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prucalopride (Resolor°) and chronic constipation in men: Avoid in both men and women. 普芦卡必利(Resolor°)与男性慢性便秘:男性和女性均避免。
Q4 Medicine Pub Date : 2016-10-01

In a placebo-controlled trial in 374 men, prucalopride was only effective in a minority of cases, as previously observed in women. In addition to its cardiovascular harms, there is evidence that prucalopride may cause depression and suicidal ideation.

在374名男性的安慰剂对照试验中,普鲁卡必利仅在少数病例中有效,正如之前在女性中观察到的那样。除了对心血管的危害,有证据表明普卡必利可能导致抑郁和自杀意念。
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引用次数: 0
Quinine, cramps and heart failure: deaths. Quinine has an unfavourable harm-benefit balance in the treatment of cramps. 奎宁,痉挛和心力衰竭:死亡。奎宁在治疗抽筋方面有不利的利弊平衡。
Q4 Medicine Pub Date : 2016-10-01
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引用次数: 0
ruxolitinib (JAKAVI°) and polycythaemia vera Inconclusive evaluation. ruxolitinib (JAKAVI°)和真性红细胞增多症尚无定论。
Q4 Medicine Pub Date : 2016-10-01

Patients with polycythaemia vera, a myeloproliferative syndrome, are at increased risk of thrombotic events. Marrow fibrosis and transformation to acute leukaemia can also occur after several years. Treatment is based on phlebotomy and aspirin at low (antiplatelet) doses, sometimes combined with hydroxycarbamide, a cytotoxic drug. Various other drugs are available if hydroxycarbamide fails or is poorly tolerated, but there is no consensus treatment. Ruxolitinib inhibits Janus tyrosine kinases, which are involved, among other roles, in haematopoiesis. Ruxolitinib has been authorised in the European Union for patients with polycythaemia vera in whom hydroxycarbamide has failed or is poorly tolerated. Clinical evaluation of ruxolitinib in this setting is based on a randomised, unblinded trial versus treatment chosen by the investigators, in 222 patients treated for 32 weeks. Hydroxycarbamide was chosen in 59% of cases, even though the patients had unacceptable adverse effects or an inadequate response to the drug. The efficacy of the investigators' other treatment choices was uncertain. Phlebotomy was less frequent in the ruxofitinib group than in the control group. The adverse effects of ruxotitinib in this situation are poorly documented, due to inadequate long-term assessment. In the short term, ruxolitinib causes anaemia and thrombocytopenia, as well as bleeding, potentially severe infections, headache, sensory disturbances, and weight gain. It is also likely to share the serious adverse effects of other immunosuppressants. Ruxolitinib is mainly metabolised by cytochrome P450 isoenzymes CYP3A4 and CYP2C9, creating a risk of multiple drug interactions. Ruxolitinib showed embryofetal toxicity in animal studies. Virtually no data are available in pregnant women. In practice, available data on the harm-benefit balance of ruxolitinib fail to show that this drug represents a tangible advance for patients with polycythaemia vera, as compared with other drugs used when hydroxycarbamide is unsuitable.

真性红细胞增多症(一种骨髓增生性综合征)患者发生血栓事件的风险增加。骨髓纤维化和转化为急性白血病也可在几年后发生。治疗是基于静脉切开术和低剂量(抗血小板)阿司匹林,有时联合羟基脲,一种细胞毒性药物。如果羟脲治疗失败或耐受性差,可使用其他多种药物,但目前尚无一致的治疗方法。Ruxolitinib抑制Janus酪氨酸激酶,在其他作用中,参与造血。Ruxolitinib已在欧盟被批准用于羟脲治疗失败或耐受性差的真性红细胞增多症患者。在这种情况下,ruxolitinib的临床评估是基于一项随机、非盲试验,与研究者选择的治疗方法相比,222名患者接受了32周的治疗。59%的病例选择羟基脲,即使患者有不可接受的不良反应或对药物的反应不足。研究者选择的其他治疗方法是否有效还不确定。鲁索非替尼组的放血频率低于对照组。由于长期评估不充分,在这种情况下,鲁索替尼的不良反应记录很少。在短期内,ruxolitinib引起贫血和血小板减少症,以及出血、潜在的严重感染、头痛、感觉障碍和体重增加。它也可能有其他免疫抑制剂的严重副作用。Ruxolitinib主要由细胞色素P450同工酶CYP3A4和CYP2C9代谢,产生多种药物相互作用的风险。Ruxolitinib在动物实验中显示胚胎毒性。实际上没有关于孕妇的数据。在实践中,关于ruxolitinib的利弊平衡的现有数据未能表明,与其他药物相比,该药物对真性红细胞增多症患者具有切实的进展,当羟基脲不适合时使用。
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引用次数: 0
Finasteride 1 mg in alopecia: sexual dysfunction, suicidal ideation. Providing balanced information to male patients is key. 非那雄胺1毫克治疗脱发:性功能障碍、自杀意念。向男性患者提供平衡的信息是关键。
Q4 Medicine Pub Date : 2016-10-01
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引用次数: 0
MedDRA and pharmacovigilance: a complex and little-evaluated tool. MedDRA和药物警戒:一个复杂的和很少评估的工具。
Q4 Medicine Pub Date : 2016-10-01

