局部胰岛素脂质体制剂治疗复发性阿弗他溃疡:一项随机安慰剂对照试验。

Naglaa M. El-Wakeel, Nadia M. Morsi, Dalia M. Ghorab, Ghada E. Yassin, Marwa H. S. Dawoud
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引用次数: 6

摘要

目的评价胰岛素脂质体凝胶外用治疗阿弗他溃疡的疗效。方法80名患有轻微阿弗他溃疡的参与者被随机分为外用胰岛素脂质体凝胶或安慰剂凝胶(每天一次),持续6天。结果评估包括疼痛的视觉模拟评分(VAS)(主要结果),次要结果包括溃疡持续时间和使用口腔健康影响档案14(OHIP-14)治疗对生活质量的影响。在VAS治疗后1、2、3、4和6天以及OHIP-14治疗后6天对结果进行测试。结果对于疼痛评分,测试组显示出随时间的显著下降,这从第1天开始就很明显(P<.001);在第3天,中位数和四分位间距(IQR)值为0(0-1)。对于安慰剂组,在基线和第1天之间报告了随时间的无显著变化;在第3天,中位数为7(IQR,7-9)。试验组的平均持续时间明显低于安慰剂组(P<0.001)。6天后OHIP-14评分显示试验组的评分明显低于安慰剂(P<.001)。结论:口服胰岛素脂质体制剂在治疗阿弗他溃疡方面表现出显著的有效性。
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Topical insulin-liposomal formulation in management of recurrent aphthous ulcers: A randomized placebo-controlled trial

Aim

To evaluate the effectiveness of topical insulin-liposomal gel in aphthous ulcer treatment.

Methods

80 participants with minor aphthous ulcers were randomly divided to receive either topical insulin-liposomal gel or placebo gel (once daily) for 6 days. Assessment of outcomes included visual analog scale (VAS) for pain (primary outcome), and secondary outcomes included ulcer duration and impact of treatment on quality of life using the Oral Health Impact Profile 14 (OHIP-14). Testing of the outcomes was carried out at 1, 2, 3, 4 and 6 days after treatment for VAS and at 6 days for OHIP-14.

Results

For pain scores, the test group showed a significant decrease by time, this was evident from day 1 (P < .001); at day 3, median and interquartile range (IQR) values were 0 (0-1). For the placebo group, a non-significant change by time was reported between baseline and day 1; at day 3, the median value was 7 (IQR, 7-9). The test group showed significantly lower mean duration than the placebo group (P < .001). OHIP-14 scores after 6 days showed that the test group had a significantly lower score than placebo (P < .001).

Conclusions

Topical insulin-liposomal formulation showed marked effectiveness in management of aphthous ulcers.

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来源期刊
Journal of Investigative and Clinical Dentistry
Journal of Investigative and Clinical Dentistry DENTISTRY, ORAL SURGERY & MEDICINE-
CiteScore
3.90
自引率
0.00%
发文量
0
期刊介绍: Journal of Investigative and Clinical Dentistry (JICD) aims to publish quality, peer reviewed original research and topical reviews on all aspects of investigative and clinical dentistry and craniofacial research, including molecular studies related to oral health and disease. Although international in outlook, the Editor especially encourages papers from the Asia Pacific. The journal also aims to provide clinicians, scientists and students of dentistry with a knowledge transfer platform for rapid publication of reports through an international journal, which will be available free online until 2012. Its scope, therefore, is broad, inclusive and international, but with a particular focus on Asia Pacific. The Editor welcomes manuscripts in the following key thematic areas in oral and maxillofacial sciences: Community Dentistry and Oral Epidemiology, Conservative Dentistry, Dental Biomaterials, Dental Pedagogy, Endodontics and Traumatology, Implant Dentistry, Oral Biosciences, Oral and Maxillofacial Surgery, Oral Medicine, Oral Pathology and Oral Microbiology, Orthodontics, Oral Radiology, Oral Rehabilitation, Paedodontics, Periodontology and Periodontal Medicine.
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