Pathological sub-analysis of a multicenter randomized controlled trial of tonsillectomy combined with steroid pulse therapy versus steroid pulse monotherapy in patients with immunoglobulin A nephropathy.
BACKGROUND
The IgA nephropathy (IgAN) Study Group in Japan conducted a multicenter, randomized, controlled trial of tonsillectomy with steroid pulse therapy (TSP) versus steroid pulse monotherapy in patients with IgAN (UMIN Clinical Trial Registry Number; C000000384). The effects of therapies in relation to pathological severity were analyzed in this study.


METHODS
The patients with IgAN, urinary protein 1.0-3.5 g/day, serum creatinine of 1.5 mg/dl or less were randomly assigned to receiving TSP (Group A) or steroid pulses alone (Group B). The primary endpoint was the disappearance of proteinuria and/or hematuria. Twenty-six biopsies in Group A and 33 in Group B were available. The histological grades (HG) according to the percentage of glomeruli with crescent or sclerosis and the Oxford classification were analyzed.


RESULTS
The patients in Group A had a 4.32- to 12.1-fold greater benefit of disappearance of proteinuria and 3.61- to 8.17-fold greater benefit of clinical remission (disappearance of proteinuria and hematuria) than those in Group B in patients with HG2-3, acute lesions (cellular or fibrocellular crescent) affecting more than 5 % of glomeruli, chronic lesions (fibrous crescents or sclerosis) affecting more than 20 % and S1. In contrast, odds ratios for disappearance of proteinuria or clinical remission in Group A to Group B were not significant in patients with HG 1, acute lesion in 5 % or less of glomeruli, chronic lesion in 20 % or less and S0. The disappearance of hematuria showed no relation to pathological severity.


CONCLUSIONS
TSP might be better employed according to the pathological severity.
Kidney Unit, National Fukuoka-Higashi Medical Center, 1-1-1, Chidori, Koga-City, Fukuoka, 811-3195, Japan. katafuchir@fukuokae2.hosp.go.jp.
Ritsuko
R
Katafuchi
Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
Tetsuya
T
Kawamura
Department of Pathology, Tohoku University Graduate School of Medicine, Sendai, Japan.
Kensuke
K
Joh
Department of Pathology, Keio University School of Medicine, Tokyo, Japan.
Akinori
A
Hashiguchi
Department of Pathology, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.
Satoshi
S
Hisano
Department of Pathology, Nihon University School of Medicine, Tokyo, Japan.
Akira
A
Shimizu
Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
Yoichi
Y
Miyazaki
Department of Medicine and Clinical Science, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan.
Masaharu
M
Nagata
Division of Nephrology, Department of Internal Medicine, University of Nagoya, Nagoya, Japan.
Seiichi
S
Matsuo
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D003131:Combined Modality Therapy; D005260:Female; D005922:Glomerulonephritis, IGA / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery* / Q000652:urine; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D007668:Kidney / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000008:administration & dosage*; D014068:Tonsillectomy; D055815:Young Adult
D005938:Glucocorticoids; D011239:Prednisolone
IgA nephropathy; Pathology; Randomized controlled trial; Steroid pulse therapy; Tonsillectomy