莫沙必利治疗餐后不适综合征和上腹痛综合征随机、双盲、安慰剂对照研究

背景：莫沙必利作为一种促胃肠动力药早已被推荐用于治疗功能性消化不良（FD），然而目前遵循罗马Ⅲ标准FD诊断分型和症状评估原则进行的莫沙必利治疗FD的临床研究尚不多见。目的：评估莫沙必利改善餐后不适综合征（PDS）和上腹痛综合征（EPS）症状的疗效和安全性。方法：病例连续选自2006年12月-2007年9月在上海仁济医院消化内科门诊就诊、符合罗马ⅢFD诊断标准中PDS和EPS诊断的患者。先经1周安慰剂筛选期，无安慰剂治疗反应者随机进入治疗流程组合A或B，给予莫沙必利5mg tid×1周或安慰剂1片tid×1周，然后进入1周药物清洗期（安慰剂1片tid），最后给予安慰剂或莫沙必利继续治疗1周。各阶段治疗前和治疗后分别行FD症状评估。结果：共纳入FD患者83例，安慰剂总有效率为19．3％，67例对安慰剂无治疗反应者进入莫沙必利疗效观察研究．随机进入治疗流程组合A或B者分别为34例和33例。与安慰剂治疗相比，莫沙必利可显著降低患者的总症状积分（14．4±6．8对1．4±1．3，P〈0．05），对PDS的餐后饱胀不适、早饱症状和EPS的上腹部疼痛和烧灼感症状均有显著治疗作用。莫沙必利对PDS和EPS治疗的总有效率分别为79．4％和60．6％，差异有统计学意义（P〈0．05）。结论：莫沙必利可明显改善FD患者的临床症状，对PDS和EPS均有治疗效果，对PDS的有效率优于EPS，是安全、有效的FD治疗药物。     

莫沙必利和泮托拉唑治疗功能性消化不良的对照研究

关于促胃肠动力药和质子泵抑制剂（PPI）改善功能性消化不良（FD）症状的疗效,国内外临床试验多为安慰剂对照研究,比较促胃肠动力药与PPI疗效的研究尚少.目的：比较莫沙必利与泮托拉唑治疗餐后不适综合征（PDS）和上腹痛综合征（EPS）的疗效和安全性.方法：采用随机、非盲试验设计.连续纳入2009年12月-2010年12月宁波市第一医院符合罗马ⅢPDS和EPS诊断标准的患者,经一周安慰剂筛选后,PDS和EPS患者分别随机接受莫沙必利（5 mg tid）或泮托拉唑（40 mg qd）治疗2周.治疗前后行FD症状评估.结果：148例患者进入治疗期,其中PDS 78例,EPS 70例.莫沙必利和泮托拉唑均能显著降低FD患者的总症状积分（P〈0.05）,但两组间总症状积分下降值（14.4±6.8对13.6±5.3）和总有效率（70.3%对67.6%）差异无统计学意义.按PDS和EPS分别评估,莫沙必利组与泮托拉唑组间PDS症状（餐后饱胀不适、早饱）,EPS症状（上腹部疼痛、烧灼感）积分下降值和总有效率差异亦无统计学意义.结论：莫沙必利和泮托拉唑均能明显改善FD患者的临床症状,是安全、有效的FD治疗药物,两者对PDS和EPS的疗效无明显差异.     

