Go Oyoo

A phase I trial to evaluate the safety and pharmacokinetics of low-dose methotrexate as an anti-malarial drug in Kenyan adult healthy volunteers

BackgroundPrevious investigations indicate that methotrexate, an old anticancer drug, could be used at low doses to treat malaria. A phase I evaluation was conducted to assess the safety and pharmacokinetic profile of this drug in healthy adult male Kenyan volunteers.MethodsTwenty five healthy adult volunteers were recruited and admitted to receive a 5 mg dose of methotrexate/day/5 days. Pharmacokinetics blood sampling was carried out at 2, 4, 6, 12 and 24 hours following each dose. Nausea, vomiting, oral ulcers and other adverse events were solicited during follow up of 42 days.ResultsThe mean age of participants was 23.9 ± 3.3 years. Adherence to protocol was 100%. No grade 3 solicited adverse events were observed. However, one case of transiently elevated liver enzymes, and one serious adverse event (not related to the product) were reported. The maximum concentration (Cmax) was 160-200 nM and after 6 hours, the effective concentration (Ceff) was <150 nM.ConclusionLow-dose methotraxate had an acceptable safety profile. However, methotrexate blood levels did not reach the desirable Ceff of 250-400-nM required to clear malaria infection in vivo. Further dose finding and safety studies are necessary to confirm suitability of this drug as an anti-malarial agent.

An evaluation of quality of life in ambulatory patients with systemic lupus erythematosus attending rheumatology clinic in Kenyatta National Hospital

Background and aims Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease that affects the quality of life of those affected by it. The aim of this study is to document the quality of life of patients with SLE in Kenyatta National Hospital using LUPUS QOL questionnaire. Methods Patients who satisfy the ACR (America College of Rheumatology) criteria were consecutively recruited. All patients with SLE attending the clinic were included in the study. Patients were examined for the presence of malar rash, discoid rash, arthritis/athralgia, photosensitivity, CNS symptoms, serositis and oral ulcers. The patients then filled the LUPUS QOL questionnaire. The data was then analysed using SPSS version 17.0 using student t test and regression analysis. Results Sixty two patients were analysed (60 females 2 males). Mean age of the population was 37.3 years ( 14–71 years). Mean age at diagnosis was 34.5 years with mean duration of illness 1.5 years. Majority (88.7%) had arthritis/athralgia, oral ulcers (62.9%), malar rash (59.7%), photosensitivity (58.1%), serositis (32.3%), CNS symptoms (27.4%) and discoid rash (17.7%). Patients scored globally low in all domains of LUPUS QOL. Highest domain was planning 63.7 (29.3), emotional health 61.3 (26.5), burden to others 58.9 (31.2), fatigue 57.5 (30.0), pain 56.6 (29.6), physical health 54.0 (23.3), body image 47.1 (24.2) intimate relations 41.1 (38.4). Conclusions The HRQOL was low in all domains correlated with advance in age in the domains of physical health, burden to others, emotional health and fatigue.