理筋通督手法治疗颈性眩晕临床研究

目的:观察理筋通督手法治疗颈性眩晕的临床疗效。方法:将120例颈性眩晕患者随机分成3组,理筋通督组、传统手法组及安慰剂组。理筋通督组采用理筋通督手法;传统手法组采用传统手法;安慰剂组口服维生素C。结果:理筋通督手法可显著减缓患者基底动脉舒张期最低血流速度(P0.05)。理筋通督组有效率为93.67%,传统手法组有效率为67.5%,安慰剂组有效率为17.5%,3组比较差异有统计学意义(P0.05),理筋通督组明显优于其他两组。结论:理筋通督手法治疗颈性眩晕临床疗效显著。     

Marmoset cytochrome P450 2B6, a propofol hydroxylase expressed in liver

1. The common marmoset (Callithrix jacchus) is a useful experimental animal to evaluate the pharmacokinetics of drug candidates. Cytochrome P450 (P450) 2B enzyme in marmoset livers has been identified; however, only limited information on the enzymatic properties and distribution has been available.

2. Marmoset P450 2B6 amino acids showed high sequence identities (>86%) with those of primates including humans and cynomolgus monkeys. Phylogenetic analysis using amino acid sequences indicated that marmoset P450 2B6 was closer to human and cynomolgus monkey P450 2B6 than to P450 2B orthologs of other species, including pigs, dogs, rabbits and rodents.

3. Quantitative polymerase chain reaction analysis using specific primers showed P450 2B6 mRNA predominantly expressed in livers among the five marmoset tissues, similar to those of humans and cynomolgus monkeys.

4. Marmoset P450 2B6 heterologously expressed in Escherichia coli membranes oxidized 7-ethoxycoumarin, pentoxyresorufin, propofol and testosterone, at roughly similar rates to those of humans and/or cynomolgus monkeys. A high capacity of marmoset P450 2B6 with propofol 4-hydroxylation (at low ionic strength conditions) with a low K_m value was relatively comparable to that for marmoset livers.

5. These results collectively indicated a high propofol 4-hydroxylation activity of P450 2B6 expressed in marmoset livers.

     

Current state of biologic pharmacovigilance in the European Union: improvements are needed

Introduction: Pharmacovigilance is essential to monitoring the safety profiles of authorized medicines. Compared with small-molecule drugs, biological drugs are more complex, more susceptible to structural variability due to manufacturing processes, and have the potential to induce immune-related reactions, underscoring the importance of safety monitoring for these products. Although highly similar to reference products, biosimilars are not expected to be structurally identical. For these reasons, proper reporting of potential adverse drug reactions (ADRs) using distinguishable names and batch numbers is essential for accurate tracing of all biological drugs. To address the need for robust pharmacovigilance, the European Parliament and Council of the European Union provided legislation regarding pharmacovigilance of biologics in 2010.

Areas covered: This narrative review examines the current state of pharmacovigilance for biologics in the European Union (EU) and discusses relevant information on pharmacovigilance of biosimilars, the current EU pharmacovigilance system, and areas that could be improved.

Expert opinion: Although steps have been taken to improve pharmacovigilance of biologics in the EU, several enhancements can still be made, including additional training for healthcare professionals on ADR reporting, the use of 2D barcodes that enhance traceability, and an open discussion of potentially missed opportunities in the pharmacovigilance of biosimilars.     

2017年安徽省某三甲医院细菌耐药性监测

目的 了解铜陵市人民医院2017年临床分离细菌对抗菌药物的耐药状况。方法 对2017年1-12月临床分离菌采用纸片扩散法(KB)进行药敏试验，按CLSI 2017年版标准判读药敏试验结果，采用WHONET 5.6软件进行数据分析。结果 临床分离细菌共3436株，其中革兰阳性菌719株，占20.9%；革兰阴性菌2717株，占79.1%。耐甲氧西林金黄色葡萄球菌(MRSA)和耐甲氧西林凝固酶阴性葡萄球菌(MRCNS)的检出率分别为23.8%和72.3%，耐甲氧西林株对β-内酰胺类抗生素和其他测试抗菌药物的耐药率显著高于甲氧西林敏感株，未发现对万古霉素和替考拉宁耐药的葡萄球菌。粪肠球菌对青霉素、氨苄西林和呋喃妥因的耐药率较低，屎肠球菌对氯霉素的耐药率较低，5.3%屎肠球菌对万古霉素耐药。大肠埃希菌、克雷伯菌属(肺炎克雷伯菌和产酸克雷伯菌)和奇异变形菌中ESBLs的检出率分别为41.4%、50.7%和19.4%。肠杆菌科细菌中克雷伯菌属和沙雷菌属对碳青霉烯类抗生素耐药率较高，分别为37.5%和36.0%，其他菌属的耐药率低于3%。鲍曼不动杆菌对亚胺培南和美罗培南的耐药率分别80.3%和79.1%；铜绿假单胞菌对亚胺培南和美罗培南的耐药率分别为29.7%和28.4%。肺炎克雷伯菌、鲍曼不动杆菌和铜绿假单胞菌中广泛耐药株的检出率分别为31.3%(171/546)、0.6%(3/508)和0.7%(3/416)。结论 本院革兰阴性菌呈增多趋势，尤其广泛耐药的肺炎克雷伯菌应引起高度关注，做好细菌耐药性监测，加强临床抗菌药物的合理使用和医院感染控制。     

An ultrasonographic monitoring of skin condition in patients receiving radiotherapy for head and neck cancers

Radiodermatitis is one of the commonest side effects of radiotherapy. They are usually assessed by semi‐quantitative clinical scores, which are not validated and may be subject to inter‐observer variability. A few previous studies suggested that high‐frequency ultrasonography (HF‐USG) is useful in the assessment of the acute phase of radiation dermatitis in breast cancer patients. (a) To monitor skin changes by HF‐USG during the course of radiotherapy due to head and neck cancers, and (b) to determine whether there is any connection between skin sonograms and the skin scoring criteria. This prospective, observational study includes patients diagnosed with head and neck cancers, treated with radiotherapy or concomitant chemoradiation. The final analysis includes six patients. In every patient, the HF‐USG as well as dermatological assessment (target lesion score—TLS and CACE v. 4.0) were performed 4×: before, in the middle, day after, and 3 months after radiotherapy. There were significant differences between non‐irradiated skin thickness and thickness of skin with clinically obvious radiodermatitis (TLS grade 1‐4; P < .0001), as well as between irradiated, unchanged skin thickness (TLS grade 0) and thickness of skin with clinically obvious radiodermatitis (TLS grade 1‐4; P = .0002). There was no significant difference between non‐irradiated and irradiated, unchanged skin thickness (TLS grade 0; P = .9318). In four patients, we demonstrated subepidermal low echogenic band (SLEB). HF‐USG can be useful tool to noninvasive and objective assessment of skin changes during radiotherapy.