医学期刊编辑对生物医学研究伦理问题的处理方式调研及建议

【目的】 探讨医学期刊编辑处理生物医学研究伦理问题的方式,为推动确立医学期刊伦理审查规范提供参考。【方法】 通过问卷星向国内医学期刊编辑发放调查问卷,对审稿时和论文出版后处理医学伦理相关问题的方式展开调研。【结果】 共回收问卷230份。调查显示:在审稿阶段,在保护患者隐私方面,英文期刊、中英双语期刊的编辑更注重要求作者提供授权同意相关证明材料;中、英文期刊以及中英双语期刊的编辑对涉及人体试验伦理问题的处理方式都比较规范。但是,对于研究是否获得患者知情同意、动物实验研究是否经过伦理委员会审查、回顾性研究是否需要伦理审查、涉及人的研究是否在临床试验注册中心注册等问题,编辑还需要进一步重视。在论文出版后,编辑发现的医学伦理问题主要是“涉及人的研究未说明是否经过伦理委员会审查”。对论文出版后发现的没有保护患者隐私和没有在临床试验注册中心注册的问题,大部分期刊缺乏相关处理方案。【结论】 编辑应加强对论文知情同意、动物实验伦理、回顾性研究伦理的审查,并审查涉及人的研究是否在临床试验注册中心注册,以推动我国医学期刊的高质量发展。     

基于网络药理学和分子对接技术探讨黄芪干预腹膜纤维化的机制

目的 运用网络药理学方法及分子对接技术探讨黄芪干预腹膜纤维化的可能机制。方法 利用中药系统药理学数据库及分析平台(TCMSP)检索黄芪的主要化学成分及靶点,并补充文献报道相关药理作用的成分作为潜在活性成分。以"peritoneal fibrosis"为关键词分别在OMIM、Genecards获取目前已知的与腹膜纤维化相关的疾病靶点,后取两者的交集靶点;对交集基因通过STRING数据库与Cytoscape 3.7.2软件构建"药物-成分-靶点-疾病"网络及蛋白互作(PPI)网络并筛选核心网络。基于R软件使用Bioconductor生物信息软件对核心靶点进行GO及KEGG富集分析,最终采用AutoDock软件将主要有效成分与核心靶点进行分子对接,得出其结合能力。结果 筛选出20个黄芪活性成分及文献报道有相关药理作用4个, 457药物作用靶点,与674个腹膜纤维化病靶点取交集,得到86个共同靶点。GO功能富集分析提示黄芪拮抗腹膜纤维化主要参与了蛋白激酶B信号转导的调节、细胞对化学的应激反应、炎症反应的调节等通路; KEGG通路富集分析主要涉及调控肿瘤、磷脂酰肌醇-3-羟激酶-蛋白激酶B(PI3K-Akt)、晚期糖基化终末产物/晚期糖基化终末产物受体(AGE-RAGE)、人类巨细胞病毒感染、HIF-1信号通路等;分子对接结果显示关键靶点与活性成分具有较好的结合能力。结论 黄芪治疗腹膜纤维化的分子机制,可能与抑制炎症及氧化应激反应、调节多种信号通路等相关。     

潜伏期脑胎盘率对预测新生儿不良结局的价值

目的 探讨低危单胎的足月妊娠自然临产后，潜伏期脑胎盘率(CPR)对预测新生儿不良结局的价值。方法 选取2018年1月至2021年3月我院住院临产分娩的673例孕妇为研究对象，测量胎儿大脑中动脉、脐动脉血流参数，获得分娩结局及新生儿结局。参考既往研究得出的不同孕周CPR正常参考值百分位作为分组指标(CPR≤10%参考值定为低CPR)。比较低CPR组(72例)与正常CPR组(601例)两组妊娠结局、新生儿不良结局。结果 低CPR组与正常CPR组在孕妇年龄、孕龄、产次、孕期体质量增长、总产程、新生儿体质量的构成上差异均无统计学意义(P>0.05)。低CPR组因胎儿窘迫行剖宫产或助产发生率、新生儿任一不良结局发生率、新生儿不良结局率均高于正常CPR组，差异均有统计学意义(P<0.05)。低CPR预测新生儿不良结局的准确率为89.5%(602/673),敏感度为51.7%(15/29),特异度为91.1%(587/644)。结论 本研究数据显示，对于无并发症及合并症、低风险的单胎足月妊娠，潜伏期低CPR与新生儿不良结局相关。     

