Documentation of Patient Outcomes for the Combination Treatment of Sodium Stibogluconate and Allopurinol in Complicated Cutaneous Leishmaniasis in Ethiopia

Outcomes of patients receiving SSG and Allopurinol combination have never been documented systematically in Ethiopia. Therefore, it is not known how effective this combination is. This study will provide evidence to help clinicians make the best choice regarding treatment for complicated cutaneous leishmaniasis (CL) cases. Due to diversity in host-pathogen interactions across the different CL forms, early immunological correlates associated with treatment responsiveness and unresponsiveness could help treatment recommendation and provide us with the basis to develop new diagnostic and treatment strategies.
This study aims to document treatment outcomes of patients with cLCL, MCL, and DCL receiving systemic treatment using SSG and Allopurinol combination within a routine care setting located in a highly endemic area in Ethiopia.

开始日期2021-02-15

申办/合作机构

Instituut voor Tropische Geneeskunde

[+1]

NCT04906031

/ Unknown status临床2期IIT

Sodium Stibogluconate in the Myelodysplastic Syndromes/Acute Myeloid Leukemia With One of the 65 Defined p53 Mutations That Can be Functionally Rescued by Sodium Stibogluconate

To evaluate the safety and effectiveness of Sodium Stibogluconate in the treatment of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) with p53 mutation from a defined list. The list includes 65 p53 mutations that were experimentally confirmed to be pharmacologically restored with tumor-suppressive function by antimonials.

开始日期2020-06-01

申办/合作机构

暨南大学附属第一医院（广州华侨医院）

[+1]

SLCTR/2016/025

/ RecruitingN/AIIT

Efficacy and safety of thermotherapy by Hand-held Exothermic Crystallization Thermotherapy device compared to ThermoMed device, for treatment of cutaneous leishmaniasis showing poor response to intralesional sodium stibogluconate in Sri Lanka - A randomized controlled pilot study

开始日期2016-10-17

申办/合作机构-

100 项与葡萄糖酸锑钠相关的临床结果

登录后查看更多信息

100 项与葡萄糖酸锑钠相关的转化医学

登录后查看更多信息

100 项与葡萄糖酸锑钠相关的专利（医药）

登录后查看更多信息

1,710

项与葡萄糖酸锑钠相关的文献（医药）

2025-06-01·Parasitology International

Comparative Assessment of colorimetric assays in evaluating intracellular drug susceptibility of Leishmania tropica against conventional antileishmanial drugs

Article

作者: Balcıoğlu, İbrahim Cüneyt ; Aksoy, Tülay ; Yıldırım, Ahmet

This study aims to identify the most sensitive colorimetric test for assessing intracellular drug susceptibility of Leishmania tropica to conventional antileishmanial drugs. To this end, the efficacy of four colorimetric methods-MTT, XTT, MTS, and WST-8-was compared using reference L. tropica promastigotes. The intracellular drug susceptibility was further evaluated using the test with the widest absorbance range on isolates from Türkiye CL patients: two responsive to a single course of meglumine antimoniate (MA) and two that showed no clinical improvement after two treatments. CL isolates were identified via real-time PCR targeting the ITS1 region. Promastigote suspensions at standardized densities (0.08 × 10⁶ to 10 × 10⁶ promastigotes/well) were prepared in both RPMI (phenol red-containing) and RPMIØRP (phenol red-free) media, then analyzed with ELISA-based MTT, XTT, MTS, and WST-8 to identify the method with the broadest specific absorbance range. Intracellular drug susceptibility of CL isolates was subsequently assessed in a macrophage/amastigote model by infecting THP-1 macrophages with promastigotes from both reference and patient isolates, followed by treatment with MA, sodium stibogluconate (SSG), miltefosine (MTF), pentamidine (PMD), and amphotericin B (AmB). Promastigotes obtained from parasite rescue and transformation assays were analyzed using the most sensitive colorimetric method to determine IC₅₀ values. Species identification confirmed all four CL isolates as L. tropica, and the XTT assay provided the widest absorbance range in RPMIØRP media. IC₅₀ values for both treatment-responsive and unresponsive isolates were similar to those of the reference isolate, showing susceptibility to all tested drugs without statistically significant differences. Expanding the isolate set is necessary to further evaluate the predictive value of Sb^V (pentavalent antimonials) susceptibility for treatment outcomes. The identification of XTT as the most sensitive method for intracellular antileishmanial susceptibility testing is expected to aid in standardizing laboratory models and provide valuable insights for researchers and clinicians managing treatment-unresponsive CL cases.

