Ramachandran Raja, Yadav Ashok Kumar, Kumar Vinod, Siva Tez Pinnamaneni Venkata, Nada Ritambhra, Ghosh Ratan, Kumar Vivek, Rathi Manish, Kohli Harbir Singh, Gupta Krishan Lal, Sakhuja Vinay, Jha Vivekanand
Department of Nephrology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Department of Histopathology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Kidney Int Rep. 2017 Feb 9;2(4):610-616. doi: 10.1016/j.ekir.2017.02.004. eCollection 2017 Jul.
Both cCTX/GCs and CNIs are recommended as first-line agents in the management of PMN. The present study is an extended report of patients randomized to receive TAC/GCs or cCTX/GCs at 2 years post randomization.
Seventy patients enrolled in the clinical trial Tacrolimus Combined With Corticosteroids Versus Modified Ponticelli Regimen in Treatment of Idiopathic Membranous Nephropathy: Randomized Control Trial were followed quarterly between 12 and 24 months. At the end of 24 months, 3 patients were lost to follow-up.
At 18 months, 66% and 89% ( = 0.04) were in remission in TAC/GCs and cCTX/GCs groups, respectively. At 18 and 24 months, 60% and 86% ( = 0.03) of cases were in remission in the TAC/GCs and cCTX/GCs groups, respectively. At 18 months, 57% and 83% ( = 0.03) of the patients in TAC/GCs and cCTX/GCs groups were in remission without need of any additional immunosuppression (persistent remission) and, at 24 months, 43% and 80% ( = 0.002) were in persistent remission in TAC/GCs and cCTX/GCs groups, respectively. Relapse rate after any remission was 40% and 6.7% in TAC/GCs and cCTX/GCs groups, respectively ( = 0.007). There was an association of aPLA2R titers with remission or resistance ( = 0.006) in relapsing PMN. The significant decrease in eGFR after 12 months of TAC/GCs therapy normalized at 18 and 24 months.
At 2 years after randomization, relapse rates are higher for TAC/GCs compared with cCTX/GCs in PMN patients. Thus, cCTX/GCs are better than TAC/GCs in the longer term in PMN patients.
环磷酰胺/糖皮质激素(cCTX/GCs)和钙调神经磷酸酶抑制剂(CNIs)均被推荐作为原发性膜性肾病(PMN)治疗的一线药物。本研究是对随机分组后2年接受他克莫司/糖皮质激素(TAC/GCs)或环磷酰胺/糖皮质激素(cCTX/GCs)治疗患者的扩展报告。
70名参与“他克莫司联合糖皮质激素与改良庞蒂切利方案治疗特发性膜性肾病:随机对照试验”临床试验的患者在12至24个月期间每季度进行随访。在24个月结束时,有3名患者失访。
在18个月时,TAC/GCs组和cCTX/GCs组的缓解率分别为66%和89%(P = 0.04)。在18个月和24个月时,TAC/GCs组和cCTX/GCs组的缓解率分别为60%和86%(P = 0.03)。在18个月时,TAC/GCs组和cCTX/GCs组分别有57%和83%(P = 0.03)的患者在无需任何额外免疫抑制的情况下缓解(持续缓解),在24个月时,TAC/GCs组和cCTX/GCs组分别有43%和80%(P = 0.002)的患者持续缓解。TAC/GCs组和cCTX/GCs组在任何缓解后的复发率分别为40%和6.7%(P = 0.007)。在复发性PMN中,抗磷脂酶A2受体(aPLA2R)滴度与缓解或抵抗相关(P = 0.006)。TAC/GCs治疗12个月后估算肾小球滤过率(eGFR)的显著下降在18个月和24个月时恢复正常。
随机分组2年后,PMN患者中TAC/GCs组的复发率高于cCTX/GCs组。因此,从长期来看,cCTX/GCs对PMN患者的治疗效果优于TAC/GCs。