Patient reported outcome and cosmetic evaluation following implant-based breast-reconstruction with a titanized polypropylene mesh (TiLOOP® Bra): A prospective clinical study in 269 patients

IntroductionImplant-based or expander-supported breast reconstruction is an established surgical method after mastectomies due to cancer or to prophylactic reasons. Patient reported outcome (PRO) and cosmetic outcome after breast reconstruction with a synthetic surgical mesh was investigated in a prospective, single-arm, multi-center study.Material and methodsPrimary or secondary implant-based breast reconstruction with support of TiLOOP® Bra was performed in 269 patients during the PRO-BRA study. PRO 12 months after breast reconstruction was evaluated using Breast-Q questionnaire. Cosmetic outcome was evaluated by two independent experts by means of pictures taken preoperatively and at the follow-up visits.ResultsBreast-Q and 12 months FU were completed by 210 women. Patients without adverse event had a significantly higher Breast-Q score for “sexual well-being” (p = 0.001); “psychosocial well-being” was negatively influenced by prior therapies (p < 0.01), and older patients had significantly lower scores at 12 months FU compared to pre-OP for “satisfaction with breasts” (p < 0.01) while the opposite was true for younger patients. Unilateral surgery resulted in reduced “satisfaction with breast” at 12 months FU (p < 0.01). Radiotherapy negatively influenced “satisfaction with breast”, “sexual well-being” and “physical well-being chest”. The cosmetic evaluation showed a significant difference (p < 0.001) in the evaluation by the patients and experts with the patients' assessment being worse compared to experts' assessment.ConclusionOur study showed that two years after implant-based breast reconstruction with support of TiLOOP® Bra PRO is influenced by different factors. This information can be used to improve the decision-making process for women who chose implant-based breast reconstruction.     

Factors Affecting the Clinical Course of Follicular Lymphoma: A Multistate Survival Analysis Using Individual Patient Data from Eight Multicenter Randomized Clinical Trials

Introduction/BackgroundLeveraging the Follicular Lymphoma Analysis of Surrogacy Hypothesis database of individual patient data from first-line clinical trials, we studied the clinical course of follicular lymphoma (FL) and investigated clinical factors associated with FL outcomes.Patients and MethodsWe examined 2428 patients from 8 randomized trials using multistate survival models with 4 states: induction treatment, progression, death from FL, and death from other causes. We utilized Aalen-Johansen estimator and Cox models to assess the likelihood of FL outcomes and quantify predictors’ effects.ResultsTwo-year progression, FL-related death, and death from other causes estimates were 26.5%, 3.4% and 1.4%, respectively. FL-associated deaths were the primary cause of mortality within 10 years of follow-up. Male sex (hazard ratio: 1.25; 95% confidence interval: 1.05-1.47), > 4 involved nodal areas (1.51; 1.23-1.86), elevated LDH (1.20; 1.01-1.43), low hemoglobin (1.44; 1.15-1.81), and elevated β-2 levels (1.23; 1.02-1.47) increased risk of progression. CD20-targeting agents reduced risks for progression (0.29; 0.22-0.39), death from FL (0.05; 0.01-0.20), and death from other causes without progression (0.13; 0.05-0.33) and following progression (0.52; 0.30-0.92). Estimated 2-year progression rates were 22.3% and 43.5% with or without CD20-targeting agents, respectively. Two-year FL-associated mortality rate was 8.3% among patients without CD20-targeting agents, 5.4% with B-symptoms, 4.9% with elevated LDH, and 9.1% with low hemoglobin.ConclusionThis study identified independent contributions of baseline clinical factors to distinct outcomes for patients with FL following first-line therapy on a clinical trial. Similar analytical approaches are needed to increase understanding of factors that influence FL outcomes in other settings.     

0~3月龄婴儿家长睡眠养育行为特点及影响因素的纵向研究

目的分析婴儿0~3月龄期间家长睡眠养育行为的特点及影响因素,为婴儿早期睡眠养育行为的预见性指导提供参考依据。方法采用纵向研究设计于2013-2015年对我国5个城市156例婴儿0~3月龄期间家长睡眠养育行为进行监测,监测时点分别为生后14 d、1、2月龄和3月龄,内容包括夜晚入睡方式、就寝时精神状态和睡床方式。按不同年龄点进行各行为发生率的统计描述和CMHχ^2检验,采用广义线性混合模型(GLMMs)进行家长睡眠养育行为的影响因素分析。结果监测期间观察夜晚婴儿由家长抱着入睡、放在床上轻拍或陪伴入睡和单独自行入睡的比例分别为54.4%、35.9%和9.7%,且随月龄增加,家长抱着入睡的比例呈上升趋势(P<0.0001)。婴儿就寝时被放置到床上时已睡着、犯困但未睡着和完全清醒的比例分别为63.7%、28.6%和7.7%,随月龄增加,犯困但未睡着的比例逐渐下降(P=0.0003)。与家人同床睡眠、同屋但单独小床睡眠、家人抱着睡眠以及单独房间睡眠的比例分别为53.8%、42.4%、2.0%和1.8%,随月龄增加,与家人同床睡眠的比例逐步增多(P<0.0001)。父母文化程度均为大学及以上、家庭月收入水平在5001~8000元和父亲抑郁情绪对睡眠养育行为有显著影响(OR=0.46,2.55,1.60,0.57,P<0.05或<0.001)。结论我国婴儿早期家长睡眠养育方式以家长安抚入睡、在已睡着的状态下放置床上睡眠和同床睡眠为主,需要加强预见性指导。     

