复方阿嗪米特治疗功能性消化不良、慢性胆囊炎、胆结石、肝硬化腹胀的疗效观察

目的观察复方阿嗪米特肠溶片对功能性消化不良、慢性胆囊炎、胆结石及肝硬化所致腹胀的疗效。方法将功能性消化不良、慢性胆囊炎、胆结石、肝硬化患者各20例纳入本研究。分别予以复方阿嗪米特肠溶片2粒，每日3次，疗程4周。观察治疗前后腹胀症状积分改变。功能性消化不良及慢性胆囊炎、胆结石患者治疗前后进行水负荷试验。结果复方阿嗪米特肠溶片可明显改善功能性消化不良、慢性胆囊炎、胆结石及肝硬化患者腹胀症状，治疗2周及4周腹胀症状积分均明显下降（P〈0．01）。治疗后功能性消化不良及慢性胆囊炎、胆结石患者最大饮水量明显增加（P〈0．01），其对腹胀的总有效率为80％～85％。治疗过程中无不良反应发生。结论阿嗪米特肠溶片是治疗功能性消化不良，慢性胆囊炎、胆结石及肝硬化患者腹胀症状安全、有效的药物。     

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.     

伊托必利联合复方阿嗪米特治疗功能性消化不良临床观察

目的观察应用伊托必利联合复方阿嗪米特治疗功能性消化不良（FD）患者的疗效和安全性。方法将119例患者随机分为两组,治疗组60例,口服伊托必利50mg／次、复方阿嗪米特2片／次,三餐后服用;对照组59例,口服多潘立酮10mg／次,三餐前服用。两组疗程均为14d。观察治疗前后餐后不适、上腹痛、食欲不振消化不良症状积分变化,计算有效率。结果治疗后两组患者的症状总积分均较治疗前下降,治疗组改善程度优于对照组（P〈0．01）,无明显不良反应。结论伊托必利和复方阿嗪米特联合使用可提高治疗FD的疗效,且安全性好。     

肠溶片治疗胆道结石术后消化不良影响

目的探讨复方阿嗪米特肠溶片对治疗胆道结石术后消化不良的影响.方法取2013-10/2016-12苍南县人民医院普外科收治胆道术后消化不良患者90例,电脑抽取随机数字法分为对照组(n=45)和观察组(n=45).对照组采用复方消化酶胶囊治疗,观察组采用复方阿嗪米特肠溶片治疗,比较2组临床疗效及安全性.结果观察组治疗后食欲不振时间(1.28 d±0.21 d)、腹胀消失时间(2.04 d±0.35 d)、嗳气消失时间(1.98 d±0.38 d)及腹痛等症状消失时间(2.13 d±0.41 d),均短于对照组(P0.05);观察组不良反应发生率为13.33%,对照组为20.00%,2组治疗2 wk药物不良反应发生率比较,差异有统计学意义(P0.05).结论胆道结石术后消化不良患者采用复方阿嗪米特肠溶片治疗效果理想,安全性高,值得推广应用.     

马来酸曲美布汀联合复方阿嗪米特治疗功能性消化不良疗效观察

目的观察马来酸曲美布汀联合复方阿嗪米特肠溶片治疗功能性消化不良的疗效。方法将确诊为功能性消化不良的患者120例分成3组,观察组（A 组）40例,给予马来酸曲美布汀、复方阿嗪米特肠溶片口服;对照组（B 组）40例,单用马来酸曲美布汀口服;对照组（C 组）40例,单用复方阿嗪米特肠溶片口服,疗程均为4周。观察患者治疗前后腹胀及上腹部不适症状的改善情况。结果3组患者治疗后腹胀及上腹部不适症状改善均有统计学意义（P ＜0．05）,观察组较对照组症状改善明显。结论马来酸曲美布汀和复方阿嗪米特肠溶片联合治疗消化不良,疗效优于单用马来酸曲美布汀和复方阿嗪米特肠溶片。     

