加味半夏泻心汤对功能性消化不良患者的疗效和胃功能学的影响

The efficacy of Modified Banxia Xiexin Decoction on patients with functional dyspepsia and its impact on gastric function

目的探讨加味半夏泻心汤对功能性消化不良(FD)患者的疗效和胃功能学的影响。方法前瞻性选择2021年6月至2022年12月于温州市中心医院消化内科门诊符合罗马Ⅳ诊断标准的FD患者56例,采用加味半夏泻心汤治疗4周,采用上消化道症状严重程度指数评分评估临床疗效,采用标准液体营养餐胃负荷试验和标准固体餐胃排空试验评估胃功能,比较治疗前和治疗结束时的消化不良症状总积分、近端胃最大饱感阈值、近端胃初始饱感阈值和5 h固体胃排空率。观察治疗期间和治疗后随访4周内不良反应事件(如恶心、腹泻、头晕、皮疹等)的发生情况。统计学方法采用Wilcoxon秩和检验和配对t检验。结果FD患者治疗后痊愈14例,显效22例,有效12例,无效8例,总有效率为85.71%(48/56)。治疗结束时消化不良症状总积分低于治疗前[3.00分(1.00分,4.00分)比13.00分(8.00分,18.00分)],差异有统计学意义(Z=-7.96,P<0.001);治疗结束时近端胃最大饱感阈值和5 h固体胃排空率均高于治疗前[(897.45±98.82)mL比(588.46±60.26)mL、(87.59±12.74)%比(36.59±15.95)%],差异均有统计学意义(t=19.98、18.70,均P<0.001);治疗前后的近端胃初始饱感阈值比较[(131.84±52.91)mL比(130.0±47.61)mL],差异无统计学意义(P>0.05)。治疗期间和治疗后随访4周均未发现与研究相关的不良反应事件。结论加味半夏泻心汤可提高FD患者近端胃容受性和胃排空功能,改善消化不良症候群,临床疗效好且安全性高。

Objective To investigate the efficacy of Modified Banxia Xiexin Decoction on patients with functional dyspepsia(FD)and its impact on gastric function.Methods From June 2021 to December 2022,at the Department of Gastroenterology,Wenzhou Central Hospital,a total of 56 patients with FD who met the diagnostic criteria of RomeⅣwere prospectively enrolled.The patients were treated with Modified Banxia Xiexin Decoction for 4 weeks.The clinical efficacy was evaluated by the upper gastrointestinal symptom severity index score.The gastric function was assessed by standard gastric loading test of liquid nutrient meal and standard gastric emptying test of solid meal.The total scores of dyspeptic symptoms,the maximal satiety threshold of proximal stomach,the initial satiety threshold of proximal stomach and 5-hour solid gastric emptying rate were compared before and after the treatment.During the treatment and in 4-week follow-up after treatment,the adverse events(such as nausea,diarrhea,dizziness and rash)were observed.Wilcoxon rank sum test and paired sample t-test were used for statistical analysis.Results After the treatment,14 FD patients were cured,22 patients showed significant improvement,12 patients had response,and 8 patients showed no improvement.The total efficacy rate was 85.71%(48/56).The total score of dyspepsia symptoms after the treatment was lower than that before treatment(3.00(1.00,4.00)vs.13.00(8.00,18.00)),and the difference was statistically significant(Z=-7.96,P<0.001).After the treatment,the maximal satiety threshold of proximal stomach and 5-hour solid gastric emptying rate were both higher than those before treatment((897.45±98.82)mL vs.(588.46±60.26)mL,(87.59±12.74)%vs.(36.59±15.95)%),and the differences were statistically significant(t=19.98 and 18.70,both P<0.001).The initial satiety threshold of proximal stomach before and after treatment was compared((131.84±52.91)mL vs.(130.0±47.61)mL),and the difference was not statistically significant(P>0.05).No adverse events related to this study were observed during treatment period and in the 4-week follow-up.Conclusions The Modified Banxia Xiexin Decoction can improve proximal gastric compliance and gastric emptying function in patients with FD.Additionally,it can alleviate dyspeptic symptoms and have good clinical efficacy and high safety.