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Expert Opinion on Drug Safety May 2024Vaccine-associated paralytic poliomyelitis (VAPP) is a rare adverse event of oral poliovirus vaccines (OPV), particularly affecting immunodeficient individuals.
BACKGROUND
Vaccine-associated paralytic poliomyelitis (VAPP) is a rare adverse event of oral poliovirus vaccines (OPV), particularly affecting immunodeficient individuals.
RESEARCH DESIGN AND METHODS
This study aimed to (1) Assess the association between OPV and VAPP using Vaccine Adverse Event Reporting System (VAERS) database (2) Outline patient characteristics and risk factors associated with the occurrence of VAPP in OPV recipients through a systematic review of case reports and case series. A disproportionality analysis was conducted using the data from VAERS, encompassing adverse events reported from 1990 till February 2023. Additionally, we conducted a systematic review of case reports and case series using PubMed, Scopus, and Embase databases.
RESULTS
The VAERS data revealed 130 VAPP reports among 1,739,903 OPV linked adverse events, with year 2010 reporting the strongest association. The systematic review of 37 studies highlighted VAPP occurrence within 2 months to 4 years post-vaccination, typically with acute flaccid paralysis. Immunodeficiency and perianal abscess emerged as major risk factors. Out of the 37 included studies, 27 showed consistent causal association of VAPP with OPV using WHO-AEFI causality assessment tool.
CONCLUSION
The study emphasized the seriousness of VAPP and highlights its association with OPV, identifying immunodeficiency as a prominent contributor to VAPP manifestation.
PubMed: 38813942
DOI: 10.1080/14740338.2024.2359616 -
A systematic review and meta-analysis of the use of packing in the management of perianal abscesses.Annals of the Royal College of Surgeons... Apr 2024Perianal abscesses are common presentations and reasons for emergency general surgery admissions. Management involves incision and drainage of the abscess and packing...
BACKGROUND
Perianal abscesses are common presentations and reasons for emergency general surgery admissions. Management involves incision and drainage of the abscess and packing the cavity with internal wound dressings. This meta-analysis aimed to assess in adults if packing an abscess or leaving it unpacked leads to a significant difference in the outcomes of pain on wound dressing, time to healing, rate of fistulation and abscess recurrence.
METHODS
Randomised controlled trials (RCTs) with participants aged 18 years or older that compared packing of perianal abscess cavities with no packing between 2002 and 2022 were searched for in December 2022 on OVID Medline and Embase, the CENTRAL register of trials, PubMed and Google Scholar. Risk of bias was assessed using the Cochrane Risk of Bias tool. Random effects meta-analysis was conducted on the data extracted.
RESULTS
Three RCTs involving 490 patients were analysed for the outcomes of abscess recurrence and postoperative fistula formation; the data were not adequate to assess pain on dressing and time to healing. For unpacked versus packed, the pooled relative risk of abscess recurrence was 1.57 (95% confidence interval (CI) 0.764, 3.29, =0.219) and for fistula formation 0.686 (95% CI 0.430, 1.09, =0.114). These results suggest there is no significant benefit to packing abscess cavities.
CONCLUSIONS
Analysis of the outcomes suggests there is no significant difference with regards to rates of abscess recurrence or fistula formation between the packed and unpacked groups; however, appropriately powered RCTs are required in this area to provide more primary evidence to inform best practice and clinical management.
PubMed: 38563064
DOI: 10.1308/rcsann.2023.0108 -
Acta Chirurgica Belgica Mar 2024We conducted a systematic review to assess the safety and efficacy of Aluminum potassium sulfate and tannic acid (ALTA) sclerotherapy for the treatment of hemorrhoidal... (Review)
Review
BACKGROUND
We conducted a systematic review to assess the safety and efficacy of Aluminum potassium sulfate and tannic acid (ALTA) sclerotherapy for the treatment of hemorrhoidal disease.
METHODS
Our study was conducted in accordance with the PRISMA statement (Preferred Reporting Items for Systematic Reviews and Meta-analyses) 2020. Primary endpoints included overall recurrence and type of recurrence while secondary endpoints included postoperative complications, reintervention, presence of rectal ulcer, rectal stricture, defecation abnormalities and perianal abscess. Α regression analysis, where the percentage of patients with grade II, III and IV hemorrhoidal disease was used as a covariate, was also performed.
RESULTS
Twelve studies with 4249 patients met all the inclusion criteria and were eventually included. The crude and pooled estimates of the overall recurrence and complications by the end of follow-up were 10% (95% CI, 6.52%-14.08%) and 5.20% (95% CI, 2.59%-8.52%), respectively. Regression analysis displayed no correlation between recurrence and the grade of hemorrhoid disease II, β= -0.0012 (95% CI, -0.0074 to 0.0049) ( = .64), grade III β= -0.0006 (95% CI, -0.0056 to 0.0045) ( = .79) and grade IV β = 0.0025 (95% CI, -0.0075 to 0.0124). However, a trend suggestive of increased recurrence was observed in patient populations with a higher proportion of grade IV disease.
CONCLUSION
ALTA sclerotherapy may be a safe and viable alternative for patients with hemorrhoidal disease. Long-term follow-up and high-quality randomized controlled trials will help define the place of ALTA sclerotherapy in the armamentarium of treatment of hemorrhoids.
PubMed: 38428446
DOI: 10.1080/00015458.2024.2326273 -
Annals of Gastroenterology 2024Managing complex perianal fistulizing Crohn's disease (CD) remains challenging, despite current medical and surgical treatment approaches. Darvadstrocel, a therapy...
