COVID-19 专题
2020年11月号

中国慢病管理模式登上柳叶刀(Lancet)

作者:生命新知

第六届柳叶刀-中国医学科学院医学与健康大会(Lancet-CAMS)于2020年11月24日~25日在线举办。

董教授代表中国风湿病专家,尤其是湖北省风湿界,展现了疫情期间湖北风湿医生的风采

第六届柳叶刀-中国医学科学院医学与健康大会(Lancet-CAMS)于2020年11月24日~25日在线举办。会议语言为英语,有同声传译。

这次盛会上,来自国内外的顶尖医学专家和研究人员分享了COVID-19的相关研究和经验,中国工程院副院长、北京协和医学院校长王辰院士、《柳叶刀》杂志总编Richard Horton主持了精彩研讨。

华中科技大学附属同济医院董凌莉教授投稿的文摘,受邀做大会发言。

董教授代表中国风湿病专家,尤其是湖北省风湿界,展现了疫情期间湖北风湿医生的风采,他们利用智能疾病管理系统(SSDM),在正常医疗秩序被完全打乱的境况下,对湖北风湿病患者开展跨越时空、超越病毒屏障的医疗服务,通过及时随访和延续用药,让病人的转归及达标非但没有下降,反而优于既往同期水平。

智能疾病管理系统(Smart System of Disease Management,SSDM)是一系列用于慢性病管理的移动应用程序,包括患者和医生的界面。

经过临床培训,患者在智能手机上定期进行疾病活动性评估、实验室检查数据和药物治疗方案录入。数据同步到经诊负责医生的手机上。医生可以根据病人的实时数据进行在线咨询、指导、干预和延续用药处方。

经过过去5年积累,一万六千余湖北风湿病人注册在SSDM平台,常规定期录入其关键数据,与其主诊医生保持跨时空的沟通。作为风湿病垂直细分领域里的慢病管理平台,重灾区的湖北风湿科医生通过SSDM,实时获知其经治病人的病情活动、实验室检查、用药数据,并利用医患互动平台,给予病人精准指导。SSDM为湖北风湿病医生和患者之间架起了沟通的桥梁,解决了随访困难和购药不便问题,使类风湿关节炎(RA)患者的达标率与往年持平,显著提高了SLE患者的达标率。

董主任团队的这篇研究,被本届柳叶刀年会作为唯一的投稿报告发言,向全世界展示了中国医生在疫情期间进行慢病管理的经验。

下面,让我们一起看看董主任在Lancet-CAMS上的精彩发言。

It’s a great honor to have this opportunity to share our study at this meeting.

The title is: Smart System of Disease Management (SSDM) for patient follow-up and medication refill during COVID-19 pandemic in Hubei: A Multicentre Retrospective Cohort Study.

Disclosures

This is our disclosures. Patients can download SSDM from app store for disease management. Patients can be trained to master this mobile tool SSDM, they can perform disease activity assessment and disease management by themselves or their family members. Some patients may be assisted by nurses.

There are 12 kinds of rheumatic disease activity assessment criteria. For example, DAS28 for patients with RA, SLEDAI for patients with SLE, and ASDAS for patients with AS.

Pictures with lab test reports, all data can be synchronously automatically authorised to the doctor’s terminal of SSDM.

In the same way, doctors can preview medication and medical data which are uploaded by the patients and managed with SSDM .

Until now, there are more than 230,000 patients with rheumatic disease who registered SSDM and followed up by over 3000 rheumatologists from 932 hospitals all over the China. In Hubei, there are 18,000 patients registered SSDM and followed up before COVID-19 pandemic.

Earlier this year, due to COVID-19 pandemic, Wuhan was in lockdown from Jan 23 to April 8. Most hospitals in Wuhan and other cities in Hubei concentrated on patients with COVID-19.

At the beginning of lock down, patients with chronic disease such as rheumatic diseases could not visit their physicians in clinic.

