| Backgroud:Stroke is one of the common reasons leading to dysphagia. Currently, many methods can treat dysphagia after stroke, such as oral taking Chinese medicine, acupuncture, swallowing function rehabilitation training. These methods have certain limitations, so it is difficult to get extensive application in clinical. Give full play to the advantages of traditional Chinese medicine, seeking effective treatment for post-stroke dysphagia, it is significant to promote rehabilitation and to improve the prognosis of patients.Objective:For the main pathogenesis of post-stroke dysphagia, we made oropharyngeal topical spray based on therapy of relieving throat and opening orifice. The purpose of this research is to clear the effectiveness and safety of treatment in dysphagia after stroke, to provide convenient, safe, and effective method in clinical.Methods:We collect the 80 cases of dysphagia after stroke patients, treatment group of 40 cases,40 cases of the control group. Both groups give conventional treatment and swallowing rehabilitation, the treatment group receives traditional Chinese medicine treatment of oropharyngeal spray, using a placebo treatment of oropharyngeal spray in control group. One course is 28 days. We judge comprehensive clinical curative effect by standardized swallowing assessment (SSA), At last, we observe efficacy within each group, and the efficacy between the two groups after treatment. According to swallowing function grading scales, we divide the patients into two subgroups, and compare efficacy in different subgroups of patients, and evaluate efficacy of different treatments in different subgroups. In addition, we record advese reactions in the treatment of the two groups and evaluate safety of two treatment methods. At the end of the treatment course, we will collect the data, using SPSS18.0 sofeware system for statistical analysis.Results:1. Baseline comparison of the treatment group and the control groupTwo groups of age, sex, stroke type, formerly medical history had no significant difference (P>0.05); Scores of SSA before treatment had no significant difference (P>0.05); so they could compare.2. Comparison of the two groupsScores of SSA had improved within each group, there was statistically siginificant difference (P<0.05). Clinical evaluation of the two groups were compared after treatment, the treatment group:1 case cured, effective 27 cases, invalid 12 cases; the control group:1 case cured, effective 16 cases, invalid 22 cases, there was statistically significant difference (P<0.05). The total effectiveness of treatment group is 70%,the total effectiveness of control group is 43.6%, there was statistically significant difference (P<0.05). After treatment, improvement of SSA scores had statistically significant difference (P<0.05).3. Baseline comparison of the two subgroupsThe two subgroups of age, sex, stroke type, formerly medical history had no significant difference (P>0.05); Scores of SSA before treatment had no significant difference in two subgroups (P>0.05); so they could compare.4. Comparison of the two subgroups1 level dysphagia patients:Observed 16 cases in the treatment group: effective 7 cases, invalid 9 cases, the total efficiency of 43.8%; observed 14 cases in the control group:effective 2 cases, invalid 12 cases, the total efficiency of 14.3%, there was no signifiacant difference in two groups of total effectiveness comparative (P>0.05). After treatment, improvement of SSA scores had no significant difference (P>0.05), but the SSA scores of treatment group reached lower than those of control group.2～3 level dysphagia patients:We observed 24 cases in the treatment group: effective 21 cases, invalid 3 cases, the total efficiency of 87.5%; observed 25 cases in the control group:effective 15 cases, invalid 10 cases, the total efficiency of 60.0%, there was statistically signifiacant difference in two groups of total effectiveness comparative (P<0.05). After treatment, improvement of SSA scores had statistically significant difference (P<0.05).5. Safety evaluation:In the process of treatment, it did not happen adverse reactions between treatment group and control group.Conclusion:1. Therapy of relieving throat and opening orifice is proven effectively, and better than the control group, especially in the patients with 2～3 level dysphagia patients, without obvious advantages to 1 level dysphagia patients.2. For 1 level dysphagia patients, effectiveness comparative of two groups had not statistically significant difference, the treatment group summed score reaches lower than the control group, which indicating these two groups have the trend to differ in efficacy.3. In the course of the study, this medicine shows saf ty and no adverse reactions, we provide safe and no side effect of treatment. It is worthy of expand sample size in merit further clinical research. |
PDF Full Text Request