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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

陈杰 宋立平 胡晓华

中国临床药理学杂志2017,Vol.33Issue(4):308-311,4.
中国临床药理学杂志2017,Vol.33Issue(4):308-311,4.DOI:10.13699/j.cnki.1001-6821.2017.04.006

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

陈杰 1宋立平 1胡晓华1

作者信息

  • 1. 华中科技大学同济医学院附属精神卫生中心,武汉430022
  • 折叠

摘要

Abstract

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,and 75-150 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 fourth and 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 (P < 0.05).The main side effects in the treatment group were pain,dystonia and elevated prolactin.The adverse drug reactions in the control group were dystonia,elevated prolactin,abnormal liver function and akathisia.The incidences of adverse reaction were 36.84% and 61.54% respectively,with significant difference(P < 0.05).There were no severe adverse events in the two groups.Conclusion Paliperidone palmitate provides good efficacy in the treatment of acute schizophrenia,such as fast absorption,well improved social function,few adverse drug reactions and excellent tolerance.

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

Key words

paliperidone palmitate/risperidone oral solution/acute schizophrenia/social function

分类

医药卫生

引用本文复制引用

陈杰,宋立平,胡晓华..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[J].中国临床药理学杂志,2017,33(4):308-311,4.

中国临床药理学杂志

OA北大核心CSCDCSTPCD

1001-6821

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