Retrospective registration

Clinical study of Mongolian medicine in the treatment of chronic obstructive pulmonary disease

Clinical study of Mongolian medicine in the treatment of chronic obstructive pulmonary disease

Jin Tao 

Buren Batu 

1742 Huolinhe Street, Horqin District, Tongliao, Inner Mongolia, China

1742 Huolinhe Street, Horqin District, Tongliao, Inner Mongolia, China

Affiliated Hospital of Inner Mongolia University for the Nationalities

Affiliated Hospital of Inner Mongolia University for the Nationalities

Yes

Medical ethics committee of Affiliated hospital of Inner Mongolia University for the Nationalities

Narisu

1742, Huolinhe Street, Horqin District, Tongliao, Inner Mongolia, P.R.China

Affiliated Hospital of Inner Mongolia University for the Nationalities

1742, Huolinhe Street, Horqin District, Tongliao, Inner Mongolia, P.R.China

National Key RESEARCH and development Program: Sdudy on modernization of Traditional Chinese Medicine

Chronic obstructive pulmonary disease

Observational study

N/A

Cohort study 

To clarify the clinical efficacy and safety of Mongolian medicine Moistening Lung and Huaji method in the treatment of COPD, and establish the prevention and treatment plan and diagnosis and treatment guidelines of Mongolian medicine Runfei Huaji therapy in the treatment of COPD.

