CAJ | 학술논문

目的探讨氟哌塞吨美利曲辛(黛力新)与莫沙必利联合治疗功能性消化不良的临床疗效及不良反应.方法选择符合罗马Ⅲ诊断标准的功能性消化不良患者120例,随机分为观察组和对照组.观察组予以黛力新1片(氟哌塞吨0.5 mg、美利曲辛10 mg)/次口服,2次/d(早、中)；莫沙必利5mg/次口服,3次/d(饭前).对照组予以奥美拉唑20 mg/次口服,1次/d(上午饭前)；莫沙必利5 mg/次口服,3次/d(饭前).分别在治疗第1、2、4周对比有效率及不良反应,同时记录两组治疗前后餐后饱胀不适,早饱感,上腹痛和上腹部烧灼感4项症状评分.结果共计102例患者完成了4周的治疗随访,其中观察组52例,对照组50例.两组治疗后症状均有所改善,观察组在1、2周及4周疗效均高于对照组(65％与46％,75％与56％,88％与64％),差异均有统计学意义(x2值分别为3.885、4.083、5.976,P均＜0.05).治疗后观察组4项症状评分均低于治疗前,差异均有统计学意义(t值分别为35.725、29.116、41.167、2.908;P均＜0.05),治疗后对照组4项症状评分亦均低于治疗前(t值分别为18.760、16.201、31.497、14.940;P均＜0.05).治疗后观察组的4项症状评分均低于对照组,除上腹部烧灼感以外(t=1.872,P＞0.05),餐后饱胀不适,早饱感,上腹痛3项症状与对照组比较差异均有统计学意义(t值分别为33.943、26.672、19.035；P均＜0.05).氟哌塞吨美利曲辛嗜睡、头晕的副作用高于对照组(13.3％与1.7％),差异有统计学意义(x2=4.324;P ＜0.05).结论氟哌塞吨美利曲辛、莫沙必利联合治疗功能性消化不良疗效确实,明显优于奥美拉唑、莫沙必利联合的对照组,未见氟哌塞吨美利曲辛严重的不良反应,安全性良好.
목적 탐토불고새둔미리곡신(대력신)여막사필리연합치료공능성소화불량적림상료효급불량반응.방법 선택부합라마Ⅲ진단표준적공능성소화불량환자120례,수궤분위관찰조화대조조.관찰조여이대력신1편(불고새둔0.5 mg、미리곡신10 mg)/차구복,2차/d(조、중)；막사필리5mg/차구복,3차/d(반전).대조조여이오미랍서20 mg/차구복,1차/d(상오반전)；막사필리5 mg/차구복,3차/d(반전).분별재치료제1、2、4주대비유효솔급불량반응,동시기록량조치료전후찬후포창불괄,조포감,상복통화상복부소작감4항증상평분.결과 공계102례환자완성료4주적치료수방,기중관찰조52례,대조조50례.량조치료후증상균유소개선,관찰조재1、2주급4주료효균고우대조조(65％여46％,75％여56％,88％여64％),차이균유통계학의의(x2치분별위3.885、4.083、5.976,P균＜0.05).치료후관찰조4항증상평분균저우치료전,차이균유통계학의의(t치분별위35.725、29.116、41.167、2.908;P균＜0.05),치료후대조조4항증상평분역균저우치료전(t치분별위18.760、16.201、31.497、14.940;P균＜0.05).치료후관찰조적4항증상평분균저우대조조,제상복부소작감이외(t=1.872,P＞0.05),찬후포창불괄,조포감,상복통3항증상여대조조비교차이균유통계학의의(t치분별위33.943、26.672、19.035；P균＜0.05).불고새둔미리곡신기수、두훈적부작용고우대조조(13.3％여1.7％),차이유통계학의의(x2=4.324;P ＜0.05).결론 불고새둔미리곡신、막사필리연합치료공능성소화불량료효학실,명현우우오미랍서、막사필리연합적대조조,미견불고새둔미리곡신엄중적불량반응,안전성량호.
Objective To explore the efficacy and side effects of flupentixol and melitracen (deanxit) and mosapride in the treatment of functional dyspepsia(FD).Methods One hundred and twenty patients with functional gastrointestinal disorder who were diagnosed according to Roma Ⅲ criteria were enrolled in this randomized study and divided into 2 treatment groups.The experimental group (n =60) was given 1 tablet deanxit(containing flupentixol(0.5 mg) and melitracen(10 mg)) twice daily(in the morning and noon) and 5 mg mosapride three times a day (before meals).The control group (n =60) was given 20 mg omeprazole daily (before breakfast) and 5 mg mosapride three times a day(before meals).Effective rates and adverse reactions were compared between the experimental and the control groups after 1 week' s,2 weeks' and 4 weeks' treatment.Scores of FD symptoms(postprandial distress,early satiety,epigastric pain and epigastric burn) were recorded before and after treatment respectively.Results There were 102 patients(52 in the experimental group and 50 in the control group) who completed the 4-week follow-up in this study.Clinical symptoms improved after treatment in both groups,with higher significantly effective rates in the experimental group at 1 week,2 weeks and 4 weeks of treatment than in the control group(1 week:65％ vs.46％,x2 =3.885 ;2 weeks:75％ vs.56％,x2 =4.083 ;4 weeks:88％ vs.64％,x2 =5.976 ; P ＜ 0.05).The scores of FD symptoms after treatment were significantly lower than pre-treatment in both groups (the experimental group:t =35.725,29.116,41.167 and 2.908 respectively,P ＜0.05 ;the control group:t =18.760,16.201,31.497 and 14.940 respectively,P ＜0.05).The experimental group had significantly lower scores of three FD symptoms after treatment than the control group did (postprandial distress:t =33.943 ; early satiety:t =26.672 ; epigastric pain:t =19.035 ; P ＜ 0.05).No significant difference was observed on epigastric burn score between the experimental and the control groups(t =1.872 ;P ＞ 0.05).The rate of somnolence or dizziness was significantly higher in the experimental group who took flupentixol and melitracen than in the control group who took omeprazole(13.3 vs.1.7％,x2 =4.324,P ＜0.05).Conclusion Deanxit and mosapride is more effective than omeprazole and mosapride in treating FD.Flupentixol and melitracen is safe to subjects and its adverse drug reactions are not serious.