研究疾病:
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慢性阻塞性肺疾病
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研究疾病代码:
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Target disease:
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Chronic obstructive pulmonary disease
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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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上市后药物
Post-marketing clinical trial
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研究目的:
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1.从临床疗效、免疫、微生态等不同维度确证玉屏风颗粒AECOPD的防治作用,阐明玉屏风颗粒防治AECOPD的作用机理
2.通过对中重度COPD稳定期动态观测,发现1-2个对慢阻肺急性加重具有预判性的危险因素等。
3.通过微生物学和免疫学疗效评估,筛选2-3个与疗效相关的指标,探讨呼吸道微生物与宿主的交互作用机制,明确其与慢阻肺急性加重的关系。
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Objectives of Study:
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1. Confirm the prevention and control effect of Yupingfeng particles AECOPD from different dimensions such as clinical efficacy, immunity, and microecology, and elucidate the mechanism of action of Yupingfeng particles in the prevention and treatment of AECOPD
2. Through dynamic observation of the stable period of moderate and severe COPD, 1-2 risk factors with predictive effectivity on acute exacerbation of COPD were found.
3. Through microbiological and immunological efficacy evaluation, 2-3 indicators related to efficacy were screened, the interaction mechanism between respiratory microorganisms and hosts was explored, and the relationship between them and acute exacerbation of COPD was clarified.
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药物成份或治疗方案详述:
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基础治疗:临床常规治疗
试验组:玉屏风颗粒(5g/袋,每次1袋,每日3次,口服给药)
对照组:玉屏风颗粒模拟剂(5g/袋,每次1袋,每日3次,口服给药)
疗程:52周,因急性加重住院期间,可暂时停止服用试验药物,待出院后继续服用。
禁用治疗:试验期间两组均禁止使用具有治疗肺脾气虚作用的中药或中成药,禁止使用定期规律的,针对肺部疾病治疗需要而进行的针灸、拔罐、中医理疗等治疗。
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Description for medicine or protocol of treatment in detail:
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Basic treatment: clinical routine treatment
Test group: Yupingfeng granules (5g/bag, 1 sachet each time, 3 times a day, oral administration)
Control group: Yupingfeng granule simulator (5g/bag, 1 sachet each time, 3 times a day, oral administration)
Course of treatment: 52 weeks, during the hospitalization due to acute exacerbations, the use of the test drug can be temporarily stopped and continued after discharge.
Forbidden treatment: During the trial period, both groups prohibited the use of traditional Chinese medicine or proprietary Chinese medicines with the effect of treating lung temper deficiency, and prohibited the use of acupuncture, cupping, traditional Chinese medicine physiotherapy and other treatments that were regular and regular for the treatment needs of lung diseases.
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纳入标准:
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1.40周岁≤年龄≤80周岁;
2.符合COPD(慢性阻塞性肺疾病)诊断标准;
3.临床症状评分中,咳痰单项评分≥1分;
4.根据 2021 版 GOLD指南诊断为中重度 COPD 的患者,应用支气管扩张剂治疗后FEV1/FVC≤70%,30%≤支气管扩张剂使用后FEV1占预测值%<80 %;
5.入选前一年内发生≥2次中度急性加重或≥1次重度急性加重或1次因急性加重住院治疗;
6.处于稳定期,在筛选前4 周无呼吸道感染及慢性阻塞性肺疾病急性加重(AECOPD);
7.受试者自愿加入本研究,并签署书面知情同意书。
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Inclusion criteria
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1. 40 years old≤ age ≤ 80 years old;
2. Meet the diagnostic criteria of COPD (chronic obstructive pulmonary disease);
3. In the clinical symptom score, the single score of sputum cough ≥ 1 point;
4. In patients diagnosed with moderate to severe COPD according to the 2021 gold guidelines, FEV1/FVC ≤ 70% after bronchodilator therapy, 30% ≤ FEV1 accounted for 80% of the predicted value after bronchodilator use<80%;
5. 2 moderate acute exacerbations occurred in the ≥ year before the admission, or 1 severe acute exacerbation ≥ or 1 hospitalization due to acute exacerbations;
6. In a stable stage, no respiratory infections and acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in the 4 weeks before screening;
