Efficacy and tolerability of oral lactoferrin supplementation in mild to moderate acne vulgaris: an exploratory study
Efficacy and tolerability of oral lactoferrin supplementation in mild to moderate acne vulgaris: an exploratory study
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口服乳铁蛋白补充剂治疗轻度至中度寻常痤疮的功效和耐受性：一项探索性研究
DOI：
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发表时间：
2011
影响因子：
2.3
通讯作者：
V. Brantl
中科院分区：
文献类型：
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作者：
E. Mueller;Sonja Trapp;A. Frentzel;W. Kirch;V. Brantl
摘要目的：乳铁蛋白是一种天然防御性铁结合蛋白，具有抗菌和抗炎活性。已经提出了对炎性疾病的有益的全身作用。本研究的目的是探讨口服牛乳铁蛋白补充剂在轻度至中度面部寻常痤疮受试者中的疗效和耐受性。研究方法：在这项开放标签、单组研究中，入组了43名青少年和年轻人，每天两次服用牛乳铁蛋白咀嚼片制剂，持续8周。主要疗效终点是与基线相比痤疮病灶计数的改善。根据不良事件频率评价耐受性。结果：39例受试者（年龄17.5 ± 3.8岁）按照方案完成了研究。在研究结束时（第8周），炎性病变计数平均减少20.2%（−2.2 ± 7.0，p = 0.054），非炎性病变计数为23.5%（−6.2 ± 9.8，p < 0.001），与基线相比，观察到总病变计数为22.5%（−8.4 ± 13.1，p < 0.001）。研究结束时，76.9%（30/39）的受试者显示总病变计数减少。炎症性痤疮病变的结果在研究过程中是可变的。试验期间，无受试者发生乳铁蛋白相关不良事件。结论：尽管一项非对照、开放标签研究存在局限性，但本研究的结果表明，乳铁蛋白在轻度至中度寻常痤疮中耐受性良好，并且当作为膳食补充剂每日两次给药时，可能导致大多数受影响青少年和年轻人的痤疮病变计数总体改善。需要进行更长时间的随机、安慰剂对照试验。
Abstract Objective: Lactoferrin, an innate defense iron-binding protein, possesses antimicrobial and anti-inflammatory activities. Beneficial systemic effects on inflammatory diseases have been proposed. The aim of the present study was to explore the efficacy and tolerability of oral bovine lactoferrin supplementation in subjects with mild to moderate facial acne vulgaris. Methods: In this open-label, single-arm study, 43 adolescents and young adults were enrolled to take a chewable tablet formulation of bovine lactoferrin twice daily for 8 weeks. The primary efficacy endpoint was the improvement in acne lesion counts compared with baseline. Tolerability was evaluated on the basis of adverse event frequencies. Results: Thirty-nine subjects, aged 17.5 ± 3.8 years, completed the study per protocol. At the end of the study (week 8), a mean reduction in inflammatory lesion count of 20.2% (−2.2 ± 7.0, p = 0.054), in non-inflammatory lesion count of 23.5% (−6.2 ± 9.8, p < 0.001), and in total lesion count of 22.5% (−8.4 ± 13.1, p < 0.001) was observed as compared with baseline. At study conclusion, 76.9% (30 of 39) of subjects showed a reduction in total lesion count. The results for inflammatory acne lesions were variable over the study course. None of the subjects experienced a lactoferrin-related adverse event during the trial. Conclusion: Despite the limitations of an uncontrolled, open-label study, the results from this study indicate that lactoferrin in mild to moderate acne vulgaris is well tolerated and may lead to an overall improvement in acne lesion counts in the majority of affected adolescents and young adults when administered as a dietary supplement on a twice daily regimen. Further randomized, placebo-controlled trials of longer duration appear warranted.