基于真实世界数据探讨中医药治疗糖尿病肾病用药规律的研究＊

目的 基于临床信息系统分析总结真实世界的数据，采用数据挖掘的方法探讨中医药治疗糖尿病肾病的用药规律。方法 收集2018年1月-2020年12月上海中医药大学附属曙光医院宝山分院健康信息系统确诊的糖尿病肾病的门诊或住院患者的诊疗信息，建立Excel数据库，采用Excel 2010软件统计高频药物的四气、五味、归经及功效；使用SPSS Modeler 18.0软件中的Apriori算法分析关联规则，采用web节点建构药对关联网状图；运用SPSS 25统计软件进行因子分析。结果 本研究最终纳入477例接受中药饮片治疗的DKD患者，在1203条方剂信息中，涉及中药462种；使用频数排名前5位的中药分别是黄芪、黄精、石斛、山茱萸、麦冬；使用频数前5类的中药类别分别是补气药、补阴药、清热燥湿药、活血调经药、息风止痉药；在30味高频药物中，苦、甘、辛药味最为常见；药性寒、温数量接近；归脾经、肝经、肺经、肾经居多；关联规则提示，药物组合中置信度最高的组合为地龙-当归-僵蚕，因子分析共得到5个有效因子，累积贡献率为47.33%。结论 中医药治疗DKD在补益气血阴阳的同时，兼顾对瘀血、湿邪和痰饮的治疗，结合证型，可考虑使用黄芪、黄精、石斛、山茱萸、麦冬、金蝉花等药物的使用，清热燥湿药物如黄连、黄芩、黄柏可适当加入，为使邪有去处，大黄、车前子或可增添疗效。     

T-DM1 Efficacy in Patients With HER2-positive Metastatic Breast Cancer Progressing After a Taxane Plus Pertuzumab and Trastuzumab: An Italian Multicenter Observational Study

BackgroundT-DM1 improves progression-free survival (PFS) and overall survival (OS) in patients with metastatic human epidermal growth factor receptor 2-positive (HER2⁺) breast cancer progressing on prior trastuzumab plus a taxane. A paucity of data is available on T-DM1 efficacy after dual anti-HER2 blockade with pertuzumab and trastuzumab plus a taxane, which represents the current first-line standard of care. The present study is a retrospective/prospective evaluation of the efficacy and activity of second-line T-DM1 after front-line pertuzumab-based therapy.Patients and MethodsEligible patients were identified within the Gruppo Italiano Mammella (GIM) 14/BIOMETA study, a retrospective/prospective multicenter study on treatment patterns and outcomes of patients with metastatic breast cancer (ClinicalTrials.gov Identifier: NCT02284581). We searched for patients who received second-line T-DM1 after taxane plus trastuzumab and pertuzumab between November 15, 2013 and May 31, 2018. We calculated median PFS, median time to treatment failure (TTF), prolonged duration of therapy (PDT), objective response rate (ORR), and 1-year OS.ResultsOf 445 patients with HER2⁺ metastatic breast cancer, 77 were eligible for the analysis. At a median follow-up of 7 months, median PFS was 6.3 months (95% confidence intervals [CI], 4.8-7.7 months), and median TTF was 6.2 months (95% CI, 4-8.6 months). More than one-third of patients (37.6%; n = 29) experienced PDT with an ORR of 27.1%. At data cutoff, the median OS was not reached, and the 1-year OS was 82%.ConclusionsOur results show meaningful activity of T-DM1 after front-line pertuzumab plus trastuzumab and a taxane, with about 27% of patients having an objective response and 40% of patients achieving durable disease control.     

Immunotherapy choice and maintenance for generalized myasthenia gravis in China

AimsTo compare long‐term efficacy and safety of immunotherapeutic strategies as maintenance to prevent disease relapses of generalized myasthenia gravis (MG) in real‐world settings.MethodsThis is a retrospective cohort study on generalized MG conducted in seven major neurological centers across China. Eligible participants were patients with generalized MG who were under minimal manifestation status or better. Main outcome measures were probability of patients free of relapses and causes of drug discontinuation.ResultsAmong 1064 patients enrolled, the median (interquartile range) age was 50.3 (37.0‐62.5) years and 641 (60.2%) were women. Disease relapse was significantly lower for rituximab (6.1%) compared with all the other monotherapies (hazard ratio [HR] = 0.18, 95% confidence interval [CI] 0.06 to 0.56, P = .0030). As combination therapies, tacrolimus in combination with corticosteroids reduced risk of disease relapses compared with azathioprine with corticosteroids (HR = 0.45, 95% CI 0.25 to 0.81, P = .0077) or mycophenolate mofetil with corticosteroids (HR = 0.32, 95% CI 0.15 to 0.67, P = .0020). Otherwise, lower‐dose corticosteroids or azathioprine as monotherapy significantly increased risk of disease relapses (HR = 2.78, 95% CI 1.94 to 3.99, P < .0001; HR = 2.14, 95% CI 1.42 to 3.23, P = .0003, respectively). The proportion of discontinuation was lowest in patients with rituximab (20.4%) as monotherapy and tacrolimus with corticosteroids (23.6%). Overall, combination treatment of immunosuppressants with corticosteroids had a lower rate of discontinuation compared with corresponding monotherapy (HR = 0.51, 95% CI 0.36 to 0.71, P < .0001).ConclusionsRituximab as monotherapy and tacrolimus with corticosteroids displayed better clinical efficacy as well as drug maintenance to prevent disease relapses in patients with generalized MG.     

