研究疾病:
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宫腔粘连
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研究疾病代码:
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Target disease:
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intrauterine adhesions
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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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探索性研究/预试验
Pilot clinical trial
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研究目的:
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宫腔粘连 ( intrauterine adhesions,IUA)是子宫内膜基底层受损所 致 的 宫 腔 闭 锁 , 可 致 不 孕 。 宫 腔镜 下 粘 连 分 离 术 (transcervical resection of adhesions,TCRA)是 IUA 的金标准治疗,但术后高复粘率 和低妊娠率是困扰临床的棘手问题。首都国医名师蔡连香在滋肾活血诊治 “月经过少”经验基础上,结合 IUA 宫腔镜下特征提出“微癥瘕”理论和 分阶段施治方案。本课题采用随机、双盲、安慰剂对照研究设计,纳入肾 虚血瘀型中重度 IUA 48 例,采用 TCRA+雌孕激素周期治疗,试验组术后 加用益气消癥汤,二探后改用益肾增膜汤治疗 2 周期,对照组同步加用中 药安慰剂。观察宫腔、子宫内膜容受等指标综合评估。旨在为中重度 IUA 探索更有效、安全的治疗方法,并探讨“微癥瘕”理论和分阶段论治改善 中重度 IUA 生育力的作用。
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Objectives of Study:
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Intrauterine adhesions (IUA) are atresia of the uterine cavity caused by damage to the endometrial basal layer, which can lead to infertility. Hysteroscopic resection of adhesions (TCRA) is the gold standard treatment for IUA, but high postoperative re-adhesion rate and low pregnancy rate are thorny problems that plague clinical practice. Cai Lianxiang, a famous Chinese doctor in the capital, based on the experience of nourishing the kidney and promoting blood circulation in the diagnosis and treatment of "menorrhagia", combined with the characteristics of IUA hysteroscopy, put forward the theory of "micro-disease" and a staged treatment plan. This subject adopts a randomized, double-blind, placebo-controlled study design, including 48 cases of moderate to severe IUA of kidney deficiency and blood stasis type, treated with TCRA + estrogen and progesterone cycle treatment, the experimental group was additionally treated with Yiqi Xiaozheng Decoction after surgery, and Yiqixiaozheng decoction was used after the second trial. Shenzengmo decoction was treated for 2 cycles, and the control group was treated with traditional Chinese medicine placebo simultaneously. The comprehensive evaluation of uterine cavity and endometrial receptivity was observed. The aim of this study is to explore more effective and safe treatment methods for moderate to severe IUA, and to explore the role of the theory of " micro-disease " and staged treatment in improving fertility in moderate to severe IUA.
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药物成份或治疗方案详述:
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分试验组和对照组。试验组:中药组(蔡连香经验方益气消癥汤和益肾增膜汤 序贯口服);对照组:中药安慰剂(5%浓度的蔡连香经验方序贯口服)。两组 TCRA 术 后均口服戊酸雌二醇+地屈孕酮片 3 个月经周期。
治疗方案:
1.试验组:中药组
西药服法: TCRA 当日或月经周期第 5 天开始戊酸雌二醇 2mg bid po×21 天;月经第 16 天 开始地屈孕酮 10mg bid po×10 天,然后同时停药。
中药服法: 经验方 1:益气消癥汤 生黄芪 莪术 皂刺 生鸡内金 水蛭 赤芍 当归 柴胡 枳实 熟大黄 怀牛膝 生甘草 TCRA 手术当日开始口服,每次 1 袋,每日 2 次,早晚餐后服。服至下次月经干 净。经验方 2:益肾增膜汤 炙龟板 熟地 菟丝子 覆盆子 桂枝 红花 陈皮 白术 生黄芪 威灵仙 元参 宫腔镜二探后术日开始口服,每次 1 袋,每日 2 次,经期继续服药,共两个月经周期,服药期间避孕。
2. 对照组:中药安慰剂 西药服法:同试验组。 中药服法:安慰剂为 5%原方剂量,用法和时间同试验组。
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Description for medicine or protocol of treatment in detail:
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1. Experimental group: Chinese medicine group
Western medicine administration: estradiol valerate 2 mg bid po for 21 days starting on the day of TCRA or the 5th day of the menstrual cycle; dydrogesterone 10 mg bid po × 10 days starting on the 16th day of the menstrual cycle, and then discontinued at the same time.
