Shaanxi BLOOM Tech Co., Ltd. yog ib qho ntawm cov tuam ntxhab thiab cov muag khoom ntawm lanreotide 120 mg hauv Suav teb. Txais tos rau cov lag luam wholesale bulk zoo lanreotide 120 mg rau muag ntawm no los ntawm peb lub hoobkas. Kev pabcuam zoo thiab tus nqi tsim nyog muaj.
Lanreotide 120 mgyog ib qho kev sib xyaw ua ke ntawm somatostatin analogues uas ua lub luag haujlwm tseem ceeb hauv kev kho acromegaly. Raws li ntev - ua yeeb yam loj hlob hormone inhibitor octapeptide analogue, nws zoo inhibits qhov tso tawm ntawm kev loj hlob hormone (GH) thiab insulin-zoo li kev loj hlob factor-1 (IGF-1) los ntawm kev khi rau somatostatin receptors (tshwj xeeb tshaj yog SSTR2 thiab SSTR5), yog li tswj kev loj hlob ntawm acromegaly hauv cov neeg mob.
Tsim nyog rau kev kho mob ntawm acromegaly hauv ntau qhov xwm txheej, suav nrog cov neeg mob uas muaj qhov txawv txav ntawm kev loj hlob hormone secretion tom qab kev phais thiab / lossis kev kho hluav taws xob, nrog rau cov neeg mob uas tsis tsim nyog rau kev phais lossis kev kho hluav taws xob. Nws txoj kev tswj hwm yog hloov tau, feem ntau yog siv qhov tob intramuscular txhaj lossis txhaj tshuaj subcutaneous.
Peb Cov Khoom Muag Khoom
lanreotide COA
Acromegaly yog tus kab mob endocrine metabolic mob ntev nrog qhov pib tshwm sim, feem ntau tshwm sim los ntawm kev tso tawm ntau dhau ntawm cov tshuaj hormones loj hlob (GH) vim cov qog pituitary anterior, uas tuaj yeem ua rau ntau yam kab mob hauv nruab nrog cev / kab mob thiab ua rau muaj kev phom sij rau tus neeg mob lub neej thiab kev noj qab haus huv.Lanreotide 120 mgRaws li kev sib txuas ua ke ntawm somatostatin receptor ligands (SRLs), lawv ua lub luag haujlwm tseem ceeb hauv kev ua haujlwm ntawm acromegaly.
Raws li thawj - kab kev xaiv tshuaj kho mob
Rau cov neeg mob acromegaly uas tsis tuaj yeem zam kev phais, muaj qhov seem seem tom qab phais, lossis muaj teeb meem ua tau raws li cov qauv biochemical, nws yog ib qho tseem ceeb rau kev kho mob. Piv txwv li, qee cov neeg mob yuav pom tias nws nyuaj rau kev phais vim mob plawv los yog ua pa nyuaj, lossis tej zaum yuav tsis kam phais. Nyob rau hauv xws li mob, kev kho tshuaj tej zaum yuav yog thawj xaiv; Qee cov neeg mob tseem muaj cov qog seem tom qab phais, thiab lawv cov qib GH thiab insulin{2}zoo li kev loj hlob-1 (IGF-1) tsis tau tswj hwm, yog li lawv kuj yuav tsum tau txais kev kho mob.
Cov ntaub ntawv Source:
Xibfwb Zhu Huijuan los ntawm Peking Union Medical College Tsev Kho Mob, Suav Academy ntawm Kev Tshawb Fawb Kev Kho Mob, tau taw qhia tias kev phais phais yog thawj zaug - kab mob rau acromegaly hauv kev kho mob, tab sis qee tus neeg mob cia siab rau kev kho tshuaj rau ntau yam laj thawj. Ntawm lawv, cov khoom siv SRLs yog thawj - kab tshuaj rau kev kho acromegaly, thiab raws li ib qho ntawm cov tshuaj sawv cev ntawm SRLs, lawv muaj qhov zoo hauv kev kho mob.
Clinical validation:
Ntau Phase III cov kev tshawb fawb soj ntsuam tau lees paub nws cov txiaj ntsig thiab kev nyab xeeb. Txoj kev tshawb fawb IPSEN-081 tau ntsuas nws qhov ua tau zoo thiab kev nyab xeeb hauv cov neeg mob uas tsis tau kho lossis tswj tsis tau acromegaly, thiab cov txiaj ntsig tau pom tias tom qab 12 lub lis piam ntawm kev kho mob, 26% ntawm cov neeg mob 'IGF-1 qib rov qab zoo li qub; Tom qab 48 lub lis piam, 85% ntawm cov neeg mob muaj cov qib GH tsawg dua lossis sib npaug li 2.5 μ g / L, thiab 43% ntawm cov neeg mob muaj qib IGF-1 li qub. Txoj kev tshawb fawb PRIMARYS tau ntsuas nws qhov ua tau zoo hauv kev txo cov qog nqaij hlav hauv cov neeg mob tshiab uas tau kho nrog GH secreting pituitary adenomas.
