Fourteen years of the Pregnancy Registry on maternal immunisation with a reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap) vaccine

BackgroundGSK initiated a Pregnancy Registry in the United States (US) for the reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap; Boostrix, GSK) vaccine with the aim to detect and describe pregnancy outcomes in women vaccinated with Boostrix 28 days before estimated conception or during pregnancy.MethodsVoluntary reports of pregnancy exposure to Boostrix received from spontaneous and post-marketing surveillance sources in the US were assessed. Reports were classified as prospective or retrospective based on the knowledge of pregnancy outcomes at the time of reporting. For completeness, reports of exposure to Boostrix or to the Tdap-inactivated poliovirus vaccine (Boostrix-IPV, GSK) reported to the global safety database from countries outside the US were also evaluated.ResultsFrom May 2005 to August 2019, 1517 (1455 prospective and 62 retrospective) pregnancy reports were received in the Boostrix US Pregnancy Registry. Of the prospective reports, 250 had known outcomes: 244 live infants with no apparent birth defects (BDs), three live infants with BDs, and three spontaneous abortions with no apparent BDs. Of the retrospective reports, 55 had known outcomes: 33 live infants with no apparent BDs, 16 live infants with BDs, one spontaneous abortion with no apparent BDs, four stillbirths with no apparent BDs, and one stillbirth with BDs. Cumulatively, 1321 pregnancy reports (1006 for Boostrix; 315 for Boostrix-IPV) were received from countries outside the US. Of these, 163 prospective reports and 551 retrospective reports had known outcomes. Results were in line with those from the Boostrix US Pregnancy Registry.ConclusionsData currently available from the Boostrix US Pregnancy Registry and from countries outside the US suggested that exposure to Boostrix or Boostrix-IPV during pregnancy does not raise safety concerns related to adverse pregnancy outcomes or BDs.     

Stratification of complexity in congenital heart surgery: comparative study of the Risk Adjustment for Congenital Heart Surgery (RACHS-1) method, Aristotle basic score and Society of Thoracic Surgeons-European Association for Cardio- Thoracic Surgery (STS-EACTS) mortality score

Objective

To determine whether stratification of complexity models in congenital heart surgery (RACHS-1, Aristotle basic score and STS-EACTS mortality score) fit to our center and determine the best method of discriminating hospital mortality.

Methods

Surgical procedures in congenital heart diseases in patients under 18 years of age were allocated to the categories proposed by the stratification of complexity methods currently available. The outcome hospital mortality was calculated for each category from the three models. Statistical analysis was performed to verify whether the categories presented different mortalities. The discriminatory ability of the models was determined by calculating the area under the ROC curve and a comparison between the curves of the three models was performed.

Results

360 patients were allocated according to the three methods. There was a statistically significant difference between the mortality categories: RACHS-1 (1) - 1.3%, (2) - 11.4%, (3)-27.3%, (4) - 50 %, (P<0.001); Aristotle basic score (1) - 1.1%, (2) - 12.2%, (3) - 34%, (4) - 64.7%, (P<0.001); and STS-EACTS mortality score (1) - 5.5 %, (2) - 13.6%, (3) - 18.7%, (4) - 35.8%, (P<0.001). The three models had similar accuracy by calculating the area under the ROC curve: RACHS-1- 0.738; STS-EACTS-0.739; Aristotle- 0.766.

Conclusion

The three models of stratification of complexity currently available in the literature are useful with different mortalities between the proposed categories with similar discriminatory capacity for hospital mortality.     

Factors associated with moderate or severe left atrioventricular valve regurgitation within 30 days of repair of incomplete atrioventricular septal defect

Introduction

Left atrioventricular valve regurgitation is the most concerning residual lesion after surgical correction of atrioventricular septal defect.

Objective

To determine factors associated with moderate or greater left atrioventricular valve regurgitation within 30 days of surgical repair of incomplete atrioventricular septal defect.

Methods

We assessed the results of 51 consecutive patients 14 years-old and younger presenting with incomplete atrioventricular septal defect that were operated on at our practice between 2002 and 2010. The following variables were considered: age, weight, absence of Down syndrome, grade of preoperative left atrioventricular valve regurgitation, abnormalities on the left atrioventricular valve and the use of annuloplasty. The median age was 4.1 years; the median weight was 13.4 Kg; 37.2% had Down syndrome. At the time of preoperative evaluation, there were 23 cases with moderate or greater left atrioventricular valve regurgitation (45.1%). Abnormalities on the left atrioventricular valve were found in 17.6%; annuloplasty was performed in 21.6%.

Results

At the time of postoperative evaluation, there were 12 cases with moderate or greater left atrioventricular valve regurgitation (23.5%). The variation between pre- and postoperative grades of left atrioventricular valve regurgitation of patients with atrioventricular valve malformation did not reach significance (P=0.26), unlike patients without such abnormalities (P=0.016). During univariate analysis, only absence of Down syndrome was statistically significant (P=0.02). However, after a multivariate analysis, none of the factors reached significance.

Conclusion

None of the factors studied was determinant of a moderate or greater left atrioventricular valve regurgitation within the first 30 days of repair of incomplete atrioventricular septal defect in the sample. Patients without abnormalities on the left atrioventricular valve benefit more of the operation.     

