研究疾病:
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非酒精性脂肪性肝病
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研究疾病代码:
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Target disease:
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non-alcoholic fatty liver disease
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Target disease code:
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研究类型:
Study type:
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观察性研究
Observational study
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研究设计:
Study design:
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析因分组(即根据危险因素或暴露因素分组)
Factorial
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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近年来,非酒精性脂肪性肝病( NAFLD) 的发病率不断攀升,且逐渐呈低龄化发展态势,包括不良饮食选择在内的不健康
的生活方式是其主要诱因之一。但是,目前 NAFLD 的治疗方案尚不确切,以体质量减轻为目标的生活方式干预依然是治疗 NAFLD
最成熟的方法。研究表明,慢性炎症反应贯穿着 NAFLD 发生发展的全过程,而饮食在炎症级联的发展和调节中发挥着重要作用。
膳食炎症指数是用于评估个人饮食结构中的炎症潜能的有效工具,自开发以来不断完善,现已广泛应用于多种疾病的临床研究中。
探讨了 NAFLD 与膳食炎症指数的相关性,以期从饮食结构上对 NAFLD 进行一级预防,降低 NAFLD 的发病率。
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Objectives of Study:
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In recent years, the incidence of non-alcoholic fatty liver disease (NAFLD) has been on the rise, and it is developing at a younger age, with unhealthy factors including poor dietary choices
Lifestyle is one of the main causes. However, the current treatment plan for NAFLD is not clear, and the lifestyle intervention aimed at reducing body mass is still the treatment of NAFLD
The most mature method. Studies have shown that chronic inflammatory reaction runs through the whole process of the occurrence and development of NAFLD, and diet plays an important role in the development and regulation of inflammatory cascade.
Dietary Inflammation Index (DII) is an effective tool for assessing the inflammatory potential of individual diet. It has been continuously improved since its development and has been widely used in clinical studies of a variety of diseases.
The correlation between NAFLD and dietary inflammatory index was discussed in order to carry out primary prevention of NAFLD from the perspective of dietary structure and reduce the incidence of NAFLD.
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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2名中医医师根据《非酒精性脂肪性肝病中医诊疗专家共识意见( 2017)》中的辩证分型,收集5种中医证候类型各20例患者。
1、肝脏肿大,平,滑,软,边缘钝圆,无明显压痛,且无其他确定肝病者。
2、过去史中有前述引起脂肪肝的原因者。如酒精性脂肪肝有长期酗酒史,尤其是酒精成分高的白酒。肥胖、糖尿病、静脉高能营养、使用有关药物及接触毒物都有各自的临床症状和体征,容易区别。
3.中医诊断标准主要参考《中药新药临床研究指导原则》中有关条目, 符合脂肪肝诊断标准, 中医辨证为湿热炎瘀证者。若患者出现胀痛不适、小腹疼痛, 或痛连腰骶, 经血量多或经期长, 质稠或夹较多黏液、色黄质稠。
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Inclusion criteria
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According to the dialectical classification in the Consensus of TCM Diagnosis and Treatment Experts in Non-alcoholic Fatty Liver Disease (2017), 2 TCM physicians collected 20 patients with each of 5 TCM syndromes.
1. Liver enlargement, flat, smooth, soft, blunt round edge, no obvious tenderness, and no other confirmed liver disease.
2. The causes of fatty liver mentioned above in the past history. If alcoholic fatty liver has a long history of alcoholism, especially high alcohol content of liquor. Obesity, diabetes, intravenous high-energy nutrition, the use of relevant drugs and exposure to poisons all have their own clinical symptoms and signs, which are easy to distinguish.
3. The TCM diagnostic criteria mainly refer to the relevant items in the Guiding Principles for Clinical Research of New Chinese Medicine, and meet the diagnostic criteria for fatty liver, and the TCM syndrome differentiation is the syndrome of dampness, heat, inflammation and stasis. If patients appear bilge pain discomfort, lower abdominal pain, or pain even lumbosacral, through the blood volume or long period, thick or clamps more mucus, yellow thick.
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排除标准:
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1.曾有酒精摄入>20g/天饮酒史患者;
2.合并存在其他肝病患者(如病毒性、药物性、自身免疫性肝病等);
3.疑有肝硬化、肝细胞癌患者;
4.伴有其他严重全身性疾病或感染性疾病,如:恶性肿瘤、严重心肺疾患、神经系统疾病、HIV感染等;
5.因疾病或其他原因无法进行饮食控制及有氧运动;
6.排除慢性病毒性肝炎、血吸虫肝、肝寄生虫等肝脏疾病。
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Exclusion criteria:
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1. Patients with a history of alcohol intake > 20g/ day;
2. Patients with other liver diseases (such as viral, drug-induced, autoimmune liver diseases, etc.);
3 Patients with cirrhosis and hepatocellular carcinoma are suspected;
4. Complicated with other serious systemic diseases or infectious diseases, such as: malignant tumor, serious heart and lung diseases, nervous system diseases, HIV infection, etc.;
5. Inability to do diet control and aerobic exercise due to illness or other reasons;
6. Chronic viral hepatitis, schistosomiasis liver, liver parasites and other liver diseases were excluded.
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研究实施时间:
Study execute time:
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从From
2021-01-22
至To
2023-02-22
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征募观察对象时间:
Recruiting time:
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从From
2021-01-22
至To
2021-04-22
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