Tom qab 12 lub lis piam ntawm tratment, 54.1% ntawm cov neeg mob tau txo cov qog ntau dua los yog sib npaug li 20%, thiab cov qauv ntawm cov qog txo qis txuas ntxiv mus txog qhov kawg ntawm txoj kev tshawb no. Tom qab 48 lub lis piam, 62.9% ntawm cov neeg mob tau txo cov qog ntim ntau dua lossis sib npaug li 20%, thiab qib GH thiab / lossis IGF-1 tau txo qis los ntawm lub lim tiam 12. Qhov feem pua ntawm cov neeg mob uas tau ua raws li cov txheej txheem tau nce ntxiv raws sijhawm.
Paub txog biochemical tswj
Daim ntawv thov xwm txheej
Cov tshuaj no tuaj yeem pab cov neeg mob acromegaly ua tiav kev tswj hwm biochemical thiab txo GH thiab IGF-1 qib. Hauv kev xyaum kho mob hauv ntiaj teb tiag hauv Suav teb, ntau tus neeg mob tau ua tiav kev tswj hwm GH thiab IGF-1 qib los ntawm kev sivlanreotide 120 mg. Piv txwv li, ib txoj kev tshawb no suav nrog 129 tus neeg mob (nrog rau hnub nyoog nruab nrab ntawm 43.3 xyoo thiab ib tug poj niam feem ntawm 58.1%) uas tau txais tsawg kawg yog ib qho tratment. Los ntawm 12 lub hlis ntawm kev kho mob, 102 tus neeg mob ua tiav txoj kev tshawb fawb thiab sau GH thiab IGF-1 cov ntaub ntawv los ntawm lub hli 12. Ntawm lawv, 19.6% (20/102) ntawm cov neeg mob ua tiav kev tswj hwm biochemical, 11.8% (12/102) ntawm cov neeg mob ua tiav GH<1 μ g/L and normal IGF-1, and 34.3% (35/102) of patients achieved GH ≤ 2.5 μ g/L and IGF-1 ≤ 1.3 × ULN. Fasting GH levels decreased from baseline 23.17 μ g/L to 8.33 μ g/L, and IGF-1 decreased from 1.974 × ULN to 1.332 × ULN.
Qhov chaw ntawm cov ntaub ntawv:
Cov ntaub ntawv tshawb fawb muaj feem cuam tshuam los ntawm kev kho mob hauv lub ntiaj teb tiag ntawm Tuam Tshoj, nrog kev koom tes ntawm cov tsev kho mob xws li Peking Union Medical College Tsev Kho Mob ntawm Suav Academy ntawm Kev Tshawb Fawb Txog Kev Kho Mob, muab pov thawj tseem ceeb rau kev tswj hwm biochemical ntawm lanrelitide hauv tratment ntawm acromegaly.
Clinical validation
Ntxiv nrog rau cov lus hais saum toj no tiag tiag- kev tshawb fawb thoob ntiaj teb hauv Suav teb, ntau qhov kev tshawb fawb thoob ntiaj teb kuj tau lees paub nws cov kev tswj hwm biochemical. Txoj kev tshawb nrhiav SODA yog qhov loj -scale multicenter tiag- kev tshawb fawb ntiaj teb ua nyob rau hauv Tebchaws Meskas los tshawb xyuas qhov ua tau zoo ntawm lanrelitide ATG hauv kev kho acromegaly. Thaum lub sij hawm ib xyoo - tratment, 72% ntawm 87 tus neeg mob tsim nyog tau txais IGF-1 qib qis dua qhov siab tshaj qhov qub;
Ntawm 50 tus neeg mob tsim nyog rau kev soj ntsuam, 60% tau yoo mov GH qib<1 µ g/mL, and 80% had fasting GH levels ≤ 2.5 µ g/mL. During the 2-year tretment, the proportion of patients with GH levels ≤ 2.5 µ g/L at 12 months (M12) and 24 months (M24) was 83.3% and 80.0%, respectively; The proportion of patients with M12 and M24 GH levels<1.0 µ g/L was 61.7% and 61.4%, respectively; The proportions of M12 and M24 with normal levels of IGF-1 and GH levels ≤ 2.5 µ g/L were 65.0% and 54.8%, respectively; The proportion of M12 and M24 patients with normal IGF-1 levels and GH levels ≤ 1.0 µ g/L was 51.7% and 42.9%, respectively.
