Interventions for preventing and treating kidney disease in Henoch‐Schönlein Purpura (HSP)

Deirdre Hahn; Elisabeth M Hodson; Narelle S Willis; Jonathan C Craig

doi:10.1002/14651858.CD005128.pub3

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Figure 1

Flow diagram of included and excluded study in Review

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Figure 2

Risk of bias: Review authors' judgements about each methodological quality item presented as percentages across all included studies.

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Figure 3

Risk of bias: Review authors' judgements about each risk of bias item for each included study

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Analysis 1.1

Comparison 1 Prednisone versus placebo/supportive treatment for preventing persistent kidney disease, Outcome 1 Persistent kidney disease at any time after treatment.

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Analysis 1.2

Comparison 1 Prednisone versus placebo/supportive treatment for preventing persistent kidney disease, Outcome 2 Number of children with any continuing kidney disease at different time points.

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Analysis 1.3

Comparison 1 Prednisone versus placebo/supportive treatment for preventing persistent kidney disease, Outcome 3 Any continuing kidney disease at different time points (study with high risk of bias excluded).

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Analysis 1.4

Comparison 1 Prednisone versus placebo/supportive treatment for preventing persistent kidney disease, Outcome 4 Number of children with kidney disease in first month/with kidney disease at follow‐up.

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Analysis 1.5

Comparison 1 Prednisone versus placebo/supportive treatment for preventing persistent kidney disease, Outcome 5 Number developing severe kidney disease.

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Analysis 1.6

Comparison 1 Prednisone versus placebo/supportive treatment for preventing persistent kidney disease, Outcome 6 Duration of kidney disease.

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Analysis 1.7

Comparison 1 Prednisone versus placebo/supportive treatment for preventing persistent kidney disease, Outcome 7 Gastrointestinal complications requiring hospital admission.

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Analysis 1.8

Comparison 1 Prednisone versus placebo/supportive treatment for preventing persistent kidney disease, Outcome 8 Eight‐year outcomes.

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Analysis 2.1

Comparison 2 Antiplatelet agents versus supportive treatment for preventing persistent kidney disease, Outcome 1 Kidney disease at any time.

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Analysis 2.2

Comparison 2 Antiplatelet agents versus supportive treatment for preventing persistent kidney disease, Outcome 2 Kidney disease at any time.

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Analysis 3.1

Comparison 3 Heparin versus placebo for preventing persistent kidney disease, Outcome 1 Any kidney disease at 3 months after onset or relapse.

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Analysis 3.2

Comparison 3 Heparin versus placebo for preventing persistent kidney disease, Outcome 2 Type of kidney disease at 3 months or more after onset or relapse.

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Analysis 3.3

Comparison 3 Heparin versus placebo for preventing persistent kidney disease, Outcome 3 Time to development of kidney disease.

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Analysis 4.1

Comparison 4 Cyclophosphamide versus supportive treatment for treating severe kidney disease, Outcome 1 Persistent kidney disease.

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Analysis 4.2

Comparison 4 Cyclophosphamide versus supportive treatment for treating severe kidney disease, Outcome 2 Persistent severe kidney disease.

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Analysis 4.3

Comparison 4 Cyclophosphamide versus supportive treatment for treating severe kidney disease, Outcome 3 ESKD.

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Analysis 5.1

Comparison 5 Cyclophosphamide + steroids versus steroids, Outcome 1 Primary outcome: BVAS at 6 months.

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Analysis 5.2

Comparison 5 Cyclophosphamide + steroids versus steroids, Outcome 2 Secondary endpoints at 12 months.

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Analysis 5.3

Comparison 5 Cyclophosphamide + steroids versus steroids, Outcome 3 Adverse effects.

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Analysis 6.1

Comparison 6 Cyclosporin versus methylprednisolone for treating severe kidney disease, Outcome 1 Number with remission at 3 months.

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Analysis 6.2

Comparison 6 Cyclosporin versus methylprednisolone for treating severe kidney disease, Outcome 2 Number with remission at last follow‐up (mean 6.3 years).

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Analysis 7.1

Comparison 7 Mycophenolate mofetil versus azathioprine for treating severe kidney disease, Outcome 1 Remission of proteinuria at 1 year.

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Analysis 7.2

Comparison 7 Mycophenolate mofetil versus azathioprine for treating severe kidney disease, Outcome 2 Regression of histological lesions at 1 year.

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Analysis 8.1

Comparison 8 Fosinopril + supportive treatment versus supportive treatment, Outcome 1 Proteinuria.

