国产与进口硼替佐米治疗多发性骨髓瘤的真实世界疗效、安全性及经济学对比

Comparison of efficacy,safety and economics of domestic and imported bortezomib in the treatment of multiple myeloma in the real world

目的:在真实世界中,对比以国产与进口原研硼替佐米为基础的方案治疗多发性骨髓瘤的疗效、不良反应及治疗费用。方法:101例多发性骨髓瘤患者,应用进口原研硼替佐米治疗组48例,国产硼替佐米治疗组53例,比较两组患者的治疗反应率、不良反应发生率及治疗费用。结果:随访截止至2018年12月31日,两组患者4个疗程结束后的完全缓解(complete response,CR)率、总缓解率(overall response rate,ORR)差异无统计学意义(P>0.05);根据不同危险因素进行分层,两组患者的CR率、ORR差异也无统计学意义(P>0.05);在血液学与非血液学不良反应方面差异无统计学意义(P>0.05);国产硼替佐米各个疗程后总花费均低于进口硼替佐米,差异具有统计学意义(P<0.05)。结论:在真实世界中,国产硼替佐米与进口原研硼替佐米治疗多发性骨髓瘤患者在早期诱导缓解方面的临床疗效相当,安全性相当,但国产硼替佐米价格相对低廉,可以广泛应用。

Objective:To compare the efficacy,adverse reactions and costs of treatment based on domestic and imported bortezomib of multiple myeloma in the real world.Methods:101 patients with multiple myeloma were treated and divided into two groups(48 cases received imported bortezomib treatment.53 cases received domestic bortezomib treatment).The treatment response rate,adverse reaction rate and treatment cost were compared between the two groups.Results:The follow-up time ended on December 31,2018.After four courses of bortezomib regimen,there was no significant difference in complete response(CR)rate and overall response rate(ORR)between the two groups(P>0.05).In different age groups,renal function groups,Durie-Salmon groups and International Staging System groups,there was no significant difference in CR rate and ORR between the two groups(P>0.05).There was no significant difference in hematological and non-hematological adverse reactions between the two groups(P>0.05).The total cost of domestic bortezomib after each course of treatment was lower than that of imported bortezomib,and the difference was statistically significant(P<0.05).Conclusion:In early stage of remission induction,domestic bortezomib has the same clinical efficacy and safety as imported bortezomib in patients with multiple myeloma,but domestic bortezomib is relatively inexpensive and can be widely used.