Clinical observation of Furongtongmai capsule on the lower extremity Atherosclerotic Occlusive Disease after Intervention Operation

Wei Yao,Xiu-Hai Su,Yuan-Song Wang,Yan-Ling Du,Zhan-Yi Gao,Yin-Sheng Gao,Na Li,Na-Na Feng,Qing Chen,Hua Guo

1Cangzhou Hospital of Integrated TCM-WM Hebei,Cangzhou,Hebei,China.

Background

Intraventricular therapy is currently one of the main treatments for lower extremity Arteriosclerosis Obliterans(ASO).It has been reported that in patients after stenting,the proportion of In-Stent Restenosis(ISR)in the first year after surgery is 18%~40%[1].Vascular endothelial injury leads to elastic retraction of blood vessels,which triggers acute and chronic inflammatory factors and other factors,causing stent restenosis.Studies have shown that furongtongmai capsule can improve vascular endothelial function and other mechanisms to delay ASO progression and improve symptoms[2].This study was to investigate the effect of FurongTongmai Capsule on the ISR of superficial femoral artery after interventional operation in ASO.The report is as follows.

Materials and Methods

General Information

To retrospectively analyze the clinical data of 110 consecutive hospitalized patients who underwent femoral artery stenting in the lower extremity arteriosclerosis obliterans from June 2014 to June 2016.

Inclusion criteria:(1)Patients meet the diagnosis of ASO[3].(2)Fontaine staging period II-IV:claudication;rest pain and tissue ulcers and gangrene.(3)PTA+stent implantation Surgery was performed for the first time,and the intraoperative angiography was recanated without residual stenosis.(4)The diagnosis in traditional Chinese medicine is gangrene of digit,syndrome differentiation of qi and Yin deficiency and venous stasis[4].

Exclusion criteria:(1)Acute lowerextremity ischemia.(2)Stent implantation or artificial bypass grafting for lower extremity arteries in the past;or unable to tolerate interventional therapy.(3)Exclude ischemic disease such as thromboangiitis obliterans,arteritis,Raynaud's disease,cold injury vascular disease,et al.(4)Patients with lesions(stenosis>50%or occlusion)involving the iliac artery,the middle and far segment of popliteal arteries and calf vessels.(5)Patients who have takenARB drugs for the past and present.

With the approval of the hospital ethics committee and informed consent of patients and their families,the patients were randomly divided into treatment group and control group,with 55 cases in each group.In the treatment group,37 patients were male and 18 were female,aged 45-71 years(52.1+8.3).The control group included 39 males and 16 females,aged 41-68 years(54.6+7.5).There was no significant difference in age,gender,Fontaine stage,basic disease and other general data between the two groups(P>0.05),which is comparable.(Table 1)

Table 1 Comparison of basic data between the two groups

Drug treatment methods

Two groups of patients after admission to control blood pressure,blood sugar,blood lipids and other symptomatic treatment.The control group was given Aspirin 100 mg/d and clopidogrel 75 mg/d.The treatment group took Furongtongmai Capsule 5 pills/time,3 times/d orally on the basis of the control group.Furongtongmai Capsule was composed by Shuizhi(Hirudo),Dilong(Rainworm),Quanxie(Scorpio),Gegen(Radix Puerariae),Xuanshen(Radix Scrophulariae), Chuanshanlong (Dioscorea nipponica Makino),Huangqi(Radix Hedysari),Niuxi(Radix Achyranthis Bidentatae), Gancao (Radix Glycyrrhizae),et al.,each of one ccapsule was equivalent to 2 g of the original medicinal material.It is prepared by the Chinese medicine room of Cangzhou Hospital of Integrated TCM-WM Hebei(Hebei Pharmaceutical word Z20070041).The treatment period was 6 months in both groups.

