业界新闻
中国富贵病日趋严重,医疗系统面临严峻挑战
十二五期间力争医药卫生重点领域改革有突破
陈竺:今年将抓好取消以药补医相关政策落实
卫生部部长陈竺:积极开展卫生人才继续教育
陈竺、王振义荣获“影响世界华人大奖”提名
卫生部:切实落实安保措施增强应急处置能力
人民日报两会之后话民生:今年医改主攻什么
卫生部部长陈竺要求:严打残害医务人员罪行
哈医大一院为被患者砍死医务人员举办追悼会
卫生部通知要求:切实维护医疗机构治安秩序
卫生部要求医疗机构要做好内部治安保卫工作
加快全民医保体系的健全,建立和谐医患关系
卫生部要求严格执行事先告知和知情同意制度
陈竺:中国传染病和慢性病双重疾病负担加重
哈尔滨医科大学附属第一医院发生恶性伤医案
中国青年报:医改规划结束“给政策不给钱”
半月谈:解读“十二·五”医改规划实施方案
医改在基层:看病“一口价”推广难点在哪?
医院杀医血案:未成年患者砍死硕士实习医生
哈尔滨二十八岁实习医生命丧十七岁患者刀下
科学学位研究生能否报考医师资格无确切说法
哈尔滨患者持水果刀捅医生致一死三伤被抓获
哈尔滨医院发生伤害医务人员案件致一死三伤
药监局提醒关注香丹注射液严重不良反应问题
《人民日报》政策聚焦公立医院收入不靠药品
中国青年报:饶毅施一公为何落选中科院院士
国务院要求扭转公立医院逐利,禁止举债建设
医改办负责人:五大措施保障十二五医改规划
新华每日电讯:为何医生宁可走穴不多点执业
卫生部部长陈竺访谈:东方智慧驯化恶性肿瘤
政协委员热议医保制度莫让患者“望医止步”
李克强:今年研发费用支出预计或达一万亿元
黄洁夫:解决医患矛盾需要在制度上找突破口
自然:中国的科学研究资助评估体系需要改革
美国癌症协会发布新的宫颈癌预防和筛查指南
陈竺:八百六十万医务工作者绝大部分是好的
卫生部部长陈竺:公立医院不能搞过度市场化
基层医院招聘难:大学生称待遇低发展空间小
人大代表呼吁出台政策支持取消“以药补医”
人大代表称医生拿红包收回扣是极个别的现象
瞭望新闻周刊:深化医改需要从三个方面突破
钟南山高调问政:作为医生就应该讲真话实话
医疗改革成效显著,加速推进需在体制上突破
医改投入虽快于经济增速看病难亟需深入破题
科学:关注中国政府工作报告的科研投入部分
肺癌等十二类大病将纳入保障和救助试点范围
卫生部:现行医疗服务体制缺陷升级医患矛盾
医疗服务没有实现公益性,医改就是做好药改
中国医改进深水区,代表委员支招破解看病难
攻坚公立医院改革,黄洁夫开出社会资本药方
抗菌药物临床不合理应用问题医师将受到处罚
国家中医药管理局局长称活熊取胆属无奈之举
新版基本药物目录扩容近一倍,医药分离试水
中国医改三年投逾一万亿,鼓励民间资本办医
陈竺:加强末期病患人文关怀以改善医患关系
陈竺:医院将撬动价格机制改革不按项目收费
特写:卫生部部长陈竺参加政协大会举步维艰
德国将定期询问成年人是否同意死后捐赠器官
荷兰推出安乐死新服务可以上门协助病人自杀
《人民日报》学术期刊出版大国的尴尬与梦想
全国首批居民健康卡今日在四个试点省区发放

临床时讯 > 专家论坛


抗击感染:人类与病原体之间永恒的战役


  美国发布其首部儿科社区获得性肺炎指南

  为有效预防、诊治婴幼儿及儿童社区获得性肺炎(CAP),儿科感染性疾病学会(PIDS)和美国感染性疾病学会(IDSA)于2011年共同出台了美国首部《儿童CAP管理临床实践指南》。该指南对我国儿童CAP临床诊疗实践具有参考与借鉴价值。

  首先,由于儿童血化验检查结果准确率不高,当其发生CAP后是否须住院治疗,原则上应主要依据临床症状。指南明确了须接受住院治疗的CAP患儿指征。由此也可推知,轻度CAP患儿无须接受住院治疗。

  其次,指南提出,门诊治疗效果良好、无明显感染中毒症状或接受了完全疫苗免疫的CAP患儿,不必常规拍摄胸部X线片,不推荐送检行血培养,也不推荐用血沉、C反应蛋白和前降钙素区分CAP病原体。患儿接受初始治疗临床症状无明显改善甚至加重时,则须接受血培养检查。

  第三,在关于门诊和住院CAP患儿初始经验治疗抗菌药物的选择部分,指南则结合患儿的年龄及可能的病原体,提出了不同的详细推荐。

  细菌性CAP首选大剂量阿莫西林,免疫功能低下者首选头孢曲松或头孢噻肟,疑似社区相关性耐甲氧西林金黄色葡萄球菌所致CAP则加用万古霉素,非典型微生物所致CAP首选阿奇霉素,流感病毒所致CAP首选奥司他韦。

  最后,指南还强调了疫苗在预防儿童CAP中的重要性。

Clin Infect Dis. 2011 Oct;53(7):617-30.

