Kev Nyab Xeeb Ntawm Lubiprostone Hauv Cov Neeg Mob Menyuam Yaus Nrog Kev Ua Haujlwm cem quav: Ib qho uas tsis yog, qhib-Label TrialⅡ

TSEEM CEEB

Cov pej xeem thiab cov yam ntxwv hauv paus ntsiab lusDemographic thiab cov yam ntxwv hauv paus tau sau tseg rau cov pej xeem kev nyab xeeb hauv Table 1. Qhov feem pua ​​​​ntawm cov neeg mob uas muaj keeb kwm ntawm kev kho cem quav tsis zoo yog sib piv hauv ob pawg kho mob: 76.8% ntawm cov neeg mob hauv lubiprostone 12-mcg BIDgroup thiab 77.4% ntawm cov neeg mob hauv 24-mcg BID pawg.

Nyem rau qhov cuam tshuam cov quav

Cov tshuaj sib xyaw ua ke feem ntau yog cov tshuaj tiv thaiv kab mob rau kev siv (26.4% ntawm tag nrho cov neeg mob), cov tshuaj tiv thaiv kab mob hauv lub ntsws (25.3% ntawm tag nrho cov neeg mob), thiab psychoanalytic (24.1% ntawm tag nrho cov neeg mob). Ib qho loj me me ntawm cov neeg mob siv cov tshuaj tiv thaiv kab mob hauv 12-mcg BIDgroup (32.1%) dua li ntawm 24-mcg BID pawg (16.1%).

Kev siv tshuaj rau obstructive airway kab mob thiab psychoanaleptics tau sib piv ntawm ob pawg kho mob (obstructiveairway kab mob 26.8% thiab 22.6% thiab psychoanaleptics 21.4% thiab 29.0% hauv 12-mcg BID thiab {{9 }}mcg BID pawg, ntsig txog).Nyob rau hauv tag nrho, 13.8% ntawm cov neeg mob siv tshuaj cawm siav (16.1% hauv lubiprostone 12-mcg BID pawg thiab 9.7% hauv lubiprostone24-mcg BID pawg). Feem ntau tau txais cov tshuaj cawm siav yog sennoside A þ B (5.7% ntawm tag nrho cov neeg mob) thiab bisacodyl (3.4% ntawm tag nrho cov neeg mob).

Kev nyab xeeb

Kev kho mob raug zoo sib xws hauv ob pawg kawm. Hauv thelubiprostone {{0}}}mcg BID pawg thiab 24-mcg BID pawg, cov tshuaj nyob nruab nrab ntawm cov tshuaj tau raug yog 169.5 thiab 169.0 hnub, raws li txoj cai; hauv tib pab pawg kho mob, tag nrho cov koob tshuaj nruab nrab yog 221.7 capsules thiab 206.1 capsules , raws. Qhov kev ua raws li kev kawm tshuaj yog 73.3% hauv lubiprostone 12-mcg BID pawg thiab 63.2% hauv 24-mcg BID pawg.Ib qho kev qhia txog kev kho mob-emergent AEs (TEAEs) yog muab rau hauv daim duab 1.

Ntawm cov neeg mob hauv lubiprostone 12-mcg BID thiab 24-mcgBID pawg, 57.1% thiab 48.4% qhia 1 TEAE, raws li. Obserious TEAEs (6.5%) were reported in the lubiprostone 24-mcg BID group, and neither one (ulcerative colitis or worsening constipation) was drug-related. The proportions of patients discontinuing because of a TEAE were 12.5% and 16.1% in the lubiprostone 12-mcg BID group and 24-mcg BID group, respectively. Upper abdominal pain was the only TEAE leading to discontinuation (of 12 patients in total) that occurred in >1 tus neeg mob. Feem ntau TEAEs hauv qhov kev tshawb fawb no yog kev siv me me thiab kev daws tus kheej.

Treatment-Related Adverse Events Reported in >–5% of Patients or Gastrointestinal Disorders Reported in >-3% ntawm cov neeg mob

Ib qho kev qhia txog kev kho mob ntsig txog cov xwm txheej tsis zoo (TRAEs) qhia los ntawm 5% ntawm cov neeg mob tau muab rau hauv daim duab 2. Cov neeg mob tau tshaj tawm tias feem ntau GI mob raws plab, raws li xeev siab, mob plab, thiab mob plab plab.

