ຊັນຟາມາ ໄດ້ນໍາສະເຫນີຂໍ້ມູນກ່ຽວກັບ ODOMZO® (ຢາສໍາລັບການປິ່ນປົວມະເຮັງຜິວຫນັງ) ແລະ LEVULAN® KERASTICK® + BLU-U®, (ສໍາລັບການປິ່ນປົວ lesions precancerous) ສະຫນັບສະຫນູນຄວາມປອດໄພແລະປະສິດທິພາບ.
ODOMZO®
ODOMZO® (Sonidegib) ໄດ້ຮັບການອະນຸມັດໂດຍ FDA ໃນເດືອນກໍລະກົດ 2015. ນີ້ແມ່ນໄດ້ມາໂດຍ ແສງຕາເວັນ Pharma ຈາກ Novartis ໃນເດືອນທັນວາ 2016 ສໍາລັບການຈ່າຍເງິນລ່ວງຫນ້າ $175 ລ້ານພ້ອມກັບການຈ່າຍເງິນທີ່ສໍາຄັນ.
It is a prescription ຢາປົວພະຍາດ taken orally in the form of tablet to treat locally advanced basal cell carcinoma, that has resurfaced following surgery or radiation or that cannot be treated with surgery or radiation. This is an inhibitor of the Hedgehog signalling pathway. The Hedgehog (Hh) pathway is active during embryogenic development and is necessary for cell differentiation, tissue polarity, and stem cell maintenance. This pathway is silent in adult tissues under normal physiological conditions, however, aberrant Hh signalling activation has been implicated in the development and promotion of certain types of ມະເຮັງ, including basal cell carcinoma (BCC), medulloblastoma, and gastrointestinal ມະເລັງ. Basal cell carcinoma and squamous cell carcinoma are most common forms of nonmelanoma ມະເຮັງຜິວ ໜັງ ແລະສົ່ງຜົນກະທົບຕໍ່ຊາວອາເມຣິກັນຫຼາຍກວ່າສາມລ້ານຄົນໃນແຕ່ລະປີ.
ການທົດລອງທາງດ້ານຄລີນິກ BOLT ສໍາລັບ Odomzo, ການສຶກສາແບບ double-blind, randomized, ຄວບຄຸມ, ການສຶກສາ 42 ເດືອນໄດ້ປະເມີນ ODOMZO 200 mg ຕໍ່ມື້ໃນຄົນເຈັບ 230 ຄົນທີ່ມີໂຣກມະເຮັງໃນຈຸລັງ basal cell carcinoma (laBCC) ແລະ metastatic basal cell carcinoma (mBCC). ອັດຕາການລອດຕາຍໂດຍລວມ 2 ປີແມ່ນພົບວ່າ 93.2% (laBCC) ແລະ 69.3% (mBCC). ຢາດັ່ງກ່າວໄດ້ຮັບການຍອມຮັບຢ່າງປອດໄພ.
LEVULAN® KERASTICK® + BLU-U®
This is only photodynamic therapy for precancerous ຜິວຫນັງ lesions approved by the FDA (in July 1999) for use on the upper extremities to treat ‘minimally to moderately’ thick actinic keratoses of the face, scalp or upper extremities. These are precancerous skin growths that, if left untreated, may turn into squamous cell carcinoma. While only about 10 per cent of actinic keratoses become ເປັນມະເລັງ, the majority of squamous cell carcinoma cases start as actinic keratosis.
ລູລູລານ ເຄຣາສຕິກ 20 % topical solution, plus blue light illumination is used to treat the lesions. After LEVULAN KERASTICK topical solution has been applied, the treatment site becomes photosensitive and patients should avoid exposure of the photosensitive treatment sites to ແສງແດດ or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours.
ໃນການທົດລອງທາງດ້ານຄລີນິກ, ມີການລ້າງບາດແຜຫຼາຍກວ່າເກົ່າ (80.6%) ໃນຄົນເຈັບທີ່ໄດ້ຮັບການປິ່ນປົວດ້ວຍຢານີ້ເມື່ອທຽບກັບ placebo (45.5%). ນອກຈາກນັ້ນ, ມີການເກັບກູ້ພື້ນທີ່ຂອງພະຍາດຫຼາຍກວ່າເກົ່າໃນ 80% ຂອງຄົນເຈັບທີ່ກິນການປິ່ນປົວດ້ວຍຢານີ້ເມື່ອທຽບກັບ 40% ຂອງ placebo. ການປິ່ນປົວໄດ້ຖືກຍອມຮັບໄດ້ດີໂດຍບໍ່ມີບົດລາຍງານກ່ຽວກັບເຫດການທາງລົບທີ່ສໍາຄັນທາງຄລີນິກ.
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