EFFECTIVENESS OF LISINOPRIL AND AMLODIPINE COMBINATION AT HYPERTENSION WITH COMORBIDITY OF ARTERIOSCLEROSIS OBLITERANS IN GENERAL PRACTICE.

OBJECTIVE: The aim: To analyze the dynamics of daily monitoring of blood pressure, intracardiac (according to echocardiography), peripheral hemodynamics (according to ultrasound of the vessels of the lower extremity), the thickness of the intima-media complex (according to carotid sonography) in patients with hypertension the effect of treatment with a combination of lisinopril and amlodipine. PATIENTS AND METHODS: Materials and methods: The study included 40 patients with hypertension with 2 (29 patients) and 3 (11 patients) degrees of hypertension in combination with AOLE with I-III stages of chronic insufficiency of the lower extremity, which revealed hyperkinetic, eukinetic, and hypokinetic types of hypertension with a predominance of the sympathetic nervous system. The groups are comparable in age, sex, duration of hypertension, and medications received in the previous stages. For antihypertensive therapy, the most common drugs for use were selected - lisinopril + amplodipine in fixed doses of 10 and 5 mg, respectively. If after 2 weeks we did not reduce the mean level of SBP and DBP by 10% or more from baseline, we doubled the dose of lisinopril without changing the dose of amlodipine. RESULTS: Results: After 6 months of treatment, in particular, an increase in the pulse index - by 24.8%, a decrease in the resistance index - by 21.1%, an increase in linear and volumetric blood velocity - by 25.6% and 27.4%, respectively, while achieving the target blood pressure. CONCLUSION: Conclusions: It is proved that in the absence of individual contraindications the combination of lisinopril and amlodipine is optimal and universal for effective treatment of patients with hypertension in combination with AOLE in all types of central hemodynamics.

Ameliorative effects of the traditional Chinese medicine formula Qing-Mai-Yin on arteriosclerosis obliterans in a rabbit model.

CONTEXT: Qing-Mai-Yin (QMY) is a clinically used herbal formula for treating arteriosclerosis obliterans (ASO). OBJECTIVE: To evaluate the chemical constituents and effects of QMY on ASO rabbit model. MATERIALS AND METHODS: Forty-eight New Zealand rabbits were divided into six groups (n = 8): normal (normal rabbits treated with 0.5% CMC-Na), vehicle (ASO rabbits treated with 0.5% CMC-Na), positive (simvastatin, 1.53 mg/kg), and QMY treatment (300, 600, and 1200 mg/kg). ASO rabbit model was prepared by high fatty feeding, roundly shortening artery, and bovine serum albumin immune injury. QMY (300, 600 and 1200 mg/kg) was orally administered for 8 weeks. The effects and possible mechanisms of QMY on ASO rabbits were evaluated by pathological examination, biochemical assays, and immunohistochemical assays. The compositions of QMY were analysed using HPLC-Q-TOF-MS/MS analysis. RESULTS: Compared to the vehicle rabbit, QMY treatment suppressed plaque formation and intima thickness in aorta, and decreased intima thickness, whereas increased lumen area of femoral artery. Additionally, QMY treatment decreased TC, TG and LDL, decreased CRP and ET, and increased NO and 6-K-PGF1α in serum. Furthermore, the potential mechanisms studied revealed that QMY treatment could suppress expression of TNF-α, IL-6, ICAM-1 and NF-κB in endothelial tissues, and increase IκB. In addition, HPLC analysis showed QMY had abundant anthraquinones, stilbenes, and flavonoids. CONCLUSION: QMY has ameliorative effects on ASO rabbit, and the potential mechanisms are correlated to reducing inflammation and down-regulating NF-κB. Our study provides a scientific basis for the future application and investigation of QMY.

[Early outcomes of therapy and indirect revascularization surgery in patients with critical ischemia of lower extremities]. / Blizhaishie rezul'taty konservativnogo lecheniya i operatsii nepryamoi revaskulyarizatsii u bol'nykh s kriticheskoi ishemiei nizhnikh konechnostei na fone distal'noi okklyuzii arterii.

