蓉丹口服液干预糖尿病性周围神经病变的疗效观察

Efficacy of Rong Dan oral liquid for intervention of diabetic peripheral neuropathy

目的评估纯中药制剂蓉丹口服液干预糖尿病性周围神经病变（DPN）的疗效。方法采用前瞻性的研究方法，2013年7月至2014年2月广州医科大学附属第一医院内分泌专科门诊符合纳入标准的合并DPN的2型糖尿病患者31例，在饮食及运动治疗、降糖方案不变的基础上，给予蓉丹口服液（20ml，每天3次）干预12周，分别采用密歇根神经病变筛查量表（MNSI）症状评分法以及神经传导速度（NCV）检测法，评估该药在DPN主观症状及客观指标方面的疗效，同时比较治疗前后体质量、血压、心率、空腹血糖（FPG）、糖化血红蛋白（HbA1c）、肝肾功能、心电图、血脂谱、眼底改变以及白蛋白尿排泄的变化，相关分析MNS1分值与NCV幅度的关系。结果干预12周的结果显示，患者皮肤干燥开裂、趾端麻木、刺痛、灼痛感、感觉过敏等症状的比例较干预前均有不同程度下降，其中皮肤干燥开裂（32．2％比87．1％）及感觉过敏（3．2％比25．8％）减少的比例差异有统计学意义（均P〈0．05）。MNS1分值较干预前下降[（3．54±0．69）分比（4．46±0．69）分，P=0．00]，NCV则明显上升[（45．2±5．1）m／s比（39．2±5．7）m／s，P=0．00]。干预前后患者体质量、血压、心率、FPG、HbA1c、血脂谱、肝肾功能、心电图、眼底检查等无明显差异（均P〉0．05）。尿白蛋白排泄率较干预前下降[（1．09±0．62）μg／min比（1．27±0．67）μg／min，P=0．001]。相关分析结果显示，MNSl分值与NCV幅度呈负相关关系（r=-0．429，P=0．05）。结论蓉丹口服液有助于改善DPN患者的多种症状，尤其在足部皮肤干燥开裂及感觉过敏方面，且能有效提高患处神经传导速度、一定幅度减少尿白蛋白排泄率，安全性良好。

Objective To evaluate the efficacy of a pure Chinese herbal product, Rong Dan oral liquid, in intervention of diabetic peripheral neuropathy （DPN）. Methods This was a prospective study from July 2013 to February 2014. Thirty-one patients with DPN-complicating type 2 diabetes, who visited Endocrinology clinic at the First Affiliated Hospital, Guangzhou Medical University and met the inclusion criteria, were included. In addition to their dietary modification, exercise program and hypoglycemic scheme, the patients received Rong Dan oral liquid （20 ml, 3 times daily） for 12 weeks. Michigan Neuropathy Screening Instrument （MNSI） symptom scores and nerve conduction velocity （NCV） were assessed to evaluate the efficacy of Rong Dan oral liquid in improving subjective symptoms and objective measures of DPN. Meanwhile, the body weight, blood pressure, heart rate, fasting plasma glucose （FPG） , glycosylated hemoglobin （HbA1c）, liver and kidney functions, ECG, lipid profile, fundus and albuminuria excretion of the patients were compared before and after treatment. Correlation analysis was used to determine the relationship between MNSI scores and NCV. Results After 12 weeks of intervention, patients showed various degree of symptomatic improvents in drying cracks skin, toe numbness, tingling, burning sensation and hyperesthesia compared with before the intervention. In particular, there were statistically significant differences in reduction of drying cracks skin （32.2% vs 87.1% ） and hypersensitivity （3.2% vs 25.8% ） （both P〈0.05）. Compared with pre-intervention, MNSI scores decreased [ （3.54±0.69） min vs （4.46±0.69） min, P=0.00] and NCV increased significantly [ （45.2±5.1） m/s vs （39.2±5.7） m/s, P=0.00]. After the intervention, The body weight, blood pressure, heart rate, FPG, HbA1c, lipid profile, liver and kidney functions, ECG, fundus examination in the patients did not change significantly from baseline （all P〉0.05）. Urinary albumin excretion rate was reduced compared with that before the intervention [ （1.09±0.62） tag/rain vs （1.27±0.67） μg/min, P=0.0011. Correlation analysis showed that MNSI scores were negatively correlated with and NCV （r=-0.429, P=0.05）. Conclusion Rong Dan oral liquid may help improve a number of symptoms related to DPN, especially in dry/cracking skin and hyperesthesia of the feet. To a certain extent, Rong Dan oral liquid may also effectively improve the nerve conduction velocity at affected sites of the body, and reduce urinary albumin excretion rate. Rong Dan oral liquid is well-tolerated.