复方阿嗪米特肠溶片对胆囊炎患者外科治疗后消化不良的影响

目的:探讨复方阿嗪米特肠溶片对胆囊炎患者外科治疗后消化不良的影响.方法:选取在浙江省江山贝林医院就诊的胆囊炎外科手术后消化不良的患者60例,随机分为研究组和对照组,每组30例.研究组口服复方阿嗪米特肠溶片,对照组服用安慰剂,150 mg/次,3次/d,连续服用4 wk.比较治疗前后两组患者消化不良症状积分、消化不良的总疗效率和两组患者的SF-NDI量表总评分.结果:两组患者治疗前消化不良积分及症状总积分情况比较,差异不具有统计学意义(P0.05),研究组患者在治疗第28天食欲不振、早饱、嗳气、腹痛或腹部不适及症状总积分明显低于对照组,差异具有统计学意义(P0.05);两组患者在治疗后1 wk,消化不良的总有效率差异不具有统计学意义(P0.05),研究组中患者于治疗后2、3、4 wk消化不良的总有效率显效高于对照组,差异具有统计学意义(P0.05);两组患者于治疗前、治疗后第7、14天的SF-NDI量表总评分差异不具有统计学意义(P0.05),研究中患者于治疗后第21天及治疗后第28天的SFN D I量表总评分低于对照组,差异具有统计学意义(P0.05).结论:复方阿嗪米特肠溶片可有效的改善胆囊炎患者外科手术后消化不良的症状,提高患者的生活质量.     

复方阿嗪米特联合盐酸伊托必利治疗老年功能性消化不良疗效及安全性观察

目的探讨复方阿嗪米特联合盐酸伊托必利治疗老年功能性消化不良的临床疗效及安全性。方法将92例老年功能性消化不良患者随机分为两组。观察组47例给予复方阿嗪米特肠溶片和盐酸伊托必利片治疗,对照组45例仅给予盐酸伊托必利片治疗。比较两组临床疗效及安全性。结果观察组治疗2周、4周后腹胀、餐后不适、食欲不振等改善程度均明显优于对照组(P0.05);观察组治疗2周、治疗4周总有效率分别为68.1%、89.4%,均明显高于对照组的46.7%、66.7%(P0.05)。治疗期间两组均未出现明显的不良反应。结论复方阿嗪米特联合盐酸伊托必利能显著改善老年功能性消化不良的症状,提高临床疗效,且安全性较高。     

复方阿嗪米特联合阿普唑仑治疗功能性消化不良疗效观察

目的观察复方阿嗪米特联合阿普唑仑治疗功能性消化不良（FD）的临床效果和安全性。方法将门诊76例FD患者进行焦虑抑郁评分后随机分为两组,治疗组38例,口服复方阿嗪米特2片/次,3次/日,阿普唑仑0.4mg3次/d;对照组38例,口服多潘立酮10mg/次,3次/d。两组疗程均为4周。比较治疗前后2组患者消化不良症状的变化和焦虑抑郁状态的改善,计算总有效率,同时记录不良反应。结果两组治疗前后的症状总积分和有效率比较,治疗组治疗前症状总积分为15.8±5.5,治疗后降至5.2±3.4,对照组治疗前症状总分积为15.2±4.9,治疗后降至8.8±5.1;治疗组总有效率为92.1%,对照组为68.4%,差异均有显著性（P〈0.01）,焦虑、抑郁的有效率治疗组为100%、90.9%,显著优于对照组9.1%,18.2%P均〈0.01,且未发现严重不良反应。结论复方阿嗪米特联合阿普唑仑治疗功能性消化不良疗效显著,且安全性好。     

中西医结合治疗功能性消化不良的临床研究

目的观察复方阿嗪米特肠溶片联合四逆散加减治疗功能性消化不良的疗效。方法将257例功能性消化不良患者随机分为治疗组129例和对照组128例。对照组给予复方阿嗪米特肠溶片治疗,治疗组在此基础上给予四逆散加减治疗,2个疗程结束后观察两组患者的疗效,随访1年。结果治疗组总有效率为94.57%显著高于对照组的77.34%,其差异有统计学意义(P0.05)。结论复方阿嗪米特肠溶片联合四逆散加减治疗功能性消化不良,可显著的改善患者的临床症状,促进患者的康复,且在停药后降低其复发率,值得临床推广应用。     

复方阿嗪米特与阿普唑仑联合治疗功能性消化不良的临床疗效

目的:探讨临床中复方阿嗪米特与阿普唑仑联合治疗功能性消化不良的效果.方法:选取海口市第三人民医院2013-01/2014-12 120例功能性消化不良患者为研究对象,将其按照随机数字表法分为联合组与常规组,常规组给予复方阿嗪米特治疗,联合组给予复方阿嗪米特与阿普唑仑联合治疗,观察两组疗效.结果:联合组vs常规组临床治疗总有效率91.7%vs 73.3%,差异有统计学意义(P0.05);治疗后联合组与常规组临床症状积分比较(5.3分±0.8分vs 8.8分±1.5分),差异有统计学意义(P0.05).结论:临床中对于功能性消化不良患者采取复方阿嗪米特与阿普唑仑联合治疗效果显著,提高临床疗效,不良反应少,值得临床中应用.     