Ankle Brachial Index(ABI)testing

The 8mhz doppler blood flow probe(provided by Japanese company Lin electric co.,LTD.,instrument model:ES21000SP)is used for ABI measurement.The cuff of the blood pressure gauge is 10 cm wide and 40 cm long.The standard supine position was used to measure the systolic blood pressure of the upper arm and ankle(posterior tibial artery or posterior pedis artery)on both sides.ABI is the ratio of the highest systolic pressure of the posterior tibia artery or posterior pedis artery to the highest systolic pressure of the two upper arms.

Interventional therapy

The patient was placed in a supine position,routinely disinfected and sputum,and 1%Lidocaine was locally infiltration anesthetized.Seldinger technique was used to puncture the femoral artery of the opposite limb of the patients,and 3000 units of Heparin were injected intravenously.The contralateral femoral artery of the affected limb was selected.If the guidewire could not pass the lesion,the distal femoral artery of the affected limb was combined with retrograde intervention.Diagnostic angiography is performed to determine the surgical plan.The head of the super-smooth guidewire was sent to the femoral artery through the angiographic catheter,which was exchanged for the 6 F sheath and sent to the proximal segment of the lesion.Subsequently,an ultra-slip guide wire or a V18 guide wire(0.018 inch in diameter and 300 cm in length)was passed through the lesion,and the balloon was introduced along the guide wire,and the lesion was subjected to Percutaneousballoon Angioplasty(PTA).Then the stent was placed.A nickel-titanium alloy self-expanding stent was used,and both ends were placed 1 to 2 cm across the lesion.Standard ofsuccessfulstentimplantation:residual stenosis<10%after surgery,no obvious interlayer and serious complications related to surgery.

result evaluation

Criteria for restenosis The main clinical manifestations ofrecurrence were typicalASO symptoms.And angiography or CTA found>50%stenosis or occlusion of the vessel at the treatment site,new hyperplastic lesions within 5 mm outside the stent margin are also considered as stents Related restenosis.

High-sensitivity C-reactive protein(Hs-CRP)test The patients were draw blood 5 mL before and 6 months after the operation in the morning respectively.Then the blood was centrifuged for 10 min,with 3000 r·min-1and serum was obtained,in charge of the park-70°C in the refrigerator.The United States Beckman coulter co.,LTD.Production of beckman coulter AU5800 series full automatic biochemical analyzer is used to detect the serum Hs-CRP.

Statistical analysis

SPSS19.0 statistical software(USA)was used to analyze the data statistically.The measurementdata were expressed by means±SD.The t test was used for the comparison before and after treatment in the same group,and the χ2test was used to compare the count data.The difference was statistically significant at P<0.05.

Results

Follow-up results

Patients in both groups were followed up for an average of 6 months.One case was lost in the control group.

Comparison of plasma Hs-CRP andABI

The plasma levels of Hs-CRP in both groups were decreased in both groups.The treatment group was significantly lower than the control group,P<0.05,which was statistically significant.There was a significant increase in ABI at different levels in the two groups,and a significant increase in the treatment group,P<0.05,showing a statistically significant difference,as shown in Table 2.

Comparison of ISR

Six months after surgery,the restenosis rate was 9.84%in the treatment group and 28.33%in the control group.There was significant difference between the two groups(P<0.05).(Table 3)

Table 2 Comparison of No,Hs-CRP andABI between the two groups

Table 3 Comparison of two groups of restenosis

Discussions

The incidence of ASO is increased year by year,and the prevalence of ASO in Chinese people over 60 years old can reach 15.91%.The ESC guidelines suggest that stents for femoral artery lesions of medium length should be the first choice[5].Studies have reported that the first-stage patency rate of PTA is only 32.8%[6].The one-year patency rate of bare stent was 73.0%[7],and the 3-year patency rate of stent implantation was 63%to 66%.Reducing the incidence of ISR is important for improving the long-term efficacy ofinterventional procedures.The formation of ISR is the result of a variety of mechanisms,including:vascular endothelial injury,vascular elastic retraction, acute and chronic inflammatory response,intimal hyperplasia,vascular remodeling and other factors[8].

