Clinical Study on Tongyan Spray(通咽喷雾剂) for Post-Stroke Dysphagia Patients:A Randomized Controlled Trial

Objective： To observe the effectiveness and safety of Tongyan Spray （通咽喷雾剂） composed of Chinese medicine for post-stroke dysphagia patients. Method： One hundred and twenty-two post-stroke dysphagia patients were randomly assigned to the treatment group （61 cases） and the control group （61 cases）. Basic treatment was given to both groups, with Tongyan Spray additionally used in oropharynx for the treatment group, and the placebo used for the control group. After 28-day treatment, the clinical effect and safety were evaluated according to the standard swallowing assessment （SSA） scale. Results： One patient dropped out in each group, and 120 patients reached the final analysis of the study. The total effective rate for the treatment group was 71.7% （43/60）, higher than 46.7% （28/60） in the control group （P〈0.05）, and the improvement on SSA scores of the two groups were significantly different after treatment （P〈0.05）. For grade 1 dysphagia patients （completely depending on nasogastric tube）, the effective rate of the treatment group was 40.9% （9/22）, and 12.5% （2/16） of the control group, without significant difference （P〉0.05）, while the improvement of SSA score was significantly different between the two groups after treatment （P〈0.05）. For grade 2-3 dysphagia patients （oral and nasogastric tube feeding）, the total effective rate of the treatment group was 89.5% （34/38）, higher than 59.1% （26/44） in the control group （P〈0.05）, and also the improvement on SSA scores was significantly different between the two groups after treatment （P〈0.05）. Conclusion： Tongyan Spray was an effective and safe method for post-stroke dysphagia patients.

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.