关于医疗器械软件变更监管要求探讨

由于医疗器械软件的特殊性，在产品注册后变更相对频繁，但现在对于医疗器械软件变更的监管要求尚未能充分考虑这种情况，应进一步科学合理设置相应监管要求。本文针对业内人士所关注焦点，分析了医疗器械软件变更类型划分原则，并基于相关变更类型划分，探讨了医疗器械软件变更的监管要求，最后提出了相关工作建议。     

The effect of salt-water bath in the management of treatment-related peripheral neuropathy in cancer patients receiving taxane and platinum-based treatment

ObjectivesIn a clinical setting, patients have been observed to complain of discomfort and to discontinue treatment because of chemotherapy-induced peripheral neuropathy. This experimental study was conducted to determine the effect of a salt-water bath in the management of chemotherapy-induced peripheral neuropathy.MethodOne hundred and three patients who received taxane and platinum-based chemotherapy due to cancer and developed peripheral neuropathy associated with the treatment between December 2018 and June 2020 were included in the study. The patients were assigned to the control and experimental groups (1-warm salt-water and 2-cold salt-water) following the randomization checklist. While control groups did not receive any interventions, the patients in the salt-water group were asked to apply warm (41 °C) or cold-water (23–26 °C) baths to their hands/feet for 30 min every other day for 14 days. The data were collected at the beginning of the study and at the end of its first and second weeks using the Patient Information Form and National Cancer Institute (NCI)-CTCAE v5.0 toxicity criteria as well as the EORTC QLQ-C30 and EORTC QLQ-CIPN20 quality of life scales.ResultsThe patients had a mean age of 55.6 ± 10.3, and most of them were treated following a breast cancer diagnosis. At the beginning of the study, Grade 3 peripheral neuropathy severity and quality of life scores of the cold/warm salt-water and control groups were similar. Due to repeated follow-ups, it was determined that the peripheral neuropathy severity decreased and the quality of life scores increased statistically significantly in the patients in the cold salt-water bath group compared to the control group.ConclusionThis study's results suggest that a cold salt-water bath can be an effective approach in managing the development of peripheral neuropathy due to taxane and platinum-based treatment.     

Sex difference in the association between surrogate markers of insulin resistance and arterial stiffness

AimsTo investigate the predictive capability of insulin resistance surrogate markers for insulin resistance and arterial stiffness based on sex.MethodsWe assessed the association of triglyceride glucose (TyG) index, triglyceride to high-density lipoprotein cholesterol ratio (TG/HDL-C), visceral adiposity index (VAI), and lipid accumulation product (LAP) with homeostasis model assessment-insulin resistance (HOMA-IR) and brachial–ankle pulse wave velocity (baPWV) in both sexes.ResultsA total of 1720 men and 1098 women were evaluated. HOMA-IR showed good correlation with the TyG index (men: r = 0.47, women: r = 0.45), TG/HDL-C (men: r = 0.45, women: r = 0.41), VAI (men: r = 0.51, women: r = 0.48), and LAP (men: r = 0.55, women r = 0.49) (all p-values < 0.001). These markers positively correlated with increased baPWV in both sexes. The standardized partial regression coefficients were 0.11 and 0.14 for the TyG index, 0.13 and 0.16 for TG/HDL-C, 0.14 and 0.19 for VAI, and 0.12 and 0.17 for LAP in men and women, respectively (all p-values < 0.01; all p-values for sex interaction < 0.05).ConclusionsAll insulin surrogate markers showed good correlation with HOMA-IR in both sexes. These indices were also associated with increased baPWV and the associations were stronger in women than in men.     

Amputation-free survival in patients with diabetic foot ulcer and peripheral arterial disease: Endovascular versus open surgery in a propensity score adjusted analysis

AimsThe aim of the present study was to compare outcomes of endovascular surgery versus open vascular surgery in patients with diabetic foot ulcer (DFU) and peripheral arterial disease (PAD).MethodsBetween 1984 and 2006, 1151 patients with DFU were admitted to the diabetic foot care team. Three hundred seventy-six patients with 408 limbs were consecutively included at a multidisciplinary foot center, 289 limbs were treated with endovascular surgery and 119 limbs with open vascular surgery first strategy. A propensity score adjusted analysis was performed to compare outcomes for type of revascularization.ResultsMajor amputation rates at 3 years were 17.0% and 16.8% (p = 0.97) and mortality at 3 years were 43.1% and 46.5% (p = 0.55) after endovascular surgery and open vascular surgery, respectively. In the propensity score adjusted analysis, patients undergoing endovascular surgery first had similar outcomes in terms of major amputation, mortality, combined major amputation/mortality compared to those undergoing open vascular surgery. Longer time to intervention (p = 0.003) was associated with increased major amputation rate in the multivariable Cox regression analysis.ConclusionThe endovascular surgery first and open vascular surgery first strategies were associated with similar long-term results in a large cohort of patients with DFU and PAD undergoing revascularization. Rapid revascularization reduces the risk of amputation.     

