木丹颗粒治疗糖尿病并下肢动脉硬化闭塞症临床研究  

Clinical Trial Research of Mudan Granule(木丹颗粒) in the Treatment of Diabetes Mellitus with Lower Extremity Arteriosclerosis Obstruction

作　　者：王宁[1] 于世家[1] 刘阳[1] WANG Ning;YU Shijia;LIU Yang(Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110032,Liaoning,China)

机构地区：[1]辽宁中医药大学附属医院,辽宁沈阳110032

出　　处：《辽宁中医药大学学报》2022年第5期203-208,共6页Journal of Liaoning University of Traditional Chinese Medicine

基　　金：辽宁省自然科学基金(2019-ZD-0956)。

摘　　要：目的木丹颗粒是于世家教授潜心多年研制而成的专门治疗糖尿病周围神经病变(diabetic peripheral Neuropathy,DPN)的药物,已于2008年获国家药监局新药批产证书,其功效为益气活血,通络止痛。而DPN与糖尿病并下肢动脉硬化闭塞症(diabetic lower extremity arteriosclerosis obliterans,DLASO)的中医病机相似,且DLASO临床表现以肢体麻木凉痛为主,治疗亦重在活血化瘀,通络止痛。依据中医“异病同治”理论,推测木丹颗粒治疗DLASO也可能存在一定疗效,为进一步探讨木丹颗粒治疗DLASO之临床疗效,设计该项研究。方法将47例DLASO患者随机分为治疗组31例和对照组16例,两组在降糖、降压、调脂、抗血小板聚集、配合治疗仪局部治疗的基础上,治疗组口服木丹颗粒,对照组口服通塞脉片,两组均服药4周,4周后观察两组治疗前后临床证候积分及疗效,空腹血糖(FPG)、餐后2 h血糖(2 h PG)、甘油三酯(TG)、总胆固醇(CHOL)、高密度脂蛋白(HDL-C)、低密度脂蛋白(LDL-C)、全血黏度、毛细血管血浆黏度、红细胞压积、纤维蛋白酶原(Fib)、双下肢动脉内径及血流峰值速度的变化情况,然后进行相应的统计学处理。结果(1)木丹颗粒组总有效率为77.41%,通塞脉片组总有效率为68.75%,经χ^(2)检验,P>0.05,无统计学意义。(2)与各自治疗前相比两组治疗后TG、CHOL、HDL-C、LDL-C、FPG、2 h PG、全血黏度、毛细血管血浆黏度、Fib、双侧胫前动脉及足背动脉的内径和血流峰值速度明显改善,P<0.05,差异有统计学意义。(3)两组治疗后双侧胫后动脉内径及血流峰值速度比较,P<0.05,差异有统计学意义,但两组治疗前上述指标比较即存在统计学意义(P<0.05),因此考虑两组治疗后的差异与治疗前即存在差异有关。结论(1)基础疗法配合木丹颗粒治疗气虚血瘀型DLASO临床疗效显著,总有效率可达77.41%,与治疗DLASO的专门药物通塞脉片疗效相当,由此可知木Objective As an effective Chinese patent medicine,which was developed from Professor YU Shijia for diabetic peripheral neuropathy(DPN),Mudan Granules(木丹颗粒,MDG)had obtained the batch production certificate from State Food and Drug Administration(SFDA)in 2008.It has the function of supplementing Qi,promoting blood circulation,dredging meridian and relieving pain.DLASO has the similar clinical manifestations and principles of treatment like DPN.According to the theory of TCM,which indicates that treating different diseases with the same method,we can infer that MDG may be has effect on the treatment of DLASO.So we designed this clinical trial in order to observe the efficacy of MDG for DLASO.Methods 47 patients were randomly assigned to the treatment group and the control group.The former with 31 patients took MDG,while the latter with 16 patients took Tongsemai Tablet(通塞脉片,TSMT)on the basic therapy of hypoglycemic,hypotensive,regulating blood lipids,anti-platelet aggregation and therapeutic apparatus.After four weeks,the integration and efficacy of clinical symptom as well as the parameters were observed,which including FPG,2 h PG,TG,CHOL,LDL-C,HDL-C,whole blood viscosity,plasma viscosity of blood capillary,hematocrit(HCT),fibrinogen(Fib),and blood dynamics of lower limbs.The results were treated statistically.Results(1)MDG group reached the total efficiency as high as 77.41%,while in TSMT group the total effective rate was 68.75%.Chi-square(χ^(2))analysis gives the result of P>0.05,without significant difference.(2)After treatment,the statistical comparison of TG,CHOL,LDL-C,HDL-C,FPG,2 h PG,whole blood viscosity,plasma viscosity of blood capillary,HCT,Fib,the inner diameter as well as peak velocity of blood flow of bilateral dorsalis pedis and anterior tibial artery between before and after treatment showed that P<0.05,which had statistically significant differences.(3)After treatment,P<0.05 showed the significant differences between two groups in the inner diameter and peak velocity of blood flow

关 键 词：糖尿病 下肢动脉硬化闭塞症 木丹颗粒 临床试验 气虚血瘀型 

分 类 号：R587.1[医药卫生—内分泌]