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. 2012 Apr 18;2012(4):CD003964. doi: 10.1002/14651858.CD003964.pub3
Methods
  • Study design: parallel RCT

  • Losses to follow‐up/withdrawals: None

Participants
  • Setting: inpatients recruited from the paediatric department of general hospital

  • Country: China

  • Ethnicity: Chinese

  • Primary nephrotic syndrome diagnosed on "the National Diagnostic Criteria for Nephrotic Syndrome in Children".

  • Course of disease: NS

  • Number: 40 children

  • Age range: 2 to 12 years

  • Gender (M/F): 24/16


Exclusion criteria: NS
Interventions Treatment group
  • Intervention: thymosin (mainly thymosin‐α1)

    • Dose: 5 mg/d (2 to 4 years); 10 mg/d (4 to 7 years); 20 mg/d (7 to 10 years) added to 5% glucose 50 to 100 mL intravenously for 2 weeks, then every other day intramuscularly for 3 weeks, then once a week intramuscularly.

  • Total duration: 2 months

  • Baseline treatment including the standard steroid protocol for nephrotic children


Control group
  • Baseline treatment including the standard steroid protocol for nephrotic children


Duration of follow‐up: NS
Outcomes
  • Infection

    • Diagnostic criteria: based on the authors' definition involving clinical symptoms, signs and general tests for blood, urine, stool and chest X‐ray

    • Immunological function was measured using APAAP

Notes
  • Spectrum of infection in order of incidence (number of patients)

    • Treatment group: URI (4); UTI (2); pneumonia (1)

    • Control group: URI (7); UTI (3); pneumonia (2); skin infection (1); peritonitis (1)

  • Spectrum of microorganisms: one E. coli was cultured in UTI

  • Source of funding: NS

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The study did not provide the information on the method of random sequence generation, and only presented with the data as "all participants with nephrotic syndrome were randomly allocated to treatment and control groups".
Allocation concealment (selection bias) Unclear risk The study did not provide the information on allocation concealment.
Blinding (performance bias and detection bias) All outcomes Unclear risk The study did not provide the information on blinding.
Incomplete outcome data (attrition bias) All outcomes Unclear risk There were no missing data in this study.
Selective reporting (reporting bias) High risk Free of selective reporting bias was assessed as "No" due to some clinically important outcomes unstated, such as adverse effects of thymosin.
Other bias Unclear risk There was insufficient information to make judgement.

BCG ‐ Bacillus Calmette‐Guerin; IVIG ‐ intravenous immunoglobulin; NA ‐ not associated; NS ‐ not stated; URI ‐ upper respiratory infection; UTI ‐ urinary tract infection