Islet Xenotransplantation: Are We Really Ready for Clinical Trials?

Four clinical trials of porcine islet transplantation have been reported, and there are verbal reports that clinical trials on much larger scales are continuing in centers in China and Russia. The four reported trials are briefly reviewed and, in the light of the present status of experimental islet xenotransplantation, consideration is given to whether such trials are currently justified. The Ethics Committee of the International Xenotransplantation Association has (1) emphasized the need for encouraging studies in non-human primates before clinical trials should be undertaken, (2) mandatory monitoring for the transfer of porcine microorganisms, and (3) careful regulation and oversight by recognized bodies. Other aspects of the topic, such as the need for informed consent, are briefly discussed. We conclude that, at the present time, more data documenting convincing efficacy, focused on clinically applicable immunosuppressive regimens, are needed to justify the initiation of closely monitored clinical trials. A clinical trial may then be justified even though the potential risk to the patients, and possibly for society, will not be zero.     

改变督导方式促进临床教学质量

目的:发挥教学督导的作用,提高医学院校临床教学的质量.方法:对教学督导工作进行了大胆的改革:①督导前移,加强了教学的环节质量;②疏通反馈通道,保证教学督导效果;③言传身教,加强对青年教师的培养和指导;④扩大督导范围,促进各层次教学质量;⑤全程随机评价,客观评价教学效果.结果:保证了教学效果,使教学质量有了明显的提高.结论:加速我军现代化建设,培养高素质医学人才,教学督导的作用显的尤其重要.     

Fetal neural grafts for Huntington's disease: a prospective view.

Intrastriatal transplantation of striatal neuroblasts from human fetuses is a promising approach for treatment of Huntington's disease, on the basis of many experimental animal studies and, most recently, pilot clinical trials. Technically, several issues remain to be resolved (e.g., the precise site of dissection of the fetal tissue; the number and location of the fetal striatal implants; or the use of immunosuppressive therapy), and await larger-scale trials and purposely designed protocols. Further clinical data must also be obtained, and preliminary promising results must be replicated in a patient group large enough to provide conclusive results. It is important to establish (1) the amount of clinical benefit provided to the patient by the grafted cells; (2) the anticipated duration of clinical benefits; and (3) the secondary rate of decline after the benefit of the graft has been overbalanced. Evaluation of these parameters will require very long-term follow-up of the patients involved, over several years after grafting, before the technique can eventually be proposed widely to patients.     

Prevalence of Candida tropicalis in clinical specimens from patients with variable clinical syndromes over a 5-year period

Summary. In this study, we have examined our records for the isolation of Candida tropicalis from clinical specimens of patients with heterogeneous clinical presentations during the past 5 years. We have found that this species ranks third among all yeasts in frequency of isolation from clinical specimens and that the trend of recovery from the specimens is rising over the years. The isolation rate of C. tropicalis was highest from urine specimens (36%) followed by respiratory specimens (22%). The frequency of isolation of C. tropicalis from vaginal specimens was relatively high (14%), however the trend was declining over the years. In general, the high recovery of Candida tropicalis from clinical specimens of patients with variable disease supports the views of this organism being a major pathogen.
Zusammenfassung. Die Studie basiert auf einer Durchsicht der Patientenarchive der letzten fünf Jahre auf die Isolationshäufigkeit von Candida tropicalis aus klinischen Untersuchungsmaterialien von Patienten mit unterschiedlichen klinischen Krankheitsbildern. Diese Hefeart war die dritthäufigste mit steigender Tendenz über die Jahre. Die Isolierungsrate von C. tropicalis war am höchsten aus Urin (36%), gefolgt von Respirationstrakt-Materialien (22%). Die Isolationshäufigkeit aus dem hinteren Scheidengewölbe war relativ hoch (14%), nahm jedoch mit den jahren ab. Allgemein unterstreicht die hohe Isolationsrate von C. tropicalis aus klinischen Untersuchungsmaterialien die ätiologische Bedeutung dieses Erregers.     

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.     

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。     

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     

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。