PET/CT in the management of differentiated thyroid cancer

The standard treatment of differentiated thyroid cancer (DTC) consists of surgery followed by iodine-131 (¹³¹I) administration. Although the majority of DTC has a very good prognosis, more aggressive histologic subtypes convey a worse prognosis. Follow-up consists of periodically measurements of serum thyroglobulin, thyroglobulin antibodies and neck ultrasound and ¹²³I/¹³¹I whole-body scan. However, undifferentiated thyroid tumors have a lower avidity for radioiodine and the ability of DTC to concentrate ¹³¹I may be lost in metastatic disease. Positron emission tomography (PET)/computed tomography (CT) has been introduced in the evaluation of patients with thyroid tumors and the 2-[18F]-fluoro-2-deoxyd-glucose (¹⁸F-FDG) has been largely validated as marker of cell's metabolism. According to the 2015 American Thyroid Association guidelines, ¹⁸F-FDG PET/CT is recommended in the follow-up of high-risk patients with elevated serum thyroglobulin and negative ¹³¹I imaging, in the assessment of metastatic patients, for lesion detection and risk stratification and in predicting the response to therapy. It should be considered that well-differentiated iodine avid lesions could not concentrate ¹⁸F-FDG, and a reciprocal pattern of iodine and ¹⁸F-FDG uptake has been observed. Beyond ¹⁸F-FDG, other tracers are available for PET imaging of thyroid tumors, such as Iodine-124 (¹²⁴I), ¹⁸F-tetrafluoroborate and Gallium-68 prostate-specific membrane antigen. Moreover, the recent introduction of PET/MRI, offers now several opportunities in the field of patients with DTC. This review summarizes the evidences on the role of PET/CT in management of patients with DTC, focusing on potential applications and on elucidating some still debating points.     

轻微症状/无症状高肌酸激酶血症诊断方法指南解读及最新进展

基于证据导向的欧洲神经病学会联盟(European Federation of Neurological Societies,EFNS)发布的"轻微症状/无症状高肌酸激酶血症诊断方法"指南,对轻微症状/无症状高肌酸激酶血症的定义、临床表现、诊断流程和预后进行说明。轻微症状/无症状高肌酸激酶血症的定义是无任何客观肌肉疾病体征且血清肌酸激酶值高于正常值上限1.5倍。收集相关家族史并排除可能导致血清肌酸激酶水平升高的非神经肌肉源性病因是鉴别诊断首先需要解决的问题。对肌电图提示有肌源性改变、血清肌酸激酶值高于正常值3倍、年龄小于25岁或同时存在运动不耐受的患者进行肌肉活检可以提高疾病检出率。轻微症状/无症状高肌酸激酶血症的总体远期预后较好。     

Progress and challenges in measles and rubella elimination in the WHO European Region

IntroductionDespite availability of safe and cost-effective vaccines to prevent it, measles remains one of the significant causes of death among children under five years of age globally. The World Health Organization (WHO) European Region has seen a drastic decline in measles and rubella cases in recent years, and a few of the once common measles genotypes are no longer detected. Buoyed by this success, all Member States of the Region reconfirmed their commitment in 2010 to eliminating measles and rubella, and made this a central objective of the European Vaccine Action Plan 2015–2020 (EVAP). Nevertheless, sporadic outbreaks continue, recently affecting primarily adolescents and young adults with no vaccination or an incomplete vaccination history. The European Regional Verification Commission for Measles and Rubella Elimination was established in 2011 to evaluate the status of measles and rubella elimination based on documentation submitted annually by each country’s national verification committee.DiscussionEach country’s commitment to eliminate measles and rubella is influenced by competing health priorities, and in some cases lack of capacity and resources. All countries need to improve case-base surveillance for both measles and rubella, ensure documentation of each outbreak and strengthen the link between epidemiology and laboratory data. Achieving high coverage with measles- and rubella-containing vaccines will require a multisectoral approach to address the root causes of lower uptake in identified communities including service delivery challenges or vaccine safety concerns caused by circulating myths about vaccination.ConclusionsThe WHO European Region has made steady progress towards eliminating measles and rubella and over half of the countries interrupted endemic transmission of both diseases by 2015. The programmatic challenges in disease surveillance, vaccination service delivery and communication in the remaining endemic countries should be addressed through periodic evaluation of the strategies by all stakeholders and exploring additional opportunities to accelerate the ongoing elimination activities.     

