S. Chattopadhyay, U. Roy, S. Biswas, P. Roy, P. Mandal
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Materials and Methods The efficacy parameters were measured by the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impression (CGI) rating. The safety parameters included the vital signs, haematological profile, lipid profile, blood sugar monitoring. Adverse drug reactions and compliance to therapy was observed through-out the study period. Appropriate statistical tests were applied to detect any significant within and between group differences using Microsoft Excel 2007 and SPSS version 17. Results There was significant decrease in the mean total score on the BPRS and CGI-S in the blonanserin arm at the 2nd and last follow up visit (p value < 0.001). Compliance was good in both groups (≤ 20% missed pills). Overall, 77 treatment-emergent adverse events were present from 56 patients. Twenty three subjects of the blonanserin arm and 33 subjects in the olanzapine arm at least experienced one adverse event (p = 0.006), metabolic adverse effects were more common with olanzapine, whereas insomnia, headache and somnolence were more often seen with blonanserin. Conclusions In the present study, blonanserin provided significantly better outcomes than olanzapine with respect to BPRS, CGI-S scores.","PeriodicalId":35746,"journal":{"name":"Acta Medica Bulgarica","volume":"48 1","pages":"45 - 52"},"PeriodicalIF":0.0000,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparative Efficacy, Safety and Tolerability of Olanzapine and Blonanserin in Patients with Schizophrenia: A Parallel Group Study\",\"authors\":\"S. Chattopadhyay, U. Roy, S. Biswas, P. Roy, P. 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Materials and Methods The efficacy parameters were measured by the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impression (CGI) rating. The safety parameters included the vital signs, haematological profile, lipid profile, blood sugar monitoring. Adverse drug reactions and compliance to therapy was observed through-out the study period. Appropriate statistical tests were applied to detect any significant within and between group differences using Microsoft Excel 2007 and SPSS version 17. Results There was significant decrease in the mean total score on the BPRS and CGI-S in the blonanserin arm at the 2nd and last follow up visit (p value < 0.001). Compliance was good in both groups (≤ 20% missed pills). Overall, 77 treatment-emergent adverse events were present from 56 patients. Twenty three subjects of the blonanserin arm and 33 subjects in the olanzapine arm at least experienced one adverse event (p = 0.006), metabolic adverse effects were more common with olanzapine, whereas insomnia, headache and somnolence were more often seen with blonanserin. 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引用次数: 0
摘要
背景抗精神病药物奥氮平是治疗精神分裂症的一线药物,而布兰色林则适用于一线抗精神病药物无效的精神分裂症耐药病例。在世界范围内,以及在印度,比较blonanserin与其他抗精神病药物在精神分裂症治疗方面的研究非常有限。目的探讨奥氮平与布朗那色林治疗精神分裂症的疗效、安全性和耐受性。背景和设计:本研究是一项前瞻性、观察性、平行组研究,研究对象为一所三级医学院精神科门诊的18-50岁男女精神分裂症患者。该研究于2015年2月至2016年10月进行,并在第4、8和12周进行随访。材料与方法采用精神病学简易评定量表(BPRS)和临床总体印象量表(CGI)评定疗效。安全参数包括生命体征、血液学、血脂、血糖监测。在整个研究期间观察药物不良反应和治疗依从性。采用Microsoft Excel 2007和SPSS version 17进行适当的统计检验,以检测组内和组间是否存在显著差异。结果两组患者第2次和最后一次随访时BPRS和CGI-S平均总分均显著降低(p值< 0.001)。两组依从性均较好(漏服药≤20%)。总的来说,56例患者中出现了77例治疗后出现的不良事件。布隆那色林组23名受试者和奥氮平组33名受试者至少经历一次不良事件(p = 0.006),代谢不良反应奥氮平组更常见,而布隆那色林组更常见失眠、头痛和嗜睡。结论在本研究中,blonanserin在BPRS、CGI-S评分方面明显优于奥氮平。
Comparative Efficacy, Safety and Tolerability of Olanzapine and Blonanserin in Patients with Schizophrenia: A Parallel Group Study
Abstract Background The antipsychotic olanzapine is a first-line drug in the treatment of schizophrenia while blonanserin is indicated in resistant cases of schizophrenia when the first line antipsychotics have failed. There are very limited studies available world-wide as well as in India that compare blonanserin with other antipsychotics in the setting of schizophrenia. Aims To study the efficacy, safety and tolerability of olanzapine and blonanserin in Schizophrenia. Settings and Design: The study was a prospective, observational, parallel group study done on schizophrenia patients aged between 18-50 years of both sexes at an outpatient Department of Psychiatry, in a tertiary medical college. The study was conducted from February 2015 to October 2016, with follow ups at weeks 4, 8 and 12. Materials and Methods The efficacy parameters were measured by the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impression (CGI) rating. The safety parameters included the vital signs, haematological profile, lipid profile, blood sugar monitoring. Adverse drug reactions and compliance to therapy was observed through-out the study period. Appropriate statistical tests were applied to detect any significant within and between group differences using Microsoft Excel 2007 and SPSS version 17. Results There was significant decrease in the mean total score on the BPRS and CGI-S in the blonanserin arm at the 2nd and last follow up visit (p value < 0.001). Compliance was good in both groups (≤ 20% missed pills). Overall, 77 treatment-emergent adverse events were present from 56 patients. Twenty three subjects of the blonanserin arm and 33 subjects in the olanzapine arm at least experienced one adverse event (p = 0.006), metabolic adverse effects were more common with olanzapine, whereas insomnia, headache and somnolence were more often seen with blonanserin. Conclusions In the present study, blonanserin provided significantly better outcomes than olanzapine with respect to BPRS, CGI-S scores.
期刊介绍:
About 30 years ago - in 1973, on the initiative of the Publishing House „Medicine and Physical Culture", namely its former director Mr. Traian Ivanov, the Ministry of Health set up and accepted to subsidize a new medical magazine that was to be published only in the English language and had to reflect the status and the achievements of the Bulgarian medical science. Thus the language barrier was overcome and stable relations were established with the international medical society, large libraries, and university centers. The famous internationally known scientist professor Assen A. Hadjiolov was elected edition-in-chief by the first editorial staff and the magazine was named Acta Medica Bulgarica.