Shock wave therapy for acute and chronic soft tissue wounds: a feasibility study

BACKGROUND: Nonhealing wounds are a major, functionally-limiting medical problem impairing quality of life for millions of people each year. Various studies report complete wound epithelialization of 48 to 56% over 30 to 65 d with different treatment modalities including ultrasound, topical rPDGF-BB, and composite acellular matrix. This is in contrast to comparison control patients treated with standard wound care, demonstrating complete epithelialization rates of 25 to 39%. Extracorporeal shock wave therapy (ESWT) may accelerate and improve wound repair. This study assesses the feasibility and safety of ESWT for acute and chronic soft-tissue wounds. STUDY DESIGN: Two hundred and eight patients with complicated, nonhealing, acute and chronic soft-tissue wounds were prospectively enrolled onto this trial between August 2004 and June 2006. Treatment consisted of debridement, outpatient ESWT [100 to 1000 shocks/cm(2) at 0.1 mJ/mm(2), according to wound size, every 1 to 2 wk over mean three treatments], and moist dressings. RESULTS: Thirty-two (15.4%) patients dropped out of the study following first ESWT and were analyzed on an intent-to-treat basis as incomplete healing. Of 208 patients enrolled, 156 (75%) had 100% wound epithelialization. During mean follow-up period of 44 d, there was no treatment-related toxicity, infection, or deterioration of any ESWT-treated wound. Intent-to-treat multivariate analysis identified age (P = 0.01), wound size < or =10 cm(2) (P = 0.01; OR = 0.36; 95% CI, 0.16 to 0.80), and duration < or =1 mo (P < 0.001; OR = 0.25; 95% CI, 0.11 to 0.55) as independent predictors of complete healing. CONCLUSIONS: The ESWT strategy is feasible and well tolerated by patients with acute and chronic soft tissue wounds. Shock wave therapy is being evaluated in a Phase III trial for acute traumatic wounds.     

Ozone therapy for the treatment of chronic wounds: A systematic review

Chronic wounds present a significant burden to the health care system and the patient. Ozone therapy has been proposed as a treatment for chronic wounds, potentially acting by eliciting mild oxidative stress or disinfection. The purpose of this systematic review is to evaluate the potential benefits and harms of ozone therapy as an advanced care intervention for chronic wounds. Studies were extracted from Google Scholar, PubMed, the Cochrane Library, and reference lists. General inclusion criteria included English‐language randomised human trials reporting the use of ozone therapy in the topical treatment of chronic wounds. Primary outcome data included the extent of chronic wound healing, and secondary outcomes included adverse effects. Studies were assessed for level of bias and data quality. Nine studies (n = 453 patients) matched the inclusion criteria and underwent meta‐analysis. Overall, there was a significant improvement in wound closure with ozone therapy. Results consistently favour the application of ozone as a treatment for chronic wounds; however, there is no conclusive evidence of ozone therapy as superior compared with standard treatments. Compared with standard care, ozone therapy as an advanced wound care treatment may improve the proportion of chronic wounds healed in a shorter amount of time, but further research is required.     

Efficacy of antioxidant therapy on sperm quality measurements after varicocelectomy: A systematic review and meta‐analysis

Antioxidants were proved to be efficient to improve the quality of spermatozoa after varicocelectomy. We carried out a systematic review and performed a meta‐analysis to evaluate the efficacy of antioxidant therapy in sperm parameters' quality after varicocelectomy during 3 or 6 months' treatment cycle. During research, randomised controlled trials were searched by MEDLINE, EMBASE and the Cochrane Controlled Trials Register, and necessary parameters were compared between two groups after varicocelectomy. Finally, six studies including 576 patients were included in our meta‐analysis. As for sperm parameters, significant improvements of sperm concentration (p < .0001), sperm motility (p = .03), progressive sperm motility (p < .00001) and sperm morphology (p < .00001) were existed in antioxidant group 3 months after varicocelectomy. With regard to the 6 months' outcomes, sperm parameters were improved as well except sperm motility (p = .72) and progressive sperm motility (p = .57). Referring to pregnancy rate, no significant difference was existed between two groups (p = .36), and the FSH level of antioxidant group was lower than placebo group 3 or 6 months after varicocelectomy (3 months, p = .02; 6 months, p = .03). In conclusion, compared with the placebo, the antioxidant therapy after varicocelectomy can improve the quality of sperm parameters and construct a favourable living condition for spermatozoa by reducing FSH level.     