高压氧辅助治疗对骨折患者血清碱性磷酸酶活性及骨折愈合的影响

目的 观察高压氧(HBO)辅助治疗对骨折患者血清碱性磷酸酶(AKP)活性及骨折愈合的影响,治疗联合持续被动活动对胫腓骨骨折愈合的影响.方法 胫腓骨骨折内固定术后患者96例,经患者知情同意,采用数字表法随机分为对照组和HBO治疗联合持续被动活动组(HBO组),对照组患者50例,HBO组患者46例.观察术后2组患者血清碱性磷酸酶(AKP)活性及骨折愈合的变化.结果 血清AKP活性,HBO治疗组在术后2、3周时明显升高,与对照组比较差异有统计学意义(P＜0.01)；第4周时HBO组血清AKP活性快速下降,与对照组比较差异有统计学意义(P＜0.05)；之后2组血清AKP活性持续下降,至术后12周时,2组差异无统计学意义(P＞0.05).6个月以内骨折愈合率HBO组为84％,对照组为70％,2组比较差异有统计学意义(P＜0.05)；延迟愈合HBO组占14％,对照组占24％,骨折愈合情况差异具有统计学意义(P＜0.01).结论 HBO治疗联合持续被动活动可影响骨折患者血清AKP的活性及促进骨折的愈合.     

An algorithm to detect unexpected increases in frequency of reports of adverse events in EudraVigilance

Purpose

The European Medicines Agency developed an algorithm to detect unexpected increases in frequency of reports, to enhance the ability to detect adverse events that manifest as increases in frequency, in particular quality defects, medication errors, and cases of abuse or misuse.

Methods

An algorithm based on a negative binomial time‐series regression model run on 6 sequential observations prior to the monitored period was developed to forecast monthly counts of reports. A heuristic model to capture increases in counts when the previous 4 observations were null supplemented the regression. Count data were determined at drug‐event combination. Sensitivity analyses were run to determine the effect of different methods of pooling or stratifying count data. Positive retrospective detections and positive predictive values (PPVs) were determined.

Results

The algorithm detected 8 of the 13 historical concerns, including all concerns of quality defects. The highest PPV (1.29%) resulted from increasing the lower count threshold from 3 to 5 and including literature reports in the counts. Both the regression model and the heuristic model components to the algorithm contributed to the detection of concerns. Sensitivity analysis indicates that stratification by commercial product reduces the PPV but suggests that pooling counts of related events may improve it.

Conclusion

The results are encouraging and suggest that the algorithm could be useful for the detection of concerns that manifest as changes in frequency of reporting; however, further testing, including in prospective use, is warranted.     

Solubility Determination of Active Pharmaceutical Ingredients Which Have Been Recently Added to the List of Essential Medicines in the Context of the Biopharmaceutics Classification System–Biowaiver

Since the publication of Lindenberg et al., which classified orally administered active pharmaceutical ingredients (APIs) on the 2004 Essential Medicines List (EML) of the World Health Organization according to the Biopharmaceutics Classification System (BCS), various APIs have been added to the EML. In this work, BCS classifications for 16 of the orally administered APIs which were added to the EML after 2004 were determined. To establish a reliable solubility classification for all these compounds, a miniaturized shake-flask method was introduced. This method enables a fast, economical determination of the BCS solubility class while reliably discriminating between “highly soluble” and “not highly soluble” compounds. Nine of the 16 APIs investigated were classified as “highly soluble” compounds, making them potential candidates for an approval of multisource drug products via the BCS-based biowaiver procedure. The choice of dose definition (which currently varies among the guidances pertaining to BCS-based bioequivalence published by various regulatory authorities) had no effect on the solubility classification of any of the 16 substances evaluated. BCS classification of the compounds was then completed using permeability data obtained from the literature. As several APIs decomposed at one or more pH values, a decision tree for determining their solubility was established.     

A Comparison of Incomplete Resection Rate of Large and Small Colorectal Polyps by Cold Snare Polypectomy

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