BACKGROUND
Managing complex perianal fistulizing Crohn's disease (CD) remains challenging, despite current medical and surgical treatment approaches. Darvadstrocel, a therapy utilizing adipose-derived stem cells, shows promise in promoting tissue regeneration and healing, offering a novel and effective treatment for fistula management.
METHOD
A systematic literature search was conducted on PubMed and Scopus to identify studies involving patients with complex perianal fistulizing CD treated with darvadstrocel.
RESULTS
In total, 2 randomized controlled trials (RCT), 5 observational studies with retrospective data collection and 2 observational studies with prospective design were included in the final review. Data from the European ADMIRE-CD RCT demonstrated that darvadstrocel is superior to placebo in terms of clinical and imaging improvement over both the short and long term. These findings align with the prospective studies analyzed in this systematic review. The rate of treatment-emergent adverse events in the ADMIRE-CD trial's RCTs was similar in both the darvadstrocel and control groups, with perianal abscess being the most common adverse event up to 52 weeks after drug administration. Retrospective studies indicated no side-effects beyond 52 weeks.
CONCLUSIONS
Darvadstrocel appears to be a new, potentially effective and safe treatment option for the management of complex perianal fistulas. However, more randomized clinical trials are needed to evaluate the efficacy and safety profile of the drug.
PubMed: 38223244
DOI: 10.20524/aog.2023.0850 -
European Journal of Pediatric Surgery :... Jun 2024This systematic review and meta-analysis of nonrandomized studies (NRSs) aimed to evaluate the clinical efficacy and safety of two types of surgical interventions... (Meta-Analysis)
Meta-Analysis Comparative Study
This systematic review and meta-analysis of nonrandomized studies (NRSs) aimed to evaluate the clinical efficacy and safety of two types of surgical interventions (respectively drainage alone and drainage with primary fistula treatment) for perianal abscesses (PAs) in children. Studies from 1992 to July 2022 were searched in 10 electronic databases. All relevant NRSs with available data which compared surgical drainage with or without primary fistula treatment were included. Patients with underlying diseases which led to abscess formation were excluded. The Newcastle-Ottawa Scale was used to assess the risk of bias and quality of the included studies. The outcomes were the healing rate, fistula formation rate, fecal incontinence, and wound healing duration. A total of 16 articles with 1,262 patients were considered suitable for the final meta-analysis. Primary fistula treatment was associated with a significantly higher healing rate when compared with incision and drainage alone (odds ratio [OR]: 5.76, 95% confidence interval [CI]: 4.04-8.22). This aggressive procedure for PA resulted in an 86% reduction in the fistula formation rate (OR: 0.14, 95% CI: 0.06-0.32). Limited data showed patients who underwent primary fistula treatment have a minor effect on postoperative fecal incontinence. Primary fistula treatment demonstrates a better clinical efficacy in promoting the healing rate and decreasing the formation of fistulas in PAs in children. The available evidence for a minor impact on anal function after this intervention is less strong.
Topics: Humans; Drainage; Child; Abscess; Rectal Fistula; Anus Diseases; Fecal Incontinence; Treatment Outcome; Wound Healing
PubMed: 37023788
DOI: 10.1055/a-2070-3613 -
Journal of Pediatric Surgery Jul 2023Perianal abscesses and anal fistulas are common. The principle of intention-to-treat has not been considered in previous systemic reviews. Thus, the comparison between... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Perianal abscesses and anal fistulas are common. The principle of intention-to-treat has not been considered in previous systemic reviews. Thus, the comparison between primary and post-recurrence management was confused, and the recommendation of primary treatment is obscure. The current study aims to identify the optimal initial treatment for pediatric patients.
METHODS
Using PRISMA guidelines, studies were identified from MEDLINE, EMBASE, PubMed, Cochrane Library, and Google Scholar without any language or study design restriction. The inclusion criteria include original articles or articles with original data, studies of management for a perianal abscess with or without anal fistula, and patient age of <18 years. Patients with local malignancy, Crohn's disease, or other underlying predisposing conditions were excluded. Studies without analyzing recurrence, case series of <5, and irrelevant articles were excluded in the screening stage. Of the 124 screened articles, 14 articles had no full texts or detailed information. Articles written in a language other than English or Mandarin were translated by Google Translation first and confirmed with native speakers. After the eligibility process, studies that compared identified primary managements were then included in the qualitative synthesis.
RESULTS
Thirty-one studies involving 2507 pediatric patients met the inclusion criteria. The study design consisted of two prospective case series of 47 patients and retrospective cohort studies. No randomized control trials were identified. Meta-analyses for recurrence after initial management were performed with a random-effects model. Conservative treatment and drainage revealed no difference (Odds ratio [OR], 1.222; 95% Confidential interval [CI]: 0.615-2.427, p = 0.567). Conservative management had a higher risk of recurrence than surgery without statistical significance (OR 0.278, 95% CI: 0.109-0.707, p = 0.007). Compared with incision/drainage, surgery can prevent recurrence remarkably (OR 4.360, 95% CI: 1.761-10.792, p = 0.001). Subgroup analysis of different approaches within conservative treatment and operation was not performed for lacking information.
CONCLUSION
Strong recommendations cannot be made due to the lack of prospective or randomized controlled studies. However, the current study based on real primary management supports initial surgical intervention for pediatric patients with perianal abscesses and anal fistula to prevent recurrence.
LEVEL OF EVIDENCE
Type of study: Systemic review; Evidence level: Level II.
Topics: Adolescent; Child; Humans; Abscess; Anus Diseases; Drainage; Rectal Fistula; Retrospective Studies; Treatment Outcome
PubMed: 36894443
DOI: 10.1016/j.jpedsurg.2023.01.055