Lee R, Yeo S T, Rogers S N, Caress A L, Molassiotis A, Ryder D, Sanghera P, Lunt C, Scott B, Keeley P, Edwards R T, Slevin N
The Christie, Research and Development, Manchester, United Kingdom.
Bangor University, Centre for Health Economics and Medicines Evaluation (CHEME), School of Healthcare Sciences, Bangor, United Kingdom.
Br J Oral Maxillofac Surg. 2018 May;56(4):283-291. doi: 10.1016/j.bjoms.2018.02.012. Epub 2018 Mar 9.
Our aim was to compare the efficacy of the Therabite jaw motion rehabilitation system (Atos Medical) with that of wooden spatulas to relieve and prevent trismus in patients who have had radiotherapy for stage three and four oral and oropharyngeal cancer. Secondary aims were to assess the feasibility and the impact of exercise on health-related quality of life (QoL), and the use of health services after treatment. We designed a randomised, open-label, controlled, three-centre feasibility study to compare the effectiveness and cost of the Therabite and wooden spatulas. We studied compliance with exercises and health-related QoL, assessed cost using three health economics measures, and conducted semistructured interviews with patients. Patients were randomised into two groups: the Therabite group (n=37) and the wooden spatula group (n=34). All patients had some sense of jaw tightening before the study started. Mean mouth opening after six months increased in both groups, but the difference between the groups was not significant (p=0.39). Completion rates for the three economic measures were good. There was no significant difference between the two groups in frequency of contact with care services or in QoL. Exercises during and after radiotherapy can ameliorate trismus in patients with stage three and four oral and oropharygeal cancers, but differences between groups in efficacy, compliance, QoL, or use of hospital or community health services, were not significant.
我们的目的是比较Therabite颌运动康复系统（阿托斯医疗公司）与木质压舌板在缓解和预防接受过三期和四期口腔及口咽癌放疗患者的牙关紧闭方面的疗效。次要目的是评估锻炼对健康相关生活质量（QoL）的可行性和影响，以及治疗后卫生服务的使用情况。我们设计了一项随机、开放标签、对照、三中心的可行性研究，以比较Therabite和木质压舌板的有效性和成本。我们研究了锻炼的依从性和与健康相关的生活质量，使用三种卫生经济学指标评估成本，并对患者进行半结构化访谈。患者被随机分为两组：Therabite组（n = 37）和木质压舌板组（n = 34）。所有患者在研究开始前都有一定程度的颌部紧绷感。两组患者六个月后的平均开口度均有所增加，但两组之间的差异不显著（p = 0.39）。三种经济指标的完成率良好。两组在与护理服务的接触频率或生活质量方面没有显著差异。放疗期间及放疗后的锻炼可改善三期和四期口腔及口咽癌患者的牙关紧闭情况，但两组在疗效、依从性、生活质量或医院或社区卫生服务的使用方面的差异并不显著。