2024-11-01·Acta dermatovenerologica Croatica : ADC

Cutaneous Leishmaniasis Masquerading as Diabetic Foot: A Call for Vigilance.

Article

作者: Al Aboud, Khalid ; Al Aboud, Ahmad

parts of the world (1,2). CL is characterized by significant clinical variability. An ulcerated nodule on the exposed parts of the body (corresponding to the parasite inoculation site by the vector insect) is the classic presentation. However, other forms of clinical presentations also exist (3,4). CL can be present on unusual locations such as the scalp, the genital region, or palmoplantar areas. Localization in the foot poses a diagnostic challenge due to similarity to disorders which produce ulcerations. The latter include diabetes and leprosy. A 75-year-old Afghani man presented with a large, progressive, cutaneous necrotic ulcer on the left foot (Figure 1) associated with pain, one year in duration. The patient has no history of trauma or any chronic systemic disorders. Additionally, the patient reported no similar diseases in the past. The patient was repeatedly diagnosed with diabetic foot in his village. Dressings were administered several times without any improvement. The patient underwent blood tests, including fasting blood sugar, which were all within normal limits. As the patient lived in an endemic area for CL, CL was suspected and confirmed by slit skin smear and skin biopsy. The latter demonstrated Leishmania amastigotes in the dermal histiocytic infiltrates (Figure 2). The patient is currently under treatment with systemic sodium stibogluconate (pentostam). Leishmaniasis is a major medical issue in several parts of the world. It is transmitted by sandflies. Visceral and cutaneous forms of the disease have been identified. There are more than 1.5 million cases of CL reported annually around the world (1-4). The classical form of CL can be easily diagnosed, particularly in the endemic areas. However, rare and an unusual clinical locations and presentations exist. The latter include annular, chancriform, acute paronychial, palmoplantar, zosteriform, and erysipeloid. Involvement of lower limbs is not common, but can occur (1,2). CL affecting the foot is much less commonly reported (3,4). In this location, CL can be confused with other conditions such as leprosy, vasculitis, neoplastic ulcers, and chronic ulcers due to vascular insufficiency or diabetes. Some authors have stated that routine diagnostic biopsies may be useful in case of clinically suspected wound infections, particularly in patients with deep ulcerations, diabetic foot syndrome, severe soft tissue infection, or fistula tissue. They believed that biopsies are indispensable in the microbiology workup of specific pathogens such as mycobacteria, Leishmania, actinomycetes, Nocardia ssp., or molds (5). The present case highlights the importance of proper investigation of foot ulcer and the importance of considering the diagnosis of leishmaniasis, particularly in endemic areas.

2024-10-01·Journal of Proteomics

Characterizing Leishmania infantum-induced resistance to trivalent stibogluconate (SbIII) through deep proteomics

Article

作者: Ramírez, Juan David ; Patiño, Luz H. ; López, Julio ; Patiño, Luz H ; Julio, López ; Antonio, Muro ; Manzano, Raúl ; Muro, Antonio ; Castillo-Castañeda, Adriana

