Geng Xinpu (耿新普), Liu Rong (劉 榮), Le Zhaoxi (樂兆喜), Liu Shoulin (劉壽林)

Department of Respiratory Medicine, Huai'an Cancer Hospital, Huai'an 223200, China

ABSTRACT OBJECTIVE: To observe the effects of Suhuang Zhike Capsules on lung function and peripheral blood eosinophil count (EOS) and exhaled nitric oxide (eNO) in patients with acute asthma attack. METHODS: A total of 80 patients with acute exacerbation of bronchial asthma admitted to Huai'an Cancer Hospital from January 2017 to January 2018 were randomly divided into an observation group and a control group, with 40 cases in each group. The control group was given conventional treatment with western medicine, and the observation group was given Suhuang Zhike Capsules on the basis of the treatment method of the control group. After 1 week of treatment, the improvement of individual symptoms (cough, wheezing, wheezing rale), lung function [1 second forced expiratory volume (FEV1), forced expiratory volume occupational capacity of vital capacity (FVC) in 1 second and peak expiratory flow (PEF)] and peripheral blood EOS and eNO levels and efficacy before and after the treatment were observed and assessed. RESULTS: The total effective rate of the observation group was 92.5%, which was significantly higher than the total effective rate of the control group (75.0%) (P ＜ 0.05). The cough, wheezing and wheezing scores of the 2 groups were significantly decreased after treatment (P ＜ 0.05). The scores of the above symptoms were significantly lower in the observation group than in the control group (P ＜ 0.05). The FEV1, FVC and PEF were significantly increased after treatment (P ＜ 0.05), and the above lung functions in the observation group were significantly higher than the control group (all P ＜ 0.05). The EOS and eNO levels in the peripheral blood of the 2 groups were significantly decreased after treatment (P ＜ 0.05), and the EOS and eNO levels in the peripheral blood in the observation group were significantly lower than those in the control group (P ＜ 0.05). CONCLUSION: Suhuang Zhike Capsules can reduce the levels of EOS and eNO in peripheral blood of patients with acute asthma attack, improve the lung function of patients, relieve the clinical symptoms and improve the prognosis.

KEYWORDS: Suhuang Zhike Capsules; Acute attack of bronchial asthma; Lung function; Airway hyperresponsiveness; EOS; eNO

Bronchial asthma is a chronic respiratory disease characterized by chronic inflammation of the airways, which is caused by a variety of cells and cellular components. Airway hyperresponsiveness is the main cause of chronic inflammation of the airways. Patients often change and become widespread. Reversible expiratory flow is limited, specifically as recurrent wheezing, shortness of breath, cough, chest tightness and other symptoms[1]. Acute exacerbation of bronchial asthma refers to sudden onset or sharp increase in symptoms such as wheezing, shortness of breath, cough, chest tightness, etc., resulting in difficulty in breathing and significant decrease in expiratory flow. Patients with severe illness may cause complications such as respiratory failure and heart failure, endangering life[2,3]. In recent years, with the increase of global environmental pollution and the great changes in people's lifestyles, the incidence of bronchial asthma has increased significantly, whose main target is adolescents and children, and it has become a serious public health problem. Drug therapy is currently the first choice for western medicine in the treatment of acute exacerbation of bronchial asthma. Commonly used drugs include glucocorticoids, theophylline, short-acting β2 receptor agonists, etc., which have the advantages of rapid onset and positive efficacy, but long-term application is easy to cause a variety of adverse reactions, thus affecting the treatment compliance of patients. A traditional Chinese medicine (TCM) preparation of Suhuang Zhike Capsules was developed in recent years for the treatment of recurrent cough, cough variant asthma and cough after a cold. A number of clinical studies have confirmed that this preparation has significant effects on a variety of airway hyperresponsive diseases with anti-inflammatory, cough, phlegm, asthma, immune regulation and other multiple effects[4,5]. Therefore, we speculate that Suhuang Zhike Capsules can be used in the controlled treatment of bronchial asthma. Therefore, in this study, the author used Suhuang Zhike Capsules to treat 40 cases of acute bronchial asthma, and compared with the conventional treatment of western medicine, by observing the changes of main clinical symptoms, lung function, eosinophil count (EOS) and exhaled nitric oxide (eNO) levels before and after treatment, the mechanism and clinical efficacy of Suhuang Zhike Capsules in the treatment of acute exacerbation of bronchial asthma.

