Fluoxetine as a Non-Surgical Intervention for Refractory Superior Mesenteric Artery Syndrome With Comorbid Somatic Symptom Disorder: A Prospective Case Series Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving GOOSS ≥ 2 at 6 months
研究概览
简要总结
The goal of this interventional study is to evaluate whether fluoxetine, a selective serotonin reuptake inhibitor (SSRI), can alleviate core symptoms and reduce the need for surgical intervention in patients with refractory superior mesenteric artery syndrome (SMAS) who meet diagnostic criteria for somatic symptom disorder (SSD). The main questions it aims to answer are:
Can fluoxetine improve abdominal symptoms and nutritional status in patients with SMAS and comorbid SSD?
Can psychiatric intervention targeting SSD reduce the likelihood of requiring duodenojejunostomy in refractory SMAS?
Participants will:
Receive oral fluoxetine therapy for a planned treatment duration of 6 months.
Undergo baseline and follow-up assessments including symptom scoring (pain, nausea, dietary intake), body weight/BMI monitoring, and psychiatric evaluation.
Complete psychological questionnaires (PHQ-15, GAD-7, PHQ-9) and resting-state fMRI at baseline and study endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SMAS was confirmed by two key indicators using imaging or angiographic criteria: aortomesenteric angle of less than 22° or aortomesenteric distance of less than 8 mm;
- •refractory SMAS was defined as failure of conservative treatments, including gastrointestinal decompression, enteral nutrition and parenteral nutrition;
- •accompanied by one or more following characteristics: Severe upper gastrointestinal symptoms (nausea, vomiting, bloating, pain), usually occurring more than once a week; body mass index (BMI)<18.5 kg/m2 related to feeding difficulties;
- •meets the aforementioned criteria for SSD;
- •voluntarily provided informed consent prior to enrollment.
排除标准
- •secondary SMAS due to identifiable causes such as tuberculosis or liver cirrhosis;
- •pregnant or lactating women;
- •patients with malignant tumors or autoimmune diseases;
- •individuals with cardiovascular diseases, organ failure, cognitive impairments, aphasia, or other chronic conditions which interfere with examinations and treatment;
- •psychotropic agents' allergic patients.
研究组 & 干预措施
Fluoxetine
Refractory SMAS patients with SSD received oral fluoxetine treatment, initiated at 20 mg/day and increased to a maximum of 60 mg/day based on therapeutic response.
干预措施: Fluoxetine (Drug)
结局指标
主要结局
Proportion of patients achieving GOOSS ≥ 2 at 6 months
时间窗: 6 months after treatment initiation
Treatment efficacy was evaluated using the Gastric Outlet Obstruction Scoring System (GOOSS), a validated 4-point scale assessing the patient's ability to tolerate oral intake: 0 = no oral intake, 1 = liquids only, 2 = semi-solids, and 3 = low-residue or full diet. The primary efficacy endpoint was the proportion of patients achieving a GOOSS score ≥ 2 at 6 months, indicating the ability to tolerate at least a semi-solid diet.
次要结局
未报告次要终点
研究者
Zhifeng Zhao, PhD
Dr.
Xijing Hospital of Digestive Diseases