Preliminary Study On Efficacy And Safety Of Domestic Bortezomib(Qianping) In The Treatment Of Multiple Myeloma

BackgroundMultiple myeloma is a malignant disease with abnormal proliferation of clonal plasma cells,which is still incurable.With the continuous advent of new drugs and the improvement of detection methods,the diagnosis and treatment of multiple myeloma have been continuously improved.Proteasome inhibitors,immunomodulators and monoclonal antibodies have been continuously improved,which play an important role in the treatment of myeloma,especially proteasome inhibitors.However,the prices of new proteasome inhibitors and imported drugs greatly increase the economic burden of patients.In order to reduce the drug burden of Chinese patients with multiple myeloma,domestic proteasome inhibitors came into being.Although there is a small gap between domestic and imported drugs in clinical trials,there are no related clinical studies reported at present.This study mainly discusses the efficacy and safety of domestic bortezomib(Qianping)and original bortezomib(Wanke)in the treatment of multiple myeloma.ObjectiveThe clinical efficacy and safety of domestic bortezomib(Qianping)and original bortezomib in the treatment of multiple myeloma were compared.MethodsAccording to the entry and excretion criteria,54 patients with multiple myeloma in our hospital were divided into observation group and control group.The observation group was treated with domestic bortezomib(Qianping)and the control group was treated with original bortezomib(Vanke).The patients in both groups were treated with VCD(bortezomib,cyclophosphamide,dexamethasone).The specific regimens were as follows: v: bortezomib 1.3mg/m2,days 1,8,15,22,D: dexamethasone injection 20mg/d,1-2,8-9,15-16,22-23 days,C: cyclophosphamide injection: 300mg/m2,days 1,8,15,22,the above regimen 28 days is a course of treatment.The indexes such as bone marrow plasma cells,immune function,M protein level,? 2 microglobulin and blood routine were detected before treatment.The curative effect was evaluated for the first time after 2 courses of treatment,and the above indexes were detected again after 8 courses of treatment for statistical analysis.Result1.There was no significant difference in total effective index(? PR)between the two groups(P =0.130);2.The percentage of CR in the control group was 29.6%,and the rate of CR in the observation group was 24.1%.The CR rate in the control group was higher than that in the observation group,but there was no significant difference between the two groups(P =0.754);3.The changes of the indexes of bone marrow plasma cells in the two groups after treatment were significantly lower than those before treatment,and the difference was statistically significant(P=0.044,P=0.002).However,there was no significant difference in the changes of bone marrow plasma cells between the two groups after treatment(P=0.440);4.The comparison of M protein levels in the two groups before and after treatment was statistically significant(P=0.021,P=0.002);there was no significant difference in M protein levels between the two groups after treatment(P=0.489);5.The anemia index of the two groups was significantly improved before and after treatment,and there was significant difference between the two groups(P<0.05),but there was no significant change in the level of Hb between the two groups after treatment(P=0.421);6.There was significant difference in the changes of ? 2-microglobulin between the two groups before and after treatment(P<0.05),but there was no significant difference between the two groups after treatment(P=0.849);7.The incidence of adverse events in domestic drugs was similar to that of the original drugs.The main hematological adverse events were thrombocytopenia and lymphocytopenia,while non-hematological events were peripheral neuropathy and infection.ConclusionDomestic bortezomib(Qianping)has good efficacy and safety in the treatment of multiple myeloma,but there is no statistical difference compared with the original bortezomib(Wanke).