莫沙必利治疗胃食管反流病的随机、双盲、安慰剂交叉对照研究

目前对促胃肠动力药莫沙必利改善中国汉族胃食管反流病（GERD）患者胃食管反流症状和食管运动障碍的作用尚缺乏系统观察。目的：观察莫沙必利对中国汉族人群中GERD患者的治疗作用。方法：采用随机、双盲、安慰剂交叉对照研究设计，选取有典型胃食管反流症状的GERD患者23例行胃食管反流症状评估、食管测压以及24h食管DH和胆红素联合监测，对比研究莫沙必利和安慰剂各1周交叉治疗对胃食管反流症状的改善情况，以及对食管运动功能和胃食管反流事件的影响。结果：与安慰剂治疗相比，莫沙必利治疗可降低胃食管反流总症状积分，加快食管体部蠕动波传导速度，增加湿咽成功率，减少食管下端pH〈4总反流次数和长时间（≥5min）反流次数，降低pH〈4总时间百分比和DeMeester计分，降低食管下端胆汁反流总时间百分比，差异均有统计学意义（P〈0．05）。结论：莫沙必利治疗1周可有效改善本组中国汉族GERD患者的胃食管反流症状，部分改善食管运动障碍以及酸反流和胆汁反流．是治疗GERD安全、有效的药物。     

有和无重叠症状的功能性消化不良患者中消化不良症状学和发病机制的比较研究

背景：目前对功能性消化不良（FD）的症状重叠现象尚缺乏深入研究和认识。目的：比较有和无重叠症状的FD患者在消化不良症状学和发病机制方面的异同点。探讨FD患者产生重叠症状的可能原因。方法：根据罗马Ⅱ标准问卷调查结果将120例FD患者分为有重叠症状（食管、肠道和肛门直肠症状）和无重叠症状组。分别行消化不良症状学（严重程度、症状分型等）和精神心理状态（Zung焦虑自评量表和Zung抑郁自评量表）评定，以及多导胃电图检查、放射性核素法或不透X线标志物法固体胃排空测定、液体营养餐负荷试验结合胃内压测定和心率变异性分析，分组比较检测结果。结果：62．5％的FD患者有重叠症状。有和无重叠症状FD患者的消化不良症状学、胃壁肌电活动、固体胃排空功能、胃敏感性和容受性功能以及自主神经功能均无显著差异（P〉0．05），但有重叠症状者合并焦虑抑郁状态的比例显著高于无重叠症状者（P〈0．05）。结论：有和无重叠症状FD患者的消化不良症状学和病理生理机制相同．提示两组患者消化不良症状的诊治原则和措施相似。异常精神心理因素可能是重叠症状产生的原因之一。     

复方阿嗪米特联合胃乐舒治疗老年功能性消化不良50例

[目的]观察复方阿嗪米特联合胃乐舒治疗老年功能性消化不良（FD）的疗效及安全性。[方法350例老年FD患者口服复方阿嗪米特（0.15g,3次／d）及胃乐舒（10g,3次／d）治疗2周,比较服药前后餐后饱胀感、早饱、上腹疼痛、上腹灼烧感等症状的评分,观察有无不良反应。[结果]所有病例均完成了整个治疗过程,未见任何严重的不良反应,治疗第2周患者餐后饱胀感、早饱、上腹疼痛、上腹灼烧感各项症状积分及症状总积分与治疗前比较均有明显下降（均P〈0.05）,治疗第2周患者餐后饱胀感、早饱及症状总积分与治疗第1周比较有明显下降（P〈0．05）。[结论]复方阿嗪米特联合胃乐舒治疗老年FD效果佳,且安全性较高。     

功能性消化不良患者胃窦壁内NO含量与胃排空关系的探讨

目的探讨功能性消化不良（FO）患者胃运动障碍的发生机制。方法应用Griess法测定33例FD患者（20例胃排空正常的患者为FD。组，13例胃排空延迟的患者为FD：组）及4例正常人胃窦壁内一氧化氮（NO）含量。结果FD2组患者胃窦壁内NO含量比FD1组及正常组明显增高，差异有显著性（P〈0．05）；FD1组与正常组胃窦壁内NO含量差异无显著性（P〉0．05）。结论胃排空延迟的FD患者胃窦壁内NO含量明显增多，提示胃窦壁内NO在胃运动障碍中具有一定的作用。     

