硼替佐米治疗多发性骨髓瘤回顾性临床研究

发布时间：2018-05-18 21:14

本文选题：多发性骨髓瘤 + 硼替佐米　；参考：《青岛大学》2017年硕士论文

【摘要】：目的:回顾性分析多发性骨髓瘤(MM)化疗疗效,进一步明确硼替佐米对多发性骨髓瘤治疗有效性;比较含有硼替佐米的化疗方案与不含硼替佐米的化疗方案疗效及不良反应的差异;比较硼替佐米不同用药方式的化疗疗效及外周神经毒性的差异。方法:回顾性分析我院自2005年-2015年诊断MM患者90例,其中男51例,女39例,中位年龄61(49~70)岁。90例患者中,肾功能正常患者55例,肾功能不正常患者35例。90例患者按照新发及复发分为:初发活动型骨髓瘤组(50例),复发难治性骨髓瘤组(40例);按化疗方案不同分为:硼替唑米组52例(主要化疗方案有PAD、PCD、PTD),非硼替唑咪组38例(主要化疗方案有:VAD、VCD、VTD)。患者接受规范化疗2-4疗程;统计患者发病时的高危FISH检出率、肾损害例数,化疗方案、2疗程及4疗程后疗效、化疗相关副作用。评估:1.硼替佐米组及非硼替佐米组化疗疗效差异(2疗程及4疗程),MM患者硼替佐米组不同化疗方案(PAD、PCD、PTD)疗效的差异;2.硼替佐米组及非硼替佐米组在外周神经毒性、血液系统不良、化疗后感染、消化系统不良反应的差异;3.初发及复发MM患者高危FISH检出及肾功能损害的恢复情况;4.硼替佐米皮下注射及静推注两种用药方式化疗疗效及外周神经毒性的差异。结果:90例患者中,初发活动型骨髓瘤组50例,复发难治性骨髓瘤组40例。1.化疗疗效方面:(1)化疗方案与化疗疗效的关系。(1)初发活动型MM,硼替佐米组(30例)与非硼替佐米组(20例),2疗程后总缓解率(ORR)分别为:73.3%、45%(P0.05);4疗程后ORR分别为:80%、52.6%(P0.05)。(2)复发难治性骨髓瘤组,硼替佐米组(22例)与非硼替佐米组(18例),2疗程后ORR分别为:59.1%、27.8%(P0.05);4疗程后ORR分别为:66.7%、35.3%(P0.05)。(3)硼替佐米组52例(初发30例+复发22例),分别予以PAD、PCD、PTD方案;初发活动型骨髓瘤患者硼替佐米组30例,2疗程ORR分别为:75%、71.4%、75%(P0.05);4疗程ORR分别为:75%、78.6%、87.5%(P0.05);复发难治性骨髓瘤患者硼替佐米组22例,2疗程ORR分别为:50%、60%、66.7%(P0.05);4疗程ORR分别为:66.7%、66.7%、66.7%(P0.05)。(2)硼替佐米用药方式与化疗疗效关系。(1)初发活动型骨髓瘤组硼替佐米组30例患者,13例患者皮下注射方式给药,17例静脉推注方式给药;化疗2及4疗程后疗程后,皮下注射组及静脉推注组ORR分别为:76.9%、70.6%(P0.05)及84.6%、76.4%(P0.05);(2)复发难治性骨髓瘤组硼替佐米组22例患者,14例患者皮下注射方式给药,8例静脉推注方式给药;化疗2及4疗程后疗程后,皮下注射组及静脉推注组ORR分别为:64.3%、50%(P0.05)及69.2%、62.5%(P0.05);(3)所有硼替佐米组52例,皮下注射组共27例,静脉推注组共25例。化疗2及4疗程后疗程后,皮下注射组及静脉推注组ORR分别为:70.4%、64%(P0.05)及76.9%、72%(P0.05)。(3)高危FISH检出。初发活动型MM中39例行FISH检测,15例检测出异常,其中高危组3例,复发难治性MM中33例行FISH检测,18例检测出异常,其中高危组11例。2组高危FISH检出率比较,P0.05。(4)化疗后肾功能改善情况。90例患者肾功能不正常患者35例;硼替佐米组21例,非硼替佐米组14例;治疗2疗程后,硼替佐米组、非硼替佐米组肾功能总缓解率分别为81.0%、42.9%(P0.05)。2.化疗副作用方面:硼替佐米组,多为I~II级、一过性、可逆性的;少数患者出现III级不良反应,主要为骨髓抑制(血小板减少为主)、周围神经病变。非硼替佐米组多为I~III级,少数患者出现Ⅳ级,主要为骨髓抑制(粒细胞减低、贫血、血小板减少)。(1)外周神经毒性方面,皮下注射组27例及静脉推注组25例,发生率分别22.2%、52%(P0.05);(2)血液系统不良反应方面,硼替佐米组52例及非硼替佐米组38例,发生率分别为:23.1%、44.7%(P0.05);(3)化疗后感染方面,硼替佐米组52例及非硼替佐米组38例,化疗后感染率分别为:30.8%、52.6%(P0.05);(4)消化系统不良反应方面,硼替佐米组52例及非硼替佐米组38例,消化系统不良反应发生率分别为32.7%、34.2%(P0.05)。结论:1.含有硼替佐米的化疗方案对初发活动型骨髓瘤及复发难治性骨髓瘤均有显著疗效,优于非硼替佐米组(P0.05)。2.含有硼替佐米的PAD、PCD、PTD三种方案比较,疗效无明显差异(P0.05)。3.不良反应方面:硼替佐米组,在外周神经毒性方面高于非硼替佐米组(P0.05);在血液学不良反应、感染发生方面低于非硼替佐米组(P0.05);在消化道不良反应方面,与非硼替佐米组无差异(P0.05)。4.硼替佐米皮下注射与静脉推注两种方式给药比较,疗效无明显差异(P0.05);皮下注射组外周神经毒性发生率低于静脉推注组(P0.05)。5.硼替佐米组肾损害改善优于非硼替佐米组(P0.05)。6.复发难治性骨髓瘤组高危FISH检查率高于初发活动型多发性骨髓瘤组(P0.05)。
[Abstract]:Objective: To review the therapeutic effect of multiple myeloma (MM), and to further clarify the efficacy of bortezomizomi in the treatment of multiple myeloma, compare the effect of bortezomib chemotherapy with the chemotherapy regimen without bortezomib and the difference in adverse reactions; compare the therapeutic effect and peripheral neurotoxicity of bortezomizo in different ways of drug use Methods: a retrospective analysis of 90 patients with MM in -2015 2005, including 51 male, 39 female, 61 (49~70) year old.90 patients, 55 cases of normal renal function and 35 cases of renal dysfunction in.90 patients were divided into primary active myeloma group (50 cases) and relapsed refractory myeloma group (50 cases). 