MATERIALS AND METHODS

Clinical materials

General materials

A total of 80 patients with acute bronchial asthma who were admitted to Huai'an Cancer Hospital from January 2017 to January 2018 were randomly divided into an observation group (40 cases) and a control group (40 cases). There were 23 males and 17 females in the observation group; the age ranged from 18 to 65 years old, mean age of (42.5 ± 6.3) years; the acute course of disease was 0.5-5 h, mean disease duration (3.8 ± 0.9) h. There were 24 males and 16 females in the control group; the age ranged from 18 to 63 years old, with an average age of (43.6±6.2) years; the acute course of disease was 0.5-4.8 h, and the average duration of disease was (3.9±0.8) h. There were no significant differences in gender, age, and duration of disease between the 2 groups (P ＞ 0.05), which was comparable.

Inclusion criteria

The diagnostic criteria were based on the Guidelines for Prevention and Treatment of Bronchial Asthma (definition, diagnosis, treatment, and management of bronchial asthma)[6]. The stage of the disease is acute and the condition is mild and moderate. Age from 18 to 65 years old and no limitation of gender; Patients with no short-acting bronchodilator treatment was used within 6 hours; patients were not used controlled drugs such as hormone, sustainedrelease theophylline, leukotriene modifier, long-acting β2 receptor agonist in the past 24 hours; patients who agreed to provide signed informed consent in advance.

Exclusion criteria

Patients with severe primary diseases such as heart, brain, liver, kidney and hematopoietic system; patients with other chronic obstructive pulmonary diseases, tuberculosis, bronchiectasis and other lung diseases; patients have acute bronchitis or acute upper respiratory tract in the past one month; people with infection, pregnancy, lactation and mental illness.

Treatment methods

The control group was treated with western medicine: oral administration of doxofylline (Ningbo Tianheng Pharmaceutical Co., Ltd., GYZZ H20000076, specification: 0.2 g) treatment, 0.2 g/time, 2 times/d; aerosol inhalation of salmeterol Carson powder inhaler (Glaxo Wellcome UK Limited, UK registration No. H20090241, specification: 50 ug/250 ug), 1 inhale per time, 2 times per day. The above treatment was continued for 1 week. On the basis of the treatment method of the control group, the observation group was treated with Suhuang Zhike Capsules (Yangzijiang Pharmaceutical Group Beijing Haiyan Pharmaceutical Co., Ltd., GYZZ Z20103075, Specification: 0.45 g), 3 capsules each time, 3 times a day, 1 week as a course of treatment. Both groups were evaluated for efficacy after 1 week of treatment.

Observation index

①Clinical efficacy: According to the efficacy standard set by the Guidelines for Prevention and Treatment of Bronchial Asthma[7], markedly effective: after treatment, the clinical symptoms of the patients disappear completely or basically, and FEV1reaches 60%-70% of the expected value or increases by 25%-35%; Effective: After treatment, the patient's clinical symptoms were significantly relieved, FEV1increased by 15% to 25%; Ineffective: After treatment, the patient's clinical symptoms did not show any relief, and FEV1increased by less than 15%. Total effective = significant + effective. ② Single symptom: compare the main symptoms and signs changes before and after treatment, and score the main syndromes such as cough, wheezing, wheezing, etc., with 0 score as asymptomatic performance, 3 scores as the most severe symptoms, seriously affecting daily life and sleeping at night. The higher the score is, the more serious the symptoms are. ③ Pulmonary function indicators: the changes of forced expiratory volume (FEV1) in one second before and after treatment, the forced expiratory volume occupancy (FVC) and the maximum expiratory flow (PEF) in the first second are tested. ④ Peripheral blood EOS and eNO detection: 3 mL of fasting peripheral blood before and after treatment were taken, and after treatment, the levels of laughter, EOS and eNO were measured.

Statistical methods

SPSS 22.0 statistical software was used for data analysis. Measurement data were expressed as mean ± standard deviationt test. Categorical comparison data were represented by n (%) by using χ2test. P ＜ 0.05 means that the statistical difference was significant.

RESULTS

Comparison of clinical effects between the 2 groups after treatment

After treatment, the clinical efficacy of the 2 groups was significantly higher than that of the control group after treatment. The difference between the 2 groups was statistically significant (P ＜ 0.05). See Table 1.

Comparison of single symptom scores before and after treatment in the 2 groups

There was no significant difference in the scores of cough, gasping and wheezing between the 2 groups before treatment (P ＞ 0.05). After treatment, the scores of cough, wheezing and wheezing were significantly decreased in the 2 groups. The difference between the 2 groups was statistically significant (P ＜ 0.05); the scores of the above symptoms were significantly lower in the observation group than in the control group, and the difference was statistically significant (P ＜ 0.05). See Table 2.

