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。     

复方阿嗪米特治疗消化不良的自身对照多中心临床研究

目的 观察复方阿嗪米特肠溶片治疗消化不良的疗效和安全性.方法 观察北京8家医院消化科门诊的180例多潘立酮(10 mg/次,3次/d)治疗2周症状积分下降<30%的消化不良患者,根据引起消化不良症状的基础疾病分成胃肠疾病相关的消化不良(A组)和胆系疾病相关的消化不良(B组),使用复方阿嗪米特肠溶片治疗(2片/次,3次/d)2周,观察治疗前、后上腹胀、上腹痛或不适、食欲不振积分变化,计算有效率,同时观察记录不良事件.结果 A、B两组患者治疗后上腹胀、上腹痛或不适、食欲不振积分及总症状积分明显下降(P<0.01),各单项症状及总症状有效率均在84.9%和92.5%以上.1例患者于复方阿嗪米特治疗14 d时出现皮疹伴有瘙痒,3 d后皮疹消退,未遗留其他不适及检验异常.结论 复方阿嗪米特肠溶片可以有效缓解多潘立酮治疗无效的消化不良患者的上腹胀、上腹痛或不适、食欲不振症状,且安全性较好.     

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。     

黛力新联合复方阿嗪米特治疗功能性消化不良63例分析

目的观察黛力新联合复方阿嗪米特治疗功能性消化不良的临床疗效。方法将142例功能性消化不良患者随机分为两组:观察组63例,接受黛力新联合复方阿嗪米特治疗;对照组79例,仅接受复方阿嗪米特治疗。结果观察组治疗总有效率为100.0%;对照组为78.5%;观察组疗效显著优于对照组(P<0.01);两组不良反应发生率差异无统计学意义(P>0.05)。结论黛力新联合复方阿嗪米特治疗功能性消化不良疗效好,无明显不良反应,值得临床推广应用。     

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.     

谓葆联合复方阿嗪米特用于儿科功能性消化不良症的临床观察

目的 评价猴头菌提取物颗粒(谓葆)和复方阿嗪米特肠溶片(泌特)治疗小儿功能性消化不良的临床疗效和安全性.方法 将儿科门诊56例7～15岁的功能性消化不良症患者,随机分为试验组、对照组各28例,除采用一般治疗,试验组加用猴头菌提取物颗粒和复方阿嗪米特肠溶片治疗.结果 试验组经联合服用谓葆、泌特后,症状改善迅速,疗效明显(P<0.05),无不良反应.结论 谓葆、泌特治疗儿科功能性消化不良安全、有效.     

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。     

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...     

复方阿嗪米特联合莫沙必利对老年胃肠疾病相关性消化不良的疗效探讨

[目的]探讨复方阿嗪米特联合莫沙必利治疗老年胃肠疾病相关性消化不良的效果以及安全性。[方法]采用临床随机对照试验,将128例门诊就医的老年胃肠疾病相关性消化不良患者纳入本研究并分为复方阿嗪米特联合莫沙必利组(治疗组,66例),莫沙必利组(对照组,62例),2组疗程均为4周,观察2组治疗前后消化不良症状的改善以及药物副作用的情况。[结果]2组药物对改善消化不良症状均有疗效,治疗组疗效优于对照组(P0.01),2组均未观察到严重的药物相关性不良反应。[结论]复方阿嗪米特联合莫沙必利治疗老年胃肠疾病相关性消化不良疗效明显,安全性好,可在临床上推广使用。     

Lifestyle versus ezetimibe plus lifestyle in patients with biopsy-proven non-alcoholic steatohepatitis (LISTEN): A double-blind randomised placebo-controlled trial

Background and aimsThe LISTEN trial (ClinicalTrial.gov accession: NCT01950884) is a phase IV 52 weeks double blind parallel randomized controlled trial that evaluated the effect of ezetimibe plus lifestyle and dietary intervention (eze) vs. lifestyle and dietary intervention alone (placebo) on progression and complications of non-alcoholic steatohepatitis (NASH) evaluated by liver histology.Methods and resultsForty patients with NASH ascertained by histology were randomly allocated on the two study groups and subjected to a follow-up of 52 weeks, when they underwent a second liver biopsy. Main composite end point (EP) was based on the histological improvement in the severity of NASH.Thirty patients completed the study, Eze treatment was not able to improve the primary EP in comparison with placebo, with and odds ratio of 1.029 (0.18–6.38), p = 0.974. Treatment emergent adverse events registered during the study were not more prevalent in the treatment arm.Conclusionsezetimibe administered on top of lifestyle and dietary modification failed to improve the histology of NASH in comparison with lifestyle and dietary modification alone.Trial accession numberClinicalTrial.gov: NCT01950884.     

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.     

