The UK Diabetes Research Network--an opportunity and a challenge.

The Department of Health has funded a national diabetes network to support clinical research. The network will facilitate recruitment into clinical trials and has been widely welcomed by clinicians. However, if the network is to reach its full potential, all those involved will need to advocate a change in attitude towards clinical trials and research, encouraging participation and contribution of data. Clinicians need to be willing to take a proactive view about research studies, and to encourage patients to adopt a positive and altruistic attitude towards trial participation. The future of trials and other important clinical research in the UK may depend on it.     

常压及控制性降压下脊髓急性牵拉损伤比较研究

目的 评价控制性降压是否增加脊髓对牵拉损伤的易感性。材料与方法健康成年杂种犬6只，随机分为常压和控制性降压脊髓牵拉损伤组。观察常压及控制性降压水平下相同程度牵拉损伤后脊髓血流(SCBF)、体感诱发电位(SEP)、神经源性运动诱发电位(NMEP)改变的差异。结果 外周血有创动脉压(MABP)平均下降幅度为40．5％。经SSPS统计软件独立样本t检验，不同牵拉水平下，常压组及低压组的SCBF(％)、SEP波幅(Asep)(％)及NMEP波幅(％)无显著差异。结论 尼卡地平控制性降压不增加脊髓对牵拉损伤的易感性。     

胫骨干骨折带锁髓内钉固定和钢板螺钉固定的对比研究

目的：对照回顾性分析带锁髓内钉和钢板内固定两种方法治疗胫骨干骨折的效果。方法：髓内钉组32例（35处骨折）,根据AO分型,42A型11处,42B型18处,42C型6处;钢板组42例（45处骨折）,42A型10处,42B型22处,42C型13处。平均伤后手术时间在髓内钉和钢板组分别为3d和3.5d。随访评估患者手术时间,活动度,愈合时间,术后并发症之间的差别。结果：术后平均随访13个月（8～26个月）。髓内钉组平均手术时间为84min,钢板螺钉组平均为93min。髓内钉组踝关节平均背屈度为13°（0°～20°）,钢板组为11°（0°～20°）;跖屈分别为41°（30°～50°）,47°（30°～50°）。愈合时间髓内钉组平均为3.3个月,钢板螺钉平均为3.5个月。术后X线片显示髓内钉固定有1例出现旋转畸形,钢板组有3例出现成角畸形,均为胫骨远端1/3骨折。结论：在治疗胫骨骨折方面,带锁髓内钉和钢板内固定两种方法都可以取得理想的效果。     

纸夹板内收位固定与石膏外展位固定治疗Bennett骨折的随机对照试验

目的：研究比较纸夹板内收位固定与石膏外展位固定治疗Bennett骨折的疗效差异。方法：选择2005年10月至2007年4月门诊就诊的70例Bennett骨折患者，按区组随机的方法分为试验组35例（纸夹板内收位固定）和对照组35例（石膏外展位固定）进行治疗。骨折达到临床愈合拆除固定后，对患者进行为期6个月的随访观察。分别于骨折后6、8、12、16、20及24周按改良的Gabriele评分系统对其患手功能进行量化评分比较。结果：两组的优良率在8、12、16及20周时比较试验组优于对照组，差异有统计学意义（P〈0．05）；6周和24周时比较差异无统计学意义（P〉0．05）。两组在功能评分方面，8、12、16、20及24周时比较试验组高于对照组，差异有统计学意义（P〈0．05）；6周时积分差异无统计学意义（P〉0．05）。结论：在Bennett骨折的治疗中，纸夹板内收位固定与石膏外展位固定相比能明显加快患手功能的恢复，而且固定轻便、舒适，患者易于接受，可以作为一种有效的固定方法在临床推广。     

左炔诺孕酮宫内节育器的制备及药物释放研究

采用改性乙烯-醋酸乙烯共聚物(mEVA)作为控释材料制备释放左炔诺孕酮(LNG)4μg/d,预期使用寿命为5年的钥匙形宫内节育器(IUD)。本IUD在体外和在人及动物子宫内均为零级释药。释药速度与释药管管壁厚度或管外内径比的对数成反比,提示本释药体系的释药模武符合膜控制释药的特性。动物血药浓度测定结果表明,家兔子宫内植入IUD 2d后,血中LNG浓度趋于稳定。     

Guidelines for Trials of Behavioral Treatments for Recurrent Headache, First Edition: American Headache Society Behavioral Clinical Trials Workgroup

Guidelines for design of clinical trials evaluating behavioral headache treatments were developed to facilitate production of quality research evaluating behavioral therapies for management of primary headache disorders. These guidelines were produced by a Workgroup of headache researchers under auspices of the American Headache Society. The guidelines are complementary to and modeled after guidelines for pharmacological trials published by the International Headache Society, but they address methodologic considerations unique to behavioral and other nonpharmacological treatments. Explicit guidelines for evaluating behavioral headache therapies are needed as the optimal methodology for behavioral (and other nonpharmacologic) trials necessarily differs from the preferred methodology for drug trials. In addition, trials comparing and integrating drug and behavioral therapies present methodological challenges not addressed by guidelines for pharmacologic research. These guidelines address patient selection, trial design for behavioral treatments and for comparisons across multiple treatment modalities (eg, behavioral vs pharmacologic), evaluation of results, and research ethics. Although developed specifically for behavioral therapies, the guidelines may apply to the design of clinical trials evaluating many forms of nonpharmacologic therapies for headache.     

A simulation study of three sequential methods for the comparison of two treatment groups when the response criterion is censored

Three recent sequential methods, group sequential analysis (GSA), the sequential probability ratio test (SPRT) and the triangular test (TT) are well suited to randomized clinical trials with a censored response criterion, as they do not require matched pairs of patients. We undertook a simulation study to investigate their statistical properties and to compare these three methods with the fixed-sample design. Our results suggest that the three methods have the expected statistical properties for size and power; they allow an important reduction of the average number of events before stopping, except with GSA when there is no treatment difference; the triangular test (closed design) appears the optimal design, as the variance of the number of events is smaller than with the sequential probability ratio test (open design) and analysis after every twenty new events does not alter the statistical properties of these sequential methods and enhances their usefulness.     

复方18甲基炔诺酮透皮控释传递系统的LNG人体药物动力学与药效学评价

复方18甲基炔诺酮/雌二醇透皮控释传递系统(LNG/E_2 TCDS)能同时恒速释放低剂量的LNG和E_2,在1周内维持一个平稳而有效的LNG血药浓度。药动学与药效学研究证明,该系统释放的LNG能达到血清LNG目标水平,产生有效的排卵抑制(6/6)。LNG/E_2 TCDS可望发展成为一种安全、有效、非侵入性的新型生育调节避孕制剂。