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【求助】心内科文献翻译(40叮当，截止周五晚24点)

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这个帖子发布于8年零176天前，其中的信息可能已发生改变或有所发展。

问题已关闭悬赏丁当:40

因时间紧迫，请求战友协助翻译，奖励40个叮当，截止时间为8月3日(周五)晚24点。
All Comers trial.pdf翻译Discussion部分，在P1244-1246，包括相关表格。
Myocardial infarction adjudication.pdf不需要翻译
翻译质量较好者可以追加10个叮当。

pdf原文下载见
http://www.dxy.cn/bbs/topic/23556613

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Unrestricted randomized use of two new generation drug-eluting coronary stents: 2-year patient-related versus stent-related outcomes from the RESOLUTE All Comers trial两种新一代药物洗脱冠脉支架简单随机对照研究——随访2年的患者相关与支架相关性的RESOLUTE全体受试者研究

Summary

Background In the RESOLUTE All Comers trial, the Resolute zotarolimus-eluting stent was non-inferior to the Xience V everolimus-eluting stent for the primary stent-related endpoint of target lesion failure (cardiac death, target vessel myocardial infarction, and ischaemia-driven target lesion revascularisation) at 1 year. However, data for long-term safety and efficacy from randomised studies of new generation drug-eluting coronary stents in patients treated in routine clinical practice are scarce. We report the prespecified 2-year clinical outcomes from the RESOLUTE All Comers trial.

背景：在RESOLUTE全体受试者研究中，佐他莫司洗脱支架(Resolute)与依维莫司洗脱支架（Xience V）在一年靶病变终点事件（心源性死亡、靶血管所致心肌梗死、缺血导致的靶病变血管血运重建）上表现相同，差异均在预设的非劣性范围之内。然而，新一代药物洗脱冠脉支架长期使用的安全性和有效性数据还比较匮乏。我们预先报告随访2年的RESOLUTE全体受试者研究结果。

Methods In 2008, patients with at least one coronary lesion 2·25–4·0 mm in diameter, with greater than 50% stenosis, were randomly assigned to a Resolute zotarolimus-eluting stent or a Xience V everolimus-eluting stent at 17 centres in Europe and Israel. Randomisation was by an interactive voice response system stratified by centre. Study investigators were not masked to treatment allocation; but those who did data management and analysis, and patients were masked. There were no restrictions as to the number of vessels or lesions treated, or the number of stents implanted. We assessed prespecified safety and efficacy outcomes at 2 years with specific focus on patient-related composite (all death, all myocardial infarction, all revascularisation) and stent-related composite outcomes. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00617084.

方法：2008年，在欧洲和以色列的17个医疗中心纳入至少有一处冠状动脉病变直径大于2.25-4.0毫米且狭窄率大于50％的患者，患者被随机分配到佐他莫司洗脱支架或依维莫司洗脱支架。按各中心的交互式语音应答系统将患者随机分配。分组情况对患者和数据分析人员设盲，但未对负责治疗的医生设盲。不限制置入支架的病变或血管数目。我们评估2年的安全性和有效性，侧重于患者相关的复合终点事件（全因死亡率，全因心肌梗死率，全因血运重建率），兼顾支架相关的复合终点事件。采用意向治疗分析。本研究在ClinicalTrials.gov上已注册，注册号为NCT00617084。

Findings 1140 patients were assigned to the zotarolimus-eluting stent and 1152 to the everolimus-eluting stent; 1121 and 1128 patients, respectively, completed 2-year follow-up. The patient-related outcome (231 [20·6%] zotarolimus vs 231 [20·5%] everolimus; diff erence 0·1%, 95%可信区间 –3·2 to 3·5; p=0·958) and stent-related outcome (126 [11·2%] vs 121 [10·7%]; difference 0·5%, –2·1 to 3·1; p=0·736) did not differ between groups, although rates of the stent-related outcome were substantially lower than were those for the patient-related outcome. Three patients in each group (0·3%) had very late (after 1 year) stent thrombosis.

