Association of great saphenous vein diameter and clinical severity score after treatment of severe chronic venous insufficiency with foam sclerotherapy

Objectives: to evaluate the association of the greater saphenous vein (GSV) diameter in the treatment of patients with severe chronic venous insufficiency (C6 CEAP classification) with ultrasound-guided polidocanol foam sclerotherapy (UGFS). Methods: A prospective, descriptive and analytical study of 28 patients (30 limbs) that underwent UGFS. Patients were divided into 2 subgroups by GSV diameter (< 8 mm and ≥ 8 mm). Variables analyzed were ulcer healing, clinical intercurrences, clinical CEAP classification, Venous Clinical Severity Score (VCSS), diameter of the treated vein and presence of occlusion or recanalization by Doppler ultrasound. Patients were analyzed at the 1st, 3rd, and 6th months post-treatment. Results: The average age was 68.7 ± 10.5 years, 23 (82,1%) were women, and the average body mass index was 29.2 kg/m2. Although an improvement in VCSS score was observed during follow-up, no significant intergroup difference was noted. Seventeen (56%) limbs presented occlusion of the treated vein at the 1st month, 11 (36%) at the 3rd month, and 9 (30%) at the 6th month of follow-up. The ulcer healing rate was 56,6%. The average ulcer healing time was 90 days. Three (10%) patients presented with ulcer recurrence at the 6th month. Survival analysis showed no significant difference in ulcer healing rate between subgroups after one year of follow-up (log-rank, p = 0,178). Conclusion: There was no difference between the subgroups of large and small VSM diameter in terms of symptom severity. However, significant reduction of VCSS and pain relief was observed after foam sclerotherapy.

Efficacy and Safety of Pentoxifylline for Venous Leg Ulcers: An Updated Meta-Analysis

The venous leg ulcers are debilitating, painful, and often unresponsive to advanced dressing treatments, so drugs used locally and systematically are essential adjuvant therapy—pentoxifylline (PTX) whose anti-inflammatory effects may offer a promising avenue to treat venous leg ulcers. However, the current results are controversial. To further evaluate the efficacy and safety of PTX, we performed an updated meta-analysis of randomized placebo-controlled trials of PTX in the treatment of venous leg ulcers. We systematically searched multiple electronic databases PubMed, Web of Science, Embase, the Cochrane Library, the Cochrane Central Register of Controlled Trials, China Science and Technology Journal Database, WanFang Data, China National Knowledge Infrastructure, and the Chinese Biomedical Literature Database to identify eligible studies. Randomized clinical trials of pentoxifylline versus placebo treatment in patients with venous leg ulcers were considered for inclusion. The primary outcomes included ulcer healing rate and the incidence of adverse events after treatment. The secondary outcomes were the ulcer significant improvement (the ulcer size shrank by more than 60% after treatment) rate, mean duration of complete wound healing and changes in mean ulcer size. A meta-analysis and qualitative analysis were conducted to estimate endpoints. A total of 13 randomized clinical trials, including 921 individuals, were finally included. Compared with placebo, pentoxifylline significantly improved the ulcer healing rate (RR = 1.59, 95%CI 1.22 to 2.07, P < .001) and significant improvement rate (RR = 2.36, 95%CI 1.31 to 4.24, P = .004) while increased the incidence of gastrointestinal disturbances (RR = 2.29, 95%CI 1.04 to 5.03, P = .04) at the same time. Moreover, pentoxifylline also shortened mean duration of complete wound healing ( P = .007) and shrank ulcer size ( P = .02). Currently available evidence suggests that pentoxifylline could help venous leg ulcers heal more quickly and effectively. However, the evidence is insufficient to prove the results due to moderate-certainty evidence. Large-scale, well-designed randomized clinical trials are warranted.

Mucosal Healing Effectiveness and Safety of Anaprazole, a Novel PPI, vs. Rabeprazole in Patients With Duodenal Ulcers: A Randomized Double-Blinded Multicenter Phase II Clinical Trial

