Ezetimibe-associated myopathy in monotherapy and in combination with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor

Two cases of myopathy associated with ezetimibe are reported. In the first case, a woman on ezetimibe monotherapy presented with muscle pain and an elevated concentration of creatine kinase (CK) on two occasions, with ezetimibe 10 mg and with ezetimibe 5 mg after a washout period. The recurrence of muscle pain after washout and the CK increase both supported the hypothesis that ezetimibe alone can be linked to myalgia. In the second case, a man had been treated with atorvastatin, and ezetimibe 10 mg was added to improve his lipid profile. Two months later, the patient complained of muscle pain and a CK increase was noted. The appearance of symptoms when adding ezetimibe to atorvastatin supports a potential pharmacokinetic and/or a pharmacodynamic interaction between these two drugs. These cases suggest that ezetimibe monotherapy as well as ezetimibe associated with the use of a statin may induce myalgia. The mechanism by which ezetimibe could cause muscle pain is not known.     

Documento de expertos del uso de broncodilatadores inhalados en monoterapia en el tratamiento de la EPOC estable leve-moderada

Objective

To describe the evidence- and experience-based expert consensus on the use of single-agent bronchodilators in patients with stable mild-moderate chronic obstructive pulmonary disease (COPD).

拉莫三嗪单药治疗儿童癫癎的系统评价

目的 系统评价拉莫三嗪单药治疗儿童癫癎的有效性和安全性。方法 计算机检索PubMed、Cochrane 图书馆、CNKI、VIP、CBM、万方等中英文数据库,获得拉莫三嗪单药治疗儿童癫癎的随机对照试验。应用Cochrane 协作网推荐的方法进行文献筛选,资料提取和文献质量评估,采用RevMan 5.2软件进行Meta分析。结果 共纳入9个RCTs （1016例）。拉莫三嗪的癫癎发作完全控制率明显低于乙琥胺,与卡马西平和丙戊酸钠的差异均无统计学意义。拉莫三嗪的不良反应发生率明显低于卡马西平,与丙戊酸钠和乙琥胺的差异均无统计学意义;3种药物的退出率比较差异无统计学意义。结论 对于传统抗癫癎药物治疗无效、不良反应明显患儿,拉莫三嗪是一种较为理想的替代药物。但仍有待高质量、大样本及较长随访时间的随机对照试验予以证实。     

Felbamate: Successful Development of a New Compound for the Treatment of Epilepsy

Summary: Felbamate (FBM) is an effective and safe novel antiepileptic drug (AED) for add-on treatment in adults with refractory partial seizures as shown in three pivotal controlled trials. In addition, FBM is effective and safe in monotherapy in adults with refractory partial seizures. FBM is also effective and safe as add-on therapy for children and adults with refractory Lennox-Gastaut syndrome. The effective daily dosage is ˜30–45 mg/kg divided into three or four doses with resulting plasma concentrations of 50–80 mg/L. The safety profile of FBM is limited to mild gastrointestinal complaints, insomnia, and nonspecific CNS symptoms. Six pivotal controlled trials, with both classic and innovative design, showed that FBM is a useful AED.     

托吡酯单药治疗难治性癫痫的临床观察

目标维持剂量100mg,初始剂量为25mg,qd。基础期4周,记录发作次数;加药期4~8周,稳定期12周。30例并联用其他抗癫痫药作为对照。记录发作情况及不良反应。结果单药治疗组控制率65.6%,显效率78.1%,不良反应发生率50.0%,多数较轻微且短暂;联合用药组分别为13.3%、20.0%和83.3%。2组比较差异有显著性(P<0.05)。结论TPM单药治疗癫痫是安全、有效的方法。     

The prevalence of antipsychotic polypharmacy in schizophrenic patients discharged from psychiatric units in Poland

