国产辛伐他汀片与原研制剂的生物等效性研究

目的：考察国产辛伐他汀片与原研制剂的的人体生物利用度,评价两制剂在健康人体的生物等效性.方法：18名健康成年男性志愿者采用随机自身交叉对照试验设计,单剂量口服辛伐他汀片40 mg,用LC-MS/MS法测定血浆中辛伐他汀浓度,采用DAS 3.2.2程序拟合药动学参数,并进行生物等效性评价.结果：单剂量口服40 mg辛伐他汀试验制剂（国产）和参比制剂后,两药的主要药动学参数分别为tmax（4.54±5.35）和（2.32±1.72） h;Cmax：（5.63±4.03）和（7.29±3.84） ng·ml-1;t1/2：（6.31±4.99）和（4.67±3.07） h;AUC（0-t）：（38.75 ±29.55）和（35.54±30.12）ng·h·ml-1;AUC（∞）：（67.31±60.25）和（40.36±34.78）ng·h·ml-1.试验制剂与参比制剂比较,相对生物利用度为117.2％.受试制剂的AUC0→t 90％可信限为89.5％～ 153.5％,AUC0→ 90％可信限为118.1％～198.7％,落在参比制剂对应参数80％ ～ 125％范围外.结论：两制剂的吸收程度有差异,不等效.     

A relative bioavailability study of 500 mg calcium p-aminosalicylate film coating tablet in healthy individuals

The purpose of this study is to evaluate the only available calcium p-aminosalicylate (Ca PAS) commercial product, which is one of the most commonly prescribed non-surveillance products from the Bureau of National Health Insurance (BNHI) database in Taiwan. An open-randomized, balanced, two-way crossover study was designed to evaluate the relative bioavailability (F) of a 500 mg Ca PAS F.C. tablet with a 500 mg Ca PAS suspension in 13 healthy individuals. Blood samples were collected according to a planned time schedule. The plasma concentrations of PAS were measured by a validated liquid chromatography coupled with tandem mass spectrometry (LC/MS/MS) method. Pharmacokinetic parameters of area under the plasma concentration-time curve from the time zero to the time of last quantifiable concentration (AUC_0–t), area under the plasma concentration-time curve from time zero to infinity (AUC_0–∞), maximum plasma concentration (C_max), time to reach measured maximum plasma concentration (T_max), elimination half-life (T_1/2), and mean residence time (MRT) were determined by non-compartment methods. F was calculated by [AUC_0–∞] of the test drug divided by [AUC_0–∞] of the reference drug. The mean geometric ratios of pharmacokinetic parameters, including AUC_0–t, AUC_0–∞, and C_max obtained were 0.873, 0.874, and 0.569, respectively. The 90% confidence intervals of ln (AUC_0–t), ln (AUC_0–∞), and ln (C_max) after being back natural log-transformed were (74.0–103.0%), (74.1–103.0%), and (38.4–84.3%), respectively. The relative bioavailability of the Ca PAS tablet was 87.4%.     

Heart Rate Distribution and Cause-specific Death in General Population of South China

Based on the development of pathologic physiologyprocess of coronary heart disease, it is considered thatlower heart rate(HR) is advantageous to the protectionof ischemic heart and the treatment of heart failure.Thus traditional normal range of HR from 60 to 100beats /min (bpm) in adult should be questioned. Thistext analyzed the baseline and follow-up data of thePRC-USA Collaborative Study of CardiovascularEpidemiology to investigate the HR distribution inhealthy community adults and to…     

Sedentary behavior and the risk of stroke: A systematic review and dose-response meta-analysis

Background and aimsThe sedentary behavior in people's daily life has continued to increase in recent years, causing many studies to focus on its relationship with diseases. Several studies have shown that sedentary behavior is an independent risk factor for cardiovascular disease and metabolic disease. Therefore, we performed a meta-analysis to assess the association between sedentary behavior and the risk of stroke.Methods and resultsTwo independent investigators searched for prospective cohort studies on the association between sedentary behavior and stroke risk, published before February 2022. We pooled adjusted effect size and performed the dose-response analysis by random-effect model. Seven studies with 677,614 participants and 15,135 stroke events during a median follow-up of 12.2 years were included. The pooled hazard ratio (HR) of stroke was 1.16 (95% confidence interval [CI]: 1.09–1.24) with no significant heterogeneity (I2 = 0.0%, p for heterogeneity = 0.983). In dose-response analysis, a nonlinear association between sedentary behavior and stroke risk was discovered. Stroke risk began to increase when sedentary time exceeded 3.7 h/d (HR, 1.01; 95% CI, 0.97–1.05). And when reached 11 h/d, a significantly increased risk of stroke was observed (HR, 1.21; 95% CI 1.12–1.31).ConclusionA nonlinear association was found in the dose-response analysis, with increased risk only when sedentary time exceeded a certain level. Further research is needed to explain the biological mechanisms by which sedentary time above a certain threshold significantly increases stroke risk. (PROSPERO registration number: CRD42022311544)     