40 cases were divided into 40 cases: 52 cases of bortezolm group (PAD, PCD, PTD) and 38 cases of non bortezolomi group (major chemotherapy regimens: VAD, VCD, VTD). The patients received standardized chemotherapy for 2-4 courses; the high risk FISH detection rate, the number of renal damage, the chemotherapy regimen, the 2 course of treatment and the 4 course of chemotherapy, the chemotherapy related side 1. bortezomizomi group and non bortezomizomi group (2 course and 4 course of treatment), different chemotherapy regimens (PAD, PCD, PTD) in bortezomizomi group of MM patients; 2. bortezomizomi group and non bortezomizomi group in peripheral neurotoxicity, poor blood system, postoperative infection, and the difference of digestive system adverse reaction; 3. first hair And the recovery of high risk FISH detection and renal function damage in patients with recurrent MM, 4. bortezomizomi subcutaneous injection and two kinds of intravenous injection of chemotherapy effect and peripheral neurotoxicity. Results: in 90 patients, 50 cases of primary active myeloma group, 40 cases of relapsed refractory myeloma group with.1. chemotherapy: (1) chemotherapy and chemotherapy The relationship of curative effect. (1) primary active MM, bortezomizomi group (30 cases) and non bortezomib group (20 cases), the total remission rate (ORR) after 2 courses were 73.3%, 45% (P0.05), and ORR after 4 courses were 80%, 52.6% (2), relapsed refractory myeloma group, bortezomizomi group (22 cases) and non bortezomizomi group (18 cases), and ORR after 2 courses respectively: 59.1%, respectively after 2 courses respectively ( P0.05); after 4 course of treatment, ORR was respectively: 66.7%, 35.3% (P0.05). (3) 52 cases of bortezomizomi group (30 cases of early onset + 22 cases), respectively, PAD, PCD, PTD scheme, bortezomizomi group 30 cases of primary active myeloma, 2 course of ORR respectively: 75%, 71.4%, 75% (P0.05); 4 course ORR respectively: recurrent refractory myeloma patients bortex Zomi group 22 cases, 2 courses of ORR were 50%, 60%, 66.7% (P0.05), 4 courses of ORR were 66.7%, 66.7%, 66.7% (P0.05). (2) bortezomizomizomizomi group, 30 patients, 13 cases of subcutaneous injection and intravenous injection; chemotherapy and treatment course of treatment After the subcutaneous injection and intravenous injection group ORR were 76.9%, 70.6% (P0.05) and 84.6%, 76.4% (P0.05); (2) 22 patients in the bortezomizomi group with relapsed refractory myeloma group, 14 patients with subcutaneous injection and 8 intravenous injection; after the chemotherapy for 2 and 4 courses, the subcutaneous injection group and the intravenous group ORR were respectively: 64.3%, 50% (P 0.05) and 69.2%, 62.5% (P0.05); (3) all bortezomizo group 52 cases, subcutaneous injection group 27 cases, intravenous injection group 25 cases. After chemotherapy 2 and 4 course of treatment, the subcutaneous injection group and intravenous injection group