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. 2018 Jun 4;2018(6):CD008687. doi: 10.1002/14651858.CD008687.pub2

He 2017.

Methods Parallel‐group randomised controlled trial
Participants Baseline characteristics
Number randomised: 120 participants
Number analysed: 120 participants
Naloxone
  • Age (years; mean (SD)): 63.1 (6.2)

  • Number of participants (n): 60

  • Gender (male/female; n): 35/25


Naloxone + pantoprazole
  • Age (years, mean (SD)): 65.1 (6.7)

  • Number of participants (n): 60

  • Gender (male/female; n): 37/23


Inclusion criteria
  • Age of about 50 years

  • No clinical manifestations of respiratory failure before admission

  • No naloxone allergy history

  • No liver, kidney dysfunction and other diseases

  • Signed informed consent

  • Voluntarily joined the clinical study


Exclusion criteria:
Baseline imbalances: no significant difference in primary disease, sex, age, and course of disease between study group and control group
Interventions Naloxene
  • Dose (total/d): ‐

  • Duration of treatment (days): ‐

  • Route: PO

  • Intervention: 0.8 mg of naloxone hydrochloride 2 mL∶ 2 mg (Shandong Xinhua Pharmaceutical Co., Ltd. production) added to 100 mL of 10% glucose water 6 times/d. When the blood gas situation improved, treatment dose was reduced by 50%

  • Concomitant medications: In addition to comparative treatment, 2 groups of patients were given the same regular treatment, including anti‐infective treatment, low‐flow oxygen therapy, phlegm treatment, correct electrolyte imbalance and maintain acid‐base balance, given the treatment of milk and timely nutrition


Naloxene + pantoprazole
  • Dose (total/d): ‐

  • Duration of treatment (days): ‐

  • Route: PO

  • Intervention: ‐

  • Concomitant medications: In addition to comparative treatment, 2 groups of patients were given the same regular treatment, including anti‐infective treatment, low‐flow oxygen therapy, phlegm treatment, correct electrolyte imbalance and maintain acid‐base balance, given the treatment of milk and timely nutrition


Adherence to regimen:
Duration of trial: May 2009 to May 2014
Duration of follow‐up:
Outcomes Outcomes sought in review and reported in trial
  • Incidence of clinically important GI bleeding

  • All‐cause mortality in hospital

  • Adverse events of interventions


Outcomes sought but not reported in trial
  • Incidence of VAP

  • Duration of ICU stay

  • Duration of intubation


Outcomes reported in trial but not used in review
  • Duration of hospital stay

  • Blood gas values

Notes Setting: ICU
Source of funding:
Conflicts of interest:
Ethics approval:
Informed consent: Signed informed consent was required by all participants
Clinical trials registration:
Sample size calculation:
Additional notes:
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: insufficient information to allow judgment
Allocation concealment (selection bias) Unclear risk Comment: insufficient information to allow judgment
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Comment: insufficient information to allow judgment
Blinding (detection bias) 
 Clinically important upper GI bleeding High risk Comment: no details about criteria for diagnosis of upper GI bleeding or blinding of outcome assessors reported
Blinding (detection bias) 
 Nosocomial pneumonia Unclear risk Comment: Study did not address this outcome
Blinding of outcome assessment (detection bias) 
 Adverse reactions of interventions Unclear risk Comment: insufficient information to allow judgement
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: insufficient information to allow judgement
Selective reporting (reporting bias) Low risk Comment: all outcomes reported in Methods section also reported in Results
Other bias Unclear risk Comment: insufficient information to allow judgement