Safety and immunogenicity of Px563L,a recombinant anthrax vaccine candidate,in a two-dose regimen for post-exposure prophylaxis in healthy adults

Px563L is a next-generation anthrax vaccine candidate consisting of a protein subunit, mutant recombinant protective antigen SNKE167-ΔFF-315-E308D (mrPA), and liposome-embedded monophosphoryl lipid A (MPLA) adjuvant. Px563L has the potential to deliver an improved safety and immunogenicity profile relative to the currently licensed vaccine, which is produced from filtered B. anthracis culture supernatants.We conducted a Phase 1, double–blind, placebo–controlled, dose–escalation study in 54 healthy subjects to evaluate Px563L at 3 dose levels of mrPA (10, 50, and 80 mcg). For each dose level, 18 subjects were randomized in an 8:8:2 ratio to Px563L (mrPA with adjuvant), RPA563 (mrPA only) or placebo (saline). Each subject received an intramuscular (IM) injection on Day 0 and Day 28. Primary safety and immunogenicity analysis was conducted after all subjects completed the Day 70 visit, a duration deemed clinically relevant for post-exposure prophylaxis. Long-term safety was assessed through Day 393.Vaccinations with Px563L at all dose levels were well-tolerated. There were no serious adverse events or adverse events (AE) leading to early withdrawal. In all treatment groups, most AEs were due to injection site reactions, and all AEs at the 10 and 50 mcg dose levels were mild. For the primary immunogenicity endpoint (protective toxin neutralizing antibody 50% neutralization factor [TNA NF₅₀]), titers started to increase significantly after the second administration of Px563L, from Day 35 through Day 70, with the geometric mean and lower bound of the 95% confidence interval exceeding 0.56, a threshold correlating with significant survival in animal models of anthrax exposure.In conclusion, Px563L, administered as two IM doses 28 days apart, was well-tolerated and elicited a protective antibody response starting at seven days after the second vaccination. These findings support the continued development of Px563L in a two-dose regimen for anthrax post-exposure prophylaxis. ClinicalTrials.gov identifier NCT02655549.     

Assessing Antibiotic Adherence and Improving Antibiotic Stewardship in Common Interventional Radiology Procedures

PurposeIn 2018, The Journal of Vascular and Interventional Radiology (JVIR) updated its guidelines regarding periprocedural antibiotics. However, some institutions are slower to adopt these new guidelines. Additionally, antibiotic-resistant bacteria and sepsis are serious concerns due in part to incorrect usage of antibiotics. The purpose of this study is to assess institutional adherence to 2018 JVIR guidelines for the purpose of improving antibiotic stewardship.Materials and methodsA total of 800 cases over a 10-month time period were retrospectively identified and charted following the release of guidelines. Inclusion criteria for the study were adults aged 21 years or older undergoing mediport placement, tunneled central line (TCL) placement, nephrostomy tube exchange, percutaneous biliary drain, or cholecystostomy tube exchange. Exclusion criteria included immunocompromised and pregnant individuals as 2018 guidelines may not fit these patient populations. Guideline adherence for each procedure was recorded as a percentage; the timing of the antibiotic usage was also recorded and compared to the guidelines (within 60 minutes before incision).ResultsIn total, 49 mediport placements, 118 tunneled central line placements – 44 hemodialysis (HD) catheters and 74 nonhemodialysis (non-HD) catheters, 100 nephrostomy exchanges, and 82 biliary tube exchanges were included. Antibiotics were used in 83.6% (41/49) of mediport patients, 11.3% (5/44) of non-HD TCL patients, 20.5% (15/74) of HD TCL patients, 55% (55/100) nephrostomy tube changes, and 65.4% (55/84) of biliary or cholecystostomy tube exchanges. Out of those given prophylaxis, guideline-recommended antibiotics were used in 100% (41/41) of mediport, 100% (20/20) of TCL (both HD and non-HD catheters), 9% (5/55) of nephrostomy tube exchanges, and 1.8% (1/55) of biliary tube exchanges. Guideline-recommended timing was followed in 75.3% across all cases (ranging from 72.2% in mediports to 79.3% in biliary exchanges).ConclusionThis study of antibiotic practices at a single university-based academic institution revealed that antibiotic usage is not fully up to date with 2018 guidelines. For mediports, non-HD TCL placements, and nephrostomy tube exchanges, institutional changes should be made to reduce periprocedural antibiotic use, as antibiotics are no longer recommended for these procedures. For HD TCL and biliary exchanges, proper adherence to recommended prophylactic antibiotics should be followed. In addition, education about the correct antibiotic timing should be emphasized to increase compliance with guidelines.     

