研究疾病:
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外阴营养不良
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研究疾病代码:
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Target disease:
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Vulvar dystrophy
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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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随机平行对照
randomized controlled trial(parallel group design)
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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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外阴营养不良是妇科疑难病,以外阴及肛周的皮肤和黏膜萎缩变薄为主要特征,呈慢性进展伴反复发作。本病具有诊断容易而治疗困难的特点,早期诊断和干预可改善患者的长期预后。因此,该疾病亟需疗效明确的治疗方式。我科在几十年的临床工作中,总结出一套独特的治疗方法,其中,中医外治法疗效显著,惠及患者数量广泛。因此,本研究拟采用前瞻性、登记注册的真实世界研究方法,于山西省中医院妇产科门诊依序纳入已明确诊断外阴营养不良患者100例,根据纳入、排除标准分为中医外治法组和糖皮质激素组,比较两组治疗前后、组间的症状、体征、生活质量变化情况,以此评价中医外治法治疗外阴营养不良的长期疗效特点,为患者特供科学的治疗方法。
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Objectives of Study:
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Vulvar dystrophy is a difficult gynecological disease, which is mainly characterized by atrophy and thinning of skin and mucosa around vulva and anus, with chronic progression and repeated attacks. The disease has the characteristics of easy diagnosis and difficult treatment. Early diagnosis and intervention can improve the long-term prognosis of patients. Therefore, there is an urgent need for effective treatment of the disease. In decades of clinical work, our department has summarized a set of unique treatment methods. Among them, the external treatment of traditional Chinese medicine has significant curative effect and benefits a wide number of patients. Therefore, this study intends to adopt a prospective and registered real-world research method to include 100 patients with vulvar dystrophy in the obstetrics and gynecology clinic of Shanxi Hospital of traditional Chinese medicine. According to the inclusion and exclusion criteria, they are divided into TCM external treatment group and glucocorticoid group. The changes of symptoms, signs and quality of life between the two groups before and after treatment are compared, In order to evaluate the long-term curative effect of external treatment of traditional Chinese medicine in the treatment of vulvar malnutrition, and provide scientific treatment methods for patients.
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药物成份或治疗方案详述:
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中医外治法:外阴穴位封闭疗法(2%利多卡因注射液+丹红/红花注射液5ml,适用于外阴瘙痒症状及皮肤角化严重者;中药涂擦治疗:蒲竭止痒软膏,适用于外阴瘙痒严重者;TDP照射:用于中药外涂后促进药物吸收;小针刀外阴粘连切开术,适用于粘连严重者;外阴红外光治疗联合局部按摩:适用于萎缩明显者。激光水浴机:适用于外阴皮肤干燥、痒痛明显者;激光水浴机,适用于外阴皮肤干燥、痒痛明显者。
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Description for medicine or protocol of treatment in detail:
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External treatment of traditional Chinese medicine: vulva acupoint sealing therapy (2% lidocaine injection + Danhong / safflower injection 5ml, suitable for vulvar pruritus and severe skin keratosis; traditional Chinese medicine rubbing treatment: PuJie antipruritic ointment, suitable for severe vulvar pruritus; TDP irradiation: used to promote drug absorption after external application of traditional Chinese medicine; small needle knife vulvar adhesion incision, suitable for severe adhesion; vulvar infrared light treatment combined with local massage: suitable for Those with obvious atrophy. Laser water bath machine: suitable for those with dry vulva skin and obvious itching and pain; Laser water bath machine is suitable for those with dry vulva skin and obvious itching and pain.
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纳入标准:
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(1)明确诊断外阴营养不良,病程在6个月以上;(2)年龄不限,性别女性;(3)采用下列长期治疗方案之一:分为中医外治法组和糖皮质激素药物组,中医外治法组仅使用中医外治法、未使用糖皮质激素药物;糖皮质激素组使用激素类药物、未使用中医外治法。(4)自愿参与,签署知情同意书。
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Inclusion criteria
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(1) Vulvar dystrophy was clearly diagnosed, and the course of disease was more than 6 months; (2) No age limit, gender female; (3) One of the following long-term treatment schemes was adopted: divided into TCM external treatment group and glucocorticoid drug group. The TCM external treatment group only used TCM External Treatment and did not use glucocorticoid drugs; Glucocorticoid group used hormone drugs and did not use external treatment of traditional Chinese medicine. (4) Participate voluntarily and sign informed consent.
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排除标准:
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(1)慢性单纯性苔藓、扁平苔藓、白癜风、黏膜类天疱疮、接触性皮炎、外阴上皮内瘤变患者;(2)合并有心、肝、肾、血液、皮肤、精神等疾病;(3)近3个月内参加过其他药物临床试验;(4)不能按要求进行信息登记和随访。
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Exclusion criteria:
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(1) Patients with chronic simple moss, lichen planus, vitiligo, mucosal pemphigoid, contact dermatitis and vulvar intraepithelial neoplasia; (2) Combined with heart, liver, kidney, blood, skin, mental and other diseases; (3) Participated in clinical trials of other drugs in recent 3 months; (4) Information registration and follow-up cannot be carried out as required.
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研究实施时间:
Study execute time:
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从From
2021-12-01
至To
2023-11-30
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征募观察对象时间:
Recruiting time:
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从From
2022-04-01
至To
2022-11-30
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