| Objective: The present study aims to investigate the effect of Xiangsha Liujunzi decoction combined with Xujiang Xie’s acupuncture(Xie’s Wuguan Tongjing Tieqi acupuncture)woo reflux pharyngitis of spleen deficiency and phlegm dampness,so as to evaluate the feasibility and safety of the combined therapy and its mechanism,so as to provide evidence and theoretical basis for the treatment.To lay the foundation for the promotion of this combination therapy.Methods: A total of 80 subjects conforming to the diagnostic criteria of this subject were randomly divided into Xiangsha Liujunzi decoction combined with Xujiang Xie’s acupuncture combined treatment group(acupuncture and drug group)and Omepazole enteric capsule treatment group(western medicine group)at 1:1,with 40 cases in each group.The patients in the acupuncture plus medication group were treated with Xiangsha Liujunzi decoction one dose a day combined with Xie ’s Wuguan Tongjing Tieqi acupuncture three times a week.The patients in the western medication group were treated with omeprazole enteric-coated capsules20 mg twice a day.The condition assessment form based on the laryngopharyngeal reflux index(RSI)scale and the reflux finding score(RFS)scale were used to evaluate the condition grade and signs of the subjects before and after treatment,and the collected data were analyzed by statistical tools.The effective rate,adverse reaction rate and recurrence rate of the two groups were obtained to evaluate the efficacy and safety of the treatment regimen.Results:(1)Comparison within the acupuncture plus medication group:the total score of disease assessment scale was 15.75±1.878 at the beginning and 6.63±3.767 at the end of the treatment course,and the total therapeutic effect difference was 9.125±2.848(P=0.00).The total score of the physical signs assessment form was 10.10±2.790 at the beginning and 6.40±2.854 at the end of the treatment.The total therapeutic effect difference was 3.70±1.539,and the difference was statistically significant(P=0.00).In the preparation stage,a total of 40 cases were observed,and the total number of adverse reactions was 3 cases(not excluded),and the adverse reaction rate was 7.5%.After the end of the treatment cycle,a total of 37 subjects had a total score of less than13 points in the disease assessment scale,which was below the diagnostic criteria of LPRD.After 3 months of drug withdrawal,3 subjects were followed up by telephone,and the recurrence rate was 8.1%.(2)Intra-group comparison in the western medicine group: the total score of the disease assessment scale was 15.82±1.691 at the beginning and 7.90±3.664 at the end of the treatment course,and the total therapeutic effect difference was 8.000±2.909,P=0.00 after paired difference analysis within the group.The total score of the physical signs assessment form was 10.17±2.432 at the beginning and 6.54±2.671 at the end of the treatment.The total therapeutic effect difference was3.66±1.410(P=0.00 after paired difference analysis).In the preparation stage,40 cases were observed,and the total number of adverse reactions was 6 cases(not excluded),the adverse reaction rate was 15.0%.After the end of the treatment cycle,a total of 36 subjects had a total score of less than 13 points in the disease assessment scale,which was below the diagnostic criteria of LPRD.After 3 months of drug withdrawal,12 subjects had recurrence of symptoms,and the recurrence rate was 33.3%.(3)Comparison between the two groups: in the acupuncture plus medication group,11 cases were markedly effective,23 cases were effective,and 34 cases were effective,with a total effective rate of85.0%.In the western medicine group,9 cases were markedly effective,23 cases were effective,the total effective number was 32,and the total effective rate was 80.0%.The difference of the total therapeutic effect between the two groups was analyzed by independent sample T test P=0.84(> 0.05),and there was no statistically significant difference between the two groups.Except for the item of pharyngeal foreign body sensation(P=0.007),there was no statistically significant difference between the two groups(P=0.618,P=0.307,P=0.484,P=0.778,P=0.587,P=0.618).P=0.702,P=0.867,P=0.246).Independent sample T test analysis showed that there was no significant difference in the therapeutic effect of the physical signs evaluation table(P=0.865),and there was no significant difference in each item(P=0.914,P=0.754,P=0.512).The adverse reaction rate was analyzed by chi-square test,P=0.131,there was no statistically significant difference.The 3-month recurrence rate was analyzed by chi-square test,P=0.011,and the difference was statistically significant.Conclusion:(1)Xiangsha Liujunzi Decoction combined with Xujiang Xie’s acupuncture and PPI can effectively treat LPRD of spleen deficiency and phlegm dampness with similar effects.(2)The combination of Xiangsha Liujunzi decoction and Xujiang Xie’s acupuncture has a significant effect on the treatment of pharyngeal foreign body sensation,and has obvious advantages over PPI.In the improvement of hoarseness or speech difficulty,frequent throat clearing,phlegm or nasal runny flu,swallowing food,tablets or water have obstruction,after eating or lying down cough,respiratory restriction or frequent asphyxia,chronic cough,heartburn,chest pain,stomach pain symptoms and PPI has the same effect.There was no significant difference between the two groups in the improvement of false vocal fold sulcus,laryngeal ventricle disappearance,erythema or congestion,vocal fold edema,diffuse laryngeal edema,posterior commissure hyperplasia,granuloma,and viscous mucus attachment in the larynx.(3)The Xiangsha Liujunzi decoction combined with Xujiang Xie’s acupuncture and PPI has a low incidence of adverse reactions and high safety,which is suitable for wide clinical use.(4)The combination of Xiangsha Liujunzi decoction and Xujiang Xie’s acupuncture has a lower recurrence rate in three months than PPI treatment alone,it is more significant to improve the long-term quality of life of patients. |
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