Kumar Mitesh, Chavan B S, Sidana Ajeet, Das Subhash
Department of Psychiatry, Government Medical College and Hospital, Chandigarh, India.
Indian J Psychol Med. 2017 Nov-Dec;39(6):770-776. doi: 10.4103/IJPSYM.IJPSYM_111_17.
To compare the efficacy and tolerability of clozapine and quetiapine in patients with treatment-resistant schizophrenia (TRS).
In this prospective, randomized, open label study of 14 weeks, 53 patients with schizophrenia diagnosed as per ICD-10 and fulfilling the modified version of Conley and Kelly's criteria of TRS were randomly assigned to receive clozapine or quetiapine as per a computer-generated random table. After 2-weeks of dose-titration phase, doses were fixed at minimum therapeutic dose and subsequently adjusted according to the clinical improvement. All patients received dosage of respective drug in therapeutic range. 13 patients were lost to follow up. Treatment efficacy and side effects were evaluated with standardized rating scales.
Clozapine group (reduction in total score: mean=14.45, SD=10.39) had significantly greater reductions (P=0.004; CI=3.541-17.059) in the Positive and Negative Syndrome Scale (PANSS) total score, PANSS positive subscale and PANSS general psychopathology subscale at 14 weeks in comparison to the quetiapine group (reduction in total score: mean=4.15, SD=10.71). Significant reduction in PANSS negative subscale was seen with both drugs but no significant difference was present between the two drugs. At 14 weeks, 30% patients in clozapine group and 15% patients in quetiapine group showed response. Clozapine led to significantly greater side effects (P< 0.001, CI=2.241-6.059) on Glassgow Antipsychotic Side-effect Scale (GASS) than quetiapine.
Clozapine was found to be more efficacious than quetiapine in patients with TRS but was associated with greater side effects. Both the drugs were found to be equally effective in reducing the negative symptoms.
比较氯氮平和喹硫平治疗难治性精神分裂症(TRS)患者的疗效和耐受性。
在这项为期14周的前瞻性、随机、开放标签研究中,53例根据ICD - 10诊断为精神分裂症且符合Conley和Kelly改良版TRS标准的患者,按照计算机生成的随机表随机分配接受氯氮平或喹硫平治疗。在2周的剂量滴定阶段后,剂量固定在最小治疗剂量,随后根据临床改善情况进行调整。所有患者均接受各自药物治疗范围内的剂量。13例患者失访。用标准化评定量表评估治疗效果和副作用。
与喹硫平组(总分降低:均值 = 4.15,标准差 = 10.71)相比,氯氮平组(总分降低:均值 = 14.45,标准差 = 10.39)在14周时阳性与阴性症状量表(PANSS)总分、PANSS阳性分量表和PANSS一般精神病理学分量表上有显著更大程度的降低(P = 0.004;可信区间 = 3.541 - 17.059)。两种药物在PANSS阴性分量表上均有显著降低,但两种药物之间无显著差异。在14周时,氯氮平组30%的患者和喹硫平组15%的患者显示有反应。氯氮平在格拉斯哥抗精神病药物副作用量表(GASS)上导致的副作用显著大于喹硫平(P < 0.001,可信区间 = 2.241 - 6.059)。
在TRS患者中,发现氯氮平比喹硫平更有效,但副作用更大。发现两种药物在减轻阴性症状方面同样有效。