“消疽1号”对糖尿病足坏疽微循环变化临床研究
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摘要
目的 以中医辨证论治的思想为指导，采用中药制剂“消疽1号”治疗糖尿病足坏疽，以山莨菪碱作对照，探讨中药对糖尿病足坏疽（气阴两虚型）微循环障碍的改善作用。同时初步阐述其作用机制。
方法 本研究将受试对象分为两组。治疗组24例，以消疽1号口服治疗；对照组24例，山莨菪碱静脉滴注。1个月为1个疗程。于治疗前和1个疗程后分别做血液流变学、甲皱微循环、足背血流变化和踝肱指数检测，将中药改善糖尿病足坏疽（气阴两虚型）微循环变化与对照组治疗的疗效相比较。
结果 治疗组愈显率87.50%，总有效率95.83%，对照组愈显率45.83%，总有效率91.67%。两组疗效比较有显著性差异，“消疽1号”（治疗组）组疗效优于山莨菪碱（对照组）组。
结论 益气养阴、和营解毒的代表方剂“消疽1号”，通过对微循环障碍的改善调节作用对于气阴两虚型糖尿病足坏疽具有良好的临床疗效，其效果肯定，且无毒副作用，为临床上中医药治疗糖尿病足坏疽提供了新的治疗方案
Objective: To discuss the effect of diabetic foot gangrene belong to qi and yin deficience type treated by“xiaojuⅠ” based on the theory of TCM compared with 654-2 and study its mechanism on the disorder of microcirculation.
Methods: Patients with diabetic foot gangrene lesions were randomly divided into two groups: treatment group and control group, each group containing 24 cases. One month was a course of treatment. Under the same basic treatment, the treatment group was treated with Chinese Materia Medicine , while the control group with the rest 24 cases was treated with anisodamine(654-2). The methods had been applied to the two groups differently for a course of treatment. We observed the changes of blood rheology and nail fold microcirculation and etc in 48 patients with diabetic foot gangrene lesions before and after treatment, who had been treated by reducing blood sugar and resisting infection.
Results：Clinical observation on 48 cases showed good results: the total effects were 95.83%and 91.67% in treatment group and control group respectively. And there was an obvious difference between them (p<0.05). In the treatment group, 12 cases were cured, 9 cases showed improved and 1 case ineffective with the total effective rate of 87.50%. For the control group, 6 case were cured, 5 cases showed improved and 2 cases ineffective, the total effective rate being 45.83%. The results indicated that the blood rheology had been significantly improved and the disorder of microcirculation had been relieved markedly after treatment in both groups. But difference between treatment group and control group were obvious, the comparison proved the curative effect in the treatment group was better than the control group(P<0.05). So we can draw a conclusion that In the treatment group the therapeutic result was better than that of control group.
Conclusion：“Xiao Ju 1" is functional for the treatment of diabetic foot gangrene and also for the improvement of the disorder of microcirculation ,witch provides an effective and safe method to treat diabetic foot gangrene with fewer side effects
方法 本研究将受试对象分为两组。治疗组24例，以消疽1号口服治疗；对照组24例，山莨菪碱静脉滴注。1个月为1个疗程。于治疗前和1个疗程后分别做血液流变学、甲皱微循环、足背血流变化和踝肱指数检测，将中药改善糖尿病足坏疽（气阴两虚型）微循环变化与对照组治疗的疗效相比较。
结果 治疗组愈显率87.50%，总有效率95.83%，对照组愈显率45.83%，总有效率91.67%。两组疗效比较有显著性差异，“消疽1号”（治疗组）组疗效优于山莨菪碱（对照组）组。
结论 益气养阴、和营解毒的代表方剂“消疽1号”，通过对微循环障碍的改善调节作用对于气阴两虚型糖尿病足坏疽具有良好的临床疗效，其效果肯定，且无毒副作用，为临床上中医药治疗糖尿病足坏疽提供了新的治疗方案
Objective: To discuss the effect of diabetic foot gangrene belong to qi and yin deficience type treated by“xiaojuⅠ” based on the theory of TCM compared with 654-2 and study its mechanism on the disorder of microcirculation.
Methods: Patients with diabetic foot gangrene lesions were randomly divided into two groups: treatment group and control group, each group containing 24 cases. One month was a course of treatment. Under the same basic treatment, the treatment group was treated with Chinese Materia Medicine , while the control group with the rest 24 cases was treated with anisodamine(654-2). The methods had been applied to the two groups differently for a course of treatment. We observed the changes of blood rheology and nail fold microcirculation and etc in 48 patients with diabetic foot gangrene lesions before and after treatment, who had been treated by reducing blood sugar and resisting infection.
