法匹拉韦最新临床结果显示：清除新冠病毒平均4天见效且安全性好
• 来源：科普时报
• 作者：刘垠
• 2020-03-12 12:14
一项最新的临床研究结果，进一步佐证了之前专家所说的“法匹拉韦安全性好、疗效明确”的观点。
记者11日晚从国务院联防联控机制科研攻关组药物专班获悉，“法匹拉韦治疗新型冠状病毒肺炎(COVID-19)患者的安全性和有效性的临床研究（注册号：ChiCTR2000029600)”结果新鲜出炉，研究提示：法匹拉韦可能通过加快病毒清除，达到缓解新型冠状病毒肺炎进展的疗效。该研究由国家应急防控药物工程技术研究中心和深圳市第三人民医院刘磊、刘映霞团队合作完成。
据介绍，以病毒的清除为主要疗效指标是国际上评价抗病毒药物临床疗效公认的金标准。在本项临床研究中，研究者对符合入组条件的35例普通型新型冠状病毒肺炎患者接受法匹拉韦治疗(首日3200毫克,第2-14日，1200毫克/天,分2次口服，疗程至病毒清除或最长14天）。并纳入年龄、性别和疾病严重程度相匹配的，接受洛匹那韦/利托那韦片（400毫克/100毫克，一日两次，口服）治疗的45例新冠肺炎患者作为对照组。比较两组的用药到病毒清除时间的中位数、疗程第14天胸部影像学改善率及安全性。
研究结果显示，两组患者的所有基线特征均具有可比性。法匹拉韦治疗组病毒清除中位时间更短，中位数（四分位间距）为4天（2.5-9天），而对照组为11天（8-13天），P<0.001，即两组具有显著差异。
在控制了年龄、起病时间、发热等潜在的混杂因素后，法匹拉韦仍然是胸部影像学改善、早期病毒清除的独立影响因素。与对照组相比，法匹拉韦组的不良反应少，耐受性更好。研究结果已投稿至中国工程院院刊。

The latest clinical results of Fapilavir show that the removal of neocoronavirus takes an average of 4 days and is safe.
Source: Popular Science Times Author: Liu Yin 2020-03-12 12:14
The results of a recent clinical study further corroborated previous experts' views that "fapilavir is safe and effective."
On the evening of the 11th, the reporter learned from the special drug research team of the Joint Prevention and Control Mechanism of the State Council, "Clinical study on the safety and effectiveness of fapilavir in the treatment of patients with new coronavirus pneumonia (COVID-19) (registration number: ChiCTR2000029600)" The results were freshly released, and the study suggests that fapivir may have the effect of alleviating the progression of new coronavirus pneumonia by accelerating virus clearance. The study was completed by the National Engineering Research Center for Emergency Prevention and Control of Drugs and Technology, and the team of Liu Lei and Liu Yingxia from Shenzhen Third People's Hospital.
According to reports, taking viral clearance as the main efficacy indicator is the internationally recognized gold standard for evaluating the clinical efficacy of antiviral drugs. In this clinical study, the researchers received fapilavir in 35 patients with common new-type coronavirus pneumonia who met the eligibility criteria (3200 mg on the first day, 1200 mg / day on the 2nd to 14th days, divided into 2 sessions Oral, until the virus clears or up to 14 days). 45 patients with neocoronary pneumonia treated with lopinavir / ritonavir (400 mg / 100 mg, twice a day, orally) matched with age, sex and disease severity were included as control group. The median time from drug administration to virus clearance, the rate of improvement of chest imaging on day 14 of treatment, and safety were compared between the two groups.
The results showed that all baseline characteristics of the two groups of patients were comparable. The median time to virus clearance was shorter in the fapilavire treatment group, with a median (interquartile range) of 4 days (2.5-9 days), compared with 11 days (8-13 days) in the control group, P <0.001, That is, there are significant differences between the two groups.
After controlling for potential confounding factors such as age, onset of onset, and fever, fapivir is still an independent influencing factor for improved chest imaging and early viral clearance. Compared with the control group, the felavir group had fewer adverse reactions and was better tolerated. The research results have been submitted to the Chinese Academy of Engineering.