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  

Clinical trial of palipiridone palmitate injection and risperidone oral solution in the treatment of acute schizophrenia

作　　者：陈杰[1] 宋立平[1] 胡晓华[1] 

机构地区：[1]华中科技大学同济医学院附属精神卫生中心,武汉430022

出　　处：《中国临床药理学杂志》2017年第4期308-311,共4页The Chinese Journal of Clinical Pharmacology

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(P<0.05)。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P<0.01,对照组P<0.05),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P<0.01);组间比较,试验组较对照组改善更为明显(P<0.05)。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(P<0.05)。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。Objective To explore the efficacy,social function and safety of paliperidone palmitate in the treatment of acute schizophrenics.Methods A total of 80 patients with acute schizophrenia were randomly divided into treatment group and control group,each group with 40 cases. The control group received 4- 6 mg ·d^-1risperidone oral solution twice a day,while the treatment group was given paliperidone palmitate injection at the dosage of 150 mg on day 1,100 mg on day 8,and75- 150 mg according to patients condition on day 36（ ± 7）. The observation lasted for eight weeks. The positive and negative symptoms scales（ PANSS） were performed at baseline,the first,the second,the fourthand the eighth weekend of the treatment. Both groups were evaluated by personal and social performance scale（ PSP）at baseline,the second weekend,the fourth weekend and the eighth weekend. The clinical efficacy,the recovery of social function and the incidence of adverse drug reactions were compared between the two groups. Results After one-week treatment,the PANSS total score of the treatment group was 80. 37 ± 9. 03,while 84. 38 ± 8. 47 in the control group with significant difference（ P〈0. 05）,the positive factor scores were 20. 37 ± 4. 01 and 22. 13 ± 3. 86,the general psychopathology scores were 40. 42 ± 4. 52 and 41. 56 ± 4. 16. After two weeks of treatment,the PANSS negative factor scores of treatment group and control group were 17. 63 ± 4. 25 and 18. 95 ± 4. 71 respectively,which were statistically different from those before treatment（ treatmen group P〈0. 01,control group P〈0. 05）. The treatment group exhibited a faster onset of action when compared with the control group. The total scores of PSP in the treatment group and the control group were 56. 26 ± 6. 50,49. 56 ± 5. 27 respectively at the eighth weekend of the treatment,which were statistically different from those before treatment（ P〈0. 01）. PSP scores were higher in the treatment group than that in the control group at the eighth weekend�

关 键 词：棕榈酸帕利哌酮 利培酮 急性期精神分裂症 社会功能 

分 类 号：R971[医药卫生—药品]