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 rau cov neeg mob, nrog rau ntau yam kev kho mob. Cov neeg mob uas muaj qhov txawv txav ntawm qhov kev loj hlob hormone secretion tom qab phais thiab / lossis kev kho hluav taws xob, nrog rau cov neeg mob uas tsis haum 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 yog cov kab mob pituitary neoplasms, uas tuaj yeem ua rau muaj ntau yam teeb meem hauv nruab nrog cev 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 neoplasms residual tom qab phais, thiab lawv cov qib GH thiab insulin{2}zoo li kev loj hlob-1 (IGF-1) tsis tau tswj, yog li lawv kuj yuav tsum tau txais 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 soj ntsuam nws qhov ua tau zoo hauv kev txo cov ntim neoplasm hauv cov neeg mob tshiab kho nrog GH secreting pituitary adenomas.
Tom qab 12 lub lis piam ntawm tratment, 54.1% ntawm cov neeg mob tau txo qis neoplasm ntim ntau dua lossis sib npaug li 20%, thiab qhov sib txawv ntawm neoplasm 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 qis neoplasm ntim ntau dua lossis sib npaug li 20%, thiab GH thiab / lossis IGF-1 qib tau txo qis los ntawm lub lim tiam 12. Qhov feem pua ntawm cov neeg mob uas ua tau raws li cov txheej txheem tau nce ntxiv raws sijhawm.
Paub txog kev tswj hwm biochemical
Daim ntawv thov xwm txheej
Cov tshuaj no tuaj yeem pab cov neeg mob acromegaly tau txais kev tswj hwm biochemical thiab txo GH thiab IGF-1 qib. Hauv kev ua haujlwm hauv ntiaj teb tiag tiag hauv Suav teb, ntau tus neeg mob tau ua tiav kev tswj hwm GH thiab IGF-1 qib los ntawm kev siv cov khoom. 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.
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
Lanreotide 120 mgNws 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%).
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 nrog cov khoom, cov neeg mob lub neej zoo ntawm cov qhab nia yuav zoo dua.
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.
Cov Lus Qhia Tseem Ceeb: Zoo -Differentiated Metastatic Neuroendocrine neoplasms
Core neoplasm Hom: Gastroenteropancreatic Neuroendocrine neoplasms (GEP-NETs)
120 mg sustained- tso tawm cov tshuaj lanreotide (somatuline) feem ntau yog qhia rau qhov zoo- sib txawv metastatic gastroenteropancreatic neuroendocrine neoplasms thiab sawv cev rau thawj tus neeg nyiam ua ntej - kab mob rau tus kab mob no. GEP-NETs muaj xws li ib pawg heterogeneous ntawm neoplasms tshwm sim los ntawm cov hlwb neuroendocrine ntawm txoj hnyuv thiab txiav txiav. Piv nrog rau qhov sib txawv tsis zoo, siab -qib neuroendocrine carcinomas, zoo- sib txawv GEP-NETs nthuav tawm qeeb qeeb thiab muaj peev xwm ua tsis zoo.
Lawv cov hlwb neoplasm nthuav qhia ntau somatostatin receptors, uas yog lub hauv paus tseem ceeb rau kev kho mob rau somatuline- kho kom haum xeeb. Cov txheej txheem kho mob qhia meej tias 120 mg formulation siv rau tag nrho cov metastatic GEP-NETs cais raws li G1 lossis G2 tsis hais qhov chaw tseem ceeb, suav nrog lub hauv paus plab hnyuv, plab hnyuv thiab pancreatic keeb kwm.
Raws li kev ua haujlwm ntawm cov tshuaj hormone secretory, cov tshuaj suav nrog ob qho tib si ua haujlwm thiab tsis yog -functioning GEP-NETs, haum rau feem ntau cov neeg mob.
Functioning GEP-NETs overproduce ntau lub plab zom mov cov tshuaj hormones thiab ua rau cov yam ntxwv ntawm cov kab mob hauv lub cev nrog cov tsos mob hnyav uas ua rau lub neej tsis zoo thiab lub cev ua haujlwm tsis zoo.Non-functioning GEP-NETs tsis muaj cov tshuaj hormones ntau dhau thiab feem ntau tshwm sim yam tsis muaj qhov tshwm sim thaum ntxov. Cov neeg mob feem ntau tsim cov kev tsis txaus siab tshwj xeeb xws li mob plab, tsam plab thiab poob phaus vim muaj kev cuam tshuam loj thiab nyob deb ntawm metastasis; Tus kab mob no feem ntau kuaj pom nyob rau theem metastatic vim nws txoj kev tsis txaus ntseeg.Lanreotide 120 mgmuab cov txiaj ntsig zoo sib xws rau ob hom subtypes los ntawm kev ua tiav ob lub hom phiaj: kev tswj cov tsos mob thiab kev tawm tsam ntawm neoplasm kev loj hlob. Nws ua tiav qhov kev xav tau ntawm qhov chaw kho mob uas tsis tau txais kev kho mob ntev ntev - ua cov phiaj xwm kev kho mob hauv qhov zoo - sib txawv metastatic GEP -NETs.
