| Objective: To evaluate the clinical effect of "libaiyin" combined with western medicine on children's pneumonia and asthma(phlegm heat and lung closing syndrome)through the framework of randomized controlled trial(RCT).Methods: This study is a single center randomized controlled trial in children's diagnosis and treatment center of Affiliated Hospital of Changchun University of traditional Chinese medicine,Jilin Province,China.The trial type is a randomized controlled trial designed by parallel group.The distribution ratio between the trial group and the control group is 1:1,the control group is a positive control,and the test framework is a non inferiority study.After defining the definition,category,diagnosis and acceptance criteria of children's asthma cough,the research group recruited 60 children who were definitely diagnosed as asthma cough.The random sequence was generated by simple random method(random number table method).The children were divided into the experimental group and the control group according to the random sequence,and no blank or placebo group was set.According to the clinical needs and ethical considerations,the blind method is to select single blind,that is,only the third-party data analysts are blinded;in the treatment plan,the experimental group is the combination of traditional Chinese medicine "libaiyin" and antibiotics,and the control group is the combination of Feilike mixture and antibiotics;the course of observation is that the patient enters the group and meets the discharge standard.The observation time point was one day before and after the admission.The clinical baseline data and therapeutic effect indexes were mainly evaluated.The main clinical efficacy evaluation index is based on the overall difference of the efficacy index at the time of enrollment and the end of intervention,that is,the total effective rate is calculated according to the difference of the index score,and the secondary clinical efficacy evaluation index is the improvement degree of the main and secondary symptoms,signs and the total score of TCM symptoms.In the statistical method,frequency was used to express the binary data,and mean plus minus standard deviation was used to express the continuous data.Chi square test was used for gender distribution and one-way ANOVA was used for age distribution.According to the data distribution,if the data meet the normal distribution and the homogeneity test of variance,the hypothesis test: independent / paired t test;if the data meet the normal distribution and the homogeneity test of variance,the hypothesis test: independent / paired t 'test;if the above conditions are not met,the nonparametric test: independent / paired rank sum test is used to compare the data Distribution significance difference level,set test level ? = 0.05.Results: according to the nimodipine method,the total effective rate of clinical efficacy in the experimental group was 84.37% and that in the control group was 85.23%,there was no significant difference between the two groups(P > 0.05);in the secondary clinical efficacy,the experimental group improved the auscultation of lung,cough and phlegm stasis in the main symptoms and signs,compared with the control group(P > 0.05)The therapeutic effect of the experimental group was better than that of the control group(P < 0.05).Conclusion: the clinical effect of libaiyin combined with antibiotics in the treatment of children's pneumonia and asthma(phlegm heat and lung closing syndrome)is exact,which is equivalent to that of Feilike mixture combined with antibiotics in the control group,but it is better than the control group in improving heart rate,thirst,vomiting,appetite and other aspects,and there is no obvious adverse reactions and side effects,so it is a safe and effective drug for the treatment of this disease. |
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