鲁拉西酮和奥氮平治疗精神分裂症的安全性研究

Divea Sharma, Amit Nayak, D. D. Dupta, Shashank Sharma, Dinesh Dutt Sharma
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摘要

本研究旨在确定鲁拉西酮和奥氮平治疗精神分裂症的安全性。在西姆拉 IGMC 精神科门诊部就诊的所有连续精神分裂症患者(批准号:HFW(MC-II)B(12)ETHICS/2020/2020)均接受了此项研究。该研究为期一年(2019 年 3 月至 2020 年 2 月)。入组患者(100名)被分为两个治疗组(每组50名),即A组(鲁拉西酮)和B组(奥氮平)。在随访期间,对患者进行了血脂、空腹血糖、心电图、血压和体重等检查,以评估药物的安全性。结果显示,奥氮平组基线收缩压平均值为(125.12±8.37),首次随访(2-4周)时的平均年龄为(33.50±11.35)岁,而鲁拉西酮组2-4周时的平均年龄为(31.71±10.44)岁。奥氮平组基线时的平均血清高密度脂蛋白水平为(43.38 ± 1.28),首次随访时为(39.46 ± 1.12);而鲁拉西酮组基线时的平均血清高密度脂蛋白水平为(49.64 ± 1.29),首次随访时为(45.19 ± 1.22);P值为0.001,具有高度显著性。在 8 周后进行的第二次随访中,奥氮平组的平均年龄为(33.24 ± 11.00)岁,而鲁拉西酮组的平均年龄为(31.91 ± 10.60)岁。研究结果表明,根据患者的经济状况、耐受程度和可及性,鲁拉西酮比奥氮平更适合治疗精神分裂症。
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Investigation of Safety Profile of Lurasidone and Olanzapine in Treatment of Schizophrenia

The objective of the study was to determine the safety profile of lurasidone and olanzapine in the treatment of schizophrenia. All consecutive patients of schizophrenia attending the Psychiatry outpatient department of IGMC, Shimla (Approval no. HFW(MC-II)B(12)ETHICS/2020/3930) were screened for enrolment in the study of 1 year duration (March 2019–Feb 2020). The patients enrolled (100 patients) were divided into two treatment groups (50 in each group), Group A (lurasidone) and Group B (olanzapine). During the follow-up period, investigations such as lipid profile, fasting blood sugar, ECG, blood pressure, and body weight were noted to assess the safety profile of the drug. Results showed that the mean systolic blood pressure at baseline in the olanzapine group was 125.12 ± 8.37 and the mean age was 33.50 ± 11.35 at the first follow-up, which was done at 2–4 weeks, while the same for the lurasidone group was 31.71 ± 10.44 at 2–4 weeks. The mean serum HDL level at baseline in the olanzapine group was 43.38 ± 1.28 while 39.46 ± 1.12 at first follow-up; however, it was 49.64 ± 1.29 at baseline and 45.19 ± 1.22 at first follow-up for the lurasidone group; this exhibited a p value of < 0.001 which was highly significant. The mean age for the olanzapine group was 33.24 ± 11.00 at the second follow-up which was done at 8 weeks, while the same for the lurasidone group was 31.91 ± 10.60 at 8 weeks. It can be concluded from the study that lurasidone is more preferable than olanzapine for the treatment of schizophrenia, depending on the patient's financial situation, tolerance level, and accessibility.

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