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目的观察α-硫辛酸(ALA)对糖尿病病人周围神经病变的疗效及安全性。方法根据密歇根神经病变筛选法(MNSI)和症状筛选有周围神经病变的2型糖尿病病人95例,测定基线时的血清空腹血糖、胰岛素、糖化血红蛋白(HbA1c)、CRP 等水平后,随机分为两组:治疗组(n=52):ALA 600 mg 加入生理盐水250 ml 中静滴,每日1次,连续14 d;对照组(n=43):丹参20 ml 加入生理盐水250 ml 中静滴,每日1次,连续14 d。分别于用药前、用药7 d、14 d 进行症状总评分(TSS)、MNSI及症状改善程度的评估并记录。结果 50例治疗组和43例对照组病人完成了研究。ALA 治疗7 d时,TSS 比对照组明显下降,而反映体征的 MNSI 评分变化不大;ALA 治疗14 d后,TSS 及 MNSI 评分较治疗前显著降低(均 P<0.01),且 TSS 较同组用药7 d 时有进一步下降(P<0.05),病人的麻木、刺痛、烧灼感等感觉性症状评分也比治疗前和同期对照组明显降低(P<0.05)。治疗组病人总体满意度为90%,而对照组仅13.95%对疗效满意(P<0.01)。治疗组有1人在用药2 d 时轻微胸闷,其余无明显不适反应。结论 ALA 可有效改善2型糖尿病病人的周围神经病变,且副反应少。
Objective To observe the efficacy and safety of α-lipoic acid (ALA) on peripheral neuropathy in diabetic patients. Methods Ninety-five type 2 diabetic patients with peripheral neuropathies were screened according to the MNSI and symptoms. Serum fasting blood glucose, insulin, HbA1c and CRP were measured at baseline and then randomly divided into two groups Group: The treatment group (n = 52): intravenous drip of ALA 600 mg in 250 ml normal saline once daily for 14 days; control group (n = 43): Salvia miltiorrhiza 20 ml added intravenous infusion of 250 ml normal saline , Once daily for 14 consecutive days. The total symptom score (TSS), MNSI and symptom improvement were evaluated and recorded before treatment, 7 d and 14 d respectively. Results Fifty patients in the treatment group and 43 in the control group completed the study. After 7 days of ALA treatment, the TSS decreased significantly compared with the control group, while the changes of the MNSI score showed little change. After 14 days of ALA treatment, the TSS and MNSI scores were significantly lower than those before treatment (all P <0.01) The scores of sensory symptoms such as numbness, tingling and burning were significantly lower than those of the control group before and after treatment (P <0.05) on the 7th day after treatment. Overall satisfaction in the treatment group was 90%, while only 13.95% in the control group was satisfactory (P <0.01). One patient in the treatment group had slight chest tightness on the 2nd day of medication, and the rest had no obvious reaction. Conclusion ALA can effectively improve the peripheral neuropathy in patients with type 2 diabetes mellitus, with fewer side effects.