Dijkmans B A, van Rijthoven A W, Goei The H S, Montnor-Beckers Z L, Jacobs P C, Cats A
Eur J Clin Pharmacol. 1987;31(5):541-5. doi: 10.1007/BF00606627.
Serum creatinine levels were measured before, during and after the administration of cyclosporin (Cy) in a double-blind placebo-controlled study in patients with rheumatoid arthritis (RA). The level rose significantly during and after Cy therapy, whereas the initial serum creatinine value did not change in the placebo group. The increase in the Cy group was not correlated with the mean Cy blood level. The rise in serum creatinine during Cy therapy was gradual and was not significantly correlated with the initial creatinine level; relative to the pretreatment value, the post-treatment increase was significantly correlated with the increase during Cy therapy. It is concluded that Cy administration for not more than 6 months, and at a maximum dosage of 10 mg/kg for 2 months, leads to an irreversible loss of more than 10% of renal function in RA patients. The damage may be ascribed to the combination of Cy with other factors compromising the kidneys, e.g., the use of non-steroidal anti-inflammatory drugs in the potentially systemic disorder of RA.
在一项针对类风湿关节炎(RA)患者的双盲安慰剂对照研究中,测量了环孢素(Cy)给药前、给药期间和给药后的血清肌酐水平。在Cy治疗期间和之后,该水平显著升高,而安慰剂组的初始血清肌酐值没有变化。Cy组的升高与平均Cy血药浓度无关。Cy治疗期间血清肌酐的升高是渐进的,且与初始肌酐水平无显著相关性;相对于治疗前值,治疗后升高与Cy治疗期间的升高显著相关。得出的结论是,在RA患者中,使用Cy不超过6个月,最大剂量为10mg/kg持续2个月,会导致超过10%的肾功能出现不可逆损失。这种损害可能归因于Cy与其他损害肾脏的因素共同作用,例如在潜在全身性疾病RA中使用非甾体抗炎药。