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 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     

两种微创方法治疗股骨颈骨折的临床对照试验

目的分别应用三针锁针加压器外固定和空心拉力钉内固定疗法治疗股骨颈骨折,探讨股骨颈骨折最佳治疗方法.方法应用三针锁针加压器外固定治疗股骨颈骨折63例,其中男24例,女39例;年龄55～89岁,平均(64.5±3.2)岁;Garderl Ⅰ型2例,Ⅱ型15例,Ⅲ型38例,Ⅳ型8例.应用空心拉力钉内固定治疗63例,其中男29例,女34例;年龄45～76岁,平均(62.2±2.9)岁;Garden Ⅰ型4例,Ⅱ型24例,Ⅲ型28例,Ⅳ型7例.对其疗效进行分析.结果126例除2例死亡外均得到随访.115例愈合,其中10例股骨头坏死.外固定组愈合58例,股骨头坏死4例,死亡1例;内固定组愈合57例,股骨头坏死6例,死亡1例.根据Harris功能评定标准评价疗效,外固定组62例中优24例,良26例,可8例,差4例,优良率80.65%;内固定组62例中优23例,良27例,可6例,差6例,优良率80.65%.Harris评分外固定组平均(80.40±1.21)分,内固定组平均(79.14±1.47)分,两组Harris评分比较差异无统计学意义(P＞0.05).结论采用内外固定治疗股骨颈骨折疗效无明显差异,但外固定创伤小、费用低、可早期离床;而采用拉力钉内固定器医疗成本高,卧病时间相对较长,且需二次手术取内固定钉.     

数据库技术新进展及其在医疗系统中的应用

论述了关系型数据库的革命性贡献与发展中的矛盾,实现医疗系统中的数据管理功能需要解决的问题,以及对临床数据输入系统的需求。     

Can a failed ileal pouch anal anastomosis be left in situ?

OBJECTIVE: Failure after ileal pouch-anal anastomosis (IPAA) is reported with a frequency of 10-20%. The failed IPAA can be excised or defunctioned. Indications for excision and further management of an indefinitely diverted pouch are poorly described. The aim of the present investigation was to investigate pouch-related problems and the histopathological pattern of the pouch mucosa in this group of patients. METHOD: In a cohort of 620 patients having IPAA with a median follow-up of 14 years, 56 patients with failure were identified. The patients with defunctioned pouches were assessed with regard to pouch-related problems and endoscopy with biopsies was performed. Biopsies were stained with haematoxylin-eosin, PAS for neutral mucins and Alcian blue/high iron diamine for sialomucins/sulphomucins. Morphological changes were grouped into three types modified according to Veress and assessed for dysplasia. RESULTS: Twenty-two patients with an indefinitely diverted pouch were found. The follow-up time after surgery for failure was 10 years. Thirteen patients completed the follow-up. Except for two patients with pelvic/perineal pain, there were no clinical problems. The majority of patients displayed mild to moderate macroscopic signs of inflammation. Morphologically, findings ranged from a preserved mucosal pattern to intense inflammatory reaction. No case of dysplasia or carcinoma was found. CONCLUSION: Most patients with an indefinitely diverted pouch had no complaints regarding the pouch. There was no case of dysplasia. Indefinite diversion may be preferable to pouch excision, especially given the associated morbidity.     

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。     

32P colloid radiosynovectomy in treatment of chronic haemophilic synovitis: Iran experience

Repeated intra-articular bleeding with subsequent development of chronic synovitis and cartilage changes, leading to haemophilic arthropathy, is one the most debilitating problems in haemophilic patients. Radiosynovectomy is a familiar therapeutic choice in management of chronic synovitis in haemophilia. We report the treatments results of synoviorthesis with (32)P chromic phosphate with emphasis on clinical aspects. Between 2002 and 2006 we performed 66 procedures in 53 patients. Seven patients were excluded. The remaining 46 patients were followed for an average of 31 months. The mean age of patients at the time of injection was 15.9 years (range: 6-28). There were three repeat injections. According to Fernandez-pallazi and Cavilgia clinical classification (Table 1) [23], nine joints were Stage II and 46 were Stage III. In latest follow-up, 77% of patients reported at least a 50% decrease in bleeding frequency after treatment (P < 0.0001). The need for antihaemophilic factor consumption dropped by about 74% postradiosynovectomy (P < 0.0001). In most of the injected joints, the range of motion remained stable or improved. A trend was found for the number of haemarthrosis to increase after a period of considerable improvement. Synoviorthesis using (32)P effectively reduces the intra-articular bleeding rate and factor concentrate use. Durability of the response seems to be unpredictable, perhaps attributable to the late intervention. An early radiosynovectomy might be more helpful in terms of stability of response to treatment.     

浅谈静脉留置针的临床应用和护理

目的:体会静脉留置针的临床应用和护理、总结经验.方法:观察48例住院患者静脉留置针的使用方法,日常护理及并发症的处理.结果:提高了护理工作的效率,减轻了病人穿刺时的痛苦.结论:护理人员除要熟练掌握操作规程、严格无菌操作外,还应严密观察病人的病情变化.要有高度责任心,从而减轻病人的痛苦.     

不同临床和病理分型对肝门部胆管癌切除术预后的影响

目的 研究临床和病理分型与肝门部胆管癌切除术疗效的关系。方法总结1993年至2004年在解放军总医院肝胆外科手术切除的肝门部胆管癌198例病例资料。结果临床分型Ⅰ型34例，Ⅱ型60例，Ⅲa型27例，Ⅲb型33例，Ⅳ型19例，Ⅴa型6例。Ⅴb型19例。病理高分化腺癌35例，中分化腺癌52例，低分化腺癌54例，三者的中位生存期分别为29．5、11、5．5个月；病理切缘阴性者与切缘阳性者生存率有显著性差异（P 〈0．05）。手术并发症出现率41．4％，围手术期死亡1例。结论肝门部胆管癌根据临床分型进行相应的手术治疗；病理切缘阴性是影响预后的主要因素之一；围手术期正确处理，是减少手术并发症，提高患者生活质量和延长生存期的关键。     

Evaluation of clinical outcomes in anterior cruciate ligament surgery

Clinical outcomes data can be used to facilitate patient management decisions, assess clinician and organizational performance, and to provide evidence for the effectiveness of surgery and rehabilitation. The validity of the inferences made from outcomes data are dependent on the validity of the outcomes measures themselves and the circumstances under which the data were collected, analyzed, and interpreted. Clinical outcomes may include measures of impairment of body structure and function, activity limitation, and participation restriction. However, because the relationship between impairment and the resulting activity limitation and participation restriction is not direct, and because activity limitations and participation restrictions are of the utmost concern to the athlete, the primary clinical outcome should be measures of activity limitation and participation restriction. Activity limitation and participation restriction may be measured either through direct observation of performance or by general or specific measures of health related quality of life. Clinical outcomes data must be collected systematically to ensure valid inferences from the data.