研究疾病:
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类风湿关节炎
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研究疾病代码:
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Target disease:
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rheumatoid arthritis
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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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非随机对照试验
Non randomized control
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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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本课题采用前瞻性研究的方法,评估蠲痹颗粒治疗类风湿关节炎(风寒湿痹证)临床疗效,同时探寻该药是否有助于激素撤减,为拓宽蠲痹颗粒的临床应用价值提供一手数据。
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Objectives of Study:
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In this project, prospective study is adopted to evaluate the clinical efficacy of Juanbi granule in the treatment of rheumatoid arthritis (Wind-cold-dampness-bi syndrome), and to explore whether the medicine contributes to hormone withdrawal and reduction, so as to provide first-hand data for broadening the clinical application value of Juanbi granule.
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药物成份或治疗方案详述:
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本课题采用前瞻性研究方法,试验期间招募符合纳入标准的患者93例,按照患者意愿分为治疗组62例(蠲痹颗粒15g po tid+醋酸泼尼松片+甲氨蝶呤片10mg po qw+来氟米特片10mg po qn)和对照组31例(醋酸泼尼松片+甲氨蝶呤片10mg po qw+来氟米特片10mg po qn),两组疗程均为12周,根据DAS28评分拟定醋酸泼尼松初始服用剂量,若DAS28评分≥5.1,醋酸泼尼松片予20mg/天口服;DAS28评分在2.6-5.1之间,醋酸泼尼松片10mg/天。分别在第0、4、8、12观察两组治疗前后各项指标的变化,结合统计学方法进行分析,评估蠲痹颗粒治疗类风湿关节炎(风寒湿痹证)临床疗效的同时,探寻该药是否有助于激素撤减,为拓宽蠲痹颗粒的临床应用价值提供一手数据。
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Description for medicine or protocol of treatment in detail:
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This subject adopts the prospectie study method, test recruited into the standards during the period of 93 cases of patients, according to the wishes is divided into the treatment group, 62 cases of patients (Juan bi particles 15 g Po dar + prednisone acetate + methotrexate pills 10 mg Po've + to fluorine milt piece of 10 mg Po qn) and control group in 31 cases (prednisone acetate + methotrexate pills 10 mg Po've + to fluorine milt piece of 10 mg Po qn), a course of 12 weeks, the two groups according to DAS28 score for initial doses of prednisone acetate, If DAS28 score ≥5.1, prednisolone acetate was given 20mg/ day orally. DAS28 score was between 2.6 and 5.1, and prednisolone acetate was 10mg/ day. At 0, 4, 8, 12, observe the change of the indicators before and after treatment in both groups, combined with statistical methods were analyzed, and the assessment Juan bi particles the treatment of rheumatoid arthritis (the wind cold dampness of) clinical efficacy, to explore whether the drug can help hormone shut down, to broaden the Juan bi particles the clinical application value of the data.
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纳入标准:
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1.符合1987年ACR和中医风寒湿痹证候诊断标准的RA患者;
2.DAS28评分>2.6的RA病情活动者;
3.既往服用糖皮质激素(若DAS28评分≥5.1,服用醋酸泼尼松片≥20mg/天或等效剂量激素;若2.6<DAS28<5.1,服用醋酸泼尼松片≥10mg/天或等效剂量激素)的患者;
4.年龄在18-65岁,男女不限;
5.自愿参加本试验并同意进入临床研究,签署知情同意书者。
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Inclusion criteria
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1. RA patients who met the 1987 ACR and Medium-to-medical syndrome criteria for diagnosis of cold and dampness syndrome;
2. RA activity subjects with DAS28 score >2.6;
3. Previous use of glucocorticoids (if DAS28 score >= 5.1, take prednisone acetate tablets >= 20mg/ day or equivalent dose of corticosteroids; For patients with 2.6 < DAS28 < 5.1, taking prednisolone acetate >= 10mg/ day or equivalent dose of hormone);
4. Ages 18-65 years, male or female;
5. Those who voluntarily participate in this trial and agree to enter into the clinical study and sign the informed consent.
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排除标准:
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1.参加试验前有严重呼吸(包括肺间质纤维化)、血液循坏、消化、内分泌、泌尿系统疾病及恶性肿瘤病史;
2.存在出血倾向活动性胃肠疾病者、近期有手术病史的患者;
3.存在抗菌药物不能控制的感染,参加试验前2月严重感染或有机会感染病史;
4.近1月来曾使用生物制剂;
5.妊娠期、哺乳期妇女;
6.正在参加其他临床试验的患者;
7.过敏体质者(对蠲痹颗粒及激素等试验药物过敏);
8.精神病患者;
9.怀疑或确有酒精、药物滥用病史,或具有降低入组可能性或使入组复杂化的其他病变,如工作环境经常变动等易造成失访的情况。
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Exclusion criteria:
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1. Had a history of severe respiratory (including pulmonary interstitial fibrosis), blood circulation, digestive, endocrine, urinary diseases and malignant tumors before taking part in the study;
2. Patients with bleeding tendency, active gastrointestinal diseases, and patients with recent surgical history;
3. There is an infection that cannot be controlled by antibiotics, and a history of severe infection or opportunistic infection 2 months before the study;
4. Use of biological agents in recent January;
5. Pregnant and lactating women;
6. Patients participating in other clinical trials;
7. People with allergic constitution (allergic to juanyi granules and hormones);
8. Persons with mental illness;
9. A history of alcohol and drug abuse is suspected or present, or other conditions that reduce the likelihood of inclusion or complicate inclusion, such as frequent changes in the work environment, are likely to cause loss of follow-up.
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研究实施时间:
Study execute time:
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从From
2021-01-01
至To
2022-05-31
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征募观察对象时间:
Recruiting time:
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从From
2021-01-01
至To
2021-12-31
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