Hide Michihiro, Hirata Kazuya, Komorita Naruyasu, Kubo Hajime, Suzuki Takamasa, Tanaka Ayaka, Aoki Hiroshi
Department of Dermatology, Graduate School of Biomedical and Health Sciences, Hiroshima University.
Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation.
Arerugi. 2020;69(3):174-183. doi: 10.15036/arerugi.69.174.
Histamine H1 receptor antagonists (antihistamines) are recommended as adjunctive therapy for atopic dermatitis (AD). However, their long-term usefulness and the effect of updosing have not been clarified.
To analyzed the long-term usefulness and the effect of updosing of rupatadine, a second generation antihistamine, for patients with AD.
Efficacy and safety of rupatadine were evaluated in 66 AD patients, including 50 patients with dose escalation by post hoc analysis of the phase III trial of rupatadine for Japanese patients with pruritus associated with skin diseases.
The mean score at baseline total pruritus score (TPS) was 4.682. It decreased to 3.885 at 2 weeks, and 2.376 at 52 weeks by rupatadine administration. The change (of one week after baseline TPS) was significant. Baseline TPS of dose escalation groups, either after 2 weeks or after week 4, were higher than those of 10mg maintenance dose cases, but no significant difference was shown in the change from baseline TPS among the groups at 52 weeks. The occurrence of adverse drug reactions and somnolence were observed in 19.7% and 15.2% of the subjects.
These results suggest the long-term usefulness of rupatadine for pruritus in AD.
组胺H1受体拮抗剂（抗组胺药）被推荐作为特应性皮炎（AD）的辅助治疗药物。然而，其长期疗效及增加剂量后的效果尚未明确。
分析第二代抗组胺药卢帕他定对AD患者的长期疗效及增加剂量后的效果。
对66例AD患者评估卢帕他定的疗效和安全性，其中50例患者通过对卢帕他定治疗日本皮肤疾病伴瘙痒患者的III期试验进行事后分析来增加剂量。
基线时总瘙痒评分（TPS）的平均分数为4.682。服用卢帕他定后，2周时降至3.885，52周时降至2.376。（与基线TPS相比1周后的）变化具有显著性。在2周或4周后增加剂量组的基线TPS高于10mg维持剂量组，但在52周时各组从基线TPS的变化中未显示出显著差异。19.7%的受试者出现药物不良反应，15.2%的受试者出现嗜睡。
这些结果表明卢帕他定对AD瘙痒具有长期疗效。
