Clinical safety of enamel matrix derivative (EMDOGAIN®) in the treatment of periodontal defects

Abstract The aim of the present clinical trial was to test tolerability during 2 treatments with EMDOGAIN® in a large number of patients. An open, controlled study design in 10 Swedish specialist clinics was chosen, with a test group of 107 patients treated with EMDOGAIN® in connection with periodontal surgery at 2 surgical test sites per patient. The procedures were performed 2 to 6 weeks apart on one-rooted teeth with at least 4 mm deep intraosseous lesions. A control group of 33 patients underwent flap surgery without EMDOGAIN® at I comparable site. In total 214 test and 33 control surgeries were performed. Serum samples were obtained from test patients for analysis of total and specific antibody levels. 10 of the patients had samples taken before and after the first surgery. 56 other samples were taken after one treatment with EMDOGAIN®, and 63 after 2 treatments. None of the samples, not even from allergy-prone patients after 2 treatments, indicated deviations from established baseline ranges. This indicates that the immunogenic potential of EMDOGAIN® is extremely low when applied in conjunction with periodontal surgery. Comparison between the test and control groups demonstrated the same type and frequency of post-surgical experiences, i.e., reactions caused by the surgical procedure itself. Clinical probing and radiographic evaluation was performed at baseline and 8 months postsurgery. About half of the patients (44 test and 21 control) were also evaluated after 3 years. There was a significant difference between the test and control results at 8 months post surgery. and this difference had increased further at the 3 year follow-up. The 2.5–3 mm increase in attachment and bone level after treatment with EMDOGAIN® was of the same magnitude as seen in the studies with split-mouth design aiming for lest of effectiveness of EMDOGAIN®.     

A critical incident study in child health

The critical incident technique is an objective method of analysing doctors' professional behaviour. It extracts the skills which should be taught and assessed in any training programme. In such a study in child health, 438 incidents were collected from general practitioners, paediatricians and others, and analysed according to the problem, the disease, the setting, the skill and the attitude involved. Most of the problems concerned non-specific symptoms (e.g. 'unwell baby', 'fever') and the main skill categories (each with many subheadings) were clinical management (especially at home), the diagnostic process and interpersonal skills. Training of doctors in child health should emphasize the competencies highlighted in this study.     

Cannabis and driving: A new perspective

Cannabis and driving is an emerging injury‐prevention concern. The incidence of driving while affected by cannabis is rising in parallel with increased cannabis use in the community. Younger drivers are at particular risk. Improvements in research methodology, technology and laboratory testing methods have occurred in the last 10 years. These cast doubt on earlier results and conclusions. Studies now show that cannabis has a significant impairing effect on driving when used alone and that this effect is exaggerated when combined with alcohol. Of particular concern is the presence of cannabis as the sole psychoactive drug in an increasing number of road fatalities and the lack of any structural response to this problem. A review of testing methods, laboratory and real driving studies, and recent epidemiological studies is presented. Suggestions for methods of further data collection and future public policy are made.     

循证护理学在实践中的应用

循证护理的核心思想是任何护理决策都要建立在临床客观证据的基础上。护理过程中应进一步开展临床试验研究，以提供更好的护理依据。对临床护理工作中存在的同一问题有不同研究结果的情况，要用系统评价的方法进行分析，得出综合可靠的结论。作举例说明循证护理的实施方法。     

环糊精在鼻腔给药系统中的应用

综述了环糊精作为鼻腔给药系统赋形剂的应用及安全性.     

下腹部Joel—Cohen切口术后切口愈合临床观察

目的探讨肥胖患者下腹部手术采用Joel—Cohen切口对预防非感染性切口裂开的临床效果。方法选择切口部位皮下脂肪层厚达4—5cm的妇产科手术患者90例，随机分为观察组44例，采用Joel—Cohen切口；对照组46例，采用下腹正中直切口。观察切口愈合和脂肪液化情况。结果观察组切口甲级愈合率显著高于对照组（P〈0．01）；脂肪液化切口裂开率显著低于对照组（P〈0．05）。结论脂肪组织厚达4—5cm以上下腹部手术切口，采用Joel—Cohen切口可以减少脂肪液化，切口愈合显著优于下腹直切口，值得临床推广应用。     

A randomized,double‐blind,placebo controlled,multi‐center study of intravenous iron sucrose and placebo in the treatment of restless legs syndrome

