Pediatric pneumonia is one of the most common diseases in pediatrics [1], and viruses account for about 50% of the causative factors of pediatric pneumonia, thus it is a common disease in pediatric period, especially in infancy and childhood.The common viruses that cause pediatric viral pneumonia are respiratory syncytial virus, adenovirus types 3 and 7, influenza virus, and parainfluenza virus [2], among which adenovirus types 3 and 7 are the common pathogen. In the TCM classification of pediatric viral pneumonia, phlegm-heat closed lung evidence accounts for 76.9% of the cases [3]. Respiratory syncytial virus pneumonia is no exception, and Clear Lung Oral Liquid is composed of roasted ephedra, almonds, and thuja, which has the effect of opening the lung and resolving phlegm, detoxifying and activating blood. The author has achieved good results in the treatment of pediatric respiratory syncytial virus pneumonia with Qinglung Oral Liquid, and the results are reported below.
1. Materials and methods
1.1 Clinical data Sixty cases were selected from our group of hospitalized children from October 2004 to October 2006, and were clinically diagnosed as viral pneumonia with phlegm-heat closed lung evidence and clearly diagnosed as respiratory syncytial virus pneumonia by pathogenesis. There were 41 males and 22 females; 12 cases aged 6 months to 1 year, 26 cases aged 1+ to 3 years, and 22 cases aged 3+ to 6 years. The 60 children were divided into a test group (30 cases) and a control group (30 cases) according to a random assignment table provided by the subject group, and the study was conducted according to the blinded, multicenter, randomized, parallel-controlled principle. The analysis of demographic and other baseline characteristics of the two groups showed that most of the clinical data before the trial were not statistically different and comparable, and the gender composition was statistically different, with more males in the trial group; there were no statistical differences in the distribution of disease onset and disease distribution between the two groups before the trial.
1.2 Trial medication
Clear Lung Oral Liquid, specification: 100ml per bottle, prepared and quality controlled by the Department of Pharmacy, Affiliated Hospital of Nanjing University of Chinese Medicine. The control drug: ribavirin injection, ribavirin injection with the product of North China Pharmaceutical Group Preparation Co.
1.3 Dosing method
Test group: Each child was given orally Clear Lung Oral Solution, 10ml per dose for 4-12 months, 20ml per dose for 1 decade to 3 years old, 30ml per dose for 3 decades to 6 years old, 3 times a day; clarified sedative solution without antiviral antibacterial drugs was added, once a day. Control group: treated with western medicine, each child was treated with ribavirin injection at 10mg/kg per day, intravenous drip, 1 time per day; plus oral liquid placebo without drug ingredients, the dosage serving method was the same as that of lung clearing oral solution. The children in both groups could apply antipyretic drugs when their body temperature exceeded 39℃ without combining with other drugs. 10 days was a course of treatment and the observation time was 1 course of treatment.
1.4 Efficacy evaluation criteria[4] Cured: symptoms and signs basically disappeared, and those who tested positive for respiratory virus before treatment turned negative; Significant effect: symptoms and signs mostly disappeared; Burst step: symptoms and signs reduced; Ineffective: symptoms and body did not change significantly or worsened.
5 Statistical treatment The comparison between groups applied log-Rank analysis or x2 test, respectively, and the comparison of comprehensive efficacy applied Wilecoxon rank sum test, P < 0.05 as statistically significant difference, P ≤ O.01 as highly statistically significant.
