机构地区:[1]广州医科大学附属第一医院内分泌科,广东广州510120 [2]广州医科大学附属第一医院肌电图室,广东广州510120
出 处:《转化医学电子杂志》2017年第4期34-39,共6页E-Journal of Translational Medicine
摘 要:目的:观察蓉丹口服液干预糖尿病周围神经病变(DPN)的临床疗效.方法:该项为期12周、随机、对照的临床研究共纳入DPN患者85例,其中蓉丹口服液组(蓉丹组,n=34)、甲钴胺组(n=34)及对照组(n=17).主要观察指标包括神经症状、体征评分(密歇根神经病变筛查量化表,MNSI)、神经肌电图结果、血清内皮素-1(ET-1)、胱抑素-C(Cys-C)、不良反应等.结果:①3组患者的血糖、Cys-C、ET-1、MNSI症状分值、体征分值神经传导速度(NCV)、波幅基线比较,差异无统计学意义(P>0.05).②蓉丹组干预后Cys-C、ET-1水平均显著低于基线,差异具有统计学意义(P<0.05),而甲钴胺组干预前后无明显变化,对照组干预后ET-1水平较基线值呈上升趋势,而Cys-C则无明显变化.③蓉丹组及甲钴胺组干预后MNSI症状分值、体征分值显著低于基线(P<0.05),两组间干预前后ΔMNSI症状、体征分值比较,差异无统计学意义(P>0.05).④蓉丹组及甲钴胺组干预后NCV、波幅显著高于基线,差异具有统计学意义(P<0.05),对照组呈下降趋势(P<0.05);蓉丹组及甲钴胺组干预前后ΔNCV、Δ波幅显著高于对照组(P<0.05),两组间干预前后ΔNCV比较,差异无统计学意义(P>0.05),但蓉丹组干预前后Δ波幅显著高于甲钴胺组,差异具有统计学意义(P<0.05).结论:采用蓉丹口服液干预12周能显著改善DPN患者的临床症状,有效提高NCV、波幅,尤其在改善足部皮肤干燥开裂、波幅方面效果优于甲钴胺,且能降低血清Cys-C、ET-1水平,在治疗DPN中安全有效.AIM: To evaluate the clinical efficacy of Rongdan oral liquid on diabetic peripheral neuropathy. METHODS: A total of 85 patients with diabetic peripheral neuropathy were enrolled in the study, and randomly divided into Rongdan oral liq- uid group ( Rongdan group, rt = 34 ), methyleohalamine group (n=34), and control group (n = 17). Therapeutic effect was assessed according to clinical symptoms and physical examinations by using Michigan Neuropathy Screening Instrument (MNSI), eleetrophysiological test and serum biomarkers, which included cystatin-C ( Cys-C ), endothelin-1 ( ET-1 ) and so on. During the follow-up medication, it is necessary to record the adverse reac- tions of medication. RESULTS: No significant differences were found among three groups of the baseline of blood glucose, Cys-C, ET-1, MNSI scores, nerve conduction velocity(NCV) and ampli- tude. Serum level of Cys-C and ET-1 after Rongdan intervention was significantly lower than those of baseline, with statistically significant differences (P〈0.05). While no differences were no- ticed between baseline and after intervention in methylcobalamine group, and the serum level of ET-1 was increased than before. There was no obvious change of Cys-C. Compared with the base- line, MNSI scores after intervention decreased significantly in Rongdan group and methylcobalamine group, with statistically significant differences ( P 〈 0.05 ), There were no statistically significant differences between Rongdan group and methylcobal- amine group in AMNSI scores ( P 〉 0.05 ). Compared with the baseline, NCV and amplitude after intervention increased signifi- candy in Rongdan group and methylcobalamine group, while a decrease was found in control group after 12 weeks, with statisti- cally significant differences (P〈0.05). ANCV and Aamplitude in Rongdan group and methylcobalamine group were significantly higher than those of control group, with statistically significant differences (P〈0.05). There were no dif
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