Results：Clinical observation on 48 cases showed good results: the total effects were 95.83%and 91.67% in treatment group and control group respectively. And there was an obvious difference between them (p<0.05). In the treatment group, 12 cases were cured, 9 cases showed improved and 1 case ineffective with the total effective rate of 87.50%. For the control group, 6 case were cured, 5 cases showed improved and 2 cases ineffective, the total effective rate being 45.83%. The results indicated that the blood rheology had been significantly improved and the disorder of microcirculation had been relieved markedly after treatment in both groups. But difference between treatment group and control group were obvious, the comparison proved the curative effect in the treatment group was better than the control group(P<0.05). So we can draw a conclusion that In the treatment group the therapeutic result was better than that of control group.
Conclusion：“Xiao Ju 1" is functional for the treatment of diabetic foot gangrene and also for the improvement of the disorder of microcirculation ,witch provides an effective and safe method to treat diabetic foot gangrene with fewer side effects
引文
1.赵永革, 钱冠清.微循环内皮细胞及其检测方法的研究. 国外医学输血及血液学分册,1995,18(1)：15.
2.骆秉铨. 微循环结构功能的某些研究进展. 中国微循环，1999,3(3):184-187
3.Yan SD,Schmidt AM,Anderson GM,et al.Enhanced cellular oxidant stress by the interaction of advanced glycation end products with their receptor/binding proteins.J Biol chem,1994,269：9889
4．Haitoglour CS,Tsilibary EC,Brownlee M,et al.Altered cellular interactions between endothelial cells and nonenzymatically glucosylated Laminin/type IV collagen.J Biol chem,1992，267：12404.
5．Nabel EG.Biology of the impaired endothelium.Am J Cardiol,1991,68(12)∶6.
6．黄敬泽，张闿珍. 糖尿病患者微循环内皮细胞的变化及其与微血管病变的关系. 临床内科杂志，1999,16(1):29
7．陈铭声，于文彬，姬秋和等. 男性糖尿病血清激素与微血管病变关系的研究. 陕西医学杂志, 1995，24(10)：592
8. 金惠铭. 微循环. 中华医学杂志, 1998,78(12):940
9．李仕明. 微循环障碍与糖尿病肢端坏疽的病因学. 1998,2(4):247
10. 孙金凤,尹晓山等. 2型糖尿病与内皮素、一氧化氮相关性研究. 山东医药, 2000,40(24):3
11．田牛，单毅，柳大昌等. 实用微循环（上册）第1版. 军事科学出版社，1989：59
12．李俊霞，吴海霞. 糖尿病与非糖尿病患者甲皱微循环的对比研究. 河南医学研究, 2000,9(3):248
13．李兴，乔炎. 糖尿病甲襞微循环改变与一氧化氮及脂质过氧化物的关系. 中国微循环,2000,4(2):91
14．Ronaldg SS.Prevention of diabetic vasaular dgsfunction by guanidines inhibition endproduct formation.Diabetes.1993,42:221
15．张顶高，谢丽丽，超楚生. 糖尿病足病变及局部血液改变. 中国现代医学杂志, 2000，10（2）：10
16．李仕明. 微循环障碍导致糖尿病足坏疽病因病理研究. 中国微循环, 1999, 3(4): 58
17．Puniyuni RR,Chandalia,Annapuras. 糖尿病的治疗方式及血液流变学类型. 中国血液流变学杂志，1993；3（3）：59
18．李晓萍，张平等. 糖尿病患者微循环及血流变改变的临床分析. 中国血液流变学杂志, 1999,9(3):180
19．袁申元，武宝玉. 微循环障碍与糖尿病慢性并发症. 中国微循环, 2000,4(2):73
20．汪恕萍,戍健,邱鸿鑫. Ⅱ型糖尿病患者白细胞和红细胞变形能力及其与微血管病变的关系. 中华医学杂志,1993,73(5):98
21．Chakrabarti R,Meade TW,and WHO Multinational Group．Clotting factors,platelet function and fibrinolyte activities in diabetics and in a comparison group．Proceedings of the European Association for the study of Diabetes［J］．Diabetologia 1976,12：383
22．Bern M．Platelet functions in diabetes mellitus［J］．Diabetes 1988,27：343-350
23.董晓薇，方新民等. 糖尿病患者血小板四项指标变化与微血管病变关系的研究. 宁夏医学院学报, 2000,22(4):239
24．ORLANI G,MICHAEL M,MEAZZA D,Diabetic foot and hyperbaric oxygen-theraphy:Aten-year experience [J] J Hyperbanric Med,1992,7:213
25．阎爽,万晓京. 高压氧综合治疗糖尿病足溃疡效果观察. 现代医学, 2002,30(3):174
26．汪玲. 东菱克栓酶治疗糖尿病足38例. 镇江医学院学报, 2000,10(1):72
27．宋杰，姜燕秋. PGE1治疗糖尿病多发性神经炎30例临床疗效分析. 吉林医学, 1996.17(1):39.