2. Results
2.1 Comparison of the main symptoms and signs between the two groups
Table 1 Comparison of the time to return to normal temperature in the two groups (days)
Subgroup n days (±SD) Statistic (t) P
Test group 23 1.67±1.797 -2.303 0.025
Control group 22 3.03±2.760
Table 2 Comparison of improvement of cough symptom scores between the two groups (points)
Subgroup n Symptom score (±SD) Intra-group comparison Inter-group comparison
Before treatment After treatment Difference Z P Z P
Test group 33 4.36±1.168 0.55±0.905 3.82±1.357 -7.133 <0.001 -3.043 0.002
Control group 30 4.60±1.192 2.00±1.486 2.60±1.589 -5.519 <0.001< span="">
Table 3 Comparison of improvement in sputum congestion symptom scores between the two groups (points)
Subgroup n Symptom score (±SD) Intra-group comparison Inter-group comparison
Before treatment After treatment Difference Z P Z P
Test group 33 3.76±1.393 0.36±0.783 3.39±1.456 -6.956 <0.001 -2.412 0.016
Control group 30 3.53±1.008 1.13±1.358 2.40±1.610 -5.507 <0.001< span="">
Table 4 Comparison of improvement of pulmonary auscultation symptom scores between the two groups (points)
Subgroup n Symptom score (±SD) Intra-group comparison Inter-group comparison
Before treatment After treatment Difference Z P Z P
Test group 33 5.15±1.417 0.30±0.728 4.85±1.734 -7.314 <0.001< span=""> -2.096 0.036
Control group 30 5.20±1.448 1.27±1.701 3.93±1.856 -6.057 <0.001< span="">
Table 5 Comparison of improvement in symptom scores on chest radiographs between the two groups (points)
Subgroup n Symptom score (±SD) Intra-group comparison Inter-group comparison
Before treatment After treatment Difference Z P Z P
Test group 33 5.09±1.422 0.79±1.317 4.30±1.944 -6.819 <0.001< span=""> -0.507 0.612
Control group 30 5.73±0.691 1.67±1.749 4.07±1.999 -6.599 <0.001< span="">
Note: The test group was better than the control group in terms of time to normalization of body temperature, improvement of cough symptom score, improvement of sputum congestion symptom score, improvement of lung auscultation and X-ray, etc. The difference was statistically significant (P < 0.05).
2.2 Comparison of comprehensive efficacy between the two groups
Table 7 Comparison of the comprehensive efficacy of the two groups
Overall efficacy
n Cured (%) Apparent effect (%) Effective (%) Ineffective (%)
Test group33 19(57.6%) 12(36.4%) 2(6.1%) 0(0%)
Control group30 6(20%) 12(40%) 8(26.7%) 4(13.3%)
Comparison of efficacy between the two groups Z -3.671
P < 0.001
Comparison of healing rate between two groups P < 0.001
The overall efficacy, healing rate and healing rate of the test group were better than those of the control group, and the difference was significant (P < 0.001).
3. Discussion
Thirty cases of pediatric respiratory syncytial virus pneumonia were treated with Qinglung Oral Liquid, while 30 cases were treated with ribavirin as the control group, and the efficacy was observed. The results showed that 19 cases (57.60%) were cured, 12 cases (36.40%) were effective, and 2 cases (6.1%) were effective in the test group, while 6 cases (20.00%) were cured and 12 cases (40.00%) were effective in the control group, and the efficacy of the test group was significantly better than that of the control group. Clear Lung Oral Liquid can effectively improve the symptoms and signs of cough, sputum congestion, lung wet rales and lung X-ray changes in children with respiratory syncytial virus pneumonia with phlegm-heat closed lung evidence, and the test group was better than the control group. This indicates that Clear Lung Oral Liquid is an effective drug for the treatment of pediatric respiratory syncytial virus pneumonia with phlegm-heat closed lung evidence. Preliminary experimental studies have shown that the efficacy mechanism of Qinglung Oral Liquid lies in the multi-targeted overall regulatory effects of dispelling evil (antiviral in vivo and in vitro, clearing heat, relieving cough and resolving phlegm) [5] and supporting righteousness (inducing γ-interferon and improving phagocytosis of mouse abdominal macrophages) [6].
Respiratory syncytial virus pneumonia belongs to the category of pneumonia and wheezing in ancestral medicine. At present, there are no specific drugs and methods for the treatment of this disease in Western medicine, and Chinese medicine has advantages and characteristics for the treatment of this type of disease. However, there is no uniform clinical classification for this disease in Chinese medicine. Prof. Wang Shouchuan summarized his years of clinical experience and suggested that the cause of the disease is mainly due to the internal weakness of the righteousness and the lack of solidity of the external guard; the external cause of the wind-heat evil poison. Although the disease can be divided into various types of evidence, according to our statistics of clinical data, about 75% of pediatric viral pneumonia belong to the evidence of phlegm-heat occlusion of the lung. Therefore, to address the pathogenesis of the disease, the main treatment is to clear the phlegm-heat and open the lung. At the same time, according to the etiology of the disease (wind-heat and evil toxins) and the signs of blood stasis in the course of the disease, the method of detoxification and blood circulation should be used. On the basis of Mao Xing Shi Gan Tang and modern pharmacological research, we have developed a convenient clear lung oral solution for pediatric syncytial virus pneumonia based on the characteristics of the pathogenesis of the disease, with the appropriate addition of products to open the lung and cleanse phlegm, detoxify and invigorate blood, and used it in clinical research of pediatric syncytial virus pneumonia.