Efficacy and safety of topical nitroglycerin in the prevention of mastectomy flap necrosis: a systematic review and meta-analysis.
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ABSTRACT:
SUBMITTER: Wang P
PROVIDER: S-EPMC7174291 | biostudies-literature | 2020 Apr
REPOSITORIES: biostudies-literature
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Efficacy and safety of topical nitroglycerin in the prevention of mastectomy flap necrosis: a systematic review and meta-analysis.
Wang Pu P Gu Luosha L Qin Zelian Z Wang Qifei Q Ma Jianxun J
Scientific reports 20200421 1
Flap necrosis is a common complication after mastectomy, and nitroglycerin (NTG) ointment has been used successfully to treat it. However, it is not clear whether topical NTG can completely prevent the occurrence of flap necrosis after breast cancer surgery, and it is also unclear whether this treatment may cause side effects. Three randomized controlled trials (RCTs) and two retrospective cohort studies (RCSs) were included in our investigation. This meta-analysis was conducted in accordance wi ...[more]
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| S-EPMC7175780 | biostudies-literature
Project description:BackgroundAccurate prediction of mastectomy skin flap viability is vital as necrosis causes significant morbidity, potentially compromising results and delaying oncological management. Traditionally assessed by clinical judgement, a more objective evaluation can be provided using intraoperative imaging modalities. This systematic review aimed to compare all intraoperative techniques for assessment of mastectomy flap viability.MethodsA systematic literature review was performed using MEDLINE and Embase databases. Primary outcomes reported included specificity, sensitivity and predictive values of each test, and mean rates of mastectomy flap necrosis and reoperation. Secondary outcomes included cost analysis.ResultsSome 18 studies were included. Designs were prospective cohort study (8), retrospective case series (4), prospective case series (3), retrospective case-control study (1), prospective pilot trial (1) and cost analysis study (1). The studies compared indocyanine green angiography (ICGA) (16 studies) and fluorescein dye angiography (FA) (3 studies) with clinical judgement. Sensitivity and specificity were highest for ICGA (5 studies) ranging from 38 to 100 and 68 to 91 per cent respectively. Both methods overpredicted necrosis. Mean rates of flap necrosis and reoperation decreased with ICGA (7·9 and 5·5 per cent respectively) and FA (3 and 0 per cent) compared with clinical judgement (19·4 and 12·9 per cent). Two studies were designed to define numerical parameters corresponding to perfusion using intraoperative techniques. Two studies performed a cost analysis for ICGA; one claimed a cost benefit and the other advocated its use in high-risk patients only.ConclusionICGA and FA are potentially useful tools for mastectomy flap assessment. However, the predictive accuracy is subject to the specific settings and model of equipment used. Current recommendations support their use in high-risk patients.
| S-EPMC6069344 | biostudies-literature
Project description:Seroma formation following mastectomy is one of the most experienced complications, with a very variable incidence ranging from 3 to 90%. In recent years, many publications have been realized to define an effective technique to prevent its formation and several approaches have been proposed. Given the potential of flap fixation in reducing seroma formation, we performed a meta-analysis of the literature to investigate the role of this approach as definitive gold standard in mastectomy surgery. Inclusion criteria regarded all studies reporting on breast cancer patients undergoing mastectomy with or without axillary lymph node dissection; studies that compared mastectomy with flap fixation to mastectomy without flap fixation were selected. Papers were eligible for inclusion if outcome was described in terms of seroma formation. As secondary outcome, also surgical site infection (SSI) was evaluated. The included studies were 12, involving 1887 female patients: 221/986 (22.41%) patients experienced seroma formation after flap fixation and 393/901 (43.61%) patients had this complication not receiving flap fixation, with a significant statistical difference between the two groups (OR = 0.267, p = 0.001, 95% CI 0.153, 0.464). About, SSI 59/686 (8.6%) in flap fixation group and 67/686 (9.7%) in patients without flap fixation, with no statistical differences between groups (OR = 0.59, p = 0.056, 95% CI 0.344, 1.013).The heterogeneity between included studies does not allow us to reach definitive conclusions but only to suggest the strong evaluation of this approach after mastectomy in seroma preventing and SSI reduction.