吗丁啉缓解消化不良症状的疗效观察——全国多中心、开放、前瞻性研究

目的评价吗丁啉（多潘立酮）2周治疗缓解消化不良症状的疗效，统计各种消化不良症状在门诊患者中的发生率；了解治疗过程中各种不良事件的发生率。方法选取2006年7月～2006年12月全国31个中心具有消化不良症状的门诊患者2067例，给予吗丁啉10mg，tid，餐前15～30min服用，连续用药2周。治疗1周、2周后对消化不良症状进行评分，记录治疗期间的合并用药、不良事件。结果患者基线时临床症状总积分为（14．49±6．70）分，中位数为14分。治疗1周和2周后总积分分别为（5．87±5．00）分和（1．97±3．08）分，中位数分别为5分和2分（P〈0．0001）。治疗1周和2周后的显效率分别为26．12％和71．65％，治疗2周效果优于1周，治疗2周末的总有效率为92．55％。患者主要症状的消失时间平均为4～8d（中位数），其中恶心和呕吐为4d，依次为食欲不振、上腹痛、早饱、嗳气、上腹胀。上腹胀的发生率最高，为90．37％，并且以中、重度者居多。其次是暖气（70．49％），以轻、巾度居多；依次为早饱（65．3％）、上腹痛（57．80％），食欲不振（48．99％）、恶心（33．37％）和呕吐（8．62％），均为轻度者居多。本研究共有26例受试者出现不良事件，占总例数的1．26％，其中23例为相关不良事件。在发生的23例相关不良事件中有5例为头晕，4例为溢乳。结论吗丁啉能够显著改善消化不良各项症状。2周治疗疗效显著优于1周治疗，提示消化不良促动力治疗应维持不少于2周。吗丁啉治疗消化不良安全性良好，不良事件发生率低。     

舒肝解郁胶囊联合马来酸曲美布丁胶囊、复方阿嗪米特肠溶片治疗功能性消化不良疗效观察

目的 观察舒肝解郁胶囊联合马来酸曲美布丁、复方阿嗪米特肠溶片治疗功能性消化不良的疗效及安全性.方法 将确诊为功能性消化不良的120例患者随机分为2组,每组60例.治疗组给予口服舒肝解郁胶囊2粒,bid,马来酸曲美布丁胶囊100 mg,tid,复方阿嗪米特肠溶片100 mg,tid;对照组给予口服马来酸曲美布丁胶囊100...     

复方消化酶治疗消化不良患者的疗效和安全性随机双盲安慰剂对照多中心临床试验

目的 评估复方消化酶(商品名:美尼)治疗消化不良的疗效和安全性.方法 采用随机双盲、安慰剂平行对照的多中心研究.应用视觉模拟评分法(visual analogue scale,VAS),食欲不振、饱胀、腹部不适和腹胀症状总积分≥20分的消化不良患者240例,随机均分为安慰剂组和治疗组,分别服用安慰剂和复方消化酶2粒/次,3次/d,疗程为2周;评价两组在治疗1、2周和停药后1周消化不良症状的缓解程度和不良反应的发生.结果 216例患者完成本研究,其中治疗组105例,安慰剂组111例.治疗组在治疗1、2周及停药1周消化不良总症状积分下降程度明显优于安慰剂组(P＜0.01);治疗组在治疗1、2周和停药后1周总有效率分别为64.76%、77.05%和66.99%,明显高于安慰剂组的27.93%、37.84%和29.36%(P＜0.05).两组在治疗过程中及停药后均未出现严重不良反应.结论 复方消化酶治疗消化不良具有良好的疗效及安全性.     

Lansoprazole in the treatment of functional dyspepsia: two double-blind, randomized, placebo-controlled trials

