研究疾病:
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风湿性多肌痛
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研究疾病代码:
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Target disease:
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polymyalgia rheumatica
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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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防己黄芪汤加减治疗风湿性多肌痛脾虚湿阻证的临床疗效观察。
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Objectives of Study:
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Clinical observation of Fangji Huangqi Decoction in the treatment of polymyalgia rheumatica with spleen deficiency and dampness syndrome.
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药物成份或治疗方案详述:
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将60例风湿性多肌痛患者随机分成中药治疗组和甲泼尼龙对照组、扶他林对照组,每组20例。中药治疗组给予防己黄芪汤加减口服;甲泼尼龙对照组给予甲泼尼松12-24 mg/d 口服,ESR和CRP正常、临床症状改善后开始减量,每2-4周减2.5 mg,减至4mg/d时维持口服。扶他林对照组给予扶他林25mg tid口服,ESR和CRP正常、临床症状改善后开始减量,25mgQd口服维持。均以4周为1个疗程,持续治疗4 个疗程。
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Description for medicine or protocol of treatment in detail:
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60 patients with polymyalgia rheumatica were randomly divided into Chinese medicine treatment group, methylprednisolone control group and Voltaren control group, 20 cases in each group. The traditional Chinese medicine treatment group was given Fangji Huangqi Decoction orally; the methylprednisolone control group was given methylprednisolone 12-24 mg/d orally, the ESR and CRP were normal, and the clinical symptoms were improved, and the dose was reduced, and the dose was reduced by 2.5 mg every 2-4 weeks. Maintain oral administration when reduced to 4 mg/d. The Voltaren control group was given Voltaren 25mg tid orally, ESR and CRP were normal, and the clinical symptoms were improved, and then the dose was reduced, and 25mg Qd was orally maintained. 4 weeks as a course of treatment, continuous treatment for 4 courses.
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纳入标准:
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1.西医诊断标准:
(1)年龄>50岁;
(2)颈、肩胛带及骨盆带三者之一出现肌肉疼痛和晨僵,病程时间≥1周;
(3)ESR增快、CRP升高;
(4)小剂量糖皮质激素(泼尼松≤15mg/天)有效;
(5)无肌力减退或肌萎缩、及肌肉红热肿;
(6)排除其他类似PMR表现的病变如肌炎、肿瘤、类风湿关节炎、慢性感染等。
2.脾虚湿阻证诊断标准:
神疲乏力,气短懒言,语声低微、肢体麻木沉重,肌肉韧带困重或酸楚疼痛,四肢酸软、抬举活动无力,面色萎黄,食欲不佳,脘腹痞闷胀满,便溏,舌质淡、体胖齿痕,苔白腻,脉沉濡缓。
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Inclusion criteria
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1. Western medicine diagnostic criteria:
(1) Aged > 50 years;
(2) Muscle pain and morning stiffness in one of the neck, shoulder girdle and pelvic girdle, and the duration of the disease is more than 1 week;
(3) ESR increases rapidly and CRP increases;
(4) Low-dose glucocorticoids (prednisone<=15mg/day) are effective;
(5) No muscle weakness or muscle atrophy, and muscle redness, heat and swelling;
(6) Exclude other lesions similar to PMR manifestations such as myositis, tumor, rheumatoid arthritis, chronic infection, etc.
2. Diagnostic criteria for spleen deficiency and damp resistance syndrome:
Shenpi fatigue, shortness of breath, lazy speech, low voice, numbness and heavy limbs, heavy muscles and ligaments, soreness and pain, soreness and weakness of limbs, inability to lift, pale complexion, poor appetite, fullness and fullness in the stomach and abdomen, loose stools, the tongue is pale, the body is fat with tooth marks, the coating is white and greasy, and the pulse is deep and slow.
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排除标准:
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1.资料不全和或未按规定用药等影响疗效或安全性判断者;
2.有肝硬化、慢性肺部炎症、近3个月有消化道溃疡患者、近期骨折等不能服用激素的患者;
3.服用类固醇药物或免疫抑制剂的患者;
4.肝肾功能明显异常;
5.精神疾病或意识障碍等不能配合治疗的患者。
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Exclusion criteria:
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1. Incomplete data and or non-prescribed medication, etc., which affect the judgment of efficacy or safety;
2. Patients with liver cirrhosis, chronic lung inflammation, patients with peptic ulcer in the past 3 months, recent fractures, etc. who cannot take hormones;
3. Patients taking steroids or immunosuppressants;
4. Obvious abnormal liver and kidney function;
5. Patients with mental illness or disturbance of consciousness who cannot cooperate with treatment.
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研究实施时间:
Study execute time:
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从From
2021-08-01
至To
2023-06-30
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征募观察对象时间:
Recruiting time:
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从From
2021-08-01
至To
2023-04-01
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