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Objective To investigate the effect of pidotimod granules and Carboxymethyl starch sodium solution in treating children with recurrent respiratory tract infection curative effect and effect on immune function of children.Methods 128 cases of children with recurrent respiratory tract infection in our hospital from June 2013 to June 2016 were selected and divided into treatment group and control group with 64 cases in each group. Children in the control group were treated with Carboxymethyl starch sodium solution, the treatment group was given pidotimod granules on the basis of the control group.Two groups of children were treated for 12 weeks.The therapeutic effects of the two groups were compared, the changes of immune function before and after treatment, cough, fever, lung rales disappear time, and the incidence of adverse reactions.Results The total effective rate of the treatment group (90.62%) was higher than the control group (75.00%), the difference was statistically significant (P<0.05), the levels of IgA, IgM and IgG increased after treatment in both groups, the levels of IgA, IgM and IgG in the treatment group were higher than those in the control group, the difference was statistically significant (P<0.05), the levels of CD3 +, CD4 +and CD4 +/CD8 +increased after treatment in both groups, and the levels of CD3 +, CD4 +and CD4 +/CD8 +in the treatment group were higher than those in the control group, the difference was statistically significant (P<0.05), the treatment group in children with cough, fever, pulmonary rales disappeared faster than the control group, the difference was statistically significant (P <0.05), two groups were no obvious adverse reactions.Conclusion Pidotimod granules combined with carboxymethyl starch sodium solution in treating children with recurrent respiratory tract infections is effective, and could significantly improve the immune function of children.
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Objective To investigate the effect of pidotimod granules combined with Yupingfeng granules in the treatment of children with recurrent respiratory infection.Methods A total of 124 patients in the treatment of children′s immunologic function with recurrent respiratory infection were taken into this research.124 patients were divided into OBG(63 patients)group and COG(61 patients)group according to random number table and treated with pidotimod granules and Yupingfeng granules.Statistics of children′s treatment in the two groups were collected and analyzed after research.Results In OBG group,there were 33 excellent cases,28 effective cases,2 void cases,and the treatment efficiency was 96.83%,which were better than those in COG group(χ2 =8.796,9.054,8.931,9.135, all P <0.05).In OBG group,the extinction time of fever,moist rale,expectoration and chest pain were significantly shorter than those in COG group(t =8.562,9.025,8.747,8.637,all P <0.05).The differences between the two groups after treatment in IMF were statistically significant (all P <0.05 ).Conclusion Pidotimod granules and Yupingfeng granules has perfect effect in the treatment of children′s immunologic function with recurrent respiratory infection,which is worthy of promotion.
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OBJECTIVE:To evaluate the bioequivalence of the domestic pidotimod granules with the imported pidotimod syrup as control.METHODS:20 healthy male volunteers were treated with a single dose(800 mg)of pidotimod granules(test formulation)or pidotimod syrup(reference formulation)by a randomized crossover design,with plasma concentrations of pidotimod determined by HPLC and pharmacokinetic parameters of pidotimod computed,and the bioequivalence between two formulations was evaluated using DAS2.0 program.RESULTS:The pharmacokinetic parameters of the reference formation vs.the test formulation of pidotimod were expressed as follows:t1/2(2.70?0.80)h vs.(2.62?0.84)h;Cmax(4.04?0.59)?g?mL-1 vs.(3.87 ?0.66)?g?mL-1;tmax(2.28?0.44)h vs.(2.13 ?0.43)h;AUC0～14(22.11?4.20)mg?h?L-1 vs.(23.00?4.25)mg?h?L-1;AUC0～∞(22.85?4.42)mg?h?L-1 vs.(23.83?4.52)mg?h?L-1.The relative bioequivalence of the test formulation as against the control was(106.08?22.05)%.CONCLUSION:The pidotimod granules and pidotimod syrup are bioequivalent.