棕榈酸帕利哌酮治疗精神分裂症急性期的开放性研究

发布时间：2019-07-01 19:25

【摘要】：目的:评价棕榈酸帕利哌酮治疗精神分裂症急性期临床疗效及安全性,初探长效针剂在首发精神分裂症患者中的应用。方法:采用开放性、单臂临床观察研究。共入组58例患者,男性23例,女性35例(其中首发患者27例,复发急性期患者3 1例),患者均按照棕榈酸帕利哌酮的说明书,第一针起始剂量150 mg,d 8注射100 mg,之后每月注射1针,剂量视临床症状控制及既往治疗情况在75~150 mg中选择。观察时间为13周。疗效评价指标为PANSS总分及CGI-S,应用药物不良反应量表(TESS)评定安全性。结果:治疗13周末,入组总体患者有效率达82.8%,首发患者组有效率为85.2%,复发患者组有效率为80.6%;两组间比较无统计学差异(P=0.549)。不良事件2/3左右发生于注射药物后的1~2周内,多为一过性,无需特殊处理,主要为注射部位疼痛、失眠和静坐不能等。结论:棕榈酸帕利哌酮对精神分裂症急性期疗效显著,可显著改善首发精神分裂症患者症状,并具有良好的安全性。
[Abstract]:Objective: to evaluate the clinical efficacy and safety of palmitazone palmitate in the treatment of schizophrenia in acute phase, and to explore the application of long-acting injection in patients with first-episode schizophrenia. Methods: open, single arm clinical observation was used. A total of 58 patients, including 23 males and 35 females (27 patients with first episode and 31 patients with acute recurrence) were enrolled in the study group. The patients were given one injection per month after the initial dose of mg, mg,d 8, including 27 patients with first onset and 31 patients with acute recurrence. The dose was selected from 75 脳 150 mg depending on the clinical symptom control and previous treatment. The observation time was 13 weeks. The total score of PANSS and the safety of CGI-S, were evaluated by adverse drug reaction scale (TESS). Results: at the end of 13 weeks, the overall effective rate was 82.8%, the effective rate was 85.2% in the first group and 80.6% in the recurrent group, and there was no significant difference between the two groups (P 鈮，

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