马来酸曲美布汀联合盐酸多塞平治疗功能性消化不良伴抑郁症的临床观察

目的:观察马来酸曲美布汀联合盐酸多塞平治疗功能性消化不良(FD)伴抑郁症的临床疗效和安全性。方法:160例FD伴抑郁症患者按随机数字表法均分为对照组和观察组。对照组患者餐前口服马来酸曲美布汀胶囊100 mg,每日3次;观察组患者在对照组治疗的基础上口服盐酸多塞平片12.5 mg,每日3次。两组患者疗程均为4周。观察两组患者的临床疗效,治疗前后临床症状改善情况,Zung抑郁自评量表(SDS)评分及不良反应发生情况。结果:观察组患者总有效率显著高于对照组,两组比较差异有统计学意义(P<0.05)。治疗前两组患者临床症状、SDS评分比较,差异均无统计学意义(P>0.05);治疗后两组患者临床症状改善例数显著优于同组治疗前,观察组患者餐后饱胀、上腹胀满、早饱、嗳气改善例数均显著优于对照组,SDS评分显著低于同组治疗前,且观察组低于对照组,差异均有统计学意义(P<0.05)。两组患者不良反应发生率比较,差异无统计学意义(P>0.05)。结论:马来酸曲美布汀联合盐酸多塞平治疗FD伴抑郁症较单用马来酸曲美布汀疗效更好,安全性较好。

Clinical Observation of Trimebutine Maleate Combined with Doxepin Hydrochloride in the Treatment of Functional Dyspepsia Complicating with Depression

OBJECTIVE： To observe clinical efficacy and safety of trimebutine maleate combined with doxepin hydrochloride in the treatment of functional dyspepsia （FD） complicating with depression. METHODS： 160 FD patients with depression were ran- domized into control group and observation group. Control group was given Trimebutine maleate capsule 100 mg, p.o tid, before meals. Observation group was additionally given doxepin hydrochloride 12.5 mg, p.o rid, on the basis of control group. Treatment course of 2 groups lasted for 4 weeks. Clinical efficacies of 2 groups were observed, and the improvement of clinical symptoms, Zung SDS and ADR were observed before and after treatment. RESULTS： The total effective rate of observation group was signifi- cantly higher than that of control group; there was statistical significance （P〈0.05）. The case number of the improvement of clini- cal symptoms in 2 groups after treatment was significantly better than before; the case number of the improvement of postprandial fullness, epigastric fullness, early satiety and belching in observation group were significantly better than in control group. SDS score of 2 groups were significantly lower then before; the observation group was lower than the control group; there was statisti- cal significance （P〈0.05）. There was no statistical significance in the incidence of ADR between 2 groups （P〉0.05）. CONCLU- SIONS ： Trimebutine maleate combined with doxepin hydrochloride is better than trimebutine alone in the treatment of FD compli- cating with depression in therapeutic efficacy and safety.