Kev kho mob ntawm kev ua haujlwm neoplasms: Precise Control of Hormone-Mediated Carcinoid Syndrome
Rau cov neeg mob uas ua haujlwm tau zoo- sib txawv metastatic GEP-NETs, lub luag haujlwm kho mob tseem ceeb ntawm cov khoom yog kev tawm tsam ntawm cov tshuaj hormones neoplasm ntau dhau. Qhov no zoo txo cov tsos mob ntawm cov tsos mob carcinoid thiab txhim kho cov neeg mob lub neej zoo. Carcinoid syndrome yog qhov teeb meem tshwj xeeb tshaj plaws ntawm kev ua haujlwm GEP-NETs, tshwm sim los ntawm neoplasm overproduction ntawm bioactive mediators suav nrog serotonin, bradykinin thiab prostaglandins.
Paroxysmal cutaneous flushing thiab refractory watery raws plab yog ob qho kev tshwm sim ntau tshaj plaws thiab tsis tu ncua, uas sawv cev rau cov teeb meem kev kho mob loj.
Paroxysmal flushing feem ntau cuam tshuam rau lub ntsej muag, caj dab thiab lub cev, nthuav tawm raws li erythema, sov thiab kub hnyiab. Cov ntu ib leeg dhau ob peb feeb mus rau kaum feeb thiab tuaj yeem ua rau muaj kev ntxhov siab, noj mov lossis kev tawm dag zog lub cev. Kev tawm tsam tsis tu ncua ua rau muaj kev tsis xis nyob, kev puas siab puas ntsws thiab kev cuam tshuam ntawm kev ua ub no txhua hnub. Refractory watery raws plab yog feem ntau tas mus li, tshwm sim ob peb mus rau ntau tshaj kaum zaug ib hnub twg.
Cov quav tsis muaj ntshav lossis cov kua paug thiab tsis cuam tshuam nrog kev mob plab; cov pa tshuaj tiv thaiv kab mob ua rau pom kev ua tau zoo. Kev mob raws plab ntev tuaj yeem ua rau lub cev qhuav dej, cuam tshuam rau electrolyte, kev noj zaub mov tsis txaus thiab poob phaus sai, ua rau lub cev tsis zoo thiab ua rau lub cev raug mob.
Raws li lub sijhawm ntev - ua yeeb yam txhawb nqa - tso tawm kev npaj, nws ua rau qeeb, txuas ntxiv tshuaj tso tawm tom qab txhaj tshuaj subcutaneous. Nws ruaj khov koom nrog SSTR2 thiab SSTR5 ntawm cov hlwb neoplasm thiab inhibits txoj hauv kev tsav cov tshuaj hormone synthesis thiab secretion, yog li txo qis cov tshuaj hormones bioactive ntawm qhov chaw.
Cov ntaub ntawv kho mob qhia tau hais tias kev kho tus qauv nrog cov qauv no ua rau txo qis cov zaus ntws tawm, ua kom lub sijhawm luv luv thiab txo qhov hnyav. Nws kuj alleviates refractory watery raws plab, txo cov plab hnyuv zaus, restores plab hnyuv muaj nuj nqi thiab kho electrolyte imbalance thiab malnutrition. Piv nrog rau luv luv -cov qauv ua yeeb yam, 120 mg ntev- ua haujlwm depot tswj cov ntshav plasma tsis tu ncua yam tsis muaj kev hloov pauv tshuaj pharmacodynamic. Lub sijhawm noj ib zaug -txhua-28-hnub noj tshuaj txhawb nqa kev tswj hwm ntawm cov tsos mob carcinoid thiab txhim kho kev kho mob thiab kev ua neej zoo.
Raws li ntev - ua yeeb yam somatostatin analog, somatuline tau tsim los kov yeej cov kev txwv kev kho mob ntawm haiv neeg somatostatin. Endogenous somatostatin muaj ib nrab luv luv - lub neej ntawm tsuas yog 2-3 feeb thiab yuav tsum tau txhaj tshuaj tas mus li, ua rau nws tsis tsim nyog rau ntev - kev tswj hwm ntawm cov mob oncological ntev.
Kev tswj hwm tsis tu ncua kuj tseem cuam tshuam rau tus neeg mob ua raws li thiab nce nqi kho mob. Hauv xyoo 1980, cov kws tshawb fawb tau ua cov kev hloov kho hluavtaws raws li cov qauv molecular ntawm haiv neeg somatostatin.
Los ntawm optimizing amino acid sequences thiab txhim kho molecular stability, lawv ua tau zoo tsim somatuline, ib tug tshiab ntev - ua derivative uas hla cov drawbacks ntawm endogenous peptide. Cov kev tshawb fawb tom qab tau lees paub tias somatuline khi nrog kev sib raug zoo rau tib neeg somatostatin receptors SSTR2 thiab SSTR5, ua rau muaj kev cuam tshuam meej ntawm cov tshuaj hormones secretion thiab neoplasm proliferation hauv cov hlwb neuroendocrine.
Pharmacological thiab kev soj ntsuam ua ntej validation ntawm qhov ntev - ua yeeb yam somatuline tiav nyob rau hauv 1990.
Nws tau txais nws thawj qhov kev tso cai ua lag luam hauv Tebchaws Europe hauv xyoo 1995, ua raws li kev txhim kho ntawm 120 mg txhawb nqa - tso tawm qauv. Raws li nws qhov kev tso tawm ntev ntev thiab cov tshuaj plasma ruaj khov, cov qauv no tau dhau los ua kev kho tseem ceeb rau kev noj qab haus huv zoo - sib txawv metastatic neuroendocrine neoplasms thiab tau pom zoo ua thawj zaug - kab kev kho mob hauv cov txheej txheem kho mob thoob ntiaj teb.
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