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.

Comparison of Mosapride and Pantoprazole in Treating Functional Dyspepsia

Most of the clinical trials concerning the efficacies of prokinetics and proton pump inhibitors(PPIs) in improving functional dyspepsia(FD) symptoms are placebo-controlled studies,but the efficacies of prokinetics and PPIs are seldom compared.Aims:To compare the efficacies and safety of mosapride and pantoprazole on postprandial distress syndrome(PDS) and epigastric pain syndrome(EPS).Methods:A randomized unblinded trial was conducted. Consecutive patients fulfilling the RomeⅢdiagnostic criteria for PDS and EPS at Ningbo First Hospital from Dec.2009 to Dec.2010 were enrolled.All patients were at first given placebo for one week,and then the nonresponders with PDS and EPS were randomly allocated to treatment with mosapride 5 mg tid or pantoprazole 40 mg qd for two weeks, respectively.FD symptoms were evaluated prior to and after treatment.Results:A total of 148 patients entered the treatment period,78 were PDS and 70 were EPS.Both mosapride and pantoprazole could significantly decrease the overall symptoms score of FD(P<0.05),the differences in decrement of overall symptoms score(14.4±6.8 vs.13.6±5.3) and the total efficacies(70.3%vs.67.6%) between the two treatment groups were not statistically significant.When stratified by FD subgroups,the decrement of PDS symptoms score(bothersome postprandial fullness and early satiation),the decrement of EPS symptoms score(epigastric pain and burning),and the total efficacies between the two treatment groups were also similar.Conclusions:Both mosapride and pantoprazole markedly improve the clinical symptoms of FD,and they are equally safe and effective for patients with PDS and EPS.