PURPOSE: The efficacy of proton pump inhibitor therapy for symptom resolution in patients with functional dyspepsia remains controversial. This study was designed to compare the efficacy of lansoprazole with placebo in relieving upper abdominal discomfort in patients with functional dyspepsia. METHODS: We enrolled 921 patients with functional dyspepsia (defined as persistent or recurrent upper abdominal discomfort during the prior 3 months) and moderate upper abdominal discomfort on at least 30% of screening days; none of the patients had predominant symptoms suggestive of gastroesophageal reflux or endoscopic evidence of erosive or ulcerative esophagitis, or gastric or duodenal ulcer or erosion. Patients were assigned randomly to receive lansoprazole 15 mg (n = 305), lansoprazole 30 mg (n = 308), or placebo (n = 308) daily for 8 weeks. Patients recorded the frequency and severity of symptoms in daily diaries. RESULTS: At week 8, significantly (P <0.001) greater mean reductions in the percentage of days with upper abdominal discomfort were reported in patients treated with lansoprazole 15 mg (35%) or 30 mg (34%) compared with those treated with placebo (19%). Similarly, more patients treated with lansoprazole 15 mg (44%) or 30 mg (44%) reported complete symptom resolution (defined as no episodes of upper abdominal discomfort in the 3 days before the study visit) at 8 weeks than did placebo-treated patients (29%, P <0.001). Improvement of upper abdominal discomfort, however, was seen only in patients who had at least some symptoms of heartburn at enrollment. CONCLUSION: Lansoprazole, at a daily dose of 15 mg or 30 mg, is significantly better than placebo in reducing symptoms of persistent or recurrent upper abdominal discomfort accompanied by at least some symptoms of heartburn.     

米曲菌胰酶片治疗消化不良症状的多中心、随机、安慰剂交叉对照临床研究

背景：米曲菌胰酶片是含有米曲菌酶和胰酶的口服双层包膜复合消化酶制剂，在国外用于治疗消化不良已有数十年．然而目前国内尚无米曲菌胰酶片治疗消化不良症状疗效和安全性的资料。目的：评价米曲菌胰酶片对中国人群消化不良症状的疗效和安全性。方法：采用多中心、随机、安慰剂交叉对照试验设计，在上海地区7个临床中心，对有消化不良症状的门诊患者先予安慰剂治疗1周，症状积分改善〈50％者中共有151例[男76例，女75例，年龄22～67岁，平均（44．67±6．46）岁]完成疗效观察研究，79例随机进入流程A（予米曲菌胰酶片2片tid，餐后立即服用，治疗2周；1周药物清洗期；再予安慰剂2片tid，餐后立即服用，治疗2周），72例进人流程B（予安慰剂2片tid，餐后立即服用，治疗2周；1周药物清洗期；再予米曲菌胰酶片2片tid，餐后立即服用，治疗2周）。分别于研究流程的第1、8、22、29和43d评估消化不良症状积分。结果：经米曲菌胰酶片治疗2周，患者消化不良症状总积分下降幅度与安慰剂相比差异有统计学意义（从27．64±1．77降至9．72±1．33对从23．99±1．28降至22．03±1．40，P〈0．01）。根据症状积分改善幅度．米曲菌胰酶片改善消化不良症状的效果依次为腹胀、腹泻、嗳气、腹痛、食欲不振和上腹部烧灼感。米曲菌胰酶片治疗消化不良症状的总有效率显著优于安慰剂（89．6％对21．7％，P〈0．01）。研究过程中无与研究药物相关的不良反应发生。结论：米曲菌胰酶片用于治疗中国人群的消化不良症状安全、有效。     

复方阿嗪米特肠溶片联合多潘立酮治疗功能性消化不良的随机、双盲、安慰剂对照临床研究

目的 评估复方阿嗪米特肠溶片与促动力剂联合使用对功能性消化不良(FD)患者症状和生活质量的影响.方法 随机、双盲、安慰剂对照临床试验.卫生部北京医院门诊就诊的208例符合罗马Ⅲ诊断标准的FD患者,随机分为复方阿嗪米特肠溶片+多潘立酮组(A组,102例)和安慰剂+多潘立酮组(B组,106例)进行治疗.复方阿嗪米特肠溶片2片/次,3次/d;多潘立酮10 mg/次,3次/d,疗程均为4周.测定治疗前后改良消化不良严重程度评估(mSODA)分数的改变值,并计算有效率.结果 mSODA各项评分:(1)腹胀痛严重度评分,A组治疗前后改变值为-12.35±5.48,B组为-10.52±4.65(P=0.009);(2)非腹胀痛症状评分改变值,A组为-5.75±3.31,B组为-4.86±2.65(P=0.033);(3)生活满意度评分改变值,A组为7.09±3.78,B组为5.62±3.54(P=0.004).A组的治疗总有效率为89.2%,B组为76.4%,A组显著高于B组(P=0.015).两组均无严重不良事件发生.结论 复方阿嗪米特肠溶片与促动力剂联合使用较单用促动力剂可更有效缓解FD患者各种消化不良症状,并显著改善生活质量.

