调神和胃方联合黛力新治疗肝胃不和型功能性消化不良临床研究

Clinical study of Tiaoshen Hewei Formula combined with deanxit in the treatment of functional dyspepsia due to liver-stomach disharmony

目的:探讨调神和胃方与黛力新联合治疗肝胃不和型功能性消化不良(FD)的疗效,以及对患者谷氨酸(Glu)、γ-氨基丁酸(GABA)、5-羟色胺(5-HT)表达水平、情绪状态以及胃肠动力的影响。方法:研究纳入96名确诊为FD且中医辨证为肝胃不和证的患者,随机分为观察组和对照组,每组48例。观察组最终完成临床治疗45例(脱落3例),对照组最终完成临床治疗44例(脱落4例)。在治疗方案上,对照组用黛力新治疗,观察组在对照组基础上联合调神和胃方治疗,治疗周期均为4周。研究评估治疗前后两组患者的中医证候评分、汉密尔顿焦虑量表(HAMA)评分、汉密尔顿抑郁量表(HAMD)评分;检测外周血清Glu、GABA、5-HT表达水平及胃动素(MTL)、胃泌素(GAS)水平;观察临床不良反应发生情况。结果:治疗后观察组患者的中医各单项证候(胃脘部胀满或疼痛、胁肋胀满、易情绪波动、嗳气、口干口苦)评分、焦虑和抑郁评分以及外周血清中Glu、5-HT水平明显下降,且低于对照组,差异有统计学意义(P<0.05);反酸烧心评分下降,但差异无统计学意义(P>0.05)。观察组外周血清中GABA、MTL、GAS水平显著上升,且高于对照组,差异有统计学意义(P<0.05)。观察组总有效率为84.4%(38/45),对照组为63.64%(28/44),差异有统计学意义(P<0.05)。结论:调神和胃方联合黛力新可有效改善肝胃不和型FD患者临床症状,值得推广。

Objective:To investigate the efficacy of Tiaoshen Hewei Formula combined with deanxit in the treatment of functional dyspepsia(FD)due to liver-stomach disharmony,as well as its effects on glutamate(Glu),γ-aminobutyric acid(GABA)expression level,emotional state,and gastrointestinal motility in patients with the disease.Methods:A total of 96 patients diagnosed with FD due to liver-stomach disharmony after syndrome differentiation were randomly divided into observation group and control group,with 48 cases in each group.The observation group finally completed the clinical treatment of 45 cases(3 cases dropped off),and the control group finally completed the clinical treatment of 44 cases(4 cases dropped off).In terms of treatment plan,patients in the control group were treated with deanxit,and patients in the observation group were treated with Tiaoshen Hewei Formula on the treatment basis of the control group.The treatment period was 4 weeks.The TCM syndrome score,Hamilton Anxiety Scale(HAMA)score,Hamilton Depression Scale(HAMD)score of the two groups were evaluated before and after treatment.The expression levels of Glu,GABA and 5-hydroxytryptamine(5-HT)in peripheral blood serum were measured.Motilin(MTL)level,gastrin(GAS)level andthe occurrence of clinical adverse reactions were measured.Results:After treatment,each TCM syndrome score(abdominal fullness or pain,lateral thorax fullness,emotional fluctuation,belching,dry mouth and bitter mouth),anxiety and depression scores,and the levels of Glu and 5-HT in peripheral blood serum in the observation group were significantly decreased,which were lower than those in the control group,the difference was statistically significant(P<0.05).There was no significant difference in acid reflux and heartburn syndrome score(P>0.05).The levels of GABA,MTL and GAS in peripheral blood serum in the observation group were significantly increased,which were higher than those in the control group,the difference was statistically significant(P<0.05).The total effective rate was 84.4%(38/45)in the observation group and 63.64%(28/44)in the control group,and the difference was statistically significant(P<0.05).Conclusion:Tiaoshen Hewei Formula combined with deanxit can effectively improve the clinical symptoms of FD patients due to liver-stomach disharmony,and it is worth promoting.