發(fā)布時間：2018-08-19 13:15

【摘要】：目的:觀察大劑量靜脈輸注甲鈷胺預(yù)防硼替佐米治療多發(fā)性骨髓瘤(MM)引起的周圍神經(jīng)病(bortezomib-induced peripheral neuropathy,BIPN)的臨床效果及安全性。方法:采用單中心隨機對照臨床研究2012年7月至2016年5月我中心65例新診斷的MM患者,將他們分為2組,其中治療組27例,采用靜脈輸注大劑量甲鈷胺預(yù)防BIPN;對照組38例,未接受任何預(yù)防BIPN的藥物。觀察2組患者BIPN的發(fā)生率及其嚴(yán)重度并分析療效、生存率及藥物的不良反應(yīng)。結(jié)果:治療組和對照組患者年齡和性別比例均無統(tǒng)計學(xué)差異(P0.05)。治療組BIPN發(fā)生率(29.63%)明顯低于對照組(55.26%)(χ~2=4.197,P0.05),治療組Ⅱ和Ⅲ級以上BIPN發(fā)生率分別為18.52%和3.71%,均明顯低于較對照組(47.37%,21.05%)(χ~2=5.746,P0.05;χ~2=3.983,P0.05);2組因Ⅲ級及Ⅲ級以上程度BIPN導(dǎo)致未完成5個療程Vel治療的分析結(jié)果顯示:治療組為3.71%,低于對照組15.79%,但無明顯統(tǒng)計學(xué)差異(χ~2=2.714,P0.05)。治療組和對照組的總有效率分別為77.78%和73.68%(P0.05)。治療組和對照組的PFS和OS均無統(tǒng)計學(xué)差異(P0.05)。靜脈輸注大劑量甲鈷胺的安全性的分析結(jié)果顯示,治療組3.71%患者出現(xiàn)輕度皮疹,無其它毒副作用發(fā)生。結(jié)論:大劑量靜脈輸注甲鈷胺能有效預(yù)防BIPN發(fā)生,或減輕其嚴(yán)重程度,具有良好安全性。
[Abstract]:Objective: to observe the efficacy and safety of high dose intravenously infusion of mecobalamin in the treatment of bortezomib-induced peripheral neuropathy-induced bortezomib-induced peripheral neuropathy (bortezomib-induced peripheral) caused by multiple myeloma (MM). Methods: from July 2012 to May 2016, 65 newly diagnosed MM patients in our center were randomly divided into two groups: treatment group (n = 27) and control group (n = 38). No medication for the prevention of BIPN was accepted. The incidence and severity of BIPN were observed and the curative effect, survival rate and adverse drug reaction were analyzed. Results: there was no significant difference in age and sex ratio between treatment group and control group (P0.05). The incidence of BIPN in the treatment group (29.63%) was significantly lower than that in the control group (55.26%) (蠂 ~ (2 / 2) / 4.197). The incidence of BIPN in the treatment group was 18.52% and 3.71% respectively, which was significantly lower than that in the control group (47.37%, 21.05%) (蠂 ~ (25.746) P 0.05; 蠂 ~ (23) 983). The results showed that the value of the treatment group was 3.71, lower than that of the control group 15.79, but there was no significant difference (蠂 2, 2.714, P 0.05). The total effective rates of treatment group and control group were 77.78% and 73.68% respectively (P0.05). There was no significant difference in PFS and OS between the treatment group and the control group (P0.05). The results of safety analysis showed that 3.71% of the patients in the treatment group had mild rash and no other side effects. Conclusion: high dose intravenous infusion of mecobalamin can effectively prevent or reduce the severity of BIPN, and has good safety.
【作者單位】： 天津醫(yī)科大學(xué);天津醫(yī)科大學(xué)總醫(yī)院血液科;
【基金】：天津市自然科學(xué)基金(12JCZDJC21500、14JCYBJC25400) 天津市抗癌重大專項攻關(guān)計劃(12ZCDZSY18000) 天津醫(yī)科大學(xué)基金(2010ky20)
【分類號】：R733.3

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