伊托必利治疗功能性消化不良:一项安慰剂对照试验

BACKGROUND:The treatment of patients with functional dyspepsia remains unsatisfactory.We assessed the efficacy of itopride,a dopamine D2 antagonist with acetylcholinesterase effects,in patients with functional dyspepsia.METHODS:Patients with functional dyspepsia were randomly assigned to receive either itopride(50,100,or 200 mg three times daily)or placebo.After eight weeks of treatment,three primary efficacy end points were analyzed:the change from baseline in the severity of symptoms of functional dyspepsia(as assessed by the Leeds Dyspepsia Questionnaire),patients’global assessment of efficacy(the proportion of patients without symptoms or with marked improvement),and the severity of pain or fullness as rated on a five-grade scale.RESULTS:We randomly assigned 554 patients;523 had outcome data and could be included in the analyses.After eight weeks,41 percent of the patients receiving placebo were symptom-free or had marked improvement,as compared with 57 percent,59 percent,and 64 percent receiving itopride at a dose of 50,100,or 200 mg three times daily,respectively(P < 0.05 for all comparisons between placebo and itopride).Although the symptom score improved significantly in all four groups,an overall analysis revealed that itopride was significantly superior to placebo,with the greatest symptom-score improvement in the 100 and 200 mg groups(-6.24 and-6.27,vs.-4.50 in the placebo group;P = 0.05).Analysis of the combined end point of pain and fullness showed that itopride yielded a greater rate of response than placebo(73 percent vs.63 percent,P = 0.04).CONCLUSIONS:Itopride significantly improves symptoms in patients with functional dyspepsia.

功能性消化不良、胃排空延迟与生活质量下降的关系

Background: It remains controversial as to whether delayed gastric emptying in functional dyspepsia is associated with a specific symptom pattern, and it is unknown if gastric emptying in functional dyspepsia is a driver of impaired health related quality of life (HRQOL). We aimed to evaluate the relationship between functional dyspepsia symptoms, gastric emptying, and HRQOL. Methods: US patients (n = 864; mean age 44 years (range 18-82); 74%female) with functional dyspepsia, as defined by Rome Ⅱ criteria, were enrolled into one of four clinical trials. All patients had a baseline scintigraphic assessment of gastric emptying of an egg substitute meal, and the trials were stratified on this assessment. Delayed gastric emptying was defined as having at least 6.3%residual volume at four hours. A total of 290 (34%) patients had delayed gastric emptying. HRQOL was assessed by the SF 36 and Nepean dyspepsia index (NDI). Results: Postprandial fullness was independently associated with delayed gastric emptying but the association was weak (odds ratio (OR) 1.98 (95%confidence interval (CI) 1.02, 3.86); p = 0.04). No independent association was seen with epigastric pain, early satiety, nausea, or bloating. Mean SF 36 physical composite score (PCS) was 42.3 (95%CI 41.6, 43.0) and the mean SF 36 mental composite score (MCS) was 46.8 (95%CI 46.0, 47.5); both mean scores were significantly lower than age and sex adjusted national norms of 50 (p < .0001). Female sex, increasing age, and higher symptom scores for fullness, epigastric pain, and nausea were each independently associated with decreased PCS scores (all p < 0.05). Higher baseline nausea symptom score, lower gastric emptying rates at one hour, and lower body mass index were associated with decreased MCS (all p < 0.05). Female sex, epigastric pain, and nausea, but not gastric emptying, were associated with an impaired score on the NDI. However, the magnitude of the significant associations were all small. Conclusions: In patients with functional dyspepsia selected for a clinical trial programme, gastric emptying did not usefully stratify them symptomatically. Quality of life of patients with functional dyspepsia enrolled in this clinical trial programme was significantly impaired but this was not explained by delayed gastric emptying.