调胃汤治疗功能性消化不良的临床及实验研究

[目的]通过实验和临床研究探讨中药复方调胃汤治疗功能性消化不良（FD）的作用机制。[方法]予大白鼠分别灌服调胃汤及其双倍剂量调胃汤、西沙必利溶液、蒸馏水，再灌服葡聚糖蓝2000，然后处死动物取胃肠，以分光光度计λ620nm测定胃内葡聚糖蓝2000残留量，并计算自幽门括约肌至色素最前端及至盲肠距离百分比为小肠推进比。FD患者95例，随机分成治疗组67例．予调胃汤加减治疗；对照组28例，子多潘立酮治疗，4周为1个疗程，观察治疗前后疗效。[结果]调胃汤组胃内色素残留率小于空白组和西沙比利组（P〈0．01，〈0．05），平均小肠推进率大于对照组（P〈0．01），与西沙比利组相似（P〉0．05）。治疗组改善主要症状作用优于对照组（P〈0．05），总疗效作用相似（P〉0．05），但显效率明显高于对照组。[结论]调胃汤有较好的促进胃肠运动的作用，是治疗FD的有效方剂，值得进一步研究。     

小剂量兰索拉唑治疗功能性消化不良75例临床分析

目的评价小剂量兰索拉唑治疗功能性消化不良(FD)的疗效。方法将130例FD随机分为两组,分别予兰索拉唑15mg每日1次和莫沙必利5mg每日3次治疗,疗程2周。结果治疗后,兰索拉唑组和莫沙必利组的反酸、饱胀、上腹痛/不适症状积分均较治疗前下降。兰索拉唑组的反酸和上腹痛/不适症状积分下降值显著高于莫沙必利组。兰索拉唑组和莫沙必利组症状缓解的总有效率分别为94.7%和76%(P<0.05)。结论小剂量兰索拉唑对溃疡样消化不良较莫沙必利有更好的疗效。     

功能性消化不良患者胃机械感觉过敏

背景：功能性消化不良（FD）是临床上常见的症候群，其发病机制目前尚未完全阐明，现逐步认识到胃感觉过敏可能在FD的发病中起着重要作用。目的：探讨FD患者是否存在胃机械感觉过敏，同时了解胃顺应性变化。方法：应用电子恒压器对52例FD患者和15名健康对照者进行检查，采用恒压梯度扩张法扩张近端胃，获得胃机械扩张感知、不适、疼痛的压力和容积闽值，计算近端胃顺应性。结果：FD患者与健康对照者相比最小扩张压（MDP）无显著性差异：FD患者对胃机械扩张刺激的感知阈值、不适闽值、疼痛压力阈值均较健康对照者显著下降，40．4％的患者胃感知感觉过敏，46．2％的患者胃不适感觉过敏，51．9％的患者胃疼痛感觉过敏；FD患者胃感知和疼痛容积闽值较健康对照者显著降低。FD患者近端胃顺应性与健康对照组相比无显著性差异（P〉0．05）。胄机械感觉压力闽值与近端胃顺应性无关。结论：部分FD患者中存在着胃机械感觉过敏，近端胃顺应性正常。     

功能性消化不良患者胃肌电紊乱的发生率

背景：功能性消化不良（FD）的病理生理机制尚未完全阐明，消化道运动功能异常可能是主要发病机制之一。目的：通过胃电图检查探讨FD患者胃肌电紊乱的发生率，证实胃动力异常在FD发生中的作用。方法：368例FD患者行餐前和餐后体表胃电图榆查，对正常胃慢波百分比和胃电主功率两项参数进行分析。结果：根据正常胃慢波百分比，本组FD患者可分为胃电节律正常组（43．2％）、胃动过缓组（33．2％）、胃动过速组（6．2％）和混合性胃电节律紊乱组（17．4％）。在胃电节律正常的FD患者中，34．0％（54例）存在餐后／餐前胃电主功率比异常。结论：本组71．5％的FD患者存在胃肌电紊乱，证实胃动力异常在FD的发病机制中起有重要作用。     

Effect of domperidone therapy on nocturnal dyspeptic symptoms of functional dyspepsia patients

AIM:To investigate the incidence of nocturnal dyspeptic symptoms in patients with functional dyspepsia(FD) and whether prokinetic drugs can alleviate them. METHODS:Eighty-five consecutive Chinese patients with FD were included in this study.One week after single-blinded placebo run-in treatment,baseline nocturnal intragastric pH,bile reflux and nocturnal dyspeptic symptoms of eligible patients,including epigastric pain or discomfort,abdominal distention and belching, were investigated with questionnaires.Pa...     

