Obstetric brachial plexus palsy: a population-based retrospective case-control study and medicolegal considerations

Aims: The aim of this study was to examine 24 cases of obstetric brachial plexus palsy (OBPP) in 41,002 deliveries occurred at San Camillo–Forlanini Hospital in Rome, during the period 2000–2012.

Materials and methods: A population-based retrospective case-control study was designed and the database of the hospital was searched; for each case, maternal and fetal records were examined and some risk factors were evaluated.

Results: A statistically significant association between the 24 cases OBPP and the following risk factors: primiparity (p?p?p?p?p?Conclusions: The absence of OBPP cases in cesarean deliveries highlighted in this study supports the option of proposing an elective cesarean in the presence of known risk factors after a full disclosure with the mother of risks and benefits in order to obtain a valid consent. Furthermore, when cases of OBPP occur, communication between the physician and the parents of newborns is crucial and it may represent a valid risk-management tool to reduce malpractice lawsuits.     

卡贝缩宫素和缩宫素治疗剖宫产高危产妇的效果比较

目的:比较卡贝缩宫素和缩宫素治疗剖宫产高危产妇的效果。方法:选取122例剖宫产高危产妇为研究对象,按照随机数字表法分为观察组与对照组各61例。两组均行剖宫产手术,胎儿娩出后,对照组给予缩宫素治疗,观察组给予卡贝缩宫素治疗,比较两组术中、产后2、24 h出血量,产后加用前列素氨丁三醇率,凝血功能指标[纤维蛋白原(FIB)、D-二聚体(D-D)、凝血酶原时间(PT)、部分凝血活酶时间(APTT)]水平,心率,血压,血红蛋白水平和不良反应发生率。结果:观察组术中、产后2、24 h出血量均低于对照组,差异有统计学意义(P<0.05);观察组加用卡前列素氨丁三醇率为4.92%(3/61),明显低于对照组的16.39%(10/61),差异有统计学意义(P<0.05);术后,两组FIB、D-D水平均高于术前,且观察组高于对照组,两组PT、APTT均短于术前,且观察组短于对照组,差异有统计学意义(P<0.05);术后,两组血红蛋白水平均低于术前,但观察组高于对照组,差异有统计学意义(P<0.05);手术前后,两组心率、血压和不良反应发生率比较,差异均无统计学意义(P>0.05)。结论:卡贝缩宫素治疗剖宫产高危产妇可减少出血量和加用卡前列素氨丁三醇率,提高其术后血红蛋白水平,以及改善凝血功能指标,效果优于缩宫素。     

HBV相关肝癌的治疗方案对HBV再激活的影响

[摘要]　HBV是肝细胞癌（hepatocellular carcinoma, HCC）最重要的危险因素，而HBV再激活很可能加快HCC的发生发展。了解HBV再激活的影响因素对HCC的治疗和预后有重要意义。本文对HCC不同治疗方案对HBV再激活的影响展开综述。     

Arsenic trioxide replacing or reducing chemotherapy in consolidation therapy for acute promyelocytic leukemia (APL2012 trial)

As all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) are widely accepted in treating acute promyelocytic leukemia (APL), deescalating toxicity becomes a research hotspot. Here, we evaluated whether chemotherapy could be replaced or reduced by ATO in APL patients at different risks. After achieving complete remission with ATRA-ATO–based induction therapy, patients were randomized (1:1) into ATO and non-ATO groups for consolidation: ATRA-ATO versus ATRA–anthracycline for low-/intermediate-risk patients, or ATRA-ATO–anthracycline versus ATRA–anthracycline–cytarabine for high-risk patients. The primary end point was to assess disease-free survival (DFS) at 3 y by a noninferiority margin of –5%; 855 patients were enrolled with a median follow-up of 54.9 mo, and 658 of 755 patients could be evaluated at 3 y. In the ATO group, 96.1% (319/332) achieved 3-y DFS, compared to 92.6% (302/326) in the non-ATO group. The difference was 3.45% (95% CI –0.07 to 6.97), confirming noninferiority (P < 0.001). Using the Kaplan–Meier method, the estimated 7-y DFS was 95.7% (95% CI 93.6 to 97.9) in ATO and 92.6% (95% CI 89.8 to 95.4) in non-ATO groups (P = 0.066). Concerning secondary end points, the 7-y cumulative incidence of relapse (CIR) was significantly lower in ATO (2.2% [95% CI 1.1 to 4.2]) than in non-ATO group (6.1% [95% CI 3.9 to 9.5], P = 0.011). In addition, grade 3 to 4 hematological toxicities were significantly reduced in the ATO group during consolidation. Hence, ATRA-ATO in both chemotherapy-replacing and -reducing settings in consolidation is not inferior to ATRA–chemotherapy (https://www.clinicaltrials.gov/, {"type":"clinical-trial","attrs":{"text":"NCT01987297","term_id":"NCT01987297"}}NCT01987297).