结果：1,140名病患被分配到佐他莫司洗脱支架组，1152名病患被分配到依维莫司洗脱支架组。两组分别有1121例和1128例完成2年的随访。病人相关事件发生率比较（佐他莫司组231 (20.6％)，依维莫司组231 (20.5％)，相差0.1％，95%可信区间-3.2到3.5，P=0.958）；支架相关事件发生率比较（佐他莫司组126(11.2％)，依维莫司组121 (10.7％]，相差0.5％，95%可信区间-2.1至3.1，P=0.736）。虽然支架相关事件发生率比病人相关事件发生率明显减低，但两组之间没有差异。两组各有3例患者（0.3％）有极晚期支架内血栓形成（超过1年）。

Interpretation Similar safety and efficacy outcomes were sustained between two new generation drug-eluting stents at 2-year follow-up. The greater number of patient-related than stent-related events in patients with complex clinical and lesion characteristics emphasises that during long-term follow-up, the optimisation of secondary prevention is at least as important as the selection of which new generation drug-eluting stent to implant in a specific lesion.

解释：两个新一代药物洗脱支架随访2年，其安全性和有效性类似。长期随访发现，具有复杂临床及靶血管特征的患者，其患者相关事件率高于支架相关事件率，说明二级预防的优化重要性，不亚于在具体病变选择何种新一代药物洗脱支架。

Results

2292 patients were enrolled and randomly assigned to treatment with the zotarolimus-eluting stent (n=1140) or the everolimus-eluting stent (n=1152). 1121 (98·3%) of zotarolimus patients and 1128 (97·9%) of everolimus patients completed follow-up at 2 years (figure 1). Table 1 summarises the baseline demographics and the clinical and angiographic characteristics of all patients.

2292例患者被随机分配到佐他莫司洗脱支架组（1140）或依维莫司洗脱支架组（1152）。1121例（98·3％）佐他莫司洗脱支架组及1128例（97·9％）佐他莫司的患者完成了2年随访（图1）。表1总结了研究人群基线值统计和所有患者的临床和血管造影的特点。

At 2 years, a patient-related outcome occurred in 231 patients in each group (table 2); the number of stent-related outcomes events was substantially lower, but did not differ between groups (table 2). Kaplan-Meier analyses showed no differences between the two groups in the incidence of patient-related or stent-related endpoints (figure 2). Furthermore, we noted no differences between the two stent groups for any major clinical event (table 2).

随访2年，两组均有231例病人出现患者相关事件（表2）；支架相关事件发生率明显较低，但两组之间没有差别（表2）。 Kaplan-Meier生存分析显示，在有关病人或支架相关的终点事件的发生率两组之间无显着差异（图2）。此外，我们注意到两组之间的重大临床事件发生率没有差异（表2）。

1520 of 2292 (66.3%) patients were classified as complex (table 1). At 2 years, the zotarolimus and everolimus patient groups had similar outcomes irrespective of complexity. For the complex group, a patient-related outcome occurred in 162 of 752 (21·5%) patients in the zotarolimus group versus 166 of 738 (22·5%) in the everolimus group (difference –1·0%, 95%CI –5·2 to 3·3; p=0·662) and stent-related outcomes in 91 of 752 (12·1%) versus 93 of 738 (12·6%) patients (difference –0·5, –3·8 to 2·8; p=0·813). For the simple group (patients not meeting complex criteria), patient-related outcomes occurred in 69 of 369 (18·7%) patients in the zotarolimus group versus 65 of 390 (16·7%) in the everolimus group (difference 2·0%, –3·4 to 7·4%; p=0·505) and stent-related outcomes in 35 of 369 (9·5%) versus 28 of 390 (7·2%) patients (difference 2·3%, –1·6 to 6·2; p=0·293).