Background: Proton pump inhibitors (PPIs) are validated gastric acid suppressors and have been widely used to treat patients with active duodenal ulcers. Although existing PPIs have shown great efficacy, many scientists are still devoted to developing more effective PPIs with better safety profile. Herein, we aimed to compare the safety and efficacy of anaprazole in duodenal mucosal healing, a novel PPI, to that of rabeprazole.Methods: In this multicenter, randomized, positive-controlled, double-blinded, parallel-group phase II clinical trial, a total of 150 qualified patients with endoscopically confirmed active duodenal ulcers were randomized (1:1:1) to receive rabeprazole 10 mg, anaprazole 20 mg or anaprazole 40 mg for 4 weeks. The ulcer healing rates after 4 weeks of treatment were compared between groups by independent central review and investigator review. In addition, symptoms and safety were evaluated.Results: Based on the independent central review, the ulcer healing rates of the 10 mg rabeprazole, 20 mg anaprazole and 40 mg anaprazole groups were 88.0, 85.1, and 87.5%, respectively, in the FAS population and 88.9, 86.0, and 90.9%, respectively, in the PPS population. The ulcer healing rate difference between anaprazole 20 mg and Rabeprazole 10 mg is −2.9% (95% CI, −16.5–10.7%), and −0.5% (95% CI, −13.5–12.5%) between anaprazole 40 mg and Rabeprazole 10 mg, in the FAS population. Based on the investigator review, the ulcer healing rates of the 10 mg rabeprazole, 20 mg anaprazole, and 40 mg anaprazole groups were 72.0, 70.2, and 77.1%, respectively, in the FAS population and 75.6, 72.1, and 79.5%, respectively, in the PPS population. The ulcer healing rate difference between anaprazole 20 mg and Rabeprazole 10 mg is −1.8% (95% CI, −19.8–16.3%), and 5.1% (95% CI, −12.2–22.3%) between anaprazole 40 mg and Rabeprazole 10 mg, in the FAS population. Most patients (&gt;90%) eventually achieved complete symptom relief. The incidence rates of adverse events were of no significant differences among the treatment groups. Potential possible better liver tolerance was observed in two anaprazole dose groups than rabeprazole 10 mg group.Conclusion: Both at a dosage of 20 and 40 mg daily, anaprazole, is effective with good safety profile in the treatment of active duodenal ulcers in this Phase 2 study, which allows anaprazole to be advanced to a phase III clinical trial.Clinical Trial Registration:https://www.clinicaltrials.gov/ct2/results?cond=&amp;term=NCT04503629&amp;cntry=&amp;state=&amp;city=&amp;dist=, Identifier: CTR20181464, NCT04503629.

A combination of ultrasonic debridement and Shenghong wet dressing in patients with chronic ulcers of the lower limbs

Objective This study aimed to examine the effects of ultrasonic debridement plus a wet dressing of Shenghong (SH) on chronic ulcer healing of the lower extremities in patients with diabetes. Methods Sixty cases of diabetes combined with chronic lower limb ulcers were randomly divided into control (n = 30) and experimental (n = 30) groups. The control group was treated with ultrasonic debridement plus recombinant human fibroblast growth factor (FGF) gel. The experimental group was treated with ultrasonic debridement plus SH wet dressing. Results The mean clinical efficacy in the experimental group was significantly higher than that in the control group (93.33% ± 6.32% versus 60.0% ± 5.87%). The mean ulcer area was significantly smaller and the mean ulcer healing rate was significantly shorter in the first 3 months, and the mean overall pain intensity score was significantly lower in the experimental group than in the control group. Moreover, the positive rates of bacterial culture on the 7th and 15th days were significantly lower in the experimental group than in the control group. Conclusion The use of ultrasonic debridement plus SH wet dressing for treating ulcers can significantly improve clinical efficacy and promote healing.

Treatment Effects of Jinlingzi Powder and Its Extractive Components on Gastric Ulcer Induced by Acetic Acid in Rats

