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基于乳香的乳膏预防乳腺癌辅助放疗皮肤损伤的安全性和有效性的临床评估:一项随机安慰剂对照试验

Clinical evaluation of safety and efficacy of Boswellia-based cream for prevention of adjuvant radiotherapy skin damage in mammary carcinoma: a randomized placebo controlled trial.

作者信息

Togni S, Maramaldi G, Bonetta A, Giacomelli L, Di Pierro F

机构信息

Indena S.p.A., Milan, Italy.

出版信息

Eur Rev Med Pharmacol Sci. 2015 Apr;19(8):1338-44.

Abstract

OBJECTIVE

Acute radiation erythema and other skin reactions are common adverse effects experienced by breast carcinoma patients undergoing radiotherapy treatment. Boswellic acids are pentacyclic triterpenes extracted from the resins of the tropical tree Boswellia serrata with strong anti-inflammatory properties. This study was designed to evaluate the safety and the efficacy of the application of a base cream containing boswellic acids in a proprietary formulation (Bosexil(R)) for the prevention and relief of radiation-induced adverse effects in breast cancer patients.

PATIENTS AND METHODS

The acute skin reactions were clinically evaluated by visual intensity and computer-assisted skin color analysis, and toxicity was assessed by the Radiation Therapy Oncology Group (RTOG) rating scale.

RESULTS

These findings indicate that the use of a boswellia-based cream is effective in reducing the use of topical corticosteroids and is able to reduce the grade of erythema and the skin superficial symptoms, being well tolerated by the patients.

CONCLUSIONS

Further studies comparing boswellia cream with other topical agents will be appropriate to confirm the effectiveness of this treatment for breast cancer patients under radiation therapy.

摘要

目的

急性放射性红斑和其他皮肤反应是接受放射治疗的乳腺癌患者常见的不良反应。乳香酸是从热带树木乳香的树脂中提取的五环三萜,具有很强的抗炎特性。本研究旨在评估一种含有乳香酸的专利配方基础乳膏(Bosexil®)在预防和缓解乳腺癌患者放疗引起的不良反应方面的安全性和有效性。

患者与方法

通过视觉强度和计算机辅助皮肤颜色分析对急性皮肤反应进行临床评估,并通过放射肿瘤学组(RTOG)分级量表评估毒性。

结果

这些发现表明,使用基于乳香的乳膏可有效减少局部皮质类固醇的使用,并能够降低红斑等级和皮肤表面症状,患者耐受性良好。

结论

进一步比较乳香乳膏与其他局部用药的研究将有助于证实这种治疗方法对接受放疗的乳腺癌患者的有效性。

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