医院-社区-家庭闭环式模式在老年糖尿病周围神经病变患者中的应用价值

【摘要】目的 探讨“医院-社区-家庭”闭环式管理模式在老年糖尿病周围神经病变（DPN）患者中的应用价值。方法 选取2017年6月～2019年6月我院收治的老年DPN患者96例，随机分为观察组与对照组，每组各48例。对照组采用常规护理，观察组采用医院-社区-家庭闭环式管理模式。比较两组患者治疗依从性、血糖控制、心理健康状况、周围神经病变情况以及神经传导速率。结果 干预后，观察组患者用药、饮食、血糖测量、健康行为等方面依从率均高于对照组（P＜0.05）；观察组空腹血糖、饭后2 h血糖、糖化血红蛋白均低于对照组（P＜0.05）；观察组SCL-90症状自评量表躯体化、人际关系敏感、抑郁、焦虑、敌对以及睡眠饮食情况得分均低于对照组（P＜0.05）；观察组密西根糖尿病周围神经病变量表（MDNS）和多伦多临床神经病变评分量表（TCSS）评分均低于对照组（P＜0.05）；观察组正中神经、腓总神经神经传导速度（SNCV）和运动神经传导速度（MNCV）均高于对照组（P＜0.05）。结论 对老年DPN患者应用医院-社区-家庭闭环式管理模式能有效提高患者自我管理效能，维持血糖平稳，缓解不良情绪以改善DPN病情。     

Predictors of survival following surgical resection of limited-stage small cell lung cancer

BackgroundAdjuvant chemotherapy, postoperative radiation (PORT), and prophylactic cranial irradiation (PCI) have been individually examined in limited-stage small cell lung cancer (SCLC). There is a paucity of data on the effectiveness of each adjuvant treatment modality when used in combination after surgical resection of SCLC.MethodsData were collected from 5 cancer centers on all patients with limited-stage SCLC who underwent surgical resection between 1986 and 2019. Univariate and multivariable models were conducted to identify predictors of long-term outcomes, focusing on freedom from recurrence and survival benefit of adjuvant chemotherapy, PORT, and PCI.ResultsA total of 164 patients were analyzed. Multivariable Cox regression analysis did not identify any adjuvant therapies to significantly influence recurrence in this cohort. Specifically, PORT was not associated with a significant influence on locoregional recurrence and PCI was not significantly associated with intracranial outcomes. Adjuvant chemotherapy improved survival in all stage I through III disease (hazard ratio, 0.49; 95% confidence interval, 0.29-0.81; P = .005) and even in pathologically node negative patients (hazard ratio, 0.49; 95% confidence interval, 0.27-0.91; P = .024). Although PCI was found to improve survival in univariate analysis, it was not significant in a multivariable model. PORT was not found to affect survival on either univariate or multivariable analysis.ConclusionsThis is among the largest multi-institutional studies on surgically resected limited-stage SCLC. Our results highlight survival benefit of adjuvant chemotherapy, but did not identify a statistically significant influence from mediastinal PORT or PCI in our cohort. Larger prospective studies are needed to determine the benefit of PORT or PCI in a surgically resected limited-stage SCLC population.     

Primary localized gastric amyloidosis: A scoping review of the literature from clinical presentations to prognosis

Localized gastric amyloidosis (LGA) is a rare disease characterized by abnormal extracellular deposition of amyloid protein restricted to the stomach and it is confirmed by positive results of Congo red staining. Over decades, only a few cases have been reported and studies or research focusing on it are few. Although LGA has a low incidence, patients may suffer a lot from it and require proper diagnosis and management. However, the pathology of LGA remains unknown and no overall review of LGA from its presentations to its prognosis has been published. Patients with LGA are often asymptomatic or manifest atypical symptoms, making it difficult to differentiate from other gastrointestinal diseases. Here, we report the case of a 70-year-old woman with LGA and provide an overview of case reports of LGA available to us. Based on that, we conclude current concepts of clinical manifestations, diagnosis, treatment, and prognosis of LGA, aiming at providing a detailed diagnostic procedure for clinicians and promoting the guidelines of LGA. In addition, a few advanced technologies applied in amyloidosis are also discussed in this review, aiming at providing clinicians with a reference of diagnostic process. With this review, we hope to raise awareness of LGA among the public and clinicians.     

Phase II Study of Panitumumab Monotherapy in Chemotherapy‐Naïve Frail or Elderly Patients with Unresectable RAS Wild‐Type Colorectal Cancer: OGSG 1602

Lessons Learned

• Panitumumab monotherapy showed favorable efficacy and feasibility in the treatment of frail or elderly patients with RAS wild‐type unresectable colorectal cancer.
• It is especially effective for left‐sided tumors; therefore, panitumumab as first‐line treatment could be an additional therapeutic option for frail elderly patients, particularly in those who are unsuitable for upfront oxaliplatin‐based or irinotecan‐based combination regimens.

