Methods Research Of Treating And Effect Evaluation On Children With Respiratory Syncytial Viral Pneumonia By Chinese Medicine

Pneumonia has been one of the three and the four important pediatric diseases by World Health Organization(WHO) and China.Viral pneumonia is a commonly type and about 50%in clinics.Respiratory syncytial viral pneumonia(RSVP) is the most common type among children's viral pneumonia,it threatens seriously the life and health of children,on which western medical drug therapy shows unsatisfactory effects.Previous studies have proven that Chinese drugs could effectively improve symptoms in patients with childhood viral pneumonia.The studing results by Prof.Wang Shou-chuan in the past years show that the different syndromes of T.C.M.are widely dispersed in pediatric viral pneumonia. There are phlegm-heat blocking fei(肺) syndrome(75.0%),wind-heat blocking fei(肺) syndrome(16.25%),deficiency of Qi in fei(肺) and pi(脾) syndrome(3.12%),wind-cold tightening fei(肺) syndrome(2.92%),fei(肺) hotness due to Yin deficiency syndrome(2.71%).So the clinic research should be take on phlegm-heat and wind-heat blocking fei(肺) syndrome.In the period from January,2005 to February,2007,supported by the national key technologies research and development program of China during the 10th five-year plan period(No.2004BA716B03),adopting the task of "the method research on effect evaluation of Traditional Chinese Medicine(TCM),and the method research on effect evaluation on TCM in the treatment of viral pneumonia" and principle of trial,a research of multi-center,blocked,randomized and parallel controlled which study on the effectiveness and safety of TCM on 297 RSVP patients [91 of wind-heat blocking fei(肺) syndrome(WHBFS) and 206 of phlegm-heat blocking fei(肺) syndrome(PHBFS)]was conducted by the special research group composed of the affiliated hospital of the Nanjing University of Traditional Chinese Medicine,the Beijing Children's Hospital affiliated to the Capital Medical University,First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,First Subsidiary Hospital of Henan College of Traditional Chinese Medicine and Guangdong Provincial Traditional Chinese Medicine Hospital.Objective1.To evaluate curative effect of TCM methods objectively on children's RSVP of wind-heat blocking fei(肺) syndrome(WHBFS) and phlegm-heat blocking fei(肺) syndrome(PHBFS).2.To compare and evaluate the safety of TCM methods on children's RSVP of wind-heat blocking fei(肺) syndrome(WHBFS) and phlegm-heat blocking fei (肺) syndrome(PHBFS).3.To discuss the method of effect evaluation and establish a new effect evaluation method on RSVP of wind-heat and phlegm-heat blocking Fei Syndrome.Methods1.Multi-center,stratified randomization,equal control methods were used on 297 children with RSVP of wind-heat blocking fei(肺) syndrome(WHBFS) and phlegm-heat blocking fei(肺) syndrome(PHBFS).Controlled by Ribavilin injection and compound guaiacol potassium sulfonale oral solution in control group, Qing-kai-ling injection(清开灵注射液) and Chinese formulated oral solution-Er-tong-qing-fei oral solution(儿童清肺口服液) for phlegm-heat blocking fei(肺) syndrome,Xiao-er-ke-chuan-ling oral solution(小儿咳喘灵口服液) for wind-heat blocking fei(肺) syndrome were administered in test group. The time of therapy was 10 days for each group.2.Dominant symptoms including fever(rectal temperature),cough,overly much sputum and short breath,secondary symptoms including aversion to cold, cyanosis,abnormal heart rate,dry mouth,tongue figure and rales in detail on Different Points during Treatment,X-ray film findings,blood oxygen saturation and level of lymphocyte subsets and virus aetiology examination were observed on Pre and Post Treatment.After treatment,the comprehensive efficacy of diseases,syndromes,difference of scores in dominant symptoms,the sum of scores of dominant symptoms between pre and post treatment in two groups were compared and evaluated.The recovery days of 25%,50%,75%children needed by survival analysis on every dominant symptoms were compared and evaluated also.SAS 9.1 and SPSS 12.0 software were used,the methods include X~2 test,paired t -test,rank-sum test,the symbol rank test,ordered logistic regression,mixed effect model,survival analysis.Results: 1.Comparison of comprehensive efficacy between groups:The total effective rate were 95.00%and 84.31%respectively(p＞0.05) in the test and control group of wind-heat blocking fei(肺) syndrome,there were no different significantly. Meanwhile,the total effective rate were 88.89%and 80.62%respectively(p＜0.05) in the test and control group of phlegm-heat blocking fei(肺) syndrome,the inter-group difference was significant statistically,which was better in the test group than in the control group.2.Comparison of the difference of scores in dominant symptoms between pre and post-treatment in two groups:The total effective rate were 77.50%and 68.63% respectively(p＞0.05) in the test and control group of wind-heat blocking fei(肺) syndrome,there were no different significantly.Meanwhile,the same item were 91.67%and 64.29%respectively(p＜0.01) in the test and control group of phlegm-heat blocking fei(肺) syndrome,the inter-group difference was significant statistically,the effect was much better in the test group than in the control group.3.Comparison of the sum of scores in dominant symptoms between two groups: The rate of 1 plus 2 grade were 72.50%and 68.63%respectively(p＞0.05) in the test and control group of wind-heat blocking fei(肺) syndrome,there were no different significantly.Meanwhile,the same item were 75.00%and 44.90% respectively(p＜0.01) in the test and control group of phlegm-heat blocking fei (肺) syndrome,the inter-group difference was significant statistically,the effect was much better in the test group than in the control group.4.Comparison by survival analysis in recovery days of 25%,50%,75%children needed:There were no different between two groups in symptoms recovery such as fever,cough,overly much sputum,rales on lung(p＞0.05) except short breath (p＜0.05) in wind-heat blocking fei(肺) syndrome.Meanwhile,the symptoms recovery such as fever,cough,overly much sputum,short breath,rales on lung in test group were much earlier than that in controlled group(p＜0.01) in phlegm-heat blocking fei(肺) syndrome.5.Comparison of the safety between two groups:the inter-group difference was significant statistically(p＜0.01),which was better in the test group than in the control group.6.Methods of disease effect evaluation should include:effect evaluating method based on the terminal recovery of dominant symptoms,reduce of score in dominant symptoms between pre and post treatment,and the difference of effect time in dominant symptoms which is a new evaluating method.Conclusion1.TCM therapy has certain advantages in treating RSVP,especially in phlegm-heat blocking fei(肺) syndrome.2.Qing-kai-ling injection(清开灵注射液) combine with Chinese formulated oral solution-Er-tong-qing-fei oral solution(儿童清肺口服液) had offered an evidence in treating phlegm-heat blocking fei(肺) syndrome of RSV pneumonia by its effective and will present a giant benefit on society and economic.3.Qing-kai-ling injection combine with Xiao-er-ke-chuan-ling oral solution(小儿咳喘灵口服液) for wind-heat blocking fei(肺) syndrome was close to the control group.It should be kept on study because of not the best scheme.4.A new and more objective method of evaluating affection can be established by survival Analysis--according to recovery time of dominant symptoms.It will show the superiority clearly in treating diseases by traditional Chinese medicine.