WHO working group meeting to amend WHO Recommendations to assure the quality,safety and efficacy of live attenuated yellow fever vaccines

The current WHO Recommendations to assure the quality, safety and efficacy of live attenuated yellow fever vaccines were adopted in 2010. This document recommends that vaccine virus master and working seed lots should be tested for viscerotropism, immunogenicity and neurovirulence in monkeys. A vaccine manufacturer has reported, recently, discrepancies on the clinical scoring of monkeys during assessment of working seed lots and suggested aligning neurotropism assessment of yellow fever vaccines virus seed lots with that of neurovirulence testing of polio vaccines virus seed lots. In this approach, clinical signs are recorded but do not form part of the assessment or pass/fail criteria. At its 71^st meeting in August 2020, the ECBS agreed to establish a drafting group and to consult with manufacturers and other stakeholders on the proposed amendment. Then a survey had been conducted to seek opinions of stakeholders on the neurotropism testing and revision of current WHO Recommendations for yellow fever vaccines. It was recognized from the answers of the survey that the test for neurovirulence in monkeys presents several technical challenges which could be addressed in the amended version of the Recommendations.On 18–19 March 2021, a virtual WHO working group meeting was held to discuss a proposed draft of the amended text with participants of yellow fever vaccine manufacturers and relevant regulators. Overall, there was a consensus among manufacturers and regulators that clinical evaluation provides important information and should be retained as part of the neurotropism test. However, there was also agreement that the test is somewhat subjective, and that analysis can be difficult. It was recognized that there was potential for improvement in both test execution and analysis to increase harmonization between manufacturers. Alternative tests to the non-human primates neurovirulence test would be useful but it was agreed that none seem to be sufficiently developed at present. Based on these working group discussions, it was proposed that the appendix on neurotropism test to be further revised by the WHO drafting group and submitted to ECBS for review and adoption.Issues other than neurotropism test were discussed in the meeting as well. There were a number of points identified during the meeting, such as new platform of production, animal models, deep sequencing, international standards, that are outside the current recommendations that are worthy of further discussion. Therefore, it is recommended that there would be a future meeting with various stakeholders to discuss the potential revision of the whole Recommendations for yellow fever vaccines in order to meet the current needs.     

含功能性油的水飞蓟宾超饱和自纳米乳的制备与体外评价

目的制备含功能性油的水飞蓟宾超饱和自纳米乳(SLB-S-SNEDDS),并对其进行表征及体外评价研究,以提高难溶性药物水飞蓟宾的生物利用度。方法铁氢化钾还原力与1,1-二苯基-2-苦肼基(DPPH)自由基清除实验筛选功能性油脂;伪三元相图考察乳化剂乳化能力;测定粒径、多分散指数(PDI)、Zeta电位等考察混合油相比例与载药量;相容性与溶出度实验筛选促过饱和物质并考察其质量浓度;从外观、粒径分布、自乳化效率、形态学等方面表征SLB-S-SNEDDS,并进行溶出度、抗氧化能力、细胞毒性等体外评价。结果所得SLB-S-SNEDDS处方为(1)小麦胚芽油/Capryol 90-Cremophor ELP-Transcutol HP与(2)沙棘籽油/Capryol 90-Cremophor ELP-Transcutol HP,1 g基质(包含0.043 g小麦胚芽油或沙棘籽油、0.387 g Capryol 90、0.380 g Cremophor ELP、0.190 g Transcutol HP),水飞蓟宾的添加量为各组分平衡溶解度之和的20%,Soluplus的添加量为上述总质量的0.1%。小麦胚芽油、沙棘籽油体系分别为淡黄色、亮黄色透明状均一液体,2种体系自乳化分散后均呈近球形白色扁平乳滴,粒径约为50 nm,乳化时间均为65 s。与药物原料及SLB-SNEDDS相比,SLB-S-SNEDDS中水飞蓟宾的累积溶出率8h内均维持在85%～110%,表明该体系能够显著提高药物的溶出度。SLB-S-SNEDDS与铁氰化钾反应后的吸光度(A值0.452～0.782,0.488～0.765)以及DPPH自由基清除率(39.09%～96.02%,30.54%～89.20%)均高于相应质量浓度下水飞蓟宾原料的A值与清除率(0.411～0.760,22.89%～63.21%),表明2种处方体系均能提高水飞蓟宾的抗氧化能力。细胞毒性实验结果显示,在5、10μmol/L药物浓度下,水飞蓟宾原料组、水飞蓟宾S-SNEDDS组及其相应的空白S-SNEDDS组细胞生存率均90%,说明SLB-S-SNEDDS及其所用辅料对人克隆结肠腺癌细胞(Caco-2)毒性较小、安全性较好。结论制备的含功能性油SLB-S-SNEDDS在提高水飞蓟宾累积溶出率的同时,增强了其抗氧化能力,为将超饱和自纳米乳(S-SNEDDS)用于改善难溶性药物水溶性及其生物活性提供有益参考。     

