Clinical Study Of Longmu Zhuanggu Granule In Treatment Of Children Recurrent Respiratory Infection(Lung-Spleen Qi Deficiency Syndrome)

Objective: To evaluate the clinical efficacy of Longmu Zhuanggu Granules in the treatment of recurrent respiratory tract infection(lung-spleen qi deficiency syndrome)in pediatric patients and the improvement of Chinese medicine symptoms,and to observe the safety of clinical application of Longmu Zhuanggu Granules.Methods: A non-inferiority test stratified-area randomized,double-blind,double-simulated,positive drug(pidotimod granules)parallel-controlled,multicenter clinical study approach was used.The plan included 240 children,divided 1:1 into two groups.The treatment course was 8 weeks and the follow-up was 12 months.The primary,secondary and safety indicators were compared between the two groups.Results:1.Baseline comparability: 237 subjects were included,including 118 cases in the test group and 119 cases in the control group.1 case without medication record shedding,a total of 236 cases entered the full analysis set(FAS),117 cases in the test group and 119 cases in the control group;210 cases entered the protocol-compliant data set(PPS),102 in the trial group and 108 in the control group,due to case shedding,combined medications,and medication adherence;236 cases were entered into the safety data set(SS),117 cases in the test group and 119 cases in the control group.For all children entering the FAS and PPS analyses,there were no statistically significant differences(P > 0.05)between the two groups in terms of baseline demographic data(age,height,weight,ethnicity,gender),disease-related conditions(number of episodes of upper sensation,number of bronchitis,number of pneumonia,past medical history,drug allergy history,family history),and comorbid conditions(pre-diagnosis comorbid conditions,pre-diagnosis comorbid medications),and the FAS and PPS analyses were consistent.The differences in efficacy correlation indexes,TCM symptom scores at baseline,single symptom scores(less facial color,morphological wasting,less breath and lazy speech,shortness of breath,less food,dullness,excessive sweating,loose stools),and immune indexes(IgA,IgG,IgM,CD4,CD8,CD4/CD8)were not statistically significant(P > 0.05),and the conclusions of FAS and PPS analyses were consistent.2.Validity analysis: For the study endpoint,the disease recovery rate was 75.21% in the test group and 73.95% in the control group,and the 95% confidence interval(CI)for the difference between the two groups,FAS was 1.26%(-9.85%,12.37%)and PPS was 3.81%(-6.28%,13.90%),and the non-inferiority test for the treatment endpoint disease recovery rate held at a non-inferiority cutoff of 10%,FAS,and PPS analyses were consistent with the findings.There were no statistically significant differences between groups in the number of respiratory infections and duration of illness.The between-group comparison of the efficacy of the TCM evidence classes showed no statistically significant difference at 4 weeks of treatment and a statistically significant difference at 8 weeks of treatment(P=0.0011).In the group comparison of the disappearance rate of individual symptoms,there was no statistically significant difference in the disappearance rate of each individual symptom(less florid face,wasted body,less breath,shortness of breath,less food,dullness,excessive sweating,loose stools)in 4 weeks of treatment;only the disappearance rate of less breath,dullness and excessive sweating in 8 weeks of treatment was statistically significant(P < 0.05).There were no statistically significant differences between groups in immune indexes at baseline and 8weeks after treatment;except for CD8 in the test group(P=0.0154),there were no statistically significant differences between the immune indexes before and after treatment itself.3.Safety analysis: During the trial period,17 cases(19 times)of adverse events occurred,including 10 cases(12 times)in the test group,with an incidence rate of 8.55%,and7 cases(7 times)in the control group,with an incidence rate of 5.88%,with no statistically significant difference between the groups.Among them,there were 2 serious adverse events(3 times),1 case(2 times)in the test group,with an incidence rate of 0.85%,and 1 case(1time)in the control group,with an incidence rate of 0.84%,and the difference between the groups was not statistically significant.Three cases(three times)of adverse events occurred in the control group,which were judged by the investigator to be adverse reactions,manifested as one case of abnormal liver function,one case of skin rash and one case of vomiting,with an incidence rate of 2.52% and no statistically significant difference between the groups.Conclusion: The treatment of recurrent respiratory tract infections(lung-spleen qi deficiency syndrome)in children with Longmu Zhuanggu Granules improved the disease recovery rate non-inferior to that of Pitocin granules,and the drug safety was good.