Medicine
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This repository contains the published and unpublished research of the Faculty of Medicine by the staff members of the faculty
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Item Application of a real time Polymerase Chain Reaction (PCR) assay for the early diagnosis of human leptospirosis in Sri Lanka(Academic Press, Elsevier, 2016) Denipitiya, D.T.H.; Chandrasekharan, N.V.; Abeyewickreme, W.; Hartskeerl, C.M.; Hartskeerl, R.A.; Jiffrey, A.M.; Hapugoda, M.D.Leptospirosis has a major impact on health in Sri Lanka but is probably grossly under-recognized due to difficulties in clinical diagnosis and lack of diagnostic laboratory services. The objective of this study was to establish and evaluate a SYBR Green-based real-time Polymerase Chain Reaction (rt-PCR) assay for early, rapid and definitive laboratory diagnosis of leptospirosis in Sri Lanka. The rt-PCR assay was established and analytical specificity and sensitivity were determined using reference DNA samples. Evaluation of the assay for diagnosis of clinical samples was performed using two panels of serum samples obtained from 111 clinically suspected adult patients. Patients were confirmed as leptospirosis (n = 65) and non-leptospirosis (n = 30) by the Patoc - MAT. Other 16 samples gave ambiguous results. The analytical sensitivity of the rt-PCR was approximately 60 genome copies and no cross-reactivity was observed with saprophytic Leptospira spp. and other pathogenic microorganisms. Based on confirmation with Patoc-MAT on paired samples this corresponds to a diagnostic sensitivity and specificity of 67.7% (44/65) and 90.0% (27/30), respectively. This study showed that rt-PCR has the potential to facilitate rapid and definitive diagnosis of leptospirosis during early phase of infection in Sri Lanka.Item Baseline characteristics of the 4011 patients recruited into the Efficacy of Nitric Oxide in Stroke' (ENOS) trial.(Sage Publications, 2014) Bath, P.M.; Adami, A.; Bereczki, D.; Berge, E.; Beridze, M.; Cala, L.; Casado, A.; Caso, V.; Chang, H.M.; Christensen, H.; Collins, R.; Czlonkowska, A.; Dineen, R.A.; El Etribi, A.; Ghani, A. R.; Gommans, J.; Koumellis, P.; Laska, A. C.; Lees, K. R.; Navarro, J.; Ntaios, G.; Ozturk, S.; Phillips, S.; Pocock, S.; Prasad, K.; Scutt, P.; de Silva, H.A.; Szatmari, S.; Díez-Tejedor E; Utton, S.; Wang, Y. J.; Wardlaw, J.M.; Whynes, D.; Wong, L.; Woodhouse, L; Sprigg, N.; ENOS Trial Investigators(36)BACKGROUND: High blood pressure is common in acute stroke and associated with a worse functional outcome. Many patients who present with acute stroke are taking prescribed antihypertensive therapy before their stroke. AIMS: ENOS tested whether lowering blood pressure and continuing pre-stroke antihypertensive therapy are each safe and effective. METHODS: This study is an international multi-centre prospective randomized single-blind blinded-endpoint parallel-group partial-factorial controlled trial of transdermal glyceryl trinitrate(a nitric oxide donor, given for seven-days) vs. no glyceryl trinitrate, and of continuing vs. stopping (temporarily for seven-days) pre-stroke antihypertensive drugs if relevant, in patients with acute ischaemic stroke or intracerebral haemorrhage and high systolic blood pressure (140–220 mmHg). RESULTS: Recruitment ran from July 2001 to October 2013. Four thousand eleven patients [2097 (52•3%) in the continue/stop arm] were recruited from 173 sites across 23 countries in 5 continents (Asia 14%, Continental Europe 16%, UK 64%). Baseline characteristics include: mean age 70 (standard deviation 12) years; male 57%; mean time from stroke to recruitment 26 (13) h; mean severity (Scandinavian Stroke Scale) 34(13) of 58; mean blood pressure 167 (19)/90 (13) mmHg; ischaemic stroke 83%; and intracerebral haemorrhage 16%. The main trial results will be presented in May 2014. The results will also be presented in updated Cochrane systematic reviews and included in individual patient data meta-analyses of all relevant randomized controlled trials. CONCLUSION: ENOS is a large completed international trial of blood pressure management in acute stroke and includes patients representative of many stroke services worldwide.Item Comparison of one week and two weeks of triple therapy for the eradication of Helicobacter pylori in a Sri Lankan population: a randomised, controlled study(Sri Lanka Medical Association, 2004) de