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Summary of findings for the main comparison. Prednisone versus placebo or supportive treatment for preventing persistent kidney disease in patients with Henoch‐Schönlein Purpura (HSP)

Prednisone versus placebo or supportive treatment for preventing persistent kidney disease in patients with Henoch‐Schönlein Purpura (HSP)
Patient or population: patients with HSP Settings: all settings Intervention: prednisone Comparison: placebo or supportive treatment
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Placebo or supportive treatment	Prednisone
Persistent kidney disease at any time after treatment	Study population		RR 0.74 (0.42 to 1.32)	746 (5)	⊕⊕⊕⊝ moderate¹
	143 per 1000	106 per 1000 (60 to 189)
	Moderate
	105 per 1000	78 per 1000 (44 to 139)
Number of children with any continuing kidney disease at 3 months	Study population		RR 0.83 (0.46 to 1.52)	655 (4)	⊕⊕⊕⊝ moderate²
	199 per 1000	165 per 1000 (92 to 303)
	Moderate
	156 per 1000	129 per 1000 (72 to 237)
Number of children with any continuing kidney disease at 6 months	Study population		RR 0.51 (0.24 to 1.11)	379 (3)	⊕⊕⊕⊝ moderate²
	100 per 1000	51 per 1000 (24 to 111)
	Moderate
	53 per 1000	27 per 1000 (13 to 59)
Number of children with any continuing kidney disease at 12 months	Study population		RR 1.06 (0.38 to 2.91)	455 (3)	⊕⊕⊝⊝ low^2,3
	84 per 1000	89 per 1000 (32 to 244)
	Moderate
	105 per 1000	111 per 1000 (40 to 306)
Any continuing kidney disease at 3 months (study with high risk of bias excluded)	Study population		RR 0.98 (0.7 to 1.36)	487 (3)	⊕⊕⊕⊕ high
	243 per 1000	238 per 1000 (170 to 330)
	Moderate
	207 per 1000	203 per 1000 (145 to 282)
Any continuing kidney disease at 12 months (study with high risk of bias excluded)	Study population		RR 1.39 (0.75 to 2.59)	287 (2)	⊕⊕⊕⊝ moderate^3,4
	105 per 1000	146 per 1000 (79 to 272)
	Moderate
	105 per 1000	146 per 1000 (79 to 272)
Number developing severe kidney disease	Study population		RR 1.58 (0.42 to 6)	418 (2)	⊕⊕⊝⊝ low^3,5
	14 per 1000	22 per 1000 (6 to 85)
	Moderate
	17 per 1000	27 per 1000 (7 to 102)
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate Very low quality: We are very uncertain about the estimate
¹ Two studies had unclear or biased allocation concealment & were not blinded ² One study had inadequate allocation concealment & no blinding & one study had large loss to follow‐up ³ 30% loss to follow‐up in largest included study ⁴ Small numbers of patients and events ⁵ Small numbers of events

Summary of findings for the main comparison. Prednisone versus placebo or supportive treatment for preventing persistent kidney disease in patients with Henoch‐Schönlein Purpura (HSP)

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Table 1. Definition of kidney disease used in outcome assessment

Study	Timing of outcome	Haematuria	Proteinuria	Blood pressure	Kidney function
Dudley 2013	1, 3 and 12 months	Any level on dipstick	UPC > 20 mg/mmol Dipstick for protein	Not defined	Not defined
Huber 2004	1, 3, 6 and 12 months	≥ 5 RBC/HPF or RBC casts	> 300 mg/L on dipstick	> 90th percentile for age and sex	Elevated Cr
Islek 1999	Unclear	Not defined	Not defined	Not defined	Not defined
Mollica 1992	1, 3, 6 and 12 months	≥ 10 RBC/HPF	≥ 4 mg/m²/h	> 2 SD above normal	Cr ≥ 0.8 mg/dL/mm²
Peratoner 1990	During initial 12 months	> 5 RBC/mm²	Not defined	Not defined	Reduced GFR
Ronkainen 2006a	1, 3 and 6 months	> 5 RBC/HPF	> 200 mg/L or urinary albumin > 30 mg/L	Not defined	Not defined
Jauhola 2010	2 years	Not defined	Remission: UPC < 200 mg/mmol or daily urine protein < 40 mg/m²/d	Not defined	Not defined
Tarshish 2004	Mean follow‐up to 7 years	Addis Count > 30,000 RBC/h/m² or ≥ 1+ on dipstick ≥ 3 cells/HPF or > 2 RBC/mm³	> 4 mg/h/m² or 2+ or more by dipstick Heavy proteinuria > 40 mg/h/m²	Not defined	GFR < 80 mL/min/1.73 m² ESKD
He 2002	Unclear	Not defined	Not defined	Not defined	Not defined
Yoshimoto 1987a	Unclear	Not defined	Not defined	Not defined	Not defined
Yoshimoto 1987b	Unclear	Not defined	Not defined	Not defined	Not defined
Cr ‐ creatinine; ESKD ‐ end‐stage kidney disease; GFR ‐ glomerular filtration rate; HPF ‐ high power field; UPC ‐ urinary protein:creatinine ratio; RBC ‐ red blood cell

Table 1. Definition of kidney disease used in outcome assessment

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Comparison 1. Prednisone versus placebo/supportive treatment for preventing persistent kidney disease