Leishmania infantum belongs to the L. donovani complex, which includes species associated with visceral leishmaniasis. Traditionally, antimonial compounds have served as the primary antiparasitic treatment for all clinical forms of leishmaniasis. However, the global spread of resistance to these compounds has posed a significant challenge in the treatment in some regions. In this study, we aimed to investigate resistance to trivalent sodium stibogluconate in vitro using promastigotes from a wild strain of L. infantum. We compared the growth rates and proteomic profiles of wild-type and resistant line conducting label-free quantitative mass spectrometry-based proteomic analyses. Statistical and bioinformatics analyses were employed to evaluate the significance of protein concentration changes, protein identity annotation, GO term analysis, biosynthetic pathways, and protein-protein interactions. Our findings revealed that the resistant line displayed a notable reduction in growth rate. Proteomic data unveiled similar protein concentrations per cell in both groups but with differing molecule copy numbers. We identified 165 proteins with increased concentration, these were associated with transcription and translation activities, lipid metabolism, energy metabolism, and peroxisome biogenesis. In the decreased protein groups were 56 proteins linked to metal acquisition and metabolism, particularly iron. These results suggest a novel perspective on antimonial resistance, highlighting the importance of post-transcriptional and post-translational regulation, alongside energy expenditure compensation and alterations in organelle membrane lipid composition in antimonial-resistant parasites. Overall, our study provides insights into the proteomic profile of stibogluconate-resistant strain, contributing to our general understanding of the complex landscape of antiparasitic resistance in L. infantum. SIGNIFICANCE: Species within the Leishmania donovani complex are implicated in cases of visceral leishmaniasis in the world. Leishmania infantum is a species that predominates in regions spanning the Mediterranean Basin, the Middle East, Central Asia, South and Central America. Antimonials were the first treatment for leishmaniasis, however in the last decades, the resistance has emerged in subregions like India, where it is not a therapeutic option. In contrast, sodium stibogluconate (SbIII) remains the first-line treatment in the Americas. Unfortunately, the emergence of resistance has outpaced the development of new therapeutic options, thereby becoming a critical point in the struggle against the disease. In this study we performed an in-depth proteomic analysis with liquid chromatography mass-mass spectrometry (LC-MS/MS) on L. infantum with Sb-induced resistance in vitro. Results showed a complex proteomic adaptation in the resistant line, involving transcriptional and translational proteins, energy compensation, and homeostasis maintenance. These insights contribute to understanding the molecular adaptation in the parasite and provide information to new investigations related to therapeutics development.

