Study on the Management of the Health Status of Patients with Stable Chronic Obstructive Pulmonary Disease Treated with Double Bronchodilator.

Objective: To investigate the patients with stable chronic obstructive pulmonary disease (COPD) to understand the use of double bronchodilator therapy and influencing factors.
Methods: The patients with stable COPD who used double bronchodilators were continuously enrolled in our hospital. The information of demographic characteristics, medical history, physical examination, drug use, and correct treatment methods after using inhaled drugs were collected by standardized questionnaire. Measurement data between groups were compared by using the independent sample t-test, and counting data between groups were compared by using the chi-square test.
Results: A total of 102 patients were included in the analysis. The proportion of patients with stable COPD who correctly used dual bronchodilators was 59.8% (61 patients). In the GOLD classification, the correct use rate of C-level patients was 69.8%, which was significantly higher than the used correct rate of D-level patients (49.0%) (P=0.032). In the age group, the correct use rate of patients <65 years old was 72.1%, which was significantly higher than that of patients ≥65 years old (50.8%) (P=0.031). In addition, education level, duration of drug use, and drug type may also affect the correct use of drugs, but no significant statistical significance was found between the groups of these three factors (P > 0.05).
Conclusion: There is still a gap between the treatment of dual bronchodilators in patients with stable COPD and the guidelines, so the management of COPD should be strengthened. Besides, the correct use rate could be affected by the GOLD classification and age.

1. Background

Chronic obstructive pulmonary disease (COPD) is a common and frequently occurring disease in the clinic, which has caused widespread concern [1]. Studies have shown that COPD has brought a heavy economic burden to the medical system and society, and it is an important reason for the decline of patients' living ability [2]. According to the 2017 Global Diagnosis and Treatment Strategy for COPD, inhaled long-acting anticholinergic agents (LAMA) combined with long-acting β2 receptor agonists (LABA), namely, double bronchodilator, are the first-line treatment for COPD patients with grade C and grade D [1]. However, the current control of patients with stable COPD is still unsatisfactory. This article intends to investigate the patients with stable COPD to understand the use of double bronchodilator and influencing factors.

2. Materials and Methods

2.1. Participants

From January 2019 to December 2020, medical history collection, physical examination, imaging evaluation, pulmonary function measurement, British Medical Research Council dyspnea score (mMRC), and COPD assessment test (CAT score) of the outpatients and inpatients in The Second Affiliated Hospital of Nanchang University were collected. Fasting venous blood was used for blood routine tests, C-reactive protein, erythrocyte sedimentation rate, liver and kidney function, electrolytes, and other indicators. COPD patients were diagnosed and graded according to the criteria of GOLD classification [1]. If the pulmonary function test is GOLD 3 or 4 or the acute exacerbation is twice a year or more, it is judged as C or D COPD patients. Among them, mMRC 0-1, CAT score <10 are judged as C grade, and mMRC ≥2, CAT score ≥10 are judged as D grade. All patients signed an informed consent form, and this study was approved by theEthics Committee of The Second Affiliated Hospital of Nanchang University (No. NC20192121).

2.2. Data Collection

Trained medical staff used standardized questionnaires to collect data. The content of the questionnaire includes the following parts: (1) Demographic characteristics: age, gender, education level, and smoking status of the patient. (2) Physical examination and past medical history: height, weight, and medical history of tuberculosis, pneumonia, diabetes, coronary heart disease, and other diseases. (3) Drug use: time of drug use, type, dosage, frequency, and method of inhaled drug. (4) Correct handling method after using inhaled drug: whether to check the balance of the drug regularly, whether to clean the inhalation device, and whether to gargle after use.

2.3. Statistical Analysis

The measurement data adopt mean ± standard deviation, and the counting data adopt frequency (rate). Measurement data were compared between groups using the independent sample t-test, and counting data were compared between groups using the chi-square test. IBM SPSS 21.0 statistical software was used for statistical analysis, and P < 0.05 on both sides was considered to be statistically significant.

