Sodium stibogluconate 10g/100ml solution for injection vials

Cutaneous leishmaniasis incidence has been rising in the past couple of decades. Standard therapy often includes antileishmanial drugs; however, due to their low safety and toxicity threshold, alternative treatments are being investigated. The association between COVID-19 and cutaneous leishmaniasis remains unclear and exploring this connection may offer crucial insights into the pathophysiology of and treatment strategies for infected patients. In this article, we describe a case of a male patient with a history of cardiac and other comorbidities who presented with cutaneous leishmaniasis in the form of impetigo-like skin lesions after being infected with COVID-19. Due to the patient's poor cardiac profile, sodium stibogluconate was not used and an alternative therapeutic approach was employed. The patient was treated with oral terbinafine, cryotherapy on specific lesions, and a course of cephalexin. Following the course of treatment and subsequent follow-up, the patient exhibited complete resolution and healing of the lesions with scarring, and no active lesions or recurrence were observed. This case highlights the potential for alternative treatment strategies for cutaneous leishmaniasis in patients with comorbidities and emphasizes the importance of further research to better understand the link between COVID-19 and cutaneous leishmaniasis.

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Topical drug delivery against cutaneous leishmaniasis (CL) signifies an effective alternate for improving the availability and reducing the toxicity associated with the parenteral administration of conventional sodium stibogluconate (SSG) injection. The basic aim of the study was to develop nano-deformable liposomes (NDLs) for the dermal delivery of SSG against CL. NDLs were formulated by a modified thin film hydration method and optimized via Box–Behnken statistical design. The physicochemical properties of SSG-NDLs were established in terms of vesicle size (195.1 nm), polydispersity index (0.158), zeta potential (−32.8 mV), and entrapment efficiency (35.26%). Moreover, deformability index, in vitro release, and macrophage uptake studies were also accomplished. SSG-NDLs were entrapped within Carbopol gel network for the ease of skin application. The ex vivo skin permeation study revealed that SSG-NDLs gel provided 10-fold higher skin retention towards the deeper skin layers, attained without use of classical permeation enhancers. Moreover, in vivo skin irritation and histopathological studies verified safety of the topically applied formulation. Interestingly, the cytotoxic potential of SSG-NDLs (1.3 mg/ml) was higher than plain SSG (1.65 mg/ml). The anti-leishmanial activity on intramacrophage amastigote model of Leishmania tropica showed that IC50 value of the SSG-NDLs was ∼ fourfold lower than the plain drug solution with marked increase in the selectivity index. The in vivo results displayed higher anti-leishmanial activity by efficiently healing lesion and successfully reducing parasite burden. Concisely, the outcomes indicated that the targeted delivery of SSG could be accomplished by using topically applied NDLs for the effective treatment of CL.

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INTRODUCTION: In 2010, WHO recommended a new first-line treatment for visceral leishmaniasis (VL) in Eastern Africa. The new treatment, a combination of intravenous (IV) or intramuscular (IM) sodium stibogluconate (SSG) and IM paromomycin (PM) was an improvement over SSG monotherapy, the previous first-line VL treatment in the region. To monitor the new treatment's safety and effectiveness in routine clinical practice a pharmacovigilance (PV) programme was developed. METHODS: A prospective PV cohort was developed. Regulatory approval was obtained in Sudan, Kenya, Uganda and Ethiopia. Twelve sentinel sites sponsored by the Ministries of Health, Médecins Sans Frontières (MSF) and Drugs for Neglected Diseases initiative (DNDi) participated. VL patients treated using the new treatment were consented and included in a common registry that collected demographics, baseline clinical characteristics, adverse events, serious adverse events and treatment outcomes. Six-monthly periodic safety update reports (PSUR) were prepared and reviewed by a PV steering committee. RESULTS: Overall 3126 patients were enrolled: 1962 (62.7%) from Sudan, 652 (20.9%) from Kenya, 322 (10.3%) from Ethiopia and 190 (6.1%) from Uganda. Patients were mostly male children (68.1%, median age 11 years) with primary VL (97.8%). SSG-PM initial cure rate was 95.1%; no geographical differences were noted. HIV/VL co-infected patients and patients older than 50 years had initial cure rates of 56 and 81.4%, respectively, while 1063 (34%) patients had at least one adverse event (AE) during treatment and 1.92% (n = 60) had a serious adverse event (SAE) with a mortality of 1.0% (n = 32). There were no serious unexpected adverse drug reactions. CONCLUSIONS: This first regional PV programme in VL supports SSG-PM combination as first-line treatment for primary VL in Eastern Africa. SSG-PM was effective and safe except in HIV/VL co-infected or older patients. Active PV surveillance of targeted safety, effectiveness and key VL outcomes such us VL relapse, PKDL and HIV/VL co-infection should continue and PV data integrated to national and WHO PV databases.