项与葡萄糖酸锑钠相关的新闻（医药）

2024-11-08

·被忽视疾病药物研发倡议组织

这种被忽视的疾病可能导致毁容，中国仍有病例报告

2023年，孟加拉国成为全球第一个获得世界卫生组织（WHO）消除内脏利什曼病认证的国家。而其他受该疾病严重影响的南亚和东非地区的国家也在朝着消除目标稳步前进——这部分归功于DNDi过去20年的研究工作帮助人们获得了更安全和更简单的治疗。当前， DNDi及其合作伙伴正专注于为内脏利什曼病患者提供全新的口服药物，从而支持全球实现和维持内脏利什曼病的消除。 //认识内脏利什曼病：现状与危害// 利什曼病（Leishmaniasis）可由20多种利什曼虫属原生动物寄生虫引起，目前已知有90多种白蛉可以传播这些利什曼虫属寄生虫。该病有三种主要形式：内脏利什曼病（Visceral leishmaniasis，VL）、皮肤利什曼病（Cutaneous leishmaniasis, CL）和皮肤粘膜利什曼病（Mucocutaneous leishmaniasis）。其中，内脏利什曼病（又名黑热病）是最严重的形式，它可能出现暴发并导致死亡，是继疟疾之后第二致命的寄生虫病。据估计，全世界有6亿多人面临感染VL的风险，每年新发病例数在5万至9万之间，大约50%的VL患者为儿童群体。研究表明，大多数患者分布在巴西、东非和印度。而在中国，近年来病例报告主要集中于新疆、甘肃和四川等地。VL患者通常会出现发烧、体重下降、肝脾肿大等症状，如果不及时治疗，超过95%的患者会发生死亡。其中，携带艾滋病毒的VL患者尤其难以治愈，具有很高的复发率和死亡率。与其他人群相比，携带艾滋病毒的人群罹患VL的风险高出100倍以上。 [图源：DNDi] //推动进步：内脏利什曼病的治疗创新// 东非的VL患者迫切需要比现有标准治疗更安全、更简单的替代方案，特别是当地占比70%的儿童患者。2003年，DNDi创建了东非利什曼病平台（Leishmaniasis East Africa Platform，LEAP），来自20个机构的60名专家参与研究，并帮助推动了肯尼亚、埃塞俄比亚、乌干达和苏丹抗击VL的进展。 2018年，DNDi与AfriKADIA联盟合作在埃塞俄比亚、肯尼亚、苏丹和乌干达开展了一项III期临床研究，比较米替福辛和帕罗霉素（miltefosine and paromomycin，MF+PM）联合治疗与目前的标准治疗——硬葡萄糖酸钠和帕罗霉素（sodium stibogluconate and paromomycin，SSG+PM）的结局。研究结果显示，MF+PM与SSG+PM一样有效，但所需注射次数较少，治疗周期较短，没有SSG相关毒性风险，并且继发黑热病后皮肤利什曼病（Post-Kala-Azar Dermal Leishmaniasis，PKDL）的风险也更低。为确保MF+PM在儿科用药中的适当剂量，研究团队开展了进一步的工作，研究结果支持在儿童和成人患者中均实施较短的14天治疗方案。 [图源：DNDi] DNDi与第七届利什曼病世界大会和第28届LEAP平台会议的与会专家以及开展研究的区域和社区的利什曼病技术和咨询小组分享了试验结果。与此同时，世卫组织指南制定小组开始审查DNDi的 III期临床试验产生的证据，为东非地区成人和儿童VL患者的治疗指南的修订提供信息。 //打破传播链条：PKDL患者的治疗// 据报告，5-10%的VL患者会继发PKDL。该病症通常表现为面部、上臂和躯干部位出现斑点、丘疹或结节，还可能导致毁容和给患者造成极大的病耻感。此外，PKDL患者仍可以作为VL的传染源，因此，早期和有效的PKDL治疗对于持续减少VL传播至关重要。基于此前完成的两项II期临床研究——在苏丹开展的旨在测试脂质体两性霉素B (LAmB)+MF和MF+PM的研究，以及在印度和孟加拉国开展的测试LAmB单药疗法和LAmB+MF组合疗法的研究，DNDi及其合作伙伴分别于2023年11月和2024年6月在期刊PLOS Neglected Tropical Diseases上发表了研究结果。由于这些新的科学证据，预计更短期、更安全的治疗方法将在未来被推荐给PKDL患者。 [图源：DNDi] //全新的口服药物：合作与创新// 2023年，DNDi与合作伙伴在开发新的分子实体方面取得了重大进展，这些实体有可能彻底改变VL的治疗方法，并支持其消除目标的实现。 LXE408是一种由DNDi与Novartis联合开发的首创新药化合物。2023年8月，印度的第二个研究点已经启动，并在当年招募了39名患者。与此同时，在埃塞俄比亚进行的一项类似的II期研究已于2024年4月入组了首位受试者。预计到2025年，这两项研究将总共招募140名参与者。 GSK245具有与LXE408相似的作用模式，由DNDi、GSK全球健康部门和邓迪大学药物发现部门合作开发。2023年，针对该化合物的研究继续进行，并完成了健康志愿者单次剂量递增的I期研究。 [图源：DNDi] 此外，DNDi及其合作伙伴也恢复了具有独特的作用机理的化合物DNDI-6899的开发。储存在药明康德的活性药物成分已完成重新加工和配制，以支持2024年启动的多次剂量递增I期研究。在上月举行的第43届DNDi科学咨询委员会会议上，DNDI-6899研发项目从40多个研发项目中脱颖而出，入选“2024年度项目”（2024 Projects of the Year），以表彰该项目在临床前研究中的突出进展。在DNDi的所有利什曼病药物组合中，DNDI-6174提供了一种全新的作用模式，并且预期具有较低的人用剂量和有前景的安全边际。该化合物由DNDi与GSK和邓迪大学合作发现，并于2019年被提名为VL候选药物，该成果已于2023年12月发表在期刊Science Translational Medicine上。自2019年来，DNDi和Eisai一直在合作开发该化合物，并于2023年继续合作研究以扩大对该化合物非临床特征的了解，从而推进首次人体临床试验。 [图源：DNDi] 我们非常感激这一路同行的合作伙伴们，他们在为被忽视的患者群体推进医学创新方面发挥了重要作用。未来，我们将继续在利用现有药物提供更安全、更短周期的治疗的同时，完成全新药物的长期开发，以拯救生命，减少与内脏利什曼病有关的社会歧视和病耻感，并最终消除内脏利什曼病。点击“阅读原文”，可了解更多DNDi为最被忽视的病人推动的医学创新。关于DNDi 被忽视疾病药物研发倡议组织（DNDi）是一个以病患需求为出发点的非营利性药物研发组织。DNDi主要为被忽视的疾病患者研发新的治疗方法，其中包括昏睡病、南美锥虫病、利什曼病、淋巴丝虫病、足菌肿、儿童艾滋病/艾滋病以及丙型肝炎的治疗方法。DNDi同时也在协调ANTICOV临床试验，为非洲的轻度至中度新冠肺炎（COVID-19）患者寻找治疗方法。自2003年成立以来，DNDi迄今已交付了13种全新的治疗方案，其中包括用于治疗利什曼病的新药物组合、两种固定剂量的抗疟药，首次成功研发的新化学实体药物非昔硝唑（fexinidazole）用于治疗昏睡病，以及通过南南合作研发的丙肝药物拉维达韦（ravidasvir），旨在为全球丙肝患者提供可负担的药物选择。 *点击下方图片，了解更多有关DNDi的介绍。

