大剂量静脉输注甲钴胺预防硼体佐米治疗诱发的多发性骨髓瘤患者周围神经病的效果

Prophylaxis of Bortezomib-Induced Peripheral Neuropathy in Patients with Multiple Myeloma by High-Dose Intravenous Mecobalamin

目的:观察大剂量静脉输注甲钴胺预防硼替佐米治疗多发性骨髓瘤(MM)引起的周围神经病(bortezomib-induced peripheral neuropathy,BIPN)的临床效果及安全性。方法:采用单中心随机对照临床研究2012年7月至2016年5月我中心65例新诊断的MM患者,将他们分为2组,其中治疗组27例,采用静脉输注大剂量甲钴胺预防BIPN;对照组38例,未接受任何预防BIPN的药物。观察2组患者BIPN的发生率及其严重度并分析疗效、生存率及药物的不良反应。结果:治疗组和对照组患者年龄和性别比例均无统计学差异(P>0.05)。治疗组BIPN发生率(29.63%)明显低于对照组(55.26%)(χ~2=4.197,P<0.05),治疗组Ⅱ和Ⅲ级以上BIPN发生率分别为18.52%和3.71%,均明显低于较对照组(47.37%,21.05%)(χ~2=5.746,P<0.05;χ~2=3.983,P<0.05);2组因Ⅲ级及Ⅲ级以上程度BIPN导致未完成5个疗程Vel治疗的分析结果显示:治疗组为3.71%,低于对照组15.79%,但无明显统计学差异(χ~2=2.714,P>0.05)。治疗组和对照组的总有效率分别为77.78%和73.68%(P>0.05)。治疗组和对照组的PFS和OS均无统计学差异(P>0.05)。静脉输注大剂量甲钴胺的安全性的分析结果显示,治疗组3.71%患者出现轻度皮疹,无其它毒副作用发生。结论:大剂量静脉输注甲钴胺能有效预防BIPN发生,或减轻其严重程度,具有良好安全性。

Objective： To evaluate the efficacy and safety of high-dose intravenous mecobalamin （HDIME） for the treatment of bortezomib-induced peripheral neuropathy（BIPN） in the patients with multiple myeloma （MM）. Methods： A total of 65 newly diagonsed patients with multiple myeloma receiving bortezomib in Tianjin Medical University General Hospital were enrolled in this single-centre randomized clinical trial from July 2012 to May 2016. Out of 65 patients 38 in control group received bortezomib - based chemotherapy and 27 patients in HDIME group received the additional high-dose intravenous mecobalamin. Results ： The incidence of BIPN in HDIME group was lower than that in control group（29.63% vs 55.26% , χ^2 = 4. 197, P 〈 0.05 ）. Whether the BIPN rate of Grade 2 or 3 and above in HDIME group significantly decreased as compared with control group （ 18.52% vs 47.37%, χ^2 = 5. 746, P 〈 0. 05 ） （3.71% vs 21.05%,χ^2 = 3. 983 ,P 〈 0.05 ）. The BIPN rate of less than 5 cycles of bortezomib was not significantly different between HDIME and control groups （ χ^2 = 2.714, P 〉 0.05 ）. Overall effective rate of HDIME group and control group was 77.78% and 73.68% （P 〉 0. 05 ） respectively. Neither PFS nor OS was significantly different between HDIME group and control group（ P 〉 0.05 ）. Treatmentrelated toxicity was only mild rash in 1 case. No other side - effects including nausea, abdominal pain, and hypotension occurred. Conelusion： HDIME has a good efficacy for the prophylaxis BIPN and and without serious side effects.