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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探讨痰热清胶囊治疗轻中度慢性阻塞性肺疾病急性加重期(AECOPD)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 acute exacerbation of mild to moderate chronic obstructive pulmonary disease (AECOPD), 240 cases are completed, the efficacy and safety are clarified, and to explore the characteristics of TCM "syndrome elements" suitable for Tanreqing capsule in 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40~80岁,性别不限;
2)轻中度的COPD患者:符合慢性阻塞性肺病全球倡议(GOLD)及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占预计值的百分比>50%;
3)符合慢性阻塞性肺疾病急性发作期(AECOPD)的诊断标准:与稳定期相比,受试者病情持续恶化,超过日间正常变化,即有 COPD 基础的受试者为急性起病,需要调整常规用药;
4)具有发热、咳嗽、咳黄脓痰等临床表现;
5)影像学检查:符合慢性支气管炎、肺气肿等表现,或者合并有肺部渗出影。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;
6)受试者充分理解并自愿签署知情同意书。
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Inclusion criteria
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1. Aged 40-80 years old;
2. Patients with mild to moderate COPD: meet the diagnostic criteria of COPD formulated by the global initiative for chronic obstructive pulmonary disease (gold) and the society of respiratory diseases of Chinese Medical Association: there was a previous year's report of pulmonary function diagnosis, that is, FEV1 / FVC was less than 70% after inhalation of bronchodilator; FEV1 accounted for more than 50% of the predicted value;
3. Patients who meet the diagnostic criteria of acute stage of chronic obstructive pulmonary disease (AECOPD): compared with the stable stage, the patients' condition continues to worsen, exceeding the normal changes during the day, that is, the patients with COPD are acute onset, and need to adjust the routine medication;
4. Patients with fever, cough, yellow cough, purulent phlegm and other clinical manifestations;
5. The imaging examination is consistent with the manifestations of chronic bronchitis and emphysema, or with pulmonary exudation shadow. Patients with pulmonary tuberculosis, pulmonary tumor, pulmonary embolism, interstitial lung disease and pulmonary edema were excluded;
6. Subjects who fully understood and voluntarily signed the informed consent.
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排除标准:
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1)已知对试验用药物所含成分及药用辅料过敏者;
2)支气管哮喘、支气管扩张症、肺间质纤维化、肺动脉高压、重度肺部感染、重度慢性阻塞性肺疾病急性加重期、肺结核、结核性胸膜炎、呼吸衰竭以及需要呼吸机辅助治疗的等患者;
3)既往或目前合并以下任何一种重大疾病史或影响研究评估:
? 无力咳痰(如长期卧床、晚期肺癌等)患者;
? 近3个有脑血管意外病史,如缺血性脑卒中和出血性脑卒中;
? 病态窦房结综合征、II~III度房室传导阻滞、房扑、房颤及其它恶性或潜在的恶性心律失常;
? 大动脉瘤或夹层动脉瘤、行经皮冠状动脉腔内成形术或心脏外科手术;
? 近3个月内有不稳定性心绞痛、心肌梗死、心力衰竭史;
? 严重的肝病患者或肝功能不全的患者(如肝硬化、慢性活动性肝炎等);
? 严重的肾病患者(如慢性肾功能不全者、肾动脉狭窄患者等);
? 恶性肿瘤病史;
? 严重的造血系统原发性疾病者或粒细胞缺乏症者。
4)入组前有任何一项实验室检查指标符合下列标准:
? 丙氨酸氨基转氨酶(ALT)、天门冬氨酸氨基转移酶(AST)>1.5倍正常值上限(ULN)(参考所在的研究中心实验室检查正常值范围);
? 血清肌酐(Cr)>1.5倍正常值上限(ULN)(参考所在的研究中心实验室检查正常值范围)。
5)其他不适合参加研究的一般情况:
? 筛选前3个月内曾参加过或正在参加其它任何临床试验者;
? 既往有吸毒、酒精或药物滥用病史;
? 存在严重神经、精神疾患而不能充分理解和合作的患者;
?妊娠、哺乳、计划怀孕或未采取可靠节育措施的育龄期妇女和男性患者,并在参加试验期间和末次用药后的30天内不愿意采取节育方法,育龄期妇女要查尿HCG;
? 无法遵从研究方案要求者;
? 研究者认为其他不适宜参加临床试验的情况者。
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Exclusion criteria:
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1. Patients who are known to be allergic to the ingredients and excipients of the test drug;
2. Patients with bronchial asthma, bronchiectasis, pulmonary fibrosis, pulmonary hypertension, severe pulmonary infection, acute exacerbation of severe chronic obstructive pulmonary disease, tuberculosis, tuberculous pleurisy, respiratory failure, and those requiring ventilator-assisted treatment;
3. Patients who have been or are currently being evaluated in any of the following major disease histories or impact studies:
(1) Patients with inability to expectorate (such as long-term bed rest, advanced lung cancer, etc.);
(2) Nearly 3 patients had history of cerebrovascular accident, such as ischemic stroke and hemorrhagic stroke;
(3) Sick sinus syndrome, degree II-III atrioventricular block, atrial flutter, atrial fibrillation and other malignant or potential malignant arrhythmias;
(4) Large aneurysm or dissecting aneurysm, percutaneous transluminal coronary angioplasty or cardiac surgery;
(5) Unstable angina, myocardial infarction and heart failure were found in the past 3 months;
(6) Patients with severe liver disease or liver dysfunction (such as cirrhosis, chronic active hepatitis, etc.);
(7) Patients with severe nephropathy (such as chronic renal insufficiency, renal artery stenosis, etc.);
(8) History of malignant tumor;
(9) Severe primary disease of hematopoietic system or agranulocytosis.
4. Patients with any laboratory test index meeting the following criteria before enrollment:
(1) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were more than 1.5 times the upper limit of normal value (ULN) (refer to the range of normal value in the laboratory of the research center);
(2) Serum creatinine (CR) is more than 1.5 times the upper limit of normal value (ULN) (refer to the range of normal value in the laboratory of the research center).
5. Other general conditions that are not suitable for the study:
(1) Patients who have participated in or are participating in any other clinical trials within 3 months before screening;
(2) Patients with previous histories of drug, alcohol or drug abuse;
(3) Patients with severe neurological and mental disorders who cannot fully understand and cooperate;
(4) Women and men of childbearing age who are pregnant, lactating, planning to be pregnant or who do not take reliable birth control measures are not willing to take birth control methods during the trial period and within 30 days after the last medication. HCG in urine should be checked in women of childbearing age;
(5) Patients who are unable to comply with the requirements of the study protocol;
(6) Other situations that the researchers think are not suitable for clinical trials.
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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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