多潘立酮片治疗功能性消化不良的临床研究

The effect of domperidone on functional dyspepsia

目的 评价多潘立酮治疗功能性消化不良 (FD)的疗效及安全性。方法 72例FD患者随机分为两组 ,治疗组予以多潘立酮 (丽珠医药集团生产 ) 10mg ,3次 /d ,对照组予以多潘立酮 (西安杨森制药有限公司生产 ) 10mg ,3次 /d ,疗程均为 4周。治疗前存在胃排空延迟者 ,治疗后用小钡条法复查固体食物胃排空。结果 两组治疗 4周均可明显改善FD患者上腹胀、早饱、腹痛、烧心、食欲不振及嗳气等症状 ,与治疗前相比 ,差异有显著性 (P <0 .0 5 ) ;治疗组治疗前症状总积分为 13.92± 2 .0 3,治疗后为 3.89± 3.72 ,差异有显著性 (P <0 .0 1) ;治疗组上腹胀、早饱、腹痛、烧心、食欲不振及嗳气症状的有效率分别为 6 3.89% ,6 4 .71% ,5 7.14 % ,6 6 .6 7% ,6 4 .0 0 %及 5 8.6 2 % ;对照组治疗前症状总积分为 13.0 8± 3.92 ,治疗后为 4 .14± 2 .91,较治疗前也明显降低 (P <0 .0 1) ,对上腹胀、早饱、腹痛、烧心、食欲不振及嗳气症状的有效率分别为 5 0 .0 0 % ,6 5 .71% ,6 5 .2 2 % ,4 1.18% ,87.5 0 %及 4 4 .0 0 %。两组治疗前后的症状总积分及症状有效率比较 ,差异均无显著性 (P <0 .0 5 )。两组均可改善胃排空延迟患者胃排空率 ,有效率均为 73.33% ,差异无显著性 (P >0 .0 5 )。

Objective To investigate the effect and safty of domperidone on functional dyspepsia. Methods Seventy two patients with functional dyspepsia were randomized into 2 groups. Domperidone(Livzon Group) 10 mg was given 3 times per day to the medical group and 10 mg domperidone (Xi'an Janssen Pharmaceutical LTD) 3 times per day to the control group for 4 weeks. At the end of the medication, gastric emptying of solid food was examined by means of radiopaque markers in patients with delayed gastric emptying before the treatment. Results Both medical and control group have significantly improved the symptoms of abdominal distention, early satiety, abdominal pain, heartburn, anorexia and belching in patients with functional dyspepsia 4 weeks after treatment ( P < 0.01 ). The scores of the symptoms of medical group before and after the treatment were 13.92±2.03 and 3.89 ±3.72 respectively ( P <0.01); the scores of the symptoms of control group before and after the treatment were 13.08±3.92 and 4.14±2.91 respectively ( P <0.01). The effective rates in medical group on the above symptoms were 63.89%, 64.71%, 57.14%, 66.67%, 64.00% and 58.62% respectively, which had no significant difference from that of control group(50.00%, 65.71%, 65.22%, 41.18%, 87.50% and 44.00% respectively). Medical and control group have also improved gastric emptying rates in patients with delayed gastric emptying, and the effective rates were 73.33% and 73.33% respectively. No side effects were found in 2 groups. Conclusion Domperidone(Livzon group) is an effective and safe medicine in the treatment of functional dyspepsia.