四种抗精神病药物治疗老年精神分裂症患者1年期停药率的研究

摘要

目的：：比较4种抗精神病药物治疗老年慢性精神分裂症患者的依从性、疗效和不良反应的差异。方法：系两阶段入组、开放性的随机对照设计,将269例次老年慢性精神分裂症患者随机分成奋乃静组、奥氮平组、利培酮组和奎硫平组,4组患者分别为67例、68例、66例和68例。4组患者分别接受单一可调剂量的奋乃静、奥氮平、利培酮和奎硫平治疗。12个月后,观察4组患者的停药前持续服药时间(TTD)、停药率(TDR)、PANSS 量表评分和首要不良反应事件频率。结果：共完成269例次观察,1年期 TTD 为(8.2±4.3)月,TDR 为49.1％,各组患者的全因 TDR 分别为50.7％、39.7％、62.1％和44.1％,TTD 分别为(8.3±4.1)月、(9.4±3.5)月、(6.9±4.6)月和(8.2±4.7)月。4组患者间 Kaplan-meier 生存分析结果,奥氮平组患者的全因 TDR 优于利培酮组( x2=9.818,P =0.002),奥氮平组、奎硫平组的因疗效差所致TDR 均优于利培酮组(x2=10.831,P =0.001和 x2=12.277,P =0.000),因药物不良反应所致 TDR 的差异无统计学意义( x2=2.871,P =0.412),各组患者间首要停药相关不良反应事件有所差异。 PANSS 评分疗效比较：以 ITT 样本分析,只有奥氮平优于利培酮( F =4.438,P =0.005),而基于 PPS 分析,只有奎硫平优于利培酮(F=8.285,P =0.006)。结论：对老年慢性精神分裂症患者,4种抗精神病药物存在疗效、依从性和不良反应的差异。总体而言,奥氮平优于利培酮,而在持续服药患者中,奎硫平的疗效最佳。%Objective: To evaluate compliance, efficacy and side effects of 4 antipsychotics for treating the aged patients with chronic schizophrenia. Methods: This trail was two-phased enrollment, open-labeled, randomized and controlled. 269 aged patients with chronic schizophrenia were randomly divided into Perphenazine (n=67), Olanzapine (n=68), Risperidone (n=66), and Que-tiapine (n=68) groups. They were treated with a single adjustable dose of the antipsychotic drugs. 12 months later, the time to medi-cation discontinuation (TTD), treatment discontinuation rate (TDR), positive and negative syndrome scale (PANSS) score, and the primary side effects of the four groups were observed. Results: 269 cases were completed with the observation with a one-year TTD of (8. 2 ± 4. 3) months and TDR of 49. 1% . The all-cause TTD were (8. 3 ± 4. 1) months, (9. 4±3. 5) months, (6. 9±4. 6) months and (8. 2±4. 7) months, and all-cause TDRs were 50. 7% , 39. 7% , 62. 1% and 44. 1% of Perphenazine, Olanzapine, Risperidone, and Quetiapine groups, respectively. The results from Kaplan-meier survival analysis displayed that Olanzapine group was favored over Risperidone group for all-causes TDR (x2 =9. 818, P=0. 002), that Olanzapine and Quetiapine groups demonstrated the lower TDR due to bad efficacy relative to Risperidone group (x2 =10. 831, P=0. 001; x2 =12. 277, P=0. 000), and that the difference was not significant in TDR due to intolerable side events (x2 =2. 871, P=0. 412); however, these primary events were various among the 4 a-gents. Based on intend-to-treat populations, the analysis on changes of PANSS scores showed that only Olanzapine group was superior to Risperidone group (F = 4. 438, P = 0. 005), and that only Quetiapine group was superior to Risperidone group (F = 8. 285, P =0. 006) based on per-protocol set. Conclusions: For the aged schizophrenia patients, there are different efficacy, compliance and side effects to the 4 agents. Olanzapine is better than Risperidone in general effectiveness, and the patients remaining on Quetiapine may achieve better improvement relative to those on Risperidone.