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Á¦¸ñ [JAMA Medicine Ãֽź¸°í] Åä½Ç¸®ÁÖ¸¿(Tocilizumab) Äڷγª 19 ÁßÁõ Æó·Å »ç¸ÁÀ² Ä¡·áÈ¿°ú
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Åä½Ç¸®ÁÖ¸¿(Tocilizumab) Äڷγª 19 ÁßÁõ Æó·Å »ç¸ÁÀ² Ä¡·áÈ¿°ú 

Effect of Tocilizumab vs Usual Care in Adults Hospitalized With COVID-19 and Moderate or Severe Pneumonia: A Randomized Clinical Trial



 

Key Points

ÁÖ¿ä ¿¬±¸Áú¹®(Question):  Äڷγª19 ȯÀÚÀÇ ÁßÁõµµ ȤÀº ÁßÁõÆó·ÅȯÀÚ¸¦ ´ë»óÀ¸·Î Åä½Ç¸®ÁÖ¸¿ Ä¡·á°¡ È¿°ú°¡ ÀÖ½À´Ï±î? 

 

Á߿伺(Importance)

°ú¿°Áõ¹ÝÀÀ ¹× ÀÎÅÍ·çŲ -6 »ó½ÂÀ» µ¿¹ÝÇÑ ÁßÁõ Æó·ÅÀº Äڷγª¹ÙÀÌ·¯½º°¨¿° ÁúȯÀÎ COVID-19ÀÇ ÈçÇÑ Áõ»óÀ¸·Î ³ªÅ¸³­´Ù. ¹Ì±¹ÀÇ»çÇùȸ Àú³Î ³»°úÇÐ(JAMA Internal Medicine) ÃÖ½ÅÈ£(2020³â 10¿ù 20ÀÏ)´Â ·ù¸¶Æ¼½º Ä¡·áÁ¦·Î »ç¿ëµÇ°í ÀÖ´Â Åä½Ç¸®ÁÖ¸¿(Tocilizumab, TCZ)ÀÌ COPVID-19 °¨¿°À¸·Î ÀÎÇÑ Æó·ÅȯÀÚÀÇ »ç¸Á À§ÇèÀ» ³·Ãâ ¼ö ÀÖ´Ù´Â ¿¬±¸°á°ú¸¦ ¹ßÇ¥ÇÏ¿´´Ù. 

 

¿¬±¸¸ñÀû(Objective)

TCZÀÌ Áߵ¿¡¼­ ÁßÁõÀÇ COVID-19 Æó·ÅÀ¸·Î ÀÔ¿øÇÑ È¯ÀÚÀÇ Ä¡·áÈ¿°ú¿Í »ç¸ÁÀ² °¨¼Ò¿¡ È¿°ú°¡ ÀÖ´ÂÁö¸¦ Æò°¡Çϱâ À§ÇØ ¿¬±¸°¡ ¼öÇàµÇ¾ú´Ù. 

 

¿¬±¸¼³°è, ȯ°æ ¹× Âü¿©È¯ÀÚ(DESIGN, SETTING, AND PARTICIPANTS)

COVID-19·Î ÀÔ¿øÇÑ È¯ÀÚ·Î ÃÖ¼Ò 3L / minÀÇ »ê¼ÒÅõ¿©°¡ ÇÊ¿äÇÏÁö¸¸ º¥Æ¿·¹ÀÌ¼Ç ÀΰøÈ£Èí±â³ª ÁßȯÀڽǿ¡ ÀÔ¿øÇÏÁö ¾Ê´Â Áߵ ¶Ç´Â ÁßÁõ Æó·Å ȯÀÚ¸¦  ´ë»óÀ¸·Î ¼öÇàµÇ¾îÁø ´Ù±â°ü, º£ÀÌÁö¾È ¹«ÀÛÀ§´ëÁ¶±ºÀÓ»ó½ÃÇ迬±¸·Î ¼³°èÇß´Ù. ¿¬±¸±â°£Àº 2020³â 3¿ù 31ÀϺÎÅÍ 2020³â 4¿ù18 ÀϱîÁö 28Àϵ¿¾È ÃßÀû°üÂûÇÏ¿´´Ù. ÇÁ¶û½ºÀÇ 9°³ ´ëÇÐ º´¿ø¿¡¼­ ȯÀÚ¸¦ ¸ðÁýÇßÀ¸¸ç, ÀÚ·áºÐ¼®Àº ¾Æ·¡¿Í °°ÀÌ Ä¡·á Àǵµ ±â¹ÝÀ¸·Î ¼öÇàµÇ¾ú°í 2 Â÷°á°ú¿¡ ´ëÇÑ ´ÙÁß¼º¿¡ ´ëÇÑ ¼öÁ¤Àº ¾ø¾ú´Ù. Àΰø È£Èí±â¸¦ ´Þ°Å³ª ÁßȯÀڽǿ¡ ÀÔ¿øȯÀÚ´Â ¿¬±¸´ë»ó¿¡¼­ Á¦¿ÜµÇ¾ú´Ù. ¹«ÀÛÀ§ ÀÓ»ó½ÃÇ迬±¸ ±â°£ 28ÀϱîÁö ÀÓ»ó°æ°ú¸¦ °üÂû Æò°¡ÇÏ¿´´Ù. ÇÁ¶û½ºÀÇ 9°³ ´ëÇк´¿ø¿¡¼­ ȯÀÚ¸¦ ¹«ÀÛÀ§ ÃßÃâ ¸ðÁýÇÏ¿´´Ù.

