ITMCTR2000003626尚未招募1 期
Evaluation of Clinical Efficacy of Pneumonia Qingjie Recipe in Treating Community-Acquired Pneumonia (Non-Severe) with Phlegm-Heat Stagnation of Lung
onghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •2.1 diagnosis and inclusion criteria
- •2.1.1 diagnostic criteria of western medicine: refer to Chinese medical association's guideline for basic diagnosis and treatment of adult community-acquired pneumonia (2018) and CURB-65 scoring system.
- •Diagnostic criteria of community-acquired pneumonia (non-severe) in 2.1.1.1
- •(1) community morbidity.
- •(2) Clinical manifestations related to pneumonia:
- •1) newly appeared cough, expectoration, or aggravation of symptoms of original respiratory diseases, and purulent sputum with or without chest pain; 2) Fever; 3) Lung solid variant sign and/or wet rale smell;4) white blood cell (WBC) count in peripheral blood was > 10 x10^9/l or < 4 x 10 ^9/l, with or without nuclear left shift;
- •(3) Imaging examination of lung showed new patchy infiltration shadow, leaf or segment consolidation shadow, ground glass shadow or interstitial change, with or without pleural effusion.
- •Meet any one of (1), (3) and (2), and exclude pulmonary tuberculosis, pulmonary tumor, non-infectious pulmonary interstitial disease, pulmonary edema, atelectasis, pulmonary embolism, pulmonary eosinophilic infiltration and pulmonary vasculitis, etc., which can establish the clinical diagnosis of community-acquired pneumonia.
- •Low and medium risk groups of CAP in 2.1.1.2 (refer to CURB-65 scoring system)
- •There are 4 indexes in total, and 1 point will be scored if one index is met.
- •(1) consciousness disorder; (2) Respiratory frequency >= 30 times/min; (3) Systolic pressure < < 90mmHg or diastolic pressure <= 60 mmHg; (4) Age >= 65 years old.
- •0 point: low risk, outpatient treatment;
- •1-2 points: moderate risk, it is recommended to be hospitalized or strictly followed up for treatment outside the hospital;
- •>= 3 points: high risk, should be hospitalized, and some should be referred.
- •2.1.2 diagnostic criteria of traditional Chinese medicine
- •According to Chinese Medicine Branch of Chinese Medicine Association, Lung Disease Branch of Chinese Medicine Association and Lung Disease Branch of Chinese Medicine Association for Nationalities, Guidelines for Diagnosis and Treatment of Community-acquired Pneumonia with Traditional Chinese Medicine (Revised Edition 2018), phlegm-heat obstructing lung syndrome was formulated [6].
- •Main symptoms: cough, excessive sputum, yellow sputum, white and sticky sputum, chest pain, red tongue, yellow and greasy tongue coating, smooth and rapid pulse.
- •Secondary symptoms: fever, thirst, red face, yellow urine, dry stool and abdominal distention.
- •Diagnosis can be made with two of the main symptoms and secondary symptoms.
- •2.1.3 inclusion criteria
- •(1) meet the diagnostic criteria of community-acquired pneumonia (non-severe);
- •(2) Those who meet the low and medium risk groups of CAP;
- •(3) It conforms to the syndrome differentiation standard of phlegm-heat obstructing lung;
- •(4) Age from 18 to 65 years old, regardless of gender;
- •(5) The onset time does not exceed 72 hours, and antibiotics are not used;
- •(6) Agree and sign the informed consent form.
排除标准
- •Exclusion criteria
- •(1) structural lung disease, diabetes, liver and kidney dysfunction and other basic diseases;
- •(2) Complicated with serious heart, brain, lung, liver, kidney, blood system diseases and mental diseases, such as acute heart failure, acute cerebral hemorrhage, viral hepatitis, hemophilia, etc.;
- •(3) Patients with immunodeficiency or taking immunosuppressant or glucocorticoid in recent 3 months;
- •(4) Other therapeutic drugs such as antibiotics, antiviral drugs and traditional Chinese medicines have been used within 48 hours of treatment;
- •(5) Pregnant and lactating women;
- •(6) Allergic constitution, such as those who have been allergic to more than two drugs or foods, and those who are known to be allergic to the ingredients of this drug and cephalosporins.
- •Having any of the above can be excluded.
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