荆花胃康胶丸对功能性消化不良疗效的观察

背景:功能性消化不良(FD)的发病机制还不十分清楚,目前尚缺乏令人满意的治疗方法。目的:评价荆花胃康胶丸对FD的治疗效果。方法:采用开放、随机、对照试验,60例FD患者随机分为两组,每组30例,分别予口服荆花胃康胶丸160mg,3次/d和多潘立酮10mg,3次/d。根据治疗前后胃排空试验结果和消化不良症状(上腹不适、餐后饱胀、早饱、上腹痛、烧心、反酸、嗳气、食欲不振)积分的比较,评估荆花胃康胶丸的疗效和安全性。结果:治疗后两组患者餐后2h胃排空率均有所提高,治疗前后胃排空率差异有统计学意义(荆花胃康胶丸组,P<0.05;多潘立酮组,P<0.01)。两组比较,多潘立酮组治疗后胃排空率较荆花胃康胶丸组显著提高,差异有统计学意义(P<0.05)。治疗后两组患者的症状总积分均较治疗前显著下降(P<0.01)。通过两组差值的比较,荆花胃康胶丸组餐后饱胀、上腹痛、嗳气的改善程度尤其优于多潘立酮组(P<0.01)。结论:荆花胃康胶丸治疗FD具有一定的疗效,在改善消化不良症状方面优于多潘立酮,并具有良好的安全性。     

A pilot study on duodenal acid exposure and its relationship to symptoms in functional dyspepsia with prominent nausea

BACKGROUND: Duodenal hypersensitivity to acid and decreased duodenal clearance of exogenous acid have been reported in functional dyspepsia (FD). However, the relevance of these abnormalities to spontaneous duodenal acid exposure and dyspeptic symptoms in FD is unknown. AIMS: To determine spontaneous duodenal acid exposure and its relationship with symptoms, duodenal sensitivity to acid, and the effects of a 5-HT(3) receptor antagonist on duodenal responses to acid in FD. METHODS: Eleven FD patients with prominent nausea and 11 healthy controls underwent 24-h ambulatory duodenal pH monitoring with assessment of dyspeptic symptoms. On the next day, duodenal bolus infusions of 5 ml of acid and normal saline were given in a randomized double-blind manner and repeated after ondansetron or a placebo. RESULTS: Nighttime duodenal acid exposure was similar, but FD patients had lower duodenal pH and higher duodenal % time (pH < 4) than controls during the daytime and in the second postprandial 2 h (p < 0.05). Seven patients (64%) with duodenal acid exposure above the normal range had higher severity scores for several dyspeptic symptoms including nausea. However, the symptom severity was poorly or weakly correlated to duodenal pH, and brief duodenal acid infusion did not affect any symptoms. Duodenal responses to exogenous acid were unaffected by 5-HT(3) receptor antagonism. CONCLUSIONS: Spontaneous duodenal acid exposure is increased in a subset of FD patients with prominent nausea, and this is associated with more severe dyspeptic symptoms. However, a direct relationship between duodenal acid exposure and symptom severity is lacking.     

