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目的评价α-硫辛酸(ALA)联合普瑞巴林(PGB)在糖尿病痛性周围神经病变(DPNP)治疗中的有效性和安全性,为糖尿病并发症的治疗提供依据。方法选择DPNP患者90例,男性41例,女性49例,随机分为3组:甲钴胺组、ALA组和ALA联合PGB组,每组30例。各组患者予以控制血糖,分别用甲钴胺、ALA以及ALA联合PGB治疗,4周后观察各组疗效、神经传导速度以及不良反应。结果与治疗前比较,治疗后各组患者疼痛程度均下降,差异有统计学意义(P<0.05)。ALA联合PGB组临床总有效率(86.7%)高于甲钴胺组(60.0%)和ALA组(66.7%),差异有统计学意义(P<0.05)。与治疗前比较,治疗后各组的神经传导速度均增加,差异均有统计学意义(P<0.05)。与甲钴胺组治疗后比较,ALA组治疗后正中神经的感觉神经传导速度[(53.6±3.9)m/s]以及腓总神经的运动神经传导速度[(52.6±4.2)m/s]和感觉神经传导速度[(52.1±3.6)m/s]增加,差异均有统计学意义(P<0.05)。与甲钴胺组治疗后比较,ALA联合PGB组治疗后腓总神经的感觉神经传导速度[(51.9±4.1)m/s]以及正中神经的运动神经传导速度[(54.1±3.7)m/s]和感觉神经传导速度[(54.2±3.6)m/s]增加,差异有统计学意义(P<0.05)。3组均未观察到需要临床干预或中止治疗的不良反应。结论 ALA联合PGB可以有效地修复神经,缓解疼痛,提高患者的生活质量,同时具有一定的安全性,为临床治疗DPNP提供一种较好的选择。
Objective To evaluate the efficacy and safety of α-lipoic acid (ALA) combined with pregabalin (PGB) in the treatment of diabetic peripheral neuropathy (DPNP) and provide evidence for the treatment of diabetic complications. Methods Ninety patients with DPNP, 41 males and 49 females were randomly divided into three groups: mecobalamin group, ALA group and ALA combined with PGB group, 30 cases in each group. The patients in each group were given blood glucose control. Mecobalamin, ALA and ALA combined with PGB were given respectively. After 4 weeks, the curative effect, nerve conduction velocity and adverse reactions of each group were observed. Results Compared with those before treatment, the pain scores of all the groups decreased after treatment, the difference was statistically significant (P <0.05). The total effective rate (86.7%) in ALA combined with PGB group was significantly higher than that in methylcobalamin group (60.0%) and ALA group (66.7%) (P <0.05). Compared with those before treatment, the nerve conduction velocity in each group increased after treatment, the differences were statistically significant (P <0.05). Compared with the mecobalamin group, the sensory nerve conduction velocity (53.6 ± 3.9) m / s and the motor nerve conduction velocity (52.6 ± 4.2) m / s) in the ALA group and Sensory nerve conduction velocity [(52.1 ± 3.6) m / s] increased, the differences were statistically significant (P <0.05). Compared with the mecobalamin group, the sensory nerve conduction velocity (51.9 ± 4.1) m / s) and the motor nerve conduction velocity (54.1 ± 3.7) m / s in the median nerve after ALA plus PGB treatment ] And sensory nerve conduction velocity [(54.2 ± 3.6) m / s], the difference was statistically significant (P <0.05). No adverse reactions requiring clinical intervention or discontinuation of treatment were observed in all three groups. Conclusions ALA combined with PGB can effectively repair nerves, relieve pain and improve the quality of life of patients with a certain degree of safety, providing a better choice for clinical treatment of DPNP.