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临床时讯 > 专家论坛


Medscape各学科2011年度之最


  每至年终,各大权威媒体、杂志、学术机构均会纷纷推出其所谓的“十大(Top 10)”,以帮助人们回顾当年度发生的最具里程碑意义的事件、研究和学术进展,本报的国际国内医学十大新闻亦将于2012年1月5日公布。在梳理《自然·医学》(Nat Med)、《柳叶刀》(Lancet)、《科学》(Science)、《时代》(TIMES)、Medscape等或专业或大众的期刊及网站2011年度医学进展Top 10的过程中,编辑惊喜地发现,在这些国外知名媒体所推选出的临床医学研究中,本报各周刊均几乎进行过相关报道,其中,“早期抗病毒治疗可有效预防艾滋病传播”的条目更是登上了包括本报在内多个Top 10之榜。

  那么,今年到底有哪些不容错过的基础与临床医学进展呢?请看本期的“外媒盘点2011”专题(A12~A14)。

  呼吸——年度高阅读率文章之最:支气管激发试验助力哮喘诊断

  临床上,常存在对哮喘诊断不足或过度诊断的问题。澳大利亚学者撰写的综述显示,进行支气管激发试验确定支气管高反应性(BHR)可弥补基于病史或症状对哮喘进行诊断所存在的不足。论文发表于《过敏与临床免疫新见》杂志。

Curr Opin Allergy Clin Immunol. 2011 Feb;11(1):46-52.

Bronchial provocation testing: the future.

Anderson SD, Brannan JD.

Department of Respiratory & Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.

PURPOSE OF REVIEW: Performing a bronchial provocation test (BPT) using a direct or indirect stimulus to identify bronchial hyper-responsiveness (BHR) reduces the possibility of over and under-diagnosis of asthma based on history and symptoms. This review discusses some long-held beliefs of BPTs to include or exclude a diagnosis of asthma or exercise-induced bronchoconstriction (EIB).

RECENT FINDINGS: A high frequency of negative methacholine tests has been reported in 240 patients given a diagnosis of asthma at the end of the study, many of whom had documented EIB. This suggests that a negative methacholine test should not be relied upon to rule out asthma. Further, a positive methacholine test alone should be interpreted with caution as it may reflect airway injury rather than asthma or EIB. Mannitol, an indirect stimulus, identified a similar prevalence of BHR to methacholine and identified more patients than a single exercise test in three studies. However, neither mannitol nor methacholine identified all patients with EIB. Mannitol has a higher specificity for a physician diagnosis of asthma than methacholine.

SUMMARY: It is likely that both a direct test and an indirect test result may be required in some patients in order to confirm or exclude a diagnosis of asthma with certainty.

  新发现:相当高比例被确诊为哮喘患者的乙酰甲胆碱试验却为阴性,这提示,乙酰甲胆碱试验阴性不是可以排除哮喘的可靠标准。此外,若单纯乙酰甲胆碱试验阳性时,也应注意,其可能仅反映了存在气道损伤或重塑而非哮喘或运动诱发的支气管收缩(EIB)。

  对于诊断BHR,甘露醇(间接刺激物)激发试验的敏感性优于单次运动试验,与乙酰甲胆碱试验效果相当。无论是甘露醇激发试验还是乙酰甲胆碱试验,其对EIB患者的诊断率均达不到100%,但前者对哮喘诊断的特异性优于后者。

  因此,为确诊或排除哮喘诊断,在某些患者中,既要进行直接支气管激发试验又要进行间接激发试验。

  肾脏——年度重要医疗实践改变之最:何为最佳起始透析时机?

  自1996年起,越来越多的人接受了在估计的肾小球滤过率(eGFR)仍较高时即应开始透析的主张,但美国学者的研究表明,早期开始透析其实可能有害。论文发表于《内科学文献》杂志。

Arch Intern Med. 2011 Mar 14;171(5):396-403.

Early start of hemodialysis may be harmful.

Rosansky SJ, Eggers P, Jackson K, Glassock R, Clark WF.

Dorn Research Institute, Wm. Jennings Bryan Dorn Veterans Hospital, 526 N Trenholm Rd, Columbia, SC 29206, USA.

BACKGROUND: A dramatic increase in the "early start" of dialysis with an estimated glomerular filtration rate (eGFR) at least 10 mL/min/1.73 m(2) has occurred in the United States since at least 1996. Several recent studies have reported a comorbidity-adjusted survival disadvantage of early start of dialysis. The current study examines a relatively "healthy" dialysis cohort to minimize confounding issues and determine whether early initiation of hemodialysis is associated with a survival benefit or harm.

