| Objective: To compare the effectiveness,safety,economy and suitability of ceftriaxone sodium for injection in the treatment of patients with bacterial infections between the national centralized drug volume-based procurement(centralized drug procurement)and non-centralized drug procurement,in order to provide reference for the rational use of centralized purchasing antibiotics in clinical practice and the better implementation of national centralized drug volume-based procurement policy.Methods: This study was a multicenter real world study.The clinical data of inpatients with bacterial infections who received centralized or non-centralized ceftriaxone sodium for injection in five tertiary hospitals in Kunming from January 2021 to July 2022 were retrospectively gathered and divided into collected group and non-collected group.The propensity score matching(PSM)method was adopted to balance the baseline differences between the two groups,and a comprehensive clinical evaluation of the effectiveness,safety,economy and suitability of ceftriaxone sodium for injection in centralized procurement and non-centralized procurement was carried out.Results: 370 patients receiving collected varieties and 1237 patients with non-collected varieties were enrolled totally.After PSM,333 individuals in the centralized group and832 individuals in the non-centralized group were successfully matched.1.Effectiveness evaluation: The primary outcome indicator,the clinical effective rate,was not statistically different between the two groups(94.3% vs.95.4%,P=0.416).As for the secondary outcome indicators,no significant difference between the two groups was found in 72 h effective rate(89.8% vs.89.4%,P=0.845),bacteriological clearance rate(93.8% vs.96.9%,P=0.845),temperature(the proportion of patients returning to normal range and duration of recovery),or infection-related indicators(the proportion of patients whose WBC,NEUT,and NEUT% returned to the normal range).However,the proportion of CRP and PCT returning to normal range in the centralized group was lower than that of the non-centralized group,and the difference was statistically significant(P<0.05).2.Safety evaluation: During the use of study drug,the incidence of adverse events in the centralized collection group and the non-centralized collection group was low,all of which were mild rash.And there was no discernible distinction between the two groups(P>0.05).Furthermore,there was no significant difference between the two groups(P>0.05)in terms of the aberrant rate of blood system(WBC,EOS,PLT,Hb),liver and renal function(AST,ALT,Cr,Urea).And no abnormal TBIL was found.Nonetheless,the incidence of NEUT reduction in the centralized group was lower than that of the noncentralized group(5.1% vs.14.4%,P =0.002).3.Economy evaluation: The cost-minimization analysis showed that there was no significant difference in other expenses during hospitalization between the two groups(P=0.848).Compared with the non-centralized group,the total hospitalization cost,drug cost and antibacterial drug cost of the centralized group were lower(the median difference of total cost was 605.95 yuan;drug cost was 668.86 yuan;antimicrobial cost521.74 yuan),and the difference between the two groups was statistically significant(P<0.05).Also,the results of univariate sensitivity analysis were consistent with those of cost-minimization analysis,which verified the conclusion was credible.4.Suitability evaluation: The hundred-mark quantitative score system of suitability showed that the suitability score of centralized varieties was higher than that of noncentralized varieties(95.5 vs.93).The differences are reflected in the following aspects:first,the storage conditions of non-collectable varieties are relatively stricter;secondly,the centralized varieties did not indicate the hint of “no auxiliary materials”;In the other two external labels,some items did not indicate the main content.In addition,some items on the external labels of both varieties did not indicate the main content.The other information,such as internal label,skin test regulations,solvent,special population medication,and specifications,were relatively complete and consistent.Conclusions: The efficacy of centralized ceftriaxone sodium injection was not inferior to non-centralized varieties,and the safety of both varieties is comparable.However,in terms of economy,centralized varieties had great economic advantages.In terms of suitability,the suitability of centralized and non-centralized drug was generally good,but there were shortcomings in the instructions,suggesting that drug instructions should be standardized and improved to better promote the rational clinical application of centrally purchased antibiotics. |
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