足月新生儿高胆红素性脑损伤不同血清指标的临床意义

目的 研究新生儿胆红素性脑损伤患儿血清神经元特异性烯醇化酶(serum neuron-specific enolase, s-NSE)含量与血清胆红素、白蛋白及B/A值的关系。方法 采用ELISA法测定高胆红素血症新生儿血清s-NSE含量, 全自动生化分析仪测定其血清间接胆红素数值(UCB)、白蛋白数值(A), 计算间接胆红素与白蛋白的比值(B/A);将62例s-NSE含量增高患儿分成两组:s-NSE值轻度增高组和s-NSE值重度增高组, 分析两组血清指标的差异, 以及s-NSE值与各指标的相关性。结果 两组间UCB值差异有统计学意义(P<0.05), A值无统计学意义(P>0.05), B/A值差异有统计学意义(P<0.001); s-NSE值与B/A值呈高度正相关性(r=0.687, P<0.001)。结论 B/A比值能较好的反应胆红素性脑损害, 临床可通过对B/A值的监测, 指导高胆红素血症患儿的合理干预。     

Suicide Among Young People in the Americas

PurposeTo examine suicide mortality trends among young people (10–24 years of age¹) in selected countries and territories of the Americas.MethodsAn ecological study was conducted using a time series of suicide mortality data from 19 countries and one territory in the Region of the Americas from 2001 to 2008, comprising 90.3% of the regional population. The analyses included age-adjusted suicide mortality rates, average annual variation in suicide mortality rates, and relative risks for suicide, by age and sex.ResultsThe mean suicide rate for the selected study period and countries/territory was 5.7/100,000 young people (10–24 years), with suicide rates higher among males (7.7/100,000) than females (2.4/100,000). Countries with the highest total suicide mortality rates among young people (10–24 years) were Guyana, Suriname, Nicaragua, El Salvador, Chile, and Ecuador; countries with the lowest total suicide mortality rates included Mexico, Venezuela, Cuba, and Brazil, and the U.S. territory of Puerto Rico. During this period, there was a significant increase in suicide mortality rates among young people in the following countries: Argentina, Chile, Ecuador, Mexico, and Suriname; countries with significant decreases in suicide mortality rates included Canada, Colombia, Cuba, El Salvador, and Venezuela. The three leading suicide methods in the Americas were hanging, firearms, and poisoning.ConclusionsSome countries of the Americas have experienced a rise in adolescent and youth suicide during the study period, with males at a higher risk of committing suicide than females. Adolescent and youth suicide policies and programs are recommended, to curb this problem. Methodological limitations are discussed.     

Genome-wide scan for analysis of simple and imperfect microsatellites in diverse carlaviruses

An exhaustive compilation and analysis of incidence, distribution and variation of simple sequence repeats (SSRs) in viruses are required to understand the evolution and functional aspects of repetitive sequences. Present study focuses on the analysis of SSRs in 32 species of carlaviruses. The full length genome sequences were assessed from NCBI (http://www.ncbi.nlm.nih.-gov/) and analyzed using IMEx software. Variance in incidence of SSRs was observed, independent of genome size. Though the conversion of SSRs to imperfect microsatellite or compound SSR is low; compound microsatellites constituted by variant motifs accounted for up to 12.5% of the SSRs. Mononucleotide A/T is most prevalent followed by dinucleotide GT/TG and trinucleotide AAG/GAA in these genomes. The SSR and cSSR are predominantly localized to the coding region RDRP (RNA dependent RNA polymerase) and ORF-6 (open reading frame). The relative frequency of different classes of simple and compound microsatellites has been highlighted in accordance with the biology of carlavirus. Characterization of such variations would be pivotal for deciphering the enigma of these widely used, but incompletely understood sequences.     

一测多评法同时测定水蛭中4种有效成分的含量

目的：建立同时测定水蛭药材中4 种主要成分含量的方法。方法：采用高效液相色谱法,以次黄嘌呤为内标,计算其对尿嘧啶、黄嘌呤和尿苷的相对校正因子(RCF),通过RCF计算上述3种成分的含量;以外标法测定的含量作实测值,比较计算值与实测值的差异。结果：尿嘧啶、次黄嘌呤、黄嘌呤和尿苷检测质量浓度线性范围分别为1.60～32.00 mg/ml、4.05～81.00 mg/ml、1.50～30.00 mg/ml、1.25～25.00 mg/ml(r>0.999);精密度、稳定性、重复性试验的RSD＜2.0％;加样回收率试验的RSD 分别为95.05％～99.45％(RSD＝1.73％,n＝6)、95.89％～99.38％(RSD＝1.52％,n＝6)、94.00％～97.88％(RSD＝1.74％,n＝6)、96.07％～99.35％(RSD＝1.18％,n＝6)。计算值与实测值差异无统计学意义(P＞0.05)。结论：该方法操作简便,精密度、稳定性、重复性良好,可用于水蛭药材中4种有效成分含量的同时测定。