Silva, H.A.; Hewavisenthi, J.; Pathmeswaran, A.; Dassanayake, A.S.; Navarathne, N.M.M.; Peiris, R.; de Silva, H.J.INTRODUCTION: Resistance of Helicobacter pylori to antibiotics may be particularly high in parts of the tropics. Infection may prove difficult to eradicate in such situations, and there is some evidence of benefit in increasing the duration of treatment (triple therapy) from 1 week to 2 or 3 weeks. AIM: To assess the efficacy and tolerability of 1 week versus 2 weeks of triple therapy for eradication of H. pylori in a Sri Lankan population. METHODS: Eighty two patients aged 18-70 years with gastritis or peptic ulcer and testing positive for H. pylori infection were randomly allocated totwo treatment groups. Both groups received omeprazole 20 mg, clarithromycin 250 mg, and tinidazole 500 mg. Group A (n = 42) received the trial medication twice daily for 1 week and the Group B (n = 40) twice daily for 2 weeks. H. pylori eradication was defined as a negative 14C labelled urea breath test at 2 weeks after completion of the therapy. RESULTS: H. pylori infection was eradicated in 36 (85.7%) patients in Group A and 36 (90%) patients in Group B (p = 0.9). Twenty three (55%) patients in Group A and 17 (43%) in Group B reported adverse effects attributable to trial medication (p = 0.387); none were serious. Three (7.5%) patients in Group B discontinued treatment due to adverse events that developed on days 7, 9 and 10. CONCLUSION: Twice daily treatment with clarithromycin, tinidazole, and omeprazole for 1 week is well tolerated and provides as good a rate of H.pylori eradication as 2-week therapy in Sri Lankan patients.Item Liv. 52 in alcoholic liver disease: a prospective controlled trial(Elsevier, 2003) de Silva, H.A.; Saparamadu, P.A.M.; Thabrew, M.I.; Pathmeswaran, A.; Fonseka, M.M.D.; de Silva, H.J.Liv.52, a hepatoprotective agent of herbal origin, is used empirically for the treatment of alcoholic liver disease in Sri Lanka. We conducted acontrolled trial to assess the efficacy of Liv.52 in patients with alcoholic liver disease. Patients with evidence of alcoholic liver disease attending outpatient clinics were included in a prospective, double blind, randomized, placebo controlled trial. During the trial period, 80 patients who fulfilled inclusion criteria were randomly assigned Liv.52 (cases; n = 40) or placebo (controls) the recommended dose of three capsules twice daily for 6 months. All patients underwent clinical examination (for which a clinical score was computed), and laboratory investigations for routine blood chemistry and liver function before commencement of therapy (baseline). Thereafter, clinical assessments were done monthly for 6 months, while laboratory investigations were done after 1 and 6 months of therapy. There was no significant difference in the age composition, alcohol intake and baseline liver function between the two groups. The two-sample t-test was used to analyze data obtained after 1 and 6 months of therapy against baseline values. There was no significant difference in clinical outcome and liver chemistry between the two groups at any time point. There were no reports of adverse effects attributable to the drug. Our results suggest that Liv.52 may not be useful in the management of patients with alcohol induced liver disease.Item Red blood cell antioxidant levels in Wuchereria bancrofti infections(Academic Press, 2002) Premaratna, R.; Chandrasena, T.G.A.N.; Abeyewickreme, W.; Chandrasena, L.G.; Senerath, S.; de Silva, N.R.; de Silva, H.J.The elimination of microfilariae of Wuchereria bancrofti is probably mediated by free radicals. Red cell catalase (C), glutathione peroxidase (GPX), and superoxide dismutase (SOD) activity levels were measured as an indirect method of assessing blood oxidant status in 29 asymptomatic microfilaraemics, 29 "endemic normals", and 29 controls living in a non-endemic area. Changes in the activity of these enzymes were also compared over a one month period in 22 asymptomatic microfilaraemics randomised to receive either single dose or 14 day treatment with diethyl carbamazine citrate (DEC). Red cell GPX activity levels were significantly higher in "endemic normals" when compared to mf positive cases and non-endemic controls. An early and significant increase in GPX activity (on days 3, 7 and 14 compared to pretreatment levels, p<0.01) was observed after DEC in both treatment groups. Increases in the activity of catalase and SOD became significant only on