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。     

Confounded association between proton pump inhibitor use and risk of biliary tract cancer: Result from three cohorts

Recent epidemiological studies suggested that proton pump inhibitor (PPI) use was associated with an increased risk of biliary tract cancer (BTC), however, confounders were not adequately controlled. Our study aimed to evaluate PPI use and subsequent risk of BTC and its subtypes in three well-established cohorts. We conducted a pooled analysis of the subjects free of cancers in UK Biobank (n = 463 643), Nurses' Health Study (NHS, n = 80 235) and NHS II (n = 95 869). Propensity score weighted Cox models were used to estimate marginal HRs of PPIs use on BTC risk, accounting for potential confounders. We documented 284 BTC cases in UK Biobank (median follow-up: 7.6 years), and 91 cases in NHS and NHS II cohorts (median follow-up: 15.8 years). In UK biobank, PPI users had a 96% higher risk of BTC compared to nonusers in crude model (HR 1.96, 95% CI 1.44-2.66), but the effect was attenuated to null after adjusting for potential confounders (HR 0.95, 95% CI 0.60-1.49). PPI use was not associated with risk of BTC in the pooled analysis of three cohorts (HR 0.93, 95% CI 0.60-1.43). We also observed no associations between PPI use with risk of intrahepatic (HR 1.00, 95% CI 0.49-2.04), extrahepatic bile duct (HR 1.09, 95% CI 0.52-2.27) and gallbladder cancers (HR 0.66, 95% CI 0.26-1.66) in UK Biobank. In summary, regular use of PPIs was not associated with the risk of BTC and its subtypes.     

Role of surgical treatments in high-grade or advanced gastroenteropancreatic neuroendocrine neoplasms

Over the last 40 years, the incidence and prevalence of gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs) have continued to increase. Compared to other epithelial neoplasms in the same organ, GEP-NENs exhibit indolent biological behavior, resulting in more chances to undergo surgery. However, the role of surgery in high-grade or advanced GEP-NENs is still controversial. Surgery is associated with survival improvement of well-differentiated high-grade GEP-NENs, whereas poorly differentiated GEP-NENs that may benefit from resection require careful selection based on Ki67 and other tissue biomarkers. Additionally, surgery also plays an important role in locally advanced and metastatic disease. For locally advanced GEP-NENs, isolated major vascular involvement is no longer an absolute contraindication. In the setting of metastatic GEP-NENs, radical intended surgery is recommended for patients with low-grade and resectable metastases. For unresectable metastatic disease, a variety of surgical approaches, including cytoreduction of liver metastasis, liver transplantation, and surgery after neoadjuvant treatment, show survival benefits. Primary tumor resection in GEP-NENs with unresectable metastatic disease is associated with symptom control, prolonged survival, and improved sensitivity toward systemic therapies. Although there is no established neoadjuvant or adjuvant strategy, increasing attention has been given to this emerging research area. Some studies have reported that neoadjuvant therapy effectively reduces tumor burden, improves the effectiveness of subsequent surgery, and decreases surgical complications.     

Process of forgiveness in the recovery of Chinese women survivors of intimate partner violence: Empowerment,transformation, and integration

Forgiveness has been found one substantial element in the recovery for women survivors from intimate partner violence following the termination of the abusive relationship. To further investigate the details of forgiveness in this specific context, the present study explored the process of forgiveness using grounded theory. In-depth and semi-structured interviews were conducted with 25 Chinese women survivors of IPV. The findings suggest that forgiveness is a strength-based process including empowerment, transformation, and integration phases. In the empowerment phase, survivors obtain strength at the intrapersonal, behavioural, and interpersonal levels. In the transformation phase, survivors complete cognitive transformation for their IPV experiences and emotional transformation towards former partners. In the integration phase, survivors—now freed from the past—reflect upon and apply the changes they have undergone. Two trajectories in the process were found. One trajectory is going through stages sequentially and the other trajectory is experiencing back and forth between empowerment and transformation stages before moving into the integration stage. The study's findings broaden our knowledge of the strength-based forgiveness process that women survivors of IPV undergo during recovery. Practitioners and policymakers could develop programmes and policies that support forgiveness by holistically facilitating their recovery and empowerment like assistance in dealing with life difficulties and promoting their reconnection with social networks. To improve the transferability and validity of the findings, the forgiveness of survivors of IPV could be explored in a diverse sample (e.g., survivors with low educational background or live in the rural area).     

