Samital(Samital) - _专利_临床

概要

基本信息

药物类型

中药

别名

Samital

靶点-

作用方式-

作用机制-

治疗领域

口颌疾病

在研适应症-

非在研适应症

化疗性口腔黏膜炎

原研机构

Indena SpA

在研机构-

非在研机构

Indena SpA

最高研发阶段无进展临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

1

项与 Samital 相关的临床试验

NCT01941992

/ Completed临床2期IIT

Role of SAMITAL® in Prevention and Treatment of Oral Mucositis in Patients Treated With Chemo-radiation (CT/RT)for Head-and-neck Squamous Cell Carcinomas. A Double-blind, Phase 2 Placebo Controlled, Randomized Trial.

The purpose of this study is to:
evaluate the activity of SAMITAL in reducing the incidence of severe mucositis in head-and-neck cancer patients undergoing chemo-radiotherapy.
assess tolerability of SAMITAL and the impact on patients reported outcomes.

开始日期2012-12-01

申办/合作机构

Istituto Oncologico Veneto

[+1]

100 项与 Samital 相关的临床结果

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100 项与 Samital 相关的转化医学

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100 项与 Samital 相关的专利（医药）

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8

项与 Samital 相关的文献（医药）

2025-02-01·Cancer Treatment Reviews

Managing strategies of chemotherapy and radiotherapy-induced oral mucositis

Review

作者: Wu, Yuqi ; Shi, Wenjin ; Qiu, Yan ; Chen, Qianming ; Luo, Xiaobo ; Jiang, Yuchen ; Li, Chunyu ; Liu, Xiangfei

Radiotherapy and chemotherapy are widely employed as primary non-surgical cancer treatments; however, their non-selective cytotoxicity often leads to adverse events such as oral mucositis (OM), particularly in head and neck cancer therapies. International guidelines provide recommendations for managing chemoradiotherapy-induced OM in various clinical contexts. Subsequently, emerging researches have introduced evidence supporting novel approaches or existing regimens for OM prevention and treatment. The repurposing of established drugs has garnered significant interest due to its shorter development timeline, improved safety profiles, and lower costs compared to new drug development. For example, clinical trials assessing established drugs such as melatonin, clonidine, and pentoxifylline indicate promising potential for managing OM. Additionally, several emerging pharmacological interventions have demonstrated considerable efficacy; SAMITAL and rhIL-11 are supported by phase II clinical trials and prospective studies, while probiotics like Streptococcus salivarius K12 and curcumin have shown effectiveness in randomized clinical trials. Furthermore, recent high-level studies have reinforced the efficacy of non-pharmacological interventions, such as photobiomodulation (PBM) and cryotherapy, over the past two years. In all, given the evidence supporting different strategies, PBM and oral cryotherapy are highly recommended for managing OM when feasible. Topical clonidine, melatonin, oral pentoxifylline, topical SAMITAL or rhIL-11, oral SsK12, and curcumin may also be utilized but would benefit from validation in larger trials. Besides, Verbascoside, Palifermin, Amifostine, and Avasopasem manganese can be suggested for OM management, while the side effects should be monitored. The accessibility and cost/effectiveness of specific managing strategies of OM should be considered when selecting appropriate options.

2022-11-01·European review for medical and pharmacological sciences

Administration of Samital® in children with oral mucositis: a feasibility study.

Article

作者: Paratella, A ; Bisogno, G ; De Salvo, G L ; Massano, D ; Petrangolini, G ; Riva, A ; Affinita, M C

OBJECTIVESAMITAL®, a botanical drug containing three highly standardized extracts (Vaccinium myrtillus, Macleaya cordata and Echinacea angustifolia), has shown promising results in treating or preventing oral mucositis (OM) in adult patients, but it has not been fully investigated in children. In this study, we assessed the feasibility of SAMITAL administration in pediatric patients receiving anticancer treatment to prevent or treat OM, focusing on identifying an appropriate dose and evaluating safety and tolerability and palatability and treatment compliance.PATIENTS AND METHODSWe conducted an open-label, monocentric, prospective study on 18 children receiving anticancer therapy to prevent or treat OM.RESULTSNo SAMITAL®-related side effects were observed or reported during the study; moreover, no systemic absorption of SAMITAL® metabolites was detected in the bloodstream. However, compliance to SAMITAL® was unsatisfactory and variable (from 2 to 100%), and patients reported low palatability (median taste of 4.8; range 1.0-8.0).CONCLUSIONSSAMITAL® administration appears to be safe in the pediatric population, as it is not absorbed in the bloodstream and does not cause any local or systemic side effects. However, the current formulation is only partially suitable for children, and future studies on SAMITAL® in children would need an adapted formulation to increase compliance.

2021-11-01·Supportive Care in Cancer

Medicinal plants used for the treatment of mucositis induced by oncotherapy: a systematic review

Review

作者: Eubank, Patrícia Leão Castillo ; Volpato, Luiz Evaristo Ricci ; Abreu, Lucas Guimaraes ; Violante, Ivana Povoa

PURPOSEThis systematic review aimed to identify effective medicinal plants for the treatment of mucositis induced by oncotherapy.METHODSThe clinical question was the following: "Which medicinal plants are effective in the treatment of oral mucositis induced by cancer treatment?" (PubMed, Medline, Web of Science, Scopus, Lilacs, and SciELO). The keywords were the following: phytotherapy OR "herbal drug" OR "plant extract" OR plant OR "medicinal plant" OR pharmacognosy OR ethnobotany OR ethnomedicine OR ethnopharmacology OR "flower essences" OR "natural product" AND mucositis OR mucositides OR stomatitis OR stomatitides OR "oral ulcer" AND chemotherapy OR radiotherapy OR immunotherapy OR cancer OR neoplasm OR neoplasm OR tumor OR tumor. The inclusion criteria for the selection of articles were the type of study design (clinical trials) and the studied population (cancer patients presenting lesions of oral mucositis having undergone treatment with medicinal plants).RESULTSAfter evaluation of the works, 24 of 893 articles were selected. Matricaria chamomilla (chamomilla) presented promising results, such as a reduction in severity and lesion incidence with improved pain symptomatology. The plant extracts Isatis indigótica, Olea europaea, Calendula officinalis, A. digitatae, and M. sylvestris improved the lesions. Mucotrol™ and QRLYD herbal products improved the degree of severity of the lesions, while SAMITAL® and MUCOSYTE allowed for greater pain control.CONCLUSIONThe complementary treatment of oral mucositis in cancer patients, with analgesic and anti-inflammatory actions with lower side effects, is an alternative for healthcare professionals.

100 项与 Samital 相关的药物交易

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