A phase 2 study of the bivalent VLP norovirus vaccine candidate in older adults; impact of MPL adjuvant or a second dose

IntroductionAcute norovirus gastroenteritis causes significant morbidity and in uncommon cases fatality in older adults. We investigated the safety and immunogenicity of bivalent virus-like particle (VLP) vaccine candidate formulations with and without monophosphoryl lipid A (adjuvant MPL) in this population.MethodsIn this phase II, double-blind, controlled trial 294 healthy adults, ≥ 60 years of age, were randomized (1:1:1:1) to four groups to receive one or two intramuscular immunizations 28 days apart, with 26 18–49 year-old controls who received one MPL-free dose. One-dose groups received placebo on Day 1. Vaccine formulations contained 15 μg GI.1 and 50 μg GII.4c VLP antigens and 500 μg Al(OH)₃, with or without 15 μg MPL. We measured histo-blood group antigen blocking (HBGA) antibodies and ELISA Ig at Days 1, 8, 29, 57, 211 and 393, and avidity indices and cell-mediated immunity (CMI). Solicited local and systemic adverse events (AE) were assessed for 7 days and unsolicited AEs for 28 days after each injection.ResultsAfter one dose HBGA antibodies to both VLP antigens increased with similar kinetics and magnitude in all groups; geometric mean titres (GMTs) persisted above baseline through Day 393. GMTs were similar across age strata (18–49, 60–74, 75–84 and ≥ 85 years of age) and unaffected by a second vaccination or MPL. Total Ig showed similar responses. No clinically relevant differences or changes in avidity or CMI were observed between formulations. Both formulations were well tolerated with no vaccine-related SAEs, the most frequent AEs being mild injection site pain and fatigue.ConclusionsAdults over 60 years of age displayed no safety concerns and had similar immune responses to the norovirus VLP vaccine candidate as younger adults, unaffected by increasing age, a second dose or inclusion of MPL. This data supports the further development of the MPL-free vaccine candidate for older adults.     

富硒酵母与TACE治疗原发性肝癌临床疗效及安全性

目的观察富硒酵母与经肝动脉化疗栓塞术(TACE)治疗原发性肝癌的临床疗效并评价其应用安全性。方法选择我院2016年11月～2018年5月收治的89例原发性肝癌患者为本次研究对象,按照患者入院后病床单双号分为单号45例为对照组,双号44例为观察组;对照组采用TACE,观察组在对照组的基础上加富硒酵母口服,2个月后对比两组患者疗效及安全性。结果血硒含量:治疗前两组比较差异无统计学意义(P0.05),观察组治疗后血硒水平明显高于治疗前,与治疗前、对照组治疗后比较,差异有统计学意义(P0.05);血清VEGF水平:治疗前两组差异无统计学意义(P0.05),观察组治疗后明显高于治疗前,差异有统计学意义(P0.05),但与对照组治疗后比较相对较低,差异有统计学意义(P0.05);KPS评分:治疗前两组比较差异无统计学意义(P0.05),治疗后观察组下降幅度低于对照组,差异有统计学意义(P0.05);两组不良反应情况比较,差异无统计学意义(P0.05)。结论富硒酵母联合TACE治疗原发性肝癌能够有效改善患者低硒状态,抑制血清VEGF水平,控制肿瘤进展,且无严重不良反应,安全性高,值得临床推广应用。     

参芪降糖颗粒联合二甲双胍对2型糖尿病患者降糖效果的分析

目的：探析2型糖尿病患者采取参芪降糖颗粒联合二甲双胍进行治疗的降糖效果。方法：选取2016年1月至2019年10月马鞍山市中心医院收治的2型糖尿病患者66例作为研究对象，按照随机数字表法分为对照组与观察组，每组33例，对照组通过二甲双胍进行治疗，观察组通过二甲双胍联合参芪降糖颗粒进行治疗，比较2组患者治疗总有效率、血糖参数、不良反应发生率等指标。结果：对照组、观察组的治疗总有效分别为75.76%、93.94%，与对照组比较，观察组的治疗总有效率明显较高（P<0.05）；观察组的空腹血糖、餐后2 h血糖等血糖参数在治疗后明显低于对照组患者（P<0.05）；对照组、观察组的治疗不良反应发生率分别为21.21%、3.03%，观察组治疗不良反应发生率明显低于对照组（P<0.05）。结论：2型糖尿病患者采取参芪降糖颗粒联合二甲双胍进行治疗能够获得较为理想的效果，可明显改善血糖指标，安全性较高，对改善患者的治疗预后有着促进的作用。     

单兆伟运用温经汤治疗女性肾虚泄泻经验

全国名中医、孟河医派传人单兆伟教授擅长胃肠病诊治,临证擅用《金匮要略》温经汤治疗女性肾虚型泄泻。认为温经汤的主要适应证是肝肾虚寒型的女性腹泻和(或)月经不调,肝脾肾三脏虚寒、寒凝而瘀、虚瘀相因、寒热错杂是温经汤证的病机特点,泄下清谷、脉象沉细或细涩、舌质淡黯有齿痕或瘀点是温经汤的主要应用指证。     