SSDM is a practical way to connect patients and rheumatologists. In addition, the risk of COVID-19 infection in rheumatic diseases need to be clarified.

Therefore, we performed a multicentre retrospective cohort study of patients with rheumatic disease in Hubei province in China.

To answer the following questions:

First, for patients with rheumatic disease, how about their susceptibility and DMARDs (disease-modifying antirheumatic drugs)efficacy to COVID-19?

The second, rheumatic disease can be well managed through SSDM during COVID-19 pandemic?

As we know, rheumatic disease is caused by immune disorder, DMARDs can be used either in immunosuppression or inhibiting inflammatory storm.

It’s widely accepted that the patients with autoimmune disorder have a higher risk of infection.

However, the risk of COVID-19 infection in rheumatic disease remains unknown, therefore, susceptibility as well as DMARDs efficacy to COVID-19 among these patients need to be clarified.

Susceptibility

To test the susceptibility to COVID-19 in patients with auto-immune rheumatic disease during the pandemic, a total of 15,697 patients with rheumatic disease in Hubei province of China was inquired by telephone about COVID-19 infection in their family.

Families with documented COVID-19 exposure history as defined by having at least one family member diagnosed with COVID-19 were followed up by medical professionals to obtain detailed information including gender, age, smoking, medication history and COVID-19 related information.

We identified 42 families in which a diagnosis of COVID-19 was made in either the patients with rheumatic disease or a family member residing at the same physical address during the outbreak.

Within these families, the infection rate in rheumatic disease and family member without rheumatic disease is 62.8% and 33.7% respectively, with odds ratio of 2.68 after adjusted OR.

Thus , patients with auto-immune rheumatic disease maybe more susceptible to COVID-19 infection.

DMARDs efficacy

To analyse if anti-rheumatic drug such as HCQ, LEF, MTX, and so on is associated with COVID-19 infection in patients with rheumatic disease, we further compare the characteristic of these patients with COVID-19 to those without COVID-19.

There were 16 of 43 rheumatic patients with COVID-19 exposure history who were on HCQ medication, there were no significant difference in age, gender, comorbidities and prescription of other immunosuppressive agents between HCQ users and those who did not take HCQ .

However, patients with SLE tended to be prescribed HCQ more often compared to patients with other rheumatic diseases, therefore, SLE was included as a  confounder when assessing the potential effect of anti-rheumatic medication on COVID-19 infection.

There are 56.3% uninfected autoimmune rheumatic patients that were taking HCQ, while only 25.9% rheumatic patients infected with COVID-19 was on HCQ treatment.

After adjusted for age, gender, smoking, infection in family members and comorbid conditions and SLE, rheumatic patients taking HCQ had a lower risk of COVID-19 infection.

Summary- 1

Compared with healthy controls, the susceptibility of patients with rheumatic disease to COVID-19 was increased.

HCQ can be used continuously during the outbreak of COVID-19.

Q2: Rheumatic disease can be well managed through SSDM during COVID-19 pandemic?

To study the influence of interruption of routine care by the COVID-19 epidemic for patients with rheumatic disease, we included patients registered with SSDM from Hubei province.

During the COVID-19 pandemic, from January 23 to Feb 27, 69 rheumatologists from 28 hospitals provided 1451 patients with 1692 consultations in Hubei province. 566 patients requested continuing medication through SSDM online refilling service and got their medication.

Method

Data on patient disease activities, online consultations, and prescription refilling, as well as surveys on satisfaction about the online service were extracted from Jan 23, 2020 to Feb 27, 2020. Acting as the study group, data from the same period during 2018 and 2019 was also extracted as a control.

For patients with rheumatoid arthritis, achieving a disease activity score with 28 joints (DAS 28) of less than 3.2 was considered to be a treat-to-target (T2T) status.

For patients with SLE, a disease activity index-2000 (SLEDAI-2K) score of less than 4 was the main target of the lupus low disease-activity state(LLDAS).

This page showed patients’ interface of DAS28 assessment on SSDM for patients with rheumatoid arthritis.

