联合用药对上腹痛综合征患者的治疗效果

Clinical Research of Efficacy of Flupentixol and Melitracen Tablets Combine Proton Pump Inhibitor in Epigastric Pain Syndrome

目的:探讨氟哌噻吨美利曲辛片联合质子泵抑制剂治疗上腹痛综合征(EPS)的有效性和安全性。方法:将2011年6月-2012年5月笔者所在医院内科门诊及住院部收集的83例EPS患者按随机数字表对照法分为氟哌噻吨美利曲辛+奥美拉唑治疗组(联合治疗组)和奥美拉唑单纯治疗组(单纯治疗组),联合治疗组42例,单纯治疗组41例;联合治疗组予氟哌噻吨美利曲辛片10.5mg口服,每日早、中两次,同时予奥美拉唑肠溶胶囊20mg口服,每日早、晚两次;单纯治疗组予奥美拉唑肠溶胶囊20mg口服,每日早、晚两次;两组均连续服药4周,观察治疗后患者临床症状的改善情况,同时比较伴有焦虑或抑郁患者情绪状态的缓解情况。结果:本研究共纳入受试者83例,其中联合治疗组有2例、单纯治疗组有1例因病情好转而退出。两组患者年龄比较差异无统计学意义[t=-0.11,P=0.911,95%CI=(-6.10,5.45)];治疗前两组患者腹痛症状比较差异无统计学意义[VAS评分:t=0.80,P=0.426,95%CI=(-0.409,0.959)];治疗2周和4周后,两组患者临床症状均得到改善,联合治疗组总体效率(分别为85.00%和90.00%)优于单纯治疗组(分别为62.50%和70.00%,字2=5.23和5.00,P<0.05);治疗前两组伴有轻、中度焦虑症状的患者分别为72.5%(29/40)和82.5%(33/40),两组平均焦虑评分比较差异无统计学意义[t=-0.16,P=0.876,95%CI=(-2.063,1.763)];治疗2周与4周后两组评分均较前降低,联合治疗组评分(9.00±3.047、8.07±2.930)低于单纯治疗组(10.45±3.266、10.43±3.281),分别为[t=-2.05,P=0.043,95%CI=(-2.856,-0.044)]和[t=-3.38,P=0.001,95%CI=(-3.735,-0.965)];治疗前两组伴有轻、中度抑郁症状的患者分别为77.5%(31/40)和80.0%(32/40),两组平均抑郁评分比较差异无统计学意义[t=-0.22,P=0.825,95%CI=(-2.74,2.19)];治疗2周与4周后两组评分均较前降低,联合治疗组评分(10.85±3.541、10.20±3.421)低于单纯治疗组(12.80±4.730、12.73±4.630),分别为[t=-2.09,P=0.040,95%CI=(-3.812,-0.088)]和[t=-2.77,P=0.007,95%CI=(-4.340,-0.710)];治疗期间两组均未发生严重不良反应事件。结论:氟哌噻吨美利曲辛片联合PPI治疗上腹痛综合征疗效显著,具有较好的安全性。

Objective： To discuss the clinical efficacy and safety of flupentixol and melitracen tablets combine proton pump inhibitor in epigastric pain syndrome（EPS）.Methods： By using table of random number control method, a total of 83 patients collected in our outpatient and inpatient department from June 2011 to May 2012 were randomly divided into flupentixol and melitracen tablets combine omeprazole treatment group（the combination group）and omeprazole treatment group（the simple group）.There were 42 cases in the combination group, and 41 in the simple group.The combination group received flupentixol and melitracen tablets 10.5 mg oral administration, twice every morning and noon, and then omeprazole 20 mg oral administration, twice daily; The simple group received omeprazole 20 mg oral administration alone, twice daily.Two groups were received continuous treatment for 4 weeks.Doctors and patients recorded the improvement of clinical symptoms during the treatment, and compared the remission rate of patients with anxiety or depression.Results： This research incorporated 83 cases of patients, which contained 2 cases in the combination group and 1 case in the simple group were exited because of improved condition.There were no statistically significant about ages between two groups[t=-0.11, P=0.911, 95%CI=（-6.10, 5.45）]; Neither symptoms of pain before treatment[VAS score： t=0.80, P=0.426, 95%CI=（-0.409, 0.959）]; Clinical symptoms of patients in two groups were both improved after treatment for 2 weeks and 4 weeks, but the total effective rate in the combination group was higher than that of the simple group（85.00% and 90.00% vs 62.50% and 70.00%, ）（2=5.23 and 5.00, P〈0.05）; 72.5%（29/40） vs 82.5%（33/40）patients with mild-to-moderate anxious state in 2 groups before the treatment.There was no difference between two groups[t=-0.16, P=0.876, 95%CI=（-2.063, 1.763）]; The scores of 2 groups were both reduced after treatment for 2 weeks and 4 weeks, but the scores of the combination group was lower than that of the simple group[9.00 ＋ 3.047, 8.07 ± 2.930 vs 10.45 ± 3.266, 10.43 ± 3.281, respectively as t=-2.05, P=0.043, 95%CI=（-2.856, -0.044）and t=-3.38, P=O.001, 95%CI=（-3.735, -0.965）]; 77.5%（31/40） vs 80.0%（32/40） patients with mild-to-moderate depression state in 2 groups before the treatment. There was no difference between the 2 groups[t=-0.22, P=0.825, 95%CI=（-2.74, 2.19）].The scores of 2 groups were both reduced after treatment for 2 weeks and 4 weeks, but the scores of the combination group was lower than that of the simple group[10.85 ± 3.541, 10.20 ± 3.421 vs 12.80 ± 4.730, 12.73 ± 4.630, respectively as t=-2.09, P=0.040, 95%CI=（-3.812, -O.088）and t=-2.77, P=O.O07, 95%CI=（-4.340, -0.710）]; Both groups had not occurred serious adverse events during the treatment.Conehtsion： Flupentixol and melitraeen tablets combine proton pump inhibitor is efeectiveness and safety in epigastric pain syndrome.