健胃消痞方治疗脾虚型功能性消化不良疗效观察

[目的]观察健胃消痞方对脾虚型功能性消化不良(FD)的临床疗效.[方法]将91例脾虚型FD患者随机分为治疗组48例和对照组43例,分别给予健胃消痞方和多潘立酮治疗,疗程4周.观察治疗后两组患者的疗效和不良反应.[结果]治疗组显效率为60.4%,总有效率为87.5%;对照组显效率为32.6%,总有效率为69.8%.治疗组显效率和总有效率均优于对照组(P＜0.01,＜0.05).治疗组在治疗过程中仅1例患者出现便前腹痛、便量增多和大便稀溏的现象,未发现肝肾功能损害和外周血象变化.[结论]健胃消痞方能明显改善脾虚型FD患者的临床症状,安全有效,疗效优于多潘立酮.     

康尔胃2号治疗功能性消化不良的临床观察

目的:观察康尔胃2号对功能性消化不良(FD)的治疗效果.方法:选择FD患者314例分为两组,其中治疗组178例,对照组136例.治疗组用康尔胃2号颗粒,每次1包,每日2次,早、晚饭前0.5 h口服;对照组用多潘立酮(商品名:吗丁啉),每次10mg,每天3次,疗程均为4周.结果:治疗组治愈率为29.8%,总有效率为84.3%;对照组治愈率为8.8%,总有效率为78.0%.经统计学处理,两组治愈率差异有统计学意义(P＜0.05).康尔胃2号对气滞证FD疗效明显优于脾虚证FD(P＜0.01).结论:康尔胃2号对FD有明显治疗作用,其作用与中医证型相关.     

旋覆代赭汤联合多潘立酮治疗围绝经期功能性消化不良58例

[目的]观察旋覆代赭汤联合多潘立酮片治疗围绝经期功能性消化不良(FD)的临床疗效。[方法]将112例围绝经期FD患者随机分成2组,治疗组58例,口服旋覆代赭汤以及多潘立酮片,对照组44例,单独口服多潘立酮片,疗程均为4周。采用临床症状积分法观察2组患者症状的改善程度。[结果]2组患者治疗4周后症状积分均低于治疗前(P0.01);对照组症状积分改善率低于治疗组(P0.01)。2组治疗4周后总有效率分别为87.93%和63.63%(P0.01)。[结论]旋覆代赭汤联合多潘立酮片治疗FD的临床疗效明显优于单独使用多潘立酮片,值得临床推广。     

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。     

升降胶囊治疗功能性消化不良的临床观察

目的 :观察升降胶囊治疗功能性消化不良 (FD)患者的疗效。方法 :将 15 2例 FD患者随机分为治疗组(10 2例 )和对照组 (5 0例 )。治疗组服用自拟升降胶囊 ,对照组服用吗丁啉 ,疗程均为 4周。结果 :治疗组临床总有效率及脾胃虚弱、肝胃不和、肝郁脾虚三种中医证型的临床治愈率均优于对照组 (P <0 .0 5～ <0 .0 1)。治疗组治疗后血浆胃动素显著增高 (P <0 .0 1) ,胃排空率及正常胃电百分率均优于对照组 (均 P <0 .0 5 )。结论 :中药升降胶囊对FD有明显疗效 ,并通过多途径改善 FD患者的胃动力。     

伊托必利联合西酞普兰治疗功能性消化不良的临床疗效观察

目的 评价伊托必利联合西酞普兰治疗功能性消化不良(FD)的临床疗效及安全性.方法 将入选的96例FD患者随机分为两组,对照组48例给予口服盐酸伊托必利分散片50 mg,tid;治疗组48例,给予口服盐酸伊托必利分散片50 mg,tid,西酞普兰20 mg,qd.两组的疗程均为4周,比较两组患者临床症状的变化情况.结果 对照组显效率20.83％,总有效率62.50％;治疗组显效率56.25％,总有效率93.75％.两组显效率及总有效率差异有统计学意义(P＜0.05).两组临床症状均明显缓解(P＜0.05):除恶心、呕吐和上腹痛外,其他症状消失率治疗组均优于对照组,两组均未见严重的药物不良反应发生.结论 伊托必利联合西酞普兰治疗FD疗效满意,安全性好,是治疗FD可行的方案.     