OBJECTIVE: To study the immediate results of therapy and indirect revascularization in patients with critical ischemia of the lower limbs. MATERIAL AND METHODS: The results of medication and surgical treatment were analyzed in 210 patients with critical ischemia of the lower limbs. Atherosclerosis obliterans was diagnosed in 142 patients, thromboangiitis obliterans - in 68 patients. Lesion of femoropopliteal segment was observed in 32 (15.2%) cases, popliteal-tibial segment - 68 (32.8%) patients, tibial and foot segment - 62 (29.5%) cases, foot - 31 (14.8%) cases, multiple-level lesion - 17 (8.1%) cases. Survey consisted of Doppler ultrasound, CT angiography, rheovasography with analysis of rheographic index (RI) and pulse oximetry. Circulatory parameters were compared with identical values in 48 almost healthy persons ("reference group"). The results of medication and surgical treatment were evaluated by using of the scale of Rutherford R.B. et al. (1997). RESULTS: Conservative treatment was performed in 48 patients (control group). The following types of indirect revascularization operations were performed to stimulate regional circulation: bone trepanation in 42 patients, lumbar sympathectomy in 51 patients, bone trepanation + lumbar sympathectomy in 38 patients, bone trepanation with intraosseous irradiation in 31 cases. CONCLUSION: Indirect revascularization improves early postoperative outcomes, ensures maintaining support function of the limb and active lifestyle in patients with critical ischemia of the lower limbs. Technical simplicity of these procedures facilitates widespread introduction of indirect revascularization in multi-field hospitals.

Baseline Characterization of Japanese Peripheral Arterial Disease Patients　- Analysis of Surveillance of Cardiovascular Events in Antiplatelet-Treated Arteriosclerosis Obliterans Patients in Japan (SEASON).

BACKGROUND: Despite mounting evidence of increased cardiovascular events in patients with peripheral arterial disease (PAD), the overall incidence of cardiovascular events in PAD patients has not been fully clarified in Japan. The prospective Surveillance of cardiovascular Events in Antiplatelet-treated arterioSclerosis Obliterans patients in JapaN (SEASON) is a prospective observational multicenter study and here we report the baseline clinical characteristics, including atherosclerosis risk factor prevalence, in PAD patients treated with antiplatelet agents. METHODS AND RESULTS: The SEASON registry enrolled 11,375 patients in 1,745 institutions and the data for 10,322 patients were analyzed. At baseline, the average age was 73.8±9.9 years, 60.0% were male and 83.9% were in Fontaine stage I or II. They had arteriosclerosis risk factors, such as current smoking (16.2%), hypertension (61.5%), diabetes mellitus (38.3%) and dyslipidemia (38.8%). There were complications including heart disease (29.7%), cerebrovascular disease (17.1%) and chronic kidney disease (14.3%). A subpopulation analysis revealed that the proportions of patients with risk factors were high in patients with lower ankle-brachial pressure index value. CONCLUSIONS: The baseline characteristics of the SEASON population demonstrate that real-world PAD patients have cardiovascular risk factors and comorbidities next to definite PAD patients. Further analysis of this database will contribute to understanding the real-world situation of PAD patients receiving antiplatelet therapy in Japan. (Circ J 2016; 80: 712-721).

[[Impact of plestazol preparation on hyperplasia of inter vascular layer in the patients, suffering obliterating atherosclerosis of the lower extremities arteries after reconstructive operations].]

In the clinic 60 patients were examined, in whom reconstructive operations on the main arteries were performed for obliterating atherosclerosis (OA) of the lower extremities vessels. Efficacy of impact of Plestazol (in a 200 mg/day dose) on neointima hyperpla- sia was studied. Clopidogrel (75 mg/day) was administered to patients of comparative group. Effective criteria for estimation of the migration-proliferation disorders state in endothelial dysfunction are concentration of the intercellular adhesion molecules (ICAM) and the basic factor of the fibroblasts growth (FGFb); morphological disorders in hyperplastic reactions of neointima - determination of thickness of "intima-media" complex in accordance to the ultrasound duplex scanning data. There was established, that Plestazol constitutes an effective disaggregate preparation, positively impacting decelerating reaction of neointima hyperplasia, including, deceleration of the smooth- muscle cells migration into subendotelial layer in the formation zone of the femoro- popliteal shunt distal anastomosis.

