PHASE III RANDOMIZED STUDY: ORAL PILOCARPINE VERSUS SUBMANDIBULAR SALIVARY GLAND TRANSFER PROTOCOL FOR THE MANAGEMENT OF RADIATION-INDUCED XEROSTOMIA

被引：49

作者：

Jha, Naresh ^{[1
]}

Seikaly, Hadi ^{[2
]}

Harris, Jeffrey ^{[2
]}

Williams, David ^{[3
]}

Sultanem, Khalil ^{[4
]}

Hier, Michael ^{[5
]}

Ghosh, Sunita ^{[6
]}

Black, Martin ^{[5
]}

Butler, James ^{[7
,8
]}

Sutherland, Donna ^{[9
]}

Kerr, Paul ^{[9
,10
]}

Barnaby, Pam ^{[1
]}

机构：

[1] Univ Alberta, Cross Canc Inst, Dept Radiat Oncol, Edmonton, AB, Canada

[2] Univ Alberta, Dept Surg, Div Otolaryngol, Edmonton, AB, Canada

[3] Univ Alberta, Dept Surg, Div Head & Neck Surg, Edmonton, AB, Canada

[4] McGill Univ, Jewish Gen Hosp, Div Radiat Oncol, Dept Oncol, Montreal, PQ H3T 1E2, Canada

[5] McGill Univ, Jewish Gen Hosp, Div Otolaryngol, Dept Surg, Montreal, PQ H3T 1E2, Canada

[6] Univ Alberta, Cross Canc Inst, Dept Expt Oncol, Edmonton, AB, Canada

[7] Univ Manitoba, Dept Radiat Oncol, Canc Care Manitoba, Winnipeg, MB, Canada

[8] Univ Manitoba, Dept Radiol, Canc Care Manitoba, Winnipeg, MB, Canada

[9] Univ Manitoba, Dept Surg Oncol, Canc Care Manitoba, Winnipeg, MB, Canada

[10] Univ Manitoba, Dept Otolaryngol, Winnipeg, MB, Canada

来源：

HEAD AND NECK-JOURNAL FOR THE SCIENCES AND SPECIALTIES OF THE HEAD AND NECK | 2009年 / 31卷 / 02期

关键词：

xerostomia; salivary gland transfer procedure; radiation; pilocarpine; cancer; INTENSITY-MODULATED RADIOTHERAPY; QUALITY-OF-LIFE; DOSE RADIOIODINE TREATMENT; NECK-CANCER PATIENTS; DOUBLE-BLIND; NASOPHARYNGEAL CARCINOMA; CLINICAL-TRIALS; HEAD; AMIFOSTINE; EFFICACY;

D O I：

10.1002/hed.20961

中图分类号：

R76 [耳鼻咽喉科学];

学科分类号：

100213 ;

摘要：

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 COL) 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. (C) 2008 Wiley Periodicals, Inc. Head Neck 31: 234-243, 2009

引用

页码：234 / 243

页数：10

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