乌灵胶囊、莫沙必利与黛力新、莫沙必利治疗功能性消化不良的对比研究

A randomized and case-control clinical study on wuling capsule and mosapride was compared to deanxit and mosapride in treatment of functional dyspepsia

目的探讨乌灵胶囊与黛力新治疗功能性消化不良各自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92例,随机分为乌灵胶囊组(n=46)和黛力新组(n=46)。乌灵胶囊组予以乌灵胶囊0.99 g/次口服,3次/日,莫沙必利5 mg/次口服,3次/d(饭前)。黛力新组予以黛力新(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5 mg/次口服,3次/d(饭前)。分别在治疗第1周、2周、4周对比有效率及不良反应,同时记录2组治疗前后4种症状评分。结果共计81例患者完成了4周的治疗随访,其中乌灵胶囊组41例,黛力新组40例。两组治疗后症状均有所改善,黛力新组在1周、2周及4周疗效均高于对照组,分别为(70%,82.5%,92.5%;48.5%,65.8%,78%),但差异无统计学意义(χ2=3.776,2.921,3.351;P均>0.05)。治疗后两组餐后饱胀不适,早饱感,上腹痛和上腹部烧灼感4项症状评分均低于治疗前,其中乌灵胶囊组治疗前后症状分级评分比较差别具有统计学意义(t'=31.811,25.263,34.763,12.392;P均<0.05);戴力新组治疗前后症状分级评分比较差异具有统计学意义(t'=30.917,25.936,35.986,13.529;P均<0.05)。治疗后黛力新组4项症状评分均低于乌灵胶囊组,除上腹痛差异有统计学意义外(t=2.157;P<0.05),其余3项症状分级评分黛力新组与乌灵胶囊组比较差异均无统计学意义(t=1.549,0.616,0.764;P均>0.05)。黛力新嗜睡、头晕的副作用高于对照组(17.4%,2.2%),差异具有统计学意义(χ2=2.157;P<0.05)。结论乌灵胶囊、莫沙必利联合治疗功能性消化不良疗的疗效接近黛力新、莫沙必利,但其嗜睡、头晕等的副作用明显少于后者,且患者的依从性良好。必要时两者可以相互替代。

Objective To explore the efficacy and adverse drug reactions among wuling capsule and deanxit（flupentixol and melitracen） in treatment of functional dyspepsia（FD）.Methods 92 patients conformed to with Roma Ⅲ-the functional gastrointestinal disorders were enrolled in this randomized,case-control and prospective study and divided into 2 groups.Wuling capsule group（n=46） was given wuling capsule 0.99 g,tid and mosapride 5 mg,tid.Deanxit group（n=46） was given deanxit 1tablet（0.5 mg flupentixol,10 mg melitracen）,bid（am,mid） and mosapride 5 mg,tid.Effective rates of clinical symptoms were compared and adverse drug reactions were investigated respectively for 1 week,2 weeks and 4weeks after treatment.Scores of FD symptom grade were recorded to postprandial distress,early satiety,epigastric pain and epigastric burn respectively before and after treatment.Results 81 patients were finally followed up for 4weeks.Clinical symptoms in 2 groups were improved after treatment.The difference of 2 group was no significant（χ2=3.776,2.921,3.351;P 0.05 respectively）,though total effective rates of deanxit group（n=40） were higher than wuling capsule group（n=41） respectively for 1 week,2 weeks and 4 weeks（70%,82.5%,92.5%;48.5%,65.8%,78%）.Scores of FD symptom grade in 2 goups after treatment all were lower than pior-treatment and the differences were significant including the wuling capsule group（t＇=31.811,25.263,34.763,12.392;P0.05respectively） and the deanxit group（t＇=30.917,25.936,35.986,13.529;P0.05 respectively）.After treatment,the scores of symptom grade inthe deanxit group were further lower than the wuling group in the 4 symtomes respectively.,but the differences were no significant（t=1.549,0.616,0.764;P0.05 respectively）,except epigastric pain（t= 2.157;P0.05）.The somnolence and dizziness rate by deanxit was higher than wuling capsule group（17.4%,2.2%） and the difference was significant（χ2=2.157;P0.05）.Conclusion The efficacy of treating FD by wuling capsule and mosapride was similar to deanxit and mosapride,but had lower rate of somnolence and dizziness obviously.Otherwise,FD patients had good compliance to wuling capsule.Sometimes,If one of the 2 treatment perscriptions had no efficacy or had adverse drug reaction to FD patients,the other could be alternative.