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11.
Marta López-Fauqued Laura Campora Frédérique Delannois Mohamed El Idrissi Lidia Oostvogels Ferdinandus J. De Looze Javier Diez-Domingo Thomas C. Heineman Himal Lal Janet E. McElhaney Shelly A. McNeil Wilfred Yeo Fernanda Tavares-Da-Silva 《Vaccine》2019,37(18):2482-2493
Background
The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies.Methods
Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30?days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12?months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period.Results
Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race.Conclusions
No safety concerns arose, supporting the favorable benefit-risk profile of RZV. 相似文献12.
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《European journal of surgical oncology》2020,46(6):1138-1143
IntroductionThe purpose of this study was to review recommendations made from a specialist pelvic exenteration (PE) multidisciplinary team (MDT) and to provide insights as to the impact of the MDT on patient selection and clinical decision making.Materials & methodsA retrospective review was conducted at Royal Prince Alfred Hospital's PE MDT between June 2014 and December 2015. Data was collected from the recorded minutes of MDT meetings. Referral information and clinical data was extracted from individual patient files. Additional data including operative dates and surgical resection margins were collected from electronic medical records.ResultsOf the 183 patients considered for PE during the MDT meeting, 104 (57%) were recommended for surgery. Factors that influenced the recommendation in favour of surgery were referral by a surgeon (P = 0.004), referral from a rural location (P = 0.05) and having locally advanced primary cancer (P < 0.001). Patients who were seen by the unit's surgeon prior to the MDT did not impact on the MDT recommendation nor the decision for or against surgery (P = 0.771). The most common reason for recommendation against PE was unresectable distant metastatic disease (43%).ConclusionsThe PE MDT meeting is a critical step in the patient care pathway and facilitates critical decision making. Anatomically-based contraindications to surgery (i.e. involvement of adjacent organs, bone and neurovascular structures) do not appear to influence MDT decision making regarding resectability. 相似文献
15.
目的探讨嵌顿痔不同治疗方法的疗效。方法回顾性分析2009年8月至2012年8月迁西县人民医院确诊为嵌顿痔的160例患者的临床资料,其中采取外剥内扎法的80例患者作为A组,吻合器痔上黏膜环切术(PPH)结合外痔血栓剥除术的80例患者作为B组。对比分析两组患者的手术时间、住院时间、住院费用等指标及临床疗效,对比分析两组术后6个月并发症发生情况。结果B组患者的手术时间、住院时间显著少于A组[(15.4±1.1)min比(38.7±0.5)min,(5.3±0.6)d比(12.4±1.3)d,P<0.01];B组患者的有效率显著高于A组(88.8%比66.3%),而总体并发症发生率及复发率显著低于A组(17.5%比33.8%,5%比18.8%,P<0.05)。结论 PPH结合外痔血栓剥除术临床疗效显著。 相似文献
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目的 探讨保留足趾的自体复合第2足趾关节移植治疗手指关节炎的临床疗效.方法 2016年2月至2018年6月,共收治创伤性手指关节炎9例,其中男7例,女2例;年龄19~53岁,平均31.7岁;示指3例,中指6例;掌指关节(MP)关节炎4例,近侧指骨间关节(PIP)关节炎5例;均为创伤后继发的手指关节炎.采用游离带血供的自体复合第2足趾跖趾或趾骨间关节移植进行治疗,同时将受区废弃关节(7例)或切取自体髂骨移植(2例)修复供区骨缺损保留足趾长度,供区创面均直接关闭.术后观察手指和足趾骨折愈合情况、外形、移植关节活动度(ROM)、术后供区愈合情况和行走功能及相关并发症.结果 本组术后9例移植关节全部成活,1例足部供区行髂骨植骨微型钢板固定,术后1周伤口不愈合,考虑为内固定物排异反应,予拆除钢板改克氏针交叉固定,2周后创口顺利愈合.术后随访6~30个月,平均16.3个月.手指骨折平均愈合时间7~10周,平均8.3周,手指外观及功能良好.移植后的MP活动度为50°~75°,平均65.3°,PIP活动度为10°~85°,平均60.6°.根据中华医学会手外科学分会上肢部分功能评定试用标准评价手指功能:优5例,良3例,可1例,优良率为88.9%.足趾骨折平均愈合时间9~12周,平均10.2周,所有患者足趾外形良好,行走功能正常.2例取髂骨患者供区仅残留一条线形瘢痕,无疼痛、麻木等不适.结论 游离带血供的自体复合第2足趾关节移植治疗手指关节炎,同时应用受区废弃关节或切取自体髂骨移植修复供区骨缺损保留足趾,不仅能恢复手指关节的正常结构,使关节具有良好的功能,而且能保留足趾外形与功能,减少供区损伤,具有良好的治疗效果. 相似文献
18.
目的探讨腹腔镜微创治疗高龄完全性直肠脱垂的手术方法,总结手术操作体会及临床治疗经验。方法总结2012年6月~2017年6月收治的22例完全性直肠脱垂患者的临床资料,患者年龄67~79岁,均在腹腔镜下行悬吊固定。结肠造影和术中均可见明显增厚且冗长的乙状结肠,直肠周围组织宽松,膀胱直肠窝或子宫直肠窝之间脂肪结缔组织明显增厚,尤其是直肠前壁。术中切除直肠周围增厚的脂肪结缔组织,切除冗长的乙状结肠和直肠上端,行结肠直肠吻合。结果所有患者手术顺利,无中转开腹。手术时间平均(86.59±14.84)min,出血量平均(63.41±23.67)ml,术后住院时间平均(10.01±1.57)d。无吻合口出血、感染、肠瘘等并发症发生,无术中死亡或术后2周内死亡病例。22患者均获得临床治愈,随访2~4年,平均(2.81±0.91)年,患者排便次数1~2次/d,肛门功能正常,无复发。结论腹腔镜下微创切除直肠周围增厚的结缔组织、切除冗长的乙状结肠和直肠上端,是一种较好的微创治疗高龄直肠脱垂的方法。 相似文献
19.
Albert De Decker Rosalie Fergusson Benjamin Ondruschka Niels Hammer Johann Zwirner 《Clinical anatomy (New York, N.Y.)》2020,33(4):522-529
For 50 years now, sacrospinous ligament fixation (SSLF) has been used to treat pelvic organ prolapse consequent on altered integrity of the pelvic myofascial structures. It is usually performed vaginally, but it has recently been performed laparoscopically through either an anterior or a posterior approach, with the broad ligament as a landmark to differentiate the two. In the present study, these two laparoscopic approaches were assessed using Thiel-embalmed cadavers. The anterior and posterior approaches were compared in terms of the closest distance to anatomical structures at risk, including pelvic viscera, the obturator nerve, and vascular structures. The posterior approach was more often closer to the investigated vessels and the rectum. The obturator nerve and the ureter were close to both the anterior and posterior approaches. The urinary bladder was closer using the anterior approach. From an anatomical standpoint, therefore, the anterior laparoscopic approach for SSLF is more likely to cause injury to the urinary bladder, whereas the posterior approach is more prone to causing rectal and vessel injuries. This study illustrates, from a basic science perspective, the importance of combining fascia research, novel endoscopic or minimally invasive surgical exposures informed by anatomy, and contemporary trends in gynecology in order to improve patient outcomes. Clin. Anat. 33:522–529, 2020. © 2019 Wiley Periodicals, Inc. 相似文献
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