临床3期

100 项与葡萄糖酸锑钠相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D00582	葡萄糖酸锑钠	P01CB02	DB05630

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
利什曼病	-	GSK Plc	-

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
皮肤利什曼病	临床1期	美国	-	-
实体瘤	临床1期	美国	-	-

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03129646 (Pubmed)	临床3期	内脏利什曼病	439	Paromomycin plus Miltefosine	鏇鬱鬱襯獵遞簾構夢醖(餘醖觸築觸壓簾鏇衊鏇) = 築壓構淵製夢願糧願艱網網餘鹽蓋鑰窪遞憲膚 (鑰鹹鑰鑰艱遞鑰選淵鹹, -6.2 ~ 7.4)	积极	2022-09-27
				Sodium Stibogluconate plus Paromomycin	鏇鬱鬱襯獵遞簾構夢醖(餘醖觸築觸壓簾鏇衊鏇) = 淵淵積醖夢鏇糧鏇蓋餘網網餘鹽蓋鑰窪遞憲膚 (鑰鹹鑰鑰艱遞鑰選淵鹹, -6.2 ~ 7.4)
NCT01067443 (Pubmed \| PLoS Negl Trop Dis)	临床2期	内脏利什曼病	151	AmBisome + SSG	衊築窪積範膚淵積鹽糧(壓網簾廠憲夢衊築築選) = 積鏇選選簾築積襯窪積顧壓鬱餘壓顧夢艱襯齋 (膚醖獵淵範鹹顧餘鬱鏇, 73 ~ 92) 更多	-	2016-09-01
				AmBisome + miltefosine	衊築窪積範膚淵積鹽糧(壓網簾廠憲夢衊築築選) = 製廠鑰鏇顧廠夢繭壓餘顧壓鬱餘壓顧夢艱襯齋 (膚醖獵淵範鹹顧餘鬱鏇, 73 ~ 92) 更多
Pubmed \| J Dermatolog Treat	N/A	-	154	Intralesional sodium stibogluconate	齋鏇壓築簾鹹繭淵艱襯(餘鹽遞築膚艱憲餘觸遞) = 積艱繭鑰築獵顧觸醖願廠鬱廠憲廠夢鏇糧簾蓋 (遞觸齋夢鏇繭繭範願艱 ) 更多	-	2010-09-01
				Intralesional 7% hypertonic sodium chloride	齋鏇壓築簾鹹繭淵艱襯(餘鹽遞築膚艱憲餘觸遞) = 範觸壓製網衊鹹遞顧構廠鬱廠憲廠夢鏇糧簾蓋 (遞觸齋夢鏇繭繭範願艱 ) 更多