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国产硼替佐米为基础的化疗方案治疗多发性骨髓瘤效果及安全性分析

Therapeutic efficacy and safety of domestic bortezomibˉbased chemotherapy in treatment of multiple myeloma

摘要:

目的 探讨国产硼替佐米治疗多发性骨髓瘤(MM)的效果及安全性.方法 回顾性分析2018年4月至10月郑州大学第一附属医院收治的接受国产硼替佐米为基础的化疗方案治疗的MM 患者60例(观察组),同时与2010年11月至2014 年11月在郑州大学第一附属医院接受原研硼替佐米为基础的化疗方案治疗的112例MM患者(对照组)进行对比.根据疾病阶段分为初治MM组和复发难治MM组,评价国产硼替佐米的临床疗效及不良反应.结果 观察组的总反应率(ORR)为71.7% (43/60),其中严格意义的完全缓解(sCR)+完全缓解(CR)率16.7%(10/60),非常好的部分缓解(VGPR)率18.3%(11/60),部分缓解(PR)率36.7%(22/60).观察组中,初治MM组45例,ORR为82.2%(37/45),复发难治MM组15例,ORR为40.0%(6/15),两组差异有统计学意义(χ2=9.877, P<0.05);国际分期系统(ISS)Ⅰ+Ⅱ期组与Ⅲ期组ORR分别为75.7%(28/37)和65.2%(15/23),差异无统计学意义(χ2=0.764,P>0.05).观察组与对照组中初治MM组和复发难治MM组的ORR、CR率分别比较,差异均无统计学意义(均P>0.05).国产硼替佐米治疗过程中最常见不良反应为外周神经病变,多为1~2级,其他不良反应包括血细胞减少、胃肠道反应、带状疱疹等,均经对症治疗后缓解或恢复正常;1例患者化疗间歇期因肺部感染、呼吸衰竭、感染性休克而死亡.结论 国产硼替佐米为基础的化疗方案治疗MM的ORR高,不良反应较原研药物无明显增加.

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abstracts:

Objective To investigate the efficacy and safety of domestic bortezomibˉbased chemotherapy for patients with multiple myeloma (MM). Methods The clinical data of 60 MM patients treated with domestic bortezomibˉbased chemotherapy regimen (the observation group) in the First Affiliated Hospital of Zhengzhou University from April 2018 to October 2018 were retrospectively analyzed, which were compared with 112 MM patients treated with original treatment regimen (the control group) at the same hospital from November 2010 to November 2014. According to the disease stage, the patients were divided into newly diagnosed MM (NDMM) group and relapsed refractory MM (RRMM) group, and efficacy and adverse reactions of domestic bortezomib were evaluated. Results The total response rate (ORR) of the observation group was 71.7% (43/60), severe complete response (sCR) + complete response (CR) rate was 16.7% (10/60), very good partial response (VGPR) rate was 18.3% (11/60), and partial response (PR) rate was 36.7% (22/60). The ORR of NDMM group (45 cases) and RRMM group (15 cases) was 82.2% (37/45) and 40.0% (6/15), respectively, and the difference was statistically significant (χ2= 9.877, P < 0.05). There was no significant difference between ISS stage Ⅰ+Ⅱ and stage Ⅲ [ORR: 75.7% (28/37) vs. 65.2% (15/23), respectively; χ2=0.764, P >0.05]. ORR and CR rates in the NDMM group and RRMM group of the observation group and the control group were not statistically different (all P>0.05). In the treatment of bortezomibˉbased chemotherapy, the common adverse reaction was peripheral neuropathy, mostly belonging to grade 1-2. Other side effects included hematocytopenia, gastrointestinal events and herpes zoster, which could be alleviated or restored to normality after supportive treatments. One patient died of pulmonary infection, respiratory failure and septic shock during the intermittent period of chemotherapy. Conclusion ORR of domestic bortezomibˉbased chemotherapy in treatment of the patients with MM is high, and the incidence of adverse reactions shows no significant increase compared with original drugs.

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