EU pom zoo Pretomanid los kho cov kab mob uas tsis muaj tshuaj ntau, thiab Fosun Pharma qhia txog Tuam Tshoj!

Lub koom haum tshawb nrhiav thiab tsis siv tshuaj yaj yeeb TB Alliance (TB Alliance) tau tshaj tawm tsis ntev los no hais tias European Commission (EC) tau pom zoo cov tshuaj tshiab Pretomanid ua cov tshuaj muaj peb-yeeb tshuaj, rau-lub hlis tag nrho kev tswj hwm BPaL (los ntawm Bedaquinoline, Pretomanid, Linezolid) Nws yog siv rau kev kho mob rau cov neeg mob uas muaj ntau yam tshuaj tiv thaiv kab mob ntsws (XDR-TB) lossis multidrug-resistant tuberculosis (MDR-TB) (suav hu ua" cov tshuaj tiv thaiv zoo heev-GG quot;) uas yog tshuaj intolerant los yog tsis-teb.

Nws tsim nyog teev tias Pretomanid yog qhov tshuaj tiv thaiv tuberculosis thib 3 raug pom zoo nyob hauv 40 xyoo dhau los, thiab nws tseem yog thawj thawj cov tshuaj tiv thaiv tuberculosis tsim los ntawm cov koom haum non-profit. Nrog kev pom zoo no, BPaL program muab txoj hauv kev tshiab, luv dua, tswj tau yooj yim thiab siv cov kev kho mob yooj yim rau EU' s cov tshuaj tiv thaiv kab mob siab rau cov neeg mob coob.

Hauv Tebchaws Meskas, Pretomanid tau pom zoo los ntawm FDA rau tib yam kev qhia uas tau hais los saud rau lub Yim Hli 2019. Kev xaiv khomob thiab kev sojntsuam rau cov neeg mob uas muaj tshuaj tiv thaiv kab mob siab heev tsis zoo. Cov ntaub ntawv los ntawm piv rau Theem III Nix-TB kev sim qhia pom tias 90% ntawm cov neeg mob tau txog qhov hnoos qeev kab mob tsis zoo 6 lub hlis tom qab tau txais qhov luv luv ntawm qhov ncauj tag nrho BPaL kev tswj hwm.

Lub Ib Hlis xyoo no, TB Alliance tau tso cai rau Fosun Pharma' s tuav lub chaw muag khoom Shenyang Hongqi Pharmaceutical daim ntawv tso cai muag pretomanid hauv Suav teb. Qhov kev koom tes no yog ib feem ntawm pretomanid' s txoj kev lag luam thoob ntiaj teb, uas yog ib feem ntawm Sanya" BPaL" kev kawm. Kev kos npe rau daim ntawv cog lus ua tiav no tau ua tiav cov kev sib koom tes ua ntej dhau los ntawm TB Alliance, Mylan thiab Maleods Pharmaceuticals ntawm kev ua lag luam ntawm BPaL program hauv lwm lub tebchaws. Qhov peb-tshuaj" BPaL" cov tshuaj tiv thaiv yog Pretomanid, bedaquilin thiab linezolid yog tsom rau XDR-TB lossis MRD-TB cov neeg mob, suav ua cov" cov tshuaj tiv thaiv zoo heev" cov neeg mob.

BPaL raws tu qauv tau kawm nyob rau hauv piv rau Phase III Nix-TB kev sim. Ntau tus neeg muaj mob ntau, qhib cov ntawv sau npe qhib 109 XDR-TB thiab MRD-TB cov neeg laus uas tsis mob siab rau thiab tsis kam lees kho nyob rau ntawm peb qho chaw hauv South Africa. Cov txiaj ntsig tau tshaj tawm hauv New England Journal of Medicine hauv lub Peb Hlis 2020 qhia tias 90% ntawm cov neeg mob hauv kev sim Nix-TB muaj kev soj ntsuam zoo-tau txais txiaj ntsig zoo (kev soj ntsuam kab mob tau kho, kab mob ntsws hnoos qeev yog tsis zoo). 11 muaj mob (10%) muaj qhov tsis raug mob tsis zoo, thiab 98 qhov tshwm sim (90%; 95% CI: 83-95%) muaj kev soj ntsuam zoo. Qhov pib ua rau qhov kawg ntawm kev sim yog qhov tshwm sim ntawm qhov tshwm sim tsis zoo (kab mob los yog chaw kho mob) lossis tus mob rov tshwm sim los ntawm kev rov qab mus txog 6 lub hlis tom qab kawg ntawm kev kho mob. Cov neeg mob feem ntau hauv Nix-TB sim tau 6 lub hlis ntawm kev kho mob nrog txoj cai BPaL. Kev kho mob ntawm 2 tus neeg mob tau txuas ntxiv mus txog 9 hlis.