应用一侧颊肌粘膜瓣修复全下唇唇红缺损的初步报告

目的：介绍应用颊肌粘膜瓣修复全下唇唇红缺损的经验。方法：外伤和肿瘤切除后引起的4例全下唇唇红缺损行蒂在121角带血管蒂的颊肌粘膜瓣转移修复，术后观察红唇形态和功能的恢复情况。结果：全部颊肌粘膜瓣完全成活，无感染、血肿、导管或神经损伤及张121障碍。红唇的长度、高度、厚度及感觉都得到恢复。结论：蒂在121角的颊肌粘膜瓣能提供足够的组织修复全下唇唇红缺损，术后形态和功能恢复好，不需二期断蒂。     

低温保存成骨细胞复合生物活性玻璃陶瓷修复兔下颌骨缺损

目的 观察经低温保存的兔骨膜源性成骨细胞(POBs)的生物学特征,及其与生物活性玻璃陶瓷(BGC)体外复合后修复颌骨缺损的能力。方法 将经鉴定的幼兔骨膜源性成骨细胞置入液氮罐中保存,取冻存6个月的细胞做生物学鉴定,并进行体外培养扩增,然后与BGC复合培养,植入兔下颌骨缺损处,对照组为植入单纯BGC组。术后第2、4、8、12周取材,行X线摄片及组织学检查,观察复合材料的成骨能力。结果 复苏的成骨细胞仍具有典型的成熟成骨细胞的生物学特征,与BGC复合植入体内后,能继续生长增殖并形成骨组织,能较快较好地修复骨缺损。结论 利用冻存复苏的成骨细胞进行组织工程学研究是可行的,细胞与材料复合所形成的组织工程化骨,可望在骨组织的修复与重建中得到更加广泛的应用。     

EDEC概念应用于牙列缺损修复的病例报告

目的 阐明EDEC的具体涵义,以更好地指导牙列缺损病例修复,减少盲目性和风险.方法 通过具体病例修复的实现过程,展示EDEC概念的临床指导作用.结果 EDEC概念具有明显的临床指导作用,修复结果与预期一致,避免了临床中的盲目性.结论 EDEC概念对牙列缺损修复有明显的指导意义,适合在临床中推广应用.     

Congenital Heart Disease as a Warning Sign for the Diagnosis of the 22q11.2 Deletion

Background

To alert for the diagnosis of the 22q11.2 deletion syndrome (22q11.2DS) in patients with congenital heart disease (CHD).

Objective

To describe the main CHDs, as well as phenotypic, metabolic and immunological findings in a series of 60 patients diagnosed with 22q11.2DS.

Methods

The study included 60 patients with 22q11.2DS evaluated between 2007 and 2013 (M:F=1.3, age range 14 days to 20 years and 3 months) at a pediatric reference center for primary immunodeficiencies. The diagnosis was established by detection of the 22q11.2 microdeletion using FISH (n = 18) and/or MLPA (n = 42), in association with clinical and laboratory information. Associated CHDs, progression of phenotypic facial features, hypocalcemia and immunological changes were analyzed.

Results

CHDs were detected in 77% of the patients and the most frequent type was tetralogy of Fallot (38.3%). Surgical correction of CHD was performed in 34 patients. Craniofacial dysmorphisms were detected in 41 patients: elongated face (60%) and/or elongated nose (53.3%), narrow palpebral fissure (50%), dysplastic, overfolded ears (48.3%), thin lips (41.6%), elongated fingers (38.3%) and short stature (36.6%). Hypocalcemia was detected in 64.2% and decreased parathyroid hormone (PTH) level in 25.9%. Decrease in total lymphocytes, CD4 and CD8 counts were present in 40%, 53.3% and 33.3%, respectively. Hypogammaglobulinemia was detected in one patient and decreased concentrations of immunoglobulin M (IgM) in two other patients.

Conclusion

Suspicion for 22q11.2DS should be raised in all patients with CHD associated with hypocalcemia and/or facial dysmorphisms, considering that many of these changes may evolve with age. The 22q11.2 microdeletion should be confirmed by molecular testing in all patients.     

The Survey of Birth Defects Rate Based on Birth Registration System

Background:To investigate the surveillance trend of birth defects,incidence,distribution,occurrence regularity,and their relevant factors in Xi'an City in the last 10 years for proposing control measur...     

四腔心平面与九平面彩超在诊断胎儿先天性心脏病的价值比较

【目的】比较四腔心平面与九平面联合彩超在胎儿先天性心脏病中的诊断价值。【方法】选择先天性心脏病胎儿80例,分别采用四腔心平面彩超与九平面彩超检查,比较两种方法的阳性符合率。【结果】九平面彩超检出声像阳性符合率93．5％（101／108）明显高于四腔心平面彩超的阳性符合率46．3％（50／108） ,其差异有统计学意义（ P ＜0．05）。【结论】九平面彩超检查胎儿先天性心脏病,检出声像阳性符合率高,值得临床推广应用。     

胸骨下段小切口在低龄儿童简单先心病直视修补术中的应用

目的：报道经胸骨下段小切口修补房／室间隔缺损术式的应用经验。方法按以下标准分为两组：1.胸骨下段小切口组：2013年8月至2014年2月连续房／室间隔缺损患者32例,均经胸骨下段小切口在心脏停跳下修补房／室间隔缺损;2.常规开胸组：2012年2月至2014年2月近两年行常规开胸房／室缺手术113例,使用倾向性评分方法选出32例,使其年龄、体重、性别比例及缺损大小、主要手术类型与胸骨下段小切口组相仿,均行常规胸骨正中劈开切口,在心脏停跳下进行修补手术。收集相关病历资料,比较两组的手术时间、体外循环时间、术后机械通气时间、术后引流量及术后住院天数。结果胸骨下段小切口组与常规开胸组相比,切口长度、术后机械通气时间及术后24 h 引流量显著短于后者而手术时间、ICU 停留时间及术后住院天数无显著差异。结论经胸骨下段小切口修补房／室间隔缺损是一种安全、可靠、美观、恢复快且疼痛小的微创手术方法。