| S-EPMC8397649 | biostudies-literature
Project description:BackgroundTopical nitroglycerin (TNG) ointment has been used for almost 3 decades to treat neonatal peripheral tissue ischemia, but this product is now no longer being produced by its Canadian manufacturer. Our aim was to investigate the efficacy and safety of TNG products in newborns in neonatal intensive care units.MethodsIn this systematic review we searched Embase, CINAHL, MEDLINE, PubMed and Web of Science from inception to April 2020 for studies on the use of TNG products (TNG ointment, TNG spray, glyceryl trinitrate [GTN] patch) for the treatment of neonatal tissue ischemia. We did not apply language or study design limitations. Animal studies and duplicate records were excluded. Two reviewers screened and extracted data. The Tool for Evaluating the Methodological Quality of Case Reports and Case Series was used to assess the risk of bias of individual studies.ResultsWe included 23 articles (20 case reports, 2 case series and 1 retrospective audit) describing the use of TNG ointment, TNG spray or GTN patch in the treatment of 39 tissue ischemia events in 37 newborns. Twenty-three (62.2%), 12 (32.4%), 1 (2.7%) and 1 (2.7%) infants received TNG ointment, GTN patch, both TNG ointment and GTN patch, and TNG spray, respectively. Nineteen (76.0%) and 7 (53.8%) injuries treated with TNG ointment and GTN patch showed complete recovery, respectively. Two (16.7%) infants treated with GTN patch experienced adverse events (i.e., methemoglobinemia) requiring treatment discontinuation.InterpretationTNG ointment presents a safe therapeutic modality for salvage therapy of neonatal tissue ischemia. Engagement of stakeholders is essential to address its recent commercial inaccessibility in Canada.
| S-EPMC8096410 | biostudies-literature
Project description:BACKGROUND: Peroral endoscopic esophageal myotomy (POEM) represents a less invasive alternative, as compared with conventional laparoscopic Heller myotomy for treating achalasia patients. In the last years, a number of prospective and retrospective experiences with POEM use for achalasia have been published. METHODS: Relevant publications in which patients affected by achalasia underwent POEM treatment were identified by PubMed databases for the period 2010 - 2013. From each study, we extracted the number and type of major complications (defined as those requiring any additional medical or surgical intervention). Data were pooled, using random-effects models. Heterogeneity among studies was assessed by using Cochran's Q and the I (2) statistic. RESULTS: We found 16 studies that provided data on 551 patients. The median surveillance period was 6 months (range: 3-12). The median of mean POEM duration was 156 minutes (range: 42-112). Median myotomy length was 10?cm (range: 6-14). Technical and clinical success were reported in 97% (95% CI: 94-98%) and 93% (407/428; 95% CI: 90-95%). No heterogeneity (I (2?)=?0%) or publication bias was present in both estimates. When limiting the analysis only to adverse events that require medical or surgical interventions, major adverse events occurred in 14% (95% CI: 11-17%); however, only one patient needed post-POEM surgery (0.2%; 95% CI: 0-0.5%). CONCLUSIONS: POEM appeared to be a highly feasible and effective endoscopic treatment for achalasia. Despite POEM being apparently associated with relatively high morbidity, most patients are successfully managed conservatively, so that POEM appears as a very safe procedure; however, POEM should only be performed in centers able to treat POEM complications, such as pneumothorax or pneumoperitoneum.
