龙岩市2009-2010年疑似预防接种异常反应监测分析

目的分析2009—2010年度龙岩市预防接种疑似异常反应（AEFI）信息管理系统报告的疑似异常反应,评价AEFI信息管理系统报告质量和疫苗安全性。方法根据《疑似预防接种异常反应信息管理系统》数据,用描述性流行病学方法进行分析。结果2009—2010年两年全市共开展17类24种疫苗预防接种异常反应监测,共报告AEF1176例,其中异常反应占48．86％,一般反应占46．59％,偶合症占3．41％,心因性反应占1．14％。百白破类疫苗（包括全细胞百白破疫苗和无细胞百白破疫苗）引起AEFI的发生率最高,达41．51／10万剂次。一般反应中多数为红肿发热（74．39％）,异常反应中最常见的临床症状是过敏性皮疹（43．02％）。≤1岁婴儿发生AEFI最多,占40．34％。AEFI报告完整率达100％,48h内及时报告率达87．5％,48h及时调查率达98．65％。结论AEFI报告质量和疫苗安全性良好,全市AEFI监测的完整性和及时性较好,但报告和调查及时性有待提高。     

Predictors of Survival after Yttrium-90 Radioembolization of Chemotherapy-Refractory Hepatic Metastases from Breast Cancer

PurposeTo determine predictors of survival after transarterial radioembolization of hepatic metastases from breast cancer.Materials and MethodsTwenty-four patients with chemotherapy-refractory hepatic metastases from breast cancer who underwent radioembolization from 2013 to 2018 were evaluated based on various demographic and clinical factors before and after treatment. Overall survival (OS) was estimated by Kaplan–Meier method. Log-rank analysis was performed to determine predictors of prolonged OS from the time of first radioembolization and first hepatic metastasis diagnosis.ResultsMedian OS times were 35.4 and 48.6 months from first radioembolization and time of hepatic metastasis diagnosis, respectively. Radioembolization within 6 months of hepatic metastasis diagnosis was a positive predictor of survival from first radioembolization, with median OS of 38.9 months vs 22.1 months for others (P = .033). Estrogen receptor (ER)–positive status predicted prolonged survival (38.6 months for ER⁺ vs 5.4 months for ER⁻; P = .005). The presence of abdominal pain predicted poor median OS: 12.8 months vs 38.6 months for others (P < .001). The presence of ascites was also a negative predictor of OS (1.7 months vs 35.4 months for others; P = .037), as was treatment-related grade ≥ 2 toxicity at 3 months (5.4 months vs 38.6 months for others; P = .017).ConclusionsIn patients with metastatic breast cancer, radioembolization within 6 months of hepatic metastasis diagnosis and ER⁺ status appear to be positive predictors of prolonged survival. Conversely, baseline abdominal pain, baseline ascites, and treatment-related grade ≥ 2 toxicity at 3 months after treatment appear to be negative predictors of OS.     

Comparative Analysis of Safety and Efficacy of Transarterial Chemoembolization for the Treatment of Hepatocellular Carcinoma in Patients with and without Pre-Existing Transjugular Intrahepatic Portosystemic Shunts

PurposeTo compare the safety and efficacy of transarterial chemoembolization for hepatocellular carcinoma (HCC) in patients with and without transjugular intrahepatic portosystemic shunts (TIPS).Materials and MethodsThis single-institution study included a retrospective review of 50 patients who underwent transarterial chemoembolization for HCC between January 2010 and April 2017. Twenty-five patients had preexisting TIPS, and 25 patients were selected to control for age, sex, and target tumor size. Baseline median Model for End-Stage Liver Disease (MELD; 13 TIPS, 9 control; P < .001) and albumin-bilirubin (ALBI; 3 TIPS, 2 control; P < .001) differed between groups. Safety was assessed on the basis of Common Terminology Criteria for Adverse Events (CTCAE) and change in MELD and ALBI grade assessed between 3 and 6 months. Efficacy was assessed by tumor response and time to progression (TTP).ResultsThere was 1 severe adverse event (CTCAE grade >2) in the TIPS group. There was no difference in the change in MELD or ALBI grade. Although there was no difference in tumor response (P = .19), more patients achieved a complete response in the control group (19/25, 76%) than in the TIPS group (13/25, 52%). There was no difference in TTP (P = .82). At 1 year, 2 patients in the control group and 3 patients in the TIPS group received a liver transplant. Seven patients died in the TIPS group.ConclusionsTransarterial chemoembolization is as safe and effective in patients with TIPS as in patients without TIPS, despite worse baseline liver function. Severe adverse events are rare and may be transient.     