[Functional methods of assessment of the blood flow in the lower limbs of the patients with obliterating atherosclerosis during complex conservative treatment].

Have been studied the changes of tissue blood flow in the distal parts of the lower limbs at the capillary level under the influence of the different complexes of rehabilitation. Were obtained the objective results of advantages of the combined use of physical therapy and drug therapy. The study showed that for evaluation of tissue blood flow is preferable to to use the laser flowmetry, and for registration of quantitative indicators of regional blood flow changes--Doppler ultrasound.

[Taohong Siwu Decoction regulated functions of endothelial cells and treated arteriosclerosis obliterans: an experimental study].

OBJECTIVE: To discuss the effect of Taohong Siwu Decoction (TSD) in regulating functions of endothelial cells and treating arteriosclerosis obliterans (ASO). METHODS: The ASO model was prepared by using high-fat diet plus intimal injury. They were randomly divided into the model group (n = 10), the normal control group (n = 9), the low dose TSD group (group A, n = 12), the middle dose TSD group (group B, n = 10), and the high dose TSD group (group C, n = 9). Eight weeks after modeling, the limb blood perfusion was observed using laser Doppler flowmetry. The arterial morphology was observed using light microscope and transmission electron microscope. The number of circulating endothelial cells (CECs) was determined using Percoll density gradient centrifugation method. Serum levels of TNF-alpha, IL-1, ET-1, and NO were detected using double antibody sandwich assay of enzyme linked immunosorbent assay (ELISA). RESULTS: The ASO rat model was successfully established. Blood lipids levels significantly increased, the blood perfusion of left hind limbs significantly decreased, the number of CECs in the peripheral blood significantly increased, the arterial lumen was irregularly narrowed, the ultra-structure of vessel walls was damaged, serum levels of TNF-alpha, IL-1, and ET-1 significantly increased, and the serum level of NO significantly decreased in the model group, showing statistical difference when compared with the normal control group (P < 0.01). Compared with the model group, significant improvement in the aforesaid indices was shown in group B and C (P < 0.05, P < 0.01). CONCLUSIONS: The injury and abnormal functions of endothelial cells is an important pathological process of ASO. As an effective recipe for treating ASO, TSD could protect vascular endothelial cells and improve the secretion function of vascular endothelial cells.

[Effectiveness of pentoxifylline and of bio-electromagnetic therapy in lower limb obliterative arterial disease]. / A pentoxifillin és a bioelektromágnes-regulációs kezelés hatása alsó végtagi obliteratív veroérbetegségben.

INTRODUCTION: There are limited therapeutic options to improve microcirculation. AIM: The question of the study was to investigate any potential beneficial effect of bio-electro-magnetic-regulation therapy on microcirculation in patients suffering from obliterative peripheral arterial disease including the circulation of lower extremities, as well as intermittent claudication. METHOD: Thirty patients suffering from obliterative peripheral arterial disease (Fontaine IIa and IIb) were recruited. The first step of the study was to determine the pain free and maximal walking distance with a treadmill unit. After the placebo period patients received 8 and 20 minutes bio-electro-magnetic-regulation treatment 16 times. After the treatment the pain free and maximal walking distance were measured again. In the second stage of the study the patients were treated by pentoxifylline infusions. RESULTS: Bio-electro-magnetic-regulation treatment increased the pain free period by 57.4% (p = 0.005) and the maximal walking distance by 36.6% (p = 0.042). The two forms of therapy together increased the pain free and maximal walking distance by 81.9% and by 84.0%, respectively. The combined therapy was very effective in contrast to placebo and bio-electro-magnetic-regulation treatment (p = 0.000373 and p = 0.00741, respectively). CONCLUSIONS: The bio-electro-magnetic-regulation therapy mainly affected the microvessels and pentoxifylline therapy rather had beneficial effects on hemorheology. The clinical effectiveness of combined therapy was good or excellent in 70% of patients.

[Ultrasound-guided peripheral nerve block for high-risk patients with arteriosclerosis obliterans in lower limb surgery--a report of nine cases].