ASO is a category of vessel bi-disease and gangrene of digit in traditional Chinese medicine,due to the decline of vital qi,the invasion of cold-dampness,causing phlegm blood stasis,poor blood circulation,or even impediment to the disease.According to ancient medical records:Gangrene is caused by the inability of blood to reach the extremities Endovascular interventional surgery is used to reconstruct the stenotic artery in a short period of time to restore blood flow.However,the patient with dialectically still exist"blood stasis due to qi deficiency",combined with intraoperative hemorrhage,aggravating qi deficiency,therefore,qi deficiency and blood stasis and vascular dysfunction are main pathogenesis of postoperativerestenosis[9]In termsoftreatment,benefiting qi for activating blood circulation,soft and firm collaterals should be adopted to prevent postoperative restenosis[10].Furongtongmai capsule contains Shuizhi,Dilong and Quanxie,which can relieve collaterals and pain,and eliminate stasis,and the compatibility of Xuanshen,Chuanshanlong and Niuxi can improve blood circulation and improve physique of patients.In addition,Gegen and Gancao can clear the fever,cure the root,and relieve the symptoms of diabetes and thirst.The whole prescription has the characteristics of occulting,warming,moistening and tong,and all the medicines are used together to play the functions of nourishing qi and Yin,invigorating blood circulation through collaterals and promoting blood circulation,and pushing away blood stasis with softness[11].

In modern researches,Gegen can significantly reduce total cholesterol, triglyceride, low-density lipoprotein,increase local micro-blood flow,inhibit platelet aggregation,and may reduce arteriosclerosis by inhibiting the expression of inflammatory factor TGF-β1 in diabetic rats[2].Shuizhi has good efficiency of anticoagulant,antithrombotic,antiplatelet aggregation,lowering blood lipids,inhibiting inflammation,etc.Dilong can anti-inflammatory,prevention of diabetic nephropathy,promotion of wound healing,lipid-lowering inhibition of platelet aggregation, inhibition of angiotensin converting enzyme. Quanxie has anticoagulant,antithrombotic,anticoagulant,fibrinolytic effects.The functions of dilates blood vessels,lower blood pressure, anti-platelet aggregation,anti-inflammatory, anti-oxidation are belonged to Xuanshen. Chuanshanjia can anti-inflammatory,hypoglycemic,blood uric acid.Niuxi has the effect of reducing inflammatory factors,lowering blood sugar,and anti-apoptosis.Patients with ASO in this study,the observation group treated with FurongTongmai capsule after stent implantation can significantly reduce the rate of restenosis.

Hs-CRP is an acute phase protein secreted by hepatocytes,which can predict the stability of arterial plaque.Increased Hs-CRP is associated with rupture of atherosclerotic plaque and intimal hyperplasia after stent implantation [12]. Furongtongmai Capsule can significantly reduce the patient'sHs-CRP and has anti-atherosclerosis effect.Thus improving the vascular endothelial function,ABI and foot skin temperature[13].This study applies Furongtongmai Capsule for 6 months afterstenting forpatients with ASO can reduce endothelial damage, reduce acute and chronic inflammation,and improve ABI by increasing NO plasma levels and inhibiting the release of Hs-CRP,which can suppress the occurrence of ISR. In addition,FurongtongmaiCapsule can improve blood flow spectrum peak and average blood flow,and improve blood supply to lower limbs[14].It can reduce fat,reduce fiber,reduce blood viscosity and other effects,improve blood rheology and increase blood supply to the lower extremities[15].Furongtongmai Capsule may have multiple targets to inhibit the occurrence of ISR,and further research is needed.

Conclusion

In summary,the reduction of the incidence of ISR by Furongtongmai Capsule may be related to the reduction of Hs-CRP expression and other factors.At present,the mechanism of ISR after intervention of ASO is a multi-faceted factor,and is further research need to be performed to clarify the mechanism of ISR and how to prevent it

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