国产富马比索洛尔耐受量及其对心功能的影响

目的 :观察国人对国产富马比索洛尔的最大耐受剂量 ,及其对心功能的影响。方法 :心力衰竭患者 5 6例 ,在口服地高辛、ACEI制剂、血管扩张剂 （非钙离子拮抗剂 ）和利尿剂等基本抗心力衰竭药物的基础上 ,加服富马比索洛尔。观察患者对此药的耐受性 ,同时在试验初始时和服药 7月后测定患者左室射血分数 （EF）等指标。结果 :心力衰竭患者服用富马比索洛尔的最大耐受剂量各不同 ,主要分布在 5 m g;随访 7月后 ,复查心脏 B超与试验初比较 ,EF值 （30 .5± 2 .3） % vs （42 .3± 3.2 ） % ,有极显著的改善 （P<0 .0 1）。结论 :在心力衰竭治疗用药的基础上 ,加用富马比索洛尔治疗 （按照个体化用药原则 ） ,国人对此药的耐受程度主要分布在 5 m g,治疗 7月后的心力衰竭患者心功能显著改善     

顶空毛细管气相色谱法测定富马酸喹硫平中残留溶剂

目的 建立富马酸喹硫平中残留溶剂乙醇、甲苯的气相色谱测定方法.方法 采用DB-624弹性石英毛细管柱(30 m×0.53 mm×3.0 μm),载气为氮气,氢火焰离子化检测器,进样口温度为180 ℃,检测器温度为300 ℃.柱温采用程序升温:初始温度为50 ℃,保持5 min,然后以8 ℃/min的速率升至130 ℃,保持5 min;流速为2 mL/min.分流比为1∶60,以80%乙腈为样品的溶剂.结果 使用该方法乙醇、甲苯得到了较好的分离与测定;回收率分别为95.72%和88.59%,相对标准偏差(RSD)分别为2.4%和4.3%;精密度RSD分别为1.1%和4.0%.结论 该方法简便、准确、可靠,可用于药品检验中富马酸喹硫平中残留溶剂的测定.     

Effectiveness of Delayed-release Dimethyl Fumarate on Clinical and Patient-reported Outcomes in Patients With Relapsing Multiple Sclerosis Switching From Glatiramer Acetate: RESPOND,a Prospective Observational Study

Purpose

The goal of this study was to evaluate clinical outcomes and patient-reported outcomes (PROs) over 12 months in patients with relapsing multiple sclerosis (RMS) who switched from glatiramer acetate (GA) to delayed-release dimethyl fumarate (DMF) 240 mg BID after suboptimal response to GA in real-world clinical practice.

两种吸入剂对支气管哮喘患者肾上腺皮质功能、糖脂代谢的影响

目的探讨长期应用布地奈德福莫特罗吸入剂(160μg/4.5μg)对支气管哮喘患者的控制作用及对肾上腺皮质功能、糖脂代谢的影响。方法将78例支气管哮喘患者随机分成治疗组和对照组,治疗组给予布地奈德福莫特罗吸入剂(160μg/4.5μg),每日两次,对照组按需应用沙丁胺醇吸入剂,口服茶碱缓释片。观察周期为一年。两组患者在治疗前1天(T0)、一个月(T1)、三个月(T3)、六个月(T6)、12个月(T12),分别给予哮喘控制测试(asthma control test,ACT)评分,呼气峰流速(peak expiratory flow,PEF)日变异率检查,分别抽血测皮质醇、促肾上腺素皮质激素(ACTH),空腹血糖(FPG)、糖化血红蛋白(HbA1c)、甘油三酯、总胆固醇。结果治疗组患者ACT评分高于对照组(P0.05),治疗组患者PEF日变异率小于对照组(P0.05)。治疗组与对照组皮质醇、ACTH、FPG、HbA1c、总胆固醇、甘油三酯之间的差异无统计学意义(P0.05)。结论布地奈德福莫特罗吸入剂对支气管哮喘患者的控制有良好作用,长期应用对患者的肾上腺皮质功能、糖脂代谢无不良影响。     

Assessment of the steady-state pharmacokinetic interaction between etravirine administered as two different formulations and tenofovir disoproxil fumarate in healthy volunteers

Objective

Two open‐label, randomized, cross‐over trials in healthy volunteers were conducted to investigate the pharmacokinetic interaction between etravirine and tenofovir disoproxil fumarate.