Executive summary: the management of community-acquired pneumonia in infants and children older than 3 months of age: clinical practice guidelines by the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America.

Bradley JS, Byington CL, Shah SS, Alverson B, Carter ER, Harrison C, Kaplan SL, Mace SE, McCracken GH Jr, Moore MR, St Peter SD, Stockwell JA, Swanson JT, Pediatric Infectious Diseases Society and the Infectious Diseases Society of America.

Department of Pediatrics, University of California San Diego School of Medicine and Rady Children's Hospital of San Diego, San Diego, California, USA.

Evidenced-based guidelines for management of infants and children with community-acquired pneumonia (CAP) were prepared by an expert panel comprising clinicians and investigators representing community pediatrics, public health, and the pediatric specialties of critical care, emergency medicine, hospital medicine, infectious diseases, pulmonology, and surgery. These guidelines are intended for use by primary care and subspecialty providers responsible for the management of otherwise healthy infants and children with CAP in both outpatient and inpatient settings. Site-of-care management, diagnosis, antimicrobial and adjunctive surgical therapy, and prevention are discussed. Areas that warrant future investigations are also highlighted.

Clin Infect Dis. 2011 Oct;53(7):e25-76.

The management of community-acquired pneumonia in infants and children older than 3 months of age: clinical practice guidelines by the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America.

Bradley JS, Byington CL, Shah SS, Alverson B, Carter ER, Harrison C, Kaplan SL, Mace SE, McCracken GH Jr, Moore MR, St Peter SD, Stockwell JA, Swanson JT, Pediatric Infectious Diseases Society and the Infectious Diseases Society of America.

Department of Pediatrics, University of California San Diego School of Medicine and Rady Children's Hospital of San Diego, San Diego, California, USA.

Evidenced-based guidelines for management of infants and children with community-acquired pneumonia (CAP) were prepared by an expert panel comprising clinicians and investigators representing community pediatrics, public health, and the pediatric specialties of critical care, emergency medicine, hospital medicine, infectious diseases, pulmonology, and surgery. These guidelines are intended for use by primary care and subspecialty providers responsible for the management of otherwise healthy infants and children with CAP in both outpatient and inpatient settings. Site-of-care management, diagnosis, antimicrobial and adjunctive surgical therapy, and prevention are discussed. Areas that warrant future investigations are also highlighted.

  治疗艰难梭菌感染新药获准上市

  2011年5月27日,美国食品与药物管理局(FDA)宣布批准窄谱抗生素非达米星(fidaxomicin)上市。该药成为近30年来首个被批准用于治疗艰难梭菌感染(CDI)的新药。

  在此之前,万古霉素是唯一一个经FDA批准上市用于治疗CDI的抗生素。此外,甲硝唑也多被用于CDI一线治疗。万古霉素和甲硝唑对CDI都很有效,但是感染复发率非常高。

  非达米星作为新一类大环内酯类抗生素,其作用机制为抑制细菌核糖核酸(RNA)聚合酶。与万古霉素和甲硝唑比,非达米星抗菌谱较窄,对肠道正常菌群影响较小,感染复发率更低。一项比较非达米星与万古霉素的Ⅲ期非劣效性研究显示,两者临床有效率相近,但非达米星组感染复发率下降了47%,显著低于万古霉素组。

  美更新预防血管内置管相关感染指南

  2011年,美国疾病控制与预防中心(CDC)与美国重症医学会等12家学会共同修订了《预防血管内置管相关感染指南》。与旧版指南相比较,更新指南要点包括:①对相关人员进行培训和教育;②放置中心静脉导管(CVC)时,须采取最严格的无菌屏障措施;③用>0.5%的氯己定酒精溶液进行皮肤消毒;④避免将常规更换CVC作为预防感染手段;⑤当严格执行上述措施仍不能降低感染率时,使用消毒剂或抗菌药涂层的短期CVC和氯己定浸泡敷料。

  除更新要点外,临床还须注意一些新版指南未作改动但国内临床未予注意的问题:静脉输液应尽量选择上肢;若暂不得已用下肢,一旦可能,应尽快改为上肢;CVC应首选锁骨下静脉;若静脉输液时间超过6天,需考虑应用中线导管或经外周中心静脉置管;中心静脉穿刺的皮肤消毒应采用最大化无菌技术;避免在压力监测管路输注葡萄糖溶液或肠外营养溶液。