247(8%) of 3237 patients with rheumatoid arthritis (RA) during the 2020 pandemic and 350 (9%) in same period during 2018 and 2019 did the DAS28 self-assessments.

T2T (DAS28≤3.2) rate was 47% in 2020 compared with 50% in 2018 and 2019, (P=0.53).

This page showed the patient’s interface of SLEDAI-2K assessment on SSDM for patients with SLE.

293 (19%) of 1566 patients with SLE in 2020 and 210 (16%) in 2018 and 2019 did the SLEDAI-2K self-assessments.

Compared with the same period of 2018-2019, patients who achieved SLEDAI≤4 in 2020 was improved significantly, P=0.03.

Summary-2

Patients with Rheumatic disease can maintain accessibility to good care in the era of the COVID-19 pandemic by using SSDM for consultations and medication refills.

The clinical outcomes, at least for both rheumatoid arthritis and SLE, are not compromised.

Finally please allow me to express our great appreciation to everyone who has helped and supported Hubei Wuhan to fight this virus and pandemic. Many thanks to doctor Xiaofei and his teams and also thanks to our rheumatology team in Hubei and every staff in department of Rheumatology and Immunology Tongji Hospital (Wuhan). That’s all my presentation. Thank you for listening.

翻译如下:

很荣幸有机会在这次会议上分享我们的研究成果。

研究的标题为:智能疾病管理系统(SSDM)使患者能够在COVID-19大流行期间进行随访和延续用药:一项多中心回顾性队列研究。

信息公开

这是我们的公示信息。患者可以从软件商店下载SSDM进行疾病管理。患者可以通过培训掌握SSDM这一移动工具的用法,他们可以自行或由其家庭成员进行疾病活动度评估和疾病管理。还有些病人是在护士的帮助下进行管理。

SSDM上有12种风湿病活动度评估。例如,用于RA患者的DAS28,用于SLE患者的SLEDAI,用于AS患者的ASDAS。

实验室检测报告的照片等所有数据均可同步自动授权至SSDM的医生终端。

同样,医生可以预览患者上传的药物和医疗数据,借助SSDM平台对数据进行管理。

目前,全国注册SSDM的风湿病患者已超过23万,由全国932家医院的3000多名风湿科医生对注册患者进行随访。在2019新型冠状病毒病(COVID-19)暴发前,湖北省在SSDM平台登记并接受随访的患者有18000人。

今年年初,COVID-19暴发,武汉从1月23日到4月8日期间一直封城。武汉和湖北其他城市的大部分医院都把工作重点放在了COVID-19患者的救治上。

在封城之初,风湿病等慢性病患者不能到诊所就诊。

SSDM是一个连接患者和风湿病学家的平台。此外,风湿病患者感染COVID-19的风险尚需要进一步明确。

因此,我们对中国湖北省的风湿病患者进行了一项多中心回顾性队列研究。

来回答以下的问题:

首先,对于风湿病患者,他们对COVID-19的易感性如何?病程改善抗风湿药(DMARDs)对于COVID-19的功效如何?

其次,在COVID-19 大流行期间,风湿病可以通过SSDM平台得到很好的控制吗?

众所周知,风湿病是由免疫紊乱引起的,DMARDs既可用于免疫抑制,也可用于抑制炎症风暴。

有自身免疫性疾病的患者感染COVID-19的风险较高,这一点已被广泛接受。

但风湿病患者感染COVID-19的风险尚不清楚,因此需要明确这些患者对COVID-19的易感性以及DMARDs对COVID-19的疗效。

易感性

为检测疫情期间自身免疫性风湿病患者对COVID-19的易感性,本研究对湖北省15697例风湿病患者进行了COVID-19感染的电话问询。

对于有明确疫情暴露史的家庭(至少有一名家庭成员确诊为COVID-19感染),本研究安排医疗专业人员进行随访,以获取详细信息,包括:性别、年龄、吸烟、用药史和COVID-19相关信息等等。

