氟哌噻吨美利曲辛片联合常规治疗对功能性消化不良疗效的临床研究

Treatment of Functional Dyspepsia with Flupentixol and Melitracen Tablets:A Randomized,Controlled Study

目的选择常规促胃肠动力剂、PPI治疗效果不佳的患者,给予氟哌噻吨美利曲辛片联合治疗,评价联合治疗的临床疗效。方法病例选自2011年10月～2012年8月在北京友谊医院消化内科门诊就诊的功能性消化不良(FD)患者,根据FD临床亚型分为餐后不适综合征(PDS)和上腹痛综合征(EPS),分别给予莫沙必利和奥美拉唑治疗4周。对于治疗效果不佳的患者随机分为继续莫沙必利或奥美拉唑常规治疗组和氟哌噻吨美利曲辛片联合莫沙必利或奥美拉唑治疗组,比较常规治疗组和联合治疗组的症状改善情况和治疗有效率。结果共纳入200名患者,男性89例,女性111例,PDS组92例,EPS组108例。PDS组莫沙必利治疗的总有效率63.0%,EPS组奥美拉唑治疗的有效率为70.3%。PDS组和EPS组中分别有34例和32例患者治疗效果不佳,随机进入治疗的第二阶段。PDS组中氟哌噻吨美利曲辛片联合治疗的总有效率为52.9%。EPS组中氟哌噻吨美利曲辛片联合治疗的总有效率为50.0%。结论对于常规治疗效果不佳的患者联合应用氟哌噻吨美利曲辛片,可以改善患者的焦虑抑郁情绪,从而改善患者的临床症状。

Objective To investigate the therapeutic effect of prokinetic agent （mosapride） on the postprandial distress syndrome （PDS） and proton pump inhibitor （omeprazoie） on the epigastric pain syndrome （EPS）. In addition, the effect of antidepressants （Flupentixol and melitracen tablets） was assessed as the second-step therapy. Methods 200 patients with PDS and EPS based on Rome Ⅲ criteria of functional dyspepsia（FD） in Outpatient Department at Gastroenterology of Beijing Friendship Hospital, from October 2011 to August 2012 were enrolled. PDS patients were at first given mosapride citrate 5 mg for 4 weeks. EPS patients were given omeprazole 20 mg for 4 weeks. When symptoms were not relieved patients received flupentixol and melitracen tablets with mosapride/omeprazole, or only mosapride/omeprazole for 4 weeks randomly. Results The total effectiveness rate of mosapride was 63.0% （58/92） and omeprazole was 70.3% （76/108）. There are 34 and 32 patients with no response to mosapride or omeprazole respectively. Compared with the mosapride-treated patients, mosapride combine with flupentixol and melitracen tablets therapy decreased significantly the total symptoms score （ P 〈 0.05 ）, and had marked therapeutic effect on the bothersome postprandial fullness and early satiety in PDS, effectiveness rates of mosapride on PDS were 52.9%. Similarly, compared with the omeprazole-treated patients ,omeprazole combine with flupentixol and melitracen therapy decreased significantly the total symptoms score, and had marked therapeutic effect on the the pain and burning sensation localized to epigastrium in EPS,effectiveness rates on EPS was 50.0%. Conclusion In conclusion, our study indicates that both mosapride and omeprazole are beneficial for FD patients in the first-step therapy. When the flupentixol and melitracen tables applied for non-responded cases in the first-step therapy, symptoms were reduced in more than 50% within 4 weeks without any adverse reaction or dropout.