冠心病患者冠状动脉介入治疗前后血浆高敏C反应蛋白水平的变化及其与主要不良心血管事件的关系

目的通过比较冠心病患者药物洗脱支架植入前后血浆高敏C反应蛋白(hs-CRP)的变化,判断机体介入前后炎症状况,并随访不良心血管事件,分析炎症因子与主要不良心血管事件的关系。方法入选从2013年10月1日至2014年6月17日在北京大学第一医院心血管内科就诊并行冠状动脉介入治疗的冠心病患者,签署知情同意书,收集其临床资料和介入手术情况,采集其介入治疗前、介入治疗后1天及30天的血样标本,测定hs-CRP浓度,比较介入治疗前后hs-CRP的变化,介入治疗1年后电话随访所有入选患者,收集主要不良心血管事件的发生率。结果共入选资料完整的冠心病患者84例。介入治疗1天后血浆hs-CRP水平与术前无显著差异(10.00±24.81 mg/L比7.52±17.90 mg/L,P=0.409),介入治疗30天后血浆hs-CRP水平较术前明显降低(2.80±4.66mg/L比7.52±17.90 mg/L,P0.001),较术后1天亦显著降低(P0.001);介入治疗后1年内有16人发生主要不良心血管事件,有事件的患者术前hs-CRP水平高于无事件患者(10.38±19.40 mg/L比6.84±17.61 mg/L,P=0.018),但术后1天hs-CRP水平无显著差异(12.91±27.76 mg/L比9.32±24.24 mg/L,P=0.175),术后30天hsCRP水平亦无显著差异(3.54±5.98 mg/L比2.63±4.32 mg/L,P=0.316)。结论冠心病患者介入治疗前hsCRP水平与术后1年内主要不良心血管事件的发生率存在正相关。冠心病患者围手术期的炎症反应在介入治疗30天后逐渐消退,这种变化可通过hs-CRP的浓度变化得到反映。     

Phase 0 Study of Vandetanib-Eluting Radiopaque Embolics as a Preoperative Embolization Treatment in Patients with Resectable Liver Malignancies

PurposeTo assess the safety and tolerability of a vandetanib-eluting radiopaque embolic (BTG-002814) for transarterial chemoembolization (TACE) in patients with resectable liver malignancies.Materials and MethodsThe VEROnA clinical trial was a first-in-human, phase 0, single-arm, window-of-opportunity study. Eligible patients were aged ≥18 years and had resectable hepatocellular carcinoma (HCC) (Child-Pugh A) or metastatic colorectal cancer (mCRC). Patients received 1 mL of BTG-002814 transarterially (containing 100 mg of vandetanib) 7–21 days prior to surgery. The primary objectives were to establish the safety and tolerability of BTG-002814 and determine the concentrations of vandetanib and the N-desmethyl vandetanib metabolite in the plasma and resected liver after treatment. Biomarker studies included circulating proangiogenic factors, perfusion computed tomography, and dynamic contrast-enhanced magnetic resonance imaging.ResultsEight patients were enrolled: 2 with HCC and 6 with mCRC. There was 1 grade 3 adverse event (AE) before surgery and 18 after surgery; 6 AEs were deemed to be related to BTG-002814. Surgical resection was not delayed. Vandetanib was present in the plasma of all patients 12 days after treatment, with a mean maximum concentration of 24.3 ng/mL (standard deviation ± 13.94 ng/mL), and in resected liver tissue up to 32 days after treatment (441–404,000 ng/g). The median percentage of tumor necrosis was 92.5% (range, 5%–100%). There were no significant changes in perfusion imaging parameters after TACE.ConclusionsBTG-002814 has an acceptable safety profile in patients before surgery. The presence of vandetanib in the tumor specimens up to 32 days after treatment suggests sustained anticancer activity, while the low vandetanib levels in the plasma suggest minimal release into the systemic circulation. Further evaluation of this TACE combination is warranted in dose-finding and efficacy studies.     