Comparison of lung function indexes before and after treatment in the 2 groups

There was no significant difference in FEV1, FVC and PEF between the 2 groups before treatment (P ＞ 0.05). After treatment, FEV1, FVC and PEF were significantly increased in the 2 groups. The difference between the 2 groups was statistically significant (P ＜ 0.05). The above lung function indexes of the observation group were significantly higher than those of the control group, and the difference was statistically significant (P ＜ 0.05). See Table 3.

Table 2. Comparison of single symptom scores before and after treatment in the 2 groups

Table 2. Comparison of single symptom scores before and after treatment in the 2 groups

Notes: ①Compared with before treatment, P ＜ 0.05; ②Compared with the control group, P ＜ 0.05.

Groups Cases Coughing Gasping Wheezing Control group 40 Before treatment 2.13±0.33 1.98±0.28 1.92±0.27 After treatment 1.06±0.18① 0.97±0.12① 0.88±0.09①Observation group 40 Before treatment 2.07±0.31 2.04±0.31 1.87±0.25 After treatment 0.45±0.06①② 0.38±0.04①②0.41±0.06①②

Table 3. Comparison of lung function indexes before and after treatment in the 2 groups

Table 3. Comparison of lung function indexes before and after treatment in the 2 groups

Notes: ①Compared with before treatment, P ＜ 0.05; ②Compared with the control group, P ＜ 0.05.

Groups Cases FEV1 (L) FVC (L) PEF (L/s)Control group 40 Before treatment 1.53±0.25 2.10±0.32 3.69±0.46 After treatment 2.18±0.33① 2.86±0.39① 4.31±0.54①Observation group 40 Before treatment 1.56±0.27 2.15±0.35 3.72±0.50 After treatment 3.07±0.41①②3.55±0.46①②4.86±0.59①②

Comparison of EOS and eNO levels in peripheral blood before and after treatment in the 2 groups

There was no significant difference in the levels of EOS and eNO between the 2 groups before treatment (P ＞ 0.05). After treatment, the EOS and eNO levels in the peripheral blood of the 2 groups were significantly decreased, and the difference was statistically significant (P ＜ 0.05). The EOS and eNO levels in the peripheral blood of the observation group were significantly lower than those in the control group, and the difference was statistically significant (P ＜ 0.05). See Table 4.

DISCUSSION

Bronchial asthma is a chronic respiratory inflammatory response involving inflammatory cells such as eosinophils, mast cells, and lymphocytes[8]. During the acute attack period of bronchial asthma, inflammatory reaction leads to increased secretion and swelling of respiratory mucus, bronchial smooth muscle spasm, and patients with cough, wheezing, chest tightness and other symptoms, seriously affecting patients' respiratory function and life safety. At present, the specific pathogenesis of bronchial asthma is still unclear. It is generally believed that patients with bronchial asthma have different degrees of airway inflammatory reaction, which causes airway mucosal edema, mucus secretion, and formation of mucus plugs, which induce epithelial cell shedding and injury, and block the airway, and other inflammatory reactions can increase airway hyperresponsiveness, triggering a wide variety of reversible airflow limitation, leading to recurrent episodes of shortness of breath, chest tightness, cough, wheezing[9]. Li Guohui et al[10]conducted a study and found that the severity of bronchial asthma was closely related to airway inflammatory response. During the course of the disease, the patient has a persistent chronic airway inflammatory response, which is aggravated during the acute phase and decreased during the remission phase. EOS count and eNO are clinically commonly used indicators for the assessment of asthmatic airway inflammatory response. They are safe and reliable, and have been widely used in the assessment of clinical asthmatic airway inflammatory response.

Table 4. Comparison of EOS and eNO levels in peripheral blood before and after treatment in both groups

Table 4. Comparison of EOS and eNO levels in peripheral blood before and after treatment in both groups

Notes: ①Compared with before treatment, P ＜ 0.05; ②Compared with the control group, P ＜ 0.05.

