枳术宽中胶囊联合氟哌噻吨美利曲辛治疗脾虚气滞型功能性消化不良的临床观察

Clinical effect of Zhizhukuanzhong capsule combined with Deanxit in the treatment of functional dyspepsia of spleen - deficiency and qi - stagnation

目的 探讨枳术宽中胶囊联合氟哌噻吨美利曲辛（黛力新）治疗脾虚气滞型功能性消化不良（ＦＤ）的疗效。方法 将７６例ＦＤ患者采用完全随机化分为三组，Ａ组（２４例）枳术宽中胶囊＋黛力新、Ｂ组（２６例）枳术宽中胶囊、Ｃ组（２６例）马来酸曲美布汀分散片治疗，８周后分别观察消化不良症状、抑郁状态及疗效。结果 治疗前各组消化不良症状差异均无统计学意义（均Ｐ＞０．０５）；治疗后消化不良症状均有不同程度改善，Ａ、Ｂ、Ｃ三组有效率分别为９１．６％、６５．４％、４２．３％，Ａ组与Ｂ组疗效差异无统计学意义（χ２ ＝１．５７９，Ｐ＝０．２０９）；Ａ组与Ｃ组差异有统计学意义（χ２ ＝１３．５４９，Ｐ＝００００）；Ｂ组与Ｃ组疗效差异无统计学意义（χ２＝２．７８６，Ｐ＝００９０）。ＦＤ伴不同程度的焦虑抑郁障碍，治疗前三组间差异无统计学意义；治疗后汉密尔顿焦虑量表、汉密顿抑郁量表评分各组间比较：Ａ组与Ｂ组差异有统计学意义（ｔＨＡＭＡ ＝６８３９，ｔＨＡＭＤ ＝４．６０７，Ｐ＜０．０５），Ａ组与Ｃ组差异有统计学意义（ｔＨＡＭＡ ＝２０．０６９，ｔＨＡＭＤ ＝１５．３４２，Ｐ＜０．０１）；Ｂ组与Ｃ组差异有统计学意义（ｔＨＡＭＡ ＝１１．９５１，ｔＨＡＭＤ ＝１２．０７１，Ｐ＜０．０１）。治疗后Ａ组、Ｂ组ＨＡＭＡ、ＨＡＭＤ评分较治疗前降低（Ａ组ｔＨＡＭＡ ＝５２．７５８，ｔＨＡＭＤ ＝４９．９７０，Ｂ组ｔＨＡＭＡ ＝３０．２３０，ｔＨＡＭＤ ＝１７．１５１，Ｐ＜０．０１），Ｃ组积分无明显下降（ｔＨＡＭＡ ＝７８４５，ｔＨＡＭＤ ＝３．５３０，Ｐ＞０．０５）。各组不良反应：Ａ组以乏力、头昏、嗜睡多见，２周内有所减轻；Ｂ组出现轻微胃病及大便次数增多，不影响治疗；Ｃ组以消化道症状常见，多持续时间约２周以上。结论 应用枳术宽中胶囊联合黛力新治疗脾虚气滞型功能性消化不良，可获得较好的疗效，用药安全、方便，不良反应小，依从性好。

Objective To investigate the curative effect of Zhizhukuanzhong capsule combined with Deanxit in the treatment of functional dyspepsia （FD） of spleen - deficiency and qi - stagnation. Methods Seventy - six patients with FD were randomly divided into three groups. A group （24 cases）_was given Zhizhukuanzhong combined with Deanxit, B group （26 cases） was given Zhizhukuanzhong, C group （26 cases） received trimebutine dispersible tablets treatment. After treatment for 8 weeks,the symptoms of indigestion, depressive state and therapeutic effect were observed. Results Before treatment, there were no statistically significant differences in the symptoms of dyspepsia （ all P 〉 O. 05 ）. After treatment, the symptoms of dyspepsia were improved in different degree, the effective rates of A, B,C three groups were 91.6% ,65.4% and 42.3%, respectively, there was no statistically significant difference between A group and B group（ X2 = 1. 579 ,P = O. 209 ） ;there was statistically significant difference between A group and C group（ X2 = 13. 549 ,P =0.000） ;there was no statistically significant difference between B group and C group （ X2 = 2. 786,P = O. 09）. The FD patients complicated with varying degrees of anxiety and depression, there was no statistically significant difference among the three groups before treatment （ P 〉 0.05 ）. After treatment, comparison of HAMA and HAMD scores among the three groups：there were statistically significant differences between A group and B group （tHAMA =6.839,tHAMD =4.607,all P 〈0.05） ,A group and C group （tHAMA =20. 069,tHAMD = 15. 342,all P 〈0.01 ） ,B group and C group （tRAMA = 11. 951 ,tHAMD = 12. 071 ,all P 〈0.01 ）. After treatment,the HAMA,HAMD scores of A group and B group were significantly decreased compared with before treatment （ A group tSAMA = 52. 758,tHAMD =49. 970,B group tHAMA = 30. 230,tHAMD = 17. 151 ,all P 〈0. 01 ）. Those in C group had no statistically significant decline compared with before treatment （ tHAMA = 7. 84-5, tHAMD = 3. 530, all P 〉 0.05 ）. The adverse reactions of A group were mainly weakness, dizziness, drowsiness, which were alleviated within 2 weeks. The adverse reactions of B group were slight stomach disease and stool frequency increased,which not affected the treatment. The adverse reactions of C group were digestive tract symptoms, which lasted for more than 2 weeks. Conclusion Zhizhukuanzhong capsule combined with Deanxit in the treatment of FD of spleen - deficiency and qi - stagnation can obtain good curative effect, it is safe, convenient, and with minor side effects, good compliance.