Reshid Zehara, Haile Kibrom, Ayano Getinet, Kebede Alem, Biru Aynalem, Yohannis Zegeye
Research and Training Department, St Amanuel Mental Specialized Hospital, Addis Ababa, Ethiopia.
PostDoc Position at Curtin University, Bentley Washington, Australia.
PLoS One. 2025 Apr 16;20(4):e0321536. doi: 10.1371/journal.pone.0321536. eCollection 2025.
Clozapine is a medication used in psychiatry. It is the first atypical antipsychotic drug and the most effective in treatment resistant cases of schizophrenia and schizoaffective disorder. Studies also show benefits of clozapine in patients with tardive dyskinesia. However, there is scarcity of studies which show the outcome of clozapine treatment and factors associated with it in the Ethiopian context.
The aim of the study was to assess treatment outcome and factors associated with it among patients treated with clozapine at Amanuel Mental Specialized Hospital Addis Ababa, Ethiopia.
A hospital-based retrospective study, compounded by cross-sectional design was conducted from June 1-30, 2022. A total of 71 clozapine treated patients were taken through census method. An interviewer administered structured questionnaire, retrospective data from patient medical records, and clinical evaluation of severity and improvement (CGI) were used to collect data. The collected data were entered into Epidata version 4.6 Software then exported to the Statistical Package for the Social Sciences (SPSS) version 25 for statistical analysis. Bivariable and multivariable logistic regression analyses were used to identify factors associated with treatment outcomes. P-values less than 0.05 were considered statistically significant and strength of the associations were presented by adjusted odds ratios with 95% confidence intervals.
Fifty one (71.8%) of participants showed improvement by clozapine treatment. Literacy level of high school and above showed significant positive association with treatment outcome (AOR: 7.65, 95% CI: 1.26-46.36, p<0.05) while extreme severity of illness at onset of clozapine treatment showed significant negative association with treatment outcomes (AOR: 0.13, 95% CI: 0.02-0.99, p<0.05).
Treatment with clozapine resulted in significant improvement in clinical and functional outcomes of treatment-resistant schizophrenia and schizoaffective disorder, as well as in tardive dyskinesia. Higher literacy level and severity of illness at onset of treatment showed significant associations with outcome. Clozapine is an atypical or second generation antipsychotic first used in the 1960s. It was withdrawn at first after its use was associated with a number of deaths due to agranulocytosis in Finland in 1975 [1,2]. In 1988 a landmark study demonstrated that the medicine was helpful to patients with schizophrenia who were unresponsive to other medications. Clozapine was then reintroduced into clinical use [3]. Since then, clozapine has been shown to be the only medicine which reduced suicidal behavior in patients with schizophrenia. Clozapine is now the medicine of choice for treatment-resistant schizophrenia [1]. The antipsychotic efficacy and the complete absence of extrapyramidal adverse effects of clozapine have been well documented. The benefit of clozapine for treating patients with treatment-resistant schizophrenia and those who are particularly prone to extrapyramidal adverse effects has been most remarkable [2].
氯氮平是一种用于精神科的药物。它是第一种非典型抗精神病药物，对难治性精神分裂症和分裂情感性障碍病例最为有效。研究还表明氯氮平对迟发性运动障碍患者有益。然而，在埃塞俄比亚背景下，显示氯氮平治疗结果及其相关因素的研究较少。
本研究的目的是评估埃塞俄比亚亚的斯亚贝巴阿马努尔精神专科医院接受氯氮平治疗的患者的治疗结果及其相关因素。
2022年6月1日至30日进行了一项基于医院的回顾性研究，并结合横断面设计。通过普查方法选取了71例接受氯氮平治疗的患者。使用访谈员管理的结构化问卷、患者病历的回顾性数据以及严重程度和改善情况的临床评估（CGI）来收集数据。收集到的数据录入Epidata 4.6软件，然后导出到社会科学统计软件包（SPSS）25版进行统计分析。采用双变量和多变量逻辑回归分析来确定与治疗结果相关的因素。P值小于0.05被认为具有统计学意义，关联强度以调整后的优势比及95%置信区间表示。
51名（71.8%）参与者经氯氮平治疗后有改善。高中及以上文化程度与治疗结果呈显著正相关（调整后的优势比：7.65，95%置信区间：1.26 - 46.36，p<0.05），而氯氮平治疗开始时疾病的极端严重程度与治疗结果呈显著负相关（调整后的优势比：0.13，95%置信区间：0.02 - 0.99，p<0.05）。
氯氮平治疗使难治性精神分裂症和分裂情感性障碍以及迟发性运动障碍的临床和功能结果有显著改善。治疗开始时较高的文化程度和疾病严重程度与结果有显著关联。氯氮平是一种非典型或第二代抗精神病药物，于20世纪60年代首次使用。1975年在芬兰，由于使用氯氮平与一些粒细胞缺乏症导致的死亡有关，它最初被撤回[1,2]。1988年一项具有里程碑意义的研究表明，这种药物对其他药物无反应的精神分裂症患者有帮助。然后氯氮平重新引入临床使用[3]。从那时起，氯氮平已被证明是唯一能降低精神分裂症患者自杀行为的药物。氯氮平现在是难治性精神分裂症的首选药物[1]。氯氮平的抗精神病疗效以及完全没有锥体外系不良反应已得到充分记录。氯氮平对治疗难治性精神分裂症患者和那些特别容易出现锥体外系不良反应的患者的益处最为显著[2]。
