Résumé
ObjectiveTo explore the effect of paliperidone palmitate treatment on schizophrenic patients in the community. Methods446 schizophrenic patients who used paliperidone palmitate injection were selected in Shanghai. Before and after the treatment， the disease family burden scale， the concise evaluation scale of drug treatment compliance， the VAS100 score of treatment satisfaction， the short form of quality of life measurement scale， and the screening scale of social function defects were used to evaluate the effects of paliperidone palmitate injection. The data were statistically analyzed using SPSS 26.0 software. ResultsAfter using paliperidone palmitate injection， the total score of family burden （13.94±12.17）， the score of daily family activities （3.26±2.74）， the score of family entertainment activities （2.21±2.30）， and the score of family relationship （2.79±2.76） were significantly higher than those before the treatment （14.98±12.64， 3.51±2.88， 2.48±2.38， 3.11±2.87， respectively， all with P<0.05）. The scores of the World Health Organization on quality of life brief scale （62.89±11.94） and the medication compliance scale （28.11±5.64） were better than those before treatment （60.67±12.62 and 27.37±6.96， all with P<0.05）. Compared with the prior treatment without paliperidone palmitate injection， the number of readmissions after treatment was significantly reduced （P<0.01）. ConclusionThe treatment of paliperidone palmitate injection has significant effect， which can effectively reduce the disease family burden of Schizophrenic patients， improve their quality of life， enhance their drug compliance， reduce the readmission rate of patients， ensure long-term treatment effect and promote disease recovery.
Résumé
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.
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OBJECTIVE:To explore the influential factors for plasma concentration of paliperidone palmitate injection for pa-tients with schizophrenia. METHODS:37 schizophrenia patients who used Paliperidone palmitate injection and took plasma concentra-tion monitoring in Wuxi Mental Health Center from Sept. 2012 to Jun. 2015 was selected,the results were statistically analyzed,and the influential factors were preliminary explored. RESULTS:Totally 37 times were conducted for the plasma concentration monitoring for paliperidone with the average plasma concentration of(17.72±13.46)ng/ml,and 24 times(accounting for 64.86%)in the range of(10-60 ng/ml);the average plasma concentration of male patients was lower than that of female patients,the difference was statisti-cally significant(P0.05);there was also no significant difference in plasma concentration/dose ratio in patients with different daily dose(P>0.05);the average plasma concentration of patients with combination treatment was higher than that of single drug,the difference was statistically signifi-cant(P0.05). CONCLUSIONS:The plasma concentration of paliperidone palmitate is affected by age,combination treat-ment and other factors,clinic can optimize the therapeutic regimen based on monitoring results of plasma concentration and patients’ symptoms to promote the rational drug use.
Résumé
A rapid, stability-indicating reversed phase ultra-performance liquid chromatographic (RP-UPLC) method was developed for the determination of paliperidone palmitate (PP), in depot injectable dosage form. The chromatographic separation was achieved on an Acquity BEH C18 (50 mm × 2.1 mm, 1.7 μm) column, with a mobile phase consisting of ammonium acetate buffer, and acetonitrile at a ratio of 10:90 (v/v) and a flow rate of 0.6 mL/min. The eluted compound was monitored at a wavelength of 238 nm using a UV detector. The method described herein separated paliperidone palmitate from all other formulation components and two major known degradation products (N-Oxide and paliperidone) within a run time of 2.5 min. The method also generated linear results over a PP concentration range of 156 to 468 μg/mL. The stability indicating capability of the method was established by performing forced degradation experiments. The RP-UPLC method that was developed was validated according to the International Conference on Harmonization (ICH) guidelines. This method was successfully applied in the quantitative determination of PP in a stability study of paliperidone palmitate depot injection. The procedure described herein is simple, selective, and reliable for routine quality control analysis as well as stability testing.