Clinical efficacy of Utilinus in combination with Astragalus in chronic obstructive pulmonary disease
To investigate the clinical efficacy of Utilinus combined with Astragalus in the treatment of chronic obstructive pulmonary disease. Methods Patients with COPD were randomly divided into two groups. Treatment group: conventional treatment plus Utilinus injection along with oral administration of Astragalus; control group used conventional treatment only. The clinical symptoms of cough, sputum and wheeze, changes in pulmonary function FVC, FEV1 and immunoglobulins were observed after six weeks. Results The total effective rates of cough, wheeze and croup in the treatment group were 75.56% (34/45), 80.00% (36/45) and 73.33% (33/45), respectively, which were significantly higher than those in the control group of 19.05% (8/42), 9.52% (4/42) and 9.52% (4/42), P=0.00; the pre-treatment FVC, FEV1 were 2.17±0.31 and 1.29±0.18L before treatment and 2.46±0.32 and 1.58±0.23L after treatment, respectively, P=0.00, while there was no statistically significant difference compared with the control group before and after treatment; IgA and IgG were 1.77±0.88 and 9.06±2.39g/L before treatment and 1.92±0.79 and 9.74±1.73g/L after treatment in the treatment group, respectively , 9.74±1.73g/L, respectively, with statistically significant differences, while there were no significant changes in IgA, IgG and IgM in the control group. Conclusion The use of Utilinus plus Chinese herbal medicine Astragalus resulted in significant enhancement of respiratory immunity, significant improvement of clinical symptoms and improvement of lung function.
The main component of Utilinus is inactivated Bacillus subtilis, which is a new type of immunomodulator with multiple immune activities. And “the herb seeking truth” said: “astragalus, into the lungs to replenish the qi, into the table of the real guard, for the most tonic qi medicines, is to have the name of astragalus”. Astragalus not only has the effect of supporting the root, but also has an activating effect on the human immune system, promoting IgG, IgA, IgM and other content to increase the level of antibodies. In order to reduce the number of acute exacerbations and mitigate the degree of exacerbations and improve the quality of life in patients with chronic obstructive pulmonary disease (COPD), 45 patients with COPD were treated with Utilis combined with the Chinese herbal medicine Astragalus from January to October 2008 in our hospital to evaluate its clinical efficacy.
Materials and methods
I. General data
The patients were outpatients and inpatients with chronic obstructive pulmonary disease in our hospital from January 2008 to October 2008, and the diagnosis was in accordance with the Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease developed by the Chinese Medical Association’s Respiratory Diseases Branch in 2007 [1]. The patients were randomly divided into 45 cases in the treatment group and 42 cases in the control group. There were 23 male and 22 female cases in the treatment group, with a mean age of 64.60±7.96 years, and 27 male and 15 female cases in the control group, with a mean age of 63.31±8.34 years. There was no statistical difference between the two groups in terms of gender and age (P>0.05), suggesting that the conditions of the two samples were similar and comparable.
II. Treatment methods
Treatment group: antispasmodic, antiasthmatic and anti-infective plus Urticilinx injection 1.72μg/ml, deep intramuscular injection, twice a week, six weeks as a course of treatment; at the same time, the raw herb Astragalus membranaceus 20g, decoction, once a day, for 20 days. The control group was treated with antispasmodic, antiasthmatic and anti-infective treatment.
III. Observation items
1. Changes in the main clinical symptoms (cough, sputum, wheezing, croup, etc.) before and after treatment.
2.Pulmonary function FVC (exertional spirometry) and FEV1 (expiratory volume in one second) before and after treatment.
3.Change of immunoglobulin IgA, IgG, IgM.
