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临床试验/NCT05524675
NCT05524675Unknown不适用

The Effect of Multiple Medications on the Incidence of Organic Dyspepsia:a Prospective Observational Cohort

Air Force Military Medical University, China4 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
4
主要终点
the rate of patients diagnosed with organic upper gastrointestinal (GI) diseases.

研究概览

简要总结

Dyspepsia is a very common gastrointestinal disease, presented as predominant symptom of upper abdominal pain. Underlying causes for dyspepsia can classified as organic or functional dyspepsia. Some medications (eg. non-steroid anti-inflammatory drugs (NSAIDs)) were associated with higher frequent incidences of organic lesions. Multiple medications showed an increased trend with aging of the population and multimorbidity. Multiple medications were suggested to be strongly relate to adverse drug events (ADEs), adverse drug reactions (ADRs), drug-drug interactions, and drug-disease interactions, which had been reported to lead to higher incidences of some diseases, including fractures, cognitive impairment and malnutrition. However, it was unknown if multiple medications was associated with more incidences of organic dyspepsia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged ≥18 years old
  • patients who met broad criteria of dyspepsia
  • undergoing upper endoscopy and abdominal ultrasonography within one year.

排除标准

  • organ failure defined by Marshall standard
  • severe psychiatric illnesses
  • suspected or identified bowel obstruction
  • known malignancy
  • pregnancy or lactation
  • unable to provide consent

结局指标

主要结局

the rate of patients diagnosed with organic upper gastrointestinal (GI) diseases.

时间窗: 1 day

All included patients underwent upper GI endoscopy and abdominal ultrasound and H. Pylori test. Barrett's esophagus, esophageal candidiasis, esophageal cancer, gastric ulcer, gastric erosion, gastric cancer, duodenal ulcer, duodenal erosion, cholecystitis, pancreatitis and biliary stones were classified as organic upper GI diseases.

次要结局

  • Functional dyspepsia(6 months)
  • Number of participants with different subtypes of functional dyspepsia(6 months)
  • Short Form of Nepean Dyspepsia Index (SF-NDI)(1 day)
  • Severity of functional dyspepsia judged by patients(1 day)
  • Number of participants with other functional gastrointestinal diseases(1 day)
  • Hospital anxiety scale(1 day)
  • Hospital depression scale(1 day)
  • Quality of Life scores(1 day)

研究者

发起方
Air Force Military Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanglin Pan

professor

Air Force Military Medical University, China

研究点 (4)

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