7. Subjects voluntarily join the study and sign a written informed consent form.
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排除标准:
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1.入组前,COPD的诊断时间少于12个月;
2.需要每天吸氧治疗;
3.在筛选前4周内或在筛选期间发生呼吸道感染及慢性阻塞性肺疾病急性加重(AECOPD);
4.在入组前4周内接种了减毒活疫苗,或计划在研究期间接种减毒活疫苗;
5.计划进行肺切除术或肺减容术或有该类手术史。参加肺康复计划急性期的患者,即在筛选前4周内开始康复的患者;
6.根据2018年全球哮喘防治倡议(GINA)指南或其他公认的指南患者目前诊断为哮喘或有哮喘病史;
7.合并患有COPD以外的重大肺部疾病(例如肺间质纤维化、活动性肺结核、肺切除、肺部肿瘤等);
8.合并患有严重的心脏系统疾病(充血性心力衰竭,按照 NYHA 分级严重程度级别 为Ⅲ~Ⅳ级;影响血液动力学状况的显著心律失常或心瓣膜异常;近6个月内有不稳定性心绞痛或心肌梗死病史);
9.控制不良的胰岛素依赖型糖尿病(HBA1c≥8.0%);具有临床意义的实验室检查指标异常(如 ALT>5ULN、 AST>5ULN 或 Scr>1.5ULN);
10.免疫缺陷患者(如:器官或骨髓移植者、艾滋病患者、筛选检查前3个月内服用免疫抑制药物者);
11.在基线前5年内,既往患有严重的神经系统、血液系统、胃肠道、脑血管疾病以及药物滥用和/或酗酒史、恶性肿瘤史或活动性恶性肿瘤(成功治愈的子宫颈原位癌、皮肤非转移性鳞状细胞癌或皮肤基底细胞癌除外),经研究者判断可能干扰研究或需要接受可能干扰研究的治疗的当前或既往重大疾病;
12.筛选前3个月经常服用冬虫草保健品、含有黄芪等补益作用的中成药,或研究者认为不适宜参加本研究的患者;
13.已知对研究用药所含成分过敏者,或过敏体质患者;
14.处于哺乳期、妊娠期的妇女,或筛选检查后6个月内计划妊娠的育龄期妇女,或尿妊娠试验阳性者;或有生育、捐精计划的男性患者;
15.筛选检查前3个月内曾参加过其它药物临床试验的患者;
16.研究者认为不适宜参加本研究的其他患者。
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Exclusion criteria:
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1. Before enlistment, the diagnosis time of COPD is less than 12 months;
2. Require daily oxygen therapy;
3. Respiratory tract infection and acute exacerbation of chronic obstructive pulmonary disease (AECOPD) occurring within 4 weeks before screening or during screening;
4. Live attenuated vaccines were given within 4 weeks prior to enrolment, or live attenuated vaccines were planned for the duration of the study;
5. Plan to perform pneumonectomy or lung volume reduction or have a history of such surgery. Patients participating in the acute phase of the pulmonary rehabilitation program, that is, patients who began rehabilitation within 4 weeks prior to screening;
6. Patients currently diagnosed with asthma or have a history of asthma in accordance with the 2018 Global Asthma Initiative (GINA) guidelines or other recognized guidelines;
7. Co-existing major lung diseases other than COPD (such as interstitial fibrosis, active tuberculosis, pulmonary resection, lung tumors, etc.);
8. Concomitantly suffering from severe heart system diseases (congestive heart failure, grade III. to IV. according to NYHA classification severity; significant arrhythmias or heart valve abnormalities affecting hemodynamic conditions; history of unstable angina or myocardial infarction in the past 6 months);
9. Poor control of insulin-dependent diabetes mellitus (HBA1c≥8.0%); Clinically significant laboratory tests (e.g., ALT>5ULN, AST>5ULN, or Scr>1.5ULN);
10. Immunodeficient patients (such as: organ or bone marrow transplanters, AIDS patients, those who take immunosuppressive drugs within 3 months before screening examinations);
11. Previously severe neurological, hematologic, gastrointestinal, cerebrovascular diseases, and a history of substance abuse and/or alcohol abuse, malignancy or active malignancy (except for cervical carcinoma in situ, non-metastatic squamous cell carcinoma of the skin, or cutaneous basal cell carcinoma) within the first 5 years of the baseline, and current or previous major diseases that the researcher determines may interfere with the study or require treatment that may interfere with the study;
12. Screening patients who often take Cordyceps health products and proprietary Chinese medicines containing astragalus and other tonic effects in the first 3 months, or who the researchers deem unsuitable to participate in this study;
13. Those who are known to be allergic to the ingredients contained in the research drugs, or patients with allergic constitutions;
14. Women who are breastfeeding or pregnant, or women of childbearing age who plan to become pregnant within 6 months after screening tests, or those who have a positive urine pregnancy test; or male patients with fertility or sperm donation plans;
15. Screening of patients who have participated in clinical trials of other drugs within 3 months before the examination;
16. Other patients who the investigator deems unfit to participate in this study.
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研究实施时间:
Study execute time:
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从From
2022-01-15
至To
2025-03-30
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征募观察对象时间:
Recruiting time:
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从From
2022-05-23
至To
2024-09-24
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