Abstract: To observe the clinical efficacy of sequential treatment of bronchial asthma patients with Ginseng, Clam, and Qinglong Tang plus and minus. METHODS: Using a prospective observational study design, patients with bronchial asthma whose conditions were graded as grade 1-3 were selected for the study, and sequential treatment with the basic formula of Ginseng Clam and Qinglong Tang plus and minus was performed to evaluate the changes of day and night symptom scores, ACT scores, pulmonary function and quality of survival after 3 months of Chinese medicine treatment. RESULTS: The day and night symptom scores, ACT scores, lung function, and quality of survival of the asthmatics after treatment were significantly improved compared with those before treatment, and the differences were statistically significant. CONCLUSION:The sequential treatment of bronchial asthma with Ginseng and Qinglong Tang plus or minus can effectively improve the patients’ symptoms and also reduce the airway hyperresponsiveness in some patients. Bronchial asthma is a common and frequent clinical disease, which has a long course and is prone to recurrent attacks, which seriously affects the quality of life of patients. The main clinical manifestations are croup in the throat, difficulty in breathing, and even wheezing and inability to lie down [1]. Asthma belongs to the category of “croup” in Chinese medicine, and Chinese medicine has accumulated rich experience and prescriptions for the treatment of “croup”, such as Xiao Qing Long Tang, Ma Heng Shi Gan Tang, and Shao Gan Ma Huang Tang for the exacerbation period, and Ginseng Clam San, Jin Kui The common prescriptions for the remission period include Ginseng Clam San, Jin Kui Kidney Qi Wan, Si Jun Zi Tang, etc. On the basis of systematizing and summarizing the experience of famous traditional Chinese medicine practitioners in treating bronchial asthma, and after long-term clinical practice, our group proposed that the core pathogenesis of asthma is the coexistence of the original deficiency (lung, spleen and kidney deficiency) and the symptoms (wind, cold and phlegm), and that the pathogenesis of both exacerbation and chronic persistence is characterized by the intermingling of deficiency and reality. According to the characteristics of the symptoms in the exacerbation and chronic persistent phases, a sequential treatment plan for the whole process of asthma intervention in each phase was concluded, which has achieved good clinical efficacy. The clinical efficacy of the sequential treatment of 38 patients with bronchial asthma treated with Ginseng and Qinglong Tang plus and minus from October 2009 to February 2011 is reported as follows: 1. Subjects and methods 1.1. Subjects: Patients who meet the criteria of cold roaring or remission in the exacerbation phase of croup in traditional Chinese medicine [2], meet the diagnostic criteria of bronchial asthma in western medicine [3], and whose severity of disease is graded from grade 1 to 3. No serious diseases such as liver, kidney, hematopoietic system and psychiatric diseases. Patients who were pregnant or lactating were excluded. 1.2. Treatment: The basic formula was Ginseng Clam and Qinglong Tang, with addition and subtraction according to the different stages of the patient’s condition. In the acute exacerbation period, formula No. 1 is used (the basic formula plus the products of dispelling wind and relieving symptoms, resolving phlegm and relieving drinks), and in the chronic persistence period, formula No. 2 is used (i.e. the basic formula plus the products of tonifying kidney and filling essence, nourishing yin and activating blood). 1.3. Duration of treatment: for patients with acute attack, Formula No. 1 was used for 1 month of treatment, and Formula No. 2 was used for 2 months of treatment after the symptoms were relieved; for patients with chronic persistence, Formula No. 2 was used for 3 months of treatment; the total duration of treatment was 3 months. 1.4. Observation indexes and observation time points: asthma day and night symptom scores and ACT (asthma control test score) were recorded before treatment, 2 weeks, 1 month, 2 months and at the end of the treatment course (after 3 months of treatment), and lung function, bronchial excitation test, survival quality, safety and other indexes were evaluated before and after 3 months of treatment. 1.5. Efficacy evaluation indexes 1. The improvement in the number of asthma attacks was evaluated using the asthma day and night symptom score [4]; 2. The asthma control test score [3] (ACT) was used to evaluate the asthma control (25 points: fully controlled; 20-24 points: partially controlled; <20 points: not controlled); 3. The improvement in lung function before and after treatment was evaluated using a lung function meter (Jäger, Germany) 1.6. safety assessment: observe and record the occurrence of any adverse events in patients during the treatment. 1.7, Statistical analysis: SPSS18.0 software was used for statistical analysis. For measurement data: paired t-test and repeated measures ANOVA were used, descriptive analysis was used for count data, and rank sum test was used for rank data. The test level α=0.05. 2. RESULTS: A total of 38 patients were included, with an age distribution of 15-69 years (39.5±14.3) and a disease duration of 4 months-15 years (37.2±44.0 months); there were 30 cases in the acute exacerbation phase and 8 cases in the chronic persistence phase; the disease was graded as grade 2 in 10 cases and grade 3 in 28 cases. Among the 38 patients included in the observation, 4 patients were discharged due to other reasons, and 5 patients were combined with western medicine due to poor results. The efficacy of these 9 patients was counted by the "last efficacy carry-over method", in which the last score before discharged or the score before the addition of western medicine was counted as each subsequent score. 2.1 The asthma day and night symptom scores of the patients before and after the treatment were analyzed, and the results showed that the difference between 1 month and half month after the treatment was not statistically significant (P>0.05), and the difference between the day and night symptom scores at all other time points was statistically significant (P<0.05), suggesting that this treatment plan can reduce the number of day and night attacks of asthma patients. 