IV. Symptom judgment criteria.
Cough: no cough = 0 points (-), light cough = 1 point (+) intermittent cough, does not affect normal life and work, medium cough = 2 points (++) between light and heavy cough, heavy cough = 3 points (++++) frequent cough or paroxysmal cough, affecting work and sleep; wheeze: no wheeze = 0 points (-), light wheeze = 1 point (+) occasional wheeze, light degree, does not affect normal life and work, medium wheeze = 2 points (+++) Between light wheezing and heavy wheezing, heavy wheezing = 3 points (++++) wheezing is obvious, cannot lie down, affects sleep and activities; croup: no croup = 0 points (-), little croup = 1 point (+) croup is heard occasionally or appears after coughing or deep breathing, medium croup = 2 points (++) croup is scattered in both lungs, heavy croup = 3 points (++++) both lungs are covered with croup.
V. Judgment criteria of clinical efficacy
Clinical control: cough, sputum, wheezing symptoms from (++++) to (-) that is, the score from 3 to 0; apparent effect: cough, sputum, wheezing symptoms from (++++) to (+) that is, the score from 3 to 1, or from (+++) to (-) that is, the score from 2 to 0; improvement: cough, sputum, wheezing symptoms from (++++) to (+++) that is, the score from 3 to 2, or from (+++) to (+) i.e. the score decreased from 2 to 1, or from (+) to (-) i.e. the score decreased from 1 to 0. Ineffective: cough, sputum and wheezing symptoms did not improve or worsened.
Effective=clinical control+effective
Total effective rate = (number of clinical control cases + number of apparent effect cases) ÷ total number of cases × 100%
VI. Statistical processing
SPSS 10.0 software was used for descriptive statistical analysis, chi-square test for comparison of two independent sample rates, one-sample t-test, and rank sum test for rank data. 0.05 was used as the test standard.
The total effective rates of cough, wheezing and croup in the treatment group were 75.56%, 80.00% and 73.33%, respectively, which were significantly higher than those of the control group of 19.05%, 9.52% and 9.52%, P=0.00.
The FVC and FEV1 in the treatment group were 2.17±0.31 and 1.29±0.18 L before treatment and 2.46±0.32 and 1.58±0.23 L after treatment, respectively, P=0.00, and the difference was statistically significant; while there was no statistically significant difference compared with the control group before and after treatment.
When the changes of serum immunoglobulin IgA, IgG and IgM were detected by one-way immunodiffusion method, it was found that IgA and IgG were 1.77±0.88 and 9.06±2.39 g/L before treatment and 1.92±0.79 and 9.74±1.73 g/L after treatment in the treatment group, respectively, and the differences were statistically significant, while IgM changed significantly before and after treatment; in the control group There were no significant changes in IgA, IgG and IgM.
Discussion
COPD is a common and frequent disease that seriously endangers human health and work ability; these patients are often prone to infections and deterioration of their condition due to the low immune function of the body. Therefore, improving the immune function of patients is an important part of the treatment of COPD. Based on its biological affinity with Mycobacterium tuberculosis, it can intervene in the immune process of human body through special substance exchange, and constantly regulate the immunity of the body’s immune system. Especially the function of the cellular immune system, thus showing the immune effect of sterilization, removal of pathogenic bacteria in the body and strengthening the resistance to achieve the therapeutic purpose. It was initially used for patients with tuberculosis and extrapulmonary tuberculosis, but was gradually extended to immunocompromised diseases such as chronic bronchitis. Effects on humoral immunity: It can enhance the activity of Th cells and promote the secretion of B-cell growth factor (BCGF) and B-cell differentiation factor (BCDF), thus stimulating B cells to enter the proliferation and differentiation stage, and ultimately promoting the formation of specific antibodies. Clinical pharmacological effects have shown that serum IgG, IgM titers increase after the use of this product [2].
Modern pharmacological studies have proved that Astragalus can enhance the immune function of the body and has a certain preventive effect on influenza 0 virus, follicular virus and coxsackievirus in mice; it can increase the levels of IgG, IgA and IgM in human blood and increase the ability of leukocytes to induce the production of interferon; it can increase the activity of natural killer cells [3].
In this study, we observed the changes of clinical symptoms, pulmonary function and immunoglobulins in COPD patients treated with Utilinus injection plus the Chinese herbal medicine Astragalus, and showed that it led to a significant improvement in respiratory function and clinical symptoms and a significant increase in exertion.