解毒通络开痹方治疗气虚瘀毒阻络型2型糖尿病下肢动脉硬化闭塞症的随机对照研究  

A Randomized Controlled Study of Jiedu Tongluo Kaibi Formula(解毒通络开痹方)in Diabetic Lower Extremity Arteriosclerosis Obstruction Patients with Qi Deficiency and Blood Stasis

作　　者：刘添娇 赵晓华 顾成娟 朴春丽 LIU Tianjiao;ZHAO Xiaohua;GU Chengjuan;PIAO Chunli(Shenzhen Hospital,Guangzhou University of Chinese Medicine(Futian),Shenzhen518000,Guangdong,China)

机构地区：[1]广州中医药大学深圳医院(福田),广东深圳518000

出　　处：《中华中医药学刊》2024年第12期103-108,共6页Chinese Archives of Traditional Chinese Medicine

基　　金：国家自然科学基金面上项目(81973813);广东省中医药局科研项目(20221329);深圳市“医疗卫生三名工程”项目(SZZYSM202202010);深圳市自然科学基金项目(JCYJ20220531091409022);广州中医药大学研究生科研创新项目(A1-2606-21-429-001Z61)。

摘　　要：目的 验证解毒通络开痹方对气虚瘀毒阻络型2型糖尿病下肢动脉硬化闭塞症患者的降糖、调脂、抗炎及血管保护作用,评价其临床疗效和安全性。方法 选取90名通过纳入和排除标准并签署知情同意书的受试者,采用随机数字表法随机分为试验组和对照组,并进行分组隐藏。对照组给予基础治疗,包括糖尿病教育、锻炼、饮食以及常规降糖降脂西药治疗,试验组在对照组的基础上接受解毒通络开痹方干预,两组疗程均为15周。在入组和干预15周后,检测血糖、血脂、体质量指标、下肢动脉内径、踝肱指数、相关炎性因子,并评估中医证候积分,在入组及干预6周、15周时进行安全性评估,运用SPSS软件进行统计分析。结果 试验组患者治疗后FBG、HbA1c、TC、LDL-C、BMI、双侧股总动脉、腘动脉、足背动脉内径、HCY、CRP、CysC、中医证候总积分较干预前降低(P<0.05),ABI、HDL-C较干预前升高(P<0.05),TG、双侧胫前动脉内径较干预前差异无统计学意义(P>0.05);对照组患者治疗后HbA1c、双侧股总动脉内径、中医证候总积分较干预前降低(P<0.05),ABI较干预前升高(P<0.05),FBG、TC、TG、LDL-C、HDL-C、BMI、双侧腘动脉、胫前动脉、足背动脉内径、HCY、CRP、CysC较干预前差异无统计学意义(P>0.05);两组患者治疗后的HbA1c差异无统计学意义(P>0.05),治疗后ABI、双侧股总动脉内径、中医证候总积分差异有统计学意义(P<0.05);试验组、对照组中医证候总有效率分别为85.71%、61.90%,两组受试者总体安全性良好。结论 解毒通络开痹方能有效改善气虚瘀毒阻络型2型糖尿病下肢动脉硬化闭塞症患者的临床症状,降低血糖和体质量,调节血脂,降低同型半胱氨酸、C反应蛋白、胱抑素C,并扩张下肢动脉内径,减轻斑块和血管狭窄,具有良好的临床疗效和安全性。Objective To verify the hypoglycemic,lipid-lowering,anti-inflammatory and vascular protective effects of Jiedu Tongluo Kaibi Formula(解毒通络开痹方)on diabetic lower extremity arteriosclerosis obstruction(DLASO)patients with Qi deficiency,blood stasis and toxin.Method Ninety subjects who passed the inclusion criteria and signed informed consent forms were randomly divided into an experimental group and a control group using a random number table,and the groups were hidden.The control group was given basic treatment,including diabetes education,exercise,diet and conventional western medicine for lowering blood sugar and lipid.The experimental group received the intervention of Jiedu Tongluo Kaibi Formula on the basis of the control group.The course of treatment of both groups was 15 weeks.Blood glucose,blood lipids,body mass index(BMI),lower limb artery diameter,ankle brachial index and related inflammatory factors were measured,and traditional Chinese medicine syndrome scores were evaluated after 15 weeks.Safety assessments were conducted at enrollment,6 and 15 weeks of intervention,and statistical analysis was performed using SPSS software.Results After treatment,the levels of fasting blood glucose(FBG),glycosylated hemoglobin(HbA1c),total cholesterol(TC),low density lipoprotein cholesterol(LDL-C),BMI,internal diameter of bilateral femoral arteries,popliteal arteries,dorsalis pedis arteries,homocysteine(HCY),C-reactive protein(CRP),cystatin C(CysC),and total score of traditional Chinese medicine syndrome in the experimental group decreased compared to before intervention(P<0.05),while high density lipoprotein cholesterol(HDL-C)and ankle brachial index(ABI)increased compared to before intervention(P<0.05).There was no statistically significant difference in triglyceride(TG)and internal diameter of bilateral anterior tibial arteries(P>0.05).In the control group,the levels of HbA1c,the internal diameter of bilateral common femoral arteries,and total scores of traditional Chinese medicine syndromes decreased

关 键 词：解毒通络开痹方 2型糖尿病 动脉粥样硬化 临床研究 

分 类 号：R255.4[医药卫生—中医内科学]