days 14 and 30 respectively. The percentage reduction in microfilaraemia correlated significantly with the percentage increase in GPX activity levels (R(2)=0.58, p=0.6 x 10(-5)). Our results may suggest a role for GPX related oxidant species in the elimination of microfilariae.Item Effect of carbohydrates meals for varying consistency on gastric myoelectrical activity(Singapore Medical Association, 2002) Ferdinandis, T.G.H.C.; Dissanayake, A.S.; de Silva, H.J.BACKGROUND: There is at present no agreement on the type of test meal to be used when performing EGG. To our knowledge the response of thestomach to high carbohydrate isocaloric meals of different consistencies has not been formally assessed. AIM: To study 1) the effects of high carbohydrate meals of varying consistency on EGG activity; and 2) the effects of increasing the calorie content of a meal without changing its consistency and composition on the postprandial EGG. SUBJECTS: Eighteen healthy volunteers, six males (age: 21-35 year, weight: 45-60 kg) and 12 females in the follicular phase of the menstrual cycle (age: 24-30 years, weight: 45-55 kg). METHODS: Following an overnight fast subjects were given three high carbohydrate, low fat, isocaloric meals (165-170 kcal) of different consistencies (solid, semisolid, liquid), on three separate days in a random order. The liquid and semisolid meals were equal in volume (200 ml) while the volume of the solid meal was smaller. One hour EGG recordings were done in the fasting and fed states in each subject. As a second step, ten of the above volunteers (taken randomly) were given the solid test meal on a separate day after increasing the calorie content of the meal to 350 kcal. RESULTS: The power of the EGG at the dominant frequency significantly increased after solid (175 kcal meal: fasting 49 +/- 12 dB vs. fed 57 +/- 13 dB; p < 0.05, 375 kcal meal: fasting 48.5 +/- 12.9 dB vs fed 58.1 +/- 11.7 dB) and semisolid (fasting 50 +/- 12 dB vs. fed 55 +/- 13; P < 0.05). The increase in power was not significantly different when fed with solids and semisolids. There was no statistically significant change in EGG power during the first 15 or 60 minutes after the liquid meal. Feeding showed no significant effect on the dominant frequency and the percentage of 2-4 cpm waves of the EGG with any of the three types of test meals. CONCLUSIONS: Solid and semisolid meals high in carbohydrate and low in fat are capable of inducing a significant increase in the EGG power in normal subjects. Isocaloric solid and semisolid meals have similar effects on gastric slow wave activity. EGG appears unaffected by the liquid meal. Therefore only an increase in the power of the EGG can be regarded as normal if a high carbohydrate solid or a semisolid meal is given as the test meal when performing an EGG.Item Do women with pre-eclampsia and their babies benifit from management sulphate? The Magpie Trial: a randomised placebo controlled trial(Lancet Publishing Group, 2002) Altman, D.; Carroli, G.; Duley, L.; Farrell, B.; Moodley, J.; Neilson, J.; Smith, D.; Fernando, S. with Magpie Trial Collaborative GroupItem Evaluation of the ICT whole-blood antigen card test to detect infection due to Wuchereria bancrofti in Sri Lanka(Oxford University Press, 2002) Chandrasena, T.G.A.N.; Premaratna, R.; Abeyewickreme, W.; de Silva, N.R.The sensitivity, specificity and cost effectiveness of an immunochromatographic card test (ICT, AMRAD) for the diagnosis of bancroftian filariasis were estimated against 2 standard parasitological techniques: thick blood film (TBF) and Nuclepore membrane filtration (NMF). Individuals were selected from endemic localities in the Western Province (n = 213) and from the non-endemic Central Province (n = 29) of Sri Lanka. Blood was collected between 21:00 and midnight. Sixty microlitre of non-heparinized blood, and 1 mL and 100 microL of heparinized blood were used in TBF, NMF andICT, respectively. NMF was positive in 31.5% (67/213) of the endemic group, with a mean microfilaria (mf) count of 343/mL (range 8-1782, SD 422). All 67 were positive by ICT (sensitivity 100%), but only 63 by TBF (sensitivity 94%). Among the endemic population there were 12 who were mf negative but antigen positive by ICT. There were, however, no false positives among the non-endemic controls, indicating the possibility that the ICTmay in fact be more sensitive and 100% specific. Thus, ICT filariasis test appears to be more effective (both