Treatment-Related Adverse Events Occurring in >1 

Patient An overview of TRAEs occurring in >1 tus neeg mob tau muab rau hauv Table 2. Ntawm cov neeg mob nyob rau hauv lubiprostone 12-mcg BID thiab 24-mcgBID pawg, 35.7% thiab 32.3%, feem, qhia TRAEs.Upper mob plab yog qhov feem ntau tshaj tawm TRAEthat ua rau kev txiav tawm hauv lubiprostone 12-mcg BID pawg (1.85%) thiab 24-mcg BID pawg (3.2%).

Pab Pawg Saib Xyuas Kev Kho Mob-RelatedAdverse Events

Female patients reported numerically higher TEAE rates (1 TEAE) than male patients in the 12-mcg BID group (21 females [65.6%] vs 11 males [45.8%]) as well as the 24-mcg BID group (10 females [58.8%] vs 5 males [35.7%]). White patients reported numerically higher TEAE rates (1 TEAE) than Black or other race patients in the 12-mcg BID group (White, 27 [62.8%]; Black, 4 [36.4%]; other race, 1 [50.0%]) as well as the 24-mcg BID group (White, 13 [52.0%]; Black, 2 [40.0%]; other race, none).  In the 12-mcg BID group, 24 patients (61.5%), 7 patients (43.8%), and 1 patient (100.0%) reported 1 TEAE in the 6–9, 10– 13, and 14–17 years age groups, respectively. In the 24-mcg BID group, one patient (33.3%), seven patients (50.0%), and seven patients (50.0%) reported 1 TEAE in the 6–9, 10–13, and 14– 17 years age groups, respectively. Additionally, among patients who weighed 50 kg (ie, patients receiving the 24-mcg BID dose), the rates of TEAEs were numerically similar between patients weighing 50 to 60, >60 rau<80 kg, and 80 kg, and did not indicate any clinically meaningful trends.

Pab Pawg Saib Xyuas Kev Kho Mob-RelatedAdverse Events

Cov poj niam cov neeg mob tau tshaj tawm cov lej ntau dua TRAE tus nqi (1TRAE) dua li cov txiv neej cov neeg mob hauv 12-mcg BID pawg (13 poj niam[40.6%] vs 7 txiv neej [29.2%), nrog rau 24-mcg BID pawg (7females [41.2%] vs 3 txiv neej [21.4%)). Hauv cov txiv neej cov neeg mob, feem ntau tshaj tawm TRAEs yog: raws plab, txo cov ntshav uricacid, thiab dyspepsia, txhua tus ntawm 8.3% ntawm 12-mcg BID pawg neeg mob; thiab raws plab, mob plab, thiab lub plawv dhia tsis xwm yeem, txhua in7.1% ntawm {{20}}mcg pab pawg neeg mob. Hauv cov poj niam cov neeg mob, feem ntau tshaj tawm TRAEs yog xeev siab thiab raws plab hauv 12.5% ​​thiab 11.8% ntawm cov neeg mob hauv 12-mcg thiab 24-mcg BIDgroups, feem. Hauv 12-mcg BID thiab 24-mcg BID pawg, TRAEs 1 tau tshaj tawm hauv 17 (39.5%) thiab 8 (32.0%) ntawm cov neeg mob Dawb, thiab 3 (27.3%) thiab 2 (40.0%) ntawm cov neeg mob Dub, raws. Hauv pawg 24-mcg, feem ntau tshaj tawm TRAE hauv cov neeg mob Dawb yog raws plab (12.0%).