结直肠癌与自然杀伤细胞的相关性探讨北大核心

目的:研究结直肠癌及其配对的癌旁组织的自然杀伤(nature killer,NK)细胞数量及分布情况。方法:结直肠癌及其配对的癌旁组织各40例,以SP免疫组化法检测NK细胞。结果:结直肠癌及其配对的癌旁组织中均未检测到NK细胞的浸润。结论:结直肠癌及其配对的癌旁组织中缺乏NK细胞浸润可能与肿瘤微环境、生理微环境、未知的NK细胞亚型相关,结直肠癌患者可能不适用NK细胞进行免疫治疗。     

多元化联合教学模式在超声引导下疼痛介入治疗中的应用

目的探讨多元化联合教学模式在超声引导下疼痛介入治疗教学中的应用效果。方法选择2018年1月至2020年12月在北京大学第三医院疼痛科进修的30名医师作为研究对象,将其分为对照组与观察组;对照组采用常规教学模式;观察组采用多元化联合教学模式,比较两组医师技能考核成绩、教学质量评分和满意度评分。结果观察组医师技能考核成绩优良率为93.3%,高于对照组的73.3%(P<0.05);观察组医师对基础理论知识掌握、临床思维能力的提高、学习兴趣的激发、疾病诊治能力的提高4个方面的评分均高于对照组(P<0.01)。结论多元化联合教学模式可促进超声引导下疼痛介入治疗技能的提高,有利于提高学员的综合临床能力。     

艾司氯胺酮复合麻醉在小儿瘢痕非插管全身麻醉患者超脉冲点阵二氧化碳激光治疗术中的应用及效果观察

目的探讨艾司氯胺酮+七氟烷+小儿布洛芬肛栓在小儿烧伤后增生性瘢痕非插管全身麻醉患者超脉冲二氧化碳点阵激光(UFCL)治疗术中的应用及效果观察。 方法选取2020年1月至2021年4月就诊于空军军医大学第一附属医院烧伤与皮肤外科门诊89例烧伤后增生性瘢痕患儿纳入本随机对照临床试验。将患儿采用随机数字表法分为氯胺酮+丙泊酚组[共42例，其中男22例，女20例，平均年龄为(44.33±14.87)个月]和复合麻醉镇痛组(艾司氯胺酮+七氟烷+小儿布洛芬肛栓)[共47例，男24例，女23例，平均年龄(44.47±14.65)个月]；在麻醉前和术中监测患儿血流动力学指标以及警觉/镇静(OAA/S)量表评分；在麻醉清醒时(T0)、麻醉清醒后1 h(T1)、麻醉清醒后2 h(T2)应用儿童疼痛行为量表(FLACC)对患儿疼痛程度进行评估；分别于术前和术后6个月应用温哥华瘢痕量表(VSS)对瘢痕进行评分。对数据行独立样本t检验和χ²检验。 结果(1)麻醉前氯胺酮+丙泊酚组血流动力学及OAA/S量表评分[平均动脉压(63.71±3.40)mmHg、心率(107.21±9.45)次/min、呼吸(25.29±2.34)次/min、血氧饱和度(99.00±0.80)%、OAA/S量表评分(4.64±0.49)分]与复合麻醉镇痛组[平均动脉压(63.87±3.57)mmHg、心率(109.34±12.21)次/min、呼吸(26.473.53)次/min、血氧饱和度(98.77±0.91)%、OAA/S量表评分(4.57±0.50)分]比较差异均无统计学意义(t＝-0.213、0.490、-1.840、1.280、0.204，P>0.05)；麻醉后手术中氯胺酮+丙泊酚组[平均动脉压(56.29±2.43)mmHg、心率(94.48±7.01)次/min、呼吸(21.07±3.03)次/min、血氧饱和度(96.12±1.64)%、OAA/S量表评分(2.07±0.71)分]与复合麻醉镇痛组[平均动脉压(62.87±3.56)mmHg、心率(108.791±1.93)次/min、呼吸(26.52±3.48)次/min、血氧饱和度(99.23±0.67)%、OAA/S量表评分(1.45±0.50)分]比较差异有统计学意义(t＝-10.068、-6.794、-7.824、-11.960、4.820，P<0.05)。(2)氯胺酮+丙泊酚组患儿麻醉清醒时[T0：(4.40±1.17)分]麻醉清醒后1 h[T1：(2.05±0.88)分]、麻醉清醒后2 h[T2：(0.43±0.63)分]FLACC评分比复合麻醉镇痛组[(1.32±0.96)、(0.43±0.62)、(0.13±0.34)分]评分高，说明患儿疼痛度高，且数据比较差异均有统计学意义(t＝10.139、13.669、2.794，P<0.05)。(3)术前及术后6个月瘢痕评分：氯胺酮+丙泊酚组[(9.33±1.60)、(4.48±1.11)分]与复合麻醉镇痛组[(8.43±2.04)、(4.26±1.04)分]相比差异均无统计学意义(t＝2.320、0.940, P>0.05)。 结论复合麻醉镇痛措施在小儿烧伤后增生性瘢痕非插管全身麻醉患者(UFCL)治疗术中应用效果较好，可使患儿术中血流动力学平稳，术中镇静良好，术后疼痛度较低，对于激光治疗效果无影响。     

