III期随机研究：口服毛果芸香碱与下颌下唾液腺转移方案治疗放射性口干症
Phase III randomized study: oral pilocarpine versus submandibular salivary gland transfer protocol for the management of radiation-induced xerostomia.
作者信息
Jha Naresh, Seikaly Hadi, Harris Jeffrey, Williams David, Sultanem Khalil, Hier Michael, Ghosh Sunita, Black Martin, Butler James, Sutherland Donna, Kerr Paul, Barnaby Pam
机构信息
Department of Radiation Oncology, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada.
出版信息
Head Neck. 2009 Feb;31(2):234-43. doi: 10.1002/hed.20961.
BACKGROUND
Xerostomia is a serious morbidity of radiation treatment in head and neck cancer.
METHODS
We conducted a prospective phase III multicenter randomized study comparing submandibular salivary gland transfer (SGT) procedure with pilocarpine during and for 3 months after XRT. Salivary flow (baseline, stimulated) and University of Washington Quality of Life Questionnaire (U of W QOL) scores were measured. RESULTS.: An interim intent to treat analysis (120 patients) at 6 months shows superior results in SGT arm: median baseline salivary flow for SGT (0.04 mL/minute) versus pilocarpine (0.01 mL/minute), p = .001; median stimulated salivary flow (0.18 mL/minute) for SGT versus (0.05 mL/minute) for pilocarpine, p = .003. Scores (U of W QOL) for amount (p = .017) and consistency of saliva (p = .005) in favor of SGT leading to premature closure of study.
CONCLUSIONS
Submandibular SGT procedure is superior to pilocarpine in management of radiation-induced xerostomia.
背景
口干症是头颈部癌放射治疗的一种严重并发症。
方法
我们进行了一项前瞻性III期多中心随机研究，比较了下颌下唾液腺转移（SGT）手术与毛果芸香碱在放疗期间及放疗后3个月的效果。测量了唾液流量（基线、刺激后）和华盛顿大学生活质量问卷（UW QOL）评分。结果：6个月时的一项中期意向性治疗分析（120例患者）显示，SGT组的结果更优：SGT组的基线唾液流量中位数（0.04毫升/分钟）与毛果芸香碱组（0.01毫升/分钟）相比，p = 0.001；SGT组的刺激后唾液流量中位数（0.18毫升/分钟）与毛果芸香碱组（0.05毫升/分钟）相比，p = 0.003。唾液量（p = 0.017）和唾液黏稠度（p = 0.005）的评分（UW QOL）支持SGT组，导致研究提前结束。结论：下颌下SGT手术在治疗放射性口干症方面优于毛果芸香碱。
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