Methods

Etravirine was administered as either 800 mg twice a day (bid) (phase II formulation in Study 1) or 200 mg bid (phase III formulation in Study 2) for 8 days followed by a 12 h pharmacokinetic evaluation. After a minimum of 14 days washout, tenofovir disoproxil fumarate 300 mg once a day was administered for 16 days. Volunteers were randomized to receive co‐administration of etravirine with tenofovir disoproxil fumarate on either days 1–8 or days 9–16 followed by a 12 h pharmacokinetic evaluation for etravirine on day 8 or 16, respectively. Plasma and urine tenofovir concentrations were determined on days 8 and 16 over 24 h.

Results

The least square mean (LSM) ratio [90% confidence interval (CI)] for the area under the plasma concentration–time curve from 0 to 12 h (AUC_{12 h}) for etravirine co‐administered with tenofovir disoproxil fumarate vs. etravirine alone was 0.69 (0.61–0.79) and 0.81 (0.75–0.88) in Studies 1 and 2, respectively. The LSM ratio (90% CI) for the effect of etravirine on tenofovir AUC_{24 h} was 1.16 (1.09–1.23) in Study 1 and 1.15 (1.09–1.21) in Study 2.

Conclusions

These alterations are not considered clinically relevant for either drug and no dose adjustment is necessary when etravirine and tenofovir disoproxil fumarate are co‐administered.     

替诺福韦酯单独与联合恩替卡韦挽救治疗恩替卡韦治疗拉米夫定经治慢性乙型肝炎失败患者疗效比较

目的比较替诺福韦酯单药与联合恩替卡韦对恩替卡韦治疗慢性乙型肝炎拉米夫定经治患者仍应答不佳或发生病毒学突破的挽救方案的临床疗效及安全性。方法将80例恩替卡韦序贯治疗仍效果欠佳的拉米夫定经治慢性乙型肝炎患者随机分为单药组40例和联合组40例。单药组给予替诺福韦酯(300 mg/d)替换治疗;联合组使用替诺福韦酯(300 mg/d)和恩替卡韦(0.5 mg/d)治疗。所有患者均治疗48周,检测基线,治疗12、24和48周时病毒学、生化学、血清学指标。比较两组患者上述治疗时间点的完全病毒学应答率、ALT复常率、病毒学突破率和HBeAg血清学转换率及观察药物不良反应。结果单药组患者治疗48周后完全病毒学应答率、ALT复常率、病毒学突破率、HBeAg血清学转换率分别为85.0%(34/40)、76.2%(16/21)、0、13.1%(3/23),联合组分别为87.5%(35/40)、77.3%(17/22)、0、16.0%(41/25),两组比较差异无统计学意义(均P0.05)。两组患者耐受性均良好,无一例出现严重不良反应而导致停药。结论对于恩替卡序贯治疗后仍应答不佳或发生病毒学突破的拉米夫定经治慢性乙型肝炎患者,替诺福韦酯单药替换恩替卡韦的挽救治疗仍能有效抑制HBV DNA复制,是一种行之有效的优化治疗方案。     

替诺福韦酯联合双重免疫方案阻断HBV携带孕妇母婴病毒传播效果研究

目的 观察应用替诺福韦酯联合双重免疫方案处理慢性乙型肝炎病毒(HBV)携带孕妇对母婴病毒传播阻断的效果.方法 2016年12月～2019年9月我院收治的HBV携带孕妇120例,采用随机数字表法分为对照组60例和观察组60例.对照组孕妇未进行抗病毒治疗,观察组孕妇在孕26～28个月时开始口服替诺福韦酯,治疗至分娩.所有新...     

Asociación Mexicana de Hepatología A.C. Guía Clínica de Hepatitis B

Hepatitis B virus (HBV) infection continues to be a worldwide public health problem. In Mexico, at least three million adults are estimated to have acquired hepatitis B (total hepatitis B core antibody [anti-HBc]-positive), and of those, 300,000 active carriers (hepatitis B surface antigen [HBsAg]-positive) could require treatment. Because HBV is preventable through vaccination, its universal application should be emphasized. HBV infection is a major risk factor for developing hepatocellular carcinoma. Semi-annual liver ultrasound and serum alpha-fetoprotein testing favor early detection of that cancer and should be carried out in all patients with chronic HBV infection, regardless of the presence of advanced fibrosis or cirrhosis. Currently, nucleoside/nucleotide analogues that have a high barrier to resistance are the first-line therapies.