Effects of Feixinning Capsules on BODE Index, CRP and Quality of Life in AECOPD

Yiqi WEN, Ruifen ZHANG, He SU*

1.Inner Mongolia Medical University, Huhhot 010010, China; 2.Inner Mongolia Hospital of Traditional Chinese Medicine, Inner Mongolia Hospital of Institute of Traditional Chinese Medicine, Huhhot 010020, China

Abstract [Objectives]To investigate the therapeutic effect of Feixinning Capsules on acute exacerbation of chronic obstructive pulmonary disease(AECOPD)complicated with right heart failure.[Methods]A total of 60 cases of AECOPD patients with right heart failure and phlegm-heat syndrome were randomly selected as the study subjects, and were divided into the Feixinning group(n=30)and the control group(n=30).The Feixinning group was treated with Feixinning Capsules combined with conventional western medicine, and the control group was treated with conventional western medicine.The pulmonary function, CRP, CAT score, BODE index item index, and EQ-5D index were compared between the two groups before and after treatment.[Results]After treatment, the pulmonary function, CRP, CAT score, 6MWD, mMRC, BODE score and EQ-5D index in the Feixinning group were significantly improved compared with the control group(P<0.05), and there was no statistical difference in the change of BMI index(P>0.05).[Conclusions]Feixinning Capsules can effectively improve the clinical symptoms and quality of life of patients with AECOPD complicated with right heart failure and phlegm-heat syndrome.

Key words AECOPD, Right heart failure, Phlegm-heat syndrome, Feixinning Capsules, BODE index, EQ-5d index

1 Introduction

Chronic obstructive pulmonary disease(COPD)is a major public health problem affecting the world.At present, it is the third leading cause of death in the world after ischemic heart disease and stroke[1], and its complications greatly affect patient’s quality of life.Acute exacerbation of COPD(AECOPD)is COPD patients’ main cause of death.Repeated AECOPD can lead to increases in pulmonary artery pressure and right heart strain, and is complicated by heart failure[2].Studies have shown that 40.3% of AECOPD patients in the respiratory ward suffer from heart failure[3].The drug and non-drug therapy of AECOPD combined with right heart failure are effective[4], but the drug resistance of antibiotics and glucocorticoids, toxic reactions caused by digitalis drugs, and acid-base imbalance and electrolyte imbalance caused by diuretics reduce patients’ quality of life.From clinical studies, it is found that traditional Chinese medicine can alleviate the symptoms of AECOPD patients, reduce the recurrence of AECOPD and the occurrence of heart failure, improve patients’ quality of life, and has significant clinical advantages[5].However, the evaluation index of traditional Chinese medicine for the treatment of this disease is single, and clinical research evidence is insufficient.In this study, based on syndrome differentiation and treatment, Feixinning Capsules were used to treat patients with AECOPD complicated with right heart failure and phlegm heat syndrome, and a significant effect was achieved.

2 Materials and methods

2.1 Case selectionInclusion criteria: the cases should meet the AECOPD diagnostic criteria[6]and right heart failure diagnostic criteria[7], and dialectically belong to the phlegm-heat syndrome in theDiagnosticEfficacyCriteriaofTCMDiseaseSyndrome[8]; patients should be under 80 years old, regardless of gender; patients should be informed and agreed.Exclusion criteria: some patients suffering from other diseases should be excluded, such as patients with bronchial asthma, tuberculosis and other lung diseases, patients with severe liver and kidney insufficiency, patients with congenital or acquired immunodeficiency, patients who cannot cooperate due to mental or speech disorders, and patients who are known to be allergic to therapeutic drugs.

2.2 Clinical dataThe 62 AECOPD patients with right heart failure were all from the cases of Pneumology Department, Hospital of Traditional Chinese Medicine in Inner Mongolia Autonomous Region from November 2018 to November 2020, and 2 cases dropped out.The 60 cases were divided into the Feixinning group and the control group by using random number table method, and each group had 30 cases.In the Feixinning group, there were 22 males and 8 females, with an average age of(71.37±7.31)years; for clinical grade, there were 11 cases in grade II and 19 cases in grade III.In the control group, there were 24 males and 6 females, with an average age of(71.60±6.85)years; for clinical grade, there were 12 cases in grade II and 18 cases in grade III.There was no statistically significant difference between the linear data of two groups, such as gender composition, average age and disease classification(P>0.05).This study was approved by the hospital ethics committee.