Left Ventricular End-Diastolic Pressure Versus Urine Flow Rate–Guided Hydration in Preventing Contrast-Associated Acute Kidney Injury

ObjectivesThis study compared left ventricular end-diastolic pressure (LVEDP)–guided and urine flow rate (UFR)-guided hydration.BackgroundTailored hydration regimens improve the prevention of contrast-associated acute kidney injury (CA-AKI).MethodsBetween July 15, 2015, and June 6, 2019, patients at high risk for CA-AKI scheduled for coronary and peripheral procedures were randomized to 2 groups: 1) normal saline infusion rate adjusted according to the LVEDP (LVEDP-guided group); and 2) hydration controlled by the RenalGuard System in order to reach UFR ≥300 ml/h (UFR-guided group). The primary endpoint was the composite of CA-AKI (i.e., serum creatinine increase ≥25% or ≥0.5 mg/dl at 48 h) and acute pulmonary edema (PE). Major adverse events (all-cause death, renal failure requiring dialysis, PE, and sustained kidney injury) at 1 month were assessed.ResultsThe primary endpoint occurred in 20 of 351 (5.7%) patients in the UFR-guided group and in 36 of 351 (10.3%) patients in the LVEDP-guided group (relative risk [RR]: 0.560; 95% confidence interval [CI]: 0.390 to 0.790; p = 0.036). CA-AKI and PE rates in the UFR-guided group and LVEDP-guided group were 5.7% and 10.0% (RR: 0.570; 95% CI: 0.300 to 0.960; p = 0.048), and, respectively, 0.3% and 2.0% (RR: 0.070; 95% CI: 0.020 to 1.160; p = 0.069). Three patients in the UFR-guided group experienced complications related to the Foley catheter. Hypokalemia rate was 6.2% in the UFR-guided group and 2.3% in the LVEDP-guided group (p = 0.013). The 1-month major adverse events rate was 7.1% in the UFR-guided group and 12.0% in the LVEDP-guided group (p = 0.030).ConclusionsThe study demonstrates that UFR-guided hydration is superior to LVEDP-guided hydration to prevent the composite of CA-AKI and PE.     

Clinical outcome of adjuvant radiotherapy for squamous cell carcinoma of the breast; a multicenter retrospective cohort study

BackgroundBecause primary squamous cell carcinoma (SCC) of the breast is a rare disease, the standard therapy has not been established. We examined the clinical outcomes of postoperative adjuvant radiotherapy for breast SCC.Material and methodsWe conducted a multicenter retrospective cohort study. Patients diagnosed with primary breast SCC who received adjuvant radiotherapy as part of their primary definitive treatment were included. Overall survival (OS), breast cancer-specific survival (BCSS), and recurrence-free interval (RFi) were evaluated.ResultsBetween January 2002 and December 2017, 25 breast SCC patients received adjuvant radiotherapy as a primary treatment were included. Median follow-up time was 43.5 months. Three (12%), fifteen (60%) and seven (28%) patients had clinical stage I, II and III disease, respectively. Fourteen patients underwent breast-conserving surgery and subsequent adjuvant radiotherapy. Eleven patients underwent mastectomy and post-mastectomy radiotherapy. Ten patients received regional lymph node irradiation. Nine (36%) patients had disease recurrence. The first site of recurrence was locoregional in five, but distant metastasis arose in one. Concurrent local and distant metastasis were seen in two. Six cases of local recurrence occurred within the irradiated site. Seven patients died, and six of the deaths were due to breast cancer. Five-year OS, BCSS, and Rfi were 69%, 70%, and 63%, respectively. In multivariate analysis, age and lymphatic invasion were associated with increased risk of recurrence.ConclusionBreast SCC has a high incidence of locoregional recurrence and poor prognosis. Age and lymphatic invasion are significant risk factors for recurrence.     

1例用药近似错误事件的根因分析

通过根本原因分析法,对1例潜在严重后果的手术患者止血药物近似错误案例进行剖析,探讨医嘱管理、相似药品、沟通不良、药物相关知识缺乏、惯性思维等对安全用药的影响。口头指示不清或不明可能导致用药错误,口头医嘱存在较高风险;医护人员用药知识不丰富是医嘱错误常见原因之一;系统不完善可能导致用药差错。确保用药安全需要优化制度流程,加强临床医务工作者的有效沟通与协作,强化医务人员角色功能定位以及完善系统等。