胸腔镜下心包厚壁囊肿切除术1例报告

面对来势汹汹的新型冠状病毒肺炎(COVID-19),如何能够正确、快速诊断和筛检出确诊病例显得尤为重要,国内诸多科技工作者都在积极开展相关的诊断试验研究。本文回顾了目前正在开展的十余项诊断试验的注册信息,针对其中存在的共性问题进行了讨论,重点阐述了如何使用PICOS原则构造COVID-19诊断试验的研究问题,还对金标准的设置、受试者的代表性、样本量计算和同步、独立、盲法的测定等诊断试验的设计要点进行了详细说明。旨在为广大研究者提供开展COVID-19诊断试验的设计建议,帮助研究者在顶层设计阶段减少、避免偏倚,完成高质量的临床研究,为临床诊疗提供循证医学证据。     

加速康复外科理念在脊柱结核围手术期护理中的应用效果分析

目的: 分析探讨加速康复外科(ERAS)理念在脊柱结核围手术期护理应用中的效果。 方法: 收集青岛市胸科医院外科2017年7月至2020年6月收治的147例脊柱结核患者。其中,2017年7月至2018年12月收治的68例脊柱结核手术患者围手术期应用常规护理,作为对照组;2019年1月至2020年6月收治的79例脊柱结核手术患者在常规护理措施基础上融入了ERAS理念,作为ERAS组。比较两组患者的引流管拔除、最初下床进行功能锻炼、最初自主排尿的时间,术后72h疼痛(采用视觉模拟评分法)评分,住院天数,恶心呕吐、肺部感染、药物性肝损伤的发生率,以及患者满意度的差异。 结果: 与对照组相比,ERAS组患者引流管拔除时间[6.00(4.00,8.00)d和8.00(7.00,8.00)d;W=4321.000,P<0.001]、最初下床进行功能锻炼时间[2.00(2.00,4.00)d和5.50(4.25,6.00)d;W=3376.000,P<0.001]、首次在床上自主排尿时间[5.00(3.00,6.00)h和9.00(7.00,9.00)h;W=3369.000,P<0.001]、术后72h疼痛评分[3.00(2.00,4.00)分和5.00(5.00,6.00)分;W=4078.500,P<0.001]、住院总天数[19.00(18.00,21.00)d和22.00(19.00,27.00)d;W=4791.500,P<0.001]均有所下降,差异均有统计学意义。与对照组相比,ERAS组术后恶心呕吐发生率[7.6%(6/79)和19.1%(13/68);χ²=4.311,P=0.038]、肺部感染发生率[2.5%(2/79)和11.8%(8/68);χ²=4.914,P=0.027]、药物性肝损伤发生率[1.3%(1/79)和13.2%(9/68),χ²=8.258,P=0.004]均有所下降,差异均有统计学意义。ERAS组患者满意度高于对照组[96.2%(76/79)和85.3%(58/68),χ²=7.100,P=0.008],差异有统计学意义。 结论: ERAS理念应用于脊柱结核围手术期护理可以加速患者的康复,减少并发症的发生,提高患者的满意度。     

Clinical observation on the effect of Chinese medicine-“TCM formula” intervention on recurrence and metastasis of triple negative breast cancer

ObjectiveThis study used a prospective cohort study to observe the effect of triple-negative breast cancer on the 2-year disease-free survival rate with or without “TCM formula”.MethodsFrom November 1 st, 2016, the first patient was enrolled in the cohort study. A total of 356 patients were enrolled on January 30, 2019. Among them, 154 cases were followed up for 2 years. During the follow-up, there were 6 cases of shedding, so 6 cases were affected. A total of 148 cases were included in the analysis, including 73 in the exposed group and 75 in the non-exposed group. The exposed group was given “TCM formula” on the basis of standardized treatment, and the non-exposed group was treated with simple triple-negative breast cancer. The two groups visited each of the three months. The interview included safety examination (hematology and imaging). The endpoint was the difference in 2-year invasive disease-free survival between the exposed and non-exposed groups and the safety of the “TCM formula”.ResultsThere were 6 cases of shedding during the experiment and the shedding rate was 3.9 %. The 2-year rate of invasive disease-free survival in the exposed team was 88.7 % and the non-exposed group was 82.5 %. Logistic multivariate regression analysis predicted that “TCM formula” could reduce the disease-related recurrence and metastasis rate by 11 % (OR = 0.89, 95 % CI 0.37−0.956, P＜0.05). Through K–M survival analysis, TNBC patients with age ≤35 years and regional lymph node stage N1 may be the benefit group of “TCM formula”(P＜0.05). During the study, the incidence of total adverse events was 8.2 % in the exposed group, mainly manifested as stomach discomfort, diarrhea, and hepatocyte damage.Conclusion1. In the exposed group, the two-year rate of invasive disease-free survival increased by 6.2 % compared with the non-exposed group(P＞0.05). 2. According to K–M survival analysis, TNBC patients with age ≤35 years and regional lymph node metastasis to N1 may be potential beneficiaries of “TCM formula”. 3. “TCM Formula” is safe and tolerable to most patients.     

