复方阿嗪米特肠溶片联合多潘立酮治疗功能性消化不良的随机、双盲、安慰剂对照临床研究

Combination therapy of azintamide and domperidone in functional dyspepsia ： a randomised, doubleblind, placebo-controlled trial

目的 评估复方阿嗪米特肠溶片与促动力剂联合使用对功能性消化不良（FD）患者症状和生活质量的影响。方法 随机、双盲、安慰剂对照临床试验。卫生部北京医院门诊就诊的208例符合罗马Ⅲ诊断标准的FD患者，随机分为复方阿嗪米特肠溶片＋多潘立酮组（A组，102例）和安慰剂＋多潘立酮组（B组，106例）进行治疗。复方阿嗪米特肠溶片2片／次，3次／d；多潘立酮10mg／次，3次／d，疗程均为4周。测定治疗前后改良消化不良严重程度评估（mSODA）分数的改变值，并计算有效率。结果 mSODA各项评分：（1）腹胀痛严重度评分，A组治疗前后改变值为-12．35±5．48，B组为-l0．52±4．65（P=0．009）；（2）非腹胀痛症状评分改变值，A组为-5．75±3．31，B组为-4．86±2．65（P=0．033）；（3）生活满意度评分改变值，A组为7．09±3．78，B组为5．62±3．54（P=0．004）。A组的治疗总有效率为89．2％，B组为76．4％，A组显著高于B组（P=0．015）。两组均无严重不良事件发生。结论 复方阿嗪米特肠溶片与促动力剂联合使用较单用促动力剂可更有效缓解FD患者各种消化不良症状，并显著改善生活质量。

Objective To study the efficacy and safety of combined therapy of compound azintamide and domperidone in functional dyspepsia. Methods A randomised, double-blind, placebo-controlled trial. Two hundred and eight patients with functional dyspepsia were randomly grouped into group A （ experimental group, 102 cases） and group B （control group, 106 cases）. The patients in the group A were given 2 tablets of compound azintamide 3 times a day in addition to domperidone 10 mg 3 times per day for four weeks. The patients in the group B were only given domperidone 10 mg 3 times per day for 4 weeks. The therapeutic efficacy was evaluated by modified Severity of Dyspepsia Assessment （mSODA） and Global Patient Assessment （GPA）. Results Subscore in mSODA： the change of bloating/pain intensity score in group A is - 12. 35 ±5.48 while group B is - 10. 52 ±4. 65 （P =0. 009）, the change of non-bloating/pain symptoms score in group A is -5.75 ±3.31 while group B is -4. 86 ±2. 65 （P =0. 033） , and the change of satisfaction score in group A is 7.09 ± 3.78 while group B is 5.62 ±3.54 （P = 0. 004）. The response rate in group A is 89.2% which is significantly higher than 76.4% in group B （P = O. 015） . Other symptoms for response assessment included loss of appetite, early satiety, fullness after meal, diarrhea. No severe side-effect was found in both groups. Conclusions Combined therapy of compound azintamide and domperidone may lead to bigger improvement in overall efficacy and health related quality of life in patients with functional dyspepsia than use of motility medicine alone. Potential mechanisms that may account for the efficacy of compound azintamide in functional dyspepsia include modulation of visceral sensitivity and/or gastrointestinal motility.