Implementing Real-World RECIST-based Tumor Response Assessment in Patients With Metastatic Non-small Cell Lung Cancer

BackgroundTo accelerate drug approvals while maintaining scientific rigor in the evaluation of a therapeutic's efficacy and safety, the United States Food and Drug Administration now considers real-world data (RWD) to support New Drug Applications and expanded indications. Response Evaluation Criteria in Solid Tumors (RECIST) are the gold standard in clinical trials, but the derivation of RECIST-based treatment response from RWD is unproven. This study investigated the feasibility of implementing RECIST criteria in RWD by comparing lung cancer response assessments from RECIST-based measurement of lesions on archived radiologic films with results from medical oncologist and radiologist narratives recorded in electronic health records (EHR).Materials and MethodsResponse to index treatment via different assessment approaches was compared among 30 metastatic non-small cell lung cancer (mNSCLC) patients receiving systemic treatment (index) after progression on a platinum or anti-PD(L)-1-containing regimen. Specifically, responses based on assessments documented in the medical oncologists’ narratives were compared to a radiologist's assessments of archived images using RECIST v1.1 criteria. Each patient's best overall response was characterized as complete or partial (CR/PR), stable disease (SD), progressive disease (PD), or not evaluable (NE).ResultsSimilar distributions of best overall response and substantial concordance (77%) between medical oncologist-reported and radiologist re-assessed responses were observed. There were no instances of CR/PR to PD or PD to CR/PR discordance.ConclusionsResults suggest that accurate treatment responses, similar to RECIST, may be derived using RWD. Further validation and improvement of real-world response assessment are needed to develop a scalable real-world approach for response assessment.     

Delayed haemolytic transfusion reaction due to Kidd antibodies

A delayed haemolytic transfusion reaction (DHTR) encompasses a positive direct antiglobulin test (DAT) developed anytime between 24 hours to 28 days after cessation of transfusion, a positive eluate or a newly identified alloantibody in the plasma or serum along with features of haemolysis in the patient. Routinely, it is expected that with the transfusion of one unit of packed red cells in a patient of average height and weight, the haemoglobin level and hematocrit increase by 1 g/dL and 3% respectively. However, in a patient with DHTR, an inadequate rise of post-transfusion haemoglobin (< 1 g/dL) or rapid fall in haemoglobin back to pre-transfusion levels is observed. Kidd antibodies are particularly known to cause DHTR, maybe alone or in unison with other antibodies. Detection of these alloantibodies is consequential in providing good transfusion support to these patients. These events may be difficult to detect as they may present as varied clinical features or immunological nuisances. In this case series, we have presented three cases of DHTR with special emphasis on their clinical presentations, immunohaematological evaluations, laboratory parameters and the role of proper transfusion support in these patients to avoid further complications.     

Robust antibody response after a third BNT162b2 vaccine compared to the second among immunocompromised and healthy individuals,a prospective longitudinal cohort study

PurposeAs protection from COVID-19 following two doses of the BNT162b2 vaccine showed a time dependent waning, a third (booster) dose was administrated. This study aims to compare the antibody response following the third dose versus the second and to evaluate post-booster seroconversion.MethodsA prospective observational study conducted in Maccabi Healthcare Services. Serial SARS-CoV-2 Spike IgG tests, 1,2,3 and 6 months following the second vaccine dose and one month following the third were obtained. Neutralizing antibody levels were measured in a subset of participants. Per individual SARS-CoV-2 Spike IgG titer ratios were calculated one month after the booster administration compared to titers one month following the second dose and prior to booster.ResultsAmong 110 participants, 56 (51%) were women. Mean age was 61.7 ± 1.9 years and 66 (60%) were immunocompromised. One month after third dose, IgG titers were induced 7.83 (95 %CI 5.25–11.67) folds and 2.40 (95 %CI 1.90–3.03) folds compared to one month after the second, in the immunocompromised and immunocompetent groups, respectively. Of the 17 immunocompromised participants who were seronegative after the second dose, 4 (24%) became seropositive following the third. Comparing the titers prior to the third dose, an increase of 50.7 (95 %CI 32.5–79.1) fold in the immunocompromised group and 25.7 (95 %CI 19.1–34.7) fold in and immunocompetent group, was observed.ConclusionA third BNT162b2 vaccine elicited robust humoral response, superior to the response observed following the second, among immunocompetent and immunocompromised individuals.     

