Sodium stibogluconate 10g/100ml solution for injection vials

BackgroundCutaneous leishmaniasis (CL) is a major public health concern, particularly in Ethiopia, where about 40 000 new cases occur annually, predominantly caused by Leishmania aethiopica. Clinical phenotypes include localized CL (LCL), mucocutaneous leishmaniasis (MCL) and diffuse CL (DCL). Despite the high disease burden, treatment options and high-quality data on treatment outcomes are limited.ObjectivesTo evaluate the effectiveness of standard treatments in Ethiopia to inform future clinical trials.MethodsWe conducted an observational cohort study of patients with parasitologically confirmed cutaneous leishmaniasis at two specialized dermatology referral hospitals. Clinical- and patient-reported outcomes were assessed at baseline and at standardized times during follow-up. The primary clinical outcome measure ('cure') was complete re-epithelialization or flattening of the index lesion at day 90. Patient-reported outcomes were assessed using skin-specific and general quality-of-life scores.ResultsWe enrolled 666 participants from April 2022 to October 2023. Median patient age was 20 years (interquartile range 14-35) and 405 patients were male (60.8%). More than half (n = 372; 55.9%) had previously received traditional treatment for CL. Most participants had LCL (n = 390; 58.6%) or MCL (n = 261; 39.1%). Intramuscular sodium stibogluconate 20 mg kg-1 daily was the most frequently used systemic therapy, either alone or in combination with lesion-directed therapy (cryotherapy or intralesional sodium stibogluconate). At day 90, 28.3% (n = 83/293) of participants with LCL, 23.5% (v = 47/200) with MCL and 8% (n = 1/12) with DCL were deemed cured. By day 90, all patient-reported outcomes of skin health improved for those with LCL or MCL, but skin and CL-related quality-of-life scores did not improve for those with DCL. Most participants (n = 522/641; 81.4%) experienced at least one clinical adverse event and 7.2% (n = 46/641) had abnormal laboratory findings during treatment.ConclusionsCurrent treatment strategies have low cure rates in Ethiopia. Well-designed randomized controlled trials are urgently needed to improve management of CL caused by L. aethiopica.

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BackgroundTo evaluate the clinical efficacy and safety of 3% diquafosol sodium combined with 0.1% fluorometholone for postoperative dry eye in pterygium patients with preoperative tear deficiency.MethodsThis single-center retrospective study included 82 pterygium patients (82 eyes) with preoperative tear deficiency who underwent pterygium excision combined with limbal stem cell transplantation. Patients were divided into an observation group (diquafosol + fluorometholone, n = 42) and a control group (sodium hyaluronate + fluorometholone, n = 40). Tear break-up time (BUT), corneal fluorescein staining (CFS) score, Ocular Surface Disease Index (OSDI), Schirmer I test (SIt), and intraocular pressure (IOP) were assessed preoperatively and at 2 and 4 weeks postoperatively. Adverse events and complications were recorded.ResultsEighty patients completed follow-up (41 in observation group, 39 in control group). At 4 weeks postoperatively, the observation group showed significantly longer BUT, lower CFS and OSDI scores, and higher SIt values compared to the control group (all p ConclusionIn this pilot study, the combination of 3% diquafosol sodium and 0.1% fluorometholone showed preliminary evidence of improving tear film stability, repairing ocular surface damage, and alleviating dry eye symptoms in pterygium patients with preoperative tear deficiency, without significantly affecting IOP. Its efficacy appeared superior to sodium hyaluronate combined with fluorometholone. These findings support further investigation in larger, longer-term randomized controlled trials.

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BackgroundTo evaluate the clinical efficacy of okra eyelid patch versus sodium hyaluronate combined with ofloxacin eye drop in the treatment of patients suffering from meibomian gland dysfunction (MGD).Methods40 patients included were randomly divided into 2 groups: okra eyelid patch group (n = 20) and control group (n = 20). Before treatment, on the 14th and 28th day of treatment, the following ophthalmic examinations were performed: symptoms and signs score, Schirmer I test (SIT), tear film break-up time (TBUT), corneal fluorescein staining (CFS), optical quality analysis system (OQAS II) and ocular surface interferometer examination. Ocular surface disease index (OSDI) questionnaire score and in vivo confocal microscopy (IVCM) were performed before treatment and on the 28th day of treatment. Adverse effects were reported during the treatment period. Results were analyzed by SPSS 25.0 software. p ResultsOn day 28, okra eyelid patch group had a better curative effect in symptoms score, signs score, total score, OSDI questionnaire score, TBUT, and CFS score, lipid layer thickness and MASD compared with control group (p  0.05).ConclusionsOkra eyelid patch has a more significant effect on MGD, especially in improving symptoms and signs, increasing lipid layer thickness, improving tear film stability, maintaining corneal epithelial integrity, and improving the quality of meibomian gland acini compared with artificial tears combining ofloxacin eye drops. It has few side effects, and provides a new therapeutic option for MGD associated with dry eye.

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