2292例入选者中，有1520（66.3％）例患者存在复杂病变（表1）。随访2年，佐他莫司??和依维莫司的患者群临床事件结果类似，和病变复杂性无关。对于复杂病变人群，752例佐他莫司组患者有162（21·5％）例出现患者相关事件； 738例依维莫司组患者有166（22.5％）例出现患者相关事件（差异-1.0％，95％可信区间为-5.2至3.3，P = 0.662）。两组的支架相关事件发生率分别为91/752（12.1％）与93/738（12.6％）（差异-0.5，95％可信区间为- 3.8至2 8，P = 0.813）。对于不存在复杂病变的患者，369例佐他莫司组患者有69（18.7％）例出现患者相关事件；390例依维莫司组患者有65（16.7％）例出现患者相关事件（差异2.0％，95％可信区间为-3.4至7.4，P = 0.662）。两组的支架相关事件发生率分别为35/369（9.5％）与28/390（7.2％）（差异2.3%，95％可信区间为1.6至6.2，P = 0.293）。

At 1 year, 933 of 1110 (84·1%) patients in the zotarolimus group and 929 of 1108 (83·8%) in the everolimus group were taking dual antiplatelet therapy (p=0·908). After 2 years, 201 of 1080 (18·6%) zotarolimus patients and 195 of 1076 (18·1%) everolimus patients were still on dual antiplatelet therapy (p=0·781). Three patients in each group (0·3% for both) had an ARC definite or probable stent thrombosis event during the second year (ie, very late stent thrombosis), with no associated mortality (table 3, figure 3).

随访1年，1110例佐他莫司组患者有933例(84.1％)服用双联抗血小板聚集治疗；而1108例依维莫司组患者有929例（83.8％）服用双联抗血小板聚集治疗（P = 0.908）。随访2年，1080例佐他莫司组患者有201例(18.6％)服用双联抗血小板聚集治疗；而1076例依维莫司组患者有195例（18.1％）服用双联抗血小板聚集治疗（P = 0.781）。在第二年，各组患者均出现3例（0.3％）ARC定义的或可能的支架血栓事件（即极晚期支架血栓形成），没有相关的死亡率（表3，图3）。

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2012-08-02 20:56 浏览 : 3563 回复 : 4

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linerzhiqiu 编辑于 2012-08-03 07:05

• 首套【肺石医生】表情上架啦，一起斗图吧！

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认领本文翻译，48小时内未完成，请其他战友认领！

2012-08-03 09:08

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• 某明星疑似「代孕」想听听老师们对代孕的看法

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Discussion

The RESOLUTE All Comers trial compared two newgeneration drug-eluting stents: the Resolute zotarolimus-elutingand the Xience V everolimus-eluting stents. Thesafety and efficacy of these two drug-eluting stents areclinically equivalent, even after 2 years in a mostlycomplex population. Our results accord with two posthocanalyses11,12 showing similar clinical outcomesbetween the two stents irrespective of complexity.Between year 1 and 2, six patients (three in each group)had an ARC definite or probable stent thrombosis,representing a very late stent thrombosis rate of 0?3% foreach stent group (fi gure 3, tables 2 and 3).

讨论

在RESOLUTE全体受试者研究中，比较了两种新一代药物洗脱支架：佐他莫司洗脱支架(Resolute)与依维莫司洗脱支架（Xience V）。即使是在2年后大部分复杂的人群样本里，这两种药物洗脱支架的安全性和有效性在临床上是等效的。我们的结果与以前的两个posthoc分析一致^11,12，表现出类似的临床结果，即两组支架之间不相关的复杂性。在第一年和第二年之间，6例(每组3例)有确诊的ARC或可能的支架血栓形成，每个支架组存在迟发血栓形成率为0.3%(图3,表2和3)。

The multicentre LEADERS trial^13,14showed that over3 years there isan increasing divergence in outcomesbetween earlygeneration and new generation drugelutingstents, in favourof the new stent. The samefinding wasdetected in the single-centre COMPAREtrial¹⁵thatalso compared a new generation drug-elutingstent with an early generation drug-eluting stent. Thus,LEADERS, COMPARE, and now the RESOLUTE AllComers trials suggest that new generation drug-elutingstents help to improve clinically important outcomes,especially in complex patient and lesion subsets(panel).¹³^–¹⁶ Our results arenot comparable with the SORTOUT III study,¹⁷which compared an earlier generationzotarolimus-elutingstent (Endeavor, Medtronic) with an early generation sirolimus-eluting stent,although as inour study thepatient population was unrestricted. TheResolutezotarolimus-eluting stent is similar to itspredecessor (Endeavor), but the drug release is sustainedover a longer period (180 days vs 14 days).^18,19

