A Randomized controlled clinical trial on dose optimization of thalidomide in maintenance treatment for recurrent aphthous stomatitis
A Randomized controlled clinical trial on dose optimization of thalidomide in maintenance treatment for recurrent aphthous stomatitis
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DOI：
10.1111/jop.13259
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发表时间：
2021-11-19
影响因子：
3.3
通讯作者：
Tang, Guoyao
中科院分区：
文献类型：
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作者：
Deng, Yiwen;Wei, Wei;Tang, Guoyao
复发性阿弗他口炎（RAS）是最常见的口腔粘膜疾病，无溃疡期是患者最关心的问题。沙利度胺已被证明是治疗RAS的有效全身药物，但进行试验以评估各种维持剂量的价值是必要的。方法采用两阶段随机对照临床试验。首先，125例RAS患者均以泼尼松15 mg/d为起始剂量，连续治疗1周。其次，实验组100例RAS患者接受沙利度胺（50 mg/d vs. 25 mg/d）作为维持药物，观察其疗效和安全性。结果沙利度胺50 mg/d和25 mg/d在第4周末和第8周末的维持治疗中，在减少溃疡发生率、溃疡数量和溃疡疼痛方面的效果相当（均p > 0.05）。沙利度胺25 mg/d组无溃疡期明显长于其他组（均P < 0.05），平均>3个月。重要的是，使用25 mg/d沙利度胺组的总不良事件明显少于使用50 mg/d组（p < 0.001）。此外，50 mg/d沙利度胺对各种唾液细胞因子水平的影响并不上级25 mg/d药物（p > 0.05）。结论沙利度胺25 mg/d剂量优化方案可延长RAS复发时间，且安全性较好。
Background Recurrent aphthous stomatitis (RAS) is the most common oral mucosal disease, and ulcer-free periods are a major concern for patients. Thalidomide has been shown to be an effective systemic drug in the treatment of RAS, but the value of undertaking a trial to evaluate various maintenance doses was warranted. Methods We performed this randomized controlled clinical trial with a two-stage design. Firstly, all the 125 cases of RAS received prednisone at a starting dose of 15 mg/d for one week as an initial therapeutic drug. Secondly, the 100 cases of RAS in the experimental group received thalidomide (50 mg/d vs. 25 mg/d) as a maintenance drug to observe its efficacy and safety. Results During maintenance medication at the fourth and eighth weekend, the two doses (50 and 25 mg/d) of thalidomide were equivalent in reducing the incidence of ulcers, ulcer number, and ulcer pain, respectively (all p > 0.05). Notably, the ulcer-free period in the group using 25 mg/d thalidomide for eight weeks was longer (mean, >3 months) than those in the other groups (all p < 0.05). Importantly, the total adverse events in the group using 25 mg/d thalidomide were significantly less than those in the group using 50 mg/d (p < 0.001). Moreover, the effect of 50 mg/d thalidomide on the levels of various salivary cytokines was not superior to 25 mg/d medication (p > 0.05). Conclusion This dose optimization study concluded that 25 mg/d thalidomide had a long-term effect on extending the recurrence interval of RAS with better safety.