甘草种子与种苗质量分级标准研究

目的:研究甘草种子、种苗质量分级标准,为甘草药材规范化生产奠定基础。方法:以全国主产区所流通的甘草种子、种苗为样本,通过收集种子的发芽率、净度、含水量、千粒质量,种苗的根长、芦头直径和百株质量等指标信息,采用K-均值聚类分析法、标准差法、平均值法并结合生产实践对甘草种子、种苗进行分级,并开展田间栽培比较试验,对等级划分的合理性进行验证。结果:甘草种子质量等级划分为3个等级,各级甘草种子的千粒质量不低于8 g,含水量不低于10%,一级种子:发芽率≥90%,净度≥90%;二级种子:90%>发芽率≥85%,90%>净度≥85%;三级种子:85%>发芽率≥80%,85%>净度≥80%。甘草种苗质量等级划分为3个等级,一级种苗:根长≥45 cm,芦头直径≥0.8 cm,1.3 kg≤百株质量<0.8 kg;二级种苗:45 cm>根长≥35 cm,0.8 cm>芦头直径≥0.6 cm,0.8 kg≤百株质量<0.4 kg;三级种苗:35 cm>根长≥25 cm,0.6 cm>芦头直径≥0.4 cm,0.4 kg≤百株质量≤0.2 kg。结论:经验证,甘草种子、种苗质量等级划分合理,便于生产实践应用。     

生大黄贴敷神阙穴在经皮肾镜钬激光碎石术后应用观察

目的探讨生大黄贴敷神阙穴配合莱菔子热熨,预防经皮肾镜钬激光碎石术后患者腹胀便秘的效果。方法选取2015年1月—2019年12月收治的行经皮肾镜钬激光碎石术后患者100例,随机分为试验组50例,对照组50例;在临床护理方法相同的基础上试验组采用生大黄加75%酒精调贴敷神阙穴配合莱菔子热熨。结果2组患者腹胀便秘发生率比较差异有统计学意义(P<0.05),试验组发生腹胀便秘发生率明显低于对照组。结论生大黄贴敷神阙穴配合莱菔子热熨有效地预防经皮肾镜钬激光碎石术后患者腹胀、便秘,促进患者康复。     

The efficacy of blueberry and grape seed extract combination on triple therapy for Helicobacter pylori eradication: a randomised controlled trial

Helicobacter pylori is a major risk factor for gastritis, gastric ulcers and gastric cancer. Traditional therapy with proton pump inhibitor and antibiotics is regarded as optimal for H. pylori eradication whereas, the eradication rate is unsatisfactory. Studies have reported that cranberry may inhibit H. pylori adhesion to the human gastric mucus but lack of other berry extracts have been evaluated in clinical study. Thus, a 9-week add-on randomised controlled trial was conducted to explore the impact of blueberry and grape seed extract (BGE) combinations traditional therapy for H. pylori eradication. In results, we found that there was no significant difference of eradication rate between the berry extract group and placebo group in the intention-to-treat analysis and in the per-protocol analysis (94.64% versus 84.62%, p?=?0.085). Diarrhoea, constipation and epigastric pain were observed increasing during ingestion of the berry extract in some cases. In conclusion, this study indicated that no significant difference existed between the BGE extract group and placebo group in eradication rate under triple therapy.     

