Cerebral Palsy — Paracetamol Study in Patients With Low Muscle Mass
Citation(s)
Caparrotta TM, Antoine DJ, Dear JW Are some people at increased risk of paracetamol-induced liver injury? A critical review of the literature. Eur J Clin Pharmacol. 2018 Feb;74(2):147-160. doi: 10.1007/s00228-017-2356-6. Epub 2017 Oct 24.
Hynson JL, South M Childhood hepatotoxicity with paracetamol doses less than 150 mg/kg per day. Med J Aust. 1999 Nov 1;171(9):497. doi: 10.5694/j.1326-5377.1999.tb123758.x. No abstract available.
Orngreen MC, Zacho M, Hebert A, Laub M, Vissing J Patients with severe muscle wasting are prone to develop hypoglycemia during fasting. Neurology. 2003 Oct 14;61(7):997-1000. doi: 10.1212/01.wnl.0000086813.59722.72.
Pearce B, Grant IS Acute liver failure following therapeutic paracetamol administration in patients with muscular dystrophies. Anaesthesia. 2008 Jan;63(1):89-91. doi: 10.1111/j.1365-2044.2007.05340.x.
Prescott LF Kinetics and metabolism of paracetamol and phenacetin. Br J Clin Pharmacol. 1980 Oct;10 Suppl 2(Suppl 2):291S-298S. doi: 10.1111/j.1365-2125.1980.tb01812.x.
Sen, C K. Glutathione: A key role in skeletal muscle metabolism. in Oxidative Stress in Skeletal Muscle 127-139 (Birkhäuser, Basel, 1998). doi:10.1007/978-3-0348-8958-2_8
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
