莫沙必利改善夜间消化不良症状的随机、双盲、安慰剂平行对照研究

摘要

Background: The pathogenesis of functional dyspepsia (FD) is still incompletely known. Nocturnal dyspeptic symptoms are important factors that affect the patients' life quality, and the efficacy and mechanism of prokinetic agents on nocturnal FD symptoms remain uncertain. Aims: To investigate the effect of mosapride on nocturnal dyspeptic symptoms in patients with FD. Methods: Consecutive patients with nocturnal FD symptoms (including epigastric pain, fullness, belching) were enrolled in this randomized, double-blinded, placebo-controlled, parallel study. All patients were given placebo initially for one week. If no response was observed, patients were then assigned to mosapride group (mosapride 5 mg tid) or placebo group. Nocturnal FD symptoms were evaluated and nocturnal intragastric Ph and bilirubin refluxed were determined before and after treatment. Results: Forty-three FD patients with nocturnal FD symptoms were enrolled, and 28 patients had no response to initial placebo. After the treatment, nocturnal symptom scores of epigastric pain, fullness, belching were significantly decreased in mosapride group (P<0.05), and nocturnal intragastric Ph and percentage time of bilirubin absorbance > 0.14 were also significantly decreased in mosapride group (P<0.05), while no significant differences of all the above-mentioned indices were seen in placebo group (P>0.05). The decrease of nocturnal FD symptom scores was significantly correlated with the reduction of nocturnal intragastric Ph and percentage time of bilirubin absorbance > 0.14 (P<0.05). Conclusions: Nocturnal dyspeptic symptoms in FD patients may be markedly improved by mosapride. This effect may be correlated with the decrease of nocturnal duodenogastric bile reflux.%背景:功能性消化不良(FD)的发病机制尚未完全明了.夜间上腹部症状是影响FD患者生活质量的重要因素.促动力药对夜间FD症状的治疗作用和机制不详.目的:探讨莫沙必利对FD患者夜间消化不良症状的治疗作用.方法:采用随机、双盲、安慰剂平行对照的前瞻性设计,连续选取主诉有夜间FD症状(上腹部疼痛、饱胀、嗳气)的患者,经一周安慰剂治疗筛选,无安慰剂治疗反应者分别给予莫沙必利(5 mg tid)和安慰剂治疗.治疗前后分别行夜间症状评估以及夜间胃内pH值和胆红素联合检测.结果:共纳入43例有夜间FD症状的患者,28例对安慰剂治疗无反应.治疗后,莫沙必利组夜间上腹部疼痛、饱胀、嗳气的症状积分均明显降低(P＜0.05),夜间胃内pH值和胆红素吸收值＞0.14的时间百分比均明显降低(P＜0.05);而安慰剂组上述指标无明显差异(P＞0.05).莫沙必利组夜间症状积分改善程度与夜间胃内pH值和胆红素吸收值＞0.14的时间百分比降低程度有明显相关性(P＜0.05).结论:莫沙必利能显著改善夜间FD症状,其机制可能与减轻夜间胃十二指肠胆汁反流有关.