  利匹韦林(Rilpivirine)获准用于治疗HIV感染

  2011年5月20日,美国食品与药物管理局(FDA)批准利匹韦林和其他抗病毒药物联用治疗1型人类免疫缺陷病毒(HIV-1)感染初治成年患者,此为自1998年依法韦仑上市以来又一个获准上市的非核苷逆转录酶抑制剂(NNRTI)。

  同年10月14日,美国卫生与人类服务部成人和青少年抗逆转录病毒指南专家组更新了成人和青少年HIV-1感染的抗逆转录病毒制剂使用指南。更新指南指出,利匹韦林作为NNRTI类药物为初治HIV-1感染患者提供了另一种治疗选择。

  利匹韦林有效性和安全性资料主要源于今年相继发表于《柳叶刀》(Lancet)的两项Ⅲ期临床研究,其结果显示,利匹韦林与依法韦仑的临床治疗有效率相当,尽管病毒学治疗失败率更高一些,但利匹韦林的安全性更佳,患者对其治疗的耐受性良好。

  与依法韦仑组相比,利匹韦林组2~4级不良反应发生率更低,不良反应停药率也更低。

  但对于基线血清HIV载量超过1×10^5拷贝/ml的患者,采用利匹韦林进行初始治疗应持慎重态度,因其应用利匹韦林治疗存在病毒学治疗失败率和耐药率升高风险。

Lancet. 2011 Jul 16;378(9787):238-46.

Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial.

Molina JM, Cahn P, Grinsztejn B, Lazzarin A, Mills A, Saag M, Supparatpinyo K, Walmsley S, Crauwels H, Rimsky LT, Vanveggel S, Boven K; ECHO study group.

Department of Infectious Diseases, Saint-Louis Hospital and University of Paris Diderot, Paris, France.

BACKGROUND: Efavirenz with tenofovir-disoproxil-fumarate and emtricitabine is a preferred antiretroviral regimen for treatment-naive patients infected with HIV-1. Rilpivirine, a new non-nucleoside reverse transcriptase inhibitor, has shown similar antiviral efficacy to efavirenz in a phase 2b trial with two nucleoside/nucleotide reverse transcriptase inhibitors. We aimed to assess the efficacy, safety, and tolerability of rilpivirine versus efavirenz, each combined with tenofovir-disoproxil-fumarate and emtricitabine.

METHODS: We did a phase 3, randomised, double-blind, double-dummy, active-controlled trial, in patients infected with HIV-1 who were treatment-naive. The patients were aged 18 years or older with a plasma viral load at screening of 5000 copies per mL or greater, and viral sensitivity to all study drugs. Our trial was done at 112 sites across 21 countries. Patients were randomly assigned by a computer-generated interactive web response system to receive either once-daily 25 mg rilpivirine or once-daily 600 mg efavirenz, each with tenofovir-disoproxil-fumarate and emtricitabine. Our primary objective was to show non-inferiority (12% margin) of rilpivirine to efavirenz in terms of the percentage of patients with confirmed response (viral load <50 copies per mL intention-to-treat time-to-loss-of-virological-response [ITT-TLOVR] algorithm) at week 48. Our primary analysis was by intention-to-treat. We also used logistic regression to adjust for baseline viral load. This trial is registered with ClinicalTrials.gov, number NCT00540449.

FINDINGS: 346 patients were randomly assigned to receive rilpivirine and 344 to receive efavirenz and received at least one dose of study drug, with 287 (83%) and 285 (83%) in the respective groups having a confirmed response at week 48. The point estimate from a logistic regression model for the percentage difference in response was -0.4 (95% CI -5.9 to 5.2), confirming non-inferiority with a 12% margin (primary endpoint). The incidence of virological failures was 13% (rilpivirine) versus 6% (efavirenz; 11%vs 4% by ITT-TLOVR). Grade 2-4 adverse events (55 [16%] on rilpivirine vs 108 [31%] on efavirenz, p<0.0001), discontinuations due to adverse events (eight [2%] on rilpivirine vs 27 [8%] on efavirenz), rash, dizziness, and abnormal dreams or nightmares were more common with efavirenz. Increases in plasma lipids were significantly lower with rilpivirine.

INTERPRETATION: Rilpivirine showed non-inferior efficacy compared with efavirenz, with a higher virological-failure rate, but a more favourable safety and tolerability profile.

FUNDING: Tibotec.

Lancet. 2011 Jul 16;378(9787):229-37.

Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial.

