【Cochrane简语概要】氟伏沙明用于治疗COVID-19

系统综述问题

氟伏沙明对COVID-19患者是一种有效的治疗方法吗？它是否会造成任何不良影响？

（图片来自torres.house.gov）

关键信息

目前尚不清楚氟伏沙明是否能有效治疗轻度至中度COVID-19。这是因为目前没有足够的研究来做出明确决定。
我们发现了5项正在进行的研究，目前正在调查氟伏沙明作为一种可能的COVID-19治疗方法，以及2项我们需要更多信息的研究。如果这些研究的结果改变了我们的结论，我们将更新本系统综述。

什么是氟伏沙明？

氟伏沙明是一种被称为选择性血清素再摄取抑制剂（selective serotonin reuptake inhibitor, SSRI）的药物，以片剂形式提供。最近的研究发现氟伏沙明可能对COVID-19有影响。免疫系统与病毒斗争时，肺和呼吸道会出现炎症，以致引起呼吸困难。氟伏沙明可以帮助减少这种炎症，通过其可能的抗炎和抗病毒作用，有可能降低发生严重 COVID-19及其相关肺部症状的风险。我们知道，大多数人在服用氟伏沙明作为抗抑郁药时不会出现任何严重的副作用。然而，有些人可能会出现以下常见的副作用，尤其是在开始服药时：恶心、焦虑或烦躁、失眠或腹泻，在极少数情况下还有自杀意念。

我们想了解什么？

我们想知道使用氟伏沙明是否会降低COVID-19患者的死亡率、病情严重程度、缩短感染时间，以及是否会对患者的生活质量产生影响，或造成其他不良影响。我们纳入的研究将氟伏沙明与安慰剂（虚拟治疗）、无治疗、常规治疗或任何其他已知在一定程度上对COVID-19有效的治疗（如瑞德西韦或地塞米松）进行了比较。我们排除了已知对COVID-19无效，例如羟氯喹，或对疾病有未知影响的治疗方法。

我们评估了氟伏沙明对COVID-19成人患者的疗效：

• 患者死亡；

• 患者是否需要住院接受治疗；

• 患者的COVID-19症状是好转还是恶化；

• 不良影响；

• 生活质量；

• 服用此药时是否有自杀或自杀未遂的风险。

我们做了什么？

我们检索了研究氟伏沙明作为治疗COVID-19成人住院或门诊患者的研究。我们对比并总结了研究结果，并根据研究方法和规模等共同标准，评价了证据质量。

我们发现了什么？

我们发现2项研究调查了氟伏沙明在1649名在家自我隔离的人（门诊患者）中作为轻度COVID-19的早期治疗方法。所有研究都将氟伏沙明与安慰剂以及标准治疗进行了比较。这2项研究采用了不同的治疗时间（10日或15日）。

我们发现了5项正在进行的研究和2项正在等待分类的研究。我们没有发现任何研究调查氟伏沙明对住院 COVID-19患者的影响。

主要研究结果

• 与安慰剂相比，氟伏沙明可能会略微减少开始治疗后28天内的死亡人数（2项研究，1,649人）。

• 与安慰剂相比，氟伏沙明可减少入院人数或入院前死亡人数（2项研究，1,649人）。

• 氟伏沙明和安慰剂治疗之间的不良（严重）事件数量没有明显差异（2项研究，1,649人）。

• 2项研究均未报告生活质量、所有初始症状消失所需的时间或自杀未遂。

证据的局限性是什么？

我们对氟伏沙明治疗COVID-19患者现有的证据没有信心，这主要是由于目前缺乏可用的研究以及研究设计存在一些缺陷。我们将继续检索新的研究来弥补目前的证据空白。

找出氟伏沙明等药物对长期COVID的影响也很重要。我们目前正在等待未来对此的相关研究。

不幸的是，现有的研究并未关注儿童和年轻人、计划怀孕的女性、已怀孕或哺乳的女性、老年人或免疫系统较弱的人（免疫功能低下的人）。同样，没有关于女性或男性是否更有可能从氟伏沙明中受益的信息。

检索日期

证据检索时间截至2022年2月。

作者结论: 

根据低质量证据，氟伏沙明可能会略微降低第28天的全因死亡率，并可能降低轻度COVID-19门诊患者入院或死亡的风险。然而，我们非常不确定氟伏沙明对不良事件或任何不良事件的影响。

