Massachusetts General Hospital Oral and Maxillofacial Surgery, Boston, MA.
Department of Oral Medicine, Infection, and Immunity, Brigham and Women's Hospital Division of Oral Medicine and Dentistry, Harvard School of Dental Medicine, Boston, MA.
Transplant Cell Ther. 2021 Jun;27(6):480.e1-480.e5. doi: 10.1016/j.jtct.2021.02.020. Epub 2021 Feb 25.
The aim of this study is to analyze utilization patterns of prescription sialagogues for management of xerostomia in patients with chronic graft-versus-host disease (cGVHD) after allogeneic hematopoietic cell transplantation (alloHSCT). There have been several small reports describing the clinical use of sialagogue therapy in the management of patients with cGVHD. While these reports suggest that sialagogue therapy is safe and effective in this unique patient population, the numbers of patients reported, and overall evidence base, remain limited. The objective of this study was to characterize medication utilization and treatment outcomes in a cohort of patients with cGVHD and xerostomia who were prescribed sialagogue therapy. A retrospective chart review was conducted of patients who were diagnosed with cGVHD and prescribed sialagogue therapy for xerostomia from 2005 to 2019. Data collected included patient demographics, date of alloHSCT, date of oral cGVHD diagnosis, concurrent immunosuppressive medications, sialagogue regimen, worst xerostomia score (on a 1 to 10 scale), and patient-reported outcomes. The study included 70 patients managed with pilocarpine (n = 57) and cevimeline (n = 13), with a median age of 62 years (range: 24 to 82). Overall median duration of therapy was 7 months (range: 1 to 154). The baseline median self-reported worst xerostomia score was 6 of 10. Median percent reported improvement was 10%, 40%, and 50% for FU1 (<6 months), FU2 (6 to 12 months), and FU3 (>12 months) accordingly. Most patients who reported lower percentage improvement utilized the medication for less than 6 months, and those with moderate response were compliant for longer than 6 months. When all patients were considered, there was a significant reduction (median of 1.5 points; range: 0 to 7) in the xerostomia score from pre (median: 6.5; range: 1 to 10) to post (median: 5; range: 0 to 10) (P< .001). Most common side effects were nausea (2.9%) and diarrhea (1.4%). Patients with cGVHD and xerostomia reported improvement in symptoms with sialagogue therapy and remained on medication for a median of 7 months with infrequent side effects. The sustained duration of therapy suggests perceived benefits, though prospective, blinded, and randomized studies are needed.
本研究旨在分析异基因造血细胞移植(alloHSCT)后慢性移植物抗宿主病(cGVHD)患者使用处方唾液剂治疗口干的利用模式。有几项小型报告描述了唾液剂治疗在 cGVHD 患者管理中的临床应用。虽然这些报告表明,唾液剂治疗在这一独特的患者群体中是安全有效的,但报告的患者数量和整体证据基础仍然有限。本研究的目的是描述一组被诊断为 cGVHD 并接受唾液剂治疗口干的患者的药物利用情况和治疗结果。对 2005 年至 2019 年期间被诊断为 cGVHD 并开具唾液剂治疗口干的患者进行了回顾性图表审查。收集的数据包括患者人口统计学特征、alloHSCT 日期、口腔 cGVHD 诊断日期、同时使用的免疫抑制剂、唾液剂治疗方案、最严重口干评分(1 到 10 分)和患者报告的结果。研究纳入了 70 名接受毛果芸香碱(n=57)和西维美林(n=13)治疗的患者,中位年龄为 62 岁(范围:24 至 82 岁)。总体中位治疗持续时间为 7 个月(范围:1 至 154 个月)。基线时自我报告的最严重口干评分中位数为 10 分中的 6 分。FU1(<6 个月)、FU2(6 至 12 个月)和 FU3(>12 个月)时报告的改善中位数分别为 10%、40%和 50%。大多数报告改善百分比较低的患者使用药物治疗时间不到 6 个月,而反应中等的患者使用药物治疗时间超过 6 个月。考虑到所有患者,口干评分从治疗前(中位数:6.5;范围:1 至 10)到治疗后(中位数:5;范围:0 至 10)显著降低(中位数为 1.5 分;范围:0 至 7)(P<0.001)。最常见的副作用是恶心(2.9%)和腹泻(1.4%)。患有 cGVHD 和口干症的患者报告使用唾液剂治疗后症状有所改善,并在中位数为 7 个月的时间内持续使用药物,副作用发生频率较低。持续的治疗时间表明存在获益,尽管需要前瞻性、盲法和随机研究。