This study intends to recruit 180 patients with stable COPD, age 18-75 years old, gender is not limited. 180 patients were divided into two groups by cohort design, 120 cases in the experimental group and 60 cases in the control group. The experimental group was treated according to the principle of syndrome differentiation of Mongolian medicine. The control group was treated according to the 2019 Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guidelines. Ⅰ. Observation group: Mongolian medicine was used to moisten lung and Huaji, can be added to alleviate asthma, phlegm, symptomatic treatment, three root types, give the medicine by hour, according to the hour of Heyi, Hila, Badakan, respectively given the main agent treatment; Choose prescription according to disease syndrome differentiation; According to the three root abnormally exuberant, Illness weight, urgency to give characteristic external treatment conditioning. In the acute episode, according to the therapeutic principles of 2019 GOLD Guidelines and combine with taking orally and external treatment in Mongolian medicine; During the stable period, Mongolian medicine was used for taking orally and external treatment , According to the condition in accordance with the period of treatment and conditioning period alternate treatment. Treatment process: the total course of treatment was 6 months, and the treatment period was 3 months. After 3 months of treatment, according to the condition, grade I patients were treated with the same recuperation period regimen, and grade II-III patients were treated with the same treatment period regimen. 1. Treatment plan: (1) oral medication of the main agent: When Heyi disease broke out: (3:00-6:00) : Uzumo-7, 3-5g/ day, oral. When Hila disease broke out: (11:00-14:00) : Zandam-20 pill, 3g/day, oral. When Badkan disease broke out: (19:00-22:00) : Qingfei Runze pill, 3-5g/ day, oral. Continuous medication for 3 months. (2) According to the disease syndrome, three root abnormally exuberant tratment: Heyi abnormally exuberant type: ① The phlegm is not easy to cough, rapid cough, the phlegm is gray or bluish-white bubble sputum, breath is short, give Agaru-15 powder or Rang Agaru-8 powder; ② When the symptoms of heart palpitations and chest distress were significant, 3-5g is selected from the drugs such as Amin-erdun, Xin-II, Zadi-5, Zandan-3 powder, Guangzao-7 pill, Gaoyou-13 as auxiliary use; ③ When the symptoms such as fullness of stomach and loss of appetite were significant, 3-5g is selected from the drugs such as Butegeqi-5, Tonglaga-5, Haodoton-10, Chagan-Urelle, Anari-5, Anari-14, Maolor-Dabs-4 powder, and Gagula-4 Powder as auxiliary use; ④ When the symptoms of constipation were significant, 3-5g is selected from the drugs such as Amur-6 and Gisiguna-3 decoction as auxiliary use; ⑤ When the symptoms of insomnia were significant, 3-5g is selected from the drugs such as Sugemul-3 powder, Amin-erdun, Agaru-19 as auxiliary use; Hila abnormally exuberant type: ①Cough, cough yellow phlegm, can not be supine to give Shashen-4 decoction or Seabuckthorn-5 honeyed pill or Zhugang-25 pill; ②When fever symptoms were significant, 3-5g is selected from the drugs such as Honger-12, erhim-8, Dogul-ebus-7, Erdun-7 decoction, Chagan decoction, Gaburi-25 as auxiliary use: ③When the symptoms of sore throat were significant, 3-5g is selected from the drugs such as Bater-7, Has-Hatugur-15, Goltebor-6, Huhe-Garidi-9, and Jizum-Dorji as auxiliary use; ④When the mouth is bitter, pantothenic acid, anorexia and other symptoms are significant, 3-5g is selected from the drugs such as Yih-har-12, Hari-Gaburi-10, and Altan-Arura -5 as auxiliary use; ⑤When the symptoms are significant, such as headache, dry mouth, remitting face, etc., 3-5g is selected from the drugs such as Obidesen Gurgu-13, Gurigum-13, Hurcha-6, Nemeritu-Gurigum-13, Gabala-3 decoction, Yihe-Ulan-13, Shari decoction, Gurban-Ulan decoction as auxiliary use. Badkan abnormally exuberant type: ①cough frequency, cough out white viscous phlegm, chest distension, breath hyperventilating, give harabur-16. ② When the fever was significant, 3-5g is selected from the drugs such as Honger-12, erhim-8, Dogul-ebus-7, Erdun-7 decoction, Chagan decoction, Gaburi-25 as auxiliary use. ③When the symptoms were significant, such as fullness of stomach and loss of appetite, 3-5g is selected from the drugs such as Butegeqi-5, Tonglaga-5, Haodoton-10, Chagan-Urelle, Anari-5, Anari-14, ruda-6 as auxiliary use. ④When symptoms such as nausea and vomiting were significant,3-5g is selected from the drugs such as Zhuangxi-6, Zhuangxi-21 as auxiliary use. When the symptoms of constipation were significant, 3-5g is selected from the drugs such as Amur-6 and Gisiguna-3 decoction as auxiliary use; (3) External treatment: according to the three root abnormally exuberant disease syndrome, the condition of urgent treatment. Hot compress therapy and rubbing therapy once every other day, leaving cupping therapy, once a week, 5-10 minutes at a time (3 minutes for the infirm). ① Heyi abnormally exuberant type: rubbing therapy (once every other day). Selection acupuncture points: Heyi acupuncture point, mother lung acupuncture point,son lung acupuncture point, alternate compatibility. ②Hila abnormally exuberant type: keep the cupping therapy (once a week). Selection of acupuncture points: select The Hila acupuncture point, mother lung acupuncture point,son lung acupuncture point, alternate compatibility. ③ Badkan abnormally exuberant type: hot compress therapy (every other day). Selection of acupuncture points: choose Badakan acupuncture point, mother lung acupuncture point, son lung acupuncture point, alternate compatibility. 