Chambers Mark S, Jones Christopher Uwe, Biel Merrill A, Weber Randal S, Hodge Kenneth M, Chen Y, Holland John M, Ship Jonathan A, Vitti Robert, Armstrong Ingrid, Garden Adam S, Haddad Robert
Department of Head and Neck Surgery, The University of Texas M. D. Anderson Cancer Center, Houston, TX 77030, USA.
Int J Radiat Oncol Biol Phys. 2007 Dec 1;69(5):1369-76. doi: 10.1016/j.ijrobp.2007.05.024. Epub 2007 Sep 12.
To assess the safety of long-term cevimeline treatment of radiation-induced xerostomia in patients with head-and-neck cancer; and to assess the efficacy of cevimeline in these patients.
A total of 255 adults with head-and-neck cancer who had received more than 40 Gy of radiation 4 months or more before entry and had clinically significant salivary gland dysfunction received cevimeline hydrochloride 45 mg t.i.d. orally for 52 weeks. Adverse events (AEs), their severity, and their relationship to the study medication were assessed by each investigator. The efficacy assessment was based on subjects' global evaluation of oral dryness on a scale of 0 (none) to 3 (severe).
Overall, 175 subjects (68.6%) experienced expected treatment-related AEs, most mild to moderate. The most frequent was increased sweating (47.5%), followed by dyspepsia (9.4%), nausea (8.2%), and diarrhea (6.3%). Fifteen subjects (5.9%) experienced Grade 3 treatment-related AEs, of which the most frequent was increased sweating. Eighteen subjects (7.1%) reported at least one serious AE, and 45 subjects (17.6%) discontinued study medication because of an AE. The global efficacy evaluation at the last study visit showed that cevimeline improved dry mouth in most subjects (59.2%). Significant improvement was seen at each study visit in the mean change from baseline of the numeric global evaluation score (p < 0.0001).
Cevimeline 45 mg t.i.d. was generally well tolerated over a period of 52 weeks in subjects with xerostomia secondary to radiotherapy for cancer in the head-and-neck region.
评估长期使用西维美林治疗头颈部癌患者放射性口干的安全性；并评估西维美林对这些患者的疗效。
共有255名头颈部癌成年患者，在入组前4个月或更长时间接受了超过40 Gy的放疗，且有临床上显著的唾液腺功能障碍，口服盐酸西维美林45 mg，每日三次，持续52周。每位研究者评估不良事件（AE）、其严重程度及其与研究药物的关系。疗效评估基于受试者对口腔干燥的整体评价，范围为0（无）至3（严重）。
总体而言，175名受试者（68.6%）经历了预期的与治疗相关的AE，大多为轻度至中度。最常见的是出汗增多（47.5%），其次是消化不良（9.4%）、恶心（8.2%）和腹泻（6.3%）。15名受试者（5.9%）经历了3级与治疗相关的AE，其中最常见的是出汗增多。18名受试者（7.1%）报告了至少一项严重AE，45名受试者（17.6%）因AE停用研究药物。最后一次研究访视时的整体疗效评估显示，西维美林改善了大多数受试者（59.2%）的口干症状。在每次研究访视中，数字整体评估评分相对于基线的平均变化均有显著改善（p < 0.0001）。
对于头颈部癌放疗后继发性口干的受试者，52周内每日三次服用45 mg西维美林通常耐受性良好。