医用粘胶相关性皮肤损伤的文献计量学分析

目的: 应用文献计量学方法,分析国内外医用粘胶相关性皮肤损伤（Medical adhesive-related skin injuries,MARSI）文献的研究主题和热点。方法: 检索Cochrane Library、PubMed、EMbase、Web of science、sinoMed、CNKI、Wanfang、VIP等数据库MARSI相关文献,检索时限为建库至2019年5月。采用SPSS 22.0 软件进行文献计量分析,利用gCLUTO统计对国内外高频主题词进行聚类分析。结果: 共纳入论文103篇,其中外文文献占总文献量的27.18%,中文文献占总文献量的72.82%。聚类分析将国内外高频主题词聚为4大类,依次为皮肤损伤及损伤类型、相关危险因素、风险评估及风险管理、护理干预措施。结论: MARSI仍是国内外研究的热点,其发病机制研究仍处于探索阶段,目前尚缺乏有效的预防策略,研究领域较局限。在今后的研究中,应加强MARSI预防的研究、注重多学科合作。     

Immunogenicity and safety of a fully liquid aluminum phosphate adjuvanted Haemophilus influenzae type b PRP-CRM197-conjugate vaccine in healthy Japanese children: A phase III,randomized, observer-blind,multicenter, parallel-group study

BackgroundBroad use of monovalent Haemophilus influenzae type b (Hib) conjugate vaccines based on the capsular polysaccharide polyribosyl-ribitol phosphate (PRP), has significantly reduced invasive Hib disease burden in children worldwide, particularly in children aged <1 year. In Japan, PRP conjugated to tetanus toxoid (PRP-T) vaccine has been widely used since the initiation of public funding programs followed by a routine vaccination designation in 2013.MethodsWe compared the immunogenicity and safety of PRP conjugated to a non-toxic diphtheria toxin mutant (PRP-CRM₁₉₇) vaccine with the PRP-T vaccine when administered subcutaneously to healthy Japanese children in a phase III study. Additionally, we evaluated the immunogenicity and safety profiles of a diphtheria–tetanus acellular pertussis (DTaP) combination vaccine when concomitantly administered with either PRP-CRM₁₉₇ or PRP-T vaccines. The primary endpoint was the “long-term seroprotection rate”, defined as the group proportion with anti-PRP antibody titers ⩾1.0 μg/mL, after the primary series.ResultsLong-term seroprotection rates were 99.3% in the PRP-CRM₁₉₇ group and 95.6% in the PRP-T group. The intergroup difference (PRP-CRM₁₉₇ group – PRP-T group) was 3.7% (95% confidence interval: 0.099–7.336), demonstrating that PRP-CRM₁₉₇ vaccine was non-inferior to PRP-T vaccine (p < 0.0001). Furthermore, the “short-term seroprotection rate” (anti-PRP antibody titer ⩾0.15 μg/mL) before booster vaccination was higher in the PRP-CRM₁₉₇ group than in PRP-T. Concomitant administration of PRP-CRM₁₉₇ vaccine with DTaP vaccine showed no differences in terms of immunogenicity compared with concomitant vaccination with PRP-T vaccine and DTaP vaccine. Although CRM₁₉₇ vaccine had higher local reactogenicity, overall, both Hib vaccines had acceptable safety and tolerability profiles.ConclusionThe immunogenicity of PRP-CRM₁₉₇ vaccine administered subcutaneously as a three-dose primary series in children followed by a booster vaccination 1 year after the primary series induced protective levels of Hib antibodies with no safety or tolerability concerns.Clinical trial registry: Registered on ClinicalTrials.gov: NCT01379846     

Adverse events due to unnecessary radiation exposure in medical imaging reported in Finland

IntroductionAdverse events in radiology are quite rare, but they do occur. Radiation safety regulations and the law obligate organizations to report certain adverse events, harm and near misses, especially events related to patients' health and safety. The aim of this study was to describe and analyse incidents related to radiation safety issues reported in Finland.MethodsThe data were collected from incident reports documented by radiology personnel concerning notifications of abnormal events in medical imaging made to the Radiation and Nuclear Safety Authority between 2010 and 2017. During these eight years, 312 reports were submitted. Only events reported from radiology departments were included; nuclear medicine, radiotherapy and animal radiology cases were excluded. The final number of reports was 293 (94%).ResultsThe majority of the 293 approved reports were related to computed tomography (CT, 68.3%) and to X-ray examinations (27.6%). Altogether 82.9% of those irradiated were adults, most of whom were exposed to unnecessary radiation through CT (86.5%), 5.5% were children, and 4.4% pregnant women. The most common effective dose of unnecessary radiation was 1 mSv or less (89.7% of all examinations). The highest effective doses were reported in CT (from under 1 mSv–20 mSv and above). The reasons for the adverse events were incorrect identification (32%), incorrect procedure, site or side (30%); and human errors or errors of knowledge (20%).ConclusionAdverse events occurred especially in CT examinations. It is important to collect and analyse incident data, assess the harmful events, learn from them and aim to reduce adverse events.Implications for practiceThis study emphasizes the need for radiological personnel to obtain evidence-based information on adverse events and focus on training to improve patient safety.