Is Tonsillectomy a Possible Treatment for IgA Nephropathy from Randomized Controlled Trial (RCT)?



Fig. 19.1
Trial profile



The two groups did not differ in age, gender distribution, eGFR, urinary protein excretion, blood pressure, the proportion of patients’ given renin-angiotensin system (RAS) inhibitors, and histological grades (Table 19.1).


Table 19.1
Baseline patient characteristics













































































 
Group A

Group B

Tonsillectomy/steroid pulse therapy

Steroid pulse therapy alone

(n = 33)

(n = 39)

Age (years)

36 (13)

40 (13)

Gender

Male

17* (52)

18* (46)

Female

16* (48)

21* (54)

eGFR (ml/min/1‧73 m2)

75 (24)

69 (22)

Proteinuria (g/day)

1.6 (0.5)

1.6 (0.6)

Proteinuria (g/g creatinine)

1.7 (1.0)

1.7 (1.0)

Systolic blood pressure (mmHg)

117 (12)

121 (10)

Diastolic blood pressure (mmHg)

69 (9)

73 (8)

Mean arterial pressure (mmHg)

85 (9)

89 (8)

Patients receiving RAS-I (%)

16* (48)

18* (46)

Histological grade

Good prognosis

0*

0*

Relatively good prognosis

2* (6)

3* (8)

Relatively poor prognosis

20* (61)

23* (59)

Poor prognosis

11* (33)

13* (33)


Data are mean (SD) or *number of patients (%). Histological grade was assessed by the classification proposed by the Special IgAN Study Group in 2004 [14]

eGFR estimated glomerular filtration rate, RASI renin-angiotensin system inhibitors


19.2.2.1 Impact of Steroid Pulses and Tonsillectomy on Proteinuria


Figure 19.2 shows the percent changes in urinary protein excretion from baseline during the trial period. As revealed by a mixed effect model employing six fixed effects (group allocation, eGFR, mean arterial pressure, the use of RAS-I at baseline, time, and the interaction of group and time), the percentage decrease in urinary protein excretion during the 12 months from baseline was significantly larger in Group A than that in Group B (coefficient estimate −1.316, 95 % CI −2.617 to −0.015, P = 0.047). The percentage of patients with the disappearance of proteinuria (<0.3 g/gCr) was significantly higher in Group A than in Group B after 10 months (P = 0.029; Fig. 19.2). However, at 12 months, the difference was not statistically significant (Group A, 63 %; Group B, 39 %; P = 0.052).

A330611_1_En_19_Fig2_HTML.gif


Fig. 19.2
Urinary protein excretion during the trial period. Mean values and standard errors are presented


19.2.2.2 Impact of Steroid Pulses and Tonsillectomy on Hematuria


The severity of microscopic hematuria gradually decreased following the initiation of therapy in both groups. However, the proportion of patients with the disappearance of hematuria was not different between the two groups at any time point (e.g., at 12 months, Group A, 68 %; Group B, 64 %, P = 0.672).


19.2.2.3 Impact of Steroid Pulses and Tonsillectomy on Clinical Remission


The disappearance of both proteinuria and hematuria (i.e., clinical remission) did not occur at a higher rate in Group A than in Group B at any time point (P = 0.160 at 10 months, P = 0.103 at 12 months).


19.2.2.4 Impact of Steroid Pulses and Tonsillectomy on Renal Function


eGFR remained stable throughout the trial period and was comparable between the two groups at 12 months (Group A, 75 mL/min/1.73 m2; Group B, 69 mL/min/1.73 m2). No patient in either group showed a 100 % increase in serum creatinine from baseline or a 50 % decrease in eGFR from baseline or had indications for renal replacement therapy.

No adverse effect related to tonsillectomy or general anesthesia was reported. One patient in Group A and three in Group B developed diabetes during the trial period, with one of these Group B patients requiring insulin therapy during the treatment with corticosteroid. At the end of the study, blood sugar levels of all four patients were restored to the normal range.


19.2.2.5 Logistic Regression Analysis


Logistic regression analysis was performed to evaluate the impact of multiple covariates on the disappearance of proteinuria or hematuria and the occurrence of clinical remission. Independent variables included the allocated treatment, eGFR, mean blood pressure, urinary protein excretion, and the use of RAS-I at baseline (Table 19.2). Only the allocated treatment had a significant and independent impact on the disappearance of proteinuria (hazard ratio, 2.98; 95 % confidence interval, 1.01–8.83; P = 0.049). No independent factors were identified as achieving the disappearance of hematuria or clinical remission.


Table 19.2
Logistic regression analysis of the impact of tonsillectomy, renal function, blood pressure, and urinary protein excretion at baseline and after disappearance of proteinuria, hematuria, or both at study completion












































 
Odds ratio

95 % CI

P value

Disappearance of proteinuria

Assigned treatment

2.98

1.01–8.83

0.049

eGFR (baseline)

0.99

0.97–1.02

0.560

Mean blood pressure (baseline)

1.04

0.97–1.11

0.297

Proteinuria (baseline)

0.61

0.33–1.13

0.115

RAS-I (baseline)

0.51

0.16–1.68

0.270

Disappearance of hematuria

Assigned treatment
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Jul 4, 2016 | Posted by in NEPHROLOGY | Comments Off on Is Tonsillectomy a Possible Treatment for IgA Nephropathy from Randomized Controlled Trial (RCT)?

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