2.2. The asthma control test scores of the patients before and after treatment were analyzed, and the results showed that the difference was not statistically significant (P>0.05) when comparing February with January after treatment, and the difference was statistically significant (P<0.05) when comparing the rest of the time points after treatment with those before treatment, and the complete control reached 42.1% and partial control reached 36.8% after three months of treatment. It is suggested that 78.9% of asthma patients had more significant improvement after this regimen. 2.3, 16 of 38 patients had their lung function rechecked, and 6 patients had their bronchial excitation test turned negative (2 of them were suspicious positive). The results showed that the mean values of all lung function indexes were higher after treatment than before treatment, among which the difference between before and after PEF values was statistically significant, P<0.05; however, the differences of the remaining items were not statistically significant (P>0.05), but there was a trend of improvement of each index after treatment. 3. Discussion: Chinese medicine believes that bronchial asthma belongs to the category of “croup”, and Zhu Danxi, who first created the name of asthma, believes that the treatment of croup “is based on supporting the righteous qi before the onset of croup, while attacking the evil qi after the onset of croup is urgent”. Chinese medicine has developed a more systematic understanding of the etiology and pathogenesis of asthma and a rich treatment plan. We believe that the core pathogenesis of asthma is that the original deficiency and the symptoms are real throughout the development of the disease, with the acute exacerbation period being dominated by the deficiency of the positive and the evil, and the chronic persistence period being dominated by the deficiency of the positive and the evil, and the remission period being dominated by the deficiency of the positive and the evil. Therefore, the principle of treatment is to strengthen the spleen, benefit the kidney, nourish the lung, and dispel the cold and phlegm at the same time. Xiao Qing Long Tang is one of the representative formulas for the treatment of cough and asthma in Chinese medicine. It is recorded in the book entitled “The Cough with Breath and Rebellion, Xiao Qing Long Tang is the main remedy.” We believe that asthma is a kind of recurrent disease. Although the acute phase of asthma is mostly caused by external evil, there are deficiencies in the three organs of the lungs, spleen and kidneys at the same time, which make it easy to feel external evil. The effect is not long-lasting. Although the pathogenesis of asthma in remission is based on the deficiency of the lung, spleen and kidney, it is still mixed with wind, phlegm, dampness, stasis of blood and other internal obstruction of the symptoms, therefore, the method of supplementation alone is not comprehensive. Zhou Zhongying, a national medical master, also believes that “treating the symptoms at the onset and treating the root at the usual time” has its relativity, as the attack may not be treated entirely from the symptoms, when treating the symptoms and taking care of the root; and the usual time may not be supported by all the support, when treating the root and taking care of the symptoms. The location of the disease is mainly in the lung, but repeated attacks are inevitable from the lung to the spleen and kidney, and the two often affect each other. When phlegm is accumulated for a long time, qi and yin are depleted and the three organs of lung, spleen and kidney are gradually deficient. Therefore, even during the exacerbation period, coughing and wheezing, phlegm, shortness of breath, fatigue, spontaneous sweating, weak pulse and other signs of positive deficiency and real evil, which should be taken into account at this time, and should not be confined to attacking evil. In the remission period, although the evidence is not obvious, but the “phlegm and beverages stay in the ambush”, the positive deficiency of the evil is real, when supporting the positive and cultivating the original, we should also take the products to resolve the phlegm and lower the qi to remove the stubborn phlegm in the ambush [6]. In this protocol, the combined formula of Ginseng Clam Tang, which strengthens the spleen and kidney, disperses cold, dissolves phlegm and relieves cough, and Si Jun Zi Tang, which strengthens the spleen and enhances qi, are used as the base formula with addition and subtraction to treat asthma, which is precisely designed to address the basic pathological mechanism of asthma, that is, the coexistence of positive deficiency and evil real Yan. Through the whole procedure of intervention, the positive energy can be consolidated and the evil can be dispelled, thus achieving the effect of significantly relieving the symptoms of asthma and improving the quality of life of patients. There are global guidelines for the treatment of asthma in Western medicine, and nearly 80% of patients can achieve good clinical control if they undergo standardized treatment [3]. However, the awareness of standardized Western medicine treatment among asthma patients in China is low, and some studies have shown that only 7.8% of patients know that long-term inhaled surface corticosteroids are the most effective anti-inflammatory treatment available [7]. Western medicine treatment uses hormonal drugs to control symptoms and requires long-term maintenance treatment, and long-term use of hormones has certain side effects, which can easily cause patients’ compliance to decrease. Previous studies have shown that TCM treatment of asthma can not only significantly reduce or eliminate symptoms, but also improve the immune status of patients with fewer clinical side effects. The present study also showed that the sequential treatment of asthma with Ginseng and Qinglong Tang plus reduction was safe and effective, and some patients were able to achieve clinical efficacy of symptom disappearance and negative excitation test. This observational study provides preliminary evidence for the effectiveness of TCM in the treatment of asthma, and further high-level clinical studies are needed to provide a higher level of evidence-based evidence for the treatment of asthma with TCM.