Peb suav nrog kev txhaj tshuaj tiv thaiv. Ntu 4. Placebo

2024 Tus sau: Seth Attwood | [email protected]. Kawg hloov kho: 2023-12-16 16:06

1. Kev nyab xeeb ntawm kev txhaj tshuaj tiv thaiv li cas? Kev tshawb fawb randomized, ob qhov muag tsis pom kev, kev tswj hwm cov placebo yog ua, saib seb cov kev mob tshwm sim twg tshwm sim hauv cov neeg tau txais cov tshuaj tiv thaiv thiab muab piv nrog pawg tswj hwm.

2. Kev sim tshuaj yog kim heev, lawv raug nqi kaum lab daus las. Kev tsim tshuaj yeeb raug nqi ntau pua lab. Tab sis cov no yog txhua yam me me rau cov tuam txhab tshuaj. Cov tshuaj tiv thaiv FDA pom zoo yog sai heev ntawm lub sijhawm txhaj tshuaj hauv ntau lub tebchaws, thiab tsim nyiaj ntau lab daus las hauv ib xyoos. Piv txwv li, kev muag khoom ntawm ib qho ntawm cov tshuaj tiv thaiv tshiab tshaj plaws, Gardasil (rau HPV), muaj ntau dua 3 billion ib xyoos.

3. Cov tuam txhab lag luam xav tau, tau kawg, txo qhov kev pheej hmoo ntawm kev sim tshuaj tsis ua tiav. Tab sis lawv puas muaj txoj cai zoo li no?

Nws hloov tawm muaj, thiab nws yog heev yooj yim. Koj tsuas yog yuav tsum tau siv tsis yog cov placebo tiag tiag es tsis txhob siv cov placebo, tab sis qee yam tshuaj lom txaus, uas ua rau tib yam kev mob tshwm sim uas cov tshuaj tiv thaiv ua rau. Ib qho tshuaj lom neeg feem ntau ntawm cov tshuaj tiv thaiv yog txhuas (qhov no yuav raug pov thawj rau lwm qhov), uas yog siv los ua ib qho tshuaj tiv thaiv hauv feem ntau cov tshuaj tiv thaiv. Yog tias tsis yog siv cov placebo, txhuas siv, lossis, piv txwv li, txhuas nrog ethylmercury, lossis tsuas yog lwm cov tshuaj tiv thaiv, ces tus naj npawb ntawm cov kev mob tshwm sim hauv pawg tswj tau nce ntxiv, thiab tom qab ntawd nws yuav muab piv rau cov kev mob tshwm sim. nyob rau hauv pab pawg uas tau txais cov tshuaj tiv thaiv tshiab. Los ntawm qhov no peb xaus lus tias cov tshuaj tiv thaiv tshiab tsis muaj kev phiv thiab muaj kev nyab xeeb tag nrho. Raws li cov ntaub ntawv no, FDA thiab CDC tseem yuav xaus lus tias cov tshuaj tiv thaiv muaj kev nyab xeeb, thiab tag nrho lwm lub tebchaws.

Puas yog raug cai? kiag li.

4. Tab sis raws li txoj cai, txawm tias nrog kev xaiv ntawm cov placebo, nws tsis tas yuav raug kev txom nyem. Kev siv cov placebo hauv randomized soj ntsuam kev sim tshuaj tiv thaiv tsis tsim nyog txhua. Thiab kev tshawb fawb tsis tas yuav randomized los yog dig muag. Koj tsuas yog muab tshuaj tiv thaiv rau txhua tus thiab saib seb cov kev mob tshwm sim yog dab tsi. Yog tias feem coob muaj sia nyob, ces cov tshuaj tiv thaiv muaj kev nyab xeeb kiag li.

Nov yog ob tsab xov xwm nthuav dav heev:

5. Dab tsi hauv cov placebos: leej twg paub? Kev soj ntsuam ntawm randomized, tswj kev sim. (Golomb, 2010, Ann Intern Med.)

Tsis muaj cov tshuaj inert, thiab tsis muaj cov lus qhia rau qhov twg cov placebo yuav tsum yog. Qhov no, ntawm chav kawm, cuam tshuam rau cov txiaj ntsig ntawm kev kawm.

Cov txiaj ntsig ntawm kev sim tshuaj tsis tas yuav tsum tau nthuav tawm qhov sib xyaw ntawm cov placebo siv yog dab tsi. Phau ntawv kho mob tsis xav tau qhov no thiab.

Cov kws sau ntawv tau tshuaj xyuas 167 cov kev tshawb fawb soj ntsuam luam tawm hauv 4 ntawm cov ntawv kho mob muaj koob npe tshaj plaws. Feem ntau cov kev tshawb fawb soj ntsuam tsis tau nthuav tawm qhov muaj pes tsawg leeg ntawm cov placebo. Cov kev tshawb fawb tsuas yog qhia tias 8% ntawm cov tshuaj thiab 26% ntawm cov tshuaj tau siv los ua cov placebo.

Piv txwv li, nyob rau hauv ib txoj kev tshawb fawb ntawm cov tshuaj rau mob qog noj ntshav anorexia, cov tshuaj tau pom tias muaj txiaj ntsig zoo rau lub plab zom mov. Txawm li cas los xij, lactose tau siv los ua cov placebo. Cov neeg mob qog noj ntshav uas tau txais tshuaj khomob thiab kev kho mob hluav taws xob feem ntau yog lactose intolerant, uas ua rau cov tshuaj tsis muaj lactose piv tau zoo nrog "placebo".

6. Kev sim tshuaj tiv thaiv hauv cov kev tshawb fawