棕榈酸帕利哌酮注射剂与利培酮口服液治疗急性期精神分裂症的临床研究

发布时间：2018-05-27 12:10

本文选题：棕榈酸帕利哌酮 + 利培酮　；参考：《中国临床药理学杂志》2017年04期

【摘要】：目的观察棕榈酸帕利哌酮治疗急性期精神分裂症的临床疗效、社会功能恢复及安全性。方法 80例急性期精神分裂症患者随机分为对照组40例和试验组40例。对照组口服利培酮口服液4~6 mg·d~(-1),每日2次;试验组肌内注射棕榈酸帕利哌酮75~150 mg,治疗第1日注射剂量为150 mg,第8日100 mg,第36(±7)日根据病情需要选择剂量为75~150 mg。2组患者均治疗8周。于基线、治疗第1,2,4,8周末分别评定阳性与阴性症状量表(PANSS),在基线、治疗第2,4,8周末分别评定个人和社会功能量表(PSP)。比较2组患者的临床疗效、社会功能恢复情况和药物不良反应发生率。结果治疗1周后,试验组和对照组的PANSS总分分别为(80.37±9.03),(84.38±8.47)分,差异有统计学意义(P0.05)。治疗1周后,阳性症状评分分别为(20.37±4.01),(22.13±3.86)分,一般精神病理评分分别为(40.42±4.52),(41.56±4.16)分;治疗2周末,试验组和对照组PANSS阴性症状评分分别为(17.63±4.25),(18.95±4.71)分;以上2时间点分别与治疗前比较,差异有统计学意义(试验组P0.01,对照组P0.05),提示试验组起效更快。治疗8周后,试验组和对照组的PSP总分分别为(56.26±6.50),(49.56±5.27)分,分别与治疗前比较,差异有统计学意义(均P0.01);组间比较,试验组较对照组改善更为明显(P0.05)。试验组的药物不良反应主要有注射部位疼痛、肌张力障碍及泌乳素升高等,药物不良反应发生率为36.84%(14/38例);对照组的药物不良反应主要有肌张力障碍、泌乳素升高、肝功能异常、静坐不能等,药物不良反应发生率为61.54%(24/39例),差异有统计学意义(P0.05)。2组均无严重药物不良反应发生。结论棕榈酸帕利哌酮治疗急性期精神分裂症疗效较好,起效较快,社会功能改善明显,且药物不良反应发生率低,耐受性好。
[Abstract]:Objective to observe the clinical effect, social function recovery and safety of palmitic acid palipiperone in the treatment of acute schizophrenia. Methods 80 patients with acute schizophrenia were randomly divided into control group (n = 40) and experimental group (n = 40). The control group was given risperidone oral solution of 4 ~ 6 mg / d, twice a day, while in the experimental group, the intramuscular injection of paliperidone palmitate was 150 mg / d, the dose was 150mg on the first day of treatment, and on the 8th day, (卤7) day, the dosage of 75 mg / 150 mg.2 was selected according to the need of the disease for 8 weeks. At the baseline, the positive and negative symptom scales were assessed at the end of the 8th week, and the personal and social function scales were assessed at the end of the 8th week of treatment. The clinical efficacy, recovery of social function and incidence of adverse drug reactions were compared between the two groups. Results after one week of treatment, the total score of PANSS in the experimental group and the control group was 80.37 卤9.03nil, 84.38 卤8.47, respectively. The difference was statistically significant (P 0.05). After 1 week of treatment, the scores of positive symptoms and general psychopathology were 20.37 卤4.01 and 22.13 卤3.86, 40.42 卤4.52 and 41.56 卤4.16, respectively, and the scores of PANSS negative symptoms in the experimental group and control group were 17.63 卤4.2518.95 卤4.71 at the end of 2 weeks respectively. The difference was statistically significant (P 0.01 in the test group and P 0.05 in the control group, indicating that the effect was faster in the test group. After 8 weeks of treatment, the total score of PSP in the test group and the control group was 56.26 卤6.50 and 49.56 卤5.27, respectively, which was significantly different from that before treatment (all P 0.01), and the improvement of the test group was more obvious than that of the control group (P 0.05). The main adverse drug reactions in the test group were injection site pain, muscular dystonia and prolactin elevation. The incidence of adverse drug reactions was 36.8414 / 38 cases, while in the control group, the main adverse drug reactions were muscular dystonia, increased prolactin, and abnormal liver function. The incidence of adverse drug reactions was 61.54 / 24 / 39, and there was no significant difference between the two groups. Conclusion Pallipiperone palmitate is effective and effective in the treatment of acute schizophrenia, with obvious improvement of social function, low incidence of adverse drug reactions and good tolerance.
【作者单位】：华中科技大学同济医学院附属精神卫生中心;
【分类号】：R749.3

【参考文献】