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一项关于扁桃体切除术联合类固醇脉冲疗法治疗免疫球蛋白A肾病患者的多中心随机对照试验。

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

作者信息

Kawamura Tetsuya, Yoshimura Mitsuhiro, Miyazaki Yoichi, Okamoto Hidekazu, Kimura Kenjiro, Hirano Keita, Matsushima Masato, Utsunomiya Yasunori, Ogura Makoto, Yokoo Takashi, Okonogi Hideo, Ishii Takeo, Hamaguchi Akihiko, Ueda Hiroyuki, Furusu Akira, Horikoshi Satoshi, Suzuki Yusuke, Shibata Takanori, Yasuda Takashi, Shirai Sayuri, Imasawa Toshiyuki, Kanozawa Koichi, Wada Akira, Yamaji Izumi, Miura Naoto, Imai Hirokazu, Kasai Kenji, Soma Jun, Fujimoto Shouichi, Matsuo Seiichi, Tomino Yasuhiko

机构信息

Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.

Department of Internal Medicine, Kanazawa Medical Centre, Kanazawa, Japan.

出版信息

Nephrol Dial Transplant. 2014 Aug;29(8):1546-53. doi: 10.1093/ndt/gfu020. Epub 2014 Mar 3.

Abstract

BACKGROUND

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).

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

摘要

背景

本研究旨在首次开展一项多中心随机对照试验,以评估扁桃体切除术对IgA肾病(IgAN)患者的疗效。

方法

经活检证实为IgAN、存在蛋白尿且血清肌酐水平较低的患者被随机分配,分别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以及蛋白尿和/或血尿的消失情况。

结果

从基线开始的12个月内,A组尿蛋白排泄量的下降百分比显著大于B组(P < 0.05)。然而,两组在12个月时蛋白尿、血尿或两者均消失(临床缓解)的频率在统计学上并无差异。逻辑回归分析显示,分配的治疗方法是导致蛋白尿消失的一个显著独立因素(优势比2.98,95%置信区间1.01 - 8.83,P = 0.049),但未发现实现血尿消失或临床缓解的独立因素。

结论

结果表明,扁桃体切除术联合类固醇脉冲疗法在减轻血尿和提高临床缓解发生率方面,相较于单纯类固醇脉冲疗法并无益处。尽管联合治疗的抗蛋白尿作用显著更强,但差异不大,其对肾功能结局的影响仍有待阐明。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aea5/4106640/d35c4d78c6f4/gfu02001.jpg

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