Department of Anaesthesiology and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12200, Berlin, Germany.
Department of Oral Medicine, Dental Radiology and Oral Surgery, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Assmannshauser Str. 4-6, 14197, Berlin, Germany.
Clin Oral Investig. 2018 Jan;22(1):305-311. doi: 10.1007/s00784-017-2112-4. Epub 2017 Mar 28.
The objective of this study was to investigate the effect of topical morphine on erosive/ulcerative lesions in patients with oral lichen planus (OLP). Previous studies reported on an enhanced remission of skin wounds when morphine was applied topically.
This was single-center, prospective, double-blind, placebo-controlled, randomized, multi-arm (3), phase II study (RCT). Patients diagnosed with erosive and/or ulcerative OLP applied 0.2 or 0.4 mg morphine dissolved in glycerine, three times a day for 5 days. The primary outcome was the extent of healing. Secondary outcomes were as follows: (1) effect on pain, (2) presence and severity of opioid-related central and local side effects, (3) whether patients required 'rescue medication' for treatment of pain, and (4) total intake of test substance.
A total of 123 patients were screened for eligibility, 45 patients were recruited into the study, and 43 completed it. Patients applied a solution of either placebo or 0.2 or 0.4% morphine in groups of n = 12, n = 15, and n = 16, respectively. Extent of healing was similar in the three groups. Severity of pain was minor pre-treatment and throughout the course of the study. Only minor adverse events were reported (dry mouth, burning sensation).
Morphine did not enhance wound healing compared to placebo-treated patients. Healing was observed in all groups, which may be attributed to an effect of glycerine or to the natural course of the disease. Patients experienced only mild levels of pain, rendering the model insensitive for assessing pain.
OLP is a chronic disease and current treatment options are limited. Healing occurred in all three study groups, an effect we attribute to the carrier.
本研究旨在探讨局部应用吗啡对口腔扁平苔藓（OLP）患者糜烂/溃疡性病变的影响。既往研究报道，局部应用吗啡可促进皮肤伤口愈合。
这是一项单中心、前瞻性、双盲、安慰剂对照、随机、多臂（3 臂）、II 期 RCT 研究。诊断为糜烂和/或溃疡性 OLP 的患者每天应用 0.2 或 0.4mg 溶于甘油的吗啡，每日 3 次，共 5 天。主要结局是愈合程度。次要结局如下：（1）对疼痛的影响，（2）阿片类药物相关的中枢和局部副作用的发生和严重程度，（3）患者是否需要“救援药物”治疗疼痛，以及（4）测试物质的总摄入量。
共有 123 名患者进行了筛选，45 名患者入组研究，43 名患者完成了研究。患者分别接受安慰剂或 0.2%或 0.4%吗啡溶液治疗，每组 n=12、n=15 和 n=16。三组患者的愈合程度相似。治疗前和整个研究过程中疼痛均较轻。仅报告了轻微的不良事件（口干、烧灼感）。
与安慰剂治疗组相比，吗啡并未促进伤口愈合。所有组均观察到愈合，这可能归因于甘油的作用或疾病的自然病程。患者仅经历轻度疼痛，使该模型对疼痛评估不敏感。
OLP 是一种慢性疾病，目前的治疗选择有限。所有三组研究组均出现愈合，我们将其归因于载体。
