The clinical efficacy and safety of Shiunko ointment (phase II clinical trial) was investigated in 40 Ethiopian patients with cutaneous leishmaniasis. Patients were randomized to receive treatment with Shiunko ointment or placebo (n = 20, each), applied on the lesion twice a day for 4 weeks. Clinicoparasitological assessments were performed before treatment, weekly for 4 weeks, and then 4, 8, and 12 weeks after the end of treatment. A marked reduction in lesion size was observed on week 16 of treatment in the Shiunko compared with placebo group (69% and 22% reduction, resp.). The overall rate of lesion reduction during the four weeks of treatment was significantly faster in the Shiunko group. Shiunko provided significant effect on wound closure in patients with ulcerated lesion. The clinical efficacy and tolerability of Shiunko were comparable to placebo with regard to its clinicoparasitological response (cure rate and parasitological clearance). Results of this preliminary study may suggest that Shiunko could be useful as adjuvant or as complementary treatment, not as alternatives to current treatment. Its attractive action includes fast lesion healing with a significantly smaller lesion at week 16 of treatment compared with placebo. In addition, its action was promoted in ulcerative lesions.
Abstract. This study aimed to investigate the pharmacokinetic interactions between quinine and lopinavir boosted with ritonavir (LPV/r) in healthy Thai adults (8 males and 12 females). Period 1 (day 1): subjects received a single oral dose of 600 mg quinine sulfate. Period 2: subjects received LPV/r (400/100 mg) twice daily. Period 3: subjects received a single quinine sulfate dose plus LPV/r twice a day. Intensive blood sampling was performed during each phase. Quinine AUC 0-48h (area under the plasma concentration-time curve from time 0 to 48 hours), AUC 0-∞ (area under the plasma concentration-time curve from time 0 to infinity), and C max (maximum concentration over the time-span specified), were 56%, 57%, and 47% lower, respectively, in the presence of LPV/r. 3-Hydroxyquinine AUC 0-48h , AUC 0-∞ , and C max were significantly lower and the metabolite-to-parent ratio was significantly reduced. Lopinavir and ritonavir exposures were not significantly reduced with quinine coadministration, but C max of both drugs were significantly lower. The geometric mean ratio (GMR) and 90% CI of AUC 0-48h , AUC 0-∞ , and C max for quinine, 3-hydroxyquinine, lopinavir, and ritonavir lay outside the bioequivalent range of 0.8-1.25. Drug treatments during all periods were generally well tolerated. The reduction in systemic exposure of quinine and 3-hydroxyquinine with concomitant LPV/r use raises concerns of suboptimal exposure. Studies in HIV/malaria coinfection patients are needed to determine the clinical impact to decide if any change to the quinine dose is warranted.
BackgroundConcomitant use of anti-malarial and antiretroviral drugs is increasingly frequent in malaria and HIV endemic regions. The aim of the study was to investigate the pharmacokinetic interaction between the anti-malarial drugs, artesunate-mefloquine and the antiretroviral drug, lopinavir boosted with ritonavir (LPV/r).MethodsThe study was an open-label, three-way, sequential, cross-over, pharmacokinetic study in healthy Thai adults. Subjects received the following treatments: Period 1: standard 3-day artesunate-mefloquine combination; Period 2 (2 months wash-out): oral LPV/r 400 mg/100 mg twice a day for 14 days; and, Period 3: artesunate-mefloquine and LPV/r twice a day for 3 days. Sixteen subjects (eight females) were enrolled and pharmacokinetic parameters were determined by non-compartmental analysis.ResultsIn the presence of LPV/r, artesunate Cmax and systemic exposure were significantly increased by 45–80 %, while the metabolic ratio of dihydroartemisinin to artesunate was significantly reduced by 72 %. In addition, mefloquine Cmax and systemic exposure were significantly reduced by 19–37 %. In the presence of artesunate-mefloquine, lopinavir Cmax was significantly reduced by 22 % but without significant change in systemic drug exposure. The 90 % CI of the geometric mean ratio (GMR) of AUC0−∞ and Cmax were outside the acceptable bioequivalent range for each drug. Drug treatments were generally well tolerated with no serious adverse events. Vertigo, nausea and vomiting were the most common adverse events reported.ConclusionThe reduction in systemic exposure of all investigated drugs raises concerns of an increased risk of treatment failure rate in co-infected patients and should be further investigated.
The outbreak of COVID-19 has brought sickness and fatality to Thai citizens. In addition, it left a tremendous psychological impact on mental health as they experienced panic and anxiety about controlling situations and preserving their physical and mental well-being. This study aimed to analyze the factors influencing COVID-19 preparedness and anxiety based on groups of Thai citizens. Online questionnaires were employed to collect data from 2,768 respondents selected through convenience sampling and snowball sampling on Facebook, having shared questionnaires with 190 other users. Data were collected from March 29 to April 3, 2020. The acquired data were analyzed using percentage and logistic regression analyses. It found that the influencing factors of preparedness included citizens’ sex, residing province, and work or off-house conditions. In contrast, the influencing factors of anxiety included their sex, age, residing province, and income adequacy. The results conveyed that Thai citizens were anxious about the pandemic and had been attempting to cope. In addition, issued policies should respond to the public promptly to prevent unnecessary panic and to maximize public cooperation against future situations put forth by the pandemic.
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