Isifo sephepha esinganyangekiyo ngamachiza amaninzi (MDR TB) sichaphazela isiqingatha sesigidi sabantu nyaka ngamnye. I-Levofloxacin icetyiswa kunyango lothintelo olusekwe kwidatha yoqwalaselo, nangona kunjalo ubungqina obuvela kulingo olukhulu lwezonyango abukho. I-TB CHAMP kunye ne-V-QUIN, izigaba ezimbini zolingo lwezonyango ziye zavavanya ukhuseleko nokusebenza kwe-levofloxacin ekuthinteleni i-MDR TB kubathathi-nxaxheba abanokuchanabeka kwimizi ye-M. yesifo sephepha esixhathisa amachiza amaninzi. I-Levofloxacin ifunyenwe ukunciphisa iziganeko ze-multidrug-resistance tuberculosis kuzo zombini izifundo kodwa ukunciphisa iziganeko kwakungabalulekanga. Uhlalutyo lwemeta lwedatha evela kulingo lwe-TB CHAMP kunye ne-V-QUIN lubonise ukuba i-levofloxacin yayinxulunyaniswa nokuncipha okunxulumene ne-3% yokwenzeka kwesifo sephepha kuqhagamshelwano lwe-MDR-TB kumakhaya.
I-Mycobacterium tuberculosis ukumelana ne-isoniazid kunye ne-rifampin ichaphazela phantse isiqingatha sesigidi sabantu ngonyaka kwihlabathi liphela. Inoxanduva lwesifo sephepha esinganyangekiyo ngamachiza amaninzi (MDR) esicela umngeni kwiinkqubo zokulawula isifo sephepha. Ngokukodwa, abantwana abancinci abasesichengeni sesifo sephepha esinganyangekiyo ngamachiza amaninzi (MDR) basengozini enkulu yesifo. Malunga nezigidi ezi-2 zabantwana abangaphantsi kweminyaka eli-15 bosulelwe sisifo sephepha se-MDR M..
I-Levofloxacin, isizukulwana sesithathu se-fluoroquinolone amayeza okubulala iintsholongwane athathwe ngomlomo, eyinxalenye yonyango oluqhelekileyo lwe-rifampicin-resistant okanye i-MDR tuberculosis iyacetyiswa ngokusekelwe kwidatha yoqwalaselo yonyango lothintelo emva kokuvezwa kwisifo sephepha esinganyangekiyo ngamachiza (MDR), nangona kunjalo ubungqina obuvela kumalingo amakhulu. ekusebenzeni kwayo bekungekho.
Ulingo lwezonyango lwesigaba sesi-3 ezibini ezinkulu – i-TB CHAMP kunye ne-V-QUIN ziphande ukhuseleko nokusebenza kwe-levofloxacin kunyango lothintelo lwe-MDR TB emva kokuba sesichengeni sesifo esinganyangekiyo ngamachiza amaninzi. Iziphumo kunye nezigqibo zezi zifundo zimbini zipapashwe nge-18 kaDisemba 2024.
The I-TB CHAMP (I-Tuberculosis Child Multidrug-Resistant Preventive Therapy Trial) ivavanye ukusebenza kunye nokhuseleko lonyango lothintelo kunye ne-levofloxacin kubantwana kunye nolutsha olusesichengeni sekhaya kwi-multidrug-resistant tuberculosis. Iqhutywe kubantwana abangama-922 kunye nolutsha olusesichengeni sesifo sephepha esinganyangekiyo ngamayeza kwiinyanga ezi-6 ezandulelayo (kodwa kungekho bungqina besifo sephepha) ukusuka kumakhaya angama-497 kwiindawo ezininzi eMzantsi Afrika. Abathathi-nxaxheba bafumana i-levofloxacin okanye i-placebo yonke imihla kwiiveki ezingama-24. Ama-453 abathathi-nxaxheba bafumana i-levofloxacin baze abanye abangama-469 banikwa i-placebo. Ngeveki ye-48, isifo sofuba siphuhliswe kubathathi-nxaxheba be-5 (1.1%) kwiqela le-levofloxacin kunye nabathathi-nxaxheba be-12 (2.6%) kwiqela le-placebo. Ngaloo ndlela, unyango lothintelo kunye ne-levofloxacin lunciphise iziganeko zesifo sofuba phakathi kwabantwana kunye nolutsha olusesichengeni se-MDR TB ekhaya kodwa ukuncipha kwesiganeko kwakungekho ngaphantsi kakhulu kune-placebo.