中西医结合治疗胃食管反流病的临床疗效观察

目的 观察胃力康联合法莫替丁和铝碳酸镁片治疗胃食管反流病(GERD)的临床疗效.方法 将98例患者随机分为二组,治疗组56例,使用胃力康联合法莫替丁和铝碳酸镁片治疗.对照组42例.以吗丁啉和法莫替丁及铝碳酸镁片治疗.疗程均为3个月.结果 治疗组显效25.0%,有效66.08%.无效8.93%.总有效率91.07%;对照组:显效16.67%,有效64.29%,无效19.08%.总有效率80.92%.两组总有效率差异有显著意义(P<0.05),而且治疗组主要体现在显效,两组显效率差异非常显著(P<0.01).结论 中西医结合疗效明显优于西药组,其机制可能为胃力康不仅有良好的促动力作用,而且有舒肝解郁抗焦虑作用,值得临床推广应用.     

运脾散治疗儿童运动障碍样型功能性消化不良30例

[目的]观察运脾散敷脐治疗运动障碍样型功能性消化不良(FD)患儿的疗效.[方法]将60例患儿,分为运脾散治疗组和西药(多潘立酮)对照组各30例,比较2组治疗前后临床症状及胃动力学指标改善情况,判定疗效.[结果]2组治疗前后胃排空率及胃电节律得到显著改善,但2组间差异无统计意义.2组治疗后,均有显著的症状疗效,治疗组痊愈率优于对照组(P＜0.05),而总有效率和对照组大致相当(P＞0.05).[结论]运脾散敷脐治疗运动障碍样型FD有显著的症状疗效,能有效调节胃排空率及胃电节律.     

生物阻抗技术评价多潘立酮对功能性消化不良胃动力的影响

目的 研究多潘立酮对功能性消化不良(functional dyspepsia,FD)患者胃动力的影响.方法 应用胃动力检测系统检测2007年6月至2008年2月重庆医科大学附属第一医院消化门诊30例FD患者餐后胃动力,同步提取胃阻抗信号和胃电信号,并对FD患者进行症状评分,多潘立酮10 mg每日3次治疗1周后,复查餐后胃动力并再次症状评分.结果 经多潘立酮治疗后FD患者腹胀、腹痛、早饱、嗳气症状积分明显下降(P＜0.05),餐后不适综合征(PDS)组症状改善较明显(P＜0.05).胃电主功率百分比治疗后[(58.03±8.05)%]较治疗前[(52.07±7.01)%]有显著提高(P＜0.05).治疗前,PDS组和上腹疼痛综合征(EPS)组主功率百分比差异无统计学意义(P＞0.05);治疗后,PDS组主功率百分比[(46.50±4.08)%]显著高于EPS组[(41.99±3.10)%](P＜0.01);PDS和EPS两组各频段功率百分比治疗前后差异均无统计学意义(P＞0.05).结论 多潘立酮可改善FD患者的临床症状,恢复异常的胃电活动,阻抗胃动力紊乱并未完全恢复正常;经多潘立酮治疗后PDS组较EPS组阻抗胃动力紊乱改善较明显.     

蒙脱石散联合多潘立酮治疗腹泻型肠易激综合征重叠功能性消化不良效果观察

[目的]观察蒙脱石散联合多潘立酮治疗腹泻型肠易激综合征(IBS-D)重叠功能性消化不良(FD)的疗效。[方法]将经胃镜及结肠镜检查排除胃、十二指肠及结肠器质性疾病的IBS-D重叠FD患者94例,随机分为治疗组48例和对照组46例,治疗组给予蒙脱石散3g、3次/d,多潘立酮10g,3次/d;对照组给予马来酸曲美布汀0.1g,3次/d;2组均连续应用4周。观察并记录2组治疗前后各项临床症状积分变化情况。[结果]治疗4周后治疗组各项症状积分较治疗前显著降低,总有效率达83.3%;对照组总有效率为37.0%,2组疗效差异统计学意义(P0.05)。[结论]蒙脱石散联合多潘立酮治疗IBS-D重叠FD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.     

