【作者】 李亚敏；

【导师】 赵靖平；

【作者基本信息】 中南大学 ， 临床医学， 2012， 博士

【摘要】 目的：比较齐拉西酮和奥氮平对首发精神分裂症患者的疗效和安全性；比较齐拉西酮和奥氮平对首发精神分裂症患者体质量和糖脂代谢的影响；评价心理健康教育对首发精神分裂症患者服药依从性的影响。方法：80例首发精神分裂症患者被随机分配到齐拉西酮组或奥氮平组,治疗观察6周。于治疗前及治疗后2周末、4周末和6周末使用阳性和阴性症状量表(Positive and Negative Syndrome Scale, PANSS)和临床疗效总评量表-疾病严重程度(Clinical Global Impressions-Severity of Illness scale, CGI-S)评定两种药物的疗效。使用PANSS总分、减分值、减分率和CGI-S总分作为评价药物疗效的主要指标,使用症状好转率和治疗有效率作为次要指标。于治疗前及治疗后2周末、4周末和6周末测量患者的体质量,计算体质量指数；于治疗前后测量记录患者的空腹血糖、空腹胰岛素、低密度脂蛋白、高密度脂蛋白、总胆固醇和甘油三酯,并计算胰岛素抵抗指数。由研究者使用不良事件记录表记录研究过程中出现的所有不良反应。对服用这两种药物的患者实施心理健康教育,评价心理健康教育对患者服药依从性的影响。结果：共79例患者完成研究,齐拉西酮组39人,平均剂量(127.50+27.43)mg/d；奥氮平组40人,平均剂量(19.13+1.92)mg/d。齐拉西酮组和奥氮平组的PANSS和CGI-S评分、症状好转率和治疗有效率的差异均无显著性(P均>0.05)。虽然齐拉西酮组更易引起锥体外系不良反应(P<0.05),但两种药物均具有较好的耐受性,均未出现严重不良反应。奥氮平组的体质量、体质量指数、空腹血糖、胰岛素、胰岛素抵抗指数和低密度脂蛋白的增加要显著高于齐拉西酮组(P均<0.05)。高密度脂蛋白、总胆固醇和甘油三酯在两组内均有升高,但两组的差异无显著性(P均>0.05)。患者实施心理健康教育后两者服药依从性均较好(P均>0.05)。结论：齐拉西酮和奥氮平对首发精神分裂症患者均具有较好的疗效,并且两种药物的疗效相当。齐拉西酮较易引起锥体外系不良反应,但两种药物均具有较好的耐受性。齐拉西酮对体质量、糖代谢和低密度脂蛋白的影响较小,而奥氮平会显著增加体质量,并且更易导致糖代谢异常和低密度脂蛋白的升高。心理健康教育可显著提高首发精神分裂症住院患者服药的依从性。更多还原

【Abstract】 Objective:To compare the efficacy and safety of Ziprasidone and Olanzapine in the treatment of first-episode schizophrenic patients; To compare the effects of ziprasidone and olanzapine on body weight and glucose and lipid metabolism in first-episode schizophrenia; To evaluate the efficacy of health education on medication compliance in first-episode schizophrenic patients.Methods:Eighty first-episode schizophrenia patients were randomly assigned to receive ziprasidone or Olanzapine for6weeks. The Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression-severity scale (CGI-SII) were used to assess the efficacy of ziprasidone and olanzapine and measured at baseline, week2, week4and week6. The primary outcomes for efficacy were the total score and rate change of PANSS and CGI-SII. The remission and response rates were used as the second efficacy outcomes. The weight was measured at baseline, week2, week4and week6. Fasting blood glucose (FBS), fasting insulin (INS), high-density lipoprotein (HDL), total-cholesterol (CHOL) and triglycerides (TG) were measured at baseline and week6. Body mass index (BMI) and insulin resistance index (IRI) were calculated. The adverse events (AEs) were recorded by the investigator. All patients received mental health education at each follow-up visit. The compliance of ziprasidone and olanzpine was evaluated at each follow-up visit.Results:Of the80patients,79patients (39for ziprasidone and40for olanzapine) completed the6-week treatment trial. The mean dosage of ziprasidone and olanzapine were127.5mg/d and19.1mg/d, respectively. The changes of the total score of PANSS and CGI-SII and remission and response rates did not differ between the two groups. Zziprasidone could induce more extrapyramidal side effects than olanzapine(P<0.05). No serious AEs were observed. The increases of body weight, FBS, INS,and LDL in the olanzapine group were significantly greated than those in the ziprasidone group. HDL, CHOL, and TG increased in the two groups without groups difference. Mental health education could improve the patients compliance of ziprasidone and olanzapine.Conclution:Ziprasidone and olanzapine could use to treat first-episode schizophrenia safely with the same efficacy. Ziprasidone could cause more extrapyramidal side effects Than olanzapine, but olanzapine could cause more weight and glucose and lipid dysfunction. Mental health education can significantly improve medication compliance in first-episode schizophrenia patients.更多还原