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目的评价多潘立酮联合复方消化酶治疗功能性消化不良(functional dyspepsia,FD)临床疗效与安全性。方法 120例符合实验要求的FD患者,随机分为对照组58例和观察组62例,对照组给予多潘立酮治疗,观察组给予多潘立酮联合复方消化酶治疗,4周后评价临床疗效。结果观察组显效率59.68%、总有效率87.10%高于对照组50.00%、68.97%,无效率12.90%低于对照组31.03%,差异具有统计学意义(P<0.05);观察组餐后饱胀、早饱、上腹痛、上腹灼烧感症状例比重降幅分别为84.78%、90.70%、67.57%、62.96%高于观察组46.51%、51.22%、42.86%、30.77%,差异具有统计学意义(P<0.05);两组均未见不良反应;观察组显效者获得显效时间第1、2、3、4周分别为9、21、6、1例,与对照组2、8、15、4例,比较差异具有统计学意义(P<0.05)。结论多潘立酮联合复方消化酶治疗功能性消化不良疗效较好、起效速度快,特别是改善餐后饱胀、早饱效果较明显,改善上腹痛、上腹灼烧感症状效果仍有待提高。
Objective To evaluate the clinical efficacy and safety of domperidone combined with compound digestive enzymes in the treatment of functional dyspepsia (FD). Methods A total of 120 FD patients who met the experimental requirements were randomly divided into control group (58 cases) and observation group (62 cases). Patients in the control group were treated with domperidone. Domperidone combined with compound digestive enzyme was given in the observation group. Clinical efficacy was evaluated after 4 weeks. Results The effective rate of observation group was 59.68%, the total effective rate was 87.10%, which was significantly higher than that of control group (50.00%, 68.97%, 12.90%, 31.03%, the difference was statistically significant (P <0.05; The proportions of swelling, early satiety, upper abdominal pain and upper abdominal burning sensation were 84.78%, 90.70%, 67.57% and 62.96%, respectively, which were 46.51%, 51.22%, 42.86% and 30.77% (P <0.05). No adverse reaction was observed in both groups. The effective time of the first, second, third and fourth week in the observation group was 9, 21, 6 and 1, respectively, which were significantly lower than those in the control group , 4 cases, the difference was statistically significant (P <0.05). Conclusion Domperidone combined with compound digestive enzyme is effective in treating functional dyspepsia and has rapid onset of action, especially for improving postprandial fullness and early satiety. It is still necessary to improve the symptoms of upper abdominal pain and upper abdominal burning sensation.