Abstract

Objective To evaluate the effectiveness of traditional drug(oral feirekechuan liquid for children) combined Azithromycin for children with Mycoplasma pneumoniae(MP) lower respiratory infection, and to provide optional method for the treatment of MP pneumonia with the combination approach. Methods This study was designed as prospective, randomized, open, paralleled, positive medicine controlled multi-center clinical trial.During Aug.2012 to Aug.2013, patients were included in the study who were suspected of MP infection in pediatric clinics and wards according to the inclusion criteria.All patients were randomly divided into two groups: treatment group(oral feirekechuan liquid for children plus Azithromycin) and control group(Azithromycin). Throat swab and serum specimens were obtained from patients, and also clinical data of all children were collected.MP DNA was detected by the nested PCR method with primers sets for amplification of the binding site of erythromycin at 23S rRNA.ELISA or particle agglutination method was applied to detect MP antibodies in serum.Clinical information of the patients was analyzed and their MP DNA was detected and/or MP-antibodies were positive. Results Seventy-nine patients with perfect clinical data and Nested PCR positive and/or MP-antibodies positive were analyzed.Thirty-seven patients received traditional chinese drug and Azithromycin(treatment group) and 42 patients received only Azithromycin(control group). There were no statistical significance in the sex, age, patients' fundamental conditions between the two groups.After treatment, in the treatment group the time of the fever was shorter than the control group [(5.14±1.40) d vs(6.12±2.45) d, P=0.014]. Also, the treatment group took less time for coughing reduction[(6.00±1.38) d vs (6.92±1.63) d, P=0.026]and disappearing[(8.06±2.16) d vs (9.83±2.60) d, P=0.036]. Conclusions Oral feirekechuan liquid for children combined with Azithromycin is more effective than Azithromycin used alone for the treatment of mycoplasma pneumoniae infection in children, and can be used as complementary medicine. Key words: Combination of traditional Chinese medicine and western methods; Oral feirekechuan liqnid for children; Mycoplasma pneumoniae infection; Clinical manifestation

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