Pure dysgerminoma of the ovary with elevated serum human chorionic gonadotropin: diagnostic and therapeutic considerations

Pure ovarian dysgerminomas with associated elevation of human chorionic gonadotropin (hCG) are rare, and their optimum management is unclear. We report here a 24-year-old woman with stage III dysgerminoma of the ovaries, with bulky intrapelvic disease, paraaortic adenopathy, and elevated pre- and postsurgical serum beta-hCG titers. Following administration of whole abdominal-pelvic and mediastinal irradiation therapy, the patient's adenopathy regressed, her serial beta-hCG titers returned to normal, and she has remained free of disease for the past 30 months. Histopathological studies revealed a pure dysgerminoma with scattered giant cells which were negative for hCG by immunoperoxidase staining. The literature is reviewed with reference to the significance of elevated hCG levels, the presence of giant cells in association with dysgerminoma of the ovary, and therapeutic implications. Serial determinations of beta-hCG titers may prove to be as valuable in the management of these patients as they are in patients with testicular tumors.     

4～7月龄婴儿接种沪_(191)麻疹疫苗临床反应和血清学效果观察

１９９５年在藁城市农村进行了４－７月龄婴儿接种沪１９１麻疹疫苗（ＭＶ）临床反应和血清学效果观察，以及对婴儿母亲麻疹抗体的监测。结果表明：婴儿的母亲麻疹抗体阳性率为８Ｉ．１５％，几何平均滴度倒数（ＧＭＲＴ）为３７３。４～７月龄婴儿胎传抗体阳性率仅为２．１７％，为６一７月龄婴儿接种０．２ｍｌ或０．５ｍｌＭＶ，免疫成功率均８０％，ＧＭＲＴ为２５２－３５６；４月龄婴儿接种０．２ｍｌ和０．５ｍｌＭＶ，免疫成功率分别为３３．３３％和２８．５７％，ＧＭＲＴ分别为１５９和１２２：５月龄婴儿接种０２ｍｌ和０．５ｍｌＭＶ免疫成功率分别为５０．００％和７１．４３％，ＧＭＲＴ分别为２００和２４４。婴儿自身免疫系统的发育完善似乎是决定能否免疫成功的主要因素。接种ＭＶ高热率（＞３８．６℃）为５．３８％，皮疹率为１０％。     

冬病夏治防治慢性阻塞性肺疾病50例

目的 观察穴位敷贴治疗慢性阻塞性肺疾病患者的疗效.方法 采用双盲对比法将100例慢性阻塞性肺疾病患者随机分为2组,治疗组50例,采用沙丁胺醇喷雾剂吸入及特布他林口服联合中药穴位敷贴（中药采用苏子、白芥子、莱菔子、射干等）,敷贴天突、膻中、大椎、定喘等穴;对照组50例,采用单纯沙丁胺醇喷雾剂联合特布他林口服治疗.结果 治疗组发病次数及程度均得到明显改善（P＜0.05）.结论 冬病夏治对于慢性阻塞性肺疾病的发作间隔及缓解症状确有疗效.     

Event-related potentials for 7-month-olds’ processing of animals and furniture items

Event-related potentials (ERPs) to single visual stimuli were recorded in 7-month-old infants. In a three-stimulus oddball paradigm, infants watched one frequently occurring standard stimulus (either an animal or a furniture item) and two infrequently occurring oddball stimuli, presenting one exemplar from the same and one from the different superordinate category as compared to the standard stimulus. Additionally, visual attributes of the stimuli were controlled to investigate whether infants focus on category membership or on perceptual similarity when processing the stimuli. Infant ERPs indicated encoding of the standard stimulus and discriminating it from the two oddball stimuli by larger Nc peak amplitude and late-slow-wave activity for the infrequent stimuli. Moreover, larger Nc latency and positive-slow-wave activity indicated increased processing for the different-category as compared to the same-category oddball. Thus, 7-month-olds seem to encode single stimuli not only by surface perceptual features, but they also regard information of category membership, leading to facilitated processing of the oddball that belongs to the same domain as the standard stimulus.     

