| 张鸿秋,朱虹霞.血塞通胶囊联合 α?硫辛酸治疗气虚血瘀证 2型糖尿病周围神经病变疗效及对血清肿瘤坏死因子 ?α、白细胞介素 ?1β的影响[J].安徽医药,2020,24(7):1448-1452. |
| 血塞通胶囊联合 α?硫辛酸治疗气虚血瘀证 2型糖尿病周围神经病变疗效及对血清肿瘤坏死因子 ?α、白细胞介素 ?1β的影响 |
| Research on clinical effect of Xuesaitong capsule combined with α?lipoic acid and its effect on serum TNF?α and IL?1β of patients with Type 2 diabetic peripheral neuropathy with Qi deficiency and blood stasis syndrome |
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| DOI：10.3969/j.issn.1009?6469.2020.07.045 |
| 中文关键词: 糖尿病神经病变/药物疗法 气虚血瘀 肿瘤坏死因子 α 白细胞介素 1β 血塞通胶囊 α?硫辛酸 于对， |
| 英文关键词: Diabetic neuropathies/drug therapy Qi?deficiency blood stasis Tumor necrosis factor?alpha Interleukin?1beta Xuesaitong capsule Alpha?lipoic acid |
| 基金项目:国家中医药管理局国家基本公共卫生服务项目( 20131012) |
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| 目的观察血塞通胶囊联合 α?硫辛酸治疗气虚血瘀证 2型糖尿病周围神经病变( DPN)的疗效和安全性以及对病人血清肿瘤坏死因子 ?α(TNF?α)、白细胞介素 ?1β(IL?1β)的影响。方法选取 2016年 10月至 2018年 10月在阜阳市人民医院就诊的 DPN病人，采用随机数字表法分为治疗组 40例，对照组 40例。入组病人在糖尿病基础治疗的基础上，治疗组予以 α?硫辛酸注射液 600 mg静脉滴注， 1次/天，同时予以中成药血塞通胶囊 0.1 g冲服， 3次/天，共 12周。对照组静脉滴注 α?硫辛酸注射液 600 mg，1次/天，共 12个周。记录病人治疗前后的临床疗效、主侧正中神经、腓总神经的运动神经传导速度( MCV)及感觉神经传导速度( SCV)，进行多伦多临床评分系统( TCSS)评分、中医证候评分与安全性观察，于治疗前、治疗 6周、 12周，利用 ELISA法检测血清 TNF?α、IL?1β水平。结果经过 12个周治疗后，治疗组和对照组总有效率分别为 87.5％( 35/40)、 67.5％( 27/40)治疗组的疗效比对照组提升明显( P＜0.05)。两组病人的 MCV、SCV均比治疗前有明显提升，且治疗组的提高更加明显( P＜0.0，5)。治疗组病人治疗后 TCSS评分( 7.2±3.0)分和中医证候评分( 7.5±2.4)分均较治疗前 TCSS评分( 10.1±2.9)分和中医证候评分(13.7±2.8)分及对照组治疗后 TCSS评分( 8.6±2.9)分和中医证候评分( 9.4±3.1)分明显下降( P＜0.05)。两组病人随着治疗时间的延长，血清中的 TNF?α、IL?1β水平逐渐降低( P＜0.05)且治疗组 6周 TNF?α(28.2±2.7)mg/L、IL?1β(18.5±2.1)mg/L水平， 12周 TNF?α(19.8±3.2)mg/L、IL?1β(11.3±2.0)mg/L水平均低照组 6周 TNF?α(32.6±4.5)mg/L、IL?1β(23.9±2.0)mg/L水平， 12周 TNF?α(28.5±3.4)mg/L、IL?1β(16.6±1.9)mg/L水平( P＜0.05)。治疗组和对照组均未出现明显不良反应。结论血塞通胶囊联合 α?硫辛酸治疗气虚血瘀证 DPN病人疗效显著，安全性好，能降低病人血清 TNF?α、IL?1β的表达。 |
| 英文摘要: |
| Objective To observe the efficacy and safety of xuesaitong capsule combined with α?lipoic acid in the treatment oftype 2 diabetic peripheral neuropathy(DPN)with qi?deficiency and blood stasis syndrome，and the effect on serum TNF?α and IL? 1β of the patients.Methods From October 2016 to October 2018，DPN patients who were treated in Fuyang People’s Hospital were selected through random number table method，80 DPN patients were randomly divided into two groups，40 in the treatment group and 40 in the control group.On the basis of the basic treatment of diabetes，the treatment group was given intravenous infu? sion of alpha?lipoic acid injection 600 mg，once a day，and Chinese patent medicine xuesaitong capsule 0.1g，3 times a day for 12weeks.The control group received intravenous infusion of alpha?lipoic acid injection 600mg once a day for 12 weeks.The clinical ef?ficacy，motor nerve conduction velocity(MCV)and sensory nerve conduction velocity(SCV)of the central median nerve and the common peroneal nerve before and after treatment were recorded，and perform multiple rounds of clinical scoring system(TCSS) score，TCM syndrome score and safety observation.Before treatment，6 weeks，12 weeks of treatment，serum TNF?α and IL?1β levels were detected by ELISA.Results After 12 weeks of treatment，the total effective rate of the treatment group and the control group was 87.5%(35/40)and 67.5%(27/40)，respectively.The therapeutic effect of the treatment group was significantly improved com? pared with that of the control group(P＜0.05).MCV and SCV in both groups were significantly improved compared with that be? fore treatment，and the improvement was more obvious in the treatment group(P＜0.05).After treatment，TCSS score(7.2±3.0)and TCM syndrome score(7.5±2.4)in treatment group were significantly lower than before treatment TCSS score(10.1±2.9)and TCM syndrome score(13.7±2.8)(P＜0.05)，and after treatment TCSS score(8.6±2.9)and TCM syndrome score(9.4±3.1)in control group.The serum levels of TNF?α and IL?1β in the two groups decreased gradually with the prolongation of treatment time(P＜0.05)， and the levels of 6 weeks TNF?α(28.2±2.7)mg/L and IL?1β(18.5±2.1)mg/L and 12 weeks TNF?α(19.8±3.2)mg/L and IL?1βIL?1β(11.3±2.0)mg/L in the treatment group were lower than the levels of 6 weeks TNF?α(32.6±4.5)mg/L and IL?1β(23.9±2.0)mg/L and 12 weeks TNF?α(28.5±3.4)mg/L and IL?1β(16.6±1.9)mg/L in the control group(P＜0.05).No significant adverse reactions occurred in the treatment group and the control group.Conclusion Xuesaitong capsule combined with α?lipoic acid is effectiveand safe in the treatment of diabetic peripheral neuropathy with qi?deficiency and blood stasis，and can reduce the expression of TNF?α and IL?1β in serum. |
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