2.3 Treatment methodThe control group was treated with conventional western medicine according to theChineseExpertConsensusontheDiagnosisandTreatmentofAcuteExacerbationofChronicObstructivePulmonaryDisease(AECOPD)(Updatedin2017)[6].That is, oxygen inhalation, cough relieving, anti-infection, bronchiectasis, anti-heart failure, nutritional support treatments, as well as glucocorticoids, mechanical ventilation and other treatments were conducted when necessary.The Feixinning group was treated with Feixinning Capsules(provided by the Preparation Center of Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine)combined with conventional western medicine.Feixinning Capsules consisted of Fructus Trichosanthis, Rhizoma Coptidis, Rhizoma Pinelliae, Fructus Aurantii Immaturus, Pericarpium Citri Reticulatae, Poria, almond, Rhizoma Alismatis, and Radix Glycyrrhizae Preparata.The mass of each capsule was 0.45 g; the dosage was 3 capsules each time, and there were 3 times a day; 4 weeks were one course of treatment.

2.4 Observation indicators(i)Pulmonary function indicators included the percentage of the forced expiratory volume in the first second to the predicted value(FEV1%prep)and the percentage of the forced expiratory volume in the first second to the forced vital capacity(FEV1/FVC).(ii)Serum CRP was tested.(iii)CAT score was calculated.(iv)BODE index[9]: the body mass index(BMI), the percentage of the forced expiratory volume in the first second FEV1to the predicted value(FEV1%prep), dyspnea scale(mMRC), and 6-minute walking distance(6MWD)were converted into points and added together to form BODE index, and the total score was 0-10 points; the higher the score was, the worse the patients’ condition was.(v)EQ-5D index: the score of each patient was calculated according to the EuroQol five dimensions questionnaire(EQ-5D)[10].According to the EQ-5D-5L scoring system, the 5 dimensions(exercise, self-care, daily activities, pain/discomfort and anxiety/depression)and the corresponding 5 levels were converted into health utility values.The higher the score was, the higher the quality of life was.EQ-VAS(eropean quality-visual analogue scale): the patients performed self-assessment of their health status on a visual analogue scale marked with a score of "0-100 points", respectively representing the worst or best health status imagined.

3 Results and analysis

3.1 Comparison of lung function indicators, BODE index and other indicators between the two groups before and after treatmentAs shown in Table 1, the FEV1/FVC, FEV1%, 6MWD, mMRC and BODE index of the two groups after treatment were improved compared with those before treatment(P<0.05), and the Feixinning group was better than the control group(P<0.05).There was no statistically significant difference in BMI values before and after treatment(P>0.05).

Table 1 Comparison of lung function indicators, BODE index and other indicators between the two groups before and after treatment (n=30)

3.2 Comparison of CRP level between the two groups before and after treatmentSeen from Table 2, after treatment, CRP was lower in the two groups than that before treatment(P<0.05), and the Feixinning group was lower than the control group(P<0.05).

Table 2 Comparison of CRP level, CAT score, EQ-5D index, and EQ-VAS score between the two groups before and after treatment (n=30)

3.3 Comparison of CAT score between the two groups before and after treatmentThe CAT score of the two groups was lower than that before treatment(P<0.05), and the Feixinning group was lower than the control group(P<0.05)(Table 2).

3.4 Comparison of EQ-5D index and EQ-VAS score between the two groups before and after treatmentAfter treatment, the EQ-5D index and EQ-VAS score of the two groups were higher than those before treatment(P<0.05), and the Feixinning group was higher than the control group(P<0.05).

4 Discussion

GOLD2020 pointed out that COPD is a progressively developing chronic respiratory disease, and its complications severely affect the functional recovery of patients.In addition to affecting the patient’s lungs, the systemic adverse effects caused by them should be paid more attention to[11].The decline rate of FEV1is a good marker of disease progression and mortality, but lung function testing cannot fully reflect the systemic manifestations and prognosis of the disease[12].As a new multi-dimensional scoring system, the BODE index combines physiological and functional indicators to jointly assess the patient’s clinical symptoms, nutritional status, exercise capacity, and lung function.It is an important predictor of disease severity, all-cause mortality and the risk of respiratory death[13], and can reflect the patient’s overall condition.Among them, the 6-minute walking test is a standardized method for evaluating the cardiopulmonary function of patients, and is considered to be a good predictor of the risk of death in patients suffering from congestive heart failure and pulmonary hypertension[9].CAT score is a COPD assessment tool widely recognized worldwide, and has obvious advantages in the evaluation of COPD comorbidities[14].mMRC questionnaire and CAT score are combined to evaluate and classify patients in GOLD.At present, the EQ-5D scale is the most widely used measurement tool in the measurement of health utility values in developed countries.It has promotional value due to its simple operation and quantitative evaluation of the quality of life.EQ-VAS refers to interviewees’ overall feelings about their health, and it is an important part of evaluating patients’ quality of life.

