自体外周血单个核细胞治疗下肢缺血性疾病的临床研究

发布时间：2018-06-25 17:34

本文选题：单个核细胞 + 重度下肢缺血　；参考：《北京协和医学院》2016年博士论文

【摘要】：目的：重度下肢缺血(CLI, critical limb ischemia)是外周动脉疾病的最严重的阶段,主要由动脉硬化闭塞症引起(ASO, atherosclerosis obliterans)。近年来,干细胞成为治疗CLI的研究热点。该研究的目的是评价自体单个核细胞治疗动脉硬化闭塞症引起的重度下肢缺血的临床疗效和安全性。方法：分析1998年6月至2014年6月本院71例动脉硬化闭塞症引起的重度下肢缺血病患者的临床资料。其中,42人接受自体外周血单个核细胞(PBMNC, peripheral blood mononuclear cell)治疗,作为研究组；29人接受保守治疗,作为对照组。通过分析PBMNC组患者治疗前与治疗1月后疼痛、溃疡、无痛行走距离的变化情况评价PBMNC治疗CLI的短期疗效。随访两组患者治疗后3年内脱离重度下肢缺血(CLI-free, critical limb ischemia-free)、大截肢和死亡的情况,并随访3年内有无出现PBMNC治疗相关的不良反应。结果：PBMNC治疗1个月后,患者疼痛分级明显降低(P=0.000)、无痛行走距离明显延长(P=0.012),但溃疡评分无明显改善(P=0.317)。PBMNC治疗后第3年,患者脱离CLI率是65%,无截肢率是78.7%,总体生存率是75.3%,无截肢死亡率(AFS, amputation free survival)是63.9%。PBMNC组脱离CLI的结果明显好于对照组(P=0.011),但两组无截肢率、总体生存率和无截肢生存率均统计学差异(P=0.545,P=0.999,P=0.561)。最严重的不良反应是两名患者在注射PBMNC后分别出现了房颤并发急性心功能不全和可疑性急性心肌梗死。结论：PBMNC能缓解患者疼痛、延长无痛行走距离。PBMNC促进患者脱离CLI的疗效好于对照组,但对总体生存率影响不大。PBMNC对截肢率的影响需要进一步验证。治疗期间注意预防冠心病患者心肌缺血症的发作。目的：评价自体外周血单个核细胞(PBMNC, peripheral blood mononuclear cells)治疗血栓闭塞脉管炎(TAO, thromboangiitis obliterans)重度下肢缺血(CLI,critical limb ischemia)的临床疗效。方法：收集2004年7月至2013年5月本院22例血栓闭塞性脉炎患者的临床资料。研究组12例,接受PBMNC治疗；对照组10例,接受保守治疗。随访所有患者治疗后2年内溃疡愈合情况、脱离重度下肢缺血(CLI, critical limb ischemia)情况、截肢情况、死亡情况及不良反应情况。结果：研究组的溃疡愈合情况和脱离CLI情况明显优于对照组(溃疡愈合：P=0.016,脱离CLI：P=0.013)。研究组和对照组2年截肢率无差异(大截肢：P=0.361,总截肢P=0.867)。2年内无死亡病例、无不良反应。结论：与保守治疗相比,PBMNC能明显促进TAO患者溃疡愈合及脱离CLI,但两者对截肢的影响相同。目的：吸烟与ASO的发病有密切关系。该研究是为了评价吸烟在PBMNC治疗ASO中对截肢和死亡的影响作用。方法：连续收集2003年1月至2014年6月应用G-CSF动员的自体PBMNC治疗的ASO患者52例。分为吸烟组(25人)和非吸烟组(26人),用Log-rank方法对比分析两组的无截肢率、总体生存率和无截肢生存率；用COX单因素和多因素分析法分析PBMNC治疗后截肢和死亡的独立影响因素。结果：吸烟组的截肢率和死亡率高于非吸烟组(P0.05),吸烟组的无截肢生存率低于非吸烟组(P0.05)。截肢的独立危险因素有近期吸烟史、Fontanie分期、血红蛋白和血糖,死亡的独立危险因素有吸烟史和年龄。结论：近期吸烟是影响单个核细胞治疗下肢动脉硬化闭塞症后截肢和死亡的独立危险因素。
[Abstract]:Objective: severe lower limb ischemia (CLI, critical limb ischemia) is the most serious stage of peripheral artery disease, mainly caused by arteriosclerosis obliterans (ASO, atherosclerosis obliterans). In recent years, stem cells have become a research hotspot in the treatment of CLI. The purpose of this study is to evaluate the treatment of arteriosclerosis obliterans by autologous mononuclear cells. Clinical efficacy and safety of severe lower limb ischemia. Methods: the clinical data of 71 patients with severe lower limb ischemia caused by arteriosclerosis obliterans from June 1998 to June 2014 were analyzed. 42 of them received autologous peripheral blood mononuclear cells (PBMNC, peripheral blood mononuclear cell) as the study group; 29 patients received the study. A conservative treatment was used as a control group. The short-term efficacy of PBMNC in the treatment of CLI was evaluated by the changes of pain, ulcer, and painless walking distance in the PBMNC group before and after January. The two groups were followed up for 3 years after treatment with severe lower limb ischemia (CLI-free, critical limb ischemia-free), large amputation and death. In 3 years, there were no adverse reactions associated with PBMNC treatment. Results: after 1 months of PBMNC treatment, the pain classification of the patients decreased significantly (P=0.000) and the painless walking distance was significantly prolonged (P=0.012), but the ulcer score was not significantly improved (P=0.317) after third years of.PBMNC treatment, the rate of disengagement of CLI was 