乌灵胶囊治疗伴轻中度抑郁焦虑症状的老年功能性消化不良的多中心随机对照临床试验

A multicenter clinical trial of Wuling capsule in treatment of functional dyspepsia with mild to moderate depression and anxiety in elderly

目的观察乌灵胶囊对伴轻、中度抑郁焦虑症状的功能性消化不良老年患者的疗效,并评估其临床应用的安全性。方法采用多中心、随机、阳性药物平行对照试验方法,以氟哌噻吨-美利曲辛为对照药物。266例功能性消化不良患者被随机分成试验组(145例)和对照组(121例)。试验组给予乌灵胶囊口服,3粒,每日3次;对照组给予氟哌噻吨-美利曲辛口服,1片,每日1次,疗程均为6wk。同时2组受试者均根据功能性消化不良分型及症状酌情给予抑酸、促动力、助消化药物。观察2组临床疗效、汉密尔顿抑郁量表(HAMD)评分、汉密尔顿焦虑量表(HAMA)评分及匹兹堡睡眠质量指数(PSQI)评分;根据副反应量表观察不良反应。结果试验组在治疗2、4及6 wk末的临床疗效与对照组相比均无显著差异(P>0.05);2组治疗6wk后与治疗前比较均有显著改善(P<0.01)。4、6wk末试验组的HAMD评分和HAMA评分的减分率均高于对照组。2组治疗6wk末PSQI评分与治疗前相比,均有显著改善(P<0.05),2组间PSQI评分的减分率无显著差异(P>0.05)。2组均无中、重度不良反应发生。结论乌灵胶囊治疗伴轻、中度抑郁焦虑症状的老年功能性消化不良患者的疗效较好,不良反应小,安全性好。

AIM To evaluate the clinical efficacy and safety of Wuling capsule on functional dyspepsia with mild to moderate depression and anxiety in the elderly. METHODS A randomized, controlled multicenter clinical trial was conducted in 266 elderly patients with functional dyspepsia with mild to moderate depression and anxiety, who were randomly divided into trial group （n = 145）and control group （n = 121）to receive Wuling capsule 0.99 g po, rid or flupenthixol and melitracen 1 po, qd respectively for six weeks. All patients were received either proton pump inhibitors or prokinetics according to the symptoms. Clinical efficacy was assessed with the symptoms including postprandial epigastric fullness, early satiety, epigastric pain and buring sensation and Hamilton Anxiety Scale （HAMA） , the Hamilton Rating Scale for Depression （HAMD） and Piccsburgh Sleep Quality Index （PSQI） . The adverse reaction were assessed with the Treatment Emergent symptoms Scale （TSEE）. RESULTS After six weeks＇ treatment, the symptoms of all patients and the score of PSQI were improved significantly （P 〈 0.01）. There was no significant difference in PSQI between the two groups （P 〉 0.05）. The score of HAMD and HAMA were higher in the trial group than those in the control group at the end of the 4 th week and the 6 th week （P 〈 0.01 ）. There was no moderate or severe adverse reaction in the two groups. CONCLUSION Wuling capsule is effective and safe in the treatment of functional dyspepsia with mild to moderate depression and anxiety in the elderly.