丹青胶囊联合他扎罗汀倍他米松治疗银屑病的临床研究

目的 探讨丹青胶囊联合他扎罗汀倍他米松治疗银屑病的临床疗效.方法 选取2019年6月—2021年6月在天津市职业病防治院门诊皮肤科就诊治疗的114例银屑病患者,根据随机数字法分为对照组和治疗组,每组各57例.对照组患者给予他扎罗汀倍他米松乳膏,洗净患处,待皮肤干爽后,将适量本品均匀涂抹于患处,1次/d.治疗组患者在对照组治疗基础上口服丹青胶囊,4粒/次,3次/d.两组患者均连续治疗7 d.观察两组患者的临床疗效和临床症状好转时间,比较两组治疗前与治疗1、4、8周的皮损面积和严重程度指数(PASI)评分和血清炎性因子水平.结果 治疗后,治疗组总有效率是98.25％,显著高于对照组的82.46％(P<0.05).治疗后,治疗组患者皮损暗红、皮损肥厚、皮肤瘙痒、皮肤疼痛等症状好转时间均显著短于对照组(P<0.05).治疗后,两组PASI评分均较治疗前显著降低(P<0.05);治疗1、4、8周治疗组PASI评分显著低于对照组(P<0.05).治疗后,两组患者血清炎性因子白细胞介素6(IL-6)、白细胞介素17(IL-17)、肿瘤坏死因子α(TNF-α)、干扰素-γ(IFN-γ)水平均较治疗前显著降低(P<0.05);治疗后,治疗组血清炎性因子水平显著低于对照组(P<0.05).结论 丹青胶囊联合他扎罗汀倍他米松治疗银屑病效果明显,能显著降低炎性因子水平,并有助于改善皮损情况,值得临床推广应用.     

Single-dose replicating poxvirus vector-based RBD vaccine drives robust humoral and T cell immune response against SARS-CoV-2 infection

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Pan-cancer proteomic map of 949 human cell lines

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橙皮苷在低压低氧所致大鼠视网膜抗氧化能力和炎症介质调控改变中的作用

目的　探讨橙皮苷（HSD）在低压低氧所致大鼠视网膜抗氧化应激能力及炎性介质调控改变中的干预作用。方法　取健康雄性清洁级成年SD大鼠72只（144眼），随机分为对照组、低压低氧组及HSD干预组，每组24只（48眼）。对照组大鼠饲养于常氧环境，低压低氧组及HSD干预组大鼠放置于模拟海拔5000 m高度的低压氧舱内喂养。HSD干预组大鼠给予HSD灌胃，对照组和低压低氧组大鼠给予生理盐水，各组大鼠每天等量灌胃一次，连续7 d。通过HE染色光镜下观察大鼠视网膜组织形态变化；采用酶联免疫吸附(ELISA)法检测大鼠视网膜谷胱甘肽(GSH)和半胱氨酸(Cys)蛋白浓度、丙二醛（MDA）含量以及肿瘤坏死因子-α（TNF-α）活性；Western-blot检测大鼠视网膜核因子-κB p65（NF-κB p65）和细胞色素C（Cyto-C)蛋白表达水平。结果　光镜下观察可见，与对照组相比，低压低氧组大鼠出现视网膜水肿，HSD干预组较低压低氧组大鼠视网膜水肿程度减轻。与对照组相比，低压低氧组大鼠视网膜中GSH蛋白浓度和Cys蛋白浓度降低，MDA含量升高，差异均有统计学意义（均为P<0.001）；与低压低氧组相比，HSD干预组提高了GSH蛋白浓度和Cys蛋白浓度，降低了MDA含量，GSH蛋白浓度和MDA含量两组相比差异均有统计学意义（均为P<0.001），Cys蛋白浓度两组相比差异无统计学意义（P>0.05）。与对照组相比，低压低氧组大鼠视网膜中NF-κB p65蛋白表达水平和TNF-α活性升高，差异均有统计学意义（P<0.01、 P<0.001）；与低压低氧组相比，HSD干预组大鼠视网膜中NF-κB p65蛋白表达水平和TNF-α活性降低，差异均有统计学意义（P<0.05、P<0.001）。与对照组相比，低压低氧组大鼠视网膜Cyto-C蛋白表达水平明显升高，差异有统计学意义（P<0.01）；与低压低氧组相比，HSD干预组大鼠视网膜中Cyto-C蛋白表达水平降低，差异有统计学意义（P<0.05）。结论　HSD能够通过提高大鼠视网膜抗氧化应激能力、抑制炎症介质释放以及减少线粒体损伤而发挥保护视网膜功能的作用。     

以患者为中心的护理模式在腹腔镜胆囊切除术中的应用及对患者应激反应的影响

目的 探讨以患者为中心的护理模式在腹腔镜胆囊切除术中的应用效果及对患者应激反应的影响。方法 选取2019年3月至2021年3月于我院行腹腔镜胆囊切除术的64例患者,按照入组单双顺序平均分为观察组(以患者为中心的护理模式)与对照组(常规急诊护理)各32例。比较两组的生理应激反应、心理应激反应和术后恢复情况。结果 干预后,观察组的胰岛素、皮质醇水平及HAMA、 HAMD评分低于对照组,肾上腺素水平高于对照组(P<0.05)。观察组的VAS评分低于对照组,肛门排气及下床活动时间短于对照组(P<0.05)。结论 以患者为中心的护理模式可减轻急诊胆囊切除术患者的生理及心理应激反应,促进患者术后康复。