Comparison of Meglumine Antimoniate and Miltefosine in Cutaneous Leishmaniasis.

OBJECTIVE: To compare the efficacy and safety of meglumine antimoniate and miltefosine in the treatment of cutaneous leishmaniasis in Pakistan. STUDY DESIGN: Randomised-controlled trial. Place and Duration of the Study: Department of Dermatology, Combined Military Hospital, Lahore and Peshawar, from January to December 2021. METHODOLOGY: Smear positive and/or skin biopsy-confirmed cases of cutaneous leishmaniasis in adult males aged between 18-60 years were enrolled after receiving informed consent. Patients were randomly divided into Group A and Group B by lottery method. Group A received intramuscular meglumine antimoniate 15-20mg/kg/day, and Group B received oral miltefosine 50 mg thrice a day for a duration of 28 days. Data were analysed by SPSS 22. Effectiveness and safety of therapeutic agents were calculated by Independent t-test and p-value of 0.05 or less was taken as significant. RESULTS: Sixty-six patients, 33 in each group, participated in the study. Total number of cutaneous leishmaniasis lesions were 77 in Group A and 76 in Group B. The duration of lesions was 3.5 months in Group A and 3.2 months in Group B. Treatment response, in terms of complete or near complete resolution of lesions, was significantly higher in Group A as compared to Group B (p = 0.011). Both therapeutic agents had considerable side-effects with more patients withdrawn from Group A as compared to Group B (p = 0.010). CONCLUSION: Intra-muscular meglumine antimoniate was more effective in comparison to oral miltefosine in the treatment of cutaneous leishmaniasis. However, efficacy of meglumine antimoniate is mired by its side-effect profile. KEY WORDS: Cutaneous leishmaniasis, Meglumine antimoniate, Miltefosine, Efficacy, Side-effects, Adverse effects, Safety, Treatment, Old world cutaneous leishmaniasis.

A mathematical model to serve as a clinical tool for assessing obstructive sleep apnea severity.

Obstructive sleep apnea (OSA) is a sleep disorder caused by periodic airway obstructions and has been associated with numerous health consequences, which are thought to result from tissue hypoxia. However, challenges in the direct measurement of tissue-level oxygenation make it difficult to analyze the hypoxia exposure pattern in patients. Furthermore, current clinical practice relies on the apnea-hypopnea index (AHI) and pulse oximetry to assess OSA severity, both of which have limitations. To overcome this, we developed a clinically deployable mathematical model, which outputs tissue-level oxygenation. The model incorporates spatial pulmonary oxygen uptake, considers dissolved oxygen, and can use time-dependent patient inputs. It was applied to explore a series of breathing patterns that are clinically differentiated. Supporting previous studies, the result of this analysis indicated that the AHI is an unreliable indicator of hypoxia burden. As a proof of principle, polysomnography data from two patients was analyzed with this model. The model showed greater sensitivity to breathing in comparison with pulse oximetry and provided systemic venous oxygenation, which is absent from clinical measurements. In addition, the dissolved oxygen output was used to calculate hypoxia burden scores for each patient and compared to the clinical assessment, highlighting the importance of event length and cumulative impact of obstructions. Furthermore, an intra-patient statistical analysis was used to underscore the significance of closely occurring obstructive events and to highlight the utility of the model for quantitative data processing. Looking ahead, our model can be used with polysomnography data to predict hypoxic burden on the tissues and help guide patient treatment decisions.