 

Ä¡·á  ÁßÀç(INTERVENTIONS)

ȯÀÚ´Â ¹«ÀÛÀ§·Î TCZ, 8 mg / kg, Á¤¸Æ ³» + ÀϹÝÄ¡·á (ÀÓ»óÀûÀ¸·Î Áö½ÃµÈ °æ¿ì) (TCZ ±×·ì) ¶Ç´Â ´Üµ¶Ä¡·á (UC ±×·ì)¸¦¹Þ´Â 1 ÀÏ ¹× 3 ÀÏ¿¡ ¹èÁ¤µÇ¾ú´Ù. 

 

Åä½Ç¸®ÁÖ¸¿ Ä¡·á±º(TCZ group): Åä½Ç¸®ÁÖ¸¿(Tocilizumab, TCZ), 8 mg/kg, Á¤¸ÆÅõ¿©¿Í ÇÔ°Ô ÀϹÝÀûÀÎ Ä¡·á¹æ¹ýÀ» º´ÇàÇÏ¿´´Ù. 

ÀϹÝÀûÀÎ Ä¡·á±º(Usual Care alone group):  ÀϹÝÀûÀÎ Ä¡·á¿¡´Â Ç×»ýÁ¦, Ç× ¹ÙÀÌ·¯½ºÁ¦, ÄÚ¸£Æ¼ÄÚ½ºÅ×·ÎÀ̵å Åõ¿©, Ç÷°ü¾ïÁ¦Á¦ ¹× Ç×ÀÀ°íÁ¦°¡ Æ÷ÇԵǾú´Ù.

 

ÁÖ¿ä °á°ú ¹× ÃøÁ¤(MAIN OUTCOMES AND MEASURES)

ÁÖ¿ä °á°ú´Â4ÀÏ°¿¡  ¼¼°èº¸°Ç±â±¸(WHO) 10Á¡ ôµµÀÇ ÀÓ»óÁøÇà°æ°ú(WHO-CPS)ôµµ¸¦ ÃøÁ¤ÇßÀ¸¸ç 5Á¡ÀÌ»óÀÇ °á°ú¸¦ ³ªÅ¸³»¾ú´Ù. 14ÀÏ°¿¡ º¥Æ¿·¹ÀÌ¼Ç ÀΰøÈ£Èí±â(ħ½À¼º Àΰø È£Èí±â Æ÷ÇÔ) ¾øÀÌ »ýÁ¸ÇÒ ¼ö ÀÖ´Â ÁöÇ¥·Î ÃøÁ¤Çß´Ù. 2 Â÷°á°ú´Â 7 ÀÏ ¹× 14 ÀÏ¿¡ WHO-CPS Á¡¼ö·Î Æò°¡ µÈ ÀÓ»ó »óÅÂ, Àüü »ýÁ¸, Åð¿ø, »ê¼Ò °ø±Þ µ¶¸³±îÁöÀÇ ½Ã°£, »ý¹°ÇÐÀû ¿äÀÎ(C-reactive protein level) ¹× ºÎÀÛ¿ë µîÀ¸·Î ¿ä¼Ò·Î Æò°¡ÇÏ¿´´Ù. 

 

±×¸² 1.  Hermine O, Mariette X, Tharaux P-L, et al. Effects of tocilizumab vs usual care in adults hospitalized with COVID-19 and moderate or severe pneumonia: a randomized clinical trial. JAMA Intern Med. Published online 20, 2020. doi:10.1001/jamainternmed.2020.6820



 

¿¬±¸°á°ú(RESULTS)

