国产硼替佐米治疗初诊多发性骨髓瘤的临床疗效及安全性研究

Clinical efficacy and safety of domestic bortezomib in the treatment of newly diagnosed multiple myeloma

目的:探讨国产硼替佐米治疗新诊断多发性骨髓瘤患者的疗效及安全性。方法:回顾性分析我院2017年1月—2020年9月收治的接受以硼替佐米为基础化疗方案的60例新诊断多发性骨髓瘤患者,分为国产硼替佐米组33例(观察组)和原研硼替佐米组27例(对照组),评估2组的临床疗效及不良反应。结果:观察组总反应率为81.82%,获得非常好的部分缓解及以上的比率为54.55%,完全缓解率为27.27%,对照组患者总反应率为77.78%,获得非常好的部分缓解及以上的比率为55.56%,完全缓解率为29.63%,2组疗效差异无统计学意义(P>0.05)。观察组及对照组不良事件类似,出现的不良反应有周围神经病变、肺部感染、便秘、乏力、腹泻、肝功能损害、呕吐、带状疱疹、皮疹,2组不良反应发生率差异无统计学意义(P>0.05)。结论:国产硼替佐米的临床疗效与原研药相当,毒副反应未增加。

Objective:To evaluate the efficacy and safety of domestic bortezomib in the treatment of newly diagnosed multiple myeloma patients.Methods:A retrospective analysis was performed on 60 newly diagnosed multiple myeloma patients who received bortezomib based chemotherapy in our hospital from January 2017 to September 2020,and they were divided into domestic bortezomib group(33 cases)(observation group)and original bortezomib group(27 cases)(control group)to evaluate the clinical efficacy and adverse events of the two groups.Results:The overall response rate of the observation group was 81.82%,the rate of achieving very good partial response or above was 54.55%,the complete remission rate was 27.27%.The overall response rate of the control group was 77.78%,the rate of achieving very good partial response or above was 55.56%,the complete remission rate was 29.63%.There was no significant difference in the efficacy between the two groups(P>0.05).The adverse events that occurred were peripheral neuropathy,lung infection,constipation,fatigue,diarrhea,liver damage,vomiting,herpes zoster and rash.There was no significant difference in the incidence of adverse events(P>0.05).Conclusion:The clinical efficacy of domestic bortezomib is similar to that of the original drug,and the toxicity and adverse events are not increased.