多中心LEADERS试验^13,14显示：超过3年后较早的洗脱支架和新一代药物洗脱支架之间在临床结果上存在着日益增加的差异，并且有利于新一代药物洗脱支架。同样的结果在也是比较新一代药物洗脱支架和较早一代洗脱支架的一个单中心COMPARE试验¹⁵中被发现。因此LEADERS, COMPARE, 和如今的RESOLUTE全体受试者研究提示：新一代药物洗脱支架有助于提高临床上重要预后，尤其是复杂患者和损伤的子群体。¹³^–¹⁶尽管在我们研究中患者群体不被限制，但是我们的结果没有和SORTOUT III期研究进行比较，¹⁷该研究比较了更早一代的佐他莫司洗脱支架(Endeavor, Medtronic)和较早一代的西罗莫司洗脱支架。虽然Resolute佐他莫司洗脱支架与它的前身(Endeavor)类似，但是其药物释放却能维持更长时间（180天vs14 天）。^18,19

Composite endpoints incardiovascular trials include awiderange of events, from patient-related death fromany cause to so-called pure stent-relatedevents, such as

stent thrombosis.Comparison of composite endpointscan be difficultbecause of the lack of consensusdefinitions, andoverlap between composite endpointcomponents. Thedifference between the patient-relatedand stent-relatedoutcomes from the RESOLUTE AllComers trialincluded any non-cardiac death, anymyocardialinfarction not related to the target vessel, andany revascularisations not related to the target vessel.The differences between stent-related and patient-relatedevents can be regarded as more indicative of the patients’underlying globaldisease,²⁰ rather than related to thespecific localised coronary obstruction treated with thestudy stents. One example of the differences betweenpatient-related and stent-related outcomes is shown byanalysis of the mortality rates from our study: of 16noncardiovasculardeaths, 13 weredue to various carcinomas(three inzotarolimus group; ten in everolimus group),contributing to a substantial difference between patientrelatedand stent-related outcomes (table 2, figure 2). Anydeath of unknown cause was by default classified as acardiac death, even if it was a non-cardiac death.

心血管试验中的复合终点包括一些广泛地事件，从源自任何原因的患者相关死亡事件到所谓纯支架相关的事件，如支架内血栓形成。比较这些复合终点是非常困难的，因为缺乏共识和这些复合终点组件间重叠。RESOLUTE全体受试者试验中患者相关的和支架相关的结果之间的差异包括非心脏病死亡，不与目标血管相关的心肌梗死和血管重建。支架相关的和患者相关的事件之间的差异被认为是更多说明患者存在潜在的全身疾病，²⁰而不是与采用研究支架治疗的具体定位的冠状动脉阻塞相关。举例分析患者相关的和支架相关的结果之间的差异，通过分析我们研究中的死亡率发现， 16例非心脏病死亡患者中， 13例是由于各种肿瘤死亡（他莫司组3例；依维莫司组10例），有助于了解患者相关的和支架相关的结果之间的实质性差异(表 2, 图 2)。任何死亡原因不明的被错误的归类为心脏死亡，即使这是一种进行非心脏死亡事件。

We recorded a substantial and surprisinglyhighnumericaldifference between patient-related and stent-relatedoutcomes, with anapproximate doubling of eventrates forpatient-related outcomes (table 2, fi gure 2). Thisfinding emphasises the importance of stent-independentcomorbidities in consideration of the prognosis of

patients indicatedfor percutaneous coronary interventionwith stenting,because these comorbidities exacerbatethe underlyinglesion-related coronary artery disease over

time. Drug-elutingstents are able to perform the functionfor which they aredesigned; however, the patient’sunderlying diseaseaff ects long-term outcomes to agreater extentthan does the need for repeatrevascularisationor stent thrombosis of the initiallytreated lesion(figure 2). Thus, optimisation of secondaryprevention and overall medical management duringlong-term follow-up seems to be more important thanthe initial choice between advanced, new generationdrug-eluting stents. However, we should note that anycomparisons between the stent-related and patient-relatedoutcomes arehypothesis generating and were notprespecified. Ourfinding could be attributable to thepathophysiology ofcoronary artery disease, such thatabout half of thecoronary events are attributable to socallednon-culprit lesions.²¹

