Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials

Background

The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies.

Cefoperazone-sulbactam and risk of coagulation disorders or bleeding: a retrospective cohort study

ABSTRACT

Objectives: Limited evidence has suggested that cefoperazone-sulbactam causes coagulation disorders and bleeding.

Methods: The authors conducted a retrospective study to compare patients receiving cefoperazone-sulbactam versus those treated with cefoperazone-tazobactam or ceftazidime. Propensity-score matching was used to explore whether treatment with cefoperazone-sulbactam increased the risk of prothrombin time (PT) prolongation, coagulation disorders, and bleeding, or decreased platelets (PLT).

Results: The cohort included 23,242 patients. Among patients receiving cefoperazone-sulbactam, the risk of PT prolongation, coagulation disorders, decreased PLT, and bleeding was 5.3%, 9.2%, 15.7%, and 4.2%, respectively. Propensity-score matching analyses suggested that cefoperazone-sulbactam increased the risk of PT prolongation (aOR 2.26, 95% CI 1.61–3.18), coagulation disorders (aOR 1.81, 95% CI 1.43–2.30), and decreased PLT (aOR 1.46, 95% CI 1.25–1.72), but not increase bleeding (aOR 1.05, 95% CI 0.79–1.40) compared with ceftazidime. Patients receiving cefoperazone-sulbactam had higher risk of PT prolongation (aOR 1.53, 95% CI 1.11–2.10), coagulation disorders (aOR 1.53, 95% CI 1.21–1.95), but not decreased PLT (aOR 0.93, 95% CI 0.81–1.07) or bleeding (aOR 1.11, 95% CI 0.87–1.42), compared with those receiving cefoperazone-tazobactam.

Conclusion: Cefoperazone-sulbactam may be associated with a higher risk of PT prolongation and coagulation disorders compared with cefoperazone-tazobactam and ceftazidime.     

Diagnosis and management of phyllodes tumours for the surgeon: An algorithm

A Phyllodes Tumour (PT) is an uncommon fibroepithelial lesion, with three histological grades – benign, borderline and malignant. PTs cause significant challenges in diagnosis, management and prognostication. Recent publications have clarified the definitions and prognostication of PTs. Contemporary data currently challenge international guidelines on PT management. We performed an in-depth literature review to develop a best-practice management algorithm for PTs.Diagnostic recommendations are that neither current imaging techniques, nor fine-needle biopsies, can reliably diagnose a PT. Core needle biopsy is the optimal diagnostic technique. Indeterminate or suspicious lesions are recommended to undergo an excisional biopsy due to the inherently heterogeneous nature of PTs.Management guidelines are that benign PTs should be completely excised, although an involved margin is acceptable in select situations. Borderline PTs should have a clear margin on excision due to their higher risk of recurrence, as well as the potential for a recurrence to progress to a malignant PT. In malignant PTs, a margin of 3 mm is acceptable as there is no reduction in recurrence risk if margins are >3 mm. Routine axillary surgery is not indicated in PTs, with axillary surgery only indicated in a histologically-confirmed positive axilla.Adjuvant treatment recommendations are that borderline and malignant PTs should be discussed at MDT, with radiotherapy considered in both. Chemotherapy should be discussed in malignant PT patients.In summary, we have developed an up-to-date simple algorithm to guide the surgeon's management of patients diagnosed with PTs and reduce excessive surgery.     

Immunisation of migrants in EU/EEA countries: Policies and practices

In recent years various EU/EEA countries have experienced an influx of migrants from low and middle-income countries. In 2018, the “Vaccine European New Integrated Collaboration Effort (VENICE)” survey group conducted a survey among 30 EU/EEA countries to investigate immunisation policies and practices targeting irregular migrants, refugees and asylum seekers (later called “migrants” in this report). Twenty-nine countries participated in the survey. Twenty-eight countries reported having national policies targeting children/adolescent and adult migrants, however vaccinations offered to adult migrants are limited to specific conditions in seven countries. All the vaccinations included in the National Immunisation Programme (NIP) are offered to children/adolescents in 27/28 countries and to adults in 13/28 countries. In the 15 countries offering only certain vaccinations to adults, priority is given to diphtheria-tetanus, measles-mumps-rubella and polio vaccinations. Information about the vaccines given to child/adolescent migrants is recorded in 22 countries and to adult migrants in 19 countries with a large variation in recording methods found across countries. Individual and aggregated data are reportedly not shared with other centres/institutions in 13 and 15 countries, respectively. Twenty countries reported not collecting data on vaccination uptake among migrants; only three countries have these data at the national level. Procedures to guarantee migrants’ access to vaccinations at the community level are available in 13 countries. In conclusion, although diversified, strategies for migrant vaccination are in place in all countries except for one, and the strategies are generally in line with international recommendations. Efforts are needed to strengthen partnerships and implement initiatives across countries of origin, transit and destination to develop and better share documentation in order to guarantee a completion of vaccination series and to avoid unnecessary re-vaccination. Development of migrant-friendly strategies to facilitate migrants' access to vaccination and collection of vaccination uptake data among migrants is needed to meet existing gaps.     

