Hilbrands L B, Hoitsma A J, Koene R A
Department of Medicine, University Hospital Nijmegen, The Netherlands.
Transplantation. 1995 May 15;59(9):1263-70.
This prospective, randomized study investigates the effect of two immunosuppressive treatment regimens on quality of life after renal transplantation. At 3 months after transplantation, patients treated with cyclosporine (CsA) and prednisone (Pred) were allocated to either withdrawal of Pred (n = 60) or to conversion of CsA to azathioprine (Aza) (Aza-Pred, n = 60). Quality of life was evaluated just before randomization, and at 6 and 12 months after transplantation using the Sickness Impact Profile (SIP), the Affect Balance Scale (ABS), the Center for Epidemiological Studies Depression Scale (CES-D), measures of satisfaction with several domains of life experience, and a population-specific physical symptoms questionnaire. In both groups, the overall SIP score as well as the scores on its physical and psychosocial dimensions improved continuously after transplantation, reaching levels that are comparable to those found in the general population. The occurrence of acute or chronic rejection had a significantly negative effect on SIP and CES-D scores. Intention-to-treat analysis showed no differences between groups for scores on SIP, ABS, CES-D, and satisfaction measures. Exclusion of 41 patients who did not strictly adhere to their originally designated therapy showed a tendency for better psychosocial SIP scores in CsA patients (P = 0.05), which mainly resulted from a difference on the category of social interaction (P = 0.01). This difference occurred despite a similar rejection rate and worse renal function in CsA-treated patients. Shortly after steroid withdrawal, a high proportion of CsA patients complained of stiff or painful muscles (CsA: 74%, Aza-Pred: 36%; P = 0.002). Our data indicate that if successfully completed, CsA monotherapy from 3 months after transplantation may lead to a higher degree of psychosocial well-being as compared with conversion from CsA-Pred to Aza-Pred. It seems likely that this advantage is related to the withdrawal of Pred.
这项前瞻性随机研究调查了两种免疫抑制治疗方案对肾移植后生活质量的影响。移植后3个月时，接受环孢素（CsA）和泼尼松（Pred）治疗的患者被随机分为两组，一组停用Pred（n = 60），另一组将CsA转换为硫唑嘌呤（Aza）（Aza-Pred组，n = 60）。在随机分组前、移植后6个月和12个月，使用疾病影响量表（SIP）、情感平衡量表（ABS）、流行病学研究中心抑郁量表（CES-D）、对生活经历多个领域的满意度测量以及一份针对特定人群的身体症状问卷对生活质量进行评估。两组患者移植后SIP总分及其身体和心理社会维度的得分均持续改善，达到与普通人群相当的水平。急性或慢性排斥反应的发生对SIP和CES-D得分有显著负面影响。意向性分析显示，两组在SIP、ABS、CES-D得分及满意度测量方面无差异。排除41例未严格遵守原指定治疗方案的患者后，CsA组患者心理社会SIP得分有更高的趋势（P = 0.05），这主要源于社交互动类别上的差异（P = 0.01）。尽管CsA治疗组患者的排斥率相似且肾功能较差，但仍出现了这种差异。停用类固醇后不久，很大一部分CsA组患者抱怨肌肉僵硬或疼痛（CsA组：74%，Aza-Pred组：36%；P = 0.002）。我们的数据表明，如果成功完成，移植后3个月开始的CsA单药治疗与从CsA-Pred转换为Aza-Pred相比，可能会带来更高程度的心理社会幸福感。这种优势似乎与停用Pred有关。