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Persistent kidney disease at any time after treatment Show forest plot	5	746	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.42, 1.32]

2 Number of children with any continuing kidney disease at different time points Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 One month	4	655	Risk Ratio (M‐H, Random, 95% CI)	0.80 [0.34, 1.84]
2.2 Three months	4	655	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.46, 1.52]
2.3 Six months	3	379	Risk Ratio (M‐H, Random, 95% CI)	0.51 [0.24, 1.11]
2.4 Twelve months	3	455	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.38, 2.91]
3 Any continuing kidney disease at different time points (study with high risk of bias excluded) Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 One month	3	487	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.54, 1.93]
3.2 Three months	3	487	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.70, 1.36]
3.3 Six months	2	211	Risk Ratio (M‐H, Random, 95% CI)	0.59 [0.23, 1.50]
3.4 Twelve months	2	287	Risk Ratio (M‐H, Random, 95% CI)	1.39 [0.75, 2.59]
4 Number of children with kidney disease in first month/with kidney disease at follow‐up Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

4.1 One month	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4.2 Three months	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4.3 Six months	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
5 Number developing severe kidney disease Show forest plot	2	418	Risk Ratio (M‐H, Random, 95% CI)	1.58 [0.42, 6.00]

6 Duration of kidney disease Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

6.1 Haematuria	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
6.2 Proteinuria	1		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
7 Gastrointestinal complications requiring hospital admission Show forest plot	3	517	Risk Ratio (M‐H, Random, 95% CI)	0.56 [0.25, 1.23]

8 Eight‐year outcomes Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

8.1 Haematuria	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
8.2 Proteinuria	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
8.3 Haematuria and proteinuria	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
8.4 Hypertension	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
8.5 Decreased GFR (Schwartz formula)	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 1. Prednisone versus placebo/supportive treatment for preventing persistent kidney disease

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Comparison 2. Antiplatelet agents versus supportive treatment for preventing persistent kidney disease

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Kidney disease at any time Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 Dipyridamole ± cyproheptadine in children without kidney disease at entry	2	101	Risk Ratio (M‐H, Random, 95% CI)	1.16 [0.46, 2.95]
1.2 Dipyridamole ± cyproheptadine in children with kidney disease at entry	1	19	Risk Ratio (M‐H, Random, 95% CI)	0.92 [0.23, 3.72]
2 Kidney disease at any time Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Aspirin versus supportive treatment	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 2. Antiplatelet agents versus supportive treatment for preventing persistent kidney disease

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Comparison 3. Heparin versus placebo for preventing persistent kidney disease

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Any kidney disease at 3 months after onset or relapse Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Type of kidney disease at 3 months or more after onset or relapse Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Haematuria	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 Proteinuria	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.3 Nephrotic syndrome	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3 Time to development of kidney disease Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

Comparison 3. Heparin versus placebo for preventing persistent kidney disease

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Comparison 4. Cyclophosphamide versus supportive treatment for treating severe kidney disease

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Persistent kidney disease Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2 Persistent severe kidney disease Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3 ESKD Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

Comparison 4. Cyclophosphamide versus supportive treatment for treating severe kidney disease

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Comparison 5. Cyclophosphamide + steroids versus steroids

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Primary outcome: BVAS at 6 months Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

1.1 BVAS = 0 at 6 months	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.2 Improvement in BVAS score	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2 Secondary endpoints at 12 months Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 BP > 125/75 mm Hg	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 eGFR < 60 mL/min	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.3 Proteinuria > 1 g/d	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.4 RAS blockers	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.5 Kidney function improvement > 50%	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.6 ESKD	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.7 Mortality	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3 Adverse effects Show forest plot	1		Risk Difference (M‐H, Random, 95% CI)	Totals not selected

3.1 infection	1		Risk Difference (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.2 Newly diagnosed or deterioration in existing diabetes	1		Risk Difference (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.3 Depression/anxiety	1		Risk Difference (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.4 Alopecia	1		Risk Difference (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.5 Insomnia	1		Risk Difference (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 5. Cyclophosphamide + steroids versus steroids

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Comparison 6. Cyclosporin versus methylprednisolone for treating severe kidney disease

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number with remission at 3 months Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2 Number with remission at last follow‐up (mean 6.3 years) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

Comparison 6. Cyclosporin versus methylprednisolone for treating severe kidney disease

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Comparison 7. Mycophenolate mofetil versus azathioprine for treating severe kidney disease

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Remission of proteinuria at 1 year Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Regression of histological lesions at 1 year Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 7. Mycophenolate mofetil versus azathioprine for treating severe kidney disease

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Comparison 8. Fosinopril + supportive treatment versus supportive treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Proteinuria Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

1.1 Complete remission of proteinuria < 150 mg/d	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.2 Partial remission	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.3 Minimal response/no response	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 8. Fosinopril + supportive treatment versus supportive treatment

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