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目的评价自体骨髓单个核细胞(bone marrow mononuclear cells,BM-MNC)移植治疗糖尿病重症下肢动脉硬化闭塞症(arteriosclerosis obliterans,ASO)的安全性和长期疗效。方法选择2007年1月-2010年1月收治的61例糖尿病重症下肢ASO患者,随机分为2组。对照组29例采用内科常规治疗,治疗组32例在内科常规治疗基础上行自体BM-MNC移植。两组患者性别、年龄、病程、Fontatine分期以及动脉硬化风险指标血糖、甘油三脂(triglyceride,TG)、总胆固醇(total cholesterol,CHOL)、低密度脂蛋白胆固醇(low density lipoprotein-cholesterol,LDL-C)、糖化血红蛋白(hemoglobin A1c,HbA1c)、收缩压(systolic blood pressure,SBP)、舒张压(diastolic blood pressure,DBP)等一般资料比较,差异均无统计学意义(P>0.05)。记录两组患者死亡及截肢情况,以死亡或截肢作为随访终点,检查并比较治疗前及末次随访时两组患者动脉硬化风险指标。结果两组患者均获随访,随访时间2~36个月,随访期间均未发生恶性肿瘤,对照组总生存(overall survival,OS)率为82.76%(24/29)、OS时间为(32.31±9.08)个月、总保肢生存(amputation-free survival,AFS)率为37.50%(9/24)、AFS时间为(21.28±13.35)个月,治疗组分别为78.13%(25/32)、(32.47±6.96)个月、68.00%(17/25)、(28.38±9.48)个月,两组比较差异均无统计学意义(P>0.05)。逐年分析显示,除治疗后1年对照组AFS时间明显短于治疗组(t=2.806,P=0.007)外,两组治疗后1、2、3年的OS率、OS时间、AFS率、AFS时间比较差异均无统计学意义(P>0.05)。共49例存活患者(对照组24例、治疗组25例)获得有效随访,血糖、TG、CHOL、LDL-C、HbA1c、SBP、DBP两组内治疗前后比较以及治疗前后两组间比较,差异均无统计学意义(P>0.05)。结论自体BM-MNC移植结合内科药物治疗糖尿病重症下肢ASO可显著提高患者3年AFS率,延长3年AFS时间且未增加其他恶性风险因素。
Objective To evaluate the safety and long-term efficacy of autologous bone marrow mononuclear cells (BM-MNC) transplantation in the treatment of diabetic lower extremity arteriosclerosis obliterans (ASO). Methods Sixty-one ASO patients with severe lower extremity diabetes mellitus were selected from January 2007 to January 2010 and were randomly divided into two groups. Control group, 29 cases of conventional medical treatment, the treatment group, 32 cases of conventional medical treatment based on autologous BM-MNC transplantation. The levels of blood glucose, triglyceride (TG), total cholesterol (CHOL), low density lipoprotein-cholesterol (LDL-C) and the risk of arteriosclerosis in both groups were analyzed by sex, age, C, HbA1c, systolic blood pressure (SBP), diastolic blood pressure (DBP), etc. There was no statistical difference between the two groups (P> 0.05). The death and amputation of two groups were recorded. The death or amputation was taken as the end point of follow-up. The risk indicators of atherosclerosis in both groups before and at the last follow-up were examined and compared. Results The patients were followed up for 2 to 36 months. No malignant tumor occurred during the follow-up. The overall survival rate (82.76%) in the control group was (82.76%), the OS time was (32.31 ± 9.08) months, the total amputation-free survival rate was 37.50% (9/24), the AFS duration was (21.28 ± 13.35) months, and the treatment group was 78.13% (25/32) (32.47 ± 6.96) months, 68.00% (17/25) and (28.38 ± 9.48) months, respectively. There was no significant difference between the two groups (P> 0.05). The yearly analysis showed that the OS rates, OS time, AFS rate, AFS and AFS were significantly higher in the two groups at 1, 2 and 3 years after treatment than those in the treatment group (t = 2.806, P = 0.007) There was no significant difference in time (P> 0.05). A total of 49 survivors (control group, 24 cases, treatment group, 25 cases) were followed-up, blood glucose, TG, CHOL, LDL-C, HbA1c, SBP, DBP within two groups before and after treatment compared before and after treatment, the difference between the two groups No statistical significance (P> 0.05). Conclusion Autologous BM-MNC transplantation combined with medical treatment of diabetic lower extremity ASO can significantly improve the 3-year AFS rate, prolong the 3-year AFS time without increasing other malignant risk factors.