Txhim kho cov tsos mob
Nws tuaj yeem txhim kho cov tsos mob ntawm cov neeg mob acromegaly. Cov tsos mob ntawm acromegaly muaj xws li kev hloov ntawm lub ntsej muag, ntiv tes loj, tawv tawv, mob taub hau, kev hloov hauv lub zeem muag, mob pob qij txha, cov nqaij mos o, tawm hws ntau dhau, thiab lwm yam. Tom qab tratment, cov tsos mob no tuaj yeem txo qis mus rau qhov sib txawv. Piv txwv li, hauv -cov kev tshawb fawb hauv ntiaj teb hauv Suav teb, qhov feem pua ntawm cov neeg mob qhia txog cov tsos mob cuam tshuam nrog acromegaly txo los ntawm 87.5% ntawm lub hauv paus mus rau 77.9% (-9.6%) ntawm 12 lub hlis, nrog kev txhim kho tseem ceeb tshaj plaws hauv kev mob taub hau (-17.1%), tom qab los ntawm cov ntaub so ntswg o (-8.1%) thiab tawm hws ntau (.5%).
Qhov chaw ntawm cov ntaub ntawv:
Qhov tiag -kev tshawb fawb thoob ntiaj teb hauv Suav teb muab cov pov thawj ncaj qha rau kev txhim kho cov tsos mob hauv cov neeg mob acromegaly los ntawm lanrelitide, uas sau qhia meej txog kev hloov pauv ntawm cov tsos mob ua ntej thiab tom qab tratment.
kev soj ntsuam validation:
Txoj kev tshawb fawb SODA kuj tau lees paub nws cov txiaj ntsig ntawm kev txhim kho cov tsos mob. Thaum lub sij hawm 2-xyoo ua raws- nce, tus neeg mob cov tsos mob tau ruaj khov lossis txhim kho ntawm M24. Qhov no qhia tau hais tias lanrelitide tuaj yeem txhim kho cov neeg mob cov tsos mob tsis tu ncua thiab txhim kho lawv lub neej zoo thaum kho mus ntev.
Txhim kho lub neej zoo
Nws tuaj yeem txhim kho lub neej zoo ntawm cov neeg mob acromegaly los ntawm kev txhim kho biochemical ntsuas thiab cov tsos mob, uas tuaj yeem txhim kho lawv lub hlwb thiab lub cev kev noj qab haus huv. Cov neeg mob acromegaly feem ntau ntsib kev puas siab puas ntsws thiab lawv lub neej zoo raug cuam tshuam loj heev vim muaj kev hloov pauv ntawm lub ntsej muag, lub cev tsis xis nyob, thiab lwm yam laj thawj. Tom qab kev kho mob nroglanreotide 120 mg, cov neeg mob cov qhab nia ntawm lub neej zoo yuav zoo dua.
Qhov chaw ntawm cov ntaub ntawv:
Qhov tiag -kev tshawb fawb thoob ntiaj teb hauv Suav teb tau siv AcroQoL nplai los ntsuas lub neej zoo ntawm cov neeg mob acromegaly. Cov txiaj ntsig tau pom tias tag nrho cov qhab nia AcroQoL tau nce los ntawm qhov nruab nrab ntawm 5.7 cov ntsiab lus piv rau cov hauv paus (95% CI: 3.1, 8.2), thiab muaj kev txhim kho zoo ib yam ntawm ob qho tib si lub hlwb thiab lub cev kev noj qab haus huv.
Clinical validation
SODA txoj kev tshawb fawb tseem tsom mus rau kev ua neej zoo ntawm cov neeg mob, ntsuas qhov cuam tshuam rau lawv lub neej los ntawm cov txheej txheem xws li cov neeg mob cov lus nug hauv lub sijhawm 1-xyoo thiab 2-xyoo tratment. Cov txiaj ntsig tau pom tias cov tshuaj muaj kev nyab xeeb zoo thiab siv tau yooj yim dua, nrog rau cov neeg mob siab, uas cuam tshuam qhov cuam tshuam zoo ntawm cov tshuaj rau cov neeg mob lub neej zoo.
Thaum lub sij hawm 2- xyoo tratment, rau cov neeg mob uas tau txais octreotide ntev ua ntej tso npe kawm (n=100), ib qho kev faib ua feem ntau dua (81.0%) suav hais tias ATG yog "zoo heev" los yog "kuj" yooj yim piv rau yav dhau los kev tswj hwm tom qab hloov mus rau ATG tretment; Piv nrog rau cov kev tshawb fawb yav dhau los ntawm tib hom, cov neeg mob hauv M12 (77.4%) thiab M24 (80.0%) muaj feem ntau ntawm cov neeg mob uas ntsuas qhov yooj yim ntawm Lanrui Peptide ATG txhaj. Txoj kev yooj yim tratment pab txhim kho cov neeg mob lub neej zoo.
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