机构地区:[1]锦州市中心医院内分泌科,辽宁锦州121000 [2]锦州市中心医院骨科,辽宁锦州121000 [3]解放军第302医院感染病诊疗与研究中心 [4]中国医师协会-中国武警总医院细胞治疗标准化临床研究中心
出 处:《中国修复重建外科杂志》2015年第7期893-898,共6页Chinese Journal of Reparative and Reconstructive Surgery
基 金:辽宁省教育厅创新团队资助项目(LT2012016)~~
摘 要: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AFSObjective To assess the long-term effectiveness and safety of autologous bone marrow mononuclear cells(BM-MNC) transplantation in the treatment of critical diabetic lower arteriosclerosis obliterans(ASO).Methods Between January 2007 and January 2010, 61 patients with critical diabetic lower ASO were treated with standard medical therapies in 29 cases(control group) or with standard medical therapies and autologous BM-MNC transplantation in 32 cases(treatment group). There was no significant difference in gender, age, disease duration,Fontatine stage, glucose(GLU), triglyceride(TG), total cholesterol(CHOL), low-density lipoprotein-cholesterol(LDL-C),hemoglobin A1c(HbA1c), systolic blood pressure(SBP), and diastolic blood pressure(DBP) between 2 groups(P〉0.05).The endpoints were overall survival(OS) and amputation-free survival(AFS). The risk indexes for ASO were observed and compared between 2 groups before and after treatments. Results The patients were followed up 2-36 months, and no malignant tumor occurred. The OS rate, OS time, AFS rate, and AFS time were 82.76%(24/29),(32.31±9.08) months,37.50%(9/24), and(21.28±13.35) months in the control group and were 78.13%(25/32),(32.47±6.96) months, 68.00%(17/25), and(28.38±9.48) months in the treatment group; all indexes showed no significant differences(P〉0.05). OS rate,OS time, AFS rate, and AFS time showed no significant differences between 2 groups at the other time(P〉0.05) except AFS time at 1 year, which was significantly short in the control group than the treatment group(t=2.806, P=0.007). At the endpoint of follow-up, the indexes of GLU, TG, CHOL, LDL-C, HbA1 c, SBP, and DBP showed no significant differences between before and after treatments and between 2 groups(P〉0.05) in 49 survival patients(24 in control group and 25 in treatment group). Conclusion Autologous BM-MNC transplantation is safe and effective in the treatment of critical diab
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