A Phase II Study of Biodegradable Stents Plus Palliative Radiotherapy in Oesophageal Cancer

AimsSelf-expanding metal stents provide rapid improvement of dysphagia in oesophageal cancer but are associated with complications. The aim of the present study was to test the effectiveness of an alternative treatment of combining biodegradable stents with radiotherapy.Materials and methodsA Simon two-stage single-arm prospective phase II trial design was used to determine the efficacy of biodegradable stents plus radiotherapy in patients with dysphagia caused by oesophagus cancer who were unsuitable for radical treatment. Fourteen patients were recruited and data from 12 were included in the final analyses.ResultsFive of 12 patients met the primary end point: one stent-related patient death; four further interventions for dysphagia within 16 weeks of stenting (41.7%, 95% confidence interval 15.2–72.3%). The median time to a 10-point deterioration of quality of life was 2.7 weeks. Nine patients died within 52 weeks of registration. The median time to death from any cause was 15.0 weeks (95% confidence interval 9.6–not reached).ConclusionThe high re-intervention observed, which met the pre-defined early stopping criteria, meant that the suggested alternative treatment was not sufficiently effective to be considered for a larger scale trial design. Further work is needed to define the place of biodegradable stents in the management of malignant oesophageal strictures.     

Effect and Safety of Tongyan Spray (通咽喷雾剂) on Hyoid Motion in Patients with Dysphagia after Ischemic Stroke

Objective: To observe the effects and safety of Tongyan Spray (通咽喷雾剂) on the range and time of hyoid motion in patients with ischemic post-stroke dysphagia. Methods: Seventy-two patients with ischemic post-stroke dysphagia were selected and randomly assigned to a treatment group (36 cases) and a control group (36 cases) by a random number table from January 2013 to October 2014. All patients swallowed 4 kinds of barium meals with different traits respectively, and each patient underwent video fluoroscopy (VF) examination twice. In the treatment group, Tongyan Spray was sprayed to the pharynx on both sides and the middle part once respectively. The spray was applied 30 min before the second examination. Purified water at room temperature was used as placebo in the control group. The changes in the range and time of hyoid motion in both groups were observed before and after treatment. Results: Six patients dropped out in each group, and 60 patients completed the study and were included in the final analysis. Significant improvement was observed in the range of superior hyoid excursion distance and the time of hyoid motion in the treatment group compared with the control group (P<0.05). There were no obvious adverse reactions observed in oral mucosa in both groups during the whole study. Conclusion: Tongyan Spray was an effective and safe medicine for improving swallowing function in patients with ischemic post-stroke dysphagia.     

针刺咽部腧穴治疗脑梗死后真性延髓麻痹:随机对照研究

目的:比较针刺患侧与针刺双侧咽部腧穴治疗脑梗死后真性延髓麻痹的临床疗效。方法:将66例脑梗死后真性延髓麻痹患者随机分为单侧组和双侧组,每组33例,最后每组各有1例脱落。两组患者在常规药物和电项针治疗的基础上,单侧组针刺患侧的吞咽、发音和治反流穴,双侧组针刺双侧吞咽、发音和治反流穴。每天1次,每周连续针刺6 d,休息1 d,治疗21 d后评定临床疗效。采用吞咽困难分级量表、洼田饮水试验和GRBAS分级评价两组患者治疗前后的吞咽和构音情况。结果:治疗21 d后,两组患者吞咽困难分级量表评分均提高(均P<0.01),且单侧组改善程度大于双侧组(P<0.01);两组患者GRBAS分级、洼田饮水试验情况均改善(均P<0.01),且单侧组改善程度大于双侧组(P<0.05,P<0.01)。结论:针刺患侧咽部腧穴治疗脑梗死后真性延髓麻痹较针刺双侧咽部腧穴疗效更优。