棕榈酸帕利哌酮对女性精神分裂症疗效与安全性的研究

Efficacy and safety study of paliperidone palmitate in female patients of schizophrenia

目的探讨棕榈酸帕利哌酮对女性精神分裂症的疗效与安全性。方法对112例患者根据性别分为研究组(女性)和对照组(男性),用棕榈酸帕利哌酮注射,首次剂量150mg,间隔8天100mg,之后每月1次,可变剂量75 mg^150 mg。采用阳性与阴性症状量表(PANSS)、临床总体印象量表疾病严重程度分量表(CGI-S)评定患者精神症状与疗效的变化;副作用量表(TESS)、实验室、血生化变化评价安全性。在治疗前与治疗1周、4周、8周、16周末评定。结果两组患者PANSS、CGI-S评分在治疗1、4、8、16周末均降低,与治疗前比较,差异均有显著性(P<0.05);34例出现EPS与胆碱能反应,10例月经紊乱。结论棕榈酸帕利酮注射后1周即起效,4~8周达到可靠疗效,易发生EPS与胆碱能反应,导致女性月经紊乱,不影响继续使用,可获得满意的临床疗效,为长期治疗提供了新选择。

Objective To explore efficacy and safety paliperidone palmitate in female patients of schizophrenia. Methods 112 patients were indived into study group （ female ） and control group （ male ） according to gender, 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 at intervals of eight days, then monthly with dose of 75mg to 150 mg, no oral medications added. Change of psychiatric symptoms and therapeutic effect were assessed with the Positive and Negative Syndrome scale （PANSS） and Clinical Global Impression Scale （ CGI-S ）. Safety was assessed with blood biochemistry in laboratory and Treatment Emergent Symptom Scale （ TESS ） . The efficacy, adverse reactions and safety were evaluated before treatment and in the lth weeks, 4th weeks, 8th weeks, 16th weeks after treatment. Results The scores of PANSS and CGI-S both were decreased in the end of the lth weeks, 4th weeks, 8th weeks, 16th weeks after treatment. As compared with before treatment, PANSS total scores and CGI-S scores were significantly different （ P〈0.05 ） .34 patients had EPS and cholinergic response, 10 patients had menstrual disorder. Conclusion Paliperidone palmitate injections begins to take effect after one weeks, reach to reliable effect after 4-8weeks, impact on body mass and menses, easily, lead to EPS and cholinergic response, result in menstrual disorder, but does not affect the continued use, obtain satisfactory clinical outcome, provides a new choice for long-term treatment.