Clinical and Oncological Psychology, Department of Neuroscience, University of Turin, Corso Bramante 88, 10126 Turin, Italy.
Support Care Cancer. 2012 Feb;20(2):375-84. doi: 10.1007/s00520-011-1118-8. Epub 2011 Mar 15.
This study aimed to compare the tolerability and efficacy of two different titrations of paroxetine (slow and standard) in a population of cancer patients with depression.
This randomized open trial included 30 cancer patients with depression (major depressive disorder, dysthymic disorder, or adjustment disorder with depressed mood) and aimed to compare the safety of slow up-titration (arm A) versus standard up-titration (arm B) of paroxetine chlorhydrate. In both arms, the maximum final dose was 20 mg/day. Patients were evaluated at baseline and after 2, 4, and 8 weeks with rating scales for depression and anxiety (MADRS, HADS, HAM-A, CGI), quality of life (EORTC-QLQ-30), and side effects (DOTES, SIDE).
Thirty consecutive cancer patients (F = 21; M = 9) meeting DSM-IV TR criteria for mood disorders (MD) were enrolled in the study and randomly assigned to slow or standard paroxetine titration. Both treatment groups showed a significant mood improvement (change in MADRS total score) from baseline to end point (arm A-F(2,18) = 33.68 p < 0.001; arm B-F(2,12) = 6.97 p < 0.005). A significantly higher rate of patients in arm A compared with arm B showed no side effects after 2 weeks (40% vs. 6.7%, respectively). A multinomial logistic regression confirmed such differences between arms (chi square = 20.89 p = 0.004). The self-evaluating scale (SIDE) confirmed this difference: 60% of subjects in arm B perceived side effects compared to only 11.1% of patients in arm A.
The results of this study suggest that slow paroxetine up-titration is better tolerated and at least as effective as the standard paroxetine up-titration in cancer patients with depression.
本研究旨在比较两种不同帕罗西汀剂量方案(缓慢滴定和标准滴定)在癌症伴抑郁患者人群中的耐受性和疗效。
这是一项随机开放试验,纳入了 30 例癌症伴抑郁(重性抑郁障碍、恶劣心境障碍或伴有抑郁心境的适应障碍)患者,旨在比较缓慢滴定(A 组)与标准滴定(B 组)帕罗西汀氢氯化物的安全性。两组的最大最终剂量均为 20mg/天。患者在基线时以及 2、4 和 8 周时,分别使用抑郁和焦虑量表(MADRS、HADS、HAM-A、CGI)、生活质量量表(EORTC-QLQ-30)和副作用量表(DOTES、SIDE)进行评估。
30 例符合 DSM-IV-TR 心境障碍(MD)标准的连续癌症患者(F=21;M=9)入组本研究,并随机分配至缓慢或标准帕罗西汀滴定组。两组治疗组的抑郁症状(MADRS 总分变化)均从基线到终点有显著改善(A 组-F(2,18)=33.68,p<0.001;B 组-F(2,12)=6.97,p<0.005)。与 B 组相比,A 组在第 2 周时无副作用的患者比例显著更高(40% vs. 6.7%)。二项逻辑回归证实了两组之间的差异(卡方=20.89,p=0.004)。自评价量表(SIDE)也证实了这种差异:B 组有 60%的患者认为有副作用,而 A 组仅有 11.1%的患者认为有副作用。
本研究结果表明,在癌症伴抑郁患者中,缓慢帕罗西汀滴定的耐受性更好,疗效至少与标准帕罗西汀滴定相当。