Real-world study of effectiveness and safety between generic in volume-based purchasing and patent drug ceftriaxone sodium for injection
OBJECTIVE To compare the effectiveness and safety between generic in volume-based purchasing and patent drug ceftriaxone sodium for injection and provide references for clinical practices.METHODS Inpatients with infections using cef-triaxone sodium for injection were included into this retrospective cohort study.The differences of safety(abnormalities in liver function,abnormalities in renal function,abnormalities in blood routine examination,allergic reactions&gastrointestinal distur-bances)and effectiveness(clinical efficacy rate,mortality rate,treatment abandonment rate&bacterial clearance rate)were com-pared between generic drug and patent drug groups.There were three subgroups of lung infection,abdominal infection and central infection for effectiveness.Univariate and multi-factor COX regression analyses were utilized for examining the influencing factors on safety and effectiveness.RESULTS As compared with patent drug group,the proportion of simultaneous abnormalities for liver function,renal function and blood routine,the proportion of co-administered drugs for balancing intestinal flora were lower in generic group(P＜0.05)and the proportion of co-administered anti-allergic drugs was higher(P＜0.05);in terms of effective-ness,bacterial clearance rate of three infections types were lower in generic drug group than that in patent drug group(P＜0.05).Clinical effectiveness rate,mortality rate and treatment abandonment rate were not statistically different between two groups(P＞0.05).The results of univariate and multivariate Logistic regression analysis indicated that age(OR=1.010,P=0.014),length of stay(OR=1.020,P=0.024),duration of ceftriaxone sodium(OR=1.104,P＜0.01),concurrent malignant tumors(OR=1.470,P=0.023),concurrent chronic liver disease(OR=2.581,P＜0.01)and use of patent drug(OR=1.595,P=0.011)were risk factors for the occurrence of adverse reactions.Duration of ceftriaxone sodium was independently associated with clinical effec-tiveness.CONCLUSION Generic drug of ceftriaxone sodium has a lower incidence for simultaneous abnormality of liver func-tion,renal function and blood routine examination and a lower bacterial clearance rate for three infections types than patent drug.Two groups have a comparable clinical effectiveness rate,mortality rate and treatment abandonment rate.Ensuring adequate anti-infection course and combined use of anti-anaerobic drugs for abdominal infection are favorable factors for clinical effectiveness.
generic drugpatent drugceftriaxone sodium for injectioneffectivenesssafety
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