EU tsab cai tswj hwm kev lag luam muaj cov ntaub ntawv ntawm 1168 cov neeg laus laus uas tau txais Pretomanid hauv 19 kev soj ntsuam sim uas ntsuas qhov kev nyab xeeb thiab zoo ntawm cov tshuaj.

EU' s kev cai pom zoo yuav tsum tau ua tiav kev soj ntsuam ntev ntawm cov neeg mob hauv Nix-TB kev sim thiab ZeNix kev sim ntawm TB Alliance, uas yog ntsuas kev nyab xeeb thiab ua tau zoo ntawm BPaL kev tswj hwm ntawm linezolid ntawm txawv koob tshuaj thiab qhov ua kom ntev.

Pretomanid qauv qog (qauv duab: Wikipedia)

Tuberculosis (tuberculosis, TB) yog tus kabmob thoob ntiaj teb uas raug tshawb pom nyob hauv txhua lub tebchaws thiab yog tus kabmob kis loj tshaj plaws uas ua rau tuag taus. Txhua hom kab mob ntsws yuav tsum tau kho nrog kev sib xyaw tshuaj, thiab qhov tshuaj tiv thaiv zoo tshaj plaws rau tuberculosis yuav tsum tau kho nrog 4 cov tshuaj tiv thaiv tuberculosis rau 6 lub hlis. Txoj kev kho rau XDR-TB lossis MDR-TB nrog kev kho mob tsis txaus / tsis teb yog ntev dua thiab nyuaj. Feem ntau ntawm cov neeg mob XDR-TB tam sim no yuav tsum tau siv ntau txog 8 yam tshuaj tua kab mob (qee qhov yuav tsum tau txhaj tshuaj txhua hnub) Kev kho mob txog 18 lub hlis lossis ntev dua.

Raws li WHO tsab ntawv ceeb toom, ua ntej qhia cov tshuaj tshiab rau kev kho tshuaj tiv thaiv tuberculosis nyob rau xyoo tsis ntev los no, qhov ua tau zoo ntawm kev siv tshuaj tiv thaiv kab mob ntsws (XDR-TB) ntau npaum li 34%, thiab cov tshuaj ntau -resistant tuberculosis (MDR-TB) kev kho mob yog kwv yees li 55%. Cov.

Pretomanid yog qhov khoom siv tshuaj tshiab tshiab uas yog rau cov chav kawm sib txuas hu ua nitroimidazosin. Cov tshuaj tau kawm ib leeg lossis ua ke nrog lwm cov tshuaj tiv thaiv tus kabmob tuberculosis hauv 20 qhov kev sim tshuaj. Txij li thaum lub sijhawm TB Alliance pib tsim cov tshuaj tiv thaiv kabmob ua ntej xyoo 2002, cov tshuaj tau raug kuaj hauv ntau dua 1,000 tus neeg hauv 14 lub tebchaws. Txog rau tam sim no, pretomanid tau txais kev pom zoo raws li lub qhov ncauj ntsiav tshuaj raws li ib feem ntawm BPaL kev tswj hwm rau kev kho mob ntawm XDR-TB lossis MDR-TB (suav nrog rau" cov tshuaj tiv thaiv kab mob&ntau heev;) nrog tshuaj tsis haum lossis tsis -sauv teb.

Hauv kev sim tshuaj, cov kev mob tshwm sim feem ntau ntawm BPaL kev tswj hwm yog peripheral neuropathy, xeev siab, ntshav txhaws, ntuav, mob taub hau, kem plab, pob txuv, tsis qab los noj mov, transaminase thiab trans-glutamyl transpeptidase, tawv nqaij ua pob, khaus, thiab mob plab, Musculoskeletal mob, txhawb nqa amylase.