基于交直轴电流耦合的单电流调节器永磁同步电机弱磁控制

基于交直轴电流耦合的单电流调节器弱磁控制是一种新颖的永磁同步电机弱磁策略，能够解决双电流调节器在电机高速域相互冲突而易于饱和的问题。交轴电压指令如何确定是此方法的研究重点，直接影响电机的电压利用率、效率以及负载能力。该文基于电机电压方程对电流耦合调节弱磁控制基本原理进行描述，并提出改进的控制方法。利用id-iq坐标平面上的定子电流轨迹，对现有方法的缺点和所提出方法的预期控制效果进行了分析。在小信号范围内，对所提出方法的动态控制过程和可控性进行了阐述。所提出的电流耦合调节变交轴电压弱磁控制策略，交轴电压指令根据电机工况自行调节，无需查表，且不依赖电机参数，易于实现。仿真和实验结果验证了所提方法的可行性和性能优势。     

Community action for health in socioeconomically deprived neighbourhoods in Barcelona: Evaluating its effects on health and social class health inequalities

BackgroundThe aim of this study was to analyse trends in several health-related indicators in socioeconomically deprived neighbourhoods in Barcelona with strong community action for health (CA), and compare them to neighbourhoods without such community action. A secondary goal was to analyse trends in socioeconomic inequalities in health in both types of neighbourhood.MethodsWe performed a quasi-experimental pre-post study using data from the Barcelona Health Surveys of 2001 and 2011. Our dependent variables were self-perceived health, mental health, previous drug use, and smoking cessation. We used Poisson regression with robust variance to calculate prevalence ratios (PR) and 95% Confidence Intervals (95% CI).ResultsThe percentage of men who had ever used drugs decreased over time in neighbourhoods with strong CA (PR = 0.48; 95% CI:0.25–0.92, from 2001 to 2011), but not in neighbourhoods without CA (PR = 1.02; 95% CI:0.74–1.40). However, the prevalence of poor mental health among men increased more in neighbourhoods with strong CA than in neighbourhoods without CA (p-value = 0.025). Among women, social class inequalities in poor mental health and smoking cessation decreased over time in neighbourhoods with strong CA but not in neighbourhoods without CA.ConclusionsOur study shows promising results regarding the effect of community action on health, particularly in terms of inequalities. Our results highlight the importance of allocating resources to implement and continuously evaluate CA initiatives.     

基于数据挖掘分析林慧娟教授诊治心系疾病的中药配伍研究＊

目的 收集并整理林慧娟教授多年诊治心系疾病临床处方资料，对林教授辨证诊治心系疾病的常用中药配伍规律进行深入分析与研究，总结其在治疗心系疾病方面的临床经验，为挖掘和继承名老中医学术经验提供借鉴与参考。方法 收集林慧娟教授于2011年1月-2019年6月在山东中医药大学附属医院门诊系统中的处方数据，筛选后保留10942个处方数据。采用频数分析、点式互信息、关联规则等数据挖掘分析方法对林教授临床处方数据资料进行药物配伍分析。总结林慧娟教授在诊治心系疾病的用药规律。结果 林教授在诊治心系疾病中，以高血压病、冠心病及心律失常患者较多，发现林教授共使用中药397味，并对中药频次进行排序，获得17对主要配伍药对，与林教授临床诊治心系疾病的经验高度吻合。结论 点式互信息、关联规则等数据挖掘分析方法可分析林慧娟教授治疗心系疾病得学术经验，为名中医传承研究提供服务。     

早期高危子宫内膜癌“夹心模式”序贯放化疗的疗效分析

目的评估“化疗-放疗-化疗”的“夹心模式”序贯放化疗在早期高危子宫内膜癌患者中疗效及可行性。方法回顾性分析2004年1月至2015年12月于北京大学人民医院行分期手术,分期(FIGO 2009)Ⅰ~Ⅱ期,且术后行“夹心疗法”的内膜癌患者,分析其临床病理特征,复发、生存及副反应。结果40例纳入研究,平均年龄(57±7)岁;随访51~182个月,仅1例术后66个月发生远处复发,其余均无瘤生存;5年总生存率及无疾病生存率均100%;无疾病生存期(178.7±3.3)m(95%CI:172.3~185.1);16例出现化疗副反应,仅1例发生Ⅲ度骨髓抑制;8例出现放疗副反应,其中1例发生左侧输尿管狭窄,其余为Ⅰ~Ⅱ度副反应。结论“夹心疗法”应用于早期高危内膜癌具有较好疗效,副反应可耐受。因病例数有限,有待积累病例,进一步总结。     

Annual Facility Treatment Volume and Patient Survival for Mycosis Fungoides and Sézary Syndrome

BackgroundManagement of mycosis fungoides and Sézary syndrome (MF/SS) is complex, and randomized evidence to guide treatment is lacking. The institutional treatment volumes for MF/SS might vary widely nationally and influence patient survival.Patients and MethodsUsing the National Cancer Database, we identified patients with a diagnosis of MF/SS from 2004 to 2011 in the United States who had received treatment at a reporting facility. The patients were grouped into quintiles according to their treatment facility's average annual treatment volume (ATV). The characteristics associated with ATV were identified and compared using χ² tests. Overall survival (OS) was compared among the ATV quintiles using the Kaplan-Meier method with log-rank tests and multivariable Cox regression with hazard ratios (HRs). OS was also analyzed using the annual patient volume as a continuous variable.ResultsA total of 2205 patients treated at 374 facilities were included for analysis. The ATV quintile cutoffs were 1, 3, 6, and 9 patients. With a median follow-up period of 59 months, the 5-year estimated OS survival increased with ATV from 56.7% in the lowest quintile (≤ 1 patient annually) to 83.8% in the highest quintile (> 9 patients annually; P < .001). On multivariable analysis, greater ATV was associated with improved survival when analyzed as a continuous variable (HR, 0.96 per patient per year; 95% confidence interval, 0.94-0.98; P < .001) and when comparing the highest quintile to the lowest quintile (HR, 0.46; 95% confidence interval, 0.39-0.55).ConclusionThe present national database analysis demonstrated that higher facility ATV is associated with improved OS for patients with MF/SS. Further study is needed to determine the underlying reasons for improved survival with higher facility ATV.