AECOPD combined with right heart failure belongs to the category of "lung swelling" in traditional Chinese medicine.Deficiency in visceral function and enrichment in symptom are the characteristics of disease.Deficiency of the lung, spleen, kidney, and heart is the origin, and phlegm, heat, drink, and blood stasis are the symptoms.Based on the statistics of TCM syndromes of 330 cases of pulmonary heart disease and right heart failure in Hohhot, Inner Mongolia, it is concluded that the proportion of phlegm-heat gathering in the lungs and spleen accounted for 61.81%[15], which is related to the living and eating habits of residents(eating more meat and wine)and the climate characteristics of large changes in seasonal temperature differences and exuberant "dryness" evil in Inner Mongolia Autonomous Region.In patients with this syndrome, the deficiency of the lung, spleen and kidney reduces the metabolic function of water and fluid, and water and fluid stagnate in the body to produce pathological products such as drink, phlegm, and blood stasis.During a long illness, phlegm and blood stasis are transformed into heat.Moreover, the eating habits and climate help to produce heat from the inside and out, and this syndrome is seen when damp-heat phlegm obstructs the spleen and stomach, so the clinical treatment should be based on clearing heat and eliminating phlegm.

Feixinning Capsules are made by the addition and subtraction of Xiaoxianxiong Decoction in the Treatise on Febrile Diseases.In the prescription, Fructus Trichosanthis is the sovereign drug, and can clear heat and eliminate phlegm; Rhizoma Coptidis is the ministerial drug, and can purging internal heat; Rhizoma Pinelliae can dissolve distension, and the combined use with Rhizoma Coptidis has the effect of acrid opening and bitter downbearing; Fructus Aurantii Immaturus and Pericarpium Citri Reticulatae can activate Qi and eliminate phlegm, relieve stagnant Qi and dissolve distension; Poria and Radix Glycyrrhizae Preparata can invigorate spleen to remove dampness; almond can diffuse the lung, and is combined with Rhizoma Alismatis to draw water downwards.This prescription considers both the root cause and symptoms, treats the lungs and spleen together, clear away heat and eliminate phlegm, alleviate water retention and eliminate stagnation, and strengthen body resistance and eliminate evil.Modern studies have shown that Fructus Trichosanthis can reduce inflammation by promoting cellular immunity, and has a clear protective effect on cardiomyocytes[16]; Rhizoma Coptidis has strong anti-inflammatory and antiviral effects[17]; Rhizoma Pinelliae has the effects of relieving cough and asthma, anti-inflammation, sedation, arresting vomiting,etc[18].Previous studies have shown that Feixinning Decoction can increase IL-10 and NO content in COPD rats, reduce IL-4, IL-8, TNF-α, and ET-1 content, reduce the symptoms of COPD rats, and effectively relieve lung inflammation[19].The results of this study show that the combination of Feixinning Capsules and western medicine can improve patients’ lung function, CRP, CAT score, BODE index and its inclusion items, EQ-5D index and EQ-VAS score, and the efficacy was better than that of western medicine.

In summary, using Feixinning Capsules to cure AECOPD combined with right heart failure and phlegm-heat syndrome can help reduce respiratory tract inflammation, improve airflow limitation, enhance cardiopulmonary function, increase exercise tolerance, and optimize patients’ psychological feelings and quality of life efficiently.In this study, there was no statistical difference in BMI index before and after treatment, which is related to the limitation of AECOPD treatment cycle and the combined effect of increased food intake and diuresis after the improvement of gastrointestinal congestion after the combined treatment.

In this study, heart function was evaluated from the 6-minute walking test, and objective indicators for evaluating the degree of heart failure were not included.It has certain limitations, and the content will be supplemented in follow-up studies.The total course of treatment in this test was only 4 weeks.The changes in the patient’s nutritional status is not ideal, and the patient’s long-term efficacy cannot be further evaluated.The long-term prognosis of the patient can be observed by extending the treatment period or conducting long-term follow-up visit.This study is not a large multi-center clinical trial study, and has limitations in grasping the overall characteristics of Inner Mongolia Autonomous Region.At present, there is no guideline for the diagnosis of AECOPD combined with right heart failure in traditional Chinese medicine and integrated traditional Chinese and western medicine, and there is no guideline for the diagnosis and medication suitable for the physical characteristics of ethnic minority areas.Continuation research can be conducted to provide reference for the localized and specialized treatment of this disease with traditional Chinese medicine in Inner Mongolia Autonomous Region.