丁螺环酮治疗功能性消化不良自身对照研究

Efficacy of buspirone in patients with functional dyspepsia in a self-controlled trial

目的观察丁螺环酮治疗功能性消化不良的疗效及安全性。方法83例常规治疗疗效差的功能性消化不良患者,随机分为对照组(41例)和丁螺环酮组(42例)进行自身对照试验。对照组继续应用常规药物治疗,丁螺环酮组在常规药物治疗础上加用丁螺环酮治疗。评估治疗前后餐后饱胀感、腹部胀满感、早饱、恶心、嗳气、上腹痛、呕吐和上腹部烧灼感8个症状及消化不良症状总积分(DSS),记录不良反应。结果本次研究丁螺环酮组脱落2例,对照组脱落1例,最后共纳入研究80例。治疗前,丁螺环酮组餐后饱胀积分(2.25±0.44)分、腹部胀满积分(1.20±0.94)分、早饱积分(1.55±0.50)分、恶心积分(1.25±0.71)分、嗳气积分(1.16±0.69)分、上腹痛积分(1.22±0.72)分、呕吐积分(0.35±0.48)分、上腹部烧灼积分(0.70±0.73)分、DSS(9.80±1.81)分;对照组餐后饱胀积分(2.10±0.50)分、腹部胀满积分(1.30±1.02)分、早饱积分(1.50±0.51)分、恶心积分(1.20±0.63)分、嗳气积分(0.95±0.39)分、上腹痛积分(1.15±0.66)分、呕吐积分(0.45±0.50)分、上腹部烧灼积分(0.65±0.60)分、DSS(9.35±1.63)分。治疗后,丁螺环酮组餐后饱胀积分(1.35±0.49)分、腹部胀满积分(1.18±0.75)分、早饱积分(0.75±0.54)分、恶心积分(1.15±0.58)分、嗳气积分(1.05±0.60)分、上腹痛积分(0.95±0.63)分、呕吐积分(0.25±0.44)分、上腹部烧灼积分(0.55±0.60)分、DSS(7.48±1.63)分;对照组餐后饱胀积分(2.03±0.42)分、腹部胀满积分(1.25±0.87)分、早饱积分(1.35±0.58)分、恶心积分(1.10±0.58)分、嗳气积分(0.85±0.39)分、上腹痛积分(0.95±0.55)分、呕吐积分(0.40±0.51)分、上腹部烧灼积分(0.60±0.59)分、DSS(8.98±1.59)分。治疗前两组餐后饱胀、腹部胀满、早饱、恶心、嗳气、上腹痛、呕吐和上腹部烧灼积分及DSS比较,差异无统计学意义(P>0.05)。丁螺环酮组治疗前后餐后饱胀积分、早饱积分、DSS比较差异有统计学意义(P<0.05);腹部胀满、恶心、嗳气、上腹痛、呕吐和上腹部烧灼积分比较,差异无统计学意义(P>0.05)。对照组治疗前后餐后饱胀、腹部胀满、早饱、恶心、嗳气、上腹痛、呕吐和上腹部烧灼积分及DSS比较,差异无统计学意义(P>0.05)。治疗前后患者血液检查无明显异常,仅有1例患者在使用丁螺环酮时出现轻微一过性头晕,能够耐受,未中断治疗。对照组患者1例出现轻微恶心,无呕吐。结论丁螺环酮可以有效改善功能性消化不良患者餐后饱胀感、上腹部胀满感、早饱感症状,改善消化不良症状总评分,且安全性好。

Objective To observe the efficacy and safety of buspirone in patients with functional dyspepsia in a self-controlled trial.Methods A total of 83 patients with functional dyspepsia who got poor effect after conventional medicine were randomly divided into a control group(41 patients)and a buspirone group(42 patients)to conduct a self-control trial.The control group continued to be treated with conventional medication,while the buspirone group was treated with buspirone on the basis of conventional medication.The eight symptoms of postprandial fullness,abdominal fullness,early satiety,nausea,belching,epigastric pain,vomiting and epigastric burning and the total dyspeptic symptom score(DSS)was evaluated,and the adverse reactions were recorded.Results In this study,2 cases dropped out in the buspirone group and 1 case dropped out in the control group,and finally a total of 80 cases were included in the study.Before treatment,the buspirone group had postprandial fullness score of(2.25±0.44)points,abdominal fullness score of(1.20±0.94)points,early satiety score of(1.55±0.50)points,nausea score of(1.25±0.71)points,belching score of(1.16±0.69)points,epigastric pain score of(1.22±0.72)points,vomiting score of(0.35±0.48)points,epigastric burning score of(0.70±0.73)points and DSS of(9.80±1.81)points;the control group had postprandial fullness score of(2.10±0.50)points,abdominal fullness score of(1.30±1.02)points,early satiety score of(1.50±0.51)points,nausea score of(1.20±0.63)points,belching score of(0.95±0.39)points,epigastric pain score of(1.15±0.66)points,vomiting score of(0.45±0.50)points,and epigastric pain score of(0.45±0.50)points,epigastric burning score of(0.65±0.60)points and DSS of(9.35±1.63)points.After treatment,the buspirone group had postprandial fullness score of(1.35±0.49)points,abdominal fullness score of(1.18±0.75)points,early satiety score of(0.75±0.54)points,nausea score of(1.15±0.58)points,belching score of(1.05±0.60)points,epigastric pain score of(0.95±0.63)points,vomiting score of(0.25±0.44)points,epigastric burning score of(0.55±0.60)points and DSS of(7.48±1.63)points;the control group had postprandial fullness score of(2.03±0.42)points,abdominal fullness score of(1.25±0.87)points,early satiety score of(1.35±0.58)points,nausea score of(1.10±0.58)points,belching score of(0.85±0.39)points,epigastric pain score of(0.95±0.55)points,vomiting score of(0.40±0.51)points,epigastric pain score of(0.40±0.51)points,epigastric burning score of(0.60±0.59)points and DSS of(8.98±1.59)points.Before treatment,there was no statistically significant difference between the two groups in the comparison of postprandial fullness,abdominal fullness,early satiety,nausea,belching,epigastric pain,vomiting and epigastric burning scores and DSS(P>0.05).The postprandial fullness score,early satiety score,and DSS in the buspirone group were compared before and after treatment,and the differences were statistically significant(P<0.05).There was no statistically significant difference in the comparison of abdominal fullness,nausea,belching,epigastric pain,vomiting and epigastric burning scores in the buspirone group(P>0.05).The postprandial fullness,abdominal fullness,early satiety,nausea,belching,epigastric pain,vomiting and epigastric burning scores and DSS in the control group were compared before and after treatment,and the differences were statistically significant(P>0.05).There were no significant abnormalities in the blood tests of the patients before and after treatment,and only 1 patient experienced mild transient dizziness while using buspirone,which was tolerated without interruption of treatment.1 patient in the control group developed mild nausea without vomiting.Conclusion Buspirone can effectively improve the symptoms of postprandial fullness,epigastric distention and early satiety in patients with functional dyspepsia,and improve the total score of dyspepsia symptoms with high safety.