Efficacy and safety of domestic Paliperidone extended-release tablets in the treatment of stable schizophrenia / 中国药房

OBJECTIVE To investigate the efficacy and safety of domestic Paliperidone extended-release tablets as a substitute for original Paliperidone extended-release tablets in the treatment of stable schizophrenia. METHODS A total of 65 patients with schizophrenia， who were treated with single original Paliperidone extended-release release tablets for 2 months or more in the outpatient or inpatient department of Shandong Daizhuang Hospital from June 2021 to June 2022， were collected and randomly divided into the domestic group （33 cases） and the original group （32 cases）. The domestic group was treated with the same dose of domestic Paliperidone extended-release tablets instead for 2 months， and the original group continued to use the previous dose of the original drug for 2 months. Positive and negative syndrome scale （PANSS） and treatment emergent symptom scale （TESS） were used to evaluate the two groups at the time of enrollment and the end of 1 week， 1 month and 2 months after enrollment. The incidence of ADR was calculated at the end of 2 months after enrollment. The fasting blood glucose， blood lipid indicators （triglyceride， total cholesterol， low-density lipoprotein， high-density lipoprotein， very-low-density lipoprotein）， serum prolactin levels， and paliperidone blood concentration were determined after the intravenous blood sample was collected. The ratio of paliperidone blood concentration to dose （C/D value） was calculated， and an electrocardiogram was performed. RESULTS There were 31 and 30 patients in the domestic group and the original group who completed the trial， respectively. There were no statistical significances in PANSS score， TESS score or C/D value at the time of enrollment and the end of 1 week， 1 month and 2 months after enrollment； there were no statistical significances in the levels of fasting blood glucose， blood lipid or serum prolactin at the time of enrollment and at the end of 2 months after enrollment （P＞0.05）. PANSS scores of both groups significantly decreased at the end of 1 month and 2 months after enrollment （P＜0.01）. The incidences of ADR were 25.81% in the domestic group and 30.00% in the original group， without significant difference （P＞0.05）， and there were no significant abnormalities in the electrocardiograms of the two groups. CONCLUSIONS Domestic Paliperidone extended-release tablets can directly replace the original tablets in the treatment of stable schizophrenia， and their clinical efficacy and safety are comparable.

Efficacy and safety of paliperidone extended-release tablets in the treatment of schizophrenia / 中国基层医药

Objective To study the clinical effect and safety of paliperidone extended-release tablets in the treatment of schizophrenia.Methods 80 patients with schizophrenia were selected as the research subjects .Accord-ing to randomized single blind,the patients were divided into two groups ,40 cases in each group.The control group was given risperidone treatment,the observation group used paliperidone extended-release tablets treatment.The total effective rate,positive and negative symptoms score (PANSS score),mental disability score (WHO-DAS score II) and the incidence of adverse reactions were compared between the two groups .Results The clinical total effective rate (95.00%) in the observation group was significantly higher than the control group (80.00%,χ2 =4.114,P <0.05).After treatment, the PANSS score and WHO-DAS II score in the observation group were significantly decreased compared with before treatment (t =8.002,7.761,all P <0.05),which were lower than those in the control group after treatment (t =4.114,3.702,all P <0.05).The incidence rate of adverse reaction between the two groups had no statistically significant difference (7.50% vs.10.00%,χ2 =0.157,P >0.05).Conclusion The clinical efficacy of paliperidone extended-release tablets in the treatment of schizophrenia is significant ,which can effectively relieve patients with mental disorders ,and it is safe and reliable.

Comparative of paliperidone extended release tablets and risperidone tablets for women's glycolipid metabolism of episode schizophrenia / 药物评价研究

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.

Efficacy and Tolerability of Paliperidone Extended-release in the Treatment of First-episode Psychosis: An Eight-week, Open-label, Multicenter Trial

OBJECTIVE: We investigated the efficacy and tolerability of paliperidone extended-release (ER) tablets in patients with first-episode psychosis (n=75). METHODS: This was an 8-week, open-label, multicenter trial. The primary outcome variable was scores on the Positive and Negative Syndrome Scale (PANSS); secondary measures included the Scale for the Assessment of Negative Symptoms (SANS), the Cognitive Assessment Interview (CAI), and the Global Assessment of Functioning (GAF). To assess safety, we measured drug-related adverse events, weight, lipid-related variables, and prolactin and administered the Simpson–Angus Rating Scale (SARS), the Abnormal Involuntary Movement Scale (AIMS), the Barnes Akathisia Scale (BAS), the Arizona Sexual Experiences Scale (ASEX), and the Udvalg for Kliniske Undersogelser side effect rating scale (UKU). RESULTS: The administration of paliperidone ER resulted in significant improvement in the PANSS, SANS, CAI, and GAF scores (p<0.001) over time. This improvement was evident as early as 1 week. The most frequent adverse events were akathisia, somnolence, anxiety, and sedation, which were well tolerated. Modest increases in weight and lipid profiles were also noted. Prolactin levels were substantially increased at the endpoint in both male and female patients. CONCLUSION: These results indicate that paliperidone ER is effective and is characterized by good tolerability in the treatment of positive and negative symptoms and cognitive functioning in first-episode psychosis.

Therapeutic Effect of Paliperidone Extended-release Tablets in Schizophrenia Patients / 中国药师

Objective:To investigate the curative effect and prognosis of schizophrenia patients treated with paliperidone extended -release tablets.Methods:Totally 72 cases of patients with schizophrenia were divided into the observation group (n=35) and the control group ( n=37 ) according to the order of admission .The obsevation group was treated with paliperidone extended-release tab-lets, while the controll group was treated with risperidone tablets , and both groups were treated for 8 weeks.The positive and negative syndrome scale(PANSS) was used to assess the effect of the two groups , the social function defect scale (SDSS) and prognosis of the two groups were compared.Results: After the 2-week treatment, the PANSS score, positive symptom score, negative symptom score and general symptom score were all decreased in the two groups when compared with those before the treatment (P<0.05),and the scores in the observation group were lower than those in the controll group (P<0.05).After the treatment, the SDSS was significantly reduced in the two groups when compared with that before the treatment (P<0.05), and the reduction in the observation group was more notable than that in the control group (P<0.05).The total effective rate of the observation group was 94.3%, which was higher than that (67.6%) of the control group (P<0.05).The incidence of adverse reactions, such as anxiety and akathisia, and the total adverse drug reactions in the observation group were both lower than those in the control group (P<0.05).Conclusion:Paliperidone extended-release tablets can effectively relieve suffering from schizophrenia with quick effect , few adverse reactions , high safety and good effect , which is worthy of promotion in clinical use .