Is the future magnetic? Magseed localisation for non palpable breast cancer. A multi-centre non randomised control study

IntroductionMagseed is an alternative method of localising non-palpable breast lesions that has addressed many of the limitations of wire guided localisation (WGL). It consists of a paramagnetic seed that can be visualised on mammography and ultrasound. Intraoperative localisation of the seed is achieved with the use of the Sentimag probe. The aim of this study was to prospectively compare localisation in patients undergoing wide local excision (WLE) for non-palpable lesions between Magseed and WGL.MethodsWe prospectively collected data on all patients undergoing image-guided WLE between October 2017 and September 2018 in two academic breast units with a planned accrual of 100 consecutive patients undergoing Magseed localisation. Data was also collected on a cohort of 100 consecutive patients undergoing WGL in the same time period.ResultsDemographic and disease characteristics were well balanced between the two groups. 4/104 patients were converted preoperatively from Magseed to WGL (2 misplaced Magseeds; 2 undetected Magseeds). Intraoperative identification and excision of the localised lesion was successful in all patients as confirmed with specimen radiography. Overall no significant differences were observed in the proportion of patients requiring re-excision between the two groups (Magseed 16% vs. WGL 14% p = 0.692). Specimens size by weight and volume was similar for both groups (Magseed 39.6 g vs. WGL 44.5 g p = 0.206 and 90.1 cm³ for Magseed vs. 95.6 cm³ for WGL p = 0.579).ConclusionsIn our series Magseed localisation proved to be as reliable and effective as WGL in terms of lesion identification, excision with tumour free margins and specimen weight.     

The effects of grape seed extract on glycemic control,serum lipoproteins,inflammation, and body weight: A systematic review and meta‐analysis of randomized controlled trials

The aim of this systematic review and meta‐analysis was to analyze the effects of grape seed extract (GSE) on glycemic control and serum lipoproteins, inflammation and body weight. Two independent authors systematically searched online databases including EMBASE, Scopus, PubMed, Cochrane Library, and Web of Science from inception until May 30, 2019. Cochrane Collaboration risk of bias tool was applied to assess the methodological quality of included trials. The heterogeneity among the included studies was assessed using Cochrane's Q test and I‐square (I²) statistic. Data were pooled using a random‐effects model and weighted mean difference (WMD) was considered as the overall effect size. Fifty trials were included in this meta‐analysis. Pooling effect sizes from studies demonstrated a significant decrease in fasting plasma glucose (FPG) (WMD): ?2.01; 95% confidence interval (CI): ?3.14, ?0.86), total cholesterol (TC; WMD: ?6.03; 95% CI: ?9.71, ?2.35), low‐density lipoprotein (LDL) cholesterol (WMD: ?4.97; 95% CI: ?8.37, ?1.57), triglycerides (WMD: ?6.55; 95% CI: ?9.28, ?3.83), and C‐reactive protein (CRP) concentrations (WMD: ?0.81; 95% CI: ?1.25, ?0.38) following GSE therapy. Grape seed did not influence HbA1c, HDL cholesterol levels, and anthropometric measurements. This meta‐analysis demonstrated that GSE intake significantly reduced FPG, TC, LDL cholesterol, triglycerides, and CRP levels.     

左氧氟沙星联合复方沙棘籽油栓治疗沙眼衣原体宫颈炎的效果观察

目的左氧氟沙星联合复方沙棘籽油栓治疗沙眼衣原体宫颈炎患者的临床疗效进行探讨。方法将在我院接受治疗的72例沙眼衣原体宫颈炎患者随机分为观察组和对照组,对照组患者仅服用左氧氟沙星,观察组患者采取左氧氟沙星联合复方沙棘籽油栓治疗。结果两组患者的治疗总有效率对比有统计学差异(P0.05);两组患者的不良反应对比没有统计学差异(P0.05)。结论治疗沙眼衣原体宫颈炎患者采取左氧氟沙星联合复方沙棘籽油栓,能够提高治疗有效率,减少不良反应。     

从外观性状识别酸枣仁伪品

探讨酸枣仁及其常见伪品的性状鉴别,确保临床用药的安全、有效。取酸枣仁及其常见伪品,对外观性状进行比对讨论发现酸枣仁及其伪品在外观性状有明显区别。性状鉴别方法能有效地识别酸枣仁及其伪品。