6 versus 12 months of adjuvant trastuzumab in HER2+ early breast cancer: A systematic review and meta-analysis

Background:Adjuvant trastuzumab improves survival outcomes of human epidermal receptor 2 positive early breast cancer patients. Currently, administration of 12 months adjuvant trastuzumab is the standard therapy. However, whether 6 months treatment is non-inferior to the standard 12 months treatment remains controversial.Methods:Relevant records were searched in PubMed, Cochrane Library, Web of Science, and EMBASE through Jan 14, 2020. Pooled hazard ratios (HRs) and 95% confidence intervals (CIs) for disease-free survival (DFS) and overall survival (OS) were meta-analyzed. The primary endpoint was DFS with a non-inferiority hazard margin of 1.2 and the second was OS with 1.43.Results:Three randomized clinical studies met the inclusion criteria, including 3974 patients in 6 months group and 3976 in 12 months group. HR for DFS was 1.18 (95% CI 0.97–1.44, P = .09), with the non-inferiority margin comprised in the 95% CI. HR for OS was 1.14 (95% CI 0.98–1.32, P= .08), whereas the upper limit of 95% CI did not exceed the non-inferiority hazard margin.Conclusion:Our analysis failed to show that 6 months treatment was non-inferior to 12 months treatment in improving the DFS. Although the non-inferiority of the 6-month adjuvant trastuzumab treatment was found for OS, considering that breast cancer patients should receive additional systematic therapies when disease progression or relapse happens, we suggest that 12 months adjuvant trastuzumab treatment should remain the standard therapeutic strategy for patients with early human epidermal receptor 2 positive breast cancer.     

A White Dean and Black Physicians at the Epicenter of the Civil Rights Movement

Robert Q. Marston, MD, a gregarious Rhodes and Markel Scholar, native Virginian, and well-connected National Institutes of Health-trained medical scientist found himself the new dean and hospital director of a promising academic medical center at age 38. It was 1961 and the University of Mississippi Medical Center (UMMC) in Jackson was, unknown to him, about to be at the geographic center of the struggle for African American civil rights. That struggle would entangle UMMC in a national search for social justice and change the course of American history and American medicine. Shortly after his arrival, the new dean received and refused a written request from the Secretary of the Mississippi Chapter of the National Medical Association (NMA) to make educational venues at the segregated medical center available to black physicians. The same year, UMMC became the primary medical provider for sick and injured Freedom Riders, sit-in and demonstration participants, and others who breached the racial divide defined by the state's feared Sovereignty Commission. That divide was violently enforced by collaboration among law enforcement, Citizens' Councils, and the Ku Klux Klan. The crescendo of the civil rights struggle that attended Marston's arrival included a deadly riot following James Meredith's integration of the Ole Miss campus in Oxford in 1962, the death of National Association for the Advancement of Colored People (NAACP) Field Secretary Medgar Evers at UMMC in 1963, a national controversy over UMMC's role in the autopsies of 3 civil rights workers murdered in Neshoba County, an attempt at limited compliance to Title VI of the Civil Rights Act of 1964, and a federal civil rights complaint against UMMC by the NAACP Legal and Educational Fund in 1965. That complaint noted that UMMC was out of compliance with the Civil Rights Act of 1964 and seriously threatened its federal funding and academic operations. Marston developed a compliance strategy that included the hiring of the first black faculty member, a request for an immediate federal civil rights inspection, and secretive overnight integration of the hospitals and clinics. A key to his strategy was engagement of support from the black community, with whom he had previously developed no relationship. Marston asked NAACP Field Director Charles Evers for support, and met with 5 black Mississippi physicians. Among the 5 was Robert Smith, MD, a founding member of the Medical Committee for Human Rights, the NMA officer whose request for NMA membership-access to the medical center was ignored. He was unaware of their local and national civil rights roles and active dialogue with the federal government on implementation of Title VI. The desire of the black physicians to see UMMC become an equal opportunity health resource resulted in their quiet assistance that aided UMMC compliance initiatives and played a major role in the successful outcome of the 1965 investigation of the charges of Title VI violations. This success established Marston as a national figure in academic medicine and contributed to his selection for positions as Director of The National Institutes of Health and President of the University of Florida. As commemorations of the 50^th anniversary of Freedom Summer of 1964 proceed, UMMC has become arguably the most racially integrated academic health center in the United States.     

Canadian Registry of Implantable Electronic Device Outcomes: Surveillance of High-Voltage Leads

Background

Cardiac implantable electrical devices (CIEDs) are subject to advisories and complications that can result in morbidity and mortality for patients; there is currently no system in Canada to track these.