2. Treatment plan during conditioning period: (1) Oral administration of the remedium cardinale: when symptoms such as cough, expectoration, chest tightness and shortness of breath appear, appropriate addition. Morning: (3:00-6:00) : Seabuckthorn-5 honeyed pill, 6g orally.Evening: (19:00-22:00) : Qingfei Runze pill, 3-5g orally. (2) External treatment: according to the three root abnormally exuberant disease syndrome, the condition of urgent treatment. Each treatment time is 5-10 minutes (the treatment time can be selected according to the specific situation of frail patients). Rubbing and hot compress once every other day and cupping once a week. 3. The follow-up treatment that continue to use external therapy toning treatment (therapeutic schedule same as conditioning period), if you have symptoms such as cough, sputum, chest condition when appropriate use of Mongolian medicine treatment (conditioning period→treatment period scheme (?Escalation therapy used Mongolian medicine), if the illness poorly controlled, further evaluation of the illness, according to the 2019 GOLD guide treatment. 4. Dialectical nursing: (1) Heyi abnormally exuberant type: Diet care: the general selection of food five sources partial leap soil, taste with acid, wei, xin, with soft, heavy, greasy, warm, solid and other efficiency of the nutrient-rich diet. Such as mutton, fresh milk of cattle and sheep, milk skin, cream, milk tofu, cheese crisp, stored for a long time butter and other dairy products, bone marrow, fat, mustard seed, sesame oil and other vegetable oil, barley, white flour, soybean, sesame and other grain grains, Onions, garlic, white radish, jujube and other non-staple food, four bone nourishing soup and other drink food. Avoid eating five sources of gas abnormally exuberant , bitter taste, astringent, with light, strong (rough), cool, dynamic, strong and other efficiency of low nutritional content of the diet, such as buckwheat noodles, goat, lettuce, dandelion, strong tea and other diet. Daily care: in warm (often exposed to the sun) quiet, fresh air, no smoke environment, so that patients feel comfortable recuperation. Avoid the wind, cold and damp in the living place, avoid the stimulation caused by quarrels, long words, panic, etc., and avoid excessive exertion and strenuous exercise. Avoid alcohol and cigarettes. (2) Hila abnormally exuberant type: Diet care: usually choose with five sources of water abnormally exuberant, taste with sweet, bitter, astringent, with cold, blunt, light, thin, and, dry and other efficacy of the drink food. Such as beef, fresh milk, butter and other oils, grains, mung beans, rice and other grains, watermelon, cucumber, tomato, pear, apple, pineapple, lychee, strawberry and other fruits, plain water, black tea, cold water, fruit juice, mineral water and other drinks. Avoid eating: food with five sources of fire, spicy taste, acid, cheng, hot, sharp, greasy and heavy efficacy. Such as ginger pepper, acid vine fruit, garlic, leek, green onion and other vegetables, dry meat strip, horse meat, beef and other meat, liquor, acid milk, milk and other drinks stored for a long time. Daily care: make the patient in the environment quiet, cool place cultivation, such as: in the shade of trees, lawn, waterfront and other quiet place to live the most suitable. Exposure to the sun should be avoided. It is forbidden to live in dry and hot places and exert too much force. Avoid alcohol and cigarettes. (3) Badkan abnormally exuberant type: Diet care: usually choose to have five sources of fire abnormally exuberant, taste with acid, cheng, xin, with hot, light, sharp, light, strong (rough), dynamic and other efficacy of the diet. Such as fresh meat of sheep, fish and other animals, liquor, water and other drinks, hot pasta, honey, dry ginger and other grains or non-staple food. Avoid eating: the five sources of soil is rich, taste sweet, bitter, astringent, with cold, dull, greasy, heavy, stable (solid) and other efficacy of food. For example, unripe fruits, deteriorated and rancorous food, diseased meat, greasy, half-cooked food, unfermented cheese, sour milk, fat, meat, etc. are not good for the treatment of badakan disease. Daily care: rest in the fresh air, no smoke, warm environment, patients are forbidden to stay in the damp and cold place for a long time, thick clothes, to prevent wind and cold, protect stomach fire, appropriate amount of physical fitness to participate in the exercise, avoid smoking and alcohol. Ⅱ. Control group: Refer to the 2019 GOLD Guidelines for the control group. 3. Treatment plan for acute exacerbation of COPD: Treatment of AECOPD patients without respiratory failure, Use SABA and/or SAMA, ICS atomization inhalation, LAMA may also be considered. Anti-infection drugs (β -lactam, lonolol, macrocyclic) were selected according to sputum traits, bacterial drug resistance, and patients' allergy history. Treatment of AECOPD patients with non-life threatening acute respiratory failure: (1) controlled oxygen therapy; (2)SAMA, SABA, ICS combined with aerosol inhalation, oral glucocorticoid may be considered to replace ICS; (3) May consider the use of methylxanthine drugs; (4)If there is bacterial infection, antibiotics should be used, and B lactam alone or in combination with macrolides and noronones can be selected; (5) Consider the use of a ventilator according to the severity of respiratory failure; (6) Monitor fluid balance and nutrition; (7) Consider low molecular weight heparin for thrombosis prevention; (8) Identification and treatment of complications. Treatment of patients with life-threatening AECOPD: (1) Oxygen therapy or mechanical ventilation support; (2) SAMA, SABA and ICS combined with aerosol inhalation, oral or intravenous glucocorticoid may be considered to replace ICS; (3) the use of methylxanthine drugs; (4)β-lactams combined with quinolones can be used if don't have pseudomonas aeruginosa risk factors , and β-lactams with pseudomonas activity combined with aminosaccharides or quinolones can be used if have pseudomonas aeruginosa and/or other intestinal bacterial risk factors.. (5) Monitor fluid balance and nutrition; (6) Consider subcutaneous injection of heparin or low molecular weight heparin for thrombosis prevention; (7) Identification and treatment of complications; 