Effects and safety of atmospheric low‐temperature plasma on bacterial reduction in chronic wounds and wound size reduction: A systematic review and meta‐analysis

The use of atmospheric low‐temperature plasma (AP) on chronic wounds and its effect on microbial bioburden in open wounds has not been explored with a systematic review and meta‐analysis. PRISMA guidelines were followed and PubMed, Embase, CENTRAL, and CINAHL databases searched for randomised controlled trials (RCTs), which compared AP with no AP for the management of open, chronic wounds. The primary outcomes of reduction of bioburden or wound size were included. Meta‐analyses were performed; odds ratio (OR) and 95% confidence intervals (CIs) were extracted and pooled in a random effects model. Four RCTs investigated the effect of AP on chronic wound healing. Chronic wounds treated with AP did not show a significant improvement in healing (AP vs control: OR = 1.46; 95% CI = 0.89‐2.38; P = 0.13). Five further RCTs investigated the reduction of bioburden in wounds, but AP demonstrated no significant reduction of bioburden (AP vs control: OR = 0.85; 95% CI = 0.45‐1.62; P = 0.63). All nine RCTs recorded the presence of any severe adverse events (SAEs) in the 268 patients studied, with only one unrelated SAE identified in each group (AP vs control: OR = 1.00; 95% CI = 0.05‐19.96; P = 1.00). Use of AP in wound care is safe, but the retrieved evidence and meta‐analysis show that there is no clinical benefit of AP in chronic open wounds using currently available AP device settings.     

Extracorporeal shock wave therapy for chronic wounds: A systematic review and meta‐analysis of randomized controlled trials

A growing number of clinical studies demonstrate that extracorporeal shock wave therapy (ESWT) is a feasible noninvasive method for improving chronic wound healing. This systematic review and meta‐analysis aimed to assess the effectiveness of ESWT compared with that of the standard care treatment for the healing of chronic wounds, irrespective of etiology, in clinical practice. Randomized controlled trials that investigated the effect of ESWT on chronic wounds with different etiologies from 2000 to 2017 were included in this review. The methodological quality of each selected article was rated using the Jadad scale. A fixed or random effects model was used to calculate the pooled effect sizes according to the heterogeneity of the studies. The cumulative effect of ESWT on each outcome was illustrated using forest plots. Seven randomized controlled trials involving 301 subjects were included in this review. Meta‐analyses revealed that the use of ESWT as an adjunct to wound treatment could significantly accelerate the impaired healing process of chronic wounds. Compared with the control treatment, ESWT markedly increased the wound healing rate by 1.86‐fold (OR = 2.86, 95% CI: 1.63–5.03, p = 0.0003) and the percentage of the wound healing area by 30.46% (SMD = 30.46; 95% CI: 23.80–37.12; p < 0.00001). In addition, the wound healing time was reduced by 19 days (SMD = ?19.11, 95% CI: ?23.74–(–14.47), p < 0.00001) in chronic wound patients. No serious complications or adverse effects were observed secondary to the application of ESWT. The above data suggested that ESWT as an adjunct to wound treatment, could more significantly improve the healing process of chronic wounds than the standard care treatment alone. More high‐quality, well‐controlled randomized trials are needed to evaluate the efficacy of ESWT in clinical practice.     

Efficacy and safety of recombinant human epidermal growth factor for diabetic foot ulcers: A systematic review and meta‐analysis of randomised controlled trials

To evaluate the efficacy and safety of recombinant human epidermal growth factor (rhEGF) in treating diabetic foot ulcers (DFUs), we conducted both database searches (PubMed, MEDLINE, EMBASE, CENTRAL, and Web of Science) and reference searches for randomised controlled trials from the inception of databases to 30 January 2020. Two reviewers independently scrutinised the trials, extracted data, and assessed the quality of trials. The primary outcome was the proportion of complete healing. The secondary outcomes were mean time to complete healing and adverse events. A subgroup analysis was performed by different administration routes. Statistical analyses were performed in RevMan 5.3. The time to complete healing Kaplan‐Meier curves was pooled in the R software. Of the 156 citations, 9 trials (720 participants) met eligibility criteria and were included. The rhEGF achieved a higher complete healing rate than placebo (OR: 2.79, [95% CI: 1.99, 3.99]). The rhEGF also significantly shorten complete healing time (MD: −14.10 days, [95% CI: −18.03, −10.16]). Subgroup analysis showed that topical application was superior to intralesional injection, but that may be because of different ulcer severity they included. No significant difference was shown in adverse events. Results were coherent with sensitivity analyses. Therefore, rhEGF is an effective and safe treatment for DFUs.     