常规疗法联用盐酸帕罗西汀治疗功能性消化不良的疗效观察

目的评价常规疗法联合应用盐酸帕罗西汀治疗功能性消化不良(FD)的疗效。方法将93例FD患者随机分为两组,对照组患者用常规方法治疗,治疗组患者在常规治疗方法基础上加用盐酸帕罗西汀治疗,20 mg/次,1次/d,疗程6周,比较两组患者的临床治疗效果。结果治疗组患者治疗总有效率(95.7%)显著高于对照组患者(76.1%),治疗组患者临床疗效显著优于对照组患者,差异有统计学意义(P0.01)。治疗组患者复发率(12.8%)显著低于对照组患者(30.4%),差异有统计学意义(P0.05)。结论在常规治疗方法基础上联用盐酸帕罗西汀治疗功能性消化不良疗效显著、安全性高,值得临床推广应用。     

Levosulpiride and cisapride in the treatment of dysmotility-like functional dyspepsia: a randomized, double-masked trial.

BACKGROUND & AIMS: Levosulpiride is a benzamide derivate D(2) dopamine antagonist with prokinetic activity that can accelerate gastric emptying and reduce discomfort in response to gastric distention. The aim of the study is to compare the clinical efficacy of levosulpiride and cisapride in patients with dysmotility-like functional dyspepsia. METHODS: In a exploratory pilot study performed as a multicenter, randomized, double-masked trial, the effects of 8 weeks of treatment with either levosulpiride, 25 mg, 3 times daily (n = 69) or cisapride, 10 mg, 3 times daily (n = 71) were compared. Individual symptoms (pain/discomfort, fullness, bloating, early satiety, and nausea/vomiting), global symptom score, effect on health-related quality of life (HRQoL), and anxiety-state and anxiety-trait were evaluated. Adverse events also were recorded. RESULTS: Both levosulpiride and cisapride improved dyspeptic symptoms and decreased total symptom score (79.9% and 71.3%, respectively); no significant statistical difference between treatments was found (P = 0.07 for total symptom score). HRQoL improved similarly after both treatments, whereas no change was observed in anxiety. Medication-related adverse effects were present in 13 of 69 patients (18.8%) in the levosulpiride group and 8 of 71 patients (11.3%) in the cisapride group. Significantly more (P = 0.03) patients treated with cisapride had to abandon the trial because of side effects. CONCLUSIONS: Levosulpiride is at least as effective as cisapride in the treatment of dysmotility-like functional dyspepsia.     

调中颗粒治疗寒热错杂型功能性消化不良的临床疗效及对血浆胃肠激素水平的影响

[目的]观察调中颗粒对寒热错杂型功能性消化不良(FD)的临床治疗效果及血浆胃肠激素水平的变化.[方法]寒热错杂型FD患者210例,随机分为2组,各105例,治疗组予调中颗粒,对照组予多潘立酮片,2组疗程均为4周.[结果]治疗组、对照组临床疗效总有效率分别为91.43％和76.19％,组间临床疗效比较,差异有统计学意义(P＜0.05).治疗组各项中医症候单项症状改善治疗前后比较差异有统计学意义(P＜0.05).治疗组血浆胃动素及促胃液素水平较前升高明显,与对照组相比差异有统计学意义(P＜0.05).2组治疗期间均未发生不良事件.[结论]调中颗粒可通过对血浆胃肠激素水平的影响缓解寒热错杂型FD患者的临床症状.     

Efficacy and safety of ecabet sodium on functional dyspepsia： A prospective, double-blinded, randomized, multi-center controlled trial

AIM: To compare ecabet sodium and cimetidine in relieving symptoms of functional dyspepsia. METHODS: We performed a multi-center, prospective, randomized, double-blinded controlled trial to compare the clinical efficacy of ecabet sodium and cimetidine in patients with functional dyspepsia. Two-hundred and seventy-two patients with dyspeptic symptoms fulfilling the Rome-II criteria were enrolled from 7 centers. In the study group (115 patients), 1.5 g ecabet sodium was given twice a day. In the control group (121 patients), 400 mg cimetidine was given twice a day. Symptoms and parameters of quality of life were analyzed at baseline, 3, 14, and 28 d after initiating the treatment. RESULTS: Two-hundred and thirty-six patients completed the clinical trial. After 4 wk of treatment, the rates of improvement in patients with dyspeptic symptoms were not different between two groups (77.4% in the ecabet group and 79.3% in the cimetidine group, respectively, P > 0.05). Likewise, the rates of symptomatic improvement were not different at 3 d and 14 d. The parameters of quality of life did not change significantly during the study period in both groups. There was no clinically significant adverse event in both groups. CONCLUSION: In patients with functional dyspepsia, ecabet sodium has similar clinical efficacy with cimetidine.     

