國藥新冠滅活疫苗Ⅲ期臨床試驗中期分析結(jié)果正式發(fā)表
中國日報網(wǎng) 2021-05-28 13:36
關(guān)于國藥集團中國生物新冠疫苗Ⅲ期臨床試驗中期分析結(jié)果的論文5月26日正式發(fā)表在《美國醫(yī)學(xué)會雜志》上。
The inactivated vaccine, developed by a Beijing unit of Sinopharm's China National Biotech Group, has 78.1 percent efficacy against symptomatic cases of COVID-19, while the vaccine made by the group's unit in Wuhan, Hubei province, has 72.8 percent efficacy, according to the study results.
研究顯示,中國生物旗下北京生物制品研究所的新冠滅活疫苗有效性為78.1%,武漢生物制品研究所的新冠滅活疫苗有效性為72.8%。
【知識點】
疫情發(fā)生以來,國務(wù)院聯(lián)防聯(lián)控機制科研攻關(guān)組專門設(shè)立疫苗研發(fā)專班,按照滅活疫苗(inactivated vaccines)、重組蛋白疫苗(recombinant protein vaccines)、腺病毒載體疫苗(adenovirus vector vaccines)、減毒流感病毒載體活疫苗(vaccines using attenuated influenza virus as vectors)、核酸疫苗(nucleic acid vaccines)5條技術(shù)路線共布局12項研發(fā)任務(wù)。
The study marks the first time a domestic COVID-19 vaccine maker had released third-stage trial data in a peer-reviewed international journal and the world's first published phase-3 study results of inactivated COVID-19 vaccines.
這是國產(chǎn)新冠疫苗首次在同行評議的國際期刊上發(fā)布疫苗Ⅲ期試驗數(shù)據(jù),也是全球首個正式發(fā)表的新冠滅活疫苗Ⅲ期臨床試驗結(jié)果。
試驗中期分析結(jié)果
The trial was initiated in mid-July and involved more than 40,400 people in the United Arab Emirates and Bahrain aged 18 and above without known history of COVID-19. It was conducted in a randomized, double-blind method.
試驗自2020年7月中旬開始,來自阿聯(lián)酋和巴林的40400多名18歲以上且沒有已知新冠肺炎患病史的受試者參與。試驗采用雙盲隨機方式進行。
About one-third of participants in the trial were given the vaccine from the Beijing unit, one-third from the Wuhan unit and the remainder were given a placebo.
三分之一受試者接種北京生物的疫苗,三分之一接種武漢生物的疫苗,剩余的三分之一接種安慰劑。
【詞匯講解】
在藥物試驗中,placebo是一個常用詞,是沒有任何效力的“安慰劑”,通常用來與藥物組做對照。在一些心理疾病的治療中,醫(yī)生有時候也會給病人一些類似安慰劑的藥物,已達(dá)到心理上的安撫作用,由此產(chǎn)生的效力就叫placebo effect(安慰劑效應(yīng))。在日常生活中,一些沒有實際作用、但是能起到安撫作用的做法、政策也可以用placebo來表示,比如:None of those placebos has reduced unemployment, but they have successfully held wages down.(這些安慰政策并沒有降低失業(yè)率,但成功地維持了工資低水平)。
Interim analysis of the trial shows that treatment of adults with either of the inactivated SARS-CoV-2 vaccines "significantly reduced the risk of symptomatic COVID-19", the study said.
試驗中期分析結(jié)果顯示,兩種新冠滅活疫苗均能在成年人身上“顯著降低新冠肺炎發(fā)病風(fēng)險”。
Both vaccines also demonstrate a good safety record, as the rates of adverse reaction within seven days after an injection were roughly the same among the three groups.
兩種疫苗也都表現(xiàn)出了良好的安全性,三組受試者在接種后7天內(nèi)出現(xiàn)的不良反應(yīng)比例基本相當(dāng)。
The most common adverse symptoms were pain at the injection site and headache, but they were mild and transient, without need for special treatment.
最普遍的不良反應(yīng)為注射部位疼痛以及頭疼,且程度輕,具有一過性,無需專門治療。
【詞匯講解】
Transient表示“轉(zhuǎn)瞬即逝的,短暫的,臨時的”,比如:a transient workforce/worker(臨時工),transient population(臨時居住人口),transient beauty(轉(zhuǎn)瞬即逝的美,曇花一現(xiàn));transient也可以直接用作名詞,表示“臨時工,臨時居住人員”,比如:It's an organization set up to provide money and help for transients.(這是專門為臨時工提供資金和援助的機構(gòu))。
The new study also noted that more research and data are needed to evaluate Sinopharm vaccines' efficacy in protecting pregnant women, people younger than 18, as well as high-risk groups including those with chronic diseases and the elderly.
結(jié)果指出,國藥疫苗對孕婦、18歲以下青少年、慢性病患者以及老年人等高危人群的有效性還需進一步研究和數(shù)據(jù)支持。
Their efficacy in preventing severe cases and asymptomatic infections and the length of immunity also require further tests, it added.
防止重癥和無癥狀感染的有效性,以及長期保護性也需要更多試驗。
【相關(guān)詞匯】
藥品和疫苗研發(fā) drug and vaccine development
隨機試驗 random trial
雙盲試驗 double-blind trial
安慰劑對照試驗 placebo-controlled trial
免疫系統(tǒng) immune system
毒性試驗 toxicology test
有效性和安全性研究 safety and efficacy research
參考來源:新華網(wǎng)、中國日報
(中國日報網(wǎng)英語點津 Helen)