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目的 :探讨脐带间充质干细胞(UC-MSC)治疗结缔组织病的安全性。方法 :80例次接受UC-MSC静脉输注治疗的结缔组织病患者作为研究对象,按不同病种、一次及多次治疗、血沉、补体进行分组,统计分析各种不良反应的发生率,并对不良反应的危险因素进行Logistic多因素回归分析,判断具有独立作用的危险因素。结果:发生不良反应36例次,发生率为45.0%(36/80);其中发热最多,占总体不良反应的58.3%(21/36),其余分别为头痛、头昏、乏力、恶心、胸闷、潮红、口干和肌肉酸痛。系统性红斑狼疮(SLE)患者中发热占42.9%,非SLE组患者中发热占17.3%,SLE组发热概率明显高于非SLE组(χ2=6.137,P=0.013)。一次治疗组有反应的例次22例(61.1%),多次治疗组有反应的例次15例(34.1%),一次治疗组不良反应发生率高于多次治疗组,两组之间比较差异具有统计学意义(χ2=5.815,P=0.016);不同年龄、性别、血沉下降和血沉正常、低补体和正常补体组别之间不良反应无明显差别。Logistic多因素回归分析显示一次输注(β=1.944,OR=6.985)、SLE是不良反应的独立危险因素(β=1.352,OR=3.863)。结论 :UC-MSC静脉输注治疗结缔组织病的的不良反应主要为发热,SLE和一次输注是不良反应的高危因素。
Objective: To investigate the safety of umbilical cord mesenchymal stem cells (UC-MSCs) for treating connective tissue diseases. Methods: Eighty cases of patients with connective tissue disease treated by UC-MSC infusion were divided into groups according to different disease types, primary and multiple treatments, ESR and complement, and the incidence of various adverse reactions were statistically analyzed. The risk factors for adverse reactions were analyzed by Logistic regression analysis to determine the risk factors with independent effects. Results: The incidence of adverse reactions was 36 cases (36/80), with the incidence of 45.0% (36/80), of which the most was fever, accounting for 58.3% (21/36) of the overall adverse reactions. The rest were headache, dizziness, fatigue, nausea, , Flushing, dry mouth and muscle aches. Fever was found in 42.9% of patients with systemic lupus erythematosus (SLE), 17.3% of those in non-SLE patients, and significantly higher in SLE patients than in non-SLE patients (χ2 = 6.137, P = 0.013). There were 22 cases (61.1%) in one treatment group, 15 cases (34.1%) in multiple treatment group, and the incidence of adverse reactions in one treatment group was higher than that in multiple treatment group. The comparison between the two groups The difference was statistically significant (χ2 = 5.815, P = 0.016). There were no significant differences in adverse reactions between low complement and normal complement groups with different age, gender, decline of ESR and normal erythrocyte sedimentation rate. Logistic regression analysis showed that one infusion (β = 1.944, OR = 6.985), SLE was an independent risk factor for adverse reactions (β = 1.352, OR = 3.863). CONCLUSION: The adverse reactions of UC-MSC intravenous infusion for the treatment of connective tissue disease are mainly fever, SLE and one infusion are the risk factors of adverse reactions.