Expanded Practice in Midwifery: Designing,Implementing, and Maintaining Programs

Advances in health care science and delivery, coupled with patient need for access to care, have driven expanded practice in midwifery for decades. The process for development and implementation of expanded practices for midwives and midwifery practices is described. Important components include assessment of need, identifying stakeholders and supporters, development of a program proposal, obtaining privileges, developing training programs, and conducting ongoing quality management and program evaluation. Examples of expanded practice in midwifery are presented.     

Use of the Covera Stent Graft for the Treatment of Dysfunctional or Thrombosed Arteriovenous Grafts: A Retrospective Analysis of 64 Patients

PurposeTo retrospectively evaluate the safety and effectiveness of the Covera stent graft (SG) for the treatment of dysfunctional or thrombosed arteriovenous grafts (AVGs).Materials and MethodsWithin 29 months (February 2016–August 2018), 79 patients underwent Covera SG placement in the authors’ department for the treatment of dysfunctional AVGs. Data were available for 64 patients who underwent 64 procedures, using 64 devices. Minimum follow-up was 6 months, unless reintervention occurred. Mean follow-up was 277 days (6–923 days). Treatment characteristics were 51 cases with venous-graft anastomosis (VGA) stenosis (79.7%), 13 cases of puncture zone stenosis (20.3%), 14 cases of in SG stenosis (21.9%), 8 cases of pseudoaneurysm treatment (12.5%) (1 treatment area might have had more than 1 characteristic). Thirty-six patients presented with thrombosis (56.2%), and 31 of 64 case were de novo treatment areas (48.4%). Primary outcome measurements were technical success and post-intervention primary patency (PIPP) at 6 months, whereas secondary outcome measurements included factors influencing primary outcome.ResultsTechnical success was 100%. Median PIPP was 336 days, and 73.6% of treatment areas were patent at 6 months. There were no significant differences in terms of PIPP when de novo treatment areas were compared with restenotic areas (519 vs. 320 days, respectively; P = .1); patients who presented with versus those who presented without thrombosis (320 vs. 583 days, respectively; P = .07); puncture zone stenosis or elsewhere (329 vs. 686 days, respectively; P = .52); and VGA stenosis or elsewhere (336 vs. 335 days, respectively; P = .9).ConclusionsUse of the Covera SG for AVG treatment was safe and effective in every type of treatment area presented in this retrospective analysis.     

Expanded access to investigational drugs: balancing patient safety with potential therapeutic benefits

Introduction: Expanded access is the use of an investigational product by patients with serious medical conditions without participation in a clinical trial. It is a complicated process involving the collaboration of many parties and pharmaceutical companies. Ongoing efforts focus on accelerating expanded access procedures in the best interest of patients with cancer.

Areas covered: We review the regulatory and ethical challenges encountered in efforts to optimize expanded access.

Expert opinion: In the era of personalized medicine, patients may benefit from novel therapeutic agents that demonstrate encouraging results in early studies. However, drug approval is a lengthy and cumbersome procedure that might exceed the time frame of a life-threatening disease. Expanded access provides options to patients with unmet needs. It may provide informative safety and efficacy data to the manufacturers and the scientific and regulatory organizations.

Ongoing efforts are being made by global governmental and scientific committees, regulatory agencies, and patient organizations to address the ethical and regulatory issues and to optimize the expanded access process. Their goal is to expand access to promising novel drugs for individual patients and to accelerate the necessary procedures while preserving patient safety.     

免疫细胞治疗产品扩增活化的淋巴细胞的成瘤性研究

目的 研究免疫细胞治疗产品扩增活化的淋巴细胞（EAL）是否具有成瘤性,为其临床应用提供安全性依据。方法 采用BALB/c裸鼠,分为溶媒对照组、阳性对照（Hela细胞）组、EAL低、高剂量（1×10⁷、5×10⁷/只）组,sc给药1次,观察裸鼠临床症状、注射部位有无结节或肿物形成;每周2次称动物体质量;测量肿物体积,绘制生长曲线;肿物组织取出后,HE染色,光镜下进行病理检查。结果 注射后1周内,阳性对照组注射部位均有肿物生长,随着时间的延长体积逐渐增大;自给药后20 d起,阳性对照组雌性裸鼠与溶媒对照组比较,体质量显著增加（P<0.05、0.01）,但身体明显消瘦;病理学检查发现,阳性对照组皮下肿瘤细胞灶状/巢状/团块状增生,肿瘤组织坏死伴炎性细胞浸润、伴或不伴有真皮炎性细胞浸润及出血。EAL低、高剂量组临床症状观察和组织病理学检测均未见肿瘤样病变,体质量增长趋势与溶媒对照组一致。结论 BALB/c裸鼠sc EAL不具有成瘤性。     

The influence of membrane exposure on the outcomes of guided tissue regeneration: clinical and microbiological aspects

