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首页> 外文期刊>Journal of pharmaceutical care. >Pimecrolimus versus Placebo in Minor, Recurrent Aphthous Stomatitis: A Randomized Double-blind Controlled Trial
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Pimecrolimus versus Placebo in Minor, Recurrent Aphthous Stomatitis: A Randomized Double-blind Controlled Trial

机译：吡美莫司与安慰剂在轻微复发性口疮性口炎中的应用：一项随机双盲对照试验

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Background: Oral aphthous is one of the most common oral mucosal inflammatory disorders which are very painful. There is no definite medical strategy up to now for aphthous treatment. Recently, some researchers have focused on immunomodulatory drugs such as tacrolimus and pimecrolimus in preventing aphthus recurrences. The aim of this study is to assess the effect of pimecrolimus cream against placebo in management of oral minor aphthous.Methods: The study is a randomized clinical trial, was done in “Shariati” hospital and Isfahan Skin Research Center. 62 patients with minor aphthuos were included and divided randomly to two groups (31 in each). In experimental group, pimecrolimus cream was applied for two weeks and cold cream for the same duration in control group. Patients were followed for 3 and one week; results were assessed in recovery after drug administration. Compared variables between two groups were including: the size of lesions, the time to recovery and pain intensity.Results: Results showed that mean size lesion in experimental and placebo group after complete recovery reduced (23.6 ±15.3 and 24.8 ±15 mm respectively) but it was not significant (P: 0.1). Mean time for recovery in both groups was 8±2.2 and 9.5±2.5 respectively which was significant in pimecrolimus treated patients (P: 0.014). Also mean degree for pain intensity measured by pain scale method was reduced significantly in test group (6 ± 1.2 before treatment and 5.3 ± 1.1 after treatment, P<0.001).Conclusion: This study stated that pimecrolimus cream has an appropriate effect in reduction of recovery time and pain in minor aphthous compared to placebo but more clinical studies are needed to better conclusion.
机译：背景：口疮是最常见的口腔粘膜炎性疾病之一，非常痛苦。到目前为止，尚无明确的治疗口疮的医疗策略。近来，一些研究人员集中在他克莫司和吡美莫司等免疫调节药物上以预防口疮复发。这项研究的目的是评估吡美莫司乳膏对安慰剂在口腔小口疮治疗中的作用。方法：该研究是一项随机临床试验，在“ Shariati”医院和伊斯法罕皮肤研究中心进行。纳入62例轻度口疮患者，随机分为两组（每组31例）。在实验组中，吡美莫司乳膏使用了两个星期，而冷霜在对照组中使用了相同的时间。随访3周和1周。在给药后评估恢复的结果。两组之间的比较变量包括：病变大小，恢复时间和疼痛强度。结果：结果显示，实验组和安慰剂组的平均大小病变在完全恢复后减少了（分别为23.6±15.3和24.8±15 mm），但差异不显着（P：0.1）。两组的平均恢复时间分别为8±2.2和9.5±2.5，这在接受吡美莫司治疗的患者中有显着意义（P：0.014）。试验组的疼痛强度平均水平也显着降低（治疗前为6±1.2，治疗后为5.3±1.1，P <0.001）。结论：本研究表明吡美莫司乳膏具有减轻疼痛的作用。与安慰剂相比，小口疮的恢复时间和疼痛程度更高，但需要更多的临床研究来得出更好的结论。

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