ORR were 70.4%, 64% (P0.05) and 76.9%, 72% (P0.05). (3) high risk FISH detection. Primary active MM routine FISH detection, abnormal detection of abnormal, Among them, 3 cases were high risk group, 33 cases of relapsed refractory MM were detected by FISH, 18 cases were detected abnormality, among which 11 cases of high risk group were at high risk of high risk of FISH, P0.05. (4) after chemotherapy, 35 cases of renal dysfunction in patients with renal function after chemotherapy, 21 cases in bortezomizomi group and 14 cases of bortezomizomi group, bortezomizomi group, bortezomizomi group and bortezomib after the 2 course of treatment. The total remission rate of kidney function in Zomi group was 81%, 42.9% (P0.05).2. chemotherapy side effects: bortezomizomi group, more I~II grade, one over, reversible, and a few patients with III side effects, mainly myelosuppression (thrombocytopenia), peripheral neuropathy, non bortezomizomi group more I~III, and a few patients with grade IV Bone marrow suppression (granulocytopenia, anemia, thrombocytopenia). (1) peripheral neurotoxicity, 27 cases in subcutaneous injection group and 25 cases of intravenous injection group, 22.2%, 52% (P0.05); (2) blood system adverse reactions, bortezomizomi group 52 cases and non bortezomizomi group 38 cases, 23.1%, 44.7% (P0.05); (3) postoperative induction of chemotherapy Infection, bortezomizomi group 52 cases and non bortezomizomi group 38 cases, after chemotherapy, the infection rate was 30.8%, 52.6% (P0.05), (4) the digestive system adverse reaction, bortezomizomi group 52 cases and non bortezomizomi group 38 cases, the incidence of digestive system adverse reaction was 32.7%, 34.2% (P0.05). Conclusion: 1. containing bortezomib chemotherapy scheme to the first hair Active myeloma and relapsed refractory myeloma had a significant effect. Compared with the three schemes of bortezomizomi (P0.05).2. containing bortezomib, PAD, PCD, and PTD, there was no significant difference (P0.05) in the adverse reaction of.3.: bortezomizomizomi group was higher than that of the non bortezomizomi group (P0.05); in the hematological adverse reactions, the peripheral neurotoxicity of bortezomizomizomizomizomi was not significantly different. The incidence of infection was lower than that of the non bortezomizomi group (P0.05), and there was no difference between the two ways of subcutaneous injection of bortezomizomi and intravenous injection of bortezomizomi (P0.05) in the digestive tract adverse reactions (P0.05), and the incidence of peripheral neurotoxicity in subcutaneous injection group was lower than that of intravenous bortezomib (P0.05).5. bortezomizomi (P0.05). Renal damage in group A was better than that in non bortezomib group (P0.05). The rate of high risk FISH in.6. relapsed refractory myeloma group was higher than that in the early active multiple myeloma group (P0.05).
【学位授予单位】：青岛大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R733.3

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