Iron deficiency may exacerbate symptoms in the Restless Legs Syndrome (RLS). We investigated the effect of intravenous iron sucrose or placebo on symptoms in patients with RLS and mild to moderate iron deficit. Sixty patients with primary RLS (seven males, age 46 (9) years, S‐ferritin ≤45 μg/L) recruited from a cohort of 231 patients were randomly assigned in a 12‐months double‐blind, multi‐centre study of iron sucrose 1000 mg (n = 29) or saline (n = 31). The primary efficacy variable was the RLS severity scale (IRLS) score at week 11. Median IRLS score decreased from 24 to 7 (week 11) after iron sucrose and from 26 to 17 after placebo (P = 0.123, N.S. for between treatment comparison). The corresponding scores at week 7 were 12 and 20 in the two groups (P = 0.017). Drop out rate because of lack of efficacy at 12 months was 19/31 after placebo and 5/29 patients after iron sucrose (Kaplan–Meier estimate, log rank test P = 0.0006) suggesting an iron induced superior long term RLS symptom control. Iron sucrose was well tolerated. This study showed a lack of superiority of iron sucrose at 11 weeks but found evidence that iron sucrose reduced RLS symptoms both in the acute phase (7 weeks) and during long‐term follow up in patients with variable degree of iron deficiency. Further studies on target patient groups, dosing and dosing intervals are warranted before iron sucrose could be considered for treatment of iron deficient patients with RLS. © 2009 Movement Disorder Society     

Cost and workforce implications of subjecting all physicians to aviation industry work hour restrictions: A response

In recent years, the surgical profession has attempted to incorporate into clinical practice certain techniques that the airline industry has used to improve safety. These mechanisms have proven to be valuable components of our efforts to ensure that surgical patients receive safe, high-quality care. However, as the authors of “Cost and workforce implications of subjecting all physicians to aviation industry work hour restrictions” note, it would be a mistake to extend aviation's work-hour restrictions to medicine, particularly to resident training programs.     

不同剂量和疗程伐昔洛韦治疗带状疱疹的多中心随机双盲对照研究

目的：比较不同剂量和疗程伐昔洛韦治疗带状疱疹的疗效和安全性。方法：选择带状疱疹患者为研究对象，采用多中心、随机、双盲、对照的临床试验。试验组患者采用伐昔洛韦1000mg每日3次口服，共服7d；对照组患者采用伐昔洛韦300mg每日2次口服，共服10d。用药后第3、6和10天观察疗效和不良反应。结果：共入组128例，全分析集（FAS）分析128例，符合方案集（PPS）分析118例。治疗后第3、6和10天，试验组和对照组患者的症状、体征积分下降值及有效率比较差异无统计学意义（P〉0．05）；疼痛视觉模拟评分法（visnal analogue scale，VAS）值比较，两组间差异无统计学意义（P〉0．05），但入组时疼痛VAS值≥8的患者，FAS集分析显示，在治疗后第6、10天VAS值下降两组均存在统计学差异（P〈0．05）；PPS集分析显示治疗后第10天VAS值下降，两组间存在统计学差异俨〈0．05）。试验组和对照组不良反应发生率分别为17．18％和12．50％．主要为嗜睡和恶心。结论：增加伐昔洛韦用量治疗带状疱疹安全、有效，与较低剂量伐昔洛韦组相比，对疼痛程度较严重的患者能更显著地减轻疼痛。     

The First‐Episode Psychosis Outcome Study: premorbid and baseline characteristics of an epidemiological cohort of 661 first‐episode psychosis patients

Aims: Studies conducted in first‐episode psychosis (FEP) samples avoid many biases. However, very few studies are based on epidemiological cohorts treated in specialized FEP services. The aim of this file audit study was to examine premorbid and baseline characteristics of a large epidemiological sample of FEP. Methods: File audit study of all patients admitted to the Early Psychosis Prevention and Intervention Centre between 1998 and 2000 using a specialized questionnaire. Results: There were 661 patient files included in the study. Premorbid evaluation revealed high rates of substance use disorder (74.1%), history of psychiatric disorder (47.5%), past traumatic events (82.7%) suicide attempts (14.3%) and family history of psychiatric illness (55.6%). Baseline characteristics revealed high intensity of illness (mean CGI 5.5), high prevalence of lack of insight (62%) and high rate of comorbidity (70%). Conclusion: High rates of traumatic events or episodes of mental illness before treatment for FEP must be considered when designing treatment approaches because a too narrow focus on positive psychotic symptoms will inevitably lead to incomplete treatment. Additionally, early intervention programmes need sufficient range of resources to address the multiple challenges presented by FEP patients such as high severity of illness, comorbidities and functional impairment. Finally, observation of an important degree of functional impairment despite short duration of untreated psychosis suggests that while early detection of FEP is a necessary step in early intervention, it may not be sufficient to improve functional recovery in psychosis and that efforts aimed at identifying people during the prodromal phase of psychotic disorders should be pursued.