How safe is paracetamol for the treatment of pain and fever in newly-abstinent patients with alcoholism?  

Oleh:

Vuppalanchi, Raj

Jenis: Article from Bulletin/Magazine - ilmiah internasional
Dalam koleksi: Medical Progress vol. 35 no. 04 (Apr. 2008), page 161.
Topik: Paracetamol

Ketersediaan

Perpustakaan FK Nomor Panggil: M36.K.2008.01 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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BACKGROUND: To assess whether a 3-day course of maximum dose paracetamol causesi liver injury in newly-abstinent patients with alcoholism. DESIGN: This randomized, double-blind, placebo controlled trial screened individuals with alcoholism aged >18 years who were admitted to one of two addiction rehabilitation centres between January 2002 and July 2004. Eligible individuals had detectable breath ethanol concentration and were assessed for medication and alcohol use, alcoholism, and nutritional status. Participants were randomly assigned in a 2 : 1 ratio to receive four daily doses of either paracetamol (2 x 500 mg tablets) or placebo for 3 consecutive days, and were followed up for an additional 2 days. Full blood biochemistry including hepatic panel (serum aspartate aminotransferase, alanine aminotransferase [ALT] and bilirubin), and international normalized ratio (INR) was assessed at baseline; hepatic panel and INR testing was repeated on study days 2 to 4, Plasma glutathione was measured in a subgroup of patients at baseline and on study day 3. RESULTS: A total of 509 individuals were screened for eligibility; 433 were enrolled and 372 completed the trial (n=258 and n=114 in the paracetamol and placebo groups, respectively). Serum ALT levels remained stable or decreased from baseline in 36% of individuals in the paracetamol group and 31 % in the placebo group, and increased in 66% of the study population. Serum ALT levels were >3 times the upper limit of normal (ULN) in 32 patients at some point during the study. There was no significant differepcein serum ALT levels between the treatment groups - mean serum ALT levels in the paracetamol group were similar to those in the placebo group at baseline (49 +/- 38 U/L and 47 +/- 37 U/L, respectively) and at day 5 (57 +/- 45 U/L and 55 +/- 48 U/L, respectively). Subgroup analyses established that patients in either group with a serum ALT greater than the ULN or with evidence of alcoholic liver disease had higher serum ALT levels throughout the trial, but that serum ALT levels were not significantly different between the treatment groups. Neither BMI nor malnutritioncor[elated with serUm ALT level. Plasma glutathione was assessed in 79 patients (n=56 and n=23 in the paracetamol and placebo groups, respectively) and was shown to have increased from baseline at day 3, bUt the increase was not significantly different between the groups. There was also no significant change in mean INR or total serum bilirubin in either group. CONCLUSION: Administration of the maximum recommended dose of paracetamol for 3 consecutive days does not cause liver injury in newly-abstinent patients with alcoholism.

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