体重指数和无法解释的慢性胃肠道症状:一项基于成年人群的内镜检查研究

Background: We aimed to determine whether obese subjects experience more gastro-oesophageal reflux (GORS) symptoms than normal subjects, and further to determine if this association was explained by oesophagitis or medications that lower oesophageal sphincter pressure. Methods: In a representative Swedish population , a random sample (n=1001, mean age 53.5 years, 51%women) had upper endoscopy. GORS was defined as any bothersome heartburn or acid regurgitation. Results: The prevalence of obesity (body mass index ≥30)was 16%; oesophagitis was significantly more prevalent in obesity (26.5%) than in normal subjects (9 .3%). There were associations between obesity and GORS (odds ratio (OR) 2.05 (9 5%confidence interval (CI) 1.39, 3.01)), epigastric pain (OR 1.63 (95%CI 1.05, 2.55)), irritable bowel symptoms (OR 1.58 (95%CI 1.05, 2.38)), any abdominal p ain (OR 1.59 (95%CI 1.08, 2.35)), vomiting (OR 3.11 (95%CI 1.18, 8.20)), retch ing (OR 1.74 (95%CI 1.1.3, 2.67)), diarrhoea (OR 2.2 (95%CI 1.38, 3.46)), any stool urgency (OR 1.60 (95%CI 1.04, 2.47)), nocturnal urgency (OR 2.57 (95%CI 1.33,4.98)), and incomplete rectal evacuation (OR 1.64 (95%CI 1.09, 2.47)), adj usting for age, sex, and education. When subjects with oesophagitis and peptic u lcer were excluded, only diarrhoea, incomplete evacuation, and vomiting were sig nificantly associated with obesity. The association between GORS and obesity rem ained significant adjusting for medication use (OR 1.9 (95%CI 1.3, 3.0)). Concl usions: GORS is associated with obesity; this appears to be explained by increas ed upper endoscopy findings in obesity.

在咨询者与未咨询者中,功能性消化不良和肠易激综合征的症状表型与胃排空紊乱及营养素激发应答的关系

Background: Our aim was to assess the relationship between gastric motor and sensory function and symptom patterns in community subjects and patients with functional dyspepsia (FD) or irritable bowel syndrome (IBS). Methods: We recruited 291 asymptomatic blood donors, 151 symptomatic blood donors (recurrent abdominal pain or discomfort), and 40 patients with FD or IBS. Abdominal symptoms were assessed using the bowel disease questionnaire (BDQ) and, in addition, the most bothersome symptom complex identified (dysmotility type, ulcer type dyspepsia, or IBS). Gastric emptying time (GET (t1/2, min)) was measured by 13C-octanoic breath test and a nutrient challenge performed. Twenty randomly selected asymptomatic blood donors, 48 symptomatic blood donors (30 FD, 18 IBS), and 40 patients (23 FD, 17 IBS) had additional function testing. Results: GET (t1/2) was significantly (p<0.05) longer in blood donors with FD symptoms (99 (6) min) and FD patients (110(12) min) compared with asymptomatic controls (76.7(7) min), but was not significant in IBS blood donors or patients. Overall, 25 of 48 blood donors with symptoms and 18 of 40 patients had slow gastric emptying. GET was most delayed in subjects with predominantly dysmotility type symptoms (167(36) min v controls; p<0.01). Symptom intensities after a nutrient challenge were significantly higher in FD patients and symptomatic blood donors compared with asymptomatic controls; 14 of 48 blood donors with symptoms and 16 of 40 patients had a symptom response to the nutrient challenge exceeding the response (mean (2SD)) of healthy asymptomatic controls. Conclusion: Gastric emptying and the global symptom response to a standardised nutrient challenge are abnormal in population based (non health care seeking) subjects with dyspepsia.

肠易激综合征和功能性消化不良社会群体的虐待史:其他社会心理变量的影响

Background/Aims: Why abuse is associated with irritable bowel syndrome and functional dyspepsia remains unclear but other psychosocial factors may be important. We hypothesized that other psychosocial variables may confound the association. Methods: 207 subjects identified from a previous population survey who also met Rome I criteria for IBS (n = 156) or functional dyspepsia (n = 51) were included in the study. Controls (n = 100) did not report having any abdominal pain in a previous population survey. Sexual, physical, emotional / verbal abuse as a child (≤ 13 years) and adult (≥ 14 years) was assessed using validated self- report questions. Other psychological variables were assessed via validated self- report. Results: Adulthood abuse was significantly more common in IBS and/or functional dyspepsia (40% ) compared with healthy controls (25% ). Abuse was not an independent predictor for IBS or functional dyspepsia when psychological and buffering factors were controlled for in the analyses. Having a diagnosis of depression and using a self-controlling coping style were significantly associated with having a history of abuse. Conclusions: Abuse occurring as an adult was significantly associated with IBS and/or functional dyspepsia, but it was not an important factor when psychosocial factors were controlled for in these disorders.