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新配方药物“诺伏斯特龙”治疗效果评估作为临床试验的实验依据

Evaluation of the Therapeutic Efficacy of the Newly Formulated Drug "Novostron" as an Experimental Basis for Clinical Trials.

作者信息

Ibragimova Nailya, Kabdraisova Aisulu, Lyu Marina, Iskakbayeva Zhanar, Krasnoshtanov Arkadiy, Tin Yuliya, Yermek Sakhipov, Turganbay Seitzhan, Karzhaubayeva Roza, Ilin Aleksander Ivanovich, Azembayev Amirkan, Mombekov Serzhan, Raheem Saki

机构信息

JSC Scientific Center for Anti-Infectious Drugs, Almaty 050060, Republic of Kazakhstan.

School of Life Sciences, University of Westminster, 115 New Cavendish Street, London W1W 6UW, U.K.

出版信息

ACS Omega. 2025 Aug 13;10(33):36946-36959. doi: 10.1021/acsomega.4c11017. eCollection 2025 Aug 26.

Abstract

Chronic wound infections driven by multidrug-resistant (MDR) bacteria continue to challenge modern medicine. This study introduces "Novostron", an innovative topical iodine-based formulation incorporating dextrin and metal halides designed to overcome the limitations of existing antiseptics, such as volatility and cytotoxicity. The complex's physicochemical properties were analyzed using infrared (IR) and ultraviolet (UV) spectroscopy, alongside thermogravimetric analysis, confirming its stability and robust iodine retention. Stability assessments revealed minimal iodine loss under optimal refrigerated conditions. In a rat skin wound model, the microbial load was significantly reduced to 1.4 ± 0.5 CFU/cm within 10 min postapplication, demonstrating rapid antimicrobial action. Wound-healing properties were evaluated on surgically induced wounds in mice, showing accelerated granulation tissue formation and epithelialization within 14 days, supported by histological findings. In infected wound models, combined therapy with "Novostron" and cefazolin enhanced immune responses (IgG and IgM levels), significantly reduced inflammation, and promoted robust tissue regeneration. Additionally, hematological studies revealed decreased leukocytes and thrombocytes, indicating reduced systemic inflammation. These findings suggest the potential of "Novostron" as a therapeutic agent for managing infected and surgical wounds, offering both antimicrobial and wound-healing benefits. However, clinical trials are essential to validate its safety, optimize its application protocol, and establish its efficacy for human use.

摘要

由耐多药(MDR)细菌引起的慢性伤口感染仍然是现代医学面临的挑战。本研究介绍了“Novostron”,这是一种创新的基于碘的外用制剂,含有糊精和金属卤化物,旨在克服现有防腐剂的局限性,如挥发性和细胞毒性。使用红外(IR)和紫外(UV)光谱以及热重分析对该复合物的物理化学性质进行了分析,证实了其稳定性和强大的碘保留能力。稳定性评估显示,在最佳冷藏条件下碘损失最小。在大鼠皮肤伤口模型中,给药后10分钟内微生物载量显著降低至1.4±0.5 CFU/cm,表明具有快速抗菌作用。在小鼠手术诱导的伤口上评估了伤口愈合特性,组织学结果表明,在14天内肉芽组织形成和上皮化加速。在感染伤口模型中,“Novostron”与头孢唑林联合治疗增强了免疫反应(IgG和IgM水平),显著减轻了炎症,并促进了强大的组织再生。此外,血液学研究显示白细胞和血小板减少,表明全身炎症减轻。这些发现表明“Novostron”作为治疗感染伤口和手术伤口的治疗剂具有潜力,具有抗菌和伤口愈合的双重益处。然而,临床试验对于验证其安全性、优化其应用方案以及确定其对人类使用的疗效至关重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e3fa/12392178/d9c0a8ec688b/ao4c11017_0001.jpg

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