Walker Rowan G, Cottrell Stephen, Sharp Kathleen, Tripodi Rosamaria, Nicholls Kathy M, Fraser Ian, Varigos George A, Butcher Belinda E
Department of Nephrology, The Royal Melbourne Hospital, Melbourne, Victoria, Australia.
Nephrology (Carlton). 2007 Dec;12(6):607-14. doi: 10.1111/j.1440-1797.2007.00884.x.
Cyclosporine-induced side-effects such as gum enlargement and hirsutism potentially limit its effectiveness as a calcineurin-antagonist if these effects contribute to a lack of compliance. Although the differences in incidence of these effects are widely recognized, few studies are available to show the extent of reduced gum enlargement and hirsutism in patients converted from cyclosporine to tacrolimus. This study aimed to determine the efficacy and safety and patient-reported outcomes of such conversions.
Twenty-one consecutive cyclosporine-treated renal-transplant recipients with evidence of gingival enlargement were randomized into two arms: 10 continued to receive cyclosporine, 11 were converted to tacrolimus. Mean differences (0-3, 0-6, 0-9 and 0-12 months) in periodontal indices (gingival inflammation, plaque, pocket depth, gingival enlargement), hirsutism, serum creatinine and glucose and subjective differences in the patient's rating of disfigurement due to hirsutism and gingival enlargement were recorded.
There were no differences in baseline periodontal scores between the two groups. Tacrolimus-treated subjects had significantly reduced pocket depth and gingival enlargement measures (Pocket Depths: -0.40 +/- 0.58 vs 0.30 +/- 0.35, P < 0.01; Gingival Enlargement Index: -1.12 +/- 0.83 vs-0.10 +/- 0.89, P < 0.05; tacrolimus vs cyclosporine, respectively), and decreased subjective disfigurement compared with the cyclosporine-treated group over the 12 months. While there was no difference in objective hirsutism scores between the two groups, tacrolimus-treated patients reported a significant improvement and cyclosporine-treated patients a significant worsening in their degree of disfigurement at the end of 12 months. There were no differences in creatinine or glucose levels.
Conversion from cyclosporine to tacrolimus in stable renal-transplant recipients with cyclosporine-induced gingival enlargement can be achieved safely and with measurably good effect.
环孢素引起的副作用，如牙龈增生和多毛症，如果这些副作用导致患者依从性降低，可能会限制其作为钙调神经磷酸酶拮抗剂的有效性。尽管这些副作用发生率的差异已得到广泛认可，但很少有研究表明从环孢素转换为他克莫司的患者牙龈增生和多毛症减轻的程度。本研究旨在确定这种转换的疗效、安全性及患者报告的结果。
21例连续接受环孢素治疗且有牙龈增生证据的肾移植受者被随机分为两组：10例继续接受环孢素治疗，11例转换为他克莫司治疗。记录牙周指数（牙龈炎症、菌斑、牙周袋深度、牙龈增生）、多毛症、血清肌酐和血糖的平均差异（0 - 3、0 - 6、0 - 9和0 - 12个月），以及患者对多毛症和牙龈增生所致容貌毁损的主观评分差异。
两组基线牙周评分无差异。他克莫司治疗的受试者牙周袋深度和牙龈增生指标显著降低（牙周袋深度：-0.40±0.58对0.30±0.35，P<0.01；牙龈增生指数：-1.12±0.83对-0.10±0.89，P<0.05；分别为他克莫司组与环孢素组），且在12个月内与环孢素治疗组相比，主观容貌毁损减轻。虽然两组客观多毛症评分无差异，但他克莫司治疗的患者报告在12个月末容貌毁损程度有显著改善，而环孢素治疗的患者有显著恶化。肌酐或血糖水平无差异。
对于因环孢素导致牙龈增生的稳定肾移植受者，从环孢素转换为他克莫司可以安全实现，且效果显著。
