安胃一号治疗功能性消化不良临床观察

Clinical observation of effect of an wei Ⅰ Granules on functional dyspepsia

目的：观察安胃一号治疗脾虚气滞型功能性消化不良的临床疗效.方法：142例患者随机分为两组,中药组70例,口服安胃一号;对照组72例,口服多潘立酮,疗程1月,疗程结束后观察两组临床疗效、生活质量评分和胃排空率的变化情况.结果：治疗组总有效率为81.43％（95％ CI=82.32％～90.54％）,对照组为66.67％ （95％ CI=55.78％ ～ 77.56％）,两组综合疗效比较（u=1.395 1,P=0.163 0）,差异尚未达到显著性意义;采用SF-16生活质量量表评分比较,与对照组治疗后比较,在八个维度中的生理机能（PF）、生理职能（RP）、一般健康状况（GH）及精神健康（MH）4个维度,差异有显著性意义（P＜0.05）;两组治疗后胃排空率比较（u=-1.815 6,P=0.069 5）,差异接近临界状态.结论：采用颗粒剂安胃一号治疗功能性消化不良属脾虚气滞型患者的疗效优于多潘立酮的证据尚不够充分,但其收益为OR =0.46（95％CI =0.21～0.99）,NNT=7（95％CI =3.52～89.29）.

Objective ： To observe the clinical effect of an wei I granules on functional dyspepsia （FD） due to spleen deficiency and qi stagnation. Methods： 142 patients with FD were randomly divided into the observation group（70 cases）and the control group（72 cases）. The patients in observation group were given oral an wei I granules , and those in control group took domperidone. The course of treatment was a-month. After treatment, the general therapeutic effects in both groups were evaluated, at the same time, the scores of life-quality and the gastric emptying ratios were recorded. Results： The total effective rate of treatment group was 81.43%o （95% CI = 82.32% -90.54% ）, the control group was 66.67% （95% CI =55.78% -77.56% ）. Compared the comprehensive effects of tow groups（ u = 1. 395 1 ,P =0. 163 0） ,the difference had not remarkable significance. Compared with the control group after treatment by SF-16 Scale of Life- Quality, the differences of Physical Function（PF） , Role Physical（RP）, General Health （GH） and Mental Health （MH）in eight dimensions had remarkable significance （P 〈 0. 05）. Compared the gastric emptying ratios of two groups after treatment（ u = - 1. 815 6, P = 0. 069 5 ） , the differences closed to the critical state. Conclusion ： The clinical effect of an wei I granules on functional dyspepsia （FD） due to spleen deficiency and qi stagnation is better than domperidone, which has not insufficient evidences, but its benefits is OR = 0. 46 （95% CI = 0. 21 N 0.99 ）, NNT = 7 （95% CI = 3.52 - 89.29）.