Objective:The clinical efficacy and safety of this combination formula in patients with RE with reflux pharyngolaryngitis of liver and stomach stagnant heat type were evaluated by observing the TCM symptom score,pharyngeal reflux RSI and RFS score,gastroscopic esophageal mucosal grading,and values related to 24-hour pH-impedance monitoring of the esophagus in patients with RE with reflux pharyngolaryngitis of liver and stomach stagnant heat type by combining Qing You Huan Gargle Formula with Jia Wei Xuan Dai Formula.Methods: The 93 patients who met the inclusion criteria were selected as the study subjects and randomly divided into 31 cases in group A,30 cases in group B and 32 cases in group C.In group A: rabeprazole sodium enteric dissolved tablets orally + plus-flavored whirlpool formula orally + clearing and gargling formula with gargling;group B: rabeprazole sodium enteric dissolved tablets orally + plus-flavored whirlpool formula orally;group C:rabeprazole sodium enteric dissolved tablets orally;all three groups were treated for 3 months,and the three groups were compared at the end of the course of treatment The clinical efficacy was evaluated by comparing the symptom scores,gastroscopic esophageal inflammation grading,pharyngeal reflux RSI and RFS scores,and changes in esophageal 24-hour pH-impedance monitoring values before and after treatment.Results:1.Comparison of clinical efficacy: After treatment,the observed indexes of the three groups improved compared with those before treatment(P < 0.05),and the total effective rate of group A was 96.66%,that of group B was 86.6%,and that of group C was 80.0%.When comparing the total effective rate of the three groups after treatment,the clinical efficacy of group A was better than that of groups B and C(P < 0.05),and the clinical efficacy of group B was better than that of group C(P < 0.05).2.Comparison of total TCM symptom scores: After treatment,all three groups had improvement effect on TCM symptoms compared with pre-treatment(P < 0.05),group A had better improvement effect than groups B and C(P < 0.05),and group B had better efficacy than group C(P < 0.05).3.Comparison of the grading of primary and secondary symptom scores of the three groups after treatment: ① Patients in group A were better than group C in improving the symptoms of acid reflux,heartburn,foreign body sensation in the throat,throat clearing action,hoarseness,dry mouth and bitterness,chest fullness and irritability(P<0.05);group A was better than group B in improving the throat symptoms(P<0.05).Except for throat symptoms,there was no significant difference between group A and group B in improving other symptoms(P>0.05).(ii)Except for throat symptoms,group B was better than group C in improving other symptoms(P<0.05).there was no significant difference between group B and group C in improving throat symptoms(P>0.05).The efficacy of the three groups in improving the symptoms of dry stool was the same(P>0.05).4.Gastroscopic comparison: before and after comparing the three groups of white light gastroscopic esophageal inflammation grading,all three groups of drugs could repair the esophageal mucosa(P < 0.05);groups A and B were better than group C in improving esophageal mucosal inflammation(P <0.05),but there was no significant difference between groups A and B in repairing esophageal mucosal inflammation(P > 0.05).5.Comparison of RSI scores and RFS scores for pharyngeal reflux symptoms: the values of the scores decreased in all three groups after treatment compared with those before treatment(P < 0.05);the overall improvement of pharyngeal symptoms and signs after treatment was significantly better in group A than in groups B and C(P < 0.05).there was no significant difference between groups B and C(P > 0.05).6.Comparison of esophageal 24-hour pH-impedance monitoring indexes:the number of total refluxability,percentage of acid reflux,number of long reflux,longest reflux time,and DeMeester score values were lower in all three groups after treatment(P < 0.05);groups A and B were better than group C in reducing esophageal acid exposure(P < 0.05),and there was no significant difference between groups A and B in reducing esophageal acid exposure(P > 0.05).Conclusion(s): 1.Through the study,the combination of Qing You Huan Gargle Formula and Jia Wei Xuan Dai Formula for the treatment of RE with reflux pharyngitis of liver and stomach stagnant heat type can significantly improve the intraesophageal symptoms such as acid reflux and heartburn and the symptoms of liver and stomach stagnant heat such as dry mouth and bitterness,chest and fullness,significantly improve the inflammation of esophageal mucosa,and significantly reduce the patients’ esophageal acid exposure compared with the treatment with western medicine alone.2.Compared with the treatment with internal medicine alone,this combined formula can significantly improve patients’ pharyngeal symptoms such as pharyngeal foreign body sensation and hoarseness,and has significant efficacy on mucosal inflammation in the hypopharynx.3.In conclusion,the clinical efficacy of the Qing Yu Gargle Formula combined with the addition of flavor spinoderm formula in the treatment of RE with reflux laryngitis is accurate,safe and reliable in clinical application,and worthy of promotion. |