The relationship between blood leptin level and bone density is specific to ethnicity and menopausal status

Leptin, the obesity hormone, has been linked to bone mineralization and tumorigenesis. In addition, both bone mineral density (BMD) and postmenopausal breast cancer are associated with obesity, but the interrelationships between obesity, leptin, BMD, and breast cancer are not yet clear. In particular, there is little published research comparing white and black women in terms of these variables. We obtained blood specimens for leptin analysis from a group of 320 breast cancer patients and controls with an ethnic composition of 49% white women and 51% black women. Distal and proximal radial BMD (DBMD and PBMD) were measured by dual-energy X-ray absorptiometry, and age- and ethnicity-specific standardized scores (Z-scores) were calculated for bone density. Blood leptin levels were determined by radioimmunoassay. Blood leptin level was not linked to breast cancer risk. Leptin levels were significantly higher in black women than in white women and were also significantly higher in obese and overweight women than in normal-weight women. Black women weighed more and had a higher body mass index (BMI) than white women. After controlling for BMI, leptin was correlated with DBMD ( r = .17; P < .05) and PBMD ( r = .21; P < .05) in whites, but not in blacks. Leptin was also correlated with both distal and proximal Z-scores in postmenopausal women ( r = .14 and .13; P < .05). Thus leptin may be a predictor for BMD in a population that is prone to have a low BMD, and this relationship is independent of the effect of body weight on leptin levels. Our results suggest that ethnicity and menopausal status should be considered when comparing results from different studies.     

A Cost-Effectiveness Analysis of a Randomized Control Trial of a Tailored,Multifactorial Program to Prevent Falls Among the Community-Dwelling Elderly

Objective

To perform a cost-effectiveness analysis of a multifactorial, tailored intervention to reduce falls among a heterogeneous group of high-risk elderly people.

通过参加美国临床实验室室间质评提高寄生虫检查质量

目的 通过参加美国病理家学会（CAP）组织的寄生虫检查能力验证（PT）来评估实验室能力，为进一步提高实验室寄生虫检查的质量奠定基础。方法 将CAP发放的寄生虫能力验证标本于10个工作日内按要求与常规病人标本一起进行检查并通过网络将结果直接提交给CAP。结果 全年共检测CAP质控标本15份，所有回报结果正确率为100％。结论 通过参加CAP能力验证将该实验室的寄生虫检查标准化，并提高了实验室全体成员识别寄生虫的能力。     

Effectiveness of Physical Therapy Combined With Epidural Steroid Injection for Individuals With Lumbar Spinal Stenosis: A Randomized Parallel-Group Trial

Objective

To examine the effectiveness of epidural steroid injection (ESI) and back education with and without physical therapy (PT) in individuals with lumbar spinal stenosis (LSS).

血栓通注射液联合利伐沙班治疗髋关节置换术后下肢深静脉血栓的疗效观察

目的探究血栓通注射液联合利伐沙班治疗髋关节置换术后下肢深静脉血栓的临床疗效。方法选取2011年11月—2014年11月在延安大学附属医院骨科接受髋关节置换术后发生下肢深静脉血栓的患者78例,按照治疗方案不同分为对照组和治疗组,每组各39例。对照组口服利伐沙班片,1片/次,1次/d。治疗组在对照组治疗的基础上静脉滴注血栓通注射液,5 m L溶于0.9%生理盐水250 m L中,1次/d。两组均连续治疗14 d。观察两组的临床疗效,比较两组治疗前后D-二聚体、患肢膝上差、膝下差、静脉血流速度、激活部分凝血活酶时间(APTT)、凝血酶原时间(PT)、凝血酶时间(TT)、纤维蛋白原(FIB)的变化情况。结果治疗后,对照组和治疗组的总有效率分别为84.62%、97.44%,两组比较差异有统计学意义(P0.05)。治疗后,两组D-二聚体、膝上差、膝下差、FIB均显著降低,患侧血流速度、APTT、PT、TT显著升高,同组治疗前后差异具有统计学意义(P0.05);且治疗组这些观察指标的改善程度优于对照组,两组比较差异具有统计学意义(P0.05)。结论血栓通注射液联合利伐沙班治疗髋关节置换术后下肢深静脉血栓具有较好的临床疗效,可显著改善患者的凝血状态,具有一定的临床推广应用价值。     

血液采集量对凝血功能检测影响的研究

目的：探讨采血量对于凝血功能检测中各项指标的影响情况。方法：收集2012年3月～2012年10月长沙市中医医院（市八医院）心胸外科病人标本32例、血液科病人30例及正常健康者标本30例,以血液采集量不足（1.4～1.5mL）为实验组,重抽采血量合格标本（1.8mL）为对照组,运用 sysmex CA1500全自动凝血分析仪检测各组样本凝血七项（血浆凝血酶原时间（PT）、纤维蛋白原（Fbg）、活化部分凝血活酶时间（APTT）、凝血酶时间（TT）、纤维蛋白原降解产物（FDP）、D 二聚体（D-D）、抗凝血酶Ⅲ（AT-Ⅲ））。运用统计学分析血液采集量对于健康者、心胸外科病人与血液内科病人凝血功能检测的影响。结果：与对照组相比,各实验组 APTT、FDP、D-D 测定值均明显增加,AT-Ⅲ明显减小,具有统计学差异。心胸外科病人则凝血七项检测值均有统计学差异。血液科病人的 PT、Fbg、TT 则无显著性差异。正常健康组 PT 无差异。结论：血液采集量影响凝血功能的检测。特别是对心胸外科的影响较血液内科病人和正常健康人更甚。