我们记录了患者相关的和支架相关的结果之间的大量的和令人惊讶的高数值的差异：患者相关的结果的事件率接近两倍（表2，图2）。这个发现强调了在考虑经皮冠状动脉介入支架治疗患者的预后时支架非依赖并存病的重要性，因为这些并存病最终会使潜在的损伤相关的冠状动脉疾病恶化。药物洗脱支架能够执行其被设计时的功能，但是比起重复的血流重建或起始治疗损伤的支架血栓形成，患者潜在的疾病会在更大程度上影响长期结果（图2）。因此，比最初的选择先进的新一代药物洗脱支架，优化的二级预防和整体医疗管理在长期随访中似乎更重要。然而，我们应该注意，任何比较支架相关的和患者相关的结果与假设产生和没有预先指明的。我们的发现可以归因于冠状动脉疾病病理生理学，这样，大约半数的冠状动脉事件都归因于所谓非祸首病变。²¹

Although drug-eluting stents do not generally increasemortality,22 valid concerns about early (less than 30days),late (31 days to 1year), and very late (after 1 year) stent thrombosis persist. In our study, twopatients (one in eachgroup) with verylate stent thrombosis were still on dualantiplatelettherapy (table 3). Overall, 18% of our patientswere still on dual antiplatelet therapy after 2 years,comparedwith 13% fromCOMPARE16 and 23% from LEADERStrials.14 Althoughthe rate of very late stent thrombosis of0.3% recorded in our study is lower than the 0.6% per yeardescribed forearly generation drug-eluting stents,23 eachvery late stent thrombosis is a crucial event withpotentiallyhigh mortality.24 In our study, none of the six patientswithvery late stentthrombosis events died (table 3). We did notrecord any differences at 2 years between the two stentgroups for any myocardial infarction or cardiac death

(table 2). Despite the abundance of evidence supportingdrug-eluting stents, whether prolonged dual antiplateletuse (beyond 12 months) can reduce the likelihood of very

late stentthrombosis is unclear.25

虽然药物洗脱支架通常不会增加死亡率,²²有效关注早期(小于30天),晚期(31天-1年)和极晚期(1年)的支架，发现血栓形成持续存在。在我们的研究中,两个病人(每组各一个) 在我们双重抗血小板治疗下仍有极晚期支架血栓形成(表3)。总体而言，双重抗血小板治疗后2年18%患者仍有极晚期支架血栓形成，相比之下,COMPARE试验中有13%¹⁶和LEADERS试验中有23%。¹⁴尽管在我们记录中极晚期支架血栓形成率为0.3%，低于早期药物洗脱支架每年0.6%,²³每个极晚期支架血栓形成是与潜在的高死亡率相关的一个至关重要的事件。²⁴在我们的研究中,所有6例有极晚期支架血栓形成事件病人没有死亡(表3)。我们没有记录到两年时间里关于两个支架组之间的心肌梗死或心源性死亡的任何差异(表2)。尽管有大量的证据支持药物洗脱支架，但是是否长时间的使用双重抗血小板治疗(12个月以上)可以减少极晚期支架血栓形成的可能性尚不清楚。²⁵

Our analysis was limited to 2 years. This study’spowered primary endpoint of stent-related target lesionfailure outcome was at 1 year; however, the prespecified

secondary endpoints included yearly reporting up to5 years of all clinical outcomes, with each eventadjudicatedby the independentClinical Events Committee. Since

results of safety and effi cacy of randomised trials canchange substantially during long-term follow-up,^14,16,26randomised trials of drug-eluting stents should report

long-termfollow-up results up to 5 years.27

我们的分析仅限于2年。这个研究关于支架相关靶病变失败结果有力的主要终点是在1年；然而，预先指定的次要终点包括了长达5年临床结果的年度报告，每个事件由独立临床事件委员会裁决的。因为随机试验的安全性和有效性结果在长期随访中可以大幅度变动,^14,16,26药物洗脱支架的随机试验应报告多达5年长期随访结果。²⁷