65%, no amputation rate was 78.7%, and the total survival rate was 75.3%, The mortality of amputation without amputation (AFS, amputation free survival) was significantly better than that in the control group (P=0.011), but there was no amputation rate in the two groups, the total survival rate and the amputation survival rate were statistically different (P=0.545, P=0.999, P=0.561). The most serious ungood reaction was the occurrence of atrial fibrillation in two patients after the injection PBMNC. Conclusion: PBMNC can relieve pain and prolong the distance of painless walking distance.PBMNC. The effect of CLI is better than that of the control group, but the effect of.PBMNC on the amputation rate is less than that of the total survival rate. Objective: To evaluate the clinical efficacy of autologous peripheral blood mononuclear cells (PBMNC, peripheral blood mononuclear cells) in the treatment of thrombovasculitis obliterans (TAO, thromboangiitis obliterans) with severe lower limb ischemia (CLI, critical limb ischemia). Methods: 22 cases of thrombotic occlusive vasculitis in our hospital from July 2004 to May 2013 were collected. The clinical data of the patients. 12 cases in the study group were treated with PBMNC, and 10 cases in the control group were treated with conservative treatment. All the patients were followed up for 2 years of ulcer healing, from severe lower limb ischemia (CLI, critical limb ischemia), amputation, death and adverse reactions. Results: the ulcer healing and disengagement of the study group. CLI was significantly better than the control group (ulcer healing: P=0.016, out of CLI:P=0.013). There was no difference in amputation rate between the study group and the control group for 2 years (large amputation: P=0.361, total amputation P=0.867) without death in.2 years. Conclusion: compared with conservative treatment, PBMNC can obviously promote the healing of ulcers and escape CLI in TAO patients, but both of them are amputated. Objective: smoking is closely related to the incidence of ASO. This study was designed to evaluate the effect of smoking on amputation and death in the PBMNC treatment of ASO. Methods: 52 consecutive ASO patients with G-CSF mobilization from January 2003 to June 2014 were collected and divided into smoking group (25) and non smoking group (26), and Log- Rank method was used to compare the amputation rate, total survival rate and no amputation survival rate in two groups. COX single factor and multiple factor analysis were used to analyze the independent factors of amputation and death after PBMNC treatment. Results: the amputation rate and mortality rate of smoking group were higher than that of non smoking group (P0.05), and the survival rate of amputation in smoking group was lower than that of non smoking group (P0.05). Independent risk factors for amputation include the history of smoking in the near future, Fontanie staging, hemoglobin and blood sugar, and the independent risk factors for death are smoking history and age. Conclusion: recent smoking is an independent risk factor for the treatment of amputation and death after the treatment of arteriosclerosis obliterans of lower extremity by mononuclear cells.
【学位授予单位】：北京协和医学院
【学位级别】：博士
【学位授予年份】：2016
【分类号】：R543.5

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