Most patients with arteriosclerosis obliterans (ASO) have severe complications such as coronary artery disease, congestive heart failure and chronic kidney disease. They receive long-term antithrombotic therapy which is a contraindication to neuraxial anesthesia. In this retrospective study, we reviewed nine high-risk patients with ASO (revised cardiac risk index more than three) who underwent an urgent lower limb surgery under ultrasound-guided peripheral nerve block (PNB). In all cases, intraoperative hemodynamic changes remained minimized. In eight of the nine cases, analgesics are not required until 10 hours after the operation. No complication related to PNB occurred. Ultrasoundguided PNB for patients with ASO undergoing lower limb surgery can be a useful anesthetic technique, providing cardiovascular stability and good postoperative analgesia.

Clinical Efficacy of Interventional Therapy on Lower Extremity Arteriosclerosis Obliterans and Prognostic Factors.

Objective: This study was designed to analyse the clinical efficacy of interventional therapy on lower extremity arteriosclerosis obliterans (LEASO) and prognostic factors. Methods: A total of 122 patients with LEASO diagnosed in our hospital from March 2017 to March 2019 were retrospectively analysed. Among them, 72 patients who received conservative therapy were assigned to a conservative group, and 50 patients who received interventional therapy additionally based on conservative therapy were assigned to an intervention group. The short-term (12 weeks after therapy) and long-term (3 years after therapy) clinical efficacies on the two groups were compared. Death, amputation, and vascular restenosis (vascular stenosis > 50% in computed tomography reexamination) were defined as unfavourable outcomes, and Cox regression was conducted to analyze the factors influencing the prognosis of patients. The incidence of adverse events in the two groups within 3 years was compared and statistically analyzed. Additionally, the hospital stay, therapy cost, claudication distance, and ankle brachial index were compared between the two groups. Results: After therapy, the conservative group showed a notably lower total effective rate than the intervention group (P < 0.05), but the clinical efficacy after 3 years was similar between the two groups (P > 0.05). Additionally, the conservative group experienced notably longer hospital stay than the intervention group (P < 0.05), and cost less in treatment than the intervention group (P < 0.05). However, the conservative group experienced a notably shorter claudication distance and showed a notably lower ankle brachial index than the intervention group (P < 0.05). The two groups were not significantly different in mortality, amputation rate, and vascular restenosis rate (P > 0.05). Moreover, Cox regression analysis revealed that age and conservative therapy were independent risk factors for the prognosis of patients (P < 0.05). Conclusion: Interventional therapy can substantially improve the short-term efficacy and prognosis of patients with LEASO, but the cost is high, so the therapeutic regimen should be selected according to the patient's economic condition.

Osteolytic metatarsal osteomyelitis regenerated by combined treatment of artificial carbon dioxide foot bathing and povidone-iodine sugar ointment: a case report.

BACKGROUND: In recent years, the number of patients with ischemic skin ulcers due to diabetes mellitus and arteriosclerosis obliterans are increasing. Accordingly, endovascular therapy, drugs, and various wound dressings have been developed and applied to diabetic foot ulcers, and negative-pressure wound therapy, which often requires expensive and burdensome procedures for medical personnel, has also become popular. So simple and minimal invasive home treatment by the patient or their caregiver is required. CASE PRESENTATION: The present patient (77 years old, male, Asian) had developed left sole ulcers with draining pus that were resistant to conventional treatment, and he suffered from gait disturbance. We report a case of metatarsal osteomyelitis in a patient with diabetes mellitus and arteriosclerosis obliterans, in whom artificial carbon dioxide foot bathing and povidone-iodine sugar ointment were used continuously to promote bone and joint regeneration, and skin ulcer healing. CONCLUSIONS: A simple therapeutic intervention with artificial carbon dioxide foot bathing and povidone-iodine sugar ointment can improve not only ischemic skin ulcers, but also the bone and joint regeneration of ischemic limbs. This therapy can lead to a reduction in healthcare costs for a huge number of diabetic patients.

Efficacy and Safety Differences between Domestic Paclitaxel Drug-Coated Balloons and Metal Bare Stents in the Treatment of ASO of Femoral-Popliteal Arteries Type IIA-C.