An ideal study should include all patients presenting forpercutaneous coronary intervention at the investigationalsites; yet in our study, a mean of 44% of patients treated atthe 17 centres were enrolled. This finding is consistentwith enrolment percentages from the LEADERS study of46%. There are many reasons why studies includingunrestricted patient populations do not include allconsecutive patients: many patients seen in routinepractice are often too ill to be able to provide consent,areunable to fullycomprehend the protocol within the giventime, or refuse toparticipate. Furthermore, our patientgroup was probablynot highly complex, as represented bya mean SYNTAXscore of 15 compared with a mean scoreof 26 in the SYNTAX trial;28 however, ourpatients weresimilar to thosestudied in the LEADERS study with amean score of 14.29

一个理想的研究应该包括在观察地点经皮冠状动脉介入治疗的所有患者,但在我们的研究中,在17个中心经治疗的病人只有平均44%的登记。这个发现和LEADERS 试验中46%登记百分比是一致的。研究中包含无限制的患者群体没有包含所有连续患者有许多原因：许多患者出现在例行检查中往往太过虚弱，以至于不赞成，或者在给定的时间里不能够充分理解理解协议，或拒绝参与。此外,我们的患者群体可能不是非常复杂，与在SYNTAX试验中平均分数为26相比，表现在SYNTAX平均分为15；²⁸然而，我们的患者与LEADERS研究中平均评分14相类似。²⁹

Randomised trials are powered for their primaryendpoints. Rare events such as very late stent thrombosisor death are clinically important events, yet to powerstudies for such rare events the number of patientsneeded to show even non-inferiority is unrealistic.Although the p value might be regarded as significant,the reported differences might still be a chance findingbecause of insufficient power. The difference in therates of definite and probable stent thrombosis between thetwo stents at 1 year (zotarolimus 1.6%; everolimus 0.7%)was unchanged at 2 years (table 2, fi gure 3). Similarly,anydifferences in therate of any death in year 1 (zotarolimus1.6%; everolimus 2.8%) were balancedin year 2 (table 2).The cumulativeincidence of the combined two rareevents of definite and probable stent thrombosis and anydeath was 4?8% for thezotarolimus-eluting stent and4?6% for theeverolimus-eluting stent (table 2, fi gure 3).

对于初始终点来说，随机试验是有力的。罕见的事件如极晚期支架血栓形成或死亡是临床上重要的事件，尚没有有力研究对于如此罕见的事件这样大量患者需要显示相等的非劣效性是不现实的。尽管p值可能被看作是显著性差异, 因为不充分的数据报道的差异性也许仍然是一个偶然的发现。在确定的和可能的两个支架组之间1年期支架血栓形成率 (佐他莫司 1.6%;依维莫司 0.7%)的差异在2年期保持不变 (表2,图3)。同样地,在1年期死亡率的差异(佐他莫司1.6%;依维莫司2.8%)和2年期的是平衡的 (表2)。关于确定的和可能的支架血栓形成和死亡的联合两个罕见的事件累积发生率在佐他莫司洗脱支架4.8%和依维莫司洗脱支架4.6% (表2,图3)。

Another limitationof this study was that we did notcollect data for cardiovascular drugs, such as statinuse,apart from dual antiplatelettherapy after the first year offollow-up; therefore we are not able to draw anyassociations between this important aspect of cardiacmedical management and patient-related outcome.Therefore,more intense secondary prevention andoverall medical management are at least as importantas the device; and only stent-oriented pharmacologicaltherapy might be insufficient for these complex patients.

本研究的另一个限制是，除了收集了随访的第1年双重抗血小板治疗数据，我们没能收集心血管药物如使用他汀类药物数据；因此，我们仍无法对这项重要的心脏医学管理这一重要方面和患者相关的结果间做出关联的分析。因此，更加强烈的二级预防和整体医疗管理可能至少要和处理同样重要；并且仅仅支架导向的药物治疗可能不能满足这些复杂的病人的需要。

2012-08-03 12:55

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• 科技部通报李红良、饶毅教授、曹雪涛院士等有关论文涉嫌造假处理情况

arsense

铁杆站友

4楼

呵呵，太长了，就看了最后一句
Another limitationof this study
本研究的另一个限制是
limitation翻译成“不足”是不是更合适些？

2012-08-03 13:06

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• 回应：饶毅发文称“正式举报裴钢为通讯作者的文章涉嫌学术不端”

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