基于移动医疗的妊娠期盆底肌训练对产后尿失禁发生的影响：一项基于随机对照试验设计的探索性研究

背景 孕产妇尿失禁（UI）发病率高，严重影响了女性生活质量。研究表明，盆底肌训练是UI有效的防治手段，本研究前期进行了一项随机对照试验（RCT），结果发现相比于常规宣教，基于移动医疗APP的盆底肌训练并未显现出预防优势，其原因需要进一步深入探讨。 目的 本研究拟对一项基于APP的妊娠期盆底肌训练的干预研究的阴性结果进行探索性分析，旨在探讨产后UI预防效果的影响因素以及获益的亚组人群。 方法 本研究数据来源于前期开展的一项RCT，采用方便抽样法，于2020年6—10月在南方医科大学深圳医院产科门诊招募了126例研究对象，采用随机数字表法分为干预组与对照组，每组各63例。对照组采用常规护理，干预组在此基础上使用"有爱屋"APP进行尿失禁自我管理，干预周期为2个月。产后42 d随访时收集两组产后相关资料，包括产后42 d UI发生情况。以产后是否发生UI为结局指标，将研究对象分为病例组和对照组，采用Logistic回归分析探讨混杂因素及其与干预方式之间的交互作用对产后UI发生的影响。针对Logistic回归分析的结果进行分层分析，探讨是否存在能从APP干预中获益的亚组人群。 结果 病例组和对照组阴道分娩史、入组时存在UI、Broome盆底肌自我效能量表（BPMSES）得分比较，差异均有统计学意义（P<0.05）。Logistic回归分析结果显示，入组时存在UI是产后发生UI的危险因素〔OR=15.897，95%CI（4.724，53.495），P<0.001〕；BPMSES得分与干预方式的交互作用可影响产后UI的发生〔OR=1.034，95%CI（1.017，1.051），P<0.001〕。分层分析结果显示，入组时存在UI症状的孕妇，干预组产后UI发生率低于对照组（χ2=4.18，P=0.041）；入组时不存在UI症状的孕妇，两组产后UI发生率比较，差异无统计学意义（χ2=1.89，P=0.284）。 结论 推荐有UI症状的孕妇使用"有爱屋"APP或许可预防产后UI的发生。而对于妊娠期没有UI症状的人群使用"有爱屋"APP预防产后UI发生的证据尚不充分。另外，不管有无UI症状，盆底肌训练自我效能高的孕妇有望从APP干预中获益。     

限时进食对恶性肿瘤的潜在防治作用

间歇性禁食是一种新的饮食干预策略,其可能改善恶性肿瘤治疗的疗效并减少并发症。 限时进食是间歇性禁食的 一种特殊形式,通常仅限制每天的进食时间窗而不限制热量,除了和其他间歇性禁食手段一样能够控制体重并改善代谢紊乱 以外,限时进食还能调节昼夜节律并影响自噬水平,具有潜在的抗衰作用,相关研究已经表明了它预防肿瘤发生以及减缓肿 瘤发展的潜力。 同时,由于实施方案便利、不良反应轻微,限时进食有着不错的依从性及安全性,有可能成为一种适合肿瘤患 者长期实施的辅助治疗方案乃至健康生活方式。 本文从改善肥胖和代谢紊乱、调节昼夜节律和自噬水平以及目前与肿瘤相 关的研究进展这三个方面阐述了限时进食对恶性肿瘤的潜在作用,旨在为将来的相关研究提供理论依据和探索方向,探讨限 时进食作为一种营养干预手段对恶性肿瘤发生的潜在预防作用以及对恶性肿瘤的治疗或辅助治疗作用,以期可以完善对肿 瘤患者的营养干预策略,改善患者的生活质量及预后。