Two weeks treatment with amoxicillin/omeprazole for eradication of Helicobacter pylori.

In an open study, 62 patients with Helicobacter pylori-associated ulcer disease or functional dyspepsia were treated for two weeks with 2 x 20 mg omeprazole preprandially and 4 x 500 mg amoxicillin suspension one hour before meals and at night. 57 patients (active ulcer disease: n = 53, functional dyspepsia: n = 4) completed the study without contravening the protocol. The rate of eradication of the bacteria at least 4 weeks after cessation of study medication was 82.5% (47/57 patients). Three patients experienced side effects during the treatment period (stomatitis, self-limiting diarrhea, allergic exanthema). In one case allergic exanthema led to discontinuation of therapy. 11 patients with H. pylori-associated ulcer disease received 2 x 20 mg omeprazole for two weeks. In this group no eradication of bacteria was observed.     

西沙必利治疗功能性消化不良的多中心临床疗效观察

本项多中心临床试验旨在对西沙必利（ｃｉｓａｐｒｉｄｅ）治疗功能性消化不良的疗效和安全性进行评估。其中治疗组４１４例，对照组１６９例。西沙必利的服药方法为每次５ｍｇ，每日３次，共服４周。结果显示西沙必利能使早饱、腹胀、上腹痛、恶心等多种消化道症状有明显改善，总有效率为９２．９９％，明显优于对照组的４１．４２％，且两组病人间差异有显著性。西沙必利的副作用主要为腹痛、腹泻，多数病人对其可以耐受。以上研究结果表明西沙必利为一种安全、有效的促动力药物。     

Eradication ofHelicobacter pylori and long-term outcome of functional dyspepsia

The aim of this study was to assess the effect of colloidal bismuth subcitrate (CBS) and metronidazole on Helicobacter pylori eradication and on the course of symptoms due to functional dyspepsia. Forty-one patients with functional dyspepsia were entered into the study and randomized to treatment with CBS (120 mg four times a day) for four weeks combined with metronidazole (250 mg four times a day) for one week (group A,N=21) or matching placebo (group B,N=20). The severity of gastritis and of bacterial colonization and the symptom score was assessed by endoscopy and clinical evaluation at baseline and after four, eight, and 24 weeks from the start of the treatment. With intent-to-treat analysis eradication was achieved in 16/25 (64%) patients in group A and in 6/24 (25%) in group B. At eight and 24 weeks the gastritis score was significantly lower only in those patients with eradication. No change was seen in patients in whom the bacteria was not eradicated. The symptom score at eight weeks was considerably lower both in patients with eradication and in those with infection. However, at 24 weeks a gradual decrease in the symptom score in patients with eradication and a worsening of symptoms in controls was observed. No differences were observed between patients with ulcerlike and those with dysmotility-like dyspepsia. The study confirms the need for a long observation period after antibacterial treatment in patients with functional dyspepsia and suggests thatHelicobacter pylori-eradicating treatment improves the course of this functional syndrome.     

泮托拉唑合旋覆代赭汤治疗反流性食管炎

目的：观察伴托拉唑合旋覆代赭汤治疗反流性食管炎(RE)的疗效。方法：60例经内镜证实的RE患者，随机分为两组，治疗组30例，予以伴托拉唑40mg，1次／d口服，同时服用中药旋覆代赭汤100m1，3次／d口服；对照组30例，予以奥美拉唑20mg，1次／d口服，同时服用旋覆代赭汤100m1，3次／d，疗程均为4周。两组分别记录治疗前后反酸、烧心、胸痛、胃胀等症状积分，于4周后复查内镜。结果：两组治疗后1周，烧心、反酸、胸痛、胃胀等症状积分较治疗前均明显下降(均P＜0．01)，4周后达到缓解。治疗组内镜下食管炎治愈率为80．0％，有效率为93．3％，与对照组(76．7％及90．0％)比较，差异无显著性意义(P＞0.05)。结论：国产伴托拉唑治疗RE与奥美拉唑的疗效相同。