Surgical therapy vs conservative therapy for patients with acute injury of lateral ankle ligament: A meta‐analysis and systematic review

The goal of this meta‐analysis was to explore the overall safety and efficacy of surgical therapy vs conservative therapy for acute injury of the lateral ankle ligament based on eligible studies. Eligible studies were identified by searching PubMed, Cochrane, and Embase databases using appropriate updated index words to January 2018. We also searched relevant publication sources. Eligible studies included randomised controlled trials and comparative studies. Mean difference or relative risk (RR), along with 95% confidence interval (CI), was used to analyse the main outcomes. A total of 13 studies were eligible for this meta‐analysis, with 834 patients in the surgical therapy group and 930 patients in the conservative therapy group. Compared with patients receiving conservative treatment, patients undergoing surgical treatment had a significant higher American Orthopedic Foot And Ankle Society (AOFAS) score (weighted mean difference(WMD): 10.33, 95% CI: 6.83‐13.83) and an effective rate (RR: 1.15, 95% CI: 1.04‐1.28). No significant differences were observed in the incidence of recurrent ankle injury (RR: 1.01, 95% CI: 0.62‐1.65), limited range of motion (RR: 1.44, 95% CI: 0.83‐2.50), deep vein thrombosis (RR: 1.33, 95% CI: 0.73‐2.41), and wound infection or necrosis (RR: 3.99, 95% CI: 0.45‐35.34). However, compared with patients receiving conservative treatment, patients undergoing surgical therapy had significantly increased rates of complications (RR: 3.31, 95% CI: 2.55‐4.28), ankylosis (RR: 3.63, 95% CI: 2.16‐6.08), scare tenderness (RR: 10.16, 95% CI: 3.89‐26.52) and sensory loss (RR: 5.66, 95% CI: 2.76‐11.59). The results demonstrated that surgical treatment increased the AOFAS score and effective rate compared with conservative treatment. Besides, surgical treatment increased the rate of complications. Nevertheless, more high‐quality randomised controlled trials with a larger sample size conducted at multiple centres with a long‐term follow up are needed to confirm our conclusions.     

Initiation time of renal replacement therapy on patients with acute kidney injury: A systematic review and meta‐analysis of 8179 participants

The early initiation of renal replacement therapy has been recommended for patients with acute renal failure by some studies, but its effects on mortality and renal recovery are unknown. We conducted an updated meta‐analysis to provide quantitative evaluations of the association between the early initiation of renal replacement therapy and mortality for patients with acute kidney injury. After applying inclusion/exclusion criteria, 51 studies, including 10 randomized controlled trials, with a total of 8179 patients were analyzed. Analysis of the included trials showed that patients receiving early renal replacement therapy had a 25% reduction in all‐cause mortality compared to those receiving late renal replacement therapy (risk ratio [RR] 0.75, 95% CI [0.69, 0.82]). We also noted a 30% increase in renal recovery (RR 1.30, 95% CI [1.07, 1.56]), a reduction in hospitalization of 5.84 days (mean difference [MD], 95% CI [–10.27, –1.41]) and a reduction in the duration of mechanical ventilation of 2.33 days (MD, 95% CI [–3.40, –1.26]) in patients assigned to early renal replacement therapy. The early initiation of renal replacement therapy was associated with a decreased risk of all‐cause mortality compared with the late initiation of RRT in patients with acute kidney injury. These findings should be interpreted with caution given the heterogeneity between studies. Further studies are needed to identify the causes of mortality and to assess whether mortality differs by dialysis dose.     

