研究疾病:
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多囊卵巢综合征
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研究疾病代码:
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Target disease:
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polycystic ovarian syndrome
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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病例对照研究
Case-Control study
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研究所处阶段:
Study phase:
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治疗新技术临床试验
New Treatment Measure Clinical Study
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研究目的:
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本课题以挖掘“燥湿化痰促生殖”理论的科学内涵为目标,以苍附导痰汤与现代辅助生殖技术相结合,通过对痰湿型PCOS患者卵泡液-颗粒细胞进行代谢路径分析,卵泡液-颗粒细胞线粒体CXCL5/STAT3/SOCS2的检测,从形态动能、分子蛋白及细胞水平分析其对卵母细胞、胚胎发育及体外受精-胚胎移植结局的影响。以期确定中医证候的内在分子机制,为中医证候的客观化提供代谢路径水平的科学依据,为多层次丰富发展“燥湿化痰促生殖”理论提供科学依据,为中医药在人类生殖医学发展中的应用提供更可靠的依据及新的思路
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Objectives of Study:
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This project aims at exploring the scientific connotation of the theory of "dampness disperses phlegm and promotes reproduction", combining Cangfu Phlegm Guide Decoction with modern assisted reproduction technology, through analyzing the metabolic path of follicle-granulosa cells of patients with phlegm-dampness PCOS, and detecting CXCL5/STAT3/SOCS2 of follicle-granulosa cells mitochondria. The effects on oocyte, embryo development and in vitro fertilization-embryo transfer were analyzed at the morphological kinetic energy, molecular protein and cellular levels. In order to determine the internal molecular mechanism of TCM syndromes, provide scientific basis for the objectification of TCM syndromes, provide scientific basis for the multi-level development of the theory of "dryness and dampness reducing phlegm promoting reproduction", and provide more reliable basis and new ideas for the application of TCM in the development of human reproductive medicine
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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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年龄在35-45岁已婚妇女;符合本病西医诊断及中医痰湿证辨证标准。
多囊卵巢综合征诊断标准:
中华医学会妇产科分会妇科内分泌学组制定了2011 “中国PCOS诊断标准”:闭经或月经稀发或不规则子宫出血是必备标准,再具备以下至少1项,可诊断为疑似PCOS:高雄激素的临床表现或高雄激素血症;超声提示多囊卵巢(至少一侧卵巢内直径0.2-0.9cm的卵泡数超过12枚,或卵巢体积大于等于10cm3)。疑似PCOS患者必须除外其他可能引发排卵障碍和高雄激素的疾病才能确诊。中国PCOS诊断标准与国际标准比较,更强调卵巢功能障碍的病理作用,且更加贴合中国女性的实际情况。
痰湿型多囊卵巢综合征辨证:参照《中华人民共和国中医药行业标准—中医病症诊断疗效标准》以及全国统编教材《中医妇科学》第七版制定。
主证:①婚久不孕;②月经后期,或渐至闭经;③月经量少,色淡红。
兼症:①形体肥胖;②胸闷呕恶;③带下量多粘腻;④大便易溏或经行泄泻。
舌脉:舌淡苔白腻,脉滑尺弱。
以上主证三项必备,具备1-2项兼证即可诊断,舌脉为参。
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Inclusion criteria
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Married women aged 35-45; This disease conforms to western medicine diagnosis and Chinese medicine phlegm-dampness syndrome differentiation standard.
Diagnostic criteria of polycystic ovary syndrome:
The Gynecological Endocrinology Group of The Chinese Society of Obstetrics and Gynecology formulated the 2011 "Chinese DIAGNOSTIC Criteria for PCOS" : amenorrhea, sporadic menstruation or irregular uterine bleeding are the necessary criteria. Suspected PCOS can be diagnosed with at least one of the following: clinical manifestations of hyperandrogen or hyperandrogenemia; Ultrasound suggests polycystic ovaries (at least one ovary has more than 12 follicles 0.2 -- 0.9cm in diameter, or an ovarian volume greater than or equal to 10cm3). Suspected PCOS patients must be excluded from other conditions that may cause ovulation disorders and high androgen levels. Compared with international standards, Chinese PCOS diagnostic criteria emphasize more on the pathological role of ovarian dysfunction and are more suitable for the actual situation of Chinese women.
Syndrome differentiation of phlegm-dampness polycystic ovary syndrome: formulated with reference to the "Chinese Medicine Industry standard of the People's Republic of China - Standard of Diagnosis and Efficacy of Chinese Medicine Diseases" and the seventh edition of the national unified textbook "Gynecology of Chinese Medicine".
Main syndrome: ① long marriage infertility; ② Late menstruation, or gradually to amenorrhea; ③ Less menstruation, light red color.
And disease: ① body fat; (2) chest nausea; (3) the amount of sticky belt; ④ Loose stool or diarrhea through menstruation.
Tongue pulse: the tongue is pale and white and greasy with moss, and the pulse is slippery and weak.
The above three main syndromes are necessary, and one or two concurrent syndromes can be diagnosed, with tongue pulse as reference.
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排除标准:
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肾上腺、甲状腺、垂体等内分泌功能异常的患者,如肾上腺皮质增生症、肾上腺皮质功能减退、甲亢、甲低、垂体肿瘤、席汉氏综合征、糖尿病等;心脑血管疾病患者,如高血压、冠心病等;肝肾疾病患者;神经、精神疾病患者;血液病患者;急性生殖泌尿系统炎症患者;生殖系统肿瘤患者;生殖器官器质性病变者;三个月内服用避孕药或其他含有激素类药物的患者;生理性月经后期及闭经者;依从性较差的患者。
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Exclusion criteria:
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Patients with abnormal adrenal, thyroid and pituitary endocrine functions, such as adrenal cortical hyperplasia, adrenal cortical hypofunction, hyperthyroidism, hypothyroidism, pituitary tumor, Sheehan's syndrome, diabetes, etc. Patients with cardiovascular and cerebrovascular diseases, such as hypertension and coronary heart disease; Patients with liver and kidney diseases; Patients with neurological or mental diseases; Patients with blood diseases; Patients with acute genitourinary inflammation; Patients with reproductive system tumors; Organic diseases of reproductive organs; Patients who take birth control pills or other hormone-containing drugs within three months; Physiologic late menstruation and amenorrhea; Patients with poor compliance.
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研究实施时间:
Study execute time:
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从From
2022-01-01
至To
2024-12-31
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征募观察对象时间:
Recruiting time:
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从From
2022-01-01
至To
2023-12-01
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