Abstract：

Objective To study the efficacy and safety of combined therapy of compound azintamide and domperidone in functional dyspepsia. Methods A randomised, double-blind, placebo-controlled trial.Two hundred and eight patients with functional dyspepsia were randomly grouped into group A (experimental group, 102 cases) and group B (control group, 106 cases). The patients in the group A were given 2 tablets of compound azintamide 3 times a day in addition to domperidone 10 mg 3 times per day for four weeks. The patients in the group B were only given domperidone 10 mg 3 times per day for 4 weeks. The therapeutic efficacy was evaluated by modified Severity of Dyspepsia Assessment (mSODA) and Global Patient Assessment (GPA). Results Subscore in mSODA:the change of bloating/pain intensity score in group A is -12.35±5.48 while group B is -10.52±4.65(P=0.009), the change of non-bloating/pain symptoms score in group A is -5.75±3.31 while group B is - 4. 86 ± 2.65 (P=0.033), and the change of satisfaction score in group A is 7. 09 ± 3. 78 while group B is 5.62 ± 3. 54 (P = 0. 004). The response rate in group A is 89. 2% which is significantly higher than 76.4% in group B (P=0. 015). Other symptoms for response assessment included loss of appetite, early satiety, fullness after meal, diarrhea. No severe side-effect was found in both groups. Conclusions Combined therapy of compound azintamide and domperidone may lead to bigger improvement in overall efficacy and health related quality of life in patients with functional dyspepsia than use of motility medicine alone. Potential mechanisms that may account for the efficacy of compound azintamide in functional dyspepsia include modulation of visceral sensitivity and/or gastrointestinal motility.     

Functional disorders of the stomach

Gastroenterologists frequently encounter patients who report vague epigastric discomforts or sensations of fullness, bloating, and distention in the upper abdomen. The discomfort is neither burning in character nor severe in intensity; there is no nocturnal pain. The epigastric location of discomfort and lack of radiation may help to exclude biliary tract and pancreatic diseases. Nausea may be present, but there is little or no vomiting. After these patients ingest liquids or solid foods, the symptoms of easy filling or early satiety and increasing discomfort and nausea are almost always present. The patient may only report "indigestion," but a specific chief complaint, such as pain, discomfort, nausea, or bloating may be elicited with further inquiries. Solid foods usually provoke more symptoms than do liquids. Symptoms of early satiety, nausea, bloating, and abdominal discomfort may culminate in the vomiting of undigested food. These vague upper gastrointestinal (GI) symptoms have been termed "dyspepsia." When peptic diseases of the stomach are excluded, the symptom complex has been called "nonulcer" dyspepsia, a vague syndrome with symptoms attributed to stomach dysfunction. Nonulcer dyspepsia has been reviewed recently. Such symptoms, commonly attributed to a "functional" disorder, are very common in clinical practice, with an incidence of 30% of patients. In this review, we will discuss an approach to the evaluation and treatment of patients with symptoms of nausea, early satiety, bloating, and vague epigastric discomfort--dyspeptic symptoms associated with functional stomach disorders. We will review the anatomy and motility of the stomach and suggest potential neuromuscular malfunctions of the stomach that may result in epigastric symptoms. The potential role of stress and other brain-gut interactions, which may underlie these symptoms, will also be reviewed.     

Symptoms associated with hypersensitivity to gastric distention in functional dyspepsia

BACKGROUND & AIMS: Hypersensitivity to gastric distention has been reported in functional dyspepsia, but its characteristics and relevance to symptoms remain unclear. The aim of this study was to define hypersensitivity to gastric distention and its association to specific symptoms in functional dyspepsia. METHODS: We used a gastric barostat to study sensitivity to gastric distention in 80 healthy subjects and in 160 functional dyspepsia patients. Demographic characteristics, gastric emptying, Helicobacter pylori status, gastric accommodation, and a dyspepsia symptom score were obtained from all patients and the relationship with visceral sensitivity was assessed using univariate and multivariate analysis. RESULTS: The increase of intra-balloon pressure over intra-abdominal pressure needed to induce discomfort or pain is the most appropriate expression of sensitivity to gastric distention because it yields a meaningful lower range of normal and it is independent from age and body mass index. Hypersensitivity to gastric distention was found in 34% of the patients, who did not differ from the other patients in demographic and other pathophysiological characteristics. Hypersensitivity to distention was associated with a higher prevalence of postprandial pain, belching, and weight loss. CONCLUSIONS: Hypersensitivity to gastric distention is present in a subset of functional dyspepsia patients. It is associated with symptoms of postprandial epigastric pain, belching, and weight loss.     

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...