| S-EPMC4528214 | biostudies-other
Project description:Objectives: Topical Chinese herbal medicine (TCHM) is widely used to prevent radiodermatitis in patients who receive radiation therapy in China. However, evidence regarding its efficacy remains limited. The purpose of the review is to evaluate the effects of TCHM in preventing radiodermatitis. Methods: The protocol of this review was registered in PROSPERO (CRD42020220620). Relevant clinical trials were identified (from January 1, 2010, to April 24, 2022) through 11 electronic databases, including PubMed, SpringerLink, Proquest, the Cochrane Central Register of Controlled Trials, Scopus, the ProQuest Dissertation & Theses Global, PsycINFO, Applied Social Sciences Index and Abstracts, the Chinese National Knowledge Infrastructure Databases, Wangfang Data Knowledge Service Platform, and the Chongqing VIP Chinese Science and Technology Periodical Database. The quality of the included trials was assessed through a risk of bias assessment using Version 2 of the Cochrane risk-of-bias tool (RoB 2.0). We included RCTs that compared TCHM single used or as adjunctive treatment with routine drugs, conventional therapy, or placebo for cancer patients who are about to start radiation therapy and do not possess any type of dermatitis or skin lesions at that time. Primary outcomes of interest were the incidence of radiodermatitis and the grade of radiodermatitis according to the RTOG (Radiation Therapy Oncology Group). Secondary outcomes included the recovery time of skin and mucosa, the occurrence time of radiodermatitis, the radiation dose, quality of life, and adverse events. Data were summarized using risk ratio (RR) calculations and 95% confidence intervals (CI) for binary outcomes or mean difference (MD) with 95% CI for continuous outcomes. Certainty of the evidence was assessed according to the GRADE criteria. Results: In this review, 38 randomized controlled trials (RCTs) were included. Risk of bias assessment through RoB 2.0 showed that two studies were rated as low risk, two studies were rated as high risk, and the rest were rated as having some concerns. Compared with routine drugs, TCHM may have an advantage in reducing RTOG grading (RR = 0.46, 95%CI 0.35-0.60), decreasing the recovery time of radiodermatitis (MD = -2.35, 95%CI 3.58 to -1.12 days), delaying the occurrence of radiodermatitis (MD = 2.36, 95%CI 1.74-2.98), and improving the quality of life of patients (RR = 1.46, 95%CI 1.03-2.06). Compared with conventional therapy, TCHM may also have an advantage in decreasing the grade of RTOG (RR = 0.28, 95%CI 0.21-0.38). Conclusion: Current low evidence revealed that TCHM may have better efficacy in the prevention of radiodermatitis; however, more high-quality RCTs are still warranted to testify this conclusion. Systematic Review Registration: (https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020220620), identifier (PROSPERO 2020 CRD42020220620).
| S-EPMC9257048 | biostudies-literature
Project description:BackgroundCore decompression (CD) is an important method for the treatment of osteonecrosis of the femoral head (ONFH). Few articles investigate the influence of core decompression on outcomes of ONFH. This study was carried out to observe the safety and effectiveness of core decompression in the treatment of ONFH.MethodsA comprehensive literature search of databases including PubMed, Embase, and Cochrane Library was performed to collect the related studies. The medical subject headings used were "femur head necrosis" and "Core decompression." The relevant words in title or abstract included but not limited to "Osteonecrosis of the Femoral Head," "femoral head necrosis," "avascular necrosis of femoral head," and "ischemic necrosis of femoral head." The methodological index for nonrandomized studies was adopted for assessing the studies included in this review.ResultsThirty-two studies included 1865 patients (2441 hips). Twenty-one studies (1301 hips) using Ficat staging standard, 7 studies (338hips) using Association Research Circulation Osseous (ARCO) staging standard, and University of Pennsylvania system for staging avascular necrosis (UPSS) staging criteria for 4 studies (802 hips). All the studies recorded the treatment, 22 studies (1379 hips) were treated with core decompression (CD) alone, and 7 studies (565 hips) were treated with core decompression combined with autologous bone (CD Autologous bone). Nine subjects (497 hips) were treated with core decompression combined with autologous bone marrow (CD Marrow). Twenty-seven studies (2120 hips) documented the number of conversion to total hip replacement (THA), and 26 studies (1752hips) documented the number of radiographic progression (RP). Twenty-one studies recorded the types of complications and the number of cases, a total of 69 cases. The random-effect model was used for meta-analysis, and the results showed that the overall success rate was 65%. The rate of success showed significant difference on the outcomes of different stages. The rate of success, conversion to THA, and radiographic progression showed significant difference on the outcomes of ONFH using different treatments.ConclusionsCore decompression is an effective and safe method of treating ONFH. The combined use of autologous bone or bone marrow can increase the success rate. For advanced femoral head necrosis, the use of CD should be cautious. High-quality randomized controlled trials and prospective studies will be necessary to clarify the effects of different etiology factors, treatments, and postoperative rehabilitation. Until then, the surgeon can choose core decompression to treat ONFH depending on the patient's condition.Level of evidenceI Meta-analysis.
| S-EPMC6737645 | biostudies-literature
Project description:Derivatives of hydrocortisone, such as mometasone furoate, a (2') furoate-17 ester with chlorine substitutions at positions 9 and 21, have been designed to improve efficacy and reduce the incidence of adverse effects. An extensive literature search of MEDLINE, Embase and other databases was conducted to review the safety and efficacy of various formulations of topical mometasone furoate. Mometasone furoate exhibits high potency with greater anti-inflammatory activity and a longer duration of action than betamethasone. In clinical trials, mometasone furoate shows comparable or significantly better efficacy, depending on the comparator, in all indications studied in both adults and children. It is well tolerated with only transient, mild to moderate local adverse effects. It is characterised by low systemic availability due to its high lipophilicity, low percutaneous absorption and rapid hepatic biotransformation, and consequently has no significant effect on the hypothalamic-pituitary-adrenal axis. The molecular biotransformation of mometasone furoate in the skin results in a lower affinity with dermal cells than epidermal cells, which contributes to its low atrophogenicity. Sensitisation to mometasone furoate is low. Overall, mometasone furoate is a highly efficacious potent corticosteroid with a low risk of both local and systemic adverse effects.
