The Clinical Observation In The Treatment Of Arteriosclerosis Obliterans Of Lower Extermities Caused By Phlegm And Blood Stasis Blocking Collaterals And In Fontaine Ⅱ

Objective:To observe the clinical efficacy and safety of modified Guizhi Fuling decoction in the treatment of lower limb arteriosclerosis occlusion(ASO)caused by phlegm and blood stasis blocking collaterals and in Fontaine Ⅱ.Methods:A total of 48 patients with gangrene diagnosed by traditional Chinese medicine(TCM)as phlegm and blood stasis blocking collaterals and FontaineⅡ ASO diagnosed by western medicine in the outpatient clinic of the Department of Peripheral Vascular Diseases of the first affiliated Hospital of Heilongjiang University of traditional Chinese Medicine from December 2019 to December 2021 were selected as subjects,the treatment group(n=24)and the experimental group(n=24).The control group was treated with Sarpogrelate Hydrochloride Tablets,and the treatment group was treated with Sarpogrelate Hydrochloride Tablets combined with modified Guizhi Fuling decoction.The prescription of modified Guizhi Fuling decoction was as follows:cinnamon twig 15 g,Poria cocos 25 g,moutan 12 g,red peony 15 g,peach kernel 12 g,Kunbu 15 g,leech 10 g.It was prepared by the Pharmacy Bureau of the first affiliated Hospital of Heilongjiang University of traditional Chinese Medicine.200 ml was taken orally in the morning and evening for one month.Sarpogrelate Hydrochloride Tablets,100mg*9s,registration number is H20110398,produced by Tianbian Mitsubishi Pharmaceutical Co.,Ltd.Jifu factory,100 mg,oral three times a day,the course of treatment is one month.The TCM symptom score and clinical efficacy,ABI,infrared thermal image temperature of lower extremities,blood lipids and FIB;were compared between the treatment group and the control group before and after treatment,and the correlation between TG/HDL-C,TC/HDL-C and the degree of ASO lesions was analyzed.SPSS23.0 software was used for statistical description and analysis,the difference was statistically significant.The venous blood of the two groups were collected before and after treatment,and the blood routine,liver and renal function and ECG were examined,and the adverse events and adverse reactions were recorded at any time.Results:1.There was no significant difference in general condition and symptom score between the two groups before treatment(P>0.05).2.Main outcome measures: the TCM symptom scores of patients with ASO after treatment were better than those before treatment.The results showed that the improvement degree of the treatment group was better than that of the control group.3.Compared with the control group,the infrared thermal image temperature of ABI and lower extremity after treatment was better than that before treatment,and the levels of TG,TC,LDL-C and FIB in the treatment group decreased,while the level of HDL-C increased,and there was significant difference compared with that before treatment.The ratio of TG/HDL-C to TC/HDL-C decreased after treatment,and it was positively correlated with the severity of ASO disease.In the control group,there was no significant difference in TG,TC,LDL-C,HDL-C,TG/HDL-C and TC/HDL-C,but the level of FIB was down-regulated.Compared between the two groups,the improvement of all indexes in the treatment group was better than that in the control group(0.05),especially,the TG 、 TC 、 TG/HDL-C 、 TC/HDL-C and FIB(0.001).4.Clinical efficacy evaluation of the two groups:the treatment group was clinically cured in 1case,markedly effective in 13 cases,effective in 6cases,ineffective in 2 cases,and markedly effective in 6 cases,effective in 12 cases and ineffective in 4 cases in the control group.There was significant difference between the two groups(P<0.05).The total effective rate was90.9% in the treatment group and 81.8% in the control group.5.There were no adverse events and adverse reactions during the trial.Conclusion:1.Modified Guizhi Fuling decoction can significantly improve the intermittent claudication distance,blood lipid level and FIB in patients with stage Ⅱ ASO of phlegm and blood stasis blocking collaterals,and the effect is better than that of Shagrel hydrochloride tablets alone.2.Jiawei Guizhi Fuling decoction combined with salbutamate hydrochloride tablets is safe in clinical application and is worth popularizing.