Àüü 131¸íÀÇ È¯ÀÚ Áß¿¡¼­ 64¸íÀÇ COVID-19 ȯÀÚ°¡ TCZ ±×·ì¿¡ ¹«ÀÛÀ§·Î ¹èÁ¤µÇ¾ú°í, 67¸íÀº UC ±×·ì¿¡ ¹èÁ¤µÇ¾ú´Ù. TCZ ±×·ì Áß 1¸íÀÇ È¯ÀÚ°¡ µ¿ÀǸ¦ öȸÇÏ¿© ºÐ¼®¿¡¼­ Á¦¿ÜµÇ¾ú´Ù. 130 ¸íÀÇ È¯ÀÚ Áß 42 ¸íÀÌ ¿©¼º (32 %)À̾ú°í Áß¾Ó°ª ¿¬·ÉÀº 64¼¼ (57.1-74.3)¿´´Ù. TCZ ±×·ì¿¡¼­ 12¸íÀÇ È¯ÀÚ´Â 4ÀÏ Â°¿¡ WHO-CPSÁ¡¼ö°¡ 5Á¡º¸´Ù ³ô¾ÒÀ¸¸ç, ÀÌ¿¡ ¹ÝÇØ UC ±×·ì¿¡¼­´Â 19 ÀÏ¿¡ WHO-CPSÁ¡¼ö°¡ 5Á¡ÀÌ»óÀ¸·Î ³ªÅ¸³µ´Ù(median posterior absolute risk difference [ARD] −9.0%; 90% credible interval [CrI], −21.0 to 3.1) 14 ÀÏ° TCZ ±×·ì¿¡¼­ ºñħ½ÀÀû ÀΰøÈ£Èí (NIV), ¶Ç´Â ±â°èÀû ÀΰøÈ£Èí (MV)ÀÌ ÇÊ¿äÇϰųª»ç¸ÁÇÑ È¯ÀÚ´Â UC ±×·ìº¸´Ù 12 % (95 % CI -28 % ~ 4 %) Àû¾ú´Ù(24 % ´ë 36 %, Áß¾Ó°ª »çÈÄ À§Çè ºñÀ² [HR] 0.58; 90 % CrI, 0.33-1.00), HRÀÇ »çÈÄ È®·üÀº 95.0 % Áß 1 ¹Ì¸¸À¸·Î »çÀü Á¤ÀÇ µÈ È¿°úÀÓ°è °ªÀ» ´Þ¼ºÇß´Ù. MV ¶Ç´Â »ç¸Á¿¡ ´ëÇÑ HRÀº 0.58 (90 % CrI, 0.30 ~ 1.09)À̾ú´Ù. 28ÀÏ° 7¸íÀÇ È¯ÀÚ°¡ TCZ ±×·ì¿¡¼­, UC ±×·ì¿¡¼­ 8¸íÀÇ È¯ÀÚ°¡ »ç¸ÁÇß´Ù(Á¶Á¤ µÈ HR, 0.92; 95 % CI 0.33-2.53). ½É°¢ÇÑ ºÎÀÛ¿ëÀº TCZ ±×·ì¿¡¼­ 20¸í (32 %), UC ±×·ì¿¡¼­ 29¸í (43 %) ¹ß»ýÇß´Ù(P = .21).



 

 

±×¸² 2. Occurrence of Primary Outcome Events During Follow-up.

(Source: Effects of tocilizumab vs usual care in adults hospitalized with COVID-19 and moderate or severe pneumonia: a randomized clinical trial. JAMA Intern Med. Published online 20, 2020. doi:10.1001/jamainternmed.2020.6820)

 

 

°á·Ð ¹× ÀÇÀÇ(CONCLUSIONS AND RELEVANCE )

À̹ø COVID-19 Æó·Å ȯÀÚ¸¦ ´ë»óÀ¸·Î ¼öÇàµÈ ¹«ÀÛÀ§ÀÓ»ó½ÃÇè¿¡¼­ »ê¼ÒÄ¡·á´Â ÇÊ¿äÇÏÁö¸¸, ICN ÁßȯÀڽǿ¡ ÀÔ¿øÇÏÁö ¾ÊÀº TCZ ±×·ìÀº Ä¡·á 4ÀÏ°¿¡ WHO-CPS Á¡¼ö¸¦ 5Á¡ ÀÌÇÏ·Î ³·ÃßÁö ¾Ê¾ÒÁö¸¸, 14 ÀÏ° NIV, MV ¶Ç´Â »ç¸Á À§ÇèÀ» °¨¼Ò½Ãų ¼ö ÀÖ´Â °¡´É¼ºµµ ÀÖ¾ú´Ù. µÎ±º°£¿¡ 28ÀÏ »ç¸Á·ü¿¡´Â Â÷ÀÌ°¡ ¾ø¾ú´Ù. °á·ÐÀûÀ¸·Î TocilizumabÀº ±â°èÀû ¹× ºñħ½ÀÀû ÀΰøÈ£ÈíÄ¡·áÀÇ Çʿ並 °¨¼Ò½Ãų ¼ö ÀÖ°í, 14ÀϱîÁö »ç¸ÁÀ² °¨¼ÒÈ¿°ú´Â ÀÖÁö¸¸,  28ÀÏ »ç¸ÁÀ² °¨¼Ò¿¡´Â Â÷ÀÌ°¡ ¾ø¾ú´Ù. ÇÏÁö¸¸ ÀÌ·¯ÇÑ ¿¹ºñ °á°ú¿¡ ´ëÇÑ Ãß°¡ ¿¬±¸°¡ ÇÊ¿äÇÏ´Ù. 

 

À̹ø ¿¬±¸ °á°ú´Â JAMA ¹Ì±¹ÀÇ»çÇùȸ Àú³Î ³»°úÇÐ(JAMA Internal Medicine) ÃÖ½ÅÈ£(2020³â 10¿ù 20ÀÏ)¿¡ ¹ßÇ¥µÇ¾ú´Ù. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT04331808 [¿ø¹®¹Ù·Îº¸±â]






 

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2020-10-21 ¿ÀÈÄ 12:37:40, Á¶È¸¼ö : 6250