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临床试验/NCT02452073
NCT02452073已完成不适用

An Analysis of the Relative Risk for Low Triiodothyronine Syndrome in Patients With Chronic Radiation Enteritis

Shengxian Fan0 个研究点目标入组 48 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
主要终点
morbidity

研究概览

简要总结

Radiation enteritis (RE) is by simple definition an inflammatory process occurring at the level of the intestines as a response to abdominal or pelvic radiation energy exposure. Due to the dosage of radiation, sensitivity of organs to radiation, and some patient characteristics, RE can present as either an acute or chronic syndrome. Clinical manifestations differ but may include abdominal pain, malabsorption, diarrhea, cachexia, intestinal bleeding, obstruction, and even perforation, which compromise quality of life. For many years, radiotherapy of the abdominal or pelvic region is commonly used for a significant percentage of patients with rectosigmoid and genitourinary system tumors. Different techniques have been developed to prevent the occurrence of radiation induced injury. However, the incidence of CRE is expected to continue to rise during the coming years. What's more, abdominal or pelvic radiotherapy can also lead to other side effects in addition to RE, such as skin desquamation, local soft tissue injury, and so on. Till now, lots of attention is only paid to local complications, there is little report on systemic damage of abdominal or pelvic radiotherapy.

Low triiodothyronine syndrome (LT3S), a condition characterized by low circulating triiodothyronine (T3) levels, normal thyroxine (T4), free thyroxine (FT4) and thyroid-stimulating hormone (TSH) levels in the absence of an intrinsic thyroid disease, is variously known as the "nonthyroidal illness syndrome (NTIS)". This condition is frequently detected in critical illness. Reichlin et al. first noticed that some aspects of thyroid hormone metabolism might change during many chronic illnesses as early as 1973. Data has shown that about 35-70% of acute and chronic critical conditions were associated with a significant abnormal thyroid hormone metabolism, of which LT3S was the most common type. Furthermore, these changes have been shown to be associated with disease severity and have been connected with poor short-term prognosis.

To date, there are lots of literatures include detailed reports on the relationship between LT3S and chronic illnesses such as rheumatoid arthritis, systemic lupus erythematosus, sepsis, and so on. However, no systematic analysis of LT3S in patients with CRE has been undertaken. As such, the present study aimed to investigate the frequency of LT3S in CRE patients.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • patients with chronic radiation enteritis
  • patients with some kinds of malignant tumors but had not previously received radiotherapy
  • age-matched healthy volunteers

排除标准

  • Patients with a chronic disease other than CRE, including RA, SLE, thyroid illness, infectious diseases, and hepatic or renal disorders were excluded.
  • patients have taken any drugs that may influence thyroid hormone secretion and metabolism during the previous 3 months.

结局指标

主要结局

morbidity

时间窗: one year

The results will be expressed as percentage

次要结局

未报告次要终点

研究者

发起方
Shengxian Fan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shengxian Fan

M.D.

Jinling Hospital, China

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