Oral and subcutaneous sumatriptan in the acute treatment of migraine: an open randomized cress-over study

In an open, randomized cross-over study in 124 patients, we compared the efficacy, safety and patient preference of oral and subcutaneous sum triptan in the acute treatment of migraine. Patients were treated for 3 attacks or 3 months and then crossed over. Primary clinical efficacy was defined as a reduction in headache severity on a four-point self-rating scale from severe (3) or moderate (2) to mild (1) or none (0), or mild (1) to none (0). Efficacy was evaluated 2 h after the administration of subcutaneous and 4h after the administration of oral sumatriptan. Subcutaneous sumatriptan was significantly more effective than oral sumatriptan in relieving headache (over all three attacks 78% vs 61% improvement), improving clinical disability (55% vs 41 % improvement) and relieving nausea (69% vs 53%), vomiting (72% vs 32%) and phono- or photophobia (67% vs 49%). Median time to recurrence was shorter after subcutaneous (12.5 h) than after oral sumatriptan (18 h); the number of patients experiencing a recurrence was similar Patients reported more adverse events after subcutaneous sumatriptan (1.32 per attack) than after the oral form (0.85 per attack), but all adverse events were mild to moderate in intensity and of short duration. Patient opinion was more often positive after subcutaneous sumatriptan. These results may be useful in counselling patients to choose between the available marketed formulations of sumatriptan.     

Accelerating effects of epidermal growth factor on skin lesions of pemphigus vulgaris: a double-blind, randomized, controlled trial

BACKGROUND: Pemphigus vulgaris (PV) is a severe blistering disease involving the skin and mucous membranes. The most common causes of death in these patients are adverse effects of drugs, and infection. Skin lesions are one of the important sources of infection. Thus, any local treatment that could reduce healing time of lesions and consequently reduce the total dosage of drugs needed to treat is favourable. OBJECTIVE: To evaluate the efficacy of epidermal growth factor (EGF) in reducing healing time of lesions in patients with pemphigus vulgaris. METHODS: In this randomized, double-blind, within-patient, left/right, controlled trial, 20 hospitalized patients with pathologial and immunohistologial (direct and indirect immunoflourecence) proven pemphigus vulgaris (PV) were chosen. In addition, all patients had at least one appropriate pemphigus lesion on each side of the body that had not healed after 2-week systemic therapy and sterile saline washing. EGF (10 microg/g) in 0.1% silver sulfadiazine cream vs. 0.1% silver sulfadiazine cream alone was applied randomly on one side of the body. RESULTS: Kaplan-Meier survival analysis suggested that median time to heal with application of EGF plus silver sulfadiazine cream was 9 days, in comparison with 15 days for silver sulfadiazine cream alone (log-rank test, P=0.0003). No intervention-related adverse effect was observed during the study. CONCLUSIONS: EGF can significantly reduce healing time of skin lesions in patients with pemphigus vulgaris, at least when this cream base is applied (Cochrane skin group identifier: CSG20).     

Informed consent, parental awareness, and reasons for participating in a randomised controlled study

BACKGROUND: The informed consent procedure plays a central role in randomised controlled trials but has only been explored in a few studies on children. AIM: To assess the quality of the informed consent process in a paediatric setting. METHODS: A questionnaire was sent to parents who volunteered their child (230 children) for a randomised, double blind, placebo controlled trial of ibuprofen syrup to prevent recurrent febrile seizures. RESULTS: 181 (79%) parents responded. On average, 73% of parents were aware of the major study characteristics. A few had difficulty understanding the information provided. Major factors in parents granting approval were the contribution to clinical science (51%) and benefit to the child (32%). Sociodemographic status did not influence initial participation but west European origin of the father was associated with willingness to participate in future trials. 89% of participants felt positive about the informed consent procedure; however, 25% stated that they felt obliged to participate. Although their reasons for granting approval and their evaluation of the informed consent procedure did not differ, relatively more were hesitant about participating in future. Parents appreciated the investigator being on call 24 hours a day (38%) and the extra medical care and information provided (37%) as advantages of participation. Disadvantages were mainly the time consuming aspects and the work involved (23%). CONCLUSIONS: Parents' understanding of trial characteristics might be improved by designing less difficult informed consent forms and by the investigator giving extra attention and information to non-west European parents. Adequate measures should be taken to avoid parents feeling obliged to participate, rather than giving true informed consent.     