3. Results

Clinical characteristics of the patients are given in Table 1. A total of 102 COPD patients who used double bronchodilator were included in the analysis. The proportion of male patients was 50%, and the proportion of smoking patients was 37.3%. The mean ± standard deviation of BMI of 102 patients was 23.0 ± 4.2 kg/m2, and the average use time±standard deviation of the double bronchodilator was 8.7 ± 14.5 months. The proportions of 102 patients with the medical history of tuberculosis, pneumonia, diabetes, and coronary heart disease were 6 (5.9%), 13 (12.7%), 15 (14.7%), and 12 (11.8%), respectively. According to the education level, there were 51 (50.0%) patients with elementary school and below and 51 (50.0%) patients with junior high school and above. According to the GOLD classification, there were 53 patients (52.0%) in grade C and 49 patients (48.0%) in grade D.

Table 1

Clinical features of the patients.

	Patient population, n = 102
Age	67.8 ± 12.6
Proportion of males, n (%)	51 (50)
Smoking rate, n (%)	38 (37.3)
BMI (kg/m2)	23.0 ± 4.2
History of tuberculosis, n (%)	6 (5.9)
History of pneumonia, n (%)	13 (12.7)
History of diabetes, n (%)	15 (14.7)
History of coronary heart disease, n (%)	12 (11.8)
Use time of double bronchodilator, months	8.7 ± 14.5
Correct rate of drug use, n (%)	61 (59.8)
Education level
Primary and below	51 (50)
Junior high school and above	51 (50)
GOLD grade
Class C	53 (52.0)
Class D	49 (48.0)

The correct rate and influencing factors of double bronchodilator use were analyzed in groups according to the GOLD classification, age, education level, and time of drug use to judge the correct rate of double bronchodilator use (Table 2). In the GOLD classification, the correct use rate of C-level patients was 69.8%, which was significantly higher than the use correct rate of D-level patients of 49.0% (P=0.032). In the age group, the correct use rate of patients <65 years old was 72.1%, which was significantly higher than the correct use rate of 50.8% of patients ≥65 years old (P=0.031). In the education level group, the correct use rate of patients with primary school and below is 64.7%, which seemed to be higher than the correct use rate of 54.9% for junior high school and above patients, but there was no statistical difference between them (P=0.313). In the time group of drug use, the correct use rate of patients less than 6 months was 55.6%, which seemed to be lower than the correct use rate of 70.0% for patients ≥6 months, but there was no statistical difference between the two groups (P=0.175).

Table 2

Correct rate of double bronchodilator and its influencing factors.

	Total cases	Correct	Error	P value
GOLD grade, n (%)				0.032
Class C	53 (52.0)	37 (69.8)	16 (30.2)
Class D	49 (48.0)	24 (49.0)	25 (51.0)
Age, n (%)				0.031
<65	43 (42.2)	31 (72.1)	12 (27.9)
≥65	59 (57.8)	30 (50.8)	29 (49.2)
Education level, n (%)				0.313
Primary and below	51 (50)	33 (64.7)	18 (35.3)
Junior high and above	51 (50)	28 (54.9)	23 (45.1)
Usage time, n (%)				0.175
<6 months	72 (70.6)	40 (55.6)	32 (44.4)
≥6 months	30 (29.4)	21 (70.0)	9 (30.0)

The correct rate of using different types of double bronchodilator is given in Table 3. The correct rate of patients in the umeclidinium bromide/vilanterol group was the highest (72.2%); the correct rate of patients in indacaterol aleate/glycopyrronium bromide group was the lowest (50.0%); the correct rate of patients in the glycopyrronium/formoterol group was intermediate (56.3%), but there was no statistical difference in the correct rate between the three groups (P=0.147).

Table 3

Correct rate of using different types of double bronchodilator.