Three-dimensional measurement of radiographic bone–implant contact lengths of zygomatic implants in zygomatic bone: a retrospective study of 66 implants in 28 patients

Zygomatic implant treatment is widely applied for severe maxillary atrophy to help rehabilitate the maxillary dentition. This retrospective study was performed to evaluate the actual radiographic bone–implant contact (rBIC) lengths of zygomatic implants. The records of 28 patients who underwent zygomatic implant surgery and subsequent follow-up examinations between August 2013 and September 2018 in the Department of Oral and Maxillofacial Surgery, Taipei Tzu Chi Hospital were reviewed. The surgeries were performed by a single surgeon using the same treatment protocol. All patients had a computed tomography scan at 1 year after the surgery. Using three-dimensional imaging software, an investigator measured the rBIC lengths of 66 implants and documented their clinical status. The implant survival rate was 100%. The mean rBIC length was significantly longer in male patients than in female patients (20.80 ± 5.88 mm versus 17.79 ± 6.34 mm; P = 0.028). The mean rBIC length of double zygomatic implants was significantly longer when compared to that of single implants (21.11 ± 6.23 mm versus 17.75 ± 5.85 mm; P = 0.027). This article is novel in reporting the exact rBIC lengths of zygomatic implants in a clinical setting. The results showed that zygomatic implants are a viable treatment modality for full-mouth rehabilitation.     

Treatment sequence network meta-analysis in Crohn’s disease: a methodological case study

Objective: Several biologic therapies are available for the treatment of mild-to-moderate Crohn’s disease (CD). This network meta-analysis (NMA) aimed to assess the comparative efficacy of ustekinumab, adalimumab, vedolizumab and infliximab in the maintenance of clinical response and remission after 1?year of treatment.

Methods: A systematic literature search was performed to identify relevant randomized controlled trials (RCTs). Key outcomes of interest were clinical response (CD activity index [CDAI] reduction of 100 points; CDAI-100) and remission (CDAI score under 150 points; CDAI < 150). A treatment sequence Bayesian NMA was conducted to account for the re-randomization of patients based on different clinical definitions, the lack of similarity of the common comparator for each trial and the full treatment pathway from the induction phase onwards.

Results: Thirteen RCTs were identified. Ustekinumab 90?mg q8w was associated with statistically significant improvement in clinical response relative to placebo and vedolizumab 300?mg. For clinical remission, ustekinumab 90?mg q8w was associated with statistically significant improvement relative to placebo and vedolizumab 300?mg q8w. Findings from sub-population analyses had similar results but were not statistically significant.

Conclusions: The NMA suggest that ustekinumab is associated with the highest likelihood of reaching response or remission at 1?year compared with placebo, adalimumab and vedolizumab. Results should be interpreted with caution because this is a novel methodology; however, the treatment sequence analysis may be the most methodologically sound analysis to derive estimates of comparative efficacy in CD in the absence of head-to-head evidence.     

Access to mechanical thrombectomy for cerebral ischaemia: A population-based study in the North-of-France

Background and purposeHospitals admitting acute strokes should offer access to mechanical thrombectomy (MT), but local organisations are still based on facilities available before MT was proven effective. MT rates and outcomes at population levels are needed to adapt organisations. We evaluated rates of MT and outcomes in inhabitants from the North-of-France (NoF) area.MethodWe prospectively evaluated rates of MT and outcomes of patients at 3 months, good outcomes being defined as a modified Rankin scale (mRS) 0 to 2 or like the pre-stroke mRS.ResultsDuring the study period (2016–2017), 666 patients underwent MT (454, 68.1% associated with intravenous thrombolysis [IVT]). Besides, 1595 other patients received IVT alone. The rate of MT was 81 (95% confidence interval [CI] 72–90) per million inhabitants-year, ranging from 36 to 108 between districts. The rate of IVT was 249 (95% CI 234–264) per million inhabitants-year, ranging from 155 to 268. After 3 months, 279 (41.9%) patients who underwent MT had good outcomes, and 167 (25.1%) had died. Patients living outside the district of Lille where the only MT centre is, were less likely to have good outcomes at 3 months, after adjustment on age, sex, baseline severity, and delay.ConclusionThe rate of MT is one of the highest reported up to now, even in low-rate districts, but outcomes were significantly worse in patients living outside the district of Lille, and this is not only explained by the delay.