Olunye uphononongo (olubiziweyo Ulingo lwe-V-QUIN) ivavanye ukusebenza kunye nokhuseleko lwerejimeni yeenyanga ezi-6 ze-levofloxacin kuthintelo lwesifo sephepha esisebenzayo phakathi koqhagamshelwano lwasekhaya lwabantu abane-rifampicin resistant okanye multidrug-resistant (MDR) isifo sephepha esiqinisekisiweyo. Olu lingo lwaqhutywa kwiindawo ezininzi eVietnam kubathathi-nxaxheba abangama-2041 ababengabafowunelwa bemizi yabantu abane-rifampicin enganyangekiyo okanye isifo sephepha se-MDR. Abathathi-nxaxheba babenosulelo lwe-M. isifo sofuba kodwa akukho sifo esisebenzayo kwaye baqalise unyango kwiinyanga ezi-3 zangaphambili. Abathathi-nxaxheba babelwa ngokungenamkhethe ukuba bafumane iinyanga ze-6 ze-levofloxacin yemihla ngemihla okanye i-placebo. Abathathi-nxaxheba be-1023 bafumana i-levofloxacin ngelixa i-1018 Abathathi-nxaxheba be-placebo. Kwiinyanga ezingama-30, abathathi-nxaxheba aba-6 (0.6%) kwiqela le-levofloxacin baye baqinisekiswa nge-bacteriologically ukuba baye baphuhla isifo sephepha ngelixa abathathi-nxaxheba abali-11 (1.1%) kwiqela le-placebo baye baqinisekiswa nge-bacteriologically ukuba babe nesifo sephepha. Ngaphezu koko, i-1 ethatha inxaxheba kwiqela le-levofloxacin kunye ne-2 kwiqela le-placebo yafunyaniswa ngekliniki ukuba inesifo sofuba. Ngaloo ndlela, iziganeko zesifo zaziphantsi kwiqela le-levofloxacin kune-placebo, kodwa umahluko wawungabalulekanga.
Zombini ezi zilingo zesigaba se-3 ezikhankanywe ngasentla ziphande ukusebenza kunye nokhuseleko lwe-levofloxacin ekuthinteleni izifo phakathi kwabathathi-nxaxheba abanovelwano lwekhaya kwi-tuberculosis enganyangekiyo ngamachiza. Kwi-TB CHAMP, abathathi-nxaxheba babengenabo ubungqina besifo sofuba, ngelixa kulingo lwe-V-QUIN, abathathi-nxaxheba babenosulelo lwe-M. lwesifo sofuba kodwa akukho sifo esisebenzayo. Kuzo zombini iimeko, i-levofloxacin yafunyanwa ukunciphisa iziganeko zesifo, kodwa ukunciphisa kwakungabalulekanga.
Nangona kunjalo, uhlalutyo lwe-meta lwedatha evela kulingo lwe-TB CHAMP kunye ne-V-QUIN lubonise ukuba i-levofloxacin yayinxulunyaniswa nokuncipha okunxulumene ne-60% yokwenzeka kwesifo sephepha kuqhagamshelwano lwe-MDR-TB kumakhaya.
NgoSeptemba 2024, WHO wayecebise nge-levofloxacin yonyango lothintelo lwe-MDR-TB ngokusekelwe kuphononongo lobungqina bolingo.
I-Delamanid kungoku nje ivavanywa kulingo lwezonyango lothintelo lwe-MDR TB. Yi-agent ye-antimicrobial evimbela ukuhlanganiswa kodonga lweseli ye-mycobacterial kwaye ivunyiwe kunyango lwesifo sephepha esinganyangekiyo ngamachiza amaninzi.
***
Iingxelo:
- Hesseling AC et al 2024. Levofloxacin Unyango loThintelo kuBantwana abavezwe kwi-MDR Tuberculosis. Ipapashwe nge-18 kaDisemba 2024. N Engl J Med 2024;391:2315-2326. Umqulu. 391 No. 24. https://www.nejm.org/doi/full/10.1056/NEJMoa2314318
- I-Fox GJ, et al 2024. I-Levofloxacin yoThintelo lweSifo sePhepha esiNganyangekiyo ngamachiza eVietnam. Ipapashwe nge-18 kaDisemba 2024. N Engl J Med 2024; 391: 2304-2314. Umqulu. 391 No. 24. DOI: https://www.nejm.org/doi/full/10.1056/NEJMoa2314325
- Duong T., et al 2024. Uhlalutyo lwe-Meta ye-Levofloxacin yoNxibelelwano lweSifo sePhepha esinganyangekiyo ngamachiza amaninzi. Ipapashwe nge-18 kuDisemba 2024. Ubungqina be-NEJM. DOI: https://evidence.nejm.org/doi/full/10.1056/EVIDoa2400190
- I-Dorman SE 2024. I-Levofloxacin yoKhuselo loThintelo kuBantu abavezwe kwi-MDR Tuberculosis. Ipapashwe nge-18 kaDisemba 2024. N Engl J Med 2024; 391: 2376-2378. Umqulu. 391 No. 24. https://www.nejm.org/doi/full/10.1056/NEJMe2413531
- I-MRC-UCL. Ulingo lwe-TB-CHAMP lufumana unyango lokuqala olukhuselekileyo nolusebenzayo ukuthintela i-TB enganyangekiyo ngamachiza ebantwaneni. 19 December 2024. Iyafumaneka e https://www.mrcctu.ucl.ac.uk/news/news-stories/2024/december/tb-champ-trial-finds-first-ever-safe-and-effective-treatment-to-prevent-multidrug-resistant-tb-in-children/
- I-WHO. Isishwankathelo se-TB CHAMP kunye ne-V-QUIN yolingo lwezonyango. https://tbksp.who.int/en/node/2745
***