METHODS: We examined demographics, year of dialysis initiation, primary etiology of renal failure, and body mass index, hemoglobin, and serum albumin levels in 81,176 nondiabetic, 20- to 64-year-old, in-center incident hemodialysis patients with no reported comorbidity besides hypertension. We compared survival, using a piecewise proportional hazards model to estimate covariate-adjusted mortality hazard ratios (HRs) for eGFR at the time of initiation of dialysis. We also performed time-dependent adjusted analysis stratified by initial serum albumin levels lower than 2.5 g/dL, 2.5 to 3.49 g/dL, and 3.5 g/dL or higher (the "healthiest" group [HG]).

RESULTS: Unadjusted 1-year mortality by eGFR ranged from 6.8% in the reference group (eGFR <5.0 mL/min/1.73 m(2)) to 20.1% in the highest eGFR group (≥15.0 mL/min/1.73 m(2)). Compared with the reference group, the HR for the HG was 1.27 (eGFR, 5.0-9.9 mL/min/1.73 m(2)), 1.53 (eGFR, 10.0-14.9 mL/min/1.73 m(2)), and 2.18 (eGFR ≥15.0 mL/min/1.73 m(2)) and ranged from 1.50 to 3.53 mL/min/1.73 m(2) in the first year of dialysis for the early-start group.

CONCLUSION: The increased HR during hemodialysis associated with early start in the healthiest group of patients undergoing dialysis indicates that early start of dialysis may be harmful.

  新发现:起始透析时eGFR越高,患者的1年期死亡率亦越高。与开始接受血液透析时eGFR水平最高(≥15.0ml/min/1.73㎡)组患者相比,eGFR<5.0ml/min/1.73㎡组患者的未校正1年期死亡率显著较低(6.8%对20.1%)。即便是在最健康的患者中(即血清白蛋白和血红蛋白水平均正常),亦得到相似结果。

  该项研究的最大意义在于大胆地对越来越盛行的早期开始透析的临床实践进行了质疑。

  神经——年度不容错过的治疗进展之最:氯巴占成为癫痫辅助治疗新药

  在癫痫治疗方面,氯巴占获美国食品与药物管理局(FDA)批准可用于辅助治疗伦诺克斯-加斯托(Lennox-Gastaut)综合征(一种特殊的癫痫综合征),适用于成人及年龄≥2岁的儿童。

  新发现:在一项纳入了238例患者的双盲、安慰剂对照、随机研究中,癫痫患者的跌倒发作以氯巴占剂量依赖的形式显著减少。与安慰剂组患者平均每周跌倒发作率减少12.1%相比,低(0.25mg/kg/d)、中(0.5mg/kg/d)、高(1.0mg/kg/d)剂量氯巴占组患者的发作率分别降低41.2%、49.4%和68.3%。

Neurology. 2011 Oct 11;77(15):1473-81.

Randomized, phase III study results of clobazam in Lennox-Gastaut syndrome.

Ng YT, Conry JA, Drummond R, Stolle J, Weinberg MA; OV-1012 Study Investigators.

St. Joseph’s Hospital Medical Center and Barrow Neurological Institute, Phoenix, AZ, USA.

OBJECTIVE: To evaluate efficacy and safety of clobazam, a 1,5-benzodiazepine, as adjunctive therapy for Lennox-Gastaut syndrome (LGS).

METHODS: Patients aged 2-60 years were randomized to placebo or clobazam 0.25, 0.5, or 1.0 mg/kg/day. Study consisted of 4-week baseline, 3-week titration, and 12-week maintenance phases, followed by a 2- or 3-week taper or continuation in an open-label extension. Primary endpoint was percentage decrease in mean weekly drop seizure rates during maintenance vs baseline phases for modified intention-to-treat (mITT) population. Secondary outcomes included other seizure types, responder rates, and physicians' and caregivers' global assessments.

RESULTS: A total of 305 patients were screened, 238 were randomized, and 217 composed the mITT population. Of patients enrolled after a protocol amendment, 125/157 (79.6%) completed. Average weekly drop seizure rates decreased 12.1% for placebo vs 41.2% (p = 0.0120), 49.4% (p = 0.0015), and 68.3% (p < 0.0001) for the clobazam 0.25-, 0.5-, and 1.0-mg/kg/day groups. Responder rates (≥50%) were 31.6% (placebo) vs 43.4% (p = 0.3383), 58.6% (p = 0.0159), and 77.6% (p < 0.0001) for clobazam 0.25-, 0.5-, and 1.0-mg/kg/day groups. Physicians' and caregivers' assessments indicated clobazam significantly improved symptoms. Somnolence, pyrexia, upper respiratory infections, and lethargy were the most frequent adverse events reported for clobazam.