The aim of the present study was to evaluate the influence of membrane exposure on guided tissue regeneration (GTR). Thirty patients with 2-wall or 3-wall intraosseous defects were treated with GTR. Periodontal index, gingival index, bleeding on probing, probing depth, clinical attachment level and recession were assessed at the baseline examination, as well as immediately prior to and six months after GTR. The numbers of Porphyromonas gingivalis and Actinobacillus actinomycetemcomitans on the retrieved expanded polytetrafluoroethylene (e-PTFE) membranes were assessed using polymerase chain reaction. The results showed that 26.3% of the membrane exposure sites had zero attachment gain. The membrane exposure sites tended to achieve a smaller clinical attachment gain and had significantly greater marginal tissue recession ( p = 0.006). In addition, the exposed membranes harbored significantly more A. actinomycetemcomitans than the non-exposed membranes (p = 0.029). In conclusion, membrane exposure resulted in a poor GTR outcome. The amount of A. actinomycetemcomitans on the exposed membrane may be a major contributing factor to the outcome of GTR.     

In vitro efficacy of a whitening toothpastecontaining calcium carbonate and perlite

Objectives : The studies described in this paper aimed to assess the stain removal efficacy, fluoride efficacy and abrasivity to enamel and dentine of a new whitening toothpaste containing calcium carbonate and perlite, using appropriate in vitro models. Methods : Stain removal efficacy was assessed using the pellicle cleaning ratio (PCR) method. Fluoride efficacy was assessed using remineralisation, demineralisation and fluoride‐uptake methods. Abrasivity was assessed using an enamel and dentine wear method. Results : The results showed that the new whitening toothpaste was able to remove extrinsic tooth stain more effectively than three commercially available toothpaste formulations. The fluoride efficacy was superior to a non‐fluoridated control and was not significantly different to a clinically tested fluoride‐containing toothpaste. The abrasivity data showed that the calcium carbonate/perlite toothpaste is no more abrasive to enamel or dentine than two other commercially available whitening toothpastes. Conclusions : The studies show that the new whitening toothpaste is effective in extrinsic stain removal, has an efficacious fluoride source and does not have an undue degree of abrasivity to enamel or dentine compared to other relevant commercially available products.     

Review of the extrinsic stain removal and enamel/dentine abrasion by a calcium carbonate and perlite containing whitening toothpaste

There has been an increase in the demand from consumers and patients for products that whiten teeth. To meet this demand, a whitening toothpaste containing calcium carbonate and perlite as the abrasive system and an efficacious fluoride source has recently been launched. The aim of the current paper is to review the toothpaste's stain removal efficacy and its effects on enamel and dentine wear. It has been shown to be effective at removing model extrinsic stain in vitro. Further, it has been shown to be more effective in removing naturally occurring extrinsic tooth stain than a silica non-whitening control toothpaste after two weeks of twice daily brushing in a parallel group, double-blind clinical study using 152 adult volunteers. In addition, the enhanced whitening effect did not give a clinically relevant level of wear to enamel or a significant increase in dentine wear compared to marketed non-whitening toothpaste formulations, as shown by using an in situ type model with ex vivo brushing.     

膨体聚四氟乙烯与固体硅胶隆鼻术后肿胀的临床分析比较

目的:临床分析比较膨体聚四氟乙烯和固体硅胶两种假体隆鼻术后的肿胀厚度消退速度,为医生与就医者选择膨体聚四氟乙烯或者固体硅胶假体提供临床资料依据。方法:将就医者分为膨体聚四氟乙烯假体组和固体硅胶假体组,运用面部三维重建技术,观察比较两组就医者在隆鼻术前、术后1天、术后3天、术后5天和术后7天肿胀厚度的变化。结果:隆鼻术后1~7天,无论是膨体聚四氟乙烯组还是固体硅胶组肿胀厚度都降低。术后1、3、5、7天比较膨体聚四氟乙烯组与固体硅胶组肿胀厚度,差异无统计学意义(P0.05)。结论:膨体聚四氟乙烯组与固体硅胶组隆鼻术后肿胀厚度消退速度趋于一致,无显著差异。从术后肿胀的角度告知医生和就医者,在隆鼻术时选择膨体聚四氟乙烯或者固体硅胶假体均可,在肿胀厚度消退速度方面的区别不大。     

四肢恶性黑色素瘤28例的治疗回顾分析

目的:讨论恶性黑色素瘤的治疗方法及预后。方法:回顾分析笔者科室2008年1月~2011年12月收治的28例四肢恶性黑色素瘤患者,其中男性13例,女性15例,年龄最大者68岁,年龄最小者25岁,平均年龄43岁,发生于上肢者10例,发生于下肢者18例。所有病例均经病理证实为恶性黑色素瘤。入院后未行手术治疗者先取活检,术中切口距病灶缘约1cm,病检结果证实为恶性黑色素瘤后即行扩大切除术。已行手术者行原切口缘扩大切除术,距原切口缘3~5cm,术后行放化疗。结果:28例患者术后切口均I期甲级愈合,术后随访2年,21例患者未出现病灶复发,生存质量良好。7例因肿瘤复发或转移死亡。结论:恶性黑色素瘤患者的治疗选择扩大切除,辅以术后放化疗是一种有效的方法。