The treatment of all-trans retinoic acid (ATRA) combined with anthracycline-based chemotherapy has remarkably improved the prognosis of patients with acute promyelocytic leukemia (APL), achieving over 90% complete remission (CR) and 60 to 80% long-term survival (1–6). For patients relapsed from ATRA-chemotherapy, arsenic trioxide (ATO) was initially used as salvage therapy and showed a satisfactory outcome (7–9). Then, the treatment of newly diagnosed APL with an ATRA-ATO combination therapy was reported in 2004, which demonstrated curative effects in 90% of patients (10–13). The advantage of ATO as the front-line treatment of APL has been further validated by a number of international working groups (14–18). Meanwhile, an exploratory study on ATRA-ATO with or without gemtuzumab ozogamicin (GO, the cytotoxic agent calicheamicin linked an anti-CD33 monoclonal antibody) by the MD Anderson Cancer Center suggested that a deescalating cytotoxic regimen might be feasible for APL patients (14, 19).A large body of evidence has been obtained to show that both ATRA and ATO target the APL-specific PML-RARA oncoprotein and the two agents may exert a synergistic effect in achieving a curative clinical effect in most APL (2, 9). However, in our previous studies, though ATRA-ATO were used as main therapeutic agents for induction, the consolidation was based on chemotherapy rather than ATO, which could cause life-threatening myelosuppression and cardiotoxicity (10, 11). Besides, risk-stratified treatment had not been introduced, leading to probable overtreatment for low- risk (a white blood cell [WBC] count ≤ 10 × 10⁹/L and a platelet count > 40 × 10⁹/L) to intermediate-risk (a WBC count ≤ 10 × 10⁹/L and a platelet count ≤ 40 × 10⁹/L) patients (20). These issues warranted further clinical investigations to address the role of ATRA-ATO in consolidation and to adapt the treatment protocols to distinct clinical risks. In order to optimize the treatment protocols by reducing their relevant toxicities and costs, as well as further improving therapeutic efficacy and tolerance, we proposed a multicenter randomized trial, APL2012, deriving from our previous ATRA-ATO–based therapy taking into consideration of Sanz risk stratification (20). The objective of this study was to examine whether chemotherapy could be replaced or reduced in consolidation therapy by ATO in patients with APL at different risks.     

Rethinking the uncertainty of African swine fever virus contamination in feed ingredients and risk of introduction into the United States

Economically relevant pathogens, such as African swine fever virus (ASFV), have been shown to survive when experimentally inoculated in some feed ingredients under the environmental conditions in transoceanic transport models. However, these models did not characterize the likelihood of virus survival under various time and temperature processes that feed ingredients undergo before they are added to swine diets. Here, we developed a quantitative risk assessment model to estimate the probability that one or more corn or soybean meal ocean vessels (25,000 tonnes) contaminated with ASFV would be imported into the United States annually. This final probability estimate was conditionally based on five likelihoods: the probability of initial ASFV contamination (p0), ASFV inactivation during processing (p1) and transport (p2), recontamination (pR), and ASFV inactivation while awaiting customs clearance at United States entry (p3). The probability of ASFV inactivation was modelled using corn and soybean (extruded or solvent extracted) processing conditions (times and temperatures), D-values (time to reduce 90% or 1-log) estimated from studies of ASFV thermal inactivation in pork serum (p1), and survival in feed ingredients during transoceanic transport (p2 and p3). ‘What-if’ scenarios using deterministic values for p0 and pR (1%, 10%, 25%, 50%, 75%, and 100%) were used to explore their impact on risk. The model estimated complete inactivation of ASFV after extrusion or solvent extraction processes regardless of the initial ASFV contamination probability assumed. The value of recontamination (ranging from 1% to 75%) was highly influential on the risk of one ASFV-contaminated soybean meal vessel entering the United States. Median risk estimates ranged from 0.064% [0.006%–0.60%; 95% probability interval (PI)], assuming a pR of 1.0%, up to 4.67% (0.45%–36.50% 95% PI) assuming a pR of 75.0%. This means that at least one vessel with ASFV-contaminated soybean meal would be imported once every 1563–21 years, respectively. When all raw corn was assumed to be contaminated (p0 = 100%), and no recontamination was assumed to occur (pR = 0%), the median probability of one vessel with ASFV-contaminated corn entering the United States was 2.02% (0.28%–9.43% 95% PI) or once every 50 years. Values of recontamination between 1% and 75% did not substantially change the risk of corn. Days of transport, virus survival during transport (D-value), and number of vessels shipped were the parameters most influential for increased likelihood of a vessel with ASFV-contaminated soybean meal or corn entering the United States. The model helped to identify knowledge gaps that are most influential on output values and serves as a framework that could be updated and parameterized as new scientific information becomes available. We propose that the quantitative risk assessment model developed in this study can be used as a framework for estimating the risk of ASFV entry into the United States and other ASFV-free countries through other types of imported feed ingredients that may potentially become contaminated. Ultimately, this model can be used to develop risk mitigation strategies and critical control points for inactivating ASFV during feed ingredient processing, storage, and transport, and contribute to the design and implementation of biosecurity measures to prevent the introduction of ASFV into the United States and other ASFV-free countries.     

Amylase level after pancreaticoduodenectomy in predicting postoperative pancreatic fistula

BackgroundIt is new clinical interest higher serum amylase level with pancreatitis after pancreaticoduodenectomy (PD) correlates with postoperative pancreatic fistula (POPF). Nevertheless, its evidence and study were scarce. We aimed to investigate correlation of serum amylase level immediate after PD and POPF occurrence.MethodsOf 163 patients who underwent PD at between January 2009 and December 2019, retrospective analysis was conducted to identify risk factors including serum amylase level immediate after PD for POPF occurrence.ResultsOverall incidence of POPF (25/163) was 15.3%. The patients occurred a POPF had significantly higher level of serum amylase on POD0 compared to in whom without a POPF (414 vs 253, p < 0.001). In univariate analysis, ASA classification, post pancreatectomy acute pancreatitis (POAP, serum amylase on POD0 >285IU/L) and Fistula Risk Grade were correlated with POPF occurrence. In multivariable analysis, Fistula risk grade and POAP were significantly associated with developing POPF.ConclusionIn patients with higher serum amylase (>285IU/L) on POD0 with higher fistula risk grade, comprehensive management to achieve mitigation of POPF is important.