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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探讨痰热清胶囊对上呼吸道感染的慢阻肺急性发作患者的临床研究,完成240例,明确有效性和安全性;并探索痰热清胶囊治疗AECOPD适宜的中医“证素”特点。
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Objectives of Study:
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To explore the clinical study of Tanreqing capsule in the treatment of patients with Chronic obstructive pulmonary disease (AECOPD) with upper respiratory tract infection, complete 240 cases, clarify the effectiveness and safety; and explore the appropriate TCM "syndrome" characteristics of Tanreqing Capsules for the treatment of AECOPD.
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药物成份或治疗方案详述:
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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)年龄:40-85岁;
2)COPD符合中华医学会呼吸病学会分会制定COPD的诊断标准;既往一年有肺功能诊断的报告,即吸入支气管扩张剂后FEV1/FVC<70%,FEV1占预计值≥30%;
3)此次因上呼吸道感染门诊就诊;
4)近3日内出现咽痛、鼻塞、流涕、喷嚏等URTI症状或发热、头痛、肌痛等流感毒性症状中的至少两项;
5)肺内没有新增的湿啰音;
6)胸片或肺部CT未见新增渗出影;
7)影像学检查:符合慢性支气管炎、肺气肿表现,未见新的肺部渗出影。排除肺结核、肺部肿瘤、肺动脉栓塞、间质性肺病及肺水肿等疾病。(继发性轻度支气管扩张不排除);
8)签署知情同意书。
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Inclusion criteria
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1) Aged 40-85 years;
2) COPD meets the diagnostic criteria for COPD formulated by the Chinese Society of Respiratory Diseases; there has been a report of lung function diagnosis in the past year, that is, FEV1/FVC<70% after inhalation of bronchodilators, and FEV1 accounts for an estimated value of >= 30%;
3) This outpatient visit due to upper respiratory tract infection;
4) At least two of URTI symptoms such as sore throat, nasal congestion, runny nose, sneezing, or flu toxicity symptoms such as fever, headache, and myalgia occurred in the past 3 days;
5) There is no newly added rales in the lungs;
6) There is no new exudation on chest radiograph or lung CT;
7) Imaging examination: In line with chronic bronchitis and emphysema, no new pulmonary exudation was seen. Exclude pulmonary tuberculosis, lung tumors, pulmonary embolism, interstitial lung disease and pulmonary edema. (Secondary mild bronchiectasis is not ruled out);
8) Sign the informed consent form.
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排除标准:
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1)支气管扩张伴咯血者,或影像学见明显支气管扩张者;
2)患者入组前合并其他活动性肺部疾病,如活动性结核病、肺癌、肺栓塞、结节病、间质性肺病、原发性肺动脉高压及支气管哮喘等;
3)有严重肝肾功能不全、心功能不全等需要相应药物治疗者;
4)入组前6个月内不稳定缺血性心脏病、心肌梗塞及脑血管意外的受试者,3个月内有急性冠状动脉综合征或接受过经皮冠状动脉介入或冠状动脉旁路移植术的受试者;
5)精神病、智力发育不全、动机不良、药物酒精滥用或其他限制参加本研究的受试者;
6)入组前4周内参加过其他临床试验;
7)正在妊娠或哺乳或者计划在研究期间妊娠的女性,或有生育能力但未采用有效避孕方法的女性(育龄期妇女要查尿HCG);
8)对痰热清胶囊药物过敏者。
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Exclusion criteria:
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1) Patients with bronchiectasis with hemoptysis, or patients with obvious bronchiectasis on imaging;
2) The patient had other active lung diseases before enrollment, such as active tuberculosis, lung cancer, pulmonary embolism, sarcoidosis, interstitial lung disease, primary pulmonary hypertension and bronchial asthma, etc.;
3) Those with severe liver and kidney insufficiency, cardiac insufficiency, etc. who need corresponding medical treatment;
4) Subjects with unstable ischemic heart disease, myocardial infarction and cerebrovascular accident within 6 months before enrollment, acute coronary syndrome within 3 months or underwent percutaneous coronary intervention or paracoronary artery Subjects of road transplantation;
5) Subjects who have mental illness, mental retardation, poor motivation, drug and alcohol abuse, or other restrictions on participating in this study;
6) Participated in other clinical trials within 4 weeks before enrollment;
7) Women who are pregnant or breastfeeding or plan to become pregnant during the study period, or women who are fertile but have not used effective contraceptive methods (women of childbearing age should check urine HCG);
8) Those who are allergic to Tanreqing capsule drugs.
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研究实施时间:
Study execute time:
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从From
2020-03-20
至To
2022-10-31
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征募观察对象时间:
Recruiting time:
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从From
2020-03-20
至To
2022-10-31
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