一种联合肠道准备方案用于胶囊内镜检查:前瞻性随机对照研究

背景:胶囊内镜检查效果常受制于肠道内的食物残渣。本研究旨在评价一种联合肠道准备方安能否改善小肠视野,从而提高疾病诊断率和检查完成率。方法:本研究为前瞻性单盲随机对照研究,研究对象为在预约进行胶囊内镜检查的Mayo Clinic门诊患者。肠道准备组患者在胶囊内镜检查前夜饮用2 L聚乙二醇溶液,检查前20 min服用5mL西甲硅油和5mg胃复安,吞入胶囊内镜30 min后采用右侧卧位。对照组不做肠道准备,仅于检查前晚7点后禁食固体食物,检查前4 h内禁水。对所有研究对象进行满意度调查。胶囊内镜读片人员进行小肠视野评估。结果:前瞻性纳入50例患者,其中女性占56%,中位年龄54.4岁。44例完成研究,其中肠道准备组21例,对照组23例。两组患者在小肠四个分区中的视野清晰度的差异均无统计学意义(均P>0.05)。两组患者的疾病诊断率(P=0.69)、胃传输时间(P=0.10)和小肠传输时间(P=0.89)也均相当。肠道准备组的检查完成率显著高于对照组(100%vs 78%,P=0.02),但患者不适感也显著增多(62%vs 17%,P=0.01)。结论:联合肠道准备应用于胶囊内镜检查并没有改善小肠视野,却给患者带来了更多不适。尽管能提高检查完成率,但联合肠道准备并没有提高疾病检出率。因此,肠道准备似乎并不能改善胶囊内镜检查效果,反而会影响患者满意度。

Development of drugs for celiac disease:review of endpoints for Phase 2 and 3 trials

Celiac disease is a lifelong disorder for which there is currently only one known,effective treatment:a gluten-free diet.New treatment approaches have recently emerged;several drugs are in Phase 2 trials and results appear promising;however,discussion around regulatory endpoints is in its infancy.We will briefly discuss the drugs that are under development and then shift our attention to potential trial endpoints,such as patient-reported outcomes,histology,serology,gene expression analysis and other tests.We will outline the differing requirements for proof-of-concept Phase 2 trials and Phase 3 registration trials,with a particular emphasis on current thinking in regulatory agencies.We conclude our paper with recommendations and a glossary of regulatory terms,to enable readers who are less familiar with regulatory language to take maximum advantage of this review.