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Cutaneous leishmaniasis (CL) is common in Ethiopia, but the national guideline does not offer specific treatment recommendations. Consequently, different treatment regimens are used in the country, without quality evidence. In Boru Meda Hospital, sodium stibogluconate (SSG) is routinely used in combination with allopurinol for systemic CL treatment, although evidence on its effectiveness is limited. An observational cohort study was carried out to document clinical treatment outcomes in patients receiving SSG/allopurinol at the end of each 28-day treatment cycle and after 180 days. Patient-reported outcomes were assessed by asking patients to rate lesion severity, and by the dermatological life quality index. A total of 104 patients were included. After one treatment cycle, only four patients were clinically cured, although patient-reported outcomes significantly improved. The majority (88) of patients were appointed for a second treatment cycle, of whom only 37 (42%) attended. Among the 36 patients who came for final outcome assessment, 50% were cured. Follow-up and treatment were severely affected by conflict; drug stock-outs and insufficient ward capacity for treatment were additional challenges. The treatment outcomes of SSG/allopurinol were relatively poor, and most patients required more than one cycle of treatment. Shortages of drugs and beds indicate the existing gaps in providing CL treatment in Ethiopia.

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Israel is endemic for Old-World cutaneous leishmaniasis. The most common species is Leishmania major. However, the available treatment options are limited. This study's objective was to compare the authors' experience with different antimony intralesional treatments of Leishmania major cutaneous leishmaniasis. A retrospective evaluation was undertaken for cases of Leishmania major cutaneous leishmaniasis treated by pentavalent antimony in a university-affiliated medical centre in Israel. The previous treatment of intralesional sodium stibogluconate (Pentostam®) was compared with the current treatment of meglumine antimoniate (Glucantime®). One hundred cases of cutaneous leishmaniasis were treated during the study period, of whom 33 were treated with intralesional sodium stibogluconate and 67 were treated with intralesional meglumine antimoniate. The patients were 78 males and 22 females, mean age 24 (range 10-67) and there was a total of 354 skin lesions. Within 3 months from treatment, 91% (30/33) of the intralesional sodium stibogluconate group and 88% (59/67) of the intralesional meglumine antimoniate group had complete healing of the cutaneous lesions after an average of 3 treatment cycles (non-statistically significant). In conclusion, the 2 different medications have the same efficacy and safety for treating cutaneous leishmaniasis. Pentavalent antimoniate intralesional infiltration treatment is safe, effective, and well tolerated with minimal side effects for Old-World cutaneous leishmaniasis.

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Ascites and pleural effusion are recognized complications of pancreatic cancer. These diseases are accompanied by ascites and pleural effusion, and drug treatment is limited by high costs, long hospital stays, and failure rates. Immunotherapy may offer new option, but in most patients with late stages of cancer, immune cells may lose the ability to recognize tumor cells, how to activate their immune cells is a major problem, sodium glucosidate (SSG) is injected into ascites as a protein tyrosine phosphatase inhibitor to wake up immune cells and prepare for immunotherapy. We used single-cell RNA sequencing (scRNA-seq) to investigate whether and how SSG injected into ascites of pancreatic cancer elicits an immune response. Our study showed that the process of SSG fusion treatment of ascites and pleural effusion, the interaction between TandNK cells, MPs cells, monocytes and neutrophils was induced, and large numbers of genes were expressed, resulting in upregulation of immune response, which also approved that SSG is not only used as a protein tyrosine phosphatase inhibitor, but also it works as a protein tyrosine phosphatase inhibitor. It can also be used to regulate immune cell function, recruiting immune cells to the right place with the help of PD-1 or PD-L1 to fight cancer cells in ascites and pleural effusions in cancer patients.

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This study presents the case of a 54-year-old woman, otherwise healthy, who presented with a 4-month history of red plaques with central ulceration, which had initially developed from painless papules. The lesions appeared on her right arm and trunk, two months after her travel to Morocco. Physical examination revealed a 7 cm × 5 cm red plaque with central ulceration and crusting on her right arm, along with papules and plaques on her trunk. Based on microbiological, histopathological, and PCR results, the patient was diagnosed with Old World cutaneous leishmaniasis. After receiving two sessions of intralesional pentavalent antimonial treatment, the patient was left with only a minor scar and experienced negligible side effects, except for moderate aching during therapy.

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