功能性消化不良患者胃排空与症状的相关性及影响因素分析

目的了解胃排空异常与消化不良症状的相关性,分析影响功能性消化不良（FD）患者胃排空的因素。方法纳入32例FD患者。量化记录餐后上腹饱胀、上腹痛、上腹烧灼感、早饱、嗳气、恶心、呕吐7组症状及静息心率。以心率的中位数将其转化为二分类变量进行非条件Logistic回归分析统计。运用核素闪烁法检测空腹固体试餐,试餐参考美国胃肠动力学会、神经胃肠学会及核医学联合推荐的标准低脂试餐以及诊断标准。结果 32例FD患者,8例（25%）T1/2延迟,7例（21.88%）Retention%2 h增加,Retention%1 h均在正常范围内。Retention%2 h正常组与Retention%2 h增加组以及T1/2正常组与T1/2延长组之间,心率均存在显著差异（P=0.031,P=0.022）,心率与Retention%2 h、T1/2存在正相关（r=0.448,P=0.01;r=0.423,P=0.016）。在控制了性别、年龄及其他症状因素的影响下,心率〉70 bpm是Retention%2 h增加、T1/2延长的独立因素（OR=12.378,P=0.042;OR=8.180,P=0.072）。在Retention%2 h正常组与Retention%2 h增加组之间恶心症状指数有显著差异（P=0.003）,恶心与Retention%2 h、T1/2存在正相关（r=0.527,P=0.002;r=0.381,P=0.032）。结论心率、恶心症状与功能性消化不良患者的胃排空存在一定相关性,在控制了性别、年龄、BMI及其他症状的因素影响下,静息心率增加、出现恶心症状可能是胃排空延缓的独立因素。     

Assessment of duodenogastric reflux by combined continuous intragastric pH and bilirubin monitoring

AIM: To assess the diagnostic value of a combination of continuous intragastric pH and bilirubin monitoring in the detection of duodenogastric reflux (DGR), and the effects of diet on the bilirubin absorbance. METHODS: 30 healthy volunteers were divided into two groups: standard diet group (Group 1) 18 cases, free diet group (Group 2)12 cases. Each subjects were subjected to simultaneous 24-hour intragastric pH and spectrophotometric bilirubin concentration monitoring (Bilitec 2000). RESULTS: There was no difference of preprandial phase bilirubin absorbance between two groups. The absorbance of postprandial phase was significantly increased in group 2 than group 1. There was no difference between preprandial phase and postprandial phase absorbance in group 1. Postprandial phase absorbance was significantly higher in group 2. In a comparison of bile reflux with intragastric pH during night time, there were 4 types of reflux: Simultaneous increase in absorbance and pH in only 19.6%, increase in bilirubin with unchanged pH 33.3%, pH increase with unchanged absorbance 36.3%, and both unchanged in 10.8%. Linear regression analysis showed no correlation between percentage total time of pH<4 and percentage total time of absorbance>0.14, r=0.068 P<0.05. CONCLUSION: Because of the dietary effect, high absorbance fluids or foods should be avoided in detection. Intragastric pH and bilirubin monitoring separately predict the presence of duodenal (and/or pancreatic) reflux and bile reflux. They can not substitute for each other. The detection of DGR is improved if the two parameters are combined simultaneously.     

复方阿嗪米特肠溶片治疗消化不良的多中心、随机、双盲、安慰剂平行对照临床研究

背景:复方阿嗪米特肠溶片(商品名:泌特)含阿嗪米特和多种消化酶,国外用于治疗慢性消化不良已有多年,但迄今为止在国内尚无多中心、随机、安慰剂平行对照研究.目的:评价应用复方阿嗪米特肠溶片治疗慢性消化不良的临床疗效、安全性和依从性.方法:采用多中心、随机、双盲、安慰剂平行对照临床研究.上海市11个临床中心共纳入消化不良患者203例,随机分为两组,资料完整并纳入统计分析者191例,治疗组86例,对照组105例.餐后分别立即服用复方阿嗪米特肠溶片或安慰剂2片,每日3次,疗程2周.治疗前后和治疗期间每天分别评估各消化不良症状的积分、药物副作用和患者的依从情况.结果:两组消化不良患者的年龄、性别、疾病类别和消化不良症状积分均有较好的匹配性,且均完成了研究规定的疗程.与对照组相比,治疗组治疗1周后各消化不良症状积分均小于对照组,腹胀、嘈杂和总症状积分显著下降(P<0.05);治疗2周后,除便秘症状(P=0.214)外,治疗组食欲不振、腹胀、腹痛、嗳气、恶心、嘈杂、腹泻症状和症状总积分均显著低于对照组(P均＜0.05).治疗1周和2周后,治疗组各消化不良症状积分和症状总积分改善率均显著高于对照组(P<0.0001).结论:复方阿嗪米特肠溶片治疗各种病因相关性消化不良安全有效,依从性好,无严重不良反应.     