The aim in this study was to investigate the efficacy and safety of domestic paclitaxel-coated balloon (DCB) and bare metal stent (BMS) in the treatment of Transatlantic Cooperative Organization Consensus II (ASC II) types A-C femoral-popliteal arteriosclerosis obliterans (ASO). A total of 103 patients with ASC II A-C femoropopliteal ASO, who received treatment in our hospital from March 2020 to March 2021, were retrospectively selected and divided into the DCB group (n = 56) and BMS group (n = 47), according to treatment methods. The general clinical data and surgical results were compared between the two groups. The patients were followed up, and the primary patency rate, restenosis rate, freedom from target lesion revascularization (f-TLR), and limb preservation rate were recorded. The liver and kidney functions before and after operation and the occurrence of major postoperative adverse events were recorded. The operation was successful in both groups. The minimum diameter of the DCB group was smaller than that of the BMS group after treatment (P < 0.05). At 6 and 12 months after operation, the Rutherford classification decreased and ABI index increased in both groups (P < 0.05), but there was no significant difference (P > 0.05). At 6 and 12 months after surgery, f-TLR was significantly higher in the DCB group than in the BMS group (P < 0.05); at 12 months after surgery, the restenosis rate was lower in the DCB group than in the BMS group (P < 0.05). There was no significant difference in the primary patency rate and limb preservation rate at 6 and 12 months after operation between the two groups (P > 0.05). Before and after operation, there was no significant difference in liver and kidney function between the two groups (P > 0.05). Within 12 months after surgery, 1 patient in the DCB group developed puncture site hematoma 3 days after surgery, and 1 patient in the BMS group developed acute thrombosis 1 day after surgery, and no intervention-related deaths occurred. Domestic paclitaxel DCB can achieve better f-TLR and lower restenosis rate than BMS in the treatment of type II A-C femoral-popliteal artery ASO. Short-term and medium-term efficacy and safety are comparable to BMS.

[The results of using cytoflavin in conservative treatment of patients with obliterating atherosclerosis of the lower extremity vessels].

Results of conservative treatment of 31 patients with PAD are presented. In 3 and 6 months after 10 everyday intravenous infusions of Cytoflavin (combination of succinic acid, inosine, nicitinamide and riboflavin) average increase of painfree walking distance among nonsmokers was 50.6% and 64.4% vs. 108.0% and 170.5% in subgroup of smokers respectively. Average increase of maximal walking distance in subgroup of nonsmoking and smoking patients was respectively 30.1% and 130.5% in three months and 37.6% and 144.8% in 6 months after Cytoflavin infusions.

Influence of pharmacological treatment on blood flow and muscle perfusion in patients with obliterative atheromatosis assessed with isotopic methods. A pilot study.

BACKGROUND: Most of the methods don't give the comparison between blood flow at rest and after exercise. Nuclear medicine allows for such assessment and determination of muscle perfusion indexes. The aim of the study was the comparison of the radioisotopic assessment of lower limbs perfusion at rest and after exercise in patients with obliterative atheromatosis subjected to combined treatment with the standard vascular examinations. MATERIAL/METHODS: 35 patients with stage II according to Fontaine and claudication distance 30-500 m, subjected to the combined medical treatment were included to the study. Basic examinations, claudication distance measurements, standard vascular examinations, and radioisotopic examinations of lower limbs perfusion with Tc99mMIBI were performed in all patients. RESULTS: After 6 months of therapy the results of perfusion scintigraphy showed that combined pharmacological treatment caused the significant improvement of calf perfusion at rest (p<0.05), which justifies its application in chronic ischemia of lower limbs. Such improvement was not observed while analyzing the results of standard vascular indexes. CONCLUSIONS: The use of perfusion scintigraphy allows for precise definition of the state of the limbs perfusion and shows the improvement of lower limbs perfusion at rest after medical treatment. It is a more precise and sensitive examination, gives more information comparing to the standard vascular examinations, and completes standard vascular diagnostics in patients with obliterative atheromatosis.

Study design of SEASON registry: prospective Surveillance of cardiovascular Events in an Antiplatelet-treated arterioSclerosis Obliterans patients in JapaN )SEASON).