基于医院信息系统的乳腺癌临床特征及中西医用药特征分析

目的 解析真实世界中乳腺恶性肿瘤患者的人群特征、诊断特征、中西医用药特征，为乳腺癌的临床防治提供参考。方法 采集2002年2月至2015年5月全国60家三级甲等医 院信息系统（Hospital Information System，HIS）中，出院诊断为“乳腺癌”的患者用药信息，采用SAS9.3统计软件，对人口学信息、诊断信息、医嘱用药信息等进行描述性分析。结果 39798例乳腺癌患者，平均年龄（50.93者，平均年龄）岁；多以门诊入院，入院病情以“一般”为主;合并疾病主要为高血压，骨肿瘤，联用西药以抑制肿瘤细胞增殖、治疗并发症、缓解放化疗不良反应为主；中医辨证以痰瘀互结证，气阴两虚证，肝气淤滞证，脾气亏虚证型最为常见，临床清热解毒剂、益气扶正剂，活血化瘀剂应用较多。结论 乳腺癌中西医结合治疗，联用药物广泛，临床治疗基本符合临床指南。     

基于真实世界数据挖掘探索新型冠状病毒肺炎危重型患者的证素分布和组方规律＊

目的 基于真实世界临床数据探索新型冠状病毒肺炎危重型患者中医证素分布特点及中药组方规律。方法 系统收集2019年12月至2020年3月武汉市中西医结合医院收治住院的新型冠状病毒肺炎危重型患者的住院数据，采用专业数据收集工具建立数据库，采用IBM SPSS Modeler 14.1 Premium 软件对中医证素信息和处方用药信息进行统计分析。结果 共纳入40例患者193次的中医诊疗信息，方剂193首，中草药种类为181味；其中病位证素信息10个，前3位分别是肺（33.81%）、脾（33.09%）、肾（12.23%）；病性证素信息12个，前5位的分别是湿（24.27%）、痰（14.81%）、阴虚（14.08%）、气虚（12.86%）、阳虚（9.22%）；用药频次最多的前5位分别是甘草（60.52%）、茯苓（44.04%）、白术（33.68%）、半夏（29.02%）、厚朴（25.91%）；中草药关联分析前5名分别是茯苓—黄芪—半夏、厚朴—草果仁、厚朴—槟榔、黄芪—党参—半夏、茯苓—党参—半夏；核心处方挖掘中所获得的4个处方分别是藿香—党参—五味子—陈皮—草果仁、藿香—附子—半夏、茯苓—半夏、黄芪-干姜。结论 新型冠状病毒肺炎危重型患者的病位多位于肺、脾、肾三脏，而病性多以湿、痰、阴虚、气虚、阳虚为主，中药治疗中健脾、祛湿、化痰是治疗危重型患者的基本用药原则，医师需根据临床表现配伍益气、养阴、温阳、行气等药物。     

实时超声弹性成像在诊断慢性乙肝肝纤维化程度中的应用价值

【摘要】 目的 探讨实时超声弹性成像在诊断慢性乙肝肝纤维化程度中的应用价值。方法 以2016年1月～2019年1月我院收治的慢性乙型肝炎（CHB）患者146例为研究对象。分别行肝脏穿刺检查及实时组织弹性成像（RTE）检查，然后进行病理分期，并记录相应的应变均值（MEAN）、标准偏差（SD）、蓝色区域面积比（%AREA）、复杂度（COMP）、峰度（KURT）、偏度（SKEW）、对比度（CONT）、均等性（ENT）、杂乱度（IDM）、一致性（ASM）、相关性（CORR），并计算得出肝纤维化指数（LFI）值。结果 与S0、S1、S2期比较，S4期MEAN显著降低（P＜0.05）；与S0、S1、S2、S3期比较，S4期%AREA、COMP显著升高（P＜0.05）；与S0、S1、S2期比较，S4期SKEW、LFI显著升高（P＜0.05）；与S0期比较，S3期LFI显著升高（P＜0.05）。Spearman相关分析结果示，MEAN、ENT与肝纤维化分期呈负相关（P＜0.05）。SD、%AREA、COMP、SKEW、IDM、ASM、LFI与肝纤维化分期呈正相关（P＜0.05）。RTE参数MEAN、%AREA、COMP、SKEW、IDM、LFI诊断肝纤维化程度的ROC曲线下面积均在0.7~0.9。当MEAN、%AREA、COMP、SKEW、IDM、LFI 6个参数的截断值分别取10029、3014、2752、042、012、281时，诊断肝纤维化程度的准确性和特异性均在70%以上。〖HT5"H〗结论〖HTK〗〓实时组织弹性成像与慢性乙型肝炎肝纤维化分期具有较高的相关性，其中与肝纤维化指数的相关系数最大，其在慢性乙型肝炎肝纤维化的诊断和评估中具有重要应用价值。