Ranitidine controls nocturnal gastric acid breakthrough on omeprazole: A controlled study in normal subjects

Background & Aims: Proton pump inhibitors administered twice daily do not provide complete nocturnal acid suppression. Acid breakthrough, or decrease in intragastric pH to <4 for an hour or longer, occurs in three quarters of normal subjects and patients at night. We compared the effect of a third dose of omeprazole at bedtime with that of a dose of ranitidine at bedtime on residual nocturnal acid secretion in patients receiving omeprazole twice daily. Methods: Twelve volunteers underwent overnight intragastric pH monitoring after 7 days of treatment with omeprazole, 20 mg twice daily, followed by different treatment supplements at bedtime: placebo; additional omeprazole, 20 mg; ranitidine, 150 mg; and ranitidine, 300 mg. Results: Additional omeprazole at bedtime reduced the percentage of time with intragastric pH of <4 from 48% to 31% (P < 0.005) compared with omeprazole twice daily with placebo at bedtime. Ranitidine at bedtime reduced this parameter more, 5% with 150 mg and 6% with 300 mg (P <0.01 vs. omeprazole twice daily plus bedtime). Results for percentage of time with intragastric pH <3 were similar. Eleven subjects had acid breakthrough with placebo at bedtime; 7 with omeprazole at bedtime (P = NS); 4 with ranitidine, 150 mg at bedtime; and 3 with ranitidine, 300 mg at bedtime (P < 0.05, ranitidine vs. placebo). Conclusions: Bedtime ranitidine is more effective than bedtime omeprazole on residual nocturnal acid secretion in patients receiving omeprazole twice daily. This finding suggests that fasting breakthrough nocturnal acid secretion in patients receiving omeprazole twice daily is most likely histamine related.GASTROENTEROLOGY 1998;115:1335-1339     

Belching: dyspepsia or gastroesophageal reflux disease?

OBJECTIVES: Eructation (belching) is a common symptom seen in clinical practice. Because either belching or heartburn may result from transient lower esophageal sphincter relaxations, it has been proposed that belching may be a manifestation of gastroesophageal reflux disease (GERD). In this retrospective study we evaluated the prevalence of belching in dyspepsia and GERD and the relation of belching to acid reflux events documented by pH monitoring. METHODS: We examined the prevalence, frequency, and severity of belching and other GERD symptoms by use of standardized questionnaires in 180 GERD patients (group A) and 78 dyspeptic controls (group B) referred for evaluation at our institution. GERD was defined as either endoscopic esophagitis (or Barrett's esophagus) or positive DeMeester score (>14.2) on pH monitoring or both. Dyspeptic patients had normal endoscopy and pH studies. We also analyzed the relationship of belching to acid reflux events during the 24-h period of pH studies. RESULTS: Of 180 GERD patients, 132 (70%) reported belching during pH monitoring, versus 63 of 78 dyspeptic patients (80%) (p = ns). Similarly, 163 of 180 GERD patients (90%) reported heartburn versus 64 of 78 of dyspeptic patients (82%) (p = ns). Review of symptom questionnaires revealed no significant difference in belching severity between groups. However, heartburn and acid regurgitation were significantly more severe among GERD patients. There was a significantly higher correlation of both heartburn and belching with acid events in patients with GERD compared with patients with dyspepsia. In addition, although both belching and heartburn were significantly improved in patients with GERD, belching scores remained unchanged after proton pump inhibitor (PPI) therapy in patients with dyspepsia. CONCLUSIONS: Belching is as common and as severe in patients with dyspepsia as it is in patients with GERD. Belching and heartburn in GERD patients are more likely correlated with episodes of pathological acid reflux. Because belching cannot be clinically used as a discriminatory symptom, ambulatory pH monitoring should be considered to elucidate the relationship of belching to acid reflux in patients with dyspepsia or GERD.