Antiplatelet therapy is widely performed for arteriosclerosis obliterans (ASO) to relieve ischemic symptoms and prevent cardiovascular events. However, the overall rate of cardiovascular events in patients with ASO under treatment with antiplatelet agents has not been fully investigated in Japan. The SEASON registry is a nationwide observational prospective cohort study designed to compile data from over 2,000 institutions across Japan, whose aims are to (1) understand the current status for the management of ASO and clarify the incidence of cardiovascular events in patients with ASO undergoing antiplatelet therapy, and (2) compare the effectiveness of sarpogrelate, a 5-HT(2A) receptor antagonist, in decreasing the event rate with those of other antiplatelet agents [UMIN ID: UMIN000003385]. The registry will recruit approximately 10,000 patients receiving antiplatelet therapy (8,000 patients for sarpogrelate and 2,000 for other antiplatelet agents), and the patients will be followed every 6 months during a two-year follow-up period. The investigators plan to report all cardiovascular events and exacerbations of ASO. Analysis focusing on the sarpogrelate-treated subgroup will also be performed. Exploratory analysis will be performed to determine the clinical characteristics of the patients and to elucidate the relationships between risk factors and cardiovascular events. The SEASON registry is the first attempt to create a nationwide database regarding the incidence of cardiovascular events in 10,000 ASO patients in Japan. In addition, it ultimately may enable us to conclude that sarpogrelate prevents cardiovascular events. Information on the severity and risk factors in ASO patients in the clinical settings will be applicable to epidemiological analysis.

[Integrated traditional Chinese and Western medicine versus Western medicine in treatment of arteriosclerosis obliterans: a systematic review of randomized controlled trials].

BACKGROUND: The conventional therapy for arteriosclerosis obliterans (ASO) is Western medicine. However, it has some adverse effects and does not respond to some patients, and it is also very expensive. OBJECTIVE: To evaluate the efficacy of integrated traditional Chinese (TCM) and Western medicine (WM) in treatment of ASO. SEARCH STRATEGY: Electronic and manual searches were conducted and the searches ended on May 20, 2009. INCLUSION CRITERIA: We included randomized controlled trials (RCT) evaluating integrated TCM and WM (as treatment group) versus WM used alone (as control group), and no language limits were set. DATA EXTRACTION AND ANALYSIS: Selection of trials for inclusion, assessment for methodological quality, data extraction and data syntheses were conducted according to protocol of a Cochrane systematic review by the authors. RESULTS: Thirteen RCT were included, which encompassed a total of 968 patients. The results showed that all of the 13 included trials did not report mortality rate of ASO. The studies displayed that the amputation rate in the treatment group was lower than that in the control group, but there was no statistical significance. Ten studies adopted inefficiency analysis and 2 of them showed that the ineffective rate in the treatment group was lower than that in the control group, and the relative risk (RR) and 95% CI were 0.36 [0.13, 0.99]. We performed descriptive analysis on other 8 studies; analyses of secondary outcomes such as intermittent claudication, ankle brachial index, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) showed that integrated TCM and WM therapy was more effective than WM treatment alone; one study showed that WM was better than integrated TCM and WM therapy in decreasing the content of fibrinogen. All of the included trials did not report any critical adverse reactions occurred in the treatment group. CONCLUSION: The current evidence shows that integrated TCM and WM therapy is safe and effective in treating ASO, and tends to reduce amputation rate, improve intermittent claudication, decrease the levels of fibrinogen, HDL and LDL, and increase ankle brachial index, without obvious adverse reactions. Due to the low methodological quality of trials included, more prospective, multicenter, large-scale, high-quality RCTs are needed.

[Antiplatelet therapy in patients with chronic obliterating diseases of lower-limb arteries].

The article deals with present-day evidence concerning the role of blood-platelet activity in the development of a pathological process and acute ischemia in patients presenting with chronic arterial insufficiency of the lower extremities. Proved herein is the necessity of long-term administration of antiplatelet drugs in order to prevent vascular complications on the part of the heart, brain, and peripheral arteries, with a description of the drugs most commonly used for these purposes.