Groups Cases EOS (109/L) eNO (ppb)Control group 40 Before treatment 0.56±0.06 49.53±6.02 After treatment 0.35±0.04① 38.17±4.91①Observation group 40 Before treatment 0.58±0.07 48.76±5.97 After treatment 0.18±0.03①② 22.83±3.41①②

Bronchial asthma belongs to the category of "gasp syndrome" and "wheezing" in TCM. Traditional Chinese medicine believes that the phlegm is in the lungs, adding unsmooth emotional factors, improper diet, the fatigue and physical weakness, the evil invasion and many other causes, leading to phlegm obstructing the airway, the lungs failing to ascend and descend. For thousands of years, TCM practitioners have been using TCM decoction, acupuncture and other methods to treat various diseases such as bronchial asthma, and accumulated rich clinical experience. Suhuang Zhike Capsules is developed by a well-known TCM practitioner, Chao Enxiang who combined with decades of clinical experience, referring to the "wind cough" theory of Chinese patent medicine preparations. It has significant effects on cough, pharynx itching, or aggravated conditions due to sudden cold air, shortness of breath and other factors. Suhuang Zhike Capsules is composed of 9 kinds of Chinese materia medica. Herba Ephedrae, Folium Perillae, and Fructus Perillae played monarch drugs roles in the prescription. Among them, Herba Ephedrae could disperse lung-qi, dispel coldness, and relieve cough and asthma; Folium Perillae could relieve exterior syndrome and dispel cold, and ventilate the lung and resolve phlegm; Fructus Perillae plays a role of relieving cough and asthma, depressing qi and resolving phlegm. Periostracum Cicadae and Fructus Schisandrae Chinensis serve as ministerial herbs. Cicada sough could dispel wind and remove heat, relieve sore throat and ease-up the voice; Fructus Schisandrae Chinensis could fold lung and promote body fluid, nourish yin and secure essence. Lumbricus, honeyed

Folium Eriobotryae, Fructus Arctii, Radix Peucedani were adjuvant medicines in the prescription. Lumbricus could clear the lung and anti-asthmatic. Honeyed Folium Eriobotryae could clear the heat of the lung, relive cough, and reverse vomiting; Fructus Arctii could dispel wind and remove heat, disperse qi of the lung and relieve sore throat. Radix Peucedani could clear heat and dispel wind and depressing qi and resolve phlegm. All kinds of medicines are compatible with each other, and they play the role of dispelling wind and diffusing lungs, relieving cough and asthma. Modern pharmacological studies have shown that the volatile oil component of Ephedra has a sweating effect, and ephedrine component has effects of relaxation of bronchial smooth muscle, inhibition of allergic transmitter release and anti-asthmatic[11]; Fructus Perillae has significant anti-asthmatic, antitussive and expectorant effects. It has a good relief effect on wheeze, shortness of breath, chest tightness and cough in patients with bronchial asthma[12]; Periostracum Cicadae has antitussive, expectorant, anti-asthmatic and antispasmodic effects[13]; Fructus Schisandrae Chinensis has anti-fatigue and enhances immunity force, anti-aging, antibacterial and other effects[14]; Lumbricus jaundice and succinic acid have the effects of inhibiting asthma airway remodeling, asthma, cough, etc.[15]; Radix Peucedani extract has the effects of relaxing bronchial smooth muscle, inhibition of allergic mediator release and calcium ion antagonism, which has significant efficacy on respiratory infections[16]. It can be seen that Suhuang Zhike Capsules has many pharmacological effects such as anti-inflammatory, reliving cough, resolving phlegm, antiasthmatic and enhancing immune function, and has a good control effect on acute exacerbation of bronchial asthma.

In this study, the EOS and eNO levels in the peripheral blood of the 2 groups were significantly decreased (P ＜ 0.05), and the EOS and eNO levels in the peripheral blood of the observation group were significantly lower than those in the control group (P ＜ 0.05). It is suggested that Suhuang Zhike Capsules can inhibit the inflammatory reaction of patients with acute bronchial asthma and improve the airway hyperresponsiveness. In addition, the cough, gasping, and wheezing scores of the 2 groups were significantly decreased after treatment (P ＜ 0.05), and the scores of the above symptoms were significantly lower in the observation group than in the control group (P ＜ 0.05), suggesting that the reduction of the high-response reaction of patient's qi airway and the improvement of the clinical symptoms of the patient, which also confirmed that Suhuang Zhike Capsules is effective for improving the inflammatory response in patients with acute bronchial asthma. In addition, FEV1, FVC, and PEF were significantly increased in both groups after treatment (P ＜ 0.05), and the above lung function indexes were significantly higher in the observation group than in the control group (P ＜ 0.05). It is suggested that Suhuang Zhike Capsules can improve the lung function of patients and help to relieve the clinical symptoms of patients. In summary, Suhuang Zhike Capsules could inhibit the inflammatory response of patients with acute bronchial asthma and improve airway hyperresponsiveness, which could help improve lung function and improve clinical symptoms of patients, and the curative effect is exact. It is worthy of clinical research and promotion.