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  • 1
    Electronic Resource
    Electronic Resource
    Oxford UK : Blackwell Science Ltd
    ISSN: 1365-2036
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Hepapoietin is a naturally occurring cytokine that promotes hepatocyte growth. Animal studies have suggested that hepapoietin and hepatocyte growth factor have a potential role in the prevention and management of liver diseases. However, human studies have been lacking.〈section xml:id="abs1-2"〉〈title type="main"〉Aim:To evaluate the safety and pharmacokinetics of single escalating doses of hepapoietin in patients with chronic liver disease.〈section xml:id="abs1-3"〉〈title type="main"〉Methods:An open-label, single escalating dose trial with five different doses of hepapoietin (1, 3, 10, 30 and 100 mg) was performed. Adults with chronic, compensated, non-viral liver disease were included. Liver function tests were obtained before dosing, 24 h after hepapoietin administration and on days 4, 7, 30 and 45. All patients were followed for 45 days.〈section xml:id="abs1-4"〉〈title type="main"〉Results:Twenty-five subjects received hepapoietin, with five subjects each at 1, 3, 10, 30 and 100 mg of hepapoietin. Significant decreases occurred in total bilirubin, ammonia, partial thromboplastin time and cholesterol levels overall, and both high-density and low-density lipoprotein cholesterol showed a downward trend. An increase in albumin was observed at the 30 mg dose level. Slight decreases in haemoglobin and red blood cell levels were observed at day 4, but returned to normal levels immediately thereafter. Child–Pugh scores from day 0 to day 7 were improved in 24%, stable in 64% and worse in 12% of patients. Hepatic encephalopathy displayed changes from day 0 to day 45 with improvement in 16%, no change in 80% and worsening in 4%.〈section xml:id="abs1-5"〉〈title type="main"〉Conclusions:Hepapoietin in doses up to 100 mg is safe for use in humans. Potential benefits are suggested by significant decreases in bilirubin, ammonia, partial thromboplastin time and cholesterol levels and an increase in albumin. Further studies with multiple dosing regimens are needed to identify the clinical utility of hepapoietin in the management of chronic liver disease.
    Type of Medium: Electronic Resource
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  • 2
    Electronic Resource
    Electronic Resource
    Oxford, UK : Blackwell Science Ltd
    ISSN: 1365-2230
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: A standardized questionnaire was used to assess mobility, activity and pain in 140 randomly chosen children, who were representative of all major types and subtypes of inherited epidermolysis bullosa (EB). Pain status in these children was compared with 374 randomly selected adults with EB. The level of independence for each of six activities of daily living (ADL) (toileting; feeding; bathing; dressing; grooming; walking) was assessed in these EB children using conventional criteria for scoring. Whereas more than 90% of all EB simplex (EBS) and dominant dystrophic EB (DDEB) children were totally independent for each function (excluding walking), the frequency of similarly totally independent patients with junctional EB (JEB) and recessive dystrophic EB (RDEB) ranged from only 39% to 73%. No DDEB children and only 2% of EBS patients were totally dependent in their individual ADL, in comparison to 8–27% of JEB and 2–27% of RDEB children. Totally independent walking was reported in only 31%, 31%, 67%, and 24% of EBS, JEB, DDEB, and RDEB children, respectively. A daily level of EB-related pain was assessed in children by their parents using a linear scale of 0 (no pain) to 10 (unbearable pain). Whereas 14–19% of all children with EBS, JEB, and DDEB were graded with pain levels of more than 5, 32% of all RDEB children reportedly suffered this much pain. Increased frequencies of pain with scores more than 5 were most often noted in those patients having more clinically extensive or severe EB subtypes. These included JEB-Herlitz (20% vs. 14% in JEB-non-Herlitz) and RDEB-Hallopeau-Siemens (47% vs. 20% in all other RDEB subtypes). Only 5% of all RDEB children reportedly were pain-free, compared to 12–14% of those with EBS, JEB, and DDEB. Collectively, these data provide the first report of the specific impact different forms of EB have on daily living and coping with this genodermatosis.
    Type of Medium: Electronic Resource
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