Feem ntau tshaj tawm TRAE byBlack cov neeg mob hauv {{{0}}}mcg BID pab pawg tau mob taub hau (18.2%); txawm li cas los xij, cov neeg mob Dub hauv 24-mcg BID pab pawg qhia mob plab, mob plab, Txo qab los noj mov, thiab mob nraub qaum, txhua tus hauv 20.0% ntawm cov neeg mob. Tsis muaj lwm tus neeg mob tau tshaj tawm 1 TRAE.Nyob rau hauv 12-mcg BID pawg, 17 (43.6%), 3 (18.8%), thiab tsis muaj tus neeg mob hauv 6–9, 10–13, thiab 14–17 xyoo pawg hnub nyoog, raws li, qhia 1 TRAE. Hauv 24-mcg BID pawg, tsis muaj neeg mob, 5 tus neeg mob (35.7%), thiab 5 tus neeg mob (35.7%) hauv pawg 6–9, 10–13, thiab 14–17 xyoo, raws li, qhia 1 TRAE .Qhov feem ntau tshaj tawm TRAE hauv cov hnub nyoog 6-9 xyoo yog xeev siab (10.3%) hauv 12-mcg BID pawg.

TRAEs hauv 12-mcg BID pawg hauv cov neeg mob hnub nyoog 10-13 xyoo tau tshaj tawm los ntawm tus neeg mob ib leeg (6.3%), thiab suav nrog raws plab, plab plab, mob plab sab sauv, dyspepsia, mob taub hau, thiab epistaxis; hauv 24-mcgBID pawg hnub nyoog 10–13 xyoo, TRAEs tau tshaj tawm los ntawm ib tus neeg mob (7.1%), thiab suav nrog raws plab, mob plab sab sauv, anaphylactoidreaction, nce alanine aminotransferase, thiab mob taub hau. Feem ntau tshaj tawm TRAEs hauv cov neeg mob hnub nyoog 14-17 xyoo yog mob plab thiab raws plab, txhua tus tshaj tawm hauv 14.3% ntawm cov neeg mob hauv 24-mcg pawg.

Clinical Laboratory Parameters

Tsawg heev kom tsis txhob muaj kev hloov pauv hauv cov ntshav chemistry hematology lossis urinalysis tsis tau. Tsis pom muaj kev hloov pauv ntawm lub hauv paus rau lub lim tiam 25 rau sodium (raws li ntawm mean137.9 mmol/L, 95% kev ntseeg siab lub sijhawm (CI) [137.4, 138.37] rau 139.4 mmol / L, 95% CI [138.8, 14{18] }}.1]; siv ntau yam 133–145 mmol/L) lossis poov tshuaj (kwv yees li 4.0 mmol/L, 95% CI [3.9, 4.1] rau 4.2 mmol/L, 95% CI [4.1, 4.3]; siv 3.4-5.2 mmol / L. Tsis muaj cov teeb meem ntawm electrolyte abnormality nyob rau hauv txoj kev tshawb no cov neeg koom, txawm nyob rau hauv cov me nyuam uas qhia tias muaj raws plab,thiab tsis muaj qhov tsim nyog ua rau muaj kev cuam tshuam ntawm electrolyte.

Tsis tas li ntawd, lub siab ua haujlwm cim cim-albumin, alkaline phosphatase, alanine aminotransferase, aspartate transaminase, thiab bilirubin (ncaj thiab tag nrho)-tsis tau qhia txog qhov muaj txiaj ntsig zoo hauv kev kho mob.Tshwj xeeb rau kev hloov pauv me me tau pom los ntawm kev kuaj mob hauv lub cev thiab cov cim tseem ceeb, uas suav nrog. qhov hnyav, lub cev qhov hnyav, lub plawv dhia, systolic ntshav siab, thiab diastolic ntshav siab; tsis muaj TAEs cuam tshuam txog kev sib hloov hauv cov ntshav siab systolic lossis diastolic.

Tshawb nrhiav

Kev soj ntsuam kev ua tau zooCov kev ua tau zoo ntawm lubiprostone hauv PFC tau raug soj ntsuam los ntawm cov neeg tshawb xyuas raws li qhov nruab nrab mus rau qhov zoo me ntsis. Thaum lub lim tiam 12, lub ntsiab lus lubiprostone 12-mcg BID pab pawg muab qhab nia yog 2.8 thiab qhov nruab nrab 24-mcg BID pab pawg muab qhab nia yog 2.9 (ntawm qhov ntsuas ntawm 0 rau 4). Thaum lub lim tiam 24, qhov nruab nrab lubiprostone 12-mcg BID pab pawg muab qhab nia yog 2.7 thiab qhov nruab nrab 24-mcg BID pab pawg muab qhab nia yog 2.2.