CONCLUSIONS: Clobazam significantly decreased weekly drop seizure rates in LGS. No new safety signals were identified.

CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that clobazam as adjunctive therapy is efficacious, in a dosage-dependent manner, in reducing mean weekly drop seizure rates of patients with LGS over 12 weeks.

  跌倒发作可能是癫痫患者致残的最主要原因,常致颜面和颈部受损,因此氯巴占成为癫痫患者辅助治疗手段显得颇具价值,但其也可致患者发生便秘、多涎、倦怠、发热和嗜睡等不良反应。

  感染——年度热点话题之最:肺结核治疗或将迎来新时代

  在全球范围内,肺结核与艾滋病的致死率相近,但各界对二者治疗方面的投入却是天壤之别。近50年来,没有任何肺结核治疗新药被研发出来,但在过去25年间,24种人免疫缺陷病毒(HIV)治疗新药诞生。

  新进展:肺结核之所以被选作热点话题是因为人们对其认知正在得到改善,对抗肺结核也成了全球待解决医疗健康问题的优先之选。

  尤其重要的是,肺结核治疗新药的研发首次有望步入繁盛时期,其中包括荧光喹诺酮类的Ⅲ期试验、利福喷汀和利奈唑胺的Ⅱ期试验,以及处于Ⅰ或Ⅱ期研发中的6种新药:SQ-109、PNU-100480、AZD-5847、TMC-207、OPC-6783和PA-824。

  风湿——年度不容错过的研究之最:类风湿关节炎缓解有新定义

  研究显示,缓解可能是判断类风湿关节炎(RA)患者转归的指标,但各个研究中所用RA缓解定义千差万别。因此,为提供一个统一的缓解定义以便临床应用,美国风湿病学会(ACR)和欧洲抗风湿病联盟(EULAR)制定了一个新的RA缓解定义。论文发表于《风湿病年鉴》杂志。

Ann Rheum Dis. 2011 Mar;70(3):404-13.

American College of Rheumatology/European League against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials.

Felson DT, Smolen JS, Wells G, Zhang B, van Tuyl LH, Funovits J, Aletaha D, Allaart CF, Bathon J, Bombardieri S, Brooks P, Brown A, Matucci-Cerinic M, Choi H, Combe B, de Wit M, Dougados M, Emery P, Furst D, Gomez-Reino J, Hawker G, Keystone E, Khanna D, Kirwan J, Kvien TK, Landewé R, Listing J, Michaud K, Martin-Mola E, Montie P, Pincus T, Richards P, Siegel JN, Simon LS, Sokka T, Strand V, Tugwell P, Tyndall A, van der Heijde D, Verstappen S, White B, Wolfe F, Zink A, Boers M.

Correspondence to Maarten Boers, Department of Epidemiology and Biostatistics, VU University Medical Center, PK 6Z 165, PO Box 7057, 1007 MB Amsterdam, The Netherlands.

OBJECTIVE: Remission in rheumatoid arthritis (RA) is an increasingly attainable goal, but there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome measure in clinical trials. This work was undertaken to develop such a definition.

METHODS: A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism, and the Outcome Measures in Rheumatology Initiative met to guide the process and review prespecified analyses from RA clinical trials. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures including, as a minimum, joint counts and levels of an acute-phase reactant to define remission. Members were surveyed to select the level of each core set measure that would be consistent with remission. Candidate definitions of remission were tested, including those that constituted a number of individual measures of remission (Boolean approach) as well as definitions using disease activity indexes. To select a definition of remission, trial data were analysed to examine the added contribution of patient-reported outcomes and the ability of candidate measures to predict later good radiographic and functional outcomes.

RESULTS: Survey results for the definition of remission suggested indexes at published thresholds and a count of core set measures, with each measure scored as 1 or less (eg, tender and swollen joint counts, C reactive protein (CRP) level, and global assessments on a 0-10 scale). Analyses suggested the need to include a patient-reported measure. Examination of 2-year follow-up data suggested that many candidate definitions performed comparably in terms of predicting later good radiographic and functional outcomes, although 28-joint Disease Activity Score-based measures of remission did not predict good radiographic outcomes as well as the other candidate definitions did. Given these and other considerations, we propose that a patient's RA can be defined as being in remission based on one of two definitions: (1) when scores on the tender joint count, swollen joint count, CRP (in mg/dl), and patient global assessment (0-10 scale) are all ≤1, or (2) when the score on the Simplified Disease Activity Index is ≤3.3.