	Umeclidinium bromide/vilanterol	Glycopyrronium/formoterol	Indacaterol aleate/glycopyrronium bromide
Total cases, n (%)	36 (35.3)	32 (31.4)	34 (33.3)
Correct	26 (72.2)	18 (56.3)	17 (50.0)
Error	10 (27.8)	14 (43.8)	17 (50.0)
P values		0.147

4. Discussion

In this study, we found that the correct use of double bronchodilator drugs was only 59.8% in patients with stable COPD. In terms of influencing factors, different GOLD grades and age may be important factors affecting the accuracy rate. In addition, education level, duration of drug use, and drug type may also affect the correct use of drugs, but no significant statistical significance was found between the groups of these three factors.

Bronchodilators are the basic drugs for the treatment of COPD, which can reduce the number of acute exacerbations of COPD patients and improve the quality of life by reducing overinflation of the lungs and bronchial dilation. In recent years, clinical studies have shown that the continuous and standardized application of long-acting bronchodilators can not only improve the clinical symptoms of patients with COPD and improve their living ability but also delay the reduction of COPD's lung function, thereby reducing the mortality rate [3]. The GOLD guidelines point out that COPD patients should be graded according to their disease severity as the basis for treatment selection. If the patient's condition is stable, long-term regular treatment should be maintained at the same level. For the COPD patients with grade C and grade D, dual bronchodilator treatment should be the first choice [1]. In addition, studies in recent years have shown that compared with single bronchodilators, double bronchodilators are better in functional aerobic capacity, symptoms, and quality of life and contribute to the pulmonary rehabilitation of COPD patients [4].

In clinical practice, the correct use of drugs is an important factor affecting the efficacy of patients. The correct use rate of drugs in the patients in this study is less than 60%, which may be the key to affecting the patients' symptom control. This study also found that the three types of double bronchodilator drugs have no statistically different effects on the correct use rate, and education level and drug use time have no significant impact on correct use. This is different from foreign studies. Foreign studies have shown that the higher the education level, the longer the duration of drug use, the higher the correct rate of drug use and the better the compliance of patients [5]. Of course, this may also be due to the sample size of this study is not large and may not have enough statistical power to find differences. Similar to this study, studies have also shown in recent years that there is no significant relationship between the drug type of double bronchodilators and the patients' drug compliance and the correct rate of drug use, which suggests that the type of drug may not be an important influencing factor [6].

In this study, age is an important factor affecting correct use, and this view has also been supported in a number of studies [7-9]. This reminds us that in elderly patients, self-care ability and knowledge understanding ability decline, if they are not supported by family members or friends and repeated patient guidance by medical staff; it may affect the efficacy of drugs due to incorrect drug inhalation methods. Medication guidance and medication support should be an important part of the diagnosis and treatment of elderly COPD patients [10]. It was worth noting that this study also found that the correct use rate of GOLD grade C patients was higher than that of D grade patients. In the past, it was believed that GOLD classification may not be an important factor affecting drug compliance and the correct rate of drug use [11]. The findings of this study may put forward a new point of view that people with lower GOLD grades may have a higher rate of correct drug use, while people with more severe levels may have a lower rate of correct drug use. This may be attributed to the poor self-care ability and self-care ability of patients with severe disease [12]. This reminds us that for patients with serious diseases, we need to guide the correct use of drugs. For severe COPD patients, the correct use of medications and compliance will be more likely to affect their symptom control.

Previous studies have shown that the penetration rate of inhalation therapy for COPD patients is not high, partly due to economic reasons, unobvious symptoms, not being able to use it, and concerns about adverse reactions [13]. This suggests that it is necessary to earnestly carry out disease knowledge education for COPD patients and carry out popular science education for the general public. It is necessary for patients to correctly understand the relationship between the curative effect and adverse reactions. At the same time, it is necessary to strengthen the disease knowledge training of primary doctors and nonrespiratory specialists and improve the correct understanding of COPD and inhaled preparations treatment.

The study had several limitations, including the small sample size and single-center data. Future prospective studies were needed to verify the findings of our study.

In conclusion, there is still a gap between the treatment of dual bronchodilators in patients with stable COPD and the guidelines, so the management of COPD should be strengthened. Besides, the correct use rate could be affected by the GOLD classification and age.