Cummins Martin J, Papas Athena, Kammer Gary M, Fox Philip C
Amarillo Biosciences, Inc., Amarillo, Texas 79101, USA.
Arthritis Rheum. 2003 Aug 15;49(4):585-93. doi: 10.1002/art.11199.
This study tested the safety and efficacy of human interferon (IFN) alfa for treatment of salivary hypofunction and dry mouth symptoms in primary Sjögren's syndrome patients.
Combined results are reported from 2 phase III clinical trials in which a total of 497 subjects with primary Sjögren's syndrome received 150 international units of human IFN alfa or matching placebo 3 times per day for 24 weeks by the oromucosal route.
Subjects given IFN alfa had a significantly (P = 0.01) greater mean increase in unstimulated whole saliva (UWS) flow, compared with subjects given placebo. In IFN alfa patients, increases in UWS correlated positively and significantly with improvements noted in 7 of 8 symptoms associated with oral and ocular dryness. The coprimary endpoints of stimulated whole saliva flow and oral dryness were not significantly improved in the IFN alfa group relative to placebo. No significant differences were found between the groups with respect to overall adverse event incidence or severity.
IFN alfa given at low dosage by the oromucosal route can significantly increase UWS flow in patients with primary Sjögren's syndrome, without causing significant adverse events.
本研究测试了人干扰素（IFN）α治疗原发性干燥综合征患者唾液分泌功能减退和口干症状的安全性和有效性。
报告了两项III期临床试验的综合结果，共有497例原发性干燥综合征患者通过口腔黏膜途径，每天3次接受150国际单位的人干扰素α或匹配的安慰剂治疗，持续24周。
与接受安慰剂的受试者相比，接受干扰素α的受试者未刺激全唾液（UWS）流量的平均增加显著更大（P = 0.01）。在干扰素α治疗的患者中，UWS的增加与8种口腔和眼部干燥相关症状中的7种症状的改善呈显著正相关。相对于安慰剂，干扰素α组的刺激全唾液流量和口腔干燥的共同主要终点没有显著改善。两组在总体不良事件发生率或严重程度方面没有发现显著差异。
通过口腔黏膜途径给予低剂量的干扰素α可以显著增加原发性干燥综合征患者的UWS流量，且不会引起显著不良事件。