体外震波对骨和骨疾病的作用及其机制

体外震波（extracorporeal shock wave，ESW）于20世纪80年代中期开始用于骨科领域，目前，它作为一种非侵入性治疗方法用于治疗多种骨相关疾病。为指导其进一步用于临床治疗并提高疗效，了解它对正常骨组织的影响和对骨疾病的治疗作用及其机制非常重要。现已有不少学者对这些方面进行了相关的基础与临床研究，取得了明显进展。本文就体外震波对骨和骨疾病的作用及其机制综述如下。     

Efficacy of confocal laser endomicroscopy for discriminating colorectal neoplasms from non‐neoplasms: a systematic review and meta‐analysis

Aim Confocal laser endomicroscopy (CLE) has evolved to allow in vivo real‐time biopsy for the classification of colorectal lesions. The primary aim of this study was to assess the effectiveness of CLE for discriminating colorectal neoplasms from non‐neoplasms and its contributing factors. The secondary aim was to compare the efficacy of endomicroscopy and chromoendoscopy for diagnosing colorectal neoplasms. Method A systematic review of the literature published between 2000 and 2012 was conducted. Pooled sensitivity and specificity were compared using univariate regression analysis according to prespecified subgroups. Pooled relative risk was computed to compare the accuracy of endomicroscopy and chromoendoscopy. Results Fifteen studies involving 719 patients and 2290 specimens were analysed. The pooled sensitivity of all studies was 0.94 [95% confidence intervals (CI): 0.88–0.97], and pooled specificity was 0.95 (95% CI: 0.89–0.97). Real‐time CLE yielded higher sensitivity (0.96 vs 0.85, P < 0.001) and specificity (0.97 vs 0.82, P < 0.001) than blinded CLE. For real‐time CLE, endoscopy‐based systems had better sensitivity (0.96 vs 0.89, P < 0.001) and specificity (0.99 vs 0.82, P < 0.0001) than probe‐based systems. CLE yielded equivalent accuracy compared with magnifying virtual chromoendoscopy and magnifying pigment chromoendoscopy (P > 0.05). Conclusion CLE is comparable to colonoscopic histopathology in diagnosing colorectal neoplasms, and is better in conjunction with conventional endoscopy. An endoscopy‐based rather than a probe‐based modality would be optimal in the application of CLE.     

Efficacy of home‐based exercise programme on physical function after hip fracture: a systematic review and meta‐analysis of randomised controlled trials

We performed a meta‐analysis to evaluate the effect of home exercise programmes on body function after hip fractures. A computerised literature search was performed for published trials in PubMed, EMBASE, CENTRAL, and Cochrane Database of Systematic Reviews. Randomised trials were selected investigating home‐based exercise programmes vs usual care without home‐based exercise in hip fracture patients. Physical health (measured by Short Form 36), normal gait speed, fast gait speed, balance, instrumental activities of daily living (IADL), activities of daily living (ADL), lower extremity strength, leg strength in fractured leg, leg strength in non‐fractured leg, and Six‐Minute Walk Test (6MWT) per randomised patient were measured as outcomes. Eleven randomised controlled trials of 1068 subjects were included, 533 in the home‐based exercise group and 535 in the control group. The results of this meta‐analysis showed that the home‐based exercise programmes were not significantly associated with physical health, normal gait speed, fast gait speed, balance, IADL, ADL, and lower extremity strength but were significantly associated with leg strength in the fractured leg, leg strength in the non‐fractured leg, and 6MWT. The home‐based exercise programme had a positive, although not significant, effect on physical function after hip fracture. Low‐intensity training and poor patient compliance are unavoidable problems in home‐based exercise rehabilitation. A more task‐oriented rehabilitation programme might possibly yield more benefits for disability outcomes.     

Erectile dysfunction and atrial fibrillation: A systematic review and meta‐analysis

Objective

To investigate the pooled incidence or the prevalence of erectile dysfunction, and to assess the risk of erectile dysfunction in patients with atrial fibrillation.

Methods

A systematic review was carried out in the MEDLINE, EMBASE and Cochrane databases from inception through January 2018 to identify: (i) studies that reported the incidence and/or prevalence of erectile dysfunction in atrial fibrillation patients; or (ii) studies that assessed the association between atrial fibrillation and erectile dysfunction. Pooled odds ratios and 95% confidence intervals were calculated using a random effects model.

Results

Five observational studies (27 841 patients) were enrolled. The pooled estimated prevalence of erectile dysfunction in atrial fibrillation patients was 57% (95% confidence interval 50–64, I² = 0). A study showed an incidence of newly diagnosed erectile dysfunction in atrial fibrillation patients of 0.96% during the mean follow‐up duration of 4.67 ± 3.20 years. There was a significant association of atrial fibrillation with an increased risk of erectile dysfunction, with a pooled odds ratio of 1.79 (95% confidence interval 1.44–2.23, I² = 0%). The data on the risk of atrial fibrillation development in patients with erectile dysfunction were limited. A study showed the comparable risk of atrial fibrillation in patients with erectile dysfunction (odds ratio 1.03, 95% confidence interval 0.67–1.5), when compared with those without erectile dysfunction.