Cohen CJ, Andrade-Villanueva J, Clotet B, Fourie J, Johnson MA, Ruxrungtham K, Wu H, Zorrilla C, Crauwels H, Rimsky LT, Vanveggel S, Boven K; THRIVE study group.

Community Research Initiative of New England, Boston, MA 02215, USA.

BACKGROUND: The non-nucleoside reverse transcriptase inhibitor (NNRTI), rilpivirine (TMC278; Tibotec Pharmaceuticals, County Cork, Ireland), had equivalent sustained efficacy to efavirenz in a phase 2b trial in treatment-naive patients infected with HIV-1, but fewer adverse events. We aimed to assess non-inferiority of rilpivirine to efavirenz in a phase 3 trial with common background nucleoside or nucleotide reverse transcriptase inhibitors (N[t]RTIs).

METHODS: We undertook a 96-week, phase 3, randomised, double-blind, double-dummy, non-inferiority trial in 98 hospitals or medical centres in 21 countries. We enrolled adults (≥18 years) not previously given antiretroviral therapy and with a screening plasma viral load of 5000 copies per mL or more and viral sensitivity to background N(t)RTIs. We randomly allocated patients (1:1) using a computer-generated interactive web-response system to receive oral rilpivirine 25 mg once daily or efavirenz 600 mg once daily; all patients received an investigator-selected regimen of background N(t)RTIs (tenofovir-disoproxil-fumarate plus emtricitabine, zidovudine plus lamivudine, or abacavir plus lamivudine). The primary outcome was non-inferiority (12% margin on logistic regression analysis) at 48 weeks in terms of confirmed response (viral load <50 copies per mL, defined by the intent-to-treat time to loss of virologic response [TLOVR] algorithm) in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT00543725.

FINDINGS: From May 22, 2008, we screened 947 patients and enrolled 340 to each group. 86% of patients (291 of 340) who received at least one dose of rilpivirine responded, compared with 82% of patients (276 of 338) who received at least one dose of efavirenz (difference 3.5% [95% CI -1.7 to 8.8]; p(non-inferiority)<0.0001). Increases in CD4 cell counts were much the same between groups. 7% of patients (24 of 340) receiving rilpivirine had a virological failure compared with 5% of patients (18 of 338) receiving efavirenz. 4% of patients (15) in the rilpivirine group and 7% (25) in the efavirenz group discontinued treatment due to adverse events. Grade 2-4 treatment-related adverse events were less common with rilpivirine (16% [54 patients]) than they were with efavirenz (31% [104]; p<0.0001), as were rash and dizziness (p<0.0001 for both) and increases in lipid levels were significantly lower with rilpivirine than they were with efavirenz (p<0.0001).

INTERPRETATION: Despite a slightly increased incidence of virological failures, a favourable safety profile and non-inferior efficacy compared with efavirenz means that rilpivirine could be a new treatment option for treatment-naive patients infected with HIV-1.

FUNDING: Tibotec.

治疗指南
临床诊疗指南肠外肠内营养学分册
中国儿科肠内肠外营养支持临床应用指南
中国新生儿营养支持临床应用指南
神经系统疾病营养支持适应证共识、神经系统疾病肠内营养支持操作规范共识
恶性肿瘤患者的营养治疗专家共识
肠屏障功能障碍临床诊治建议
外科患者胶体治疗临床应用专家指导意见
美国国家癌症综合网络(NCCN)临床实践指南(国际版)
美国国家癌症综合网络(NCCN)临床实践指南(中国版)
美国肠外肠内营养学会(ASPEN)临床指南
欧洲肠外肠内营养学会(ESPEN)指南
欧洲肠外肠内营养学会肠内营养指南
美国东部创伤外科学会创伤患者营养支持实践治疗指南
美国感染病学会(IDSA)实践指南
美国长期护理机构居住者发热及感染评估指南
中国抗菌药物临床应用指导原则
儿童社区获得性肺炎管理指南(试行)概要
美国国家癌症综合网络(NCCN)《非小细胞肺癌临床实践指南》
2011年美国国家癌症综合网络(NCCN)老年肿瘤指南详解
2012V1版美国国家癌症综合网络(NCCN)结肠癌指南更新解读
2011年《美国国家癌症综合网络(NCCN)胰腺癌临床实践指南》(中国版)解读
欧洲《恶性胸膜间皮瘤诊疗指南》
学术会议
美国肠外肠内营养学会(ASPEN)
欧洲临床营养与代谢学会(ESPEN)
中华医学会肠外肠内营养学分会(CSPEN)
国际感染病学会(ISID)
美国感染病学会(IDSA)
美国微生物学会(ASM)
美国微生物学会(ASM)
国际人与动物真菌学会(ISHAM)
联系我们
《临床时讯》仅供临床医生及相关专业人士参考,如果您有任何意见或建议,请发邮件至:
© 2012 EDDINGPHARM