| S-EPMC6099284 | biostudies-literature
Project description:BACKGROUND:A number of clinical systematic review and meta-analysis have been published on the use of tranexamic in the obstetric setting. The aim of this meta-analysis was to evaluate the safety and effectiveness of tranexamic acid in reducing blood loss when given prior to caesarean delivery. MATERIALS AND METHODS:We searched the Cochrane Wounds Specialized Register, Cochrane Central, MEDLINE (through PUBMED), Embase, and SCOPUS electronic databases. We also searched clinical trials registries for ongoing and unpublished studies, and checked reference lists to identify additional studies. We used no restrictions with respect to language and date of publication. Two review authors independently performed study selection, "Risk of bias" assessment, and data extraction. Initial disagreements were resolved by discussion, or by including a third review author when necessary. RESULTS:We found 18 randomised controlled trials (RCTs) that met our inclusion criteria. Overall, 1,764 women receiving intravenous tranexamic acid for prevention of bleeding following caesarean sections and 1,793 controls receiving placebo were enrolled in the 18 RCTs evaluated. The use of tranexamic acid compared to controls (placebo or no intervention) reduces post-partum haemorrhage >400 mL (risk ratio [RR] 0.40, 95% confidence interval [CI] 0.24-0.65; 5 trials with a total of 786 participants), severe post-partum haemorrhage >1,000 mL (RR 0.32, 95% CI: 0.12-0.84; 5 trials with a total of 1,850 participants), and need for red blood cell transfusion (RR 0.30, 95% CI: 0.18-0.49; 10 trials with a total of 1,873 participants). No particular safety concerns on the use of this antifibrinolytic agent emerged from the analysis of the 18 RCTs included. DISCUSSION:Overall, the results of this meta-analysis support the evidence of a beneficial effect of tranexamic acid in reducing blood loss and need for blood transfusion in pregnant women undergoing caesarean section.
| S-EPMC6034773 | biostudies-literature
Project description:Vancomycin and teicoplanin are the glycopeptides currently in use for the treatment of infections caused by invasive beta-lactam-resistant gram-positive organisms. We conducted a systematic review and meta-analysis of randomized controlled trials that have compared vancomycin and teicoplanin administered systemically for the treatment of suspected or proven infections. A comprehensive search of trials without year, language, or publication status restrictions was performed. The primary outcome was all-cause mortality. Two reviewers independently extracted the data. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled by using the fixed-effect model (RRs of >1 favor vancomycin). Twenty-four trials were included. All-cause mortality was similar overall (RR, 0.95; 95% CI, 0.74 to 1.21), and there was no significant heterogeneity. In trials that used adequate allocation concealment, the results favored teicoplanin (RR, 0.82; 95% CI, 0.63 to 1.06), while in trials with unknown methods or inadequate concealment, the results favored vancomycin (RR, 3.61; 95% CI, 1.27 to 10.30). The latter trials might have recruited more severely ill patients. No other variable affected the RRs for mortality, including the assessment of glycopeptides administered empirically or for proven infections, neutropenia, the participant's age, and drug dosing. There were no significant differences between teicoplanin and vancomycin with regard to clinical failure (RR, 0.92; 95% CI, 0.81 to 1.05), microbiological failure (RR, 1.24; 95% CI, 0.93 to 1.65), and other efficacy outcomes. Lower RRs (in favor of teicoplanin) for clinical failure were observed with a lower risk of bias and when treatment was initiated for infections caused by gram-positive organisms rather than empirically. Total adverse events (RR, 0.61; 95% CI, 0.50 to 0.74), nephrotoxicity (RR, 0.44; 95% CI, 0.32 to 0.61), and red man syndrome were significantly less frequent with teicoplanin. Teicoplanin is not inferior to vancomycin with regard to efficacy and is associated with a lower adverse event rate than vancomycin.
| S-EPMC2764163 | biostudies-other