Conclusions

The present study suggests a significant association between erectile dysfunction and atrial fibrillation. The overall estimated prevalence of erectile dysfunction among atrial fibrillation patients is 57%. However, despite limited data, the current evidence suggests a low incidence of new erectile dysfunction in atrial fibrillation patients.

     

Metalloproteinases in chronic and acute wounds: A systematic review and meta‐analysis

A systematic review and meta‐analysis were undertaken in order to explore the influence of matrix metalloproteinases and their diagnostic methods in chronic and acute wounds. Searches were conducted in the PubMed (Medline) and Embase (Elsevier) databases from inception to late November 2017. We included clinical trials enrolling patients with cutaneous chronic and acute wounds where a validated diagnostic method was employed for metalloproteinases. We excluded in vitro, animal or preclinical studies, nonoriginal articles, and studies without available data for analysis. In addition, references of narrative and systematic reviews were scrutinized for additional articles. Eight studies met the inclusion criteria. Results revealed that the most frequently determined matrix metalloproteinases were MMP‐2 and MMP‐9, and were found in 54.5% of wounds. MMP‐9 was present in more than 50% of the chronic wounds with a range from 37 to 78%. However, metalloproteinases were found in only 20% of acute wounds, and other types of metalloproteinases were also observed (MMP‐2 and MMP‐3). On the basis of the available evidence, high levels of metalloproteinases have been correlated with significantly delayed wound healing in wounds of a variety of etiologies.     

Extracorporeal shock wave therapy role in the treatment of burn patients. A systematic literature review

IntroductionExtracorporeal shock wave therapy (ESWT), first described in the eighties for the treatment of urolithiasis, has also been applied in other fields such as orthopaedics and chronic wound care. Recently it has also been used in the treatment of burns and its sequelae since several studies suggest it could be an important tool in the conservative management of these conditions. The aim of this article is to review the literature for published evidence on the use of ESWT for the treatment of acute burn patients and its sequelae and to elaborate a brief report on the current state of the matter.Material and methodsWe carried on a search on PUBMED database and Cochrane database with the following terms: (‘burns’ [title/abstract] OR ‘burn’ [title/abstract]) AND “shock wave” ([title/abstract]). For an optimal reporting of the studies found we followed the PRISMA statement.ResultsThis search found 34 articles from which only 15 were actually related to the use of ESWT in burn patients. From these 15 articles, 7 involved the use of ESWT in the treatment of acute burns, 6 related to its application in post-burn scars, 1 in the treatment of heterotopic ossification and 1 was about the use of ESWT in skin-graft donor site. Except for the latter, all of them were carefully reviewed.ConclusionScientific evidence on the use of ESWT for the treatment of burn patients is weak due to the paucity of studies and their low quality. However, ESWT seems to be a promising tool in this field and therefore more high-quality trials should be conducted.     

Human amniotic membrane allograft,a novel treatment for chronic diabetic foot ulcers: A systematic review and meta‐analysis of randomised controlled trials

To evaluate the efficacy and safety of human amniotic membrane (HAM) allograft in treating chronic diabetic foot ulcers (DFUs), a comprehensive search of randomised controlled trials in MEDLINE, EMBASE, PubMed, CENTRAL and Web of Science was conducted to December 7, 2019. Two reviewers independently screened the studies, extracted data, and evaluated the quality of studies. The primary outcome was the proportion of complete healing. The secondary outcomes were mean time to complete healing and adverse events. Statistical analyses were performed using RevMan 5.3. We identified 257 articles, of which 7 articles (465 participants) were included in the meta‐analysis. The proportion of complete wound healing in HAM plus standard of care (SOC) group was 3.88 times as high as that in SOC alone (RR: 3.88 [95% CI: 2.34, 6.44]) at 6 weeks, and 2.01 times at 12 weeks (RR: 2.01 [95%CI: 1.45, 2.77]). The intervention group had a significantly shorter time to complete healing (MD: −30.33 days, [95% CI: −37.95, −22.72]). The number needed to treat within 6 weeks was 2.3 ([95% CI: 1.8, 3.1]). No significant difference was shown in adverse events. Results were consistent in a sensitivity analysis. Hence, HAM plus SOC is effective and safe in treating chronic DFUs.