硼替佐米为主治疗多发性骨髓瘤的疗效与安全性临床观察

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目的:研究以硼替佐米为主的联合化疗对多发性骨髓瘤(MM)的疗效及其不良反应。方法:回顾性分析52例MM患者,其中42例接受以硼替佐米为主的联合化疗方案:初发MM 31例,复发难治MM 11例;轻链型12例,非轻链型30例;肾功能正常27例,肾功能损害15例;另外10例接受传统型(含长春新碱+蒽环类+地塞米松)化疗方案。比较硼替佐米初治组与传统化疗组,硼替佐米治疗组中轻链型与非轻链型、肾功功能正常者与肾功能损害者的疗效。同时观察42例硼替佐米治疗患者的不良反应。结果:硼替佐米初治组总有效率(ORR)和完全缓解(CR)+非常好的部分缓解(VGPR)率分别为87.10%(27/31)和64.52%(20/31),分别优于传统化疗组的20.00%(2/10)和10.00%(1/10),2组比较均差异有统计学意义(均P<0.05)。硼替佐米治疗组中非轻链型患者的ORR和CR+VGPR率分别为76.67%(23/30)和56.67%(17/30),分别高于轻链型患者的75.00%(9/12)和50.00%(6/12),但2组比较差异无统计学意义;肾功能正常患者的ORR和CR+VGPR率分别为77.78%(21/27)和59.26%(16/27),分别高于肾功能损害者的73.33(11/15)和46.67%(7/15),但2组比较差异亦无统计学意义。接受硼替佐米治疗的42例患者中,不良反应主要为乏力(28.57%、12/42)和周围神经炎(35.71%、15/42)。在给药途径方面,硼替佐米静脉给药组乏力和周围神经炎的发生率,均分别高于硼替佐米皮下注射组(42.86%∶14.28%,52.38%∶19.05%,均P<0.05)。结论:以硼替佐米为主的方案治疗初发MM疗效优于传统化疗方案,肾功能不全患者可以安全使用。硼替佐米的主要不良反应为乏力和周围神经炎,不良反应可以耐受。硼替佐米皮下注射给药可以有效减少不良反应,安全性相对较高。 Objective: To study the efficacy and adverse reactions of bortezomib-based combination chemotherapy in multiple myeloma (MM). Methods: A total of 52 patients with MM were retrospectively analyzed. Forty-two patients received bortezomib-based combination chemotherapy: 31 cases were newly diagnosed with MM, 11 cases were refractory to MM, 12 cases were light-chain and 30 cases were non-light-chain ; Normal renal function in 27 cases, renal dysfunction in 15 cases; the other 10 cases accepted the traditional (including vincristine + anthracycline + dexamethasone) chemotherapy. To compare the efficacy of bortezomib-naive group with traditional chemotherapy group and bortezomib-treated group in patients with mild to light type, normal renal function and renal dysfunction. At the same time observation of 42 cases of bortezomib treatment of patients with adverse reactions. RESULTS: The rates of total effective rate (ORR) and complete remission (CR) + very good partial response (VGPR) were 87.10% (27/31) and 64.52% (20/31) in the bortezomib-naive group, There were significant differences between the two groups (all P <0.05) in 20.00% (2/10) and 10.00% (1/10) of the traditional chemotherapy group. The rates of ORR and CR + VGPR in non-light chain patients in bortezomib group were 76.67% (23/30) and 56.67% (17/30), respectively, which were higher than 75.00% (9/12) in light chain patients ) And 50.00% (6/12), respectively, but the difference between the two groups was not statistically significant. The ORR and CR + VGPR rates in patients with normal renal function were 77.78% (21/27) and 59.26% (16/27), respectively 73.33 (11/15) and 46.67% (7/15) higher than those with renal dysfunction, but there was no significant difference between the two groups. Among the 42 patients receiving bortezomib, adverse reactions were mainly weak (28.57%, 12/42) and peripheral neuritis (35.71%, 15/42). In terms of route of administration, the incidence of fatigue and peripheral neuritis in the bortezomib intravenous group were significantly higher than those in the bortezomib subcutaneous injection group (42.86% vs14.28%, 52.38% vs19.05%, all P <0.05) . CONCLUSIONS: Bortezomib-based regimens are superior to traditional chemotherapy in the treatment of first-episode MM, and patients with renal insufficiency are safe to use. The main adverse reactions to bortezomib were fatigue and peripheral neuritis, and adverse reactions were tolerated. Bortezomib subcutaneous injection can be effective in reducing adverse reactions, the safety is relatively high.
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