Clevudine for chronic hepatitis B: antiviral response,predictors of response,and development of myopathy

Summary. Clevudine has been approved for the treatment of chronic hepatitis B (CHB) in South Korea. However, its long‐term antiviral effect and safety awaits more study. The aim of this study was to evaluate antiviral efficacy, predictors of virologic response, and development of myopathy after clevudine therapy for CHB. The study included 102 nucleoside naïve CHB patients who had received clevudine for more than 6 months with good compliance. The median duration of clevudine treatment was 53 weeks (range, 25–90 weeks). A retrospective analysis of data retrieved from medical records was performed. The cumulative rate of virologic response [hepatitis B virus (HBV) DNA level <2000 copies/mL] at 48 weeks of clevudine therapy was 81%, and cumulative rate of clevudine resistance was 11% at 60 weeks of treatment. Independent predictors of virologic response to clevudine therapy were hepatitis B e antigen (HBeAg) negativity and rapid decrease of viral load during the early phase of treatment. The clevudine‐related myopathy developed in 3.9% of patients, and was reversible after discontinuation of clevudine. Clevudine showed a potent antiviral response, and its effect was higher in HBeAg‐negative patients, with rapid viral load reduction after therapy. However, long‐term therapy for more than 1 year resulted in the development of considerable resistance and myopathy. Therefore, we should consider alternative antiviral agents if clevudine resistance or clevudine‐induced myopathy is developed in patients on clevudine for the treatment of CHB.     

慢性肾脏病肾阳虚证证候特征与临床生物学指标相关性及危险因素

目的 观察慢性肾脏病（CKD）肾阳虚证证候特征、与临床指标的相关性并探索影响CKD肾阳虚证的危险因素。方法 通过对符合纳入标准的225例慢性肾脏病患者进行中医证候判断，获得肾阳虚证组99例，非肾阳虚证组126例。总结肾阳虚证组症状、舌脉及兼证，运用因子分析和聚类分析归纳证候特征，运用方差分析及非参数检验方法比较肾阳虚证组、非肾阳虚证组及正常对照组之间的血红蛋白、红细胞计数、尿蛋白、尿葡萄糖、肌酐、尿素氮、肾小球滤过率水平，采用二分类Logistic回归分析模型对生活习惯、身体质量指数（BMI）、血糖、血脂等危险因素进行证候相关性分析。结果 CKD肾阳虚证患者高频症状是腰部酸痛、畏寒喜暖、精神萎靡、腰膝畏寒等。脉象以沉脉、细脉、弱脉为主，舌象中以白苔、暗淡舌、薄苔、腻苔为主。因子分析获得13个公因子分为5类，发现肾阳虚证患者症状病位在四肢尤以下肢为主、心胸、膀胱、肌表和胃部，病性表现主要是虚寒、气虚、水饮及血瘀。聚类分析可聚为11类，反映了肾阳虚证患者以气虚、血瘀和水饮停滞为主的舌脉及症状表现，证候体现病位特征集中在肌表、四肢、脾胃、耳窍、心神和膀胱等，总体而言病性表现与因子分析基本一致，一派虚寒衰弱表现兼有水饮、血瘀表现。频数分析也显示常见兼证证候要素主要包括气虚证、饮停证、寒湿证、血瘀证。与非肾阳虚证组比较，肾阳虚证组CKD 3-5期出现比例更高，肾功能尿素氮明显增高（P<0.05），肾小球滤过率明显降低（P<0.05）；血红蛋白和红细胞计数明显降低（P<0.05）；尿蛋白定性等级明显提升。此外，经回归分析结果显示女性、不运动或很少运动、存在饮食偏嗜是CKD肾阳虚证产生的危险因素（P<0.05）。结论 CKD肾阳虚证症状表现在病位病性表现上均具有相应特征，其中医证型与其对应的生物学指标具有一定程度上的相关性，血红蛋白、红细胞计数及肾小球滤过率、尿素氮和尿蛋白等能够一定程度反映CKD肾阳虚证的证候内涵，生活中相关危险因素能够影响CKD肾阳虚证的产生。     

Rescue therapy: ciclosporin or infliximab?

