研究疾病:
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慢性前列腺炎/慢性盆底疼痛综合征
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研究疾病代码:
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Target disease:
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Chronic prostatitis / chronic pelvic floor pain 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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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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其它
Others
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研究目的:
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本研究旨在评价针刺改善慢性前列腺炎/慢性盆底痛综合征患者生活质量的近期疗效,并探讨其远期疗效。在此基础上形成规范化方案,以推广应用,造福广大患者。
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Objectives of Study:
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The purpose of this study was to evaluate the short-term efficacy of acupuncture in improving the quality of life of patients with chronic prostatitis / chronic pelvic floor pain syndrome, and to explore its long-term efficacy. On this basis, a standardized scheme is formed to promote the application and benefit the majority of patients.
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药物成份或治疗方案详述:
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(1)针刺组
取穴:肾俞,中髎,会阳,三阴交
穴位定位:参照 2006 年中华人民共和国国家标准(GB/T 12346-2006)《腧穴名称与定位》。肾俞:位于第 2 腰椎棘突下,旁开 1.5 寸。
中髎:次髎下内方,适对第 3 骶后孔。
会阳:在骶部,尾骨端旁开 0.5 寸。
三阴交:在小腿内侧,当足内踝尖上 3 寸,胫骨内侧缘后方。
操作:患者为俯卧位,全身放松,常规消毒,粘贴一次性消毒垫。针刺肾俞穴,医生使用
1.5 寸 0.3mm*40mm 针向下方向缓慢刺入,深度 30mm;针刺会阳穴,常规定位,用0.30mm*75mm 针灸针,方向与皮肤呈 70°向外上方,深度 50-70mm,患者自觉局部酸胀感;针刺中髎穴,使用 0.40mm*75mm 针灸针向内下斜刺进针深度 50-70mm,患者感觉局部酸痛。针刺三阴交穴,使用 0.3mm*40mm 针灸针向下方缓慢刺入,深度 30mm。针刺所有腧穴均在得气基础上,小幅度均匀提插捻转 3 次,留针 30 分钟,期间每 10 分钟行针 1 次,共 3 次。
疗程:隔天针刺一次,每周治疗三次,治疗 8 周,共治疗 24 次。
(2)对照组(非穴点微针刺):
取穴:肾俞,中髎,会阳,三阴交旁开非经非穴点。
定位:前 3 个非经非穴点位于肾俞、中髎和会阳水平向外旁开 2cm,三阴交非穴点位于三阴交水平向后,脾经和肾经连线中点。
操作:患者为俯卧位,穴位局部皮肤常规消毒,采用 1 寸毫针直刺 2-3mm,不做提插捻转手法,留针 30 分钟,留针期间不做手法。疗程:隔天针刺一次,每周治疗三次,治疗 8
周,共治疗 24 次。
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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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(1)临床表现为最近半年内,反复持续发作的前列腺疼痛并伴有排尿异常和精神神经症状,同时未证实感染或其他明显的病理情况,症状持续 3 个月以上。主要临床表现在以前列腺为中心辐射周围组织的疼痛,常见于阴囊、睾丸、小腹及会阴、腰骶、股内侧等部位的疼痛、坠胀或不适感;排尿异常表现为尿频、尿急、尿痛、尿道灼热、尿余沥或晨起、尿末或大便时自尿道溢出白色的分泌物;精神神经症状表现为头晕耳鸣、失眠多梦、焦虑抑郁等,甚或出现阳痿、早泄等性功能障碍;
(2)年龄 18-50 岁;
(3)NIH-CPSI 评分≥15;
(4)自愿参与本试验并签著知情同意书。
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Inclusion criteria
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(1) The clinical manifestations were recurrent and persistent prostate pain in the last six months, accompanied by abnormal urination and psychoneurological symptoms. At the same time, infection or other obvious pathological conditions were not confirmed, and the symptoms lasted for more than 3 months. The main clinical manifestations are pain radiated from the surrounding tissues with the prostate as the center, and pain, swelling or discomfort in the scrotum, testis, lower abdomen, perineum, lumbosacral and medial thigh; Abnormal micturition showed frequent micturition, urgent micturition, urinary pain, urethral burning, residual urine or white secretion overflowing from the urethra in the morning, at the end of urine or defecation; Mental and neurological symptoms include dizziness, tinnitus, insomnia, dreaminess, anxiety and depression, or even sexual dysfunction such as impotence and premature ejaculation;
(2) Age 18-50 years old;
(3) NIH-CPSI score >= 15;
(4) Voluntarily participate in the trial and sign the informed consent form.
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排除标准:
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(1)膀胱出口梗阻、膀胱过度活动症、神经源性膀胱、间质性膀胱炎、腺性膀胱炎、性传 播疾病、原位癌等膀胱肿瘤、前列腺癌、尿路感染、其他类型的前列腺炎等;
(2)经腹部 B 超残余尿≥100ML;最大尿流率<15ml/秒;
(3)近 1 个月内服用缓解 CP/CPPS 症状的药物,或接受治疗 CP/CPPS 的非药物疗法( 针灸、生物反馈等);正在服用影响下泌尿道功能的药物;
(4)症状性泌尿系感染及泌尿系统器质性疾病;
(5)影响下尿道功能的疾病,如多发性硬化、老年性痴呆、帕金森病、脊髓损伤、马尾神 经损伤、脑卒中及多系统萎缩等;
(6)伴有严重心、肺、脑、肝、肾和造血系统疾病、精神疾病及认知功能明显障碍者。
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Exclusion criteria:
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(1) Bladder outlet obstruction, overactive bladder, neurogenic bladder, interstitial cystitis, glandular cystitis, sexually transmitted diseases, carcinoma in situ and other bladder tumors, prostate cancer, urinary tract infection, other types of prostatitis, etc;
(2) Transabdominal B-ultrasound residual urine >= 100ml; Maximum urinary flow rate < 15ml /S;
(3) Taking drugs to alleviate CP / CPPS symptoms or receiving non drug therapy for CP / CPPS (acupuncture, biofeedback, etc.) in recent 1 month; Taking drugs that affect lower urinary tract function;
(4) Symptomatic urinary tract infection and organic diseases of urinary system;
(5) Diseases affecting lower urethral function, such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, spinal cord injury, cauda equina nerve injury, stroke and multisystem atrophy;
(6) Patients with severe heart, lung, brain, liver, kidney and hematopoietic system diseases, mental diseases and obvious cognitive impairment.
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研究实施时间:
Study execute time:
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从From
2019-12-31
至To
2022-12-31
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征募观察对象时间:
Recruiting time:
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从From
2020-01-01
至To
2022-06-01
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