| Abstract |
[Abstract] Objective: To explore efficacy and safety of injectable paliperidone palmitate in female patients of schizophrenia for 16 weeks. Methods:62 patientswere given orally paliperidone extended-release tablets for three days before injection, In the case of no allergic reaction, were injected with the first dose of 150mg of paliperidone palmitate injections, given fixed-dose 100mg injection at intervals of eight days,then were injected monthly with dose of 75mg to 150 mg, no oral medications added. Psychiatric symptoms and change of therapeutic effect were assessed with the Positive and Negative Syndrome scale (PANSS) and Clinical Global Impression Scale (CGI).Adverse reactions were evaluated with treatment emergent scale (TESS).Safety was assessed with blood biochemistry in laboratory .By self-contrast method, the efficacy, adverse reactions and safety were evaluated before treatment and in the 4th weeks, 8th weeks, 12th weeks, 16th weeks after treatment.Results: The scores of PANSS and CGI-S were decreased in the end of the 4th weeks, 8th weeks, 12th weeks, 16th weeks after treatment.As compared with before treatment. PANSS total scores and CGI-S scores were significantly reduced (P <0.01 or 0.05). The body mass of 16 patients increased by more than 10%;12 patients had mild EPS and cholinergic response ,10 patients had menstrual disorder, 8 patients had significant EPS(Extrapyramidal reactions);6 cases had the abnormal blood glucose; 6 cases had abnormal cholesterol . Conclusion: Paliperidone palmitate injections begins to take effect after four weeks, reach to reliable effect after 8-12 weeks ,impact on body mass and menses , but does not affect the continued use, have better compliance, obtain satisfactory clinical outcome, provides a new choice for long-term treatment.
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