28．冯加纯,丁箭,付跃波等. 东菱克栓酶治疗脑梗塞27例疗效观察.中风与神经疾病杂志，1995：12（2）：111
29．宋宪，王建利等. 蝮蛇抗栓酶、山莨菪碱治疗糖尿病足30例. 《临床汇粹》, 1996,11(12):555
30．孙国新. 脉络宁注射治疗50例高粘血症患者的血液流变性观察. 中国血液流变学杂志,1999,9(1):44
31．张醒民. 降粘汤治疗高粘滞综合征50例. 辽宁中医杂志， 1995， 22(8)：356
2.骆秉铨. 微循环结构功能的某些研究进展. 中国微循环，1999,3(3):184-187
3.Yan SD,Schmidt AM,Anderson GM,et al.Enhanced cellular oxidant stress by the interaction of advanced glycation end products with their receptor/binding proteins.J Biol chem,1994,269：9889
4．Haitoglour CS,Tsilibary EC,Brownlee M,et al.Altered cellular interactions between endothelial cells and nonenzymatically glucosylated Laminin/type IV collagen.J Biol chem,1992，267：12404.
5．Nabel EG.Biology of the impaired endothelium.Am J Cardiol,1991,68(12)∶6.
6．黄敬泽，张闿珍. 糖尿病患者微循环内皮细胞的变化及其与微血管病变的关系. 临床内科杂志，1999,16(1):29
7．陈铭声，于文彬，姬秋和等. 男性糖尿病血清激素与微血管病变关系的研究. 陕西医学杂志, 1995，24(10)：592
8. 金惠铭. 微循环. 中华医学杂志, 1998,78(12):940
9．李仕明. 微循环障碍与糖尿病肢端坏疽的病因学. 1998,2(4):247
10. 孙金凤,尹晓山等. 2型糖尿病与内皮素、一氧化氮相关性研究. 山东医药, 2000,40(24):3
11．田牛，单毅，柳大昌等. 实用微循环（上册）第1版. 军事科学出版社，1989：59
12．李俊霞，吴海霞. 糖尿病与非糖尿病患者甲皱微循环的对比研究. 河南医学研究, 2000,9(3):248
13．李兴，乔炎. 糖尿病甲襞微循环改变与一氧化氮及脂质过氧化物的关系. 中国微循环,2000,4(2):91
14．Ronaldg SS.Prevention of diabetic vasaular dgsfunction by guanidines inhibition endproduct formation.Diabetes.1993,42:221
15．张顶高，谢丽丽，超楚生. 糖尿病足病变及局部血液改变. 中国现代医学杂志, 2000，10（2）：10
16．李仕明. 微循环障碍导致糖尿病足坏疽病因病理研究. 中国微循环, 1999, 3(4): 58
17．Puniyuni RR,Chandalia,Annapuras. 糖尿病的治疗方式及血液流变学类型. 中国血液流变学杂志，1993；3（3）：59
18．李晓萍，张平等. 糖尿病患者微循环及血流变改变的临床分析. 中国血液流变学杂志, 1999,9(3):180
19．袁申元，武宝玉. 微循环障碍与糖尿病慢性并发症. 中国微循环, 2000,4(2):73
20．汪恕萍,戍健,邱鸿鑫. Ⅱ型糖尿病患者白细胞和红细胞变形能力及其与微血管病变的关系. 中华医学杂志,1993,73(5):98
21．Chakrabarti R,Meade TW,and WHO Multinational Group．Clotting factors,platelet function and fibrinolyte activities in diabetics and in a comparison group．Proceedings of the European Association for the study of Diabetes［J］．Diabetologia 1976,12：383
22．Bern M．Platelet functions in diabetes mellitus［J］．Diabetes 1988,27：343-350
23.董晓薇，方新民等. 糖尿病患者血小板四项指标变化与微血管病变关系的研究. 宁夏医学院学报, 2000,22(4):239
24．ORLANI G,MICHAEL M,MEAZZA D,Diabetic foot and hyperbaric oxygen-theraphy:Aten-year experience [J] J Hyperbanric Med,1992,7:213
25．阎爽,万晓京. 高压氧综合治疗糖尿病足溃疡效果观察. 现代医学, 2002,30(3):174
26．汪玲. 东菱克栓酶治疗糖尿病足38例. 镇江医学院学报, 2000,10(1):72
27．宋杰，姜燕秋. PGE1治疗糖尿病多发性神经炎30例临床疗效分析. 吉林医学, 1996.17(1):39.
28．冯加纯,丁箭,付跃波等. 东菱克栓酶治疗脑梗塞27例疗效观察.中风与神经疾病杂志，1995：12（2）：111
29．宋宪，王建利等. 蝮蛇抗栓酶、山莨菪碱治疗糖尿病足30例. 《临床汇粹》, 1996,11(12):555
30．孙国新. 脉络宁注射治疗50例高粘血症患者的血液流变性观察. 中国血液流变学杂志,1999,9(1):44
31．张醒民. 降粘汤治疗高粘滞综合征50例. 辽宁中医杂志， 1995， 22(8)：356