Ntuj Herbal Tshuaj Rau Relieving cem quav-Cistanche

Cistanche yog ib tug genus ntawm parasitic nroj tsuag uas belongs rau tsev neeg Orobanchaceae. Cov nroj tsuag no paub txog lawv cov khoom siv tshuaj thiab tau siv hauv Cov Tshuaj Suav Tshuaj (TCM) rau ntau pua xyoo. Cov hom Cistanche feem ntau pom muaj nyob hauv thaj av qhuav thiab suab puam ntawm Tuam Tshoj, Mongolia, thiab lwm qhov chaw ntawm Central Asia. Cistanche nroj tsuag yog tus cwj pwm los ntawm lawv cov nqaij tawv, yellowish stems thiab muaj nuj nqis heev rau lawv cov txiaj ntsig kev noj qab haus huv. Hauv TCM, Cistanche ntseeg tau tias muaj cov khoom siv tonic thiab feem ntau yog siv los kho lub raum, txhim kho qhov tseem ceeb, thiab txhawb kev ua haujlwm ntawm kev sib deev. Nws kuj yog siv los daws cov teeb meem ntsig txog kev laus, qaug zog, thiab kev noj qab haus huv tag nrho. Thaum Cistanche muaj keeb kwm ntev ntawm kev siv tshuaj ib txwm siv, kev tshawb fawb tshawb fawb txog nws txoj kev ua tau zoo thiab kev nyab xeeb yog tsis tu ncua thiab txwv. Txawm li cas los xij, nws paub tias muaj ntau yam bioactive tebchaw xws li phenylethanoid glycosides, iridoids, lignans, thiab polysaccharides, uas tuaj yeem ua rau nws cov teebmeem tshuaj.

Wecistanche covcistanche hmoov, cistanche ntsiav tshuaj, cistanche capsules, thiab lwm yam khoom tsim los sivsuab puamcistancheraws li cov khoom siv raw, txhua yam muaj txiaj ntsig zoo rau kev tshem tawm cem quav. Cov txheej txheem tshwj xeeb yog raws li hauv qab no: Cistanche ntseeg tau tias muaj cov txiaj ntsig zoo rau kev tshem tawm cem quav raws li nws cov kev siv ib txwm siv thiab qee cov tshuaj uas nws muaj. Thaum scientific kev tshawb fawb tshwj xeeb rauCistanche covcuam ​​tshuam rau cem quav yog txwv, nws xav tias muaj ntau yam mechanisms uas yuav pab tau rau nws lub peev xwm los daws cem quav. Laxative nyhuv: Cistanche tau ntev tau siv nyob rau hauv Tsoos Suav Tshuaj raws li ib tug tshuaj rau cem quav. Nws ntseeg tau tias muaj cov nyhuv laxative me me, uas tuaj yeem pab txhawb kev zom zaub mov thiab ua rau cem quav. Cov nyhuv no tej zaum yuav raug ntaus nqi rau ntau cov tebchaw nyob hauvCistanche, xws li phenylethanoid glycosides thiab polysaccharides. Moistening cov hnyuv: Raws li kev siv ib txwm siv, Cistanche suav hais tias muaj cov khoom siv moisturizing, tshwj xeeb yog tsom rau cov hnyuv. Txhawb nqa dej thiab lubrication ntawm cov hnyuv yuav pab tau cov cuab yeej soften thiab yooj yim dua, yog li no relieving cem quav. Anti-inflammatory Effect: cem quav tej zaum yuav txuam nrog o nyob rau hauv lub plab zom mov. Cistanche muaj qee qhov sib txuas, suav nrog phenylethanoid glycosides thiab lignans, uas ntseeg tau tias muaj cov tshuaj tiv thaiv kab mob. Los ntawm kev txo cov kab mob hauv cov hnyuv, nws tuaj yeem pab txhim kho kev zom zaub mov tsis tu ncua thiab txo qhov cem quav.