CAJ | 학술논문

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10 mg/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-10.52±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.
목적 평고복방아진미특장용편여촉동력제연합사용대공능성소화불량(FD)환자증상화생활질량적영향.방법 수궤、쌍맹、안위제대조림상시험.위생부북경의원문진취진적208례부합라마Ⅲ진단표준적FD환자,수궤분위복방아진미특장용편+다반립동조(A조,102례)화안위제+다반립동조(B조,106례)진행치료.복방아진미특장용편2편/차,3차/d;다반립동10 mg/차,3차/d,료정균위4주.측정치료전후개량소화불량엄중정도평고(mSODA)분수적개변치,병계산유효솔.결과 mSODA각항평분:(1)복창통엄중도평분,A조치료전후개변치위-12.35±5.48,B조위-10.52±4.65(P=0.009);(2)비복창통증상평분개변치,A조위-5.75±3.31,B조위-4.86±2.65(P=0.033);(3)생활만의도평분개변치,A조위7.09±3.78,B조위5.62±3.54(P=0.004).A조적치료총유효솔위89.2%,B조위76.4%,A조현저고우B조(P=0.015).량조균무엄중불량사건발생.결론 복방아진미특장용편여촉동력제연합사용교단용촉동력제가경유효완해FD환자각충소화불량증상,병현저개선생활질량.
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=0. 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.