Wong Raimond K W, Jones Glenn W, Sagar Stephen M, Babjak Angelica-Fargas, Whelan Tim
Department of Medicine, Division of Radiation Oncology, McMaster University, Hamilton, ON, Canada.
Int J Radiat Oncol Biol Phys. 2003 Oct 1;57(2):472-80. doi: 10.1016/s0360-3016(03)00572-8.
Recent studies have suggested that acupuncture may improve radiation-induced xerostomia with an increase in the median salivary flow rate and sustained symptom relief. An acupuncture-like transcutaneous nerve stimulation method (Codetron) without invasive needles was developed to mimic acupuncture treatment. This Phase I-II study examined the effectiveness of Codetron in treating radiation-induced xerostomia.
Patients with symptomatic xerostomia after radical radiotherapy for head-and-neck cancer but with evidence of residual salivary function were recruited into the study. Two 6-week courses of Codetron treatment of acupuncture points preselected according to traditional Chinese medicine principles were given with a 2-week break between each course. Basal and citric acid-primed whole saliva production were measured at baseline and up to 1 year after treatment completion. Xerostomia symptoms were assessed by a five-item xerostomia symptom questionnaire with a visual analog scale and quality of life was evaluated using the Head and Neck Radiotherapy Questionnaire.
We enrolled 46 patients in the study. All patients had received radiotherapy doses of >or=50 Gy to bilateral head-and-neck fields, including the parotid glands. Of the 46 patients, 37 completed the follow-up assessments at 3 and 6 months after treatment completion. No Codetron treatment-related complications occurred. Improvement in xerostomia symptoms was noted, with a mean increase in the visual analog scale score of 86 (p < 0.0005) and 77 (p < 0.0001) at 3 and 6 months after treatment completion, respectively. For all patients, the increase in the mean basal and citric acid-primed whole saliva production at 3 and 6 months after treatment completion was also statistically significant (p < 0.001 and p < 0.0001, respectively). No statistically significant change in the quality-of-life evaluation compared with baseline was observed.
The results suggest that Codetron treatment improves whole saliva production and related symptoms in patients with radiation-induced xerostomia. The treatment effects were sustained for at least 6 months after Codetron treatment completion. A prospective randomized Phase III trial with appropriate controls is being planned.
近期研究表明，针灸可通过提高唾液流量中位数和持续缓解症状来改善放射性口干。一种无侵入性针头的类似针灸的经皮神经刺激方法（Codetron）被开发出来以模拟针灸治疗。这项I-II期研究考察了Codetron治疗放射性口干的有效性。
招募头颈部癌根治性放疗后出现症状性口干但有残余唾液功能证据的患者进入研究。根据中医原理预先选择穴位进行两个为期6周的Codetron治疗疗程，每个疗程之间休息2周。在基线时以及治疗完成后长达1年的时间里测量基础唾液和柠檬酸激发后的全唾液分泌量。通过一项带有视觉模拟量表的五项口干症状问卷评估口干症状，并使用头颈放疗问卷评估生活质量。
我们招募了46名患者进入研究。所有患者双侧头颈部区域，包括腮腺，均接受了≥50 Gy的放疗剂量。46名患者中，37名在治疗完成后3个月和6个月完成了随访评估。未发生与Codetron治疗相关的并发症。观察到口干症状有所改善，在治疗完成后3个月和6个月时，视觉模拟量表评分平均分别提高了86（p < 0.0005）和77（p < 0.0001）。对于所有患者，治疗完成后3个月和6个月时基础唾液和柠檬酸激发后的全唾液分泌量的平均增加也具有统计学意义（分别为p < 0.001和p < 0.0001）。与基线相比，生活质量评估未观察到统计学上的显著变化。
结果表明，Codetron治疗可改善放射性口干患者的全唾液分泌及相关症状。Codetron治疗完成后，治疗效果至少持续6个月。正在计划进行一项有适当对照的前瞻性随机III期试验。