sensitive and specific) than TBF or NMF in diagnosing infection in lymphatic filariasis. The direct unit recurrent costs of the 2 survey tools, TBF and ICT, were US$ 0.30 (Rs. 27/=) and US$ 2.75 (Rs. 248/=), respectively. The high cost of the ICT may be offset by other factors that are difficult to cost.Item Efficacy of single dose combinations of albendazole, ivermectin and diethylcarbamazine for the treatment of bancroftian filariasis(Oxford University Press, 1998) Ismail, M.M.; Jayakody, R.L.; Weil, G.J.; Nirmalan, N.; Jayasinghe, K.S.A.; Abeyewickreme, W.; Sheriff, M.M.R.; Rajaratnam, H.N.; Amarasekera, N.; de Silva, D.C.; Michalski, M.L.; Dissanaike, A.S.In a 'blind' trial on 50 male asymptomatic microfilaraemic subjects with Wuchereria bancrofti infection, the safety, tolerability and filaricidal efficacy of a single dose of albendazole (alb) 600 mg alone or in combination with ivermectin (iver) 400 microg/kg or diethylcarbamazine citrate (DEC) 6 mg/kg was compared with a single dose of the combination DEC 6 mg/kg and iver 400 micro g/kg over a period of 15 months after treatment. All but one subject, with 67 micro filariae (mf)/mL, had pre-treatment counts 100 mf/mL. All 4 treatments significantly reduced mf counts, but alb/iver was the most effective regimen for clearing mf from night blood: 9 of 13 subjects (69 percent) were amicro filaraemic by membrane filtration 15 months after treatment compared to one of 12 (8 percent), 3 of 11 (27 percent), and 3 of 10 (30 percent) in the groups treated with alb, alb/DEC, and DEC/iver, respectively. Filarial antigen tests suggested that all 4 treatments had significant activity against adult W. bancrofti; alb/DEC had the greatest activity according to this test, with antigen levels decreasing by 77percent 15 months after therapy. All 4 regimens were well tolerated and clinically safe, although mild, self-limited systemic reactions were observed in all treatment groups. These results suggest that alb/iver is a safe and effective single dose regimen for suppression of micro filaraemia in bancroftian filariasis that could be considered for control programmes. Additional benefits of this combination are its potent, broad spectrum activity against intestinal helminths and potential relative safety in areas of Africa where DEC cannot be used for filariasis control because of co-endemicity with onchocerciasis or loiasisItem Prolonged clearence of microfilaraemia in patients with bancroftian filariasis after multiple high doses of ivermectin of diethylacarbamizine(Oxford University Press, 1996) Ismail, M.M.; Weil, G.J.; Jayasinghe, K.S.A.; Premaratne, U.N.; Abeyewickreme, W.; Rajaratnam, H.N.; Sheriff, M.M.R.; Perera, C.S.; Dissanaike, A.S.In a double-blind trial on 37 asymptomatic microfilaraemic subjects (minimum 400 microfilariae [mf] per mL) with Wuchereria bancrofti infection, the safety, tolerability and macrofilaricidal efficacy of 12 fortnightly doses of ivermectin, 400 microg/kg (ivermectin group), was compared with 12 fortnightly doses of diethylcarbamazine (DEC), 10 mg/kg (DEC group), over a period of 129 weeks after treatment. A control group (LDIC group) was treated with low dose ivermectin to clear microfilaraemia, for ethical reasons. Both ivermectin and DEC in high multiple doses were well tolerated and clinically safe. Macrofilaricidal efficacy was assessed by prolonged clearance of microfilaraemia, appearance of local lesions, and reduction of circulating W. bancrofti adult antigen detected by an antigen capture enzyme-linked immunoassay based on the monoclonal antibody AD12. Mf counts fell more rapidly after ivermectin than after DEC, but low residual mf levels were equivalent in these groups after week 4. Conversely, filarial antigen levels fell more rapidly after DEC than after ivermectin, but low residual antigen levels in these groups were statistically equivalent at all times beyond 12 weeks. Mild, self-limited systemic reactions to therapy were observed in all 3 treatment groups. Local reactions, such as development of scrotal nodules, were observed in several subjects in the DEC and ivermectin groups. These results suggested that high dose ivermectin and DEC both had significant macrofilaricidal activity against W. bancrofti, but neither of these intensive therapeutic regimens consistently produced complete cures. Thus, new drugs or dosing schedules are needed to achieve the goal of killing all filarial parasites in the majority of patients.