酒石酸泰万菌素肠溶颗粒治疗猪支原体肺炎临床试验OA

To systematically evaluate the therapeutic efficacy of tylvalosin tartrate enteric-coated granules in cases of Mycoplasma hyopneumoniae(Mhp)in pigs,phase Ⅱ and Ⅲ clinical trials were conducted.The recommended clinical dosage range for the tylvalosin tartrate enteric-coated granules was identified and the therapeutic outcomes of the granules and premix formulation were compared,thereby providing a scientific basis for the rational clinical use of the drug.All trials selected three-way crossbred pigs(Duroc×Landrace×Large White)as test subjects.In the phase Ⅱ trial,following experimental grouping and artificial infection with Mhp,the pigs were confirmed as infected and then grouped for treatment.After confirmation,80 infected pigs were divided into 8 groups and administered tylvalosin tartrate enteric-coated granules at doses of 25.0 g/1 000 kg,50.0 g/1 000 kg,62.5 g/1 000 kg,75.0 g/1 000 kg or 100.0 g/1 000 kg of feed of tylvalosin tartrate enteric-coated granules for 7 consecutive days;the drug control group was administered premix(62.5 g/1 000 kg of feed,calculated as tylvalosin),and positive and negative control groups were also established.In the phase Ⅲ trial,120 naturally infected pigs with Mhp were selected and randomly divided into 2 groups of 60 pigs each.Group A was fed tylvalosin tartrate enteric-coated granules;group B was fed tylvalosin tartrate premix.Both groups were administered the treatment via feed mixing,with a dose of 62.5 g/1 000 kg of feed(calculated as tylvalosin),administered continuously for 7 days,followed by a 7-day observation period after discontinuation.In both phase Ⅱ and phase Ⅲ trials,clinical symptom scores,lung lesion scores,Mhp antigen detection and weight gain were used as indicators for statistical analysis to comprehensively evaluate the efficacy of the drugs.The results indicated that there were no significant differences in clinical symptom scores between the groups of experimental pigs before and after administration(P>0.05)in the Phase Ⅱ clinical trial.Lung lesion scores 21 days after administration showed extremely significant differences(P<0.01)between groups A and G and group H(healthy control group);groups B and F showed significant differences(P<0.05)compared with group H;whereas groups C to E showed no significant differences(P>0.05)compared with group H.Post-treatment detection of the Mhp antigen revealed that individual animals in all infected groups continued to carry the pathogen.Further analysis indicated that the administered doses in groups B to F were effective in inhibiting Mhp.The therapeutic efficacy in groups B to D increased with rising dosage,demonstrating a certain degree of dose-dependence;however,group E did not exhibit compared to group D.Furthermore,prior to administration,the body weights of experimental animals in all groups were essentially consistent(P>0.05).Following administration,group G piglets exhibited the lowest average weight gain and a relative weight gain rate of only 36.7%,which was extremely significantly lower(P<0.01)than that of group H.Groups A-E demonstrated varying degrees of growth-promoting effects,with a dose-response relationship.In the phase Ⅲ clinical trial,14 days after administration,clinical symptom scores in groups A and B were both significantly reduced compared to pre-administration levels(P<0.01).Regarding lung lesion scores,the difference in group A before and after administration was highly significant(P<0.01),while the difference in group B was significant(P<0.05);furthermore,post-administration scores in group A were significantly lower than those in group B(P<0.05).In addition,the cure rate and effective rate in group A were 87%and 93%,respectively,both significantly higher than the 67%and 78%observed in group B(P<0.05).The results indicate that both formulations can effectively alleviate clinical symptoms caused by Mhp infection.The enteric-coated granules outperformed the conventional premix in terms of reducing pulmonary pathological damage,eliminating Mhp from the respiratory tract,and clinical treatment efficacy.The optimal dosage and administration method for the treatment of MPS with tylvalosin tartrate enteric-coated granules is 50-75 g/1 000 kg of feed(calculated as tylvalosin),mixed into the feed and administered continuously for 7 days;clinically,the use of 62.5 g/1 000 kg of feed(calculated as tylvalosin)of tylvalosin tartrate enteric-coated granules for the treatment of MPS yields better effects than premixes.