BackgroundThe term antipsychotic polypharmacy (APP) refers to the concurrent use of two or more antipsychotic drugs in schizophrenia. The aim of this study was to investigate the range of APP in schizophrenic patients discharged from psychiatric units in Poland, and to determine its demographical and clinical correlates.MethodsData on the pharmacological treatment of 207 patients with a diagnosis of schizophrenia, discharged from six psychiatric hospitals from September–December 2011 were recorded by experienced psychiatrists. Clinical and demographical information was obtained on each patient. The severity of symptoms at admission, and their improvement during hospitalization were assessed using the Clinical Global Impression Scale.ResultsAt discharge, 52.7% of the patients were prescribed one, 42.5% two and 4.8% three antipsychotic drugs (AP). When two AP were applied, it was usually a combination of two second generation antipsychotics (SGA) (46%), or of both first generation antipsychotics (FGA) and SGA (48%). The SGA's olanzapine and risperidone were those most commonly prescribed. Patients treated with two or more AP had a higher number of previous hospitalizations than patients receiving antipsychotic monotherapy. Mood stabilizers were prescribed for nearly one third of the patients, while antidepressants and benzodiazepines were prescribed for fewer than 10%.ConclusionsThe prevalence of polypharmacy in Poland is similar to that reported in other countries. This may suggest that, in a substantial proportion of schizophrenic patients clinical response to the antipsychotic monotherapy is unsatisfactory. Further studies focusing on the efficacy and safety of strategies in the treatment of patients with schizophrenia not responding to antipsychotic monotherapy are necessary.     

Gemcitabine for palliative treatment in metastatic breast cancer

Gemcitabine is one of the recently developed drugs with a high efficacy in various malignant tumours and a mild toxicity profile. As monochemotherapy in metastatic breast cancer, gemcitabine yielded response rates up to 46% as first- and second-line treatment. Neutropenia is the clinically most relevant unwanted effect. Haematological and nonhaematological toxicities are mild, making dose reductions, delays of treatment or withdrawal from treatment very rare. The first phase I and phase II studies of gemcitabine in combination with anthracyclines have shown a good toxicity profile and promising remission rates. Phase I experiences with long-time infusion schedules reveal good feasibility and high patient acceptance. Received: 5 March 1998 / Accepted: 15 July 1998     

拉莫三嗪单药治疗新诊断小儿癫痫的临床疗效分析

目的：观察拉莫三嗪对新诊断小儿癫痫的疗效。方法：47例新诊断小儿癫痫患者给予拉莫三嗪单药治疗。结果：47例患者中完全控制18例,显效15例,有效8例,无效6例,总有效率为87．2％。结论：拉莫三嗪是治疗新诊断小儿癫痫的一种安全、有效药物。     

左乙拉西坦单药治疗≤4岁儿童癫痫112例临床观察

目的：评价左乙拉西坦（LEV）治疗≤4岁儿童癫痫的疗效及安全性。方法：对该院2010年1月至2012年1月LEV单药治疗的112例癫痫患儿（≤4岁）进行疗效及不良反应等观察，起始剂量10 mg·kg^-1·d^-1，每1周增加10 mg·kg^-1·d^-1，逐渐加量至最小有效剂量维持。结果：14例提前退出，98例随访时间≥1年，1年保留率为87.5%；78.6%（77/98）的患儿发作减少≥50%，48%（47/98）的患儿无发作；部分性发作的无发作率为50.9%（28/55），有效率为30.9%（17/55），全面性发作的无发作率45.0%（18/40），有效率为30.0%（12/40），部分性和全面性发作疗效比较差异无统计学意义（p>0.05）；不良反应主要包括嗜睡7.1%（7/98）、行为异常5.1%（5/98）、乏力4.1%（4/98）、食欲不振2.0%（2/98）、皮疹1.0%（1/98）等，不良反应通常发生在治疗的1个月内，症状轻微，绝大部分对症处理后逐渐消失。结论：LEV单药治疗≤4岁儿童癫痫的疗效肯定，安全性好。