| Children pneumonia is one of the commonly encountered respiratory systemdiseases, WHO defines it as one of the three most serious pediatric diseases, and it isone of the four pediatric diseases that the Administration for Health Care of Chinastresses prevention and cure, too. Children pneumonia covers 24.5-65.2% of thehospitalized children patients below 5 years old, and it results in deaths of 300thousand children patients below 5 years old, so it is the first death causes of 5-year-old children patients. Virus infection makes up 50% of Children pneumonia, ofwhich respiratory syncytial virus, RSV, is the important antigen ,which can cause theserious lower respiratory tract infection of infants and children, and also can causeover 90% bronchiolitis and most of the pneumonia. Although antibody exists in bodyafter infection, repeated infection is still commonly seen, however, its pathogenesisis not clear, and at present, there is no effective anti-virus vaccine. Ribavirin is theonly one to used as RSV virus infection, yet, its clinical effect is not satisfyingbecause small dose has no ideal effect, and large dose will bring toxic and adversereaction. Chinese medicine and Chinese herbal drugs have advantage in improvingchildren patients’ symptoms and signs and shortening the course of treatment. ByTCM theory, the cause of virus pneumonia is externally contracting wind warm andpathogenic toxin, the mechanism of the disease is accumulation of phlegm-heat inlung .Because the main symptoms of RSV pneumonia, including cough, phlegmand asthma, are influenced each other, the treatment method should be clearinglung-heat and stopping cough, dissipating phlegm and relieving asthma. QingKailing injection is a kind of pure Chinese herbal injection produced in the base of Angong Niuhuang Pills, which is used widely in various virus infection diseases. But,treating children RSV pneumonia with Qing Kailing injection and oral traditionalChinese patent medicines according to the treatment based on syndromedifferentiation lacks large sample, multiply centered and randomized, paralleled andcontrolled study, so we conduct this systemic and standard clinical research to reflectthe advantage on treatment of children virus pneumonia with Chinese medicine andherbs.Study on patterns and treatment rules of children pneumonia is a one of thetenth five-year national subjects in natural scientific and technical study, it took therandomized, double-blind, placebo-controlled and multiply centered study and theresult showed accumulation of phlegm-heat in lung syndrome is the main pattern inacute children pneumonia, the effective rate in the tested group is 89.62%, andribavirin group is 73.92%.On the base of last study, we conducted large sample, multiply centered andrandomized, paralleled and controlled clinical study with Qing Kailing injection andoral traditional Chinese patent medicines according to the treatment based onsyndrome differentiation, five centers in China joined the study , figures andstatistics are arranged uniformly.ObjectiveMain objective: to evaluate the clinical effect of the different treatment plans intreating RSV with the method of watching fever, cough, phlegm, asthma andauscultation on lung, X-ray of chest, the virus and pathogen examine, appetite,aversion to cold, vitality ,cyanosis, cardiac rhythm, expression, thirst, nausea,sweating, tongue picture, degree of blood oxygen saturation.Second objective: to detect the safety of Qing Kailing injection by watchingblood routine, liver and kidney function and impossible adverse reaction.MethodsAccording to the following principle: single blind、stratified randomization、equal control multicentre clinical study, In 5 Centers hospitalization, 206 cases hadbeen carefully chosen as study subjects according to the western medicine’s diagnostic criterion of children’s virus pneumonia and the TCM diagnostic criterionof "wind and heat invasion of lung" syndrome and "accumulation ofphlegrn-heat"syndrome of children’s virus pneumonia, whose legal guardian knowthe fact and consent. According to the rule of randomization, all subjects weredivided into two groups, trial group and controlled group.The ration was 1:1.Therandomized code envelope was also created by SAS 8.0 computer program. NanjingUniversity of TCM provides the investigational products and the randomized codeform.①Qing kai ling injection group: The 96 patients in the trial group were treatedwith Qing kai ling injection(the key component is the sterile water solution ofextractive from isatis root、flos lonicerae、cape jasmine fruit、baicalin etc.,10ml everytime for 3 month to 1 year, 15ml everytime for exceed 1 year to3 years old.) andChinese formulated products;②The 103 patients in the control group were treatedwith Ribavirin injection (10mg/kg.d))and Compound guaiacol potassium sulfonaleoral solution, the time of therapy is 10 day for each group. Compare the conditionof the integration amelioration for present symptoms(integration decrease meanssymptome amelioration) such as time of body temperature from fever to normal,cough, phlegm blockage, accelerated breathing, auscultation of lung , appetiteand,cyanosis, nausea and vomitting, the time of RSV darkening etc., then getting theLogistic regression analysis for the curative effect of two groups.ResultsThere are, prior to the study, no significant differences between the two groups’general information, the leading symptoms and signs, secondary symptoms and signsand physical examinations and laboratory tests except for the body height. It meansthat the two groups can be compared. 96 cases of trial group and 103 cases ofcontrolled group accorded with the Per-Protocol(PP). The cured, significant effective,improved and ineffective cases of trial group were 64(66.6%)、26(27%)、6(6.4%)、0(0.00). The cured, significant effective, improved and ineffective cases ofcontrolled group were 43(41.7%)、41(39.8%)、19(18.5%)、0(0.00). With rank sumtest ,it showed that Z=-2.36, P＜0.001.The effect of trial group was much betterthan of the controlled group. Compared with the controlled group, the indexes of trial group of the symptoms, signs, physical examinations and laboratory testsincluding cough, flaring of nares, auscultation on lung, cyanopathy, urine, limb,X-ray of chest were much better. There are no significant differences between thetwo groups in treating fever, sputum, short breath, aversion to cold, feces, vitality,sweating, thirst, nausea, blood routine test and the virus test of the secretion of noseand throat. The study of clinical safety showed that Qingfei oral liquid had not anyharms and side effects on important organs, cough, phlegm blockage , acceleratedbreathing and the time for RSV darkening are all entering Logistic model, The resultdisplay that the model is established. (P＜0.05) . The 4 symptomatic regressioncoefficient is -1.676, -1.420, 1.14, -0.593 respectively ,The modulus for the threesymptomatic (cough, phlegm blockage, accelerated breathing) regression coefficientis bigger.Conclusions:The treatment plan which Qing kai ling injection and Chinese formulatedproducts for oral use is effective and safe in treating "wind and heat invasion oflung" syndrome and "accumulation of phlegm-heat" syndrome of children’srespiratory syncytial viral pneumonia. |
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