BackgroundFirst‐line panitumumab monotherapy is expected to be well tolerated and improve survival in patients ineligible for intensive chemotherapy. However, its safety and efficacy in chemotherapy‐naïve frail or elderly patients with unresectable RAS wild‐type (WT) colorectal cancer (CRC) have not been studied. The aim of this phase II trial was to evaluate the efficacy and safety of panitumumab as first‐line treatment.MethodsWe conducted a multicenter phase II study on patients aged ≥76 years or ≥65 years considered unsuitable for intensive chemotherapy. Panitumumab 6 mg/kg of intravenous infusion was administered every 2 weeks. The primary endpoint was disease control rate (DCR). Secondary endpoints included progression‐free survival (PFS), overall survival (OS), response rate (RR), time to treatment failure (TTF), and incidence of grade 3 or 4 toxicities.ResultsThirty‐six patients (median age: 81 [range, 67–88] years) were enrolled between February 2017 and August 2018. Two patients were excluded from the analysis of efficacy: one from lack of image examination at baseline and the other from lack of a measurable lesion. Thirty‐three (91.6%) patients had a performance status (PS) of 0 or 1, whereas two (5.6%) patients and one (2.8%) patient had a PS of 2 and 3, respectively. Twenty‐eight patients (77.8%) had left‐sided CRC, whereas eight (22.2%) had right‐sided CRC. The RR was 50.0% (95% confidence interval [CI], 32.4–67.6), including three patients (8.8%) who had complete responses. A total of 26.5% had stable diseases, resulting in a DCR of 76.5% (90% CI, 61.5–87.7). The RR of patients with left‐ and right‐sided tumors was 65.4% (95% CI, 44.3–82.8) and 0.0% (95% CI, 0.0–36.9), respectively. Major grade 3 or 4 nonhematologic toxicities were rash (n = 6, 16.7%), hypomagnesemia (n = 4, 11.1%), fatigue (n = 3, 8.3%), paronychia (n = 2, 5.6%), and hyponatremia (n = 2, 5.6%). The only grade 3 hematologic toxicity was neutropenia (n = 1, 2.8%).ConclusionPanitumumab monotherapy showed favorable efficacy and feasibility in frail or elderly patients with RAS WT unresectable CRC. Survival analysis including OS, PFS, and TTF is currently in progress.     

不同剂量羟考酮PCEA与PCIA用于前列腺术后镇痛效果比较

【摘要】 目的 探讨不同剂量羟考酮通过患者硬膜外自控镇痛（PCEA）与患者静脉自控镇痛（PCIA）用于前列腺术后的镇痛效果。 方法 选取在2018年1月~2020年1月期间于我院行前列腺术的210例患者，采用随机数字表法将患者分成A1、A2、A3、B1、B2、B3 6组，每组各35例。其中A1、A2、A3组术后镇痛采用PCIA方案，分别使用0.6mg/kg、0.8mg/kg、1.0mg/kg的羟考酮+托烷司琼10mg+0.9%氯化钠溶液至100mL；B1、B2、B3术后镇痛采取PCEA方案，分别使用0.6mg/kg、0.8mg/kg、1.0mg/kg的羟考酮+托烷司琼10mg+0.9%氯化钠溶液至100mL。比较手术前（T0）、术后6h(T1)、术后12h(T2)、术后24h(T3)及术后48h(T4)6组患者的生命体征、视觉疼痛模拟评分（VAS）及不良反应的发生情况。 结果 各组患者在不同时间点的MAP、HR及SPO2的水平比较差异无统计学意义（P＞0.05）。B1、B2、B3组患者分别在T1、T2、T3、T4时间的VAS评分显著低于A1、A2、A3组（均P＜0.05），A2、A3组患者分别在T1、T2、T3、T4时间的VAS评分显著低于A1组（均P＜0.05），B2、B3组患者分别在T1、T2、T3、T4时间的VAS评分显著低于B1组（均P＜0.05）。B1、B2、B3不良反应的发生率分别显著低于A1、A2、A3组（均P＜0.05）。B1、B2不良反应的发生率显著低于A2、A3组（P＜0.05），且A3组不良反应的发生率显著高于A1、A2，B3组的不良反应的发生率显著高于B1、B2组（均P＜0.05）。 结论 对前列腺手术患者术后，不同剂量羟考酮PCEA的镇痛效果及不良反应发生率均显著优于不同剂量羟考酮的PCIA，且当羟考酮的剂量为0.8mg/kg时，效果最佳。     

基于十二指肠异常探讨功能性消化不良的中医研究进展＊

功能性消化不良（functional dyspepsia， FD）是一种常见的功能性胃肠病（functional gastrointestinal disorder， FGID），属于中医“痞满”“胃脘痛”范畴，多因“气机升降失常”所致。目前，FD发病机制主要涉及脑肠互动异常、胃容受性受损、内脏敏感性增高、胃动力不足、幽门螺杆菌感染、十二指肠异常、心理精神因素等。随着罗马Ⅳ标准的颁布，十二指肠的作用在FD的发病中日益凸显。十二指肠高敏性、十二指肠黏膜屏障受损及十二指肠黏膜低度炎症等在FD病理生理过程中起着非常重要的作用，十二指肠可能是治疗FD的新靶点。本文综述FD发病中十二指肠的作用及中医药研究，为FD的基础研究及临床治疗提供理论依据。