银丹心脑通软胶囊联合α-硫辛酸注射液治疗糖尿病周围神经病变49例

Effect of Soft Capsule of Yindan Xinnaotong Combined with DL-thioctic Acid in Treating 49 Cases with Diabetic Peripheral Neuropathy

目的:观察银丹心脑通软胶囊联合α-硫辛酸注射液治疗糖尿病周围神经病变的临床疗效及机制探讨。方法:将98例糖尿病周围神经病变患者随机按数字表法分为治疗组和对照组各49例;两组患者均接受糖尿病的常规治疗。对照组给予α-硫辛酸注射液静脉滴注治疗,600 mg/次,1次/d;治疗组在对照组治疗的基础上口服银丹心脑通软胶囊,4粒/次,3次/d;两组疗程均为4周。触觉用尼龙丝单丝法检测,温度觉采用Tip Thcrm温度浅感觉仪检测;腱反射检测包括踝反射及膝反射检测,采用多伦多临床神经病变(TCSS)进行评分;证候积分参照糖尿病症状分级量化表进行评分;检测两组患者治疗前后正中神经、腓总神经的运动神经传导速度(MNCV)及感觉神经传导速度(SNCV)的变化,检测治疗前后血糖、血脂、血清丙二醛(MDA),一氧化氮(NO),超氧化物歧化酶(SOD)和血管内皮素(ET-1)水平。结果:治疗组临床总有效率为89.8%,对照组为73.47%,治疗组优于对照组(P<0.05);治疗后治疗组的正中神经MNCV和SNCV传导速度明显高于对照组(P<0.05);两组患者治疗后血糖均比治疗前下降(P<0.01),但两组间比较无统计学意义;治疗组治疗后血脂水平较治疗前显著下降(P<0.01);治疗后治疗组患者血清SOD和NO水平均明显高于对照组(P<0.05);治疗后治疗组血清MDA和ET-1水平均低于对照组(P<0.05)。结论:银丹心脑通软胶囊联合α-硫辛酸注射液治疗糖尿病周围神经病变临床疗效显著,其作用机制可能与调节血脂代谢和MDA,SOD,NO及ET-1水平有关。

Objective： To observe the clinical effect of soft capsule of Yindan Xinnaotong combined with DL-thioctic acid in the treatment of diabetic peripheral neuropathy and explore its mechanisms. Method： Ninety- eight patients with diabetic peripheral neuropathy were randomly divided into observation group and control group by the number table method, with 49 patients in each group. The patients in both groups received conventional treatment. The patients in control group were given Lipoic acid injection with 600 mg/time and qd. In addition to the therapy of control group, patients in treatment group were given 4 pieces soft capsules of Yindan Xinnaotong, tid. Both groups received a 4-week treatment. Tactile sensation and temperature sensation were detected by Semmes-weinstein method and Tip Thcrem sensation detector method respectively. Tendon jerk includes knee jerk and ankle jerk. Toronto clinical scoring system （TCSS） was used to evaluate the aforementioned detection. Sensory nerve conduction velocity （SNCV） and motor nerve conduction velocity （MNCV） for median nerve and peroneal nerve in both groups were observed, and blood sugar and blood lipids, the level of serum acetylcholinesterase malondialdehyde （MDA） , nitric oxide （NO） , superoxide dismutase （SOD） and endothelin-1 （ ET-1 ） were compared between two groups. Result： The total effective rate in the treatment group was 89.8% , which was superior to 73.47% in the control group （P 〈 0. 05）. After treatment, SNCV and MNCV of median nerve for patients in treatment groups were higher than those of control （P 〈 0.05 ）. After treatment, level of blood sugar wasdecreased in both groups （P 〈 0.05） , but with no significant difference between them. Blood lipids were obviously decreased in treatment group than before the treatment （P 〈0.01）. After treatment, levels of SOD and NO in the treatment group were higher than those of control group （P 〈 0.05）, while levels of MDA and ET-1 in the treatment group were lower than the control group （P 〈 0.05）. Conclusion： The curative effect of soft capsule of Yindan Xinnaotong combined with DL-thioctic acid is efficient in treating diabetic peripheral neuropathy, and its mechanism may be related with adjustment of the organism lipid metabolism and levels of MDA, SOD, NO and ET-1.