OBJECTIVE:To compare Paliperidone sustained-release tablet and Paliperidone palmitate injection in the treatment of schizophrenia in respects of medium-term and long-term efficacy,safety,insight,medication compliance and social function of patients,so ad to provide reference for drug selection in the clinic.METHODS:Eighty-four schizophrenia patients selected from our center during Mar.2015-Jun.2016 were divided into Paliperidone sustained-release tablet group (group H,44 cases) and Paliperidone palmitate injection group (group Z,40 cases).Group H was given Paliperidone sustained-release tablet orally with initial dose of 3 mg/d,gradually increasing to 9 mg/d 2 weeks later according to disease condition;the drug dose was adjusted and ranged 3-12 mg/d according to disease condition.Group Z was given Paliperidone palmitate injection intramuscularly,150 mg on 1st day,100 mg on 8th day,and then given injection once a month,drug dose was adjusted according to disease condition (75,100,150 mg).Treatment course of 2 groups lasted for 12 months.Before treatment,1,2,3,6,9,12 months after treatment,Positive and Negative Syndrome Scale (PANSS) was used to evaluate therapeutic efficacy;Scale to Assess Unawareness of Mental Disorder (SAUMD) was used to evaluate the cognition of patients to disease;Medication Adherence Rating Scale (MARS) was used to evaluate medication compliance;Personal and Social Performance Scale (PSP) was used to evaluate patient's social function.The occurrence of ADR was observed during treatment.RESULTS:3,2 patients withdrew from group H,Z during treatment.Before treatment,there was no statistical significance in PANSS,SAUMD,MARS,PSP scores between 2 groups (P＞0.05).1,2,3,6,9,12 months after treatment,PANSS and SAUMD scores of 2 groups were decreased significantly,while MARS and PSP scores were increased significantly,compared to before treatment,with statistical significance (P＜0.05).9,12 months after treatment,PANSS and SAUMD scores of group Z were decreased significantly,while MARS and PSP scores were increased significantly,compared to group H,with statistical significance (P＜0.05).There was no statistical significance in the occurrence of ADR between 2 groups (P＞0.05).CONCLUSIONS:For schizophrenia,Paliperidone palmitate injection is better than Paliperi done sustained-release tablet in respects of medium-term and long-term efficacy,patient's insight,medication compliance,social function recovery;the longer the time,the more prominent the superiority.There is no significant difference in safety between them.%目的:比较帕利哌酮缓释片与棕榈酸帕利哌酮注射液治疗精神分裂症的中长期疗效、安全性,患者的自知力、药物依从性和社会功能,为该病的临床选药提供参考.方法:选择2015年3月-2016年6月在我中心接受治疗的84例精神分裂症患者,按照随机数字表法分为帕利哌酮缓释片组(H组)44例和棕榈酸帕利哌酮注射液组(Z组)40例.H组患者给予帕利哌酮缓释片口服,起始剂量为3 mg/d,2周内根据病情逐渐加至9 mg/d,以后根据具体病情使剂量在3～12 mg/d之间调整.Z组患者给予棕榈酸帕利哌酮注射液肌内注射,第1天150mg,第8天100mg,以后每个月肌内注射1次,剂量可根据具体病情调整(75、100、150mg).两组疗程均为12个月.分别于治疗前和治疗后1、2、3、6、9、12月末采用阳性和阴性症状量表(PANSS)评定疗效、自知力评估量表(SAUMD)评定患者对疾病的认知程度、药物依从性量表(MARS)评定患者对药物治疗的依从性、个体和社会功能量表(PSP)评定患者的社会功能,并观察治疗过程中发生的不良反应.结果:治疗中,H组和Z组各有3、2例患者脱落.治疗前,两组患者的PANSS、SAUMD、MARS、PSP评分比较,差异均无统计学意义(P＞0.05).治疗后1、2、3、6、9、12月末,两组患者的PANSS和SAUMD评分较治疗前显著降低,MARS和PSP评分较治疗前显著升高,差异均有统计学意义(P＜0.05);治疗后9、12月末,Z组患者的PANSS和SAUMD评分较H组显著降低,MARS和PSP评分较H组显著升高,差异均有统计学意义(P＜0.05).两组患者的不良反应发生情况比较,差异无统计学意义(P＞0.05).结论:棕榈酸帕利哌酮注射液较帕利哌酮缓释片治疗精神分裂症在中长期疗效和患者自知力、药物依从性、社会功能恢复方面均有明显的优越性,且时间越长,优越性越突出;二者的安全性无明显差异.
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