Maitra Arpita, Bhattacharyya Swati, Mukhopadhyay Sabyasachi, Mallick Asim Kumar, Biswas Supreeti, Singh Om Prakash
Department of Pharmacology, Burdwan Medical College, Burdwan, India.
Department of Pharmacology, RG Kar Medical College, India.
Clin Psychopharmacol Neurosci. 2020 Nov 30;18(4):587-598. doi: 10.9758/cpn.2020.18.4.587.
: Schizophrenia is a serious disease characterized by impairment in the perception or expression of reality, leading to occupational and social dysfunction. The use of antipsychotic medication is now universal in the first-line treatment of schizophrenia. This study was undertaken to compare the efficacy of asenapine with a standard atypical antipsychotic, olanzapine in treating this disease.
It was designed as a single blind, randomized, controlled, parallel group, single centre Phase IV trial of a newer atypical antipsychotic, asenapine versus existing standard atypical antipsychotic, olanzapine. Total 80 subjects were enrolled as per eligibility criteria.Each recruited subject received daily treatment with the trial medication (Olanzapine 10 mg or Asenapine 10 mg daily) for duration of 12 weeks. BPRS, CGI-S, CGI-I, Laboratory parameters and compliance was assessed and analyzed. Continuous variables were compared by t test and non-parametric data was analyzed by Mann-Whitney test and Wilcoxon signed rank test. Likely categorical variables were analyzed by chi-square test or Fisher's exact test, as appropriate.
The duration of schizophrenia at presentation was comparable in both the treatment groups. There was significant reduction of BPRS score between any two visits of each treatment groups. The decline in CGI-S and CGI-I scores was statistically significant ( < 0.001) when compared between visits of any of the both treatment arms. Adherence to treatment was excellent for all patients.
Newer atypical antipsychotic asenapine is more effective than standard olanzapine in reducing the symptoms of schizophrenia in this study and further larger studies are to be done.
精神分裂症是一种严重疾病，其特征为现实感知或表达受损，导致职业和社会功能障碍。抗精神病药物目前在精神分裂症的一线治疗中普遍使用。本研究旨在比较阿塞那平与标准非典型抗精神病药物奥氮平治疗该疾病的疗效。
本研究设计为一项单盲、随机、对照、平行组、单中心的IV期试验，比较新型非典型抗精神病药物阿塞那平与现有标准非典型抗精神病药物奥氮平。根据纳入标准共招募80名受试者。每位入选受试者接受试验药物（奥氮平每日10 mg或阿塞那平每日10 mg）治疗，为期12周。对简明精神病评定量表（BPRS）、临床总体印象量表严重程度（CGI-S）、临床总体印象量表改善程度（CGI-I）、实验室参数及依从性进行评估和分析。连续变量采用t检验进行比较，非参数数据采用曼-惠特尼检验和威尔科克森符号秩检验进行分析。分类变量根据情况采用卡方检验或费舍尔精确检验进行分析。
两个治疗组患者精神分裂症的病程相当。每个治疗组在任意两次访视之间BPRS评分均有显著降低。两个治疗组在任意访视之间比较，CGI-S和CGI-I评分的下降具有统计学意义（P < 0.001）。所有患者的治疗依从性均良好。
在本研究中，新型非典型抗精神病药物阿塞那平在减轻精神分裂症症状方面比标准药物奥氮平更有效，有待进一步开展更大规模的研究。