Jinlingzi powder comprises Melia toosendan Sieb. et Zucc. and Corydalis yanhusuo (Y.H. Chou & Chun C.Hsu) W.T. Wang ex Z.Y. Su & C.Y. Wu and is usually applied in clinic as traditional Chinese medicine for pain. The present study aims to investigate the therapeutic actions of Jinlingzi powder and its extracted components and theirs treatment mechanism on the acetic acid induced-gastric ulcer in rats. The gastric ulcer model was induced by the administration of acetic acid in rats (84 male). Jinlingzi powder water decoction, its polysaccharide, and nonalkaloid and alkaloid components were used to investigate the therapeutic actions on the acetic acid induced-gastric ulcer by measuring the related pharmacy and pharmacodynamic factors, including ulcer index, ulcer area, ulcer healing rate, interleukin-8 (IL-8), tumor necrosis factor-α (TNF-α), neurotensin (NT), platelet activating factor (PAF), thromboxane B2 (TXB2), and vascular endothelial growth factor (VEGF) in rat serum, acetylcholinesterase (AChE) in brain tissue, prostaglandin E2 (PGE2), and basic fibroblast growth factor (bFGF) in gastric tissue. Among the various groups, Jinlingzi powder and the nonalkaloid components caused significant changes in IL-8, TNF-α, NT, PAF TXB2, and VEGF values in the serum. The AChE content in the rats’ brain tissue was also reduced after using Jinlingzi powder and the nonalkaloid components. Additionally, Jinlingzi powder and the nonalkaloid components considerably affect the amount of PGE2 and bFGF in a rat’s stomach tissue. Therefore, Jinlingzi powder and the nonalkaloid components can effectively inhibit neutral neutrophil activation, prevent capillaries thrombosis, and protect gastric mucosa. Thus, the nonalkaloid components of the Jinlingzi powder play a key role in the treatment of gastric ulcer.

Surgical methods and clinical results of subfascial endoscopic perforator surgery in Japan

Objectives To clarify the surgical methods and the clinical results of subfascial endoscopic perforator surgery in Japan. Methods This study included 1287 limbs of 1091 patients who underwent subfascial endoscopic perforator surgery in 14 hospitals. Simultaneous saphenous vein treatment was performed in 1079 limbs (83.8%), and 118 limbs (9.2%) had deep venous lesions. The venous clinical severity score was calculated before and 6 to 12 months after surgery. The ulcer healing rate and ulcer recurrence rate were calculated cumulatively. Results Preoperative venous clinical severity score was significantly decreased from 10.0 ± 6.6 to 3.1 ± 3.4 ( P < .0001) postoperatively. The primary ulcer healing rate was 96.2% (332/345 C6 limbs) at an average follow-up of 47.7 months, and the ulcer recurrence rate was 12.0% (49/393 C5, C6 limbs) at the average follow-up of 46.0 months after the ulcer healed. Conclusion These results indicate that subfascial endoscopic perforator surgery is an alternative to improve the long-lasting disease severity and/or clinical outcome.

Effect of Laser Irradiation at Different Wavelengths (940, 808, and 658 nm) on Pressure Ulcer Healing: Results from a Clinical Study

The aim of the study was to assess the efficacy of laser therapy (at different wavelengths: 940, 808, and 658 nm) for treating pressure ulcers. The primary endpoint in this trial included both the percentage reduction of the ulcer surface area and the percentage of completely healed wounds after one month of therapy (ulcer healing rate). The secondary endpoint was the ulcer healing rate at the follow-up evaluation (3 months after the end of the study). In total, 72 patients with stage II and III pressure ulcers received laser therapy once daily, 5 times per week for 1 month using a (GaAlAs) diode laser with a maximum output power of 50 mW and continuous radiation emission. Three separate wavelengths were used for the laser treatment: 940 nm (group I), 808 nm (group II), and 658 nm (group III). An average dose of 4 J/cm2was applied. In group IV, a placebo was applied (laser device was turned off). The laser therapy at a wavelength of 658 nm appeared to be effective at healing pressure ulcers. The wavelengths of 808 and 940 nm did not have any effect in our study.

Catheter-directed foam sclerotherapy treatment of saphenous vein incompetence

Background: The aim of this study is to report the short-term results of catheter-directed foam sclerotherapy (CDFS) in the treatment of axial saphenous vein incompetence. Patients and methods: Data of all patients undergoing CDFS for symptomatic primary incompetence of the great or small saphenous vein were prospectively collected. Treatment results in terms of occlusion rate and patients’ grade of satisfaction were analysed. All successfully treated patients underwent clinical and duplex follow-up examinations one year postoperatively. Results: Between September 2006 and September 2010, 357 limbs (337 patients) were treated with CDFS at our institution. Based on the CEAP classification, 64 were allocated to clinical class C3 , 128 to class C4, 102 to class C5 and 63 to class C6. Of the 188 patients who completed the one year follow up examination, 67 % had a complete and 14 % a near complete obliteration of the treated vessel. An ulcer-healing rate of 54 % was detected. 92 % of the patients were satisfied with the results of treatment. We registered six cases of thrombophlebitis and two cases of venous thromboembolism, all requiring treatment. Conclusions: The short-term results of CDFS in patients with axial vein incompetence are acceptable in terms of occlusion and complications rates.