根据本系统综述的实时方法，我们将不断更新我们的检索并在符合条件的试验出现时将其纳入，以弥补证据中的任何空白。

作者:Nyirenda JLZ, Sofroniou M, Toews I, Mikolajewska A, Lehane C, Monsef I, Abu-taha A, Maun A, Stegemann M, Schmucker C；译者：陶安，Cochrane Hong Kong，香港中文大学医学院那打素护理学院；审校：牟焕玉，Cochrane Hong Kong，香港中文大学医学院那打素护理学院；编辑排版：索于思，北京中医药大学循证医学中心

相关文章链接

【Cochrane Plain Language Summary】

Fluvoxamine for treating COVID-19

Background to the question

Asthma is one of the most common long-term conditions worldwide. There are effective medicines available to treat symptoms, such as inhalers containing steroids. However, for best effect, maintenance medication need to be taken as prescribed. Many people do not take their medication, due to busy schedules and the belief that medication is only needed short-term. This is known as 'non-adherence', which can lead to more symptoms and attacks. Non-adherence is a major health problem; achieving adherence is very important to prevent attacks and reduce the risk of death. In healthcare there is increasing use of digital interventions such as mobile phones, text messages, and 'smart' inhalers that can feed back information about medication-taking. However, there is limited evidence on whether these technologies work to improve asthma medication-taking or improve symptoms.

This review aimed to find out whether digital technologies really work to improve asthma medication-taking, and whether this improved adherence leads to improvements in asthma symptoms and other benefits.

Study characteristics

We found 40 studies including more than 15,000 adults and children with asthma. Studies ranged from about 2 weeks to 24 months' duration, so we cannot say whether these methods are effective in the long term (a long period of years). We searched multiple information sources to identify relevant studies. This review is current as of June 2020. Looking at the data, we aimed to find out whether digital technologies helped people with asthma to take their medication as prescribed, and whether people who used the technology had better asthma control, and fewer asthma attacks, than those who did not use the technology.

Key results

People with asthma who were given the digital technology to support asthma medication-taking were better at taking their medication as prescribed compared to people who did not get the technology; 15% more people (likely to be somewhere between 8% and 22%) took their medication as prescribed when they received the digital technology, compared to those who did not (who took their medication on average 45% of the amount prescribed). Importantly, people who got the digital technology had much better asthma control and half the risk of asthma attacks (likely somewhere between 32% and 91%), which has direct benefits for reducing the risk of asthma-related deaths. We saw improvements in quality of life and lung function, but the effect on lung function was small and may be of limited clinical relevance. No improvements were seen in unscheduled healthcare visits. There was not enough information to tell us about the effect of digital technologies on time off work or school or the cost-benefits, nor whether there are any harms. Technologies were generally acceptable to patients. Certain types of technologies such as 'smart' inhalers and text messages seemed to be better for improving medication-taking than other technology types, although the small number of studies means we cannot be certain that these technologies definitely work better than others.

Quality of the information

There is some uncertainty about our results because the studies were quite different from each other. These differences mean that we cannot be completely sure what the real benefit is, as the benefits may be due to other factors not directly related to the technology - for example, being involved in a study can improve medication-taking. Sometimes the studies did not give us enough information for us to include them with the other studies to work out their effectiveness. We had concerns about a quarter of the studies where people did not finish the study, and we were uncertain whether studies reported everything they measured.

Key message

The studies we found suggest that digital technologies may help people with asthma take their medication better, improve their asthma control, and potentially halve their risk of asthma attacks, compared with people who did not get the technology. Certain types of digital technologies, such as text-message interventions, may work better than others. However, we have some uncertainties about the quality of the information reported in some studies, and the small number of studies for the different technology types, which means we cannot be 100% certain of their benefits.

Authors' conclusions: 

Based on a low-certainty evidence, fluvoxamine may slightly reduce all-cause mortality at day 28, and may reduce the risk of admission to hospital or death in outpatients with mild COVID-19. However, we are very uncertain regarding the effect of fluvoxamine on serious adverse events, or any adverse events.

In accordance with the living approach of this review, we will continually update our search and include eligible trials as they arise, to complete any gaps in the evidence.

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