A multicenter randomized controlled trial of tonsillectomy combined with steroid pulse therapy in patients with immunoglobulin A nephropathy.

A multicenter randomized controlled trial of tonsillectomy combined with steroid pulse therapy in patients with immunoglobulin A nephropathy.
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DOI:
10.1093/ndt/gfu020
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发表时间:
2014-08
期刊:
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association
影响因子:
--
通讯作者:
Special IgA Nephropathy Study Group
Special IgA Nephropathy Study Group
中科院分区:
其他
文献类型:
--
作者:
Kawamura T;Yoshimura M;Miyazaki Y;Okamoto H;Kimura K;Hirano K;Matsushima M;Utsunomiya Y;Ogura M;Yokoo T;Okonogi H;Ishii T;Hamaguchi A;Ueda H;Furusu A;Horikoshi S;Suzuki Y;Shibata T;Yasuda T;Shirai S;Imasawa T;Kanozawa K;Wada A;Yamaji I;Miura N;Imai H;Kasai K;Soma J;Fujimoto S;Matsuo S;Tomino Y;Special IgA Nephropathy Study Group

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本研究的目的是,首次进行多中心随机对照试验,以评估扁桃体切除术对IgA肾病(IgAN)患者的影响。活检证实IgAN、蛋白尿和低血清肌酐的患者被随机分配接受扁桃体切除术联合类固醇脉冲治疗(A组; n = 33)或单纯类固醇脉冲治疗(B组; n = 39)。主要终点为尿蛋白排泄和蛋白尿和/或血尿消失。12个月内,A组尿蛋白排泄量下降百分比显著大于B组(P <0.05)。然而,12个月时蛋白尿、血尿或两者(临床缓解)消失的频率在两组之间没有统计学差异。Logistic回归分析显示,分配的治疗是一个重要的,独立的因素,有助于蛋白尿的消失(比值比2.98,95% CI 1.01 - 8.83,P = 0.049),但没有确定一个独立的因素,实现血尿消失或临床缓解。结果表明扁桃体切除术联合类固醇脉冲治疗对减轻血尿和增加临床缓解的发生率没有比单独类固醇脉冲更有益的效果。虽然联合治疗的抗蛋白尿作用显著更强,但差异很小,其对肾功能结局的影响仍有待澄清。
The study aim was, for the first time, to conduct a multicenter randomized controlled trial to evaluate the effect of tonsillectomy in patients with IgA nephropathy (IgAN). Patients with biopsy-proven IgAN, proteinuria and low serum creatinine were randomly allocated to receive tonsillectomy combined with steroid pulses (Group A; n = 33) or steroid pulses alone (Group B; n = 39). The primary end points were urinary protein excretion and the disappearance of proteinuria and/or hematuria. During 12 months from baseline, the percentage decrease in urinary protein excretion was significantly larger in Group A than that in Group B (P < 0.05). However, the frequency of the disappearance of proteinuria, hematuria, or both (clinical remission) at 12 months was not statistically different between the groups. Logistic regression analyses revealed the assigned treatment was a significant, independent factor contributing to the disappearance of proteinuria (odds ratio 2.98, 95% CI 1.01–8.83, P = 0.049), but did not identify an independent factor in achieving the disappearance of hematuria or clinical remission. The results indicate tonsillectomy combined with steroid pulse therapy has no beneficial effect over steroid pulses alone to attenuate hematuria and to increase the incidence of clinical remission. Although the antiproteinuric effect was significantly greater in combined therapy, the difference was marginal, and its impact on the renal functional outcome remains to be clarified.
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