我们发现了42个确诊为COVID-19的家庭,感染者除了风湿病患者本人,也包括疫情期间与风湿病患者住在同一住址的家庭成员。

在这些家庭中,风湿病患者和无风湿病的家庭成员的COVID-19感染率分别为62.8%和33.7%。

因此,自身免疫性风湿病患者可能更容易感染COVID-19。

DMARDs 疗效

为分析HCQ(羟氯喹)、LEF(来氟米特)、MTX(甲氨蝶呤)等抗风湿药与风湿病患者COVID-19感染的相关性,研究人员进一步比较了感染及未感染COVID-19的两组患者的特点。

43例有COVID-19暴露史的风湿病患者中,有16例服用HCQ,使用HCQ的患者与未服用HCQ的患者相比,在年龄、性别、共病及接受其他免疫抑制剂处方等方面无显著差异。

然而,与其他风湿病患者相比,SLE患者往往更常用HCQ治疗,因此,在评估抗风湿病药物对感染COVID-19的潜在影响时,SLE被列为混淆因素。

未感染COVID-19的风湿病患者中有56.3%在服用HCQ,而确诊感染COVID-19的风湿病患者中只有25.9%在服用HCQ。

经过对年龄、性别、吸烟、家庭成员感染、共病及SLE因素的调整后,本研究发现服用HCQ的风湿病患者感染COVID-19的风险较低。

总结1

与健康对照组相比,风湿病患者对COVID-19的易感性更强。

在COVID-19暴发期间,HCQ可持续使用。

以上是对第一个问题的回答。

问题2: 在COVID-19大流行期间,患者通过SSDM平台可以很好地管理风湿病吗?

为研究COVID-19对风湿病患者常规护理的干扰,本研究将纳入湖北省的SSDM注册患者。

1月23日至2月27日,湖北省28家医院69名风湿病医师为1451例患者提供1692次咨询服务。566例患者通过SSDM在线延续用药功能获得药物。

方法

研究提取SSDM中2020年1月23日至2月27日患者的疾病活动、在线咨询、在线延续用药、在线服务满意度调查数据作为研究组数据,对照组选取2019年和2018年同一阶段的数据。

对于RA患者,疾病活动度DAS28得分低于3.2视为实现了达标治疗(treat-to-target,T2T)。

对于SLE患者,疾病活动性指数SLEDAI-2K评分低于4视为狼疮低疾病活动度(lupus low disease-activity state,LLDAS)。

此页(见P35)为类风湿关节炎患者在SSDM患者平台上进行DAS28评估的界面。

2020年疫情期, 3237名RA患者进行了247次(8%)DAS28自评,2008年和2019年同期进行了350次(9%) 。

2020年T2T (DAS28≤3.2)率为47%,2018年和2019年为50%,(P=0.53)。

本页(见P35)展示了SSDM患者平台中SLE患者的SLEDAI-2K评估界面。

关于SLE患者的SLEDAI-2K自评,1566名SLE患者2020年评估了293次 (19%),2018年和2019年评估了210次(16%)。

与2018年~2019年同期相比,患者SLEDAI≤4 的达标率在2020年明显改善,P = 0.03。

总结-2

在COVID-19大流行的时代,使用SSDM进行在线会诊和延续用药,风湿病患者可以对疾病进行良好的管理。

至少对RA和SLE患者而言,使用SSDM后,临床结局没有受到疫情影响。

最后,请允许我向所有帮助和支持湖北武汉抗击新冠病毒的人表示衷心的感谢。非常感谢肖飞医生和他的团队,也感谢我们湖北省的风湿科团队和武汉同济医院风湿免疫科的每一位工作人员。我的演讲到此结束。谢谢大家的聆听。

后记:董凌莉教授作为第一作者的这篇文章已刊载于《Lancet》(柳叶刀)杂志(DOI:https://doi.org/10. 1016/S0140-6736(20)32421-1)。

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