Traditional Chinese Medicine Dosing Method: Experienced Formula 1: Yiqi Xiaozheng Recipe, Huangqi Ezhu Zaoci Jineijin Shuizhi Chishao Danggui Chaihu Zhishi Shudahuang Huainiuxi Shenggancao, Oral starting on the day of TCRA surgery , bag each time, daily 2 times, after breakfast and dinner. Take it until the next menstrual period is clean. Experience recipe 2: Yishen Zengmu Recipe,Zhiguiban Shudihuang Tusizi Fupenzi Guizhi Honghua Chenpi Baizhu Shenghuangqi Weilingxian Yuanshen , start to take orally on the day of surgery after the second hysteroscopy, 1 bag each time, 2 times a day, menstrual period Continue taking the medicine for a total of two menstrual cycles, and contraception during the taking of the medicine.
2. Control group: Chinese medicine placebo, Western medicine administration: the same as the experimental group. Dosage of traditional Chinese medicine: The placebo is 5% of the original dosage, and the usage and time are the same as those of the experimental group.
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纳入标准:
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(1)符合宫腔粘连西医诊断标准; (2)符合宫腔粘连肾虚血瘀证中医诊断标准; (3)宫腔镜术中诊断为中重度粘连者(中国宫腔粘连诊断分级评分标准中度 粘连 9 分-18 分,重度粘连 19 分-28 分者); (4)有生育要求者; (5)年龄≤40 岁。
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Inclusion criteria
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(1) Meet the diagnostic criteria of western medicine for intrauterine adhesions; (2) Meet the diagnostic criteria of traditional Chinese medicine for intrauterine adhesions with kidney deficiency and blood stasis syndrome; (3) Those who were diagnosed as moderate to severe adhesions during hysteroscopy (in the Chinese diagnostic grading standards for intrauterine adhesions) 9-18 points for severe adhesion and 19-28 points for severe adhesion); (4) Those with fertility requirements; (5) Age ≤40 years old.
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排除标准:
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⑴先天性子宫发育异常;合并宫腔占位性病变,如子宫黏膜下肌瘤或子宫内膜 息肉;⑵排卵障碍性不孕者; ⑶卵巢功能低下造成的月经过少者; ⑷未确诊的阴道出血 ⑸已知或可疑乳腺癌;已知或可疑受性激素影响的癌前病变或恶性肿瘤; ⑹现有或既往有肝脏肿瘤病史(良性或恶性); ⑺急性动脉血栓栓塞,活动性静脉血栓形成,血栓栓塞性疾病或病史,静脉或 动脉血栓高危因素者; ⑻重度高甘油三酯血症; ⑼合并有心血管、肝、肾和造血系统等严重原发性疾病;可疑精神病患者; ⑽对研究药物或任何辅料过敏者;
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Exclusion criteria:
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(1) Congenital dysplasia of the uterus; combined with space-occupying lesions in the uterine cavity, such as submucosal fibroids or endometrial polyps; (2) ovulatory infertility; (3) oligomenorrhea caused by low ovarian function; (4) undiagnosed Vaginal bleeding (5) known or suspected breast cancer; known or suspected precancerous lesions or malignant tumors affected by sex hormones; (6) current or past history of liver tumors (benign or malignant); (7) acute arterial thromboembolism, active venous thrombosis Formation, thromboembolic disease or medical history, high risk factors for venous or arterial thrombosis; ⑻ severe hypertriglyceridemia; ⑼ combined with serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system; suspected mental patients; ⑽ for Those who are allergic to the study drug or any excipients;
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研究实施时间:
Study execute time:
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从From
2021-10-01
至To
2024-09-30
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征募观察对象时间:
Recruiting time:
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从From
2022-07-01
至To
2023-09-30
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