1. Patients diagnosed with stable COPD according to GOLD Guidelines 2019;
2. Meet the diagnostic criteria of Mongolian medicine;
3. Patients in the stable phase of CHRONIC obstructive pulmonary disease (if the disease exacerbates after enrollment and causes AECOPD, the condition is stabilized and the disease condition shall be evaluated again after the hospital discharge in the month,when meets the inclusion criteria of the last consecutive visit (the last visit period before acute exacerbation), with lung function FEV1/FVC<70%, and can follow the trial regimen;
4. A history of COPD for at least one year prior to V1, with at least twice exacerbations of COPD or once hospitalization due to exacerbations in the past year;
5.18 ≤ age ≤75;
6. The subject has informed consent and signed the informed consent form.

1. Other lung diseases (cystic pulmonary fibrosis, bronchiolitis, pneumonectomy, lung cancer, diffuse interstitial lung disease, tuberculosis, severe bronchiectasis, lung tumors, etc.);
2. Serious cardiac diseases (congestive heart failure,NYHA classification of severity is III~IV severity; Significant arrhythmias affecting hemodynamic status (affecting hemodynamic atrial fibrillation, atrial flutter, supraventricular tachycardia, degree II or higher atrioventricular block, ventricular tachycardia); History of unstable angina pectoris or myocardial infarction within the last month);
3. Serious diseases of digestive system, endocrine system, nervous system or other diseases;
4. A history of serious mental illness or depression;
5. Resting heart rate >120 beats/min, or systolic blood pressure >180mmHg, or diastolic blood pressure >100mmHg;
6. Those who were unable to complete the six-minute walking test due to limited lower limb activities;
7. Abnormal laboratory tests with clinical significance (e.g. ALT>2ULN, AST>2ULN, or Scr>1.5ULN) require further clinical evaluation;
8. Alcohol and drug abuse in the year prior to the test;
9. Suspected allergy to, or contraindications to, any of the following substances, including the active ingredient of the test drug or first-aid drug and other ingredients contained in the test drug or first-aid drug;
10. Pregnant, lactating women, planning to become pregnant or unable to use reliable contraceptive methods;
11. Patients who have participated in any clinical trial within 30 days prior to screening, or who have previously been enrolled in this trial;
12. Suffers from any concomitant disease that may interfere with the procedure or evaluation of the study, or is otherwise deemed unsuitable for inclusion in the study by the investigator.

No

No

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