MedDRA (Medical Dictionary tor Regulatory Activities) is a standardised medical terminology, published by the International Council for Harmonisation, used in particular for coding cases of adverse effects in clinical study reports and pharmacovigilance databases, and to facilitate searches in these databases. MedDRA has a 5-level, hierarchical structure. Some levels are used to code adverse effects, and the others are designed to group together related terms for database searches. The links between these terms are hierarchical and complex. In addition to searches for terms, broad or narrow searches of MedDRA-coded databases can be performed using predefined "standardised Med-DRA queries", of which about a hundred are available in early 2016. A French study on 4 adverse effects recorded in France's national pharma- covigilance database showed that the effectiveness of MedDRA and stan- dardised MedDRA queries is highly variable, depending on the adverse effect examined. In some cases, less than half of the cases retrieved were relevant. A study on the adverse effects most frequently reported in clinical trials of 10 randomly selected drugs showed that a given adverse effect could be described using between 4 and several hundred different codes. One risk of fragmenting the reporting of adverse effects across multiple terms is that their true frequency will be underestimated. The development of a harmonised international terminology is a worth-while endeavour. But the complexity of MedDRA and its poorly evaluated performance make it susceptible to manipulation, errors of interpretation and bias. This applies in particular to the adverse effect statistics in the clinical study reports of clinical trials. The evaluation of the effectiveness of MedDRA as a tool for identifying and quantifying the adverse effects of new drugs must continue. For healthcare professionals, the limitations of MedDRA are one more reason to recognise that the known adverse effects of drugs, and their quantification, tend to be underestimated.

MedDRA(监管活动医学词典)是一个标准化的医学术语,由国际协调理事会出版,主要用于临床研究报告和药物警戒数据库中的不良反应病例编码,并便于在这些数据库中进行检索。MedDRA有5个层次结构。一些级别用于编码不利影响,其他级别用于将相关术语组合在一起,以便进行数据库搜索。这些术语之间的联系是分层的、复杂的。除了搜索术语外,还可以使用预定义的“标准化Med-DRA查询”对meddra编码数据库进行广泛或狭窄的搜索,其中大约有100个在2016年初可用。一项法国研究记录在法国国家医药共同警戒数据库的4种不良反应表明,MedDRA和标准化MedDRA查询的有效性是高度可变的,取决于所检查的不良反应。在某些情况下,检索到的案件中只有不到一半是相关的。一项对随机选择的10种药物的临床试验中最常报告的副作用的研究表明,一种给定的副作用可以用4到几百种不同的代码来描述。将不良反应的报告分散到多个术语的一个风险是,它们的真实频率将被低估。制定统一的国际术语是一项值得努力的工作。但是,MedDRA的复杂性及其评估不佳的表现使其容易受到操纵、解释错误和偏见的影响。这尤其适用于临床试验的临床研究报告中的不良反应统计。必须继续评估MedDRA作为识别和量化新药不良反应的工具的有效性。对于医疗保健专业人员来说,MedDRA的局限性是认识到药物的已知副作用及其量化往往被低估的又一个理由。
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引用次数: 0
bevacizumab (Avastin°) in persistent, recurrent or metastatic cervical cancer: Prolongs survival by a few months, but highly toxic. 贝伐单抗(阿瓦斯汀°)用于持续性、复发性或转移性宫颈癌:延长生存数月,但剧毒。
Q4 Medicine Pub Date : 2016-10-01

In an unblinded trial in 452 patients with persistent, recurrent or metastatic cervical cancer, adding bevacizumab to other cytotoxic drugs prolonged median survival by 4 months, but adverse effects were often severe and sometimes fatal. Tailored symptomatic care is also a valid option.

在一项针对452例持续性、复发性或转移性宫颈癌患者的非盲法试验中,贝伐单抗与其他细胞毒性药物联合使用可延长中位生存期4个月,但副作用往往很严重,有时甚至致命。量身定制的对症治疗也是一种有效的选择。
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引用次数: 0
intravenous cangrelor (Kengrexal°) and coronary angioplasty: No advantage over first-line clopidogrel. 静脉注射康格瑞洛和冠状动脉成形术:与一线氯吡格雷相比没有优势。
Q4 Medicine Pub Date : 2016-10-01

In three comparative trials in a total of about 25,000 patients requiring coronary angioplasty, IV cangrelor was not more effective in reducing mortality than oral clopidogrel, and it only improved cardiovascular morbidity in a biased trial. Cangrelor can provoke bleeding, kidney failure and dyspnea.

在三项比较试验中,总共约25,000名需要冠状动脉血管成形术的患者,静脉注射氯吡格雷在降低死亡率方面并不比口服氯吡格雷更有效,在一项有偏倚的试验中,它只改善了心血管发病率。angrelor可引起出血、肾衰竭和呼吸困难。
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引用次数: 0
Exercise useful for elderly women. 锻炼对老年妇女有益。
Q4 Medicine Pub Date : 2016-10-01

In a randomized trial in elderly women living at home who had fallen during the previous year, regular exercise reduced the incidence of falls resulting in injury. Routine vitamin D supplementation did not.

在一项随机试验中,住在家里的老年妇女在过去的一年中摔倒了,有规律的运动减少了摔倒导致受伤的发生率。常规补充维生素D则没有。
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引用次数: 0
Idelalisib: deaths from infections. Toxicity and doubtful efficacy. Idelalisib:感染致死。毒性和可疑的功效。
Q4 Medicine Pub Date : 2016-10-01
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引用次数: 0
Advances too rarely implemented. 进步很少得到落实。
Q4 Medicine Pub Date : 2016-10-01
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引用次数: 0
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