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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 and out patients recruited from the paediatric department of general hospital

  • Country: China

  • Ethnicity: Chinese

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

  • Course of disease: NS

  • Number: 102 children

  • Age: NS

  • Gender (M/F): NS


Exclusion criteria: NS
Interventions Treatment group 1
  • Mannan peptide (oral)

    • Dose: 10 mg three times/day

  • Baseline treatment

  • Duration: 6 to 24 months


Treatment group 2
  • Huangqi injection (IV)

    • Dose: 20 mL daily for a continuous 10 days every month

  • Baseline treatment

  • Duration: 6 to 24 months


Control group
  • Baseline treatment

    • Standard steroid protocol for nephrotic children

    • Dipyridamole, lower molecular weight heparin depending on medical conditions of the patients

  • Duration:6 to 24 months


Duration of follow‐up: NS
Outcomes
  • Infection

    • Diagnostic criteria: NS

Notes
  • Spectrum of infection in order of incidence: respiratory infection, urological infection, intestinal infection and other infection.

  • Spectrum of microorganisms: NS

  • 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 Low 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 events.
Other bias Unclear risk There was insufficient information to make judgement.