【摘要】 目的:评价达体朗(噻萘普汀)改善精神分裂症患者负性情绪的疗效和安全性。方法:实验于2003-05/2004-04在上海市公安局安康医院精神病房完成。观察对象为因肇祸住院精神分裂症患者30例,以自制负性情绪评分表评估患者,总分≥10分。所有入选患者都保持原来使用的精神病药物,负性情绪总评分较低的患者(安慰剂组,n=10)给予安慰剂,1片/次,3次/d,合并语言暗示。其余患者随机分为达体朗组(n=10),服用达体朗(法国施维雅公司提供),12.5mg/次,2次/d或3次/d;氟西汀(n=10)组服用氟西汀20mg/次,1次/d。3组患者连续服用上述药物4周后,达体朗在第4周的最后5d内分2次或3次完全撤退;氟西汀与安慰剂都在第4周末1次撤除。于治疗前、治疗后2周、治疗后4周和停药后2周应用自制负性情绪评分量表(共25项,归纳抑郁、焦虑;强迫和敌对5项因子,每项问题设0～4五级分值,相应定义为“无症状、可疑、轻微、明显和极明显)对3组患者的负性情绪总分、因子分进行评定;按治疗后负性情绪总分减分率(减分率≥25%为有效,<25%为不肯定,0或总评分增加为无效或恶化)评定疗效;于治疗前、治疗后第4周末各评定1次药物不良事件和副反应,并设标准对照和空白对照。结果:每组各10例患者纳入结果分析。①各组疗效比较:治疗4周后,达体朗组和氟西汀组有效者各8例,安慰剂组为4例,达体朗组的疗效与氟西汀组的相当(P>0.05),高于安慰剂组的疗效(P<0.05)。②各组治疗后负性情绪评定比较:达体朗组在2周时减分比氟西汀组多,4周时两药继续减分至接近水平,停药2周后达体朗组总分及抑郁、焦虑分略有回升,强迫和敌对项继续减分,而氟西汀组各项评分继续减分达到最大值。安慰剂组各项分值在用药2周后有增有减少,4周时普遍增分,停药2周后总分、抑郁和焦虑项减分,其余两项恢复到治疗前水平。③影响因素分析:重复二因素方差分析显示,对负性情绪减分的影响,3种药物之间差异极显著(P<0.01),且药物和时间的交互影响显著(P<0.05),单独时间因素的影响差异无显著性(P>0.05)。④两组不良事件和副反应比较:达体朗组有12例次,氟西汀组有7例次,安慰剂组有14例次,达体朗组与氟西汀组差异无显著性(P>0.05)。结论:达体朗改善精神分裂症患者负性情绪的效果与氟西汀相当,发挥作用比氟西汀快,两药安全性相当。更多还原

【Abstract】 AIM: To evaluate the efficacy and safety of Tatinol (tianeptine) in ameliorate the negative emotions of patients with schizophrenia.METHODS:The study was completed in the sickroom of psychiatry, Ankang Hospital of Shanghai Police Bureau between May 2003 and April 2004. Thirty inpatients with schizophrenia for causing trouble, whose score of the self-designed negative emotion scale ≥10 points, were treated with the psychiatric drugs used before: The patients with lower total score of negative emotions (placebo group, n=10) were given placebo once for each time, three time a day, language suggestion was also applied; the other patients were randomly divided into Tatinol group (n=10, the patients were treated with Tatinol, provided by France Servier Company, 12.5 mg for each time, twice or 3 times a day) and fluoxetine group (n=10, the patients were treated with fluoxetine, 20 mg for each time, once a day). After treated with the above drugs for 4 weeks, Tatinol was ceased by twice or 3 times in the last 5 days of the 4th week, and fluoxetine and placebo were ceased all at one at the end of the 4th week. Before treatment and 2 and 4 weeks after treatment and 2 weeks after drug withdrawal, the total score and factor scores of negative emotion of the patients in the 3 groups were assessed with the self-designed negative emotion scale (consisted of 25 items, the factors were depression, anxiety, obsession-compulsion and hostility, each problem was scored by 5 grades of 0 to 4, represented "no symptom, suspectable, mild, obvious and extremely obvious" respectively). The efficacy was evaluated with the decreasing rate of the total score of negative emotions after treatment (decreasing rate of the total score≥25% was taken as valid, < 25% as uncertain, 0 or increased total score as invalid or aggravated). The adverse events and side effects of the drugs were evaluated before treatment and at the end of the 4th week respectively, and the standard controls and blank controls were also established. RESULTS: Ten cases in each group were involved in the analysis of results. 1 Valid efficacy was observed in 8 cases in the Tatinol group and fluoxetine group respectively and 4 cases in the placebo group, the efficacies in the Tatinol group and fluoxetine group were close (P > 0.05), and both were higher than that in the placebo group (P < 0.05). 2 Comparison of negative emotions after treatment: The scores were decreased more at 2 weeks in the Tatinol group than in the fluoxetine group, at 4 weeks the scores in the two groups continued to decreased and to a close level, and at 2 weeks after drug withdrawal, the total score and the scores of depression and anxiety were increased a little and the scores of obsession-compulsion and hostility continued to decrease in the Tatinol group, and the scores of each item continued to decrease to the maximal values. In the placebo group, both the increase or decrease of scores could be observed at 2 weeks, and the scores were increased generally at 4 weeks, the total score and the scores of depression and anxiety were decreased and those of the other 2 items recovered to the levels before treatment at 2 weeks after drug withdrawal. 3 Analysis of the influencing factors: The repetitive two-factor variance of analysis showed that there were extremely significant differences among the 3 groups in the influence on the decreasing score of negative emotions (P < 0.01), and the interactions between drug and time were significant (P < 0.05), and the influence of time only was not significant (P > 0.05). 4 Comparison of adverse events and side effects among the groups: Those were observed in 12, 7 and 14 cases in Tatinol group, fluoxetine group and placebo group respectively, and there was insignificant difference between the Tatinol group and fluoxetine group (P > 0.05). CONCLUSION: Tatinol has comparative effects with fluoxetine in improving the negative emotions of patients with schizophrenia, its action time is faster than fluoxetine, and the safety of the two drugs is close.更多还原