分子生物学技术在植入前诊断中的应用

植入前诊断是产前诊断非常早的一种方法，目的是放弃携带严重遗传病的胚胎，将健康胚胎植入母体。两种主要的方法是聚合酶链反应（PCR）和荧光原位杂交（FISH）。PCR用于单基因病诊断，FISH用于染色体异常诊断。临床主要应用于存在遗传风险的患者如携带单基因病和染色体易位的患者。随着分子生物学技术的飞速发展，如比较基因组（CGH），全基因组扩增技术（WGA），引物延伸预扩增（PEP），间期核转换技术及DNA芯片技术（DNAchip）等PGD先进检测手段的应用，单细胞用于诊断单基因或多基因突变及染色体疾病，为期不远。     

氟伐他汀对心衰大鼠基质金属蛋白酶、转化生长因子及左室重构的影响

目的:了解基质金属蛋白酶-2(MMP-2)及转化生长因子-β1(TGF-β1)在心肌梗死大鼠左室重构及心衰发展过程中的改变,以及氟伐他汀的干预作用,探讨心梗后心衰的发生机制。方法:选用雄性SD大鼠67只随机分为假手术组、心梗组和心梗他汀组,经冠状动脉前降支结扎术建立心肌梗死后心衰模型,手术24 h后心梗他汀组大鼠管饲氟伐他汀4 mg·kg-1·d-1,假手术组和心梗组大鼠管饲安慰剂。术后3 d、4周、8周检测大鼠非梗死区心肌MMP-2的含量(Western-blot法)、胶原、TGF-β1的改变(免疫组化法),压力传感器记录左室血流动力学改变。结果:术后各时点非梗死区心肌的MMP-2含量,心梗组及心梗他汀组显著高于假手术组(P<0.05),而心梗他汀组显著低于心梗组(P<0.05);术后各组各时点非梗死区心肌TGF-β1表达的变化趋势与MMP-2相同;与心梗组比较,心梗他汀组术后4周和8周的心功能明显改善,胶原容积分数(CVF)及Ⅰ／Ⅲ型胶原比值(Ratio of type Ⅰ／Ⅲ)降低(P<0.05)。结论:氟伐他汀通过减少非梗死区心肌MMP-2和TGF-β1的含量,而减轻心梗后非梗死区心肌胶原网络的破坏及反应性胶原的过度沉积,从而预防和逆转心室重构,改善心脏功能。     

金牛草药材质量标准研究

提高金牛草药材质量标准,为评价和控制金牛草药材质量提供依据。修订金牛草的性状及显微鉴别特征,参照《中国药典》2010年版附录相关方法,对金牛草药材的水分、总灰分、酸不溶性灰分及醇溶性浸出物进行测定。以粉背蕨素A和对照药材为对照,采用薄层色谱法进行定性鉴别;制备粉背蕨素A标准品,建立金牛草指标成分粉背蕨素A的含量测定方法。建立的性状、显微、薄层鉴别方法易于操作,具有较强的专属性;样品测定结果:水分8.8%~10.9%,总灰分7.6%~11.4%,酸不溶性灰分2.5%~4.2%,醇溶性浸出物9.3%~10.2%,粉背蕨素A质量分数0.56%~0.71%。通过完善金牛草的药材质量标准,能够更有效地评价其内在质量,保证用药品质。     

易感小鼠花生过敏诱导的中毒反应

花生过敏是造成人ＩｇＥ诱导中毒反应的主要原因之一,本试验组制作Ｃ３Ｈ小鼠动物模型,并给其口服花生蛋白（ＰＮ）及霍乱毒素（ＣＴｘ）,然后在腹腔内注射ＰＮ（溶于明矾中的ＰＮ）,使这种鼠即刻发生高度敏感症状（包括致死性的中毒反应）及花生特异性ＩｇＥ水平增高,血浆息斯地明水平、脱颗粒肥大细胞及血管渗漏水平也大幅度升高。对照组小鼠未给药或仅仅接受了ＣＴｘ,则未显示出花生特异性ＩｇＥ水平升高及中毒症状。本文又分析了几种与中毒反应有关的参数。结果证明,小鼠花生过敏中毒反应与人花生过敏类似,同时小鼠花生过敏中毒反应模型,为研究中毒性免疫病理发生机制及研究更有效的治疗方案提供了一个有用的工具。