR（70.27%）被评估为轻度，64.30%的ADR不可预防。
ADR在双相情感障碍患者中频繁发生，大多数情况下为轻度。通过早期检测和管理可以降低ADR的发生率，并提高患者的依从性和生活质量。
