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Objective To compare the sustained-release tablets paliperidone and risperidone tablets starting glycolipid metabolism in female patients with schizophrenia.Methods Eighty-five cases of women treated in our hospital episode schizophrenia patients were randomly divided into observation group (42 cases) and control group (43 cases).were treated with sustained-release tablets paliperidone and risperidone tablets monotherapy two months.Measuring body mass index before and after treatment (BMI),waist circumference (waist),triglyceride (TG),high density lipoprotein (HDL),fasting plasma glucose (FPG),2 h glucose after OGTT (2 h PG),Positive and Negative Syndrome scale (PANSS) for efficacy evaluation.Results Comparison minutes before treatment PANSS total score and factors,the difference was not statistically significant.After treatment,PANSS total score and factor scores,the difference was not statistically significant.Compared with the previous treatment,both groups PANSS total score and factor scores were significantly decreased after treatment,the difference was statistically significant (P ＜ 0.05).Two groups of patients before treatment indexes,the difference was not statistically significant.After treatment in the control group TG,former TC,HDLC,LDLC,BMI,and waist circumference with treatment,the difference was statistically significant (P ＜ 0.05);the observation group BMI and waist circumference compared with before treatment,the difference was statistically significant (P ＜ 0.05).After observation group TG,TC,LDLC,BMI and waist circumference were significantly lower than the control group,HDLC significantly higher,the difference was statistically significant (P ＜ 0.05).Two FPG,2hPG,SBP and DBP,the difference was not statistically significant (P ＞ 0.05).Adverse reactions in patients in the observation group were significantly lower than the control group,the difference was statistically significant (P ＜ 0.05).Conclusion The sustained-release tablets paliperidone and risperidone female first-episode schizophrenia patients have the same effect,but paliperidone extended release tablets in female patients improve blood lipids,BMI and waist circumference is superior to risperidone.
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Objective To investigate association of IL-10 gene promoter polymorphisms with first episode schizophrenic and efficacy of risperidone.Methods 513 schizophrenic patients with first episode(patient group) and 627 health controls(control group)participated in this study.Genotyping for IL-10 gene label single nucleotide polymorphism(SNP) sites-592A/C (rs1800872),-1082A/G (rs1800896),-819T/C (rs1800871) were performed by polymerase chain reaction and restriction fragment length polymorphism (PCR-RFLP)genotyping technology.513 patients were administered orally risperidone for 8 weeks.Clinical efficacy were evaluated with PANSS.Results The frequences of rs1800896 genotypes (332:166:15,453:161:13 ; x2 =7.55,df=2,P=0.02) and alleles(830:196,1067:187; x2 =7.09,df=1,P=0.008,OR=1.35,95％ CI=1.08 ～ 1.68) showed significant differences between patient group and control group,however only allele differences showed statistical significance after Bonferroni correction (P=0.024).The frequencies of rs1800872and rs1800871 genotypes and alleles had no significant differences between patient group and control group(P＞0.05).There were no significant differences of haplotype frequences between patient group and control group (P＞ 0.05).There were no significant differences of genotypes (134:209:38,61:59:12;x2 =5.16,df=2,P=0.08;244:129:8,88:37:7;x2 =4.57,df=2,P=0.10; 188:158:35,54:64:14;x2=2.80,df=2,P=0.25) and alleles (477:285,181:83;x2 =3.03,df=1,P=0.08;617:145,213:51 ;x2 =0.01,df=1,P=0.92;534:228,172:92;x2 =2.22,df=1,P=0.14) frequences of rs1800872,rs1800896,rs 1800871 between effective group (381 cases) and invalid group (132 cases) of Risperidone efficacy (P＞ 0.05),while ATC haplotype frequences had significant difference between two groups(x2 =7.501,P=0.006,OR (95％ CI) =2.420(1.262-4.640)).Conclusion IL-10 gene rs1800896 polymorphism may be associated with susceptibility to schizophrenia.The clinical curative effect of risperidone in the treatment of schizophrenia is associated with ATC haplotype,ATC haplotype may be good predictors to the overall curative effect of risperidone.
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BACKGROUND: Risperidone is one of the atypical antipsychotic drugs that have effectiveness in the management of a range of psychiatric illnesses. Orally disintegrating (OD) formulations of risperidone that rapidly dissolve in the mouth, prior to swallowing without water have been developed to overcome any problems related to swallowing and improve acceptability. The goal of this study was to evaluate the bioequivalence of Risperdal OD(R) tablet 1mg and Quicklet(R) tablet 1mg. METHODS: This randomized, open-label, 2-way crossover trial was conducted in 36 healthy male volunteers that received OD risperidone tablet, either the reference formulation (Risperdal Quicklet(R) tablet 1mg), or the test formulation (Risperdal OD(R) tablet 1mg), each in a single administration. Blood samples were obtained during a 24-hour period after dosing. Plasma was analyzed for risperidone by a validated LC-MS/MS. Adverse events were monitored by safety assessments including clinical interview by clinician. Pharmacokinetics were calculated by noncompartmental analysis and compared between two formulations. RESULTS: A total of 36 male volunteers (mean age, 24.2 years; height 174.5 cm; weight 67.6 kg) completed the study. The ANOVA showed no significant effect of sequence, formulation and period of Ln (AUClast) and Ln (Cmax). The 90% confidence intervals for the mean treatment ratios of the Ln (AUClast) and Ln (Cmax) were Ln 0.96 ~ Ln 1.12, Ln 0.97 ~ Ln 1.16, respectively. No serious adverse events were caused by both formulations. CONCLUSION: In this study, a single administration of Risperdal OD(R) tablet 1mg was bioequivalent to a single administration of Risperdal Quicklet(R) tablet 1mg.