Guleria S, Jain S, Dinda A K, Mahajan S, Gupta S, Mehra N K
Department of Surgery, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India.
Indian J Nephrol. 2013 Jul;23(4):253-8. doi: 10.4103/0971-4065.114474.
The aim of the study was to assess the impact of protocol biopsies in a live-related renal transplant program using tacrolimus-based immunosuppression in the short term. Eighty-three live-related transplant recipients were randomly allocated to protocol biopsy group (Group I, n = 40) and a control group (Group II, n = 43). Other immunosuppressants in these groups consisted of either mycophenolate mofetil or azathioprine and steroids. Protocol biopsies were conducted in biopsy group at 1, 6, and 12 months post-transplant. The non-biopsy group was followed by serial serum creatinine and biopsies in them were conducted as and when clinically indicated. Both groups were analyzed at 12 months with respect to graft function and survival. The two groups were similar with respect to age, number of dialysis pre-operatively, tacrolimus levels, induction therapy, donor age, and donor glomerular filtration rate. Forty protocol biopsies were conducted at 1 month, 31 at 6 months, and 26 at 12 months. The prevalence of sub-clinical rejection at 1, 6, and 12 months in these biopsies was 17.5%, 11.2%, and 10.3%, respectively. The prevalence of calcineurin inhibitor toxicity during same period was 15%, 15.5%, and 14.4%, respectively. The cumulative rejection rate in Group I and Group II at 12-month follow-up was 10.3% and 11.3% (P = 0.78), respectively, and cumulative calcineurin inhibitor toxicity at 12 months was 14.4% and 9.3% (P = 0.59), respectively, were not statistically significant. There was no difference in graft survival and function at 1 year. Protocol biopsies have a limited role in a well-matched renal transplant program with tacrolimus-based immunosuppression in the short term. However, the long-term impact of protocol biopsies needs further evaluation.
本研究的目的是评估在短期使用以他克莫司为基础的免疫抑制方案的亲属活体肾移植项目中，方案活检的影响。83名亲属活体移植受者被随机分配到方案活检组（I组，n = 40）和对照组（II组，n = 43）。这些组中的其他免疫抑制剂包括霉酚酸酯或硫唑嘌呤以及类固醇。活检组在移植后1、6和12个月进行方案活检。非活检组通过连续监测血清肌酐进行随访，根据临床指征进行活检。在12个月时对两组的移植肾功能和存活情况进行分析。两组在年龄、术前透析次数、他克莫司水平、诱导治疗、供体年龄和供体肾小球滤过率方面相似。在1个月时进行了40次方案活检，6个月时进行了31次，12个月时进行了26次。在这些活检中，1、6和12个月时亚临床排斥反应的发生率分别为17.5%、11.2%和10.3%。同期钙调神经磷酸酶抑制剂毒性的发生率分别为15%、15.5%和14.4%。在12个月的随访中，I组和II组的累积排斥率分别为10.3%和11.3%（P = 0.78），12个月时累积钙调神经磷酸酶抑制剂毒性分别为14.4%和9.3%（P = 0.59），均无统计学意义。1年时移植肾存活和功能无差异。在短期使用以他克莫司为基础的免疫抑制方案的匹配良好的肾移植项目中，方案活检的作用有限。然而，方案活检的长期影响需要进一步评估。