Management of recurrent urinary tract infections in adults

Many women will experience one or more urinary tract infection (UTI) during their life. The most unfortunate will have many. Men presenting with infections, and women with recurrent episodes, require further investigation. A diagnosis of a UTI is often based on a typical spectrum of symptoms, with confirmatory urine cultures lagging a few days behind. Unfortunately, symptoms of a UTI may not be typical, and other conditions can manifest similarly. Treatment of UTI with antibiotics is usually required, but there is increasing awareness of the need for antimicrobial stewardship to avoid the misuse and overuse of antibiotics, even as patients are increasingly reluctant to take them. Recurrent UTI can cause significant morbidity and disruption to daily activities yet investigations rarely demonstrate a reversible cause. There are a host of different antibiotic and non-antibiotic interventions that aim to lower the risk of further infections. However, these are not reliably effective, bring side effects of their own and are often proposed to this desperate population of patients on the back of weak evidence of efficacy.     

甲状腺手术患者围术期优质护理干预效果探讨

目的观察分析在甲状腺手术患者护理中予以围术期优质护理干预的应用价值。方法此研究从本院甲状腺手术患者中选取样本,总例数为80例,研究时间始于2017年4月,止于2019年4月,依据护理方案的异同对患者进行分组,试验组予以围术期优质护理干预,对照组予以常规性护理干预,对比两组护理结果。结果研究可得,试验组护理满意率相对较高,组间数据对比得知与对照组相比统计值合理(P<0.05)。研究可得,试验组并发症发生率相对较低,组建数据对比得知与对照组相比统计值合理(P<0.05);研究可得,试验组预后生活质量相对较高,组建数据对比得知与对照组相比统计值合理(P<0.05)。结论此研究得知,在甲状腺手术患者护理中予以围术期优质护理干预,能提高患者护理效果,降低其并发症发生情况,并进一步改善患者预后效果。     

Antibiotic prophylaxis in orthognathic surgery: an overview of systematic reviews

The purpose of this overview was to assess different antibiotic regimens used in orthognathic surgery and to establish an evidence-based protocol so that beneficial and adverse effects can be determined. A comprehensive literature search for systematic reviews and/or meta-analyses was conducted in MEDLINE (PubMed), EMBASE, and the Cochrane Library until March 2020. Grey literature was investigated in Google Scholar, and a manual search was done of references lists. Two meta-analyses and four systematic reviews met the inclusion criteria. The AMSTAR-2-tool was used to ascertain the potential risk of bias in the included studies, which presented moderate to high methodological quality. Lower infection rates were associated with long-term therapies of penicillin, cefazolin-cephalexin, and amoxicillin-clavulanic-acid, with rates varying from 0% - 3.13%. Higher rates were reported in placebo groups (52.6%) and short-term penicillin therapy (60%). Side effects were reported with cefazolin, clindamycin, and penicillin therapies, including nausea, pain, swelling, headache, vomiting, and skin rash. Evidence suggests that long-term antibiotics can reduce the risk of a surgical site infection (SSI) in orthognathic surgery, but there is uncertainty regarding the effects of one dose of antibiotics preoperatively versus short-term antibiotics. In the same way, intravenous penicillin, cefazolin, clindamycin, and amoxicillin-clavulanic acid kept the infection rates associated with bimaxillary procedures under 3.5%.     

白内障围手术期结膜囊菌群分布及药敏试验

目的 分析白内障围手术期结膜囊菌群的分布及药敏试验结果。方法 选取264例白内障患者,分别在患者入院后、手术消毒前、手术消毒后、手术结束后四个时间点取样,进行细菌培养及药敏试验,比较不同时期的细菌培养结果和药敏结果。结果 入院后结膜囊细菌培养阳性率明显高于手术消毒前、手术消毒后及手术结束后;入院后结膜囊细菌培养以表皮葡萄球菌为主;革兰氏阳性球菌对头孢西丁、加替沙星、左氧氟沙星等敏感性较高。结论 表皮葡萄球菌是结膜囊最常见的细菌,术前应常规应用抗生素点眼,聚维酮碘冲洗结膜囊等来预防术后感染性眼内炎。