Evaluation of: Laharie D, Bourreille A, Branche J et al.; Groupe d’Etudes Thérapeutiques des Affections Inflammatoires Digestives. Ciclosporin versus infliximab in patients with severe ulcerative colitis refractory to intravenous steroids: a parallel, open-label randomised controlled trial. Lancet 380(9857), 1909–1915 (2012).

Severe active refractory ulcerative colitis is a potentially life-threatening disease. The introduction of intensive steroid treatment and early surgery has reduced mortality in recent years. Ciclosporin and infliximab are effective rescue therapies in steroid refractory colitis. A head-to-head study proposed by Laharie et al. failed to demonstrate the superiority of ciclosporin but confirmed the efficacy and safety of infliximab to control active disease and to maintain remission.     

两种HBV DNA定量试剂在慢性乙型肝炎医疗决策点的比较研究

目的比较两种实时荧光定量HBV-DNA检测试剂对慢性乙型肝炎（CHB）患者管理的一致性。方法选取某国产试剂H和Roche公司COBAS AmpliPrep/COBAS TaqMan（CAP/CTM）高灵敏核酸检测系统作为比较对象,分别检测133例CHB患者血清HBV-DNA。选择HBV-DNA〈500 IU/mL、500～2000 IU/mL、〉2000 IU/mL等三个浓度进行两检测系统的一致性监测。结果 （1）两系统检测结果比较,试剂H组HBV-DNA浓度为500～2000 IU/mL时,其结果的Log值为2.84±0.27,相应标本在CAP/CTM组的检测结果为3.48±0.54,两种系统检测结果差异有统计学意义（P=0.000）。试剂H组HBV-DNA浓度为〉2000 IU/mL时,其结果的Log值为4.74±1.06,相应标本在CAP/CTM组的检测结果为5.32±1.01,两种系统检测结果差异有统计学意义（P=0.000）。（2）以CAP/CTM为标准,试剂H在HBV-DNA〈500 IU/mL、500～2000 IU/mL、〉2000 IU/mL时的敏感度分别为100%、81.5%和75.9%;特异度分别为87.5%、95.3%和100%。结论国产试剂H系统和CAP/CTM系统在对CHB患者的抗病毒治疗筛选上以及停药的关键医疗决策浓度监测上有较大差异。     

Association between visit-to-visit clinic blood pressure variability and home blood pressure variability in patients with chronic kidney disease

Abstract

Although both clinic blood pressure (BP) variability and home BP variability are associated with the risk of cardiovascular disease, the relationship between both BP variabilities remain unclear. We evaluated the association between visit-to-visit variability of clinic BP (VVV) and day-by-day home BP variability (HBPV) in patients with chronic kidney disease (CKD). We recruited 143 CKD patients in whom we performed HBP measurements every morning and evening over seven consecutive days. We obtained clinic BP data during 9.6?±?1.0 consecutive visits within 24 months. The associations between the variables of VVV and HPBV were examined. The CV values of clinic systolic BP (CSBP) was significantly correlated with the mean values of morning systolic BP (MSBP) and those of evening systolic BP (ESBP) (r?=?0.23, 0.20; p?=?0.007, 0.02, respectively). The CV values of CSBP was significantly correlated with the CV values of MSBP and those of ESBP (r?=?0.19, 0.31; p?=?0.02, <0.001, respectively). On the multivariate regression analysis, the CV values of CSBP was significantly correlated with the CV values of MSBP and those of ESBP [standardized regression coefficient (β)?=?0.19, 0.34; p?=?0.03, <0.001, respectively]. In conclusion, VVV showed a weak but significant association with HBPV, especially the CV values of ESBP in CKD patients. Further studies are necessary to clarify whether these different BPV elements will be alternative marker of BPV.     

Sex-specific Associations of Sex Hormone Binding Globulin with CKD and Kidney Function: A Univariable and Multivariable Mendelian Randomization Study in the UK Biobank

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