Selective and sustained delivery of basic fibroblast growth factor (bFGF) for treatment of peripheral arterial disease: results of a phase I trial.

OBJECTIVES: The aim of this study was to evaluate the safety of selective and sustained delivery of basic fibroblast growth factor (bFGF) using acidic gelatine hydrogel microspheres (AGHMs) for the treatment of peripheral arterial disease (PAD). MATERIALS AND METHODS: We conducted a non-randomised and uncontrolled trial involving prospective observation of eight patients (eight limbs) with PAD - five limbs with arteriosclerosis obliterans and three limbs with thromboangiitis obliterans, five limbs (three arms and two legs) with critical limb ischaemia (CLI) and three limbs with intermittent claudication (IC) - who were followed up for 6 months or more. AGHM suspension containing 100 microg bFGF was infused into the artery of the affected limb. Besides evaluation of safety and changes in symptoms, resting ankle-brachial pressure index measurement and transcutaneous PO(2) (tcPO(2)), angiography were conducted at baseline and then at various time points. Skin perfusion pressure as an index of CLI and claudication distance as an index of IC were also used to assess clinical improvement and limb perfusion. RESULTS: No serious adverse events were observed. All cases showed improvement in symptoms, although this was temporary in some patients. CONCLUSION: Selective delivery of bFGF using AGHMs was suggested to be safe and well-tolerated in patients with PAD.

[Treatment of lower extremity diabetic atherosclerotic obliterans with shuxuetong injection].

OBJECTIVE: To observe the effect and safety of Shuxuetong Injection (SXT) in treating patients with type 2 diabetes mellitus accompanying lower extremity atherosclerotic obliterans. METHODS: The selected patients were assigned by randomized digital table to the treated group (180 cases treated with SXT) and the control group (80 cases treated with alprostadil). The clinical efficacy was assessed after 4 weeks of treatment, and the inner diameters and blood flow of the superficial femoral artery, the posterior tibial artery and the foot dorsal artery were measured and compared before and after treatment using Doppler's ultrasonography. RESULTS: The total effective rate in the treated group was 94.4% (170/180), better than that in the control group, 85.0% (68/80, P < 0.01). Ultrasonic examination showed that the inner diameter and the blood flow of all the arteries measured in the treated groups increased after treatment (P < 0.01), with the increase superior to those in the control group (P < 0.05). No adverse reaction was found during the treatment. CONCLUSION: SXT has the effect of activating blood circulation, dissolving stasis and dredging collaterals, it could reduce or eliminate the formation of thrombi, being effective and safe when applied in clinical practice for the treatment of lower extremity diabetic atherosclerotic obliterans.

Therapeutic potential of atrial natriuretic peptide administration on peripheral arterial diseases.

Peripheral arterial diseases are caused by arterial sclerosis and impaired collateral vessel formation, which are exacerbated by diabetes, often leading to leg amputation. We have reported that an activation of the natriuretic peptides/cGMP/cGMP-dependent protein kinase pathway accelerated vascular regeneration and blood flow recovery in murine legs, for which ischemia had been induced by a femoral arterial ligation as a model for peripheral arterial diseases. In this study, ip injection of carperitide, a human recombinant atrial natriuretic peptide, accelerated blood flow recovery with increasing capillary density in ischemic legs not only in nondiabetic mice but also in mice kept upon streptozotocin-induced hyperglycemia for 16 wk, which significantly impaired the blood flow recovery compared with nondiabetic mice. Based on these findings, we tried to apply the administration of carperitide to the treatment of peripheral arterial diseases. The study group comprised a continuous series of 13 patients with peripheral arterial diseases (Fontaine's classification I, one; II, five; III, two; and IV, five), for whom conventional therapies had not accomplished appreciable results. Carperitide was administrated continuously and intravenously for 2 wk to Fontaine's class I-III patients and for 4 weeks to class IV patients. The dose was gradually increased to the maximum, with the patient's systolic blood pressure being kept above 100 mm Hg. Carperitide administration improved the ankle-brachial pressure index, intermittent claudication, rest pain, and ulcers. In conclusion, this study showed a therapeutic potential of carperitide to treat peripheral arterial diseases refractory to conventional therapies.