艾拉莫德治疗类风湿关节炎多中心随机双盲安慰剂对照研究

目的 研究艾拉莫德片（T-614）治疗类风湿关节炎（RA）的疗效和安全性。方法 280例活动期RA患者分别采用T-61450mg／d（25mg／次，每天2次）、25mg／d（25mg／次，每天1次）和安慰剂治疗。疗程为24周，并在2、6、12、18、24周时进行疗效及观察指标评估。结果 直到用药后6周治疗组达到ACR20及ACR50的比例才显著高于安慰剂组（P〈0．05），而12周、18周和24周的疗效观察显示治疗组的疗效随时间推移而逐渐增高，在24周时，25mg组、50mg组和安慰剂组的ACR20分别为39．1％、61．3％和24．2％，ACR50分别为23．9％、31．2％和7．4％，ACR20及ACR50治疗组优于安慰剂组．50mg组优于25mg组（P〈0．05）。治疗组在红细胞沉降率、C反应蛋白、类风湿因子改善程度差值组间比较有统计学意义。T-614治疗组耐受性良好。结论 艾拉莫德治疗RA具有良好的安全性和显著的疗效。     

阿达木单抗联合甲氨蝶呤治疗类风湿关节炎的多中心、随机、双盲、安慰剂对照临床研究

目的 评价阿达木单抗联合甲氨蝶呤(MTX)治疗类风湿关节炎(RA)的疗效与安全性.方法 随机、双盲、平行、安慰剂对照的多中心临床试验.302例入组前已经至少接受MTX 3个月治疗且剂量稳定≥28 d的活动性RA患者,随机分为40 mg阿达木单抗+MTX组(A组,121例)、80 mg阿达木单抗+MTX组(B组,121例)、安慰剂+MTX组(C组,60例).患者隔周皮下注射阿达木单抗或安慰剂,双盲治疗期为12周.完成双盲期的患者进入后12周开放期,3组患者均予隔周皮下注射40 mg阿达木单抗.在双盲期和开放期的患者同时继续接受研究前稳定剂量的MTX.观察主要疗效指标[双盲期治疗第12周修改的美国风湿病学会疗效标准提高20%(ACR20)有效率]、次要疗效指标[第24周ACR20有效率;第12周、第24周修改的美国风湿病学会疗效标准提高50%(ACR50)、修改的美国风湿病学会疗效标准提高70%(ACR70)有效率]、压痛关节数、肿胀关节数、疼痛视觉模拟评分,医生对疾病活动性整体评价、患者对疾病活动性整体评价、健康评价问卷(HAQ)评分、评估健康相关生活质量简表36(SF-36)评分及不良事件.结果 (1)双盲期,ACR20有效率C组为35.0%,A组为57.0%,B组为51.2%,A组、B组与C组比较,P<0.05;A组ACR50、ACR70有效率分别为32.2%、15.7%,与C组比较,P<0.05;A组压痛关节数、肿胀关节数、C反应蛋白水平的改善优于C组(P<0.05);B组肿胀关节数、C反应蛋白水平的改善优于C组(P<0.05).(2)开放期,A组、B组ACR20、ACR50、ACR70有效率仍维持或有所提高,而C组的ACR20、ACR50、ACR70有效率则升高至与A组、B组类似的水平.在压痛关节数、肿胀关节数、疼痛视觉模拟评分、HAQ、SF-36方面,3组均比基线、第12周时有更明显的好转.(3)双盲期与开放期中超过5%的患者有不良事件(上呼吸道感染、鼻咽炎和注射部位瘙痒),多数为轻～中度.有3例患者在研究期间出现结核病.在双盲期,有3例(1.2%)受试者出现了严重不良事件,但研究者判定与药物无关或可能无关.在开放期,有8例(2.7%)受试者出现了严重不良事件,其中3例判定与药物无关或可能无关.结论 阿达木单抗联合MTX治疗RA的疗效优于单用MTX,可显著提高治疗有效率并持续改善症状、体征、实验室炎性活动指标,减少功能障碍并提高整体生活质量,同时具有良好的安全性与耐受性.     

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...     

Treatment of functional dyspepsia with sertraline: A double-blind randomized placebo-controlled pilot study

