| Objective: This research is to study clinical efficacy and safety in the treatment of children’s cough Syndrome of Wind-heat invading lung by Xiaoer Xuanfeizhike syrup.Method: The children all see the doctors in Hubei Province Hospital Of the traditional Chinese Medicine from April 2014 to December 2015.According to the western medicine on acute trachea – bronchitis and traditional Chinese medicine on cough Syndrome of Wind-heat invading lung standard, 100 cases of children are divided into two groups with a stratified randomization method 1: 1 ratio: Xiaoer Xuanfeizhike syrup group and the control group. Depending on the age of each group is segmented into three subgroups: 1-3 age group(from 13 to 36 months),4-6 age group(from 37 to 72 months), 7-14 age group(from 73 to 168 months). In light of the groups of children are to be Xiaoer Xuanfeizhike syrup or positive control medicine(Jizhisyrup) treatment. The medicine method:1 to 3 years 7ml every time, 4 to 6years 10 ml every time,7 to 14 years 15 ml every time, oral three times a day. Treatment is consecutive seven days. Observe and record before and after treatment in children with cough, cough up phlegm and other secondary symptom integral and total integral symptoms, and find out the differences between two groups. Observe and record in children before and after treatment of vital signs, ecg, laboratory examination and the adverse reactions to evaluate its safety.Result: 1.Diseases main symptoms curative effect: three days after medication, the curative effect of cough :treatment group total effective rate is 53.33%, and the control group is 47.83%.Treatment group effectiveness is better than that of control group, P > 0.05, no statistical significance.The curative effect of cough up phlegm:treatment group total effective rate is 71.11%, and the control group is 69.57%. Treatment group effectiveness is better than that of control group, P > 0.05, no statistical significance. Seven days after medication, the curative effect of cough :treatment group total effective rate is 93.33%, and the control group is 86.96%. Compared the two groups, P < 0.05, with statistical significance. The curative effect of cough up phlegm: treatment group total effective rate is 93.33%, and the control group is 78.26%. Compared the two groups, P < 0.05, with statistical significance. 2. The total effect of disease: after seven days, the treatment group total effective rate is 100%, and the control group is 91.30%. Comparing the two groups, P < 0.05, suggesting that the treatment grouptreat the hot wind make lung cough is better than that of controlgroup. 3. Total integral of symptoms: The control group and treatment group after treatment was decreased. Xiaoer Xuanfeizhike syrup can improve the cough, cough up phlegm and children with wind heat cough symptoms. And the total score after treatment group and control group by t test, P <0.05, treatment group described children wind hot cough symptoms is efficacy than the control group. 4. Safety analysis: During the test, each group before and after treatment in children with blood routine, urine routine, stool routine, liver function, renal function, electrocardiogram(ecg) did not appear abnormal. And no adverse event happens. Explain that Xiaoer Xuanfeizhike syrup is safety.Conclustion: The curative effect on the treatment of children’s cough Syndrome of Wind-heat invading lung by Xiaoer Xuanfeizhike syrup is satisfied.This syrup is safety and reliable, worthy of continued in-depth study and promotion of the clinic. |