Sugai Susumu, Takahashi Hiroki, Ohta Shuji, Nishinarita Makoto, Takei Masami, Sawada Shigemasa, Yamaji Ken, Oka Hiroshi, Umehara Hisanori, Koni Ichiro, Sugiyama Eiji, Nishiyama Susumu, Kawakami Atsushi
Kanazawa Medical University, Ishikawa, Japan.
Mod Rheumatol. 2009;19(2):114-24. doi: 10.1007/s10165-008-0141-1. Epub 2008 Dec 17.
The effects of rebamipide on dry mouth and salivary secretion in Sjögren's syndrome patients were investigated in a double-blind placebo-controlled study. Rebamipide (100 mg TID) or placebo was administered for eight weeks and patient-assessed improvement of dry mouth and increase in salivary secretion measured by the Saxon test were evaluated. At two, four, and eight weeks, dry mouth improvement rates were, respectively, 26.0, 44.0, and 46.9% for rebamipide and 20.0, 27.1, and 39.1% for placebo, and mean increases in salivary secretion were, respectively, 0.14, 0.24, and 0.35 g for rebamipide and 0.03, 0.09, and 0.17 g for placebo, indicating higher values in the rebamipide group for both parameters at all timepoints but no significant differences between the two groups. Analysis by baseline characteristics suggested a statistically significant salivary secretion increasing effect of rebamipide in cases of primary Sjögren's syndrome. No difference in the incidence of adverse events was seen between the two groups, confirming the safety of rebamipide. As a salivary secretion increasing effect was strongly suggested in cases of primary Sjögren's syndrome, further study on the administration of rebamipide for the treatment of dry mouth in patients with Sjögren's syndrome is required.
在一项双盲安慰剂对照研究中，调查了瑞巴派特对干燥综合征患者口干及唾液分泌的影响。给予瑞巴派特（100毫克，每日三次）或安慰剂，为期八周，并评估患者自我评估的口干改善情况以及通过萨克森试验测量的唾液分泌增加情况。在第2周、第4周和第8周时，瑞巴派特组的口干改善率分别为26.0%、44.0%和46.9%，安慰剂组分别为20.0%、27.1%和39.1%；唾液分泌的平均增加量，瑞巴派特组分别为0.14克、0.24克和0.35克，安慰剂组分别为0.03克、0.09克和0.17克，表明在所有时间点，瑞巴派特组这两个参数的值均更高，但两组之间无显著差异。根据基线特征进行的分析表明，瑞巴派特对原发性干燥综合征患者的唾液分泌有统计学上显著的增加作用。两组不良事件发生率无差异，证实了瑞巴派特的安全性。由于强烈提示瑞巴派特对原发性干燥综合征患者有唾液分泌增加作用，因此需要进一步研究瑞巴派特用于治疗干燥综合征患者口干的给药情况。