AIM:To evaluate sertraline,a selective serotonin reuptake inhibitor in the treatment of patients with functional dyspepsia.METHODS:Consecutive tertiary hospital patients with a clinical diagnosis of functional dyspepsia(FD) according to the Rome Ⅱ criteria with a Hong Kong dyspepsia index(HKDI) of greater than 16 were recruited.Patients commenced enrolment prior to the inception of the Rome Ⅲ criteria for functional dyspepsia.All patients were ethnic Chinese,had a normal upper endoscopy and were Helicobacter pylori negative prior to enrolment.Study patients were randomized to receive sertraline 50 mg or placebo daily for 8 wk.HKDI symptom scores,quality of life,hospital anxiety and depression(HAD) scale and global symptom relief were evaluated before,during and after treatment.Adverse effects were monitored during and after treatment.RESULTS:A total of 193 patients were randomized in the intention to treat(ITT),and 150 patients were included in the per protocol(PP) analysis.In both the ITT and PP,there was no difference in the primary outcome of global dyspepsia symptoms between the sertraline and placebo groups at week 8.In the ITT analysis,98 and 95 patients were randomized to the sertraline and placebo groups respectively.A total of 43 patients withdrew from the study(22.3%) by week 8,with 23 of the 24 drop-outs in the sertraline group occurring prior to week 4(95.8%).In contrast,in the placebo arm,11 of 19 patients dropped out by week 4(57.9%).Utilizing the last response carried forward to account for the drop-outs,there were no differences between the sertraline and placebo groups at baseline in terms of the HKDI,HKDI 26.08 ± 6.19 vs 26.70 ± 5.89,P = 0.433;and at week 8,HKDI 22.41 ± 6.36 vs 23.25 ± 7.30,P = 0.352 respectively.In the PP analysis,74 and 76 patients were randomized to the sertraline and placebo groups respectively.At baseline,there were no statistically significant differences between the sertraline and placebo groups,HKDI 25.83 ± 6.313 vs 27.19 ± 5.929 respectively,P = 0.233;however by week 8,patients in the sertraline group demonstrated a statistically significant difference in their Hong Kong Dyspepsia Index compared to placebo,HKDI 20.53 ± 6.917 vs 23.34 ± 7.199,P = 0.02,respectively).There was also no statistically significant difference in overall quality of life measures or the HAD scale related to treatment in either the ITT or PP analysis at week 8.CONCLUSION:This pilot study,the first to examine sertraline,a selective serotonin reuptake inhibitor,for the management of FD,did not find that it was superior to placebo.     

气滞胃痛颗粒治疗功能性消化不良患者随机、双盲、安慰剂对照临床研究

[目的]评估气滞胃痛颗粒对功能性消化不良的临床疗效与安全性。[方法]采用随机、双盲、安慰剂对照方法,观察餐后不适综合征(PDS组)与上腹痛综合征(EPS组)患者各20例,将2组分别随机分为气滞胃痛颗粒亚组10例(给予气滞胃痛颗粒,3次/d,每次2.5g,餐前服用)与安慰剂亚组10例(给予安慰剂,3次/d,每次2.5g,餐前服用),疗程均为4周,于治疗前和治疗后第2、4、6周进行随访,观察各组症状变化,并记录不良事件。[结果]PDS组患者治疗第6周时,气滞胃痛颗粒亚组主要症状综合疗效高于安慰剂亚组,差异有统计学意义(P0.05);气滞胃痛颗粒亚组治疗4周后主要症状缓解显效率以及治疗6周后完全缓解率均高于安慰剂亚组,差异有统计学意义(P0.05);气滞胃痛颗粒亚组治疗第4周、第6周时主要症状积分均下降,与同组治疗前比较、与安慰剂亚组治疗后比较,均差异有统计学意义(P0.05)。EPS组患者,气滞胃痛颗粒亚组治疗后总体疗效、症状改善率以及症状积分同安慰剂亚组比较,差异无统计学意义(P0.05)。纳入研究的所有功能性消化不良患者治疗4周后,气滞胃痛颗粒亚组与安慰剂亚组中医证候总分差异均无统计学意义(P0.05)。所有患者均未出现严重不良事件。[结论]气滞胃痛颗粒治疗功能性消化不良餐后不适综合征有效、安全。     

Effect of profound acid suppression in functional dyspepsia: a double-blind,randomized, placebo-controlled trial

BACKGROUND: Functional dyspepsia (FD) is defined as persistent or recurrent pain/discomfort centred in the upper abdomen, where no structural explanation for the symptoms is found. The role of drug treatment remains controversial. The aim in this study was to evaluate the effect of omeprazole 20 mg twice daily (b.i.d) and to test methods for symptom assessment. METHODS: 197 patients fulfilling the criteria for FD were randomly allocated to double-blind treatment with omeprazole 20 mg b.i.d (n = 100) or placebo (n = 97) for 14 days. Patients with a known gastrointestinal disorder or with main symptoms indicating gastro-oesophageal reflux disease or irritable bowel syndrome were excluded. Helicobacter pylori testing and 24-h intra-oesophageal 24-h pH-metry were performed before randomization. The patients recorded dyspeptic symptoms on diary cards. RESULTS: A stringent endpoint, 'complete symptom relief on the last day of treatment', was the primary efficacy variable. For the APT cohort, this was achieved in 29.0% and 17.7% on omeprazole and placebo, respectively (95% CI of difference (11.3%): -0.4%-23.0%, P = 0.057). Similar figures in the PP cohort were 31.0% and 15.5%, respectively (95% Cl of difference (15.5%): 3.2%-27.7%, P = 0.018). The benefit of omeprazole in the PP cohort was confirmed by secondary endpoints such as, no dyspeptic symptoms on the last 2 days of treatment and overall treatment response. H. pylori status and the level of oesophageal acid exposure did not significantly influence the response to therapy. CONCLUSION: A subset of patients with FD will respond to therapy with omeprazole.