CONCLUSION: We propose two new definitions of remission, both of which can be uniformly applied and widely used in RA clinical trials. The authors recommend that one of these be selected as an outcome measure in each trial and that the results on both be reported for each trial.

  新发现:若满足以下两条之一者,可定义为RA缓解,即①关节压痛计数、关节肿胀计数、C反应蛋白(CRP,mg/dl)、患者全身评估分(0~10)均≤1;②简化疾病活动度评分≤3.3。

  这个新定义为临床研究中判定RA缓解提供了标准,但该定义在真实的RA患者管理中的效果如何还有待进一步的验证研究。此外,为达到提高缓解率与治疗效价比及安全性问题间的平衡,哪些药物及治疗策略(如起始治疗时机等)适用于RA患者等问题亦有待更多研究去了解。

《柳叶刀》杂志:“2011这一年”精选

  一小步,大跨越

  5月,《柳叶刀》(Lancet)杂志刊发的1例病例报告显示,在无任何大脑神经传导支配的情况下,脊髓电刺激联合特定任务培训可使截瘫患者站立及协调步行数分钟。

  该23岁男性患者于2006年被摩托车撞致截瘫,尽管接受了2年的康复治疗但仍不能进行脊髓控制的运动。当在其低位脊髓硬膜外植入电极以给予连续直接电刺激、并产生类似大脑神经冲动传递的效果后,患者最终得以站立和步行。正如同期配发的述评所言,这项病例研究可谓“史无前例”。

Lancet. 2011 Jun 4;377(9781):1938-47.

Effect of epidural stimulation of the lumbosacral spinal cord on voluntary movement, standing, and assisted stepping after motor complete paraplegia: a case study.

Harkema S, Gerasimenko Y, Hodes J, Burdick J, Angeli C, Chen Y, Ferreira C, Willhite A, Rejc E, Grossman RG, Edgerton VR.

Department of Neurological Surgery, Kentucky Spinal Cord Research Center, University of Louisville, KY, USA.

BACKGROUND: Repeated periods of stimulation of the spinal cord and training increased the ability to control movement in animal models of spinal cord injury. We hypothesised that tonic epidural spinal cord stimulation can modulate spinal circuitry in human beings into a physiological state that enables sensory input from standing and stepping movements to serve as a source of neural control to undertake these tasks.

METHODS: A 23-year-old man who had paraplegia from a C7-T1 subluxation as a result of a motor vehicle accident in July 2006, presented with complete loss of clinically detectable voluntary motor function and partial preservation of sensation below the T1 cord segment. After 170 locomotor training sessions over 26 months, a 16-electrode array was surgically placed on the dura (L1-S1 cord segments) in December 2009, to allow for chronic electrical stimulation. Spinal cord stimulation was done during sessions that lasted up to 250 min. We did 29 experiments and tested several stimulation combinations and parameters with the aim of the patient achieving standing and stepping.

FINDINGS: Epidural stimulation enabled the man to achieve full weight-bearing standing with assistance provided only for balance for 4·25 min. The patient achieved this standing during stimulation using parameters identified as specific for standing while providing bilateral load-bearing proprioceptive input. We also noted locomotor-like patterns when stimulation parameters were optimised for stepping. Additionally, 7 months after implantation, the patient recovered supraspinal control of some leg movements, but only during epidural stimulation.

INTERPRETATION: Task-specific training with epidural stimulation might reactivate previously silent spared neural circuits or promote plasticity. These interventions could be a viable clinical approach for functional recovery after severe paralysis.

FUNDING: National Institutes of Health and Christopher and Dana Reeve Foundation.

  首个疟疾疫苗可使感染减半

  11月,《新英格兰医学杂志》发表了首个疟疾疫苗Ⅲ期临床试验中期报告,结果显示,该疫苗可使疟疾感染风险降低约50%。

  在此项纳入了15460名非洲儿童的研究中,被称为RTS,S/AS01的疟疾疫苗可使56%的5~17个月的儿童免于疟疾感染,并可预防47%的严重疟疾感染;但同时,脑膜炎和抽搐发作在接种了疫苗的儿童中更常见,且该疫苗也不能减少疟疾所致死亡病例。

  该疫苗对6~12周婴儿的作用效果将于明年发布,整个试验将于2014年完成。

N Engl J Med. 2011 Nov 17;365(20):1863-75.

First results of phase 3 trial of RTS,S/AS01 malaria vaccine in African children.

Agnandji ST, Lell B, Soulanoudjingar SS, Fernandes JF, Abossolo BP, Conzelmann C, Methogo BG, Doucka Y, Flamen A, Mordmüller B, Issifou S, Kremsner PG, Sacarlal J, Aide P, Lanaspa M, Aponte JJ, Nhamuave A, Quelhas D, Bassat Q, Mandjate S, Macete E, Alonso P, Abdulla S, Salim N, Juma O, Shomari M, Shubis K, Machera F, Hamad AS, Minja R, Mtoro A, Sykes A, Ahmed S, Urassa AM, Ali AM, Mwangoka G, Tanner M, Tinto H, D'Alessandro U, Sorgho H, Valea I, Tahita MC, Kaboré W, Ouédraogo S, Sandrine Y, Guiguemdé RT, Ouédraogo JB, Hamel MJ, Kariuki S, Odero C, Oneko M, Otieno K, Awino N, Omoto J, Williamson J, Muturi-Kioi V, Laserson KF, Slutsker L, Otieno W, Otieno L, Nekoye O, Gondi S, Otieno A, Ogutu B, Wasuna R, Owira V, Jones D, Onyango AA, Njuguna P, Chilengi R, Akoo P, Kerubo C, Gitaka J, Maingi C, Lang T, Olotu A, Tsofa B, Bejon P, Peshu N, Marsh K, Owusu-Agyei S, Asante KP, Osei-Kwakye K, Boahen O, Ayamba S, Kayan K, Owusu-Ofori R, Dosoo D, Asante I, Adjei G, Adjei G, Chandramohan D, Greenwood B, Lusingu J, Gesase S, Malabeja A, Abdul O, Kilavo H, Mahende C, Liheluka E, Lemnge M, Theander T, Drakeley C, Ansong D, Agbenyega T, Adjei S, Boateng HO, Rettig T, Bawa J, Sylverken J, Sambian D, Agyekum A, Owusu L, Martinson F, Hoffman I, Mvalo T, Kamthunzi P, Nkomo R, Msika A, Jumbe A, Chome N, Nyakuipa D, Chintedza J, Ballou WR, Bruls M, Cohen J, Guerra Y, Jongert E, Lapierre D, Leach A, Lievens M, Ofori-Anyinam O, Vekemans J, Carter T, Leboulleux D, Loucq C, Radford A, Savarese B, Schellenberg D, Sillman M, Vansadia P; RTS,S Clinical Trials Partnership.

Albert Schweitzer Hospital, Lambarene, Gabon.

BACKGROUND: An ongoing phase 3 study of the efficacy, safety, and immunogenicity of candidate malaria vaccine RTS,S/AS01 is being conducted in seven African countries.

METHODS: From March 2009 through January 2011, we enrolled 15,460 children in two age categories--6 to 12 weeks of age and 5 to 17 months of age--for vaccination with either RTS,S/AS01 or a non-malaria comparator vaccine. The primary end point of the analysis was vaccine efficacy against clinical malaria during the 12 months after vaccination in the first 6000 children 5 to 17 months of age at enrollment who received all three doses of vaccine according to protocol. After 250 children had an episode of severe malaria, we evaluated vaccine efficacy against severe malaria in both age categories.

RESULTS: In the 14 months after the first dose of vaccine, the incidence of first episodes of clinical malaria in the first 6000 children in the older age category was 0.32 episodes per person-year in the RTS,S/AS01 group and 0.55 episodes per person-year in the control group, for an efficacy of 50.4% (95% confidence interval [CI], 45.8 to 54.6) in the intention-to-treat population and 55.8% (97.5% CI, 50.6 to 60.4) in the per-protocol population. Vaccine efficacy against severe malaria was 45.1% (95% CI, 23.8 to 60.5) in the intention-to-treat population and 47.3% (95% CI, 22.4 to 64.2) in the per-protocol population. Vaccine efficacy against severe malaria in the combined age categories was 34.8% (95% CI, 16.2 to 49.2) in the per-protocol population during an average follow-up of 11 months. Serious adverse events occurred with a similar frequency in the two study groups. Among children in the older age category, the rate of generalized convulsive seizures after RTS,S/AS01 vaccination was 1.04 per 1000 doses (95% CI, 0.62 to 1.64).

CONCLUSIONS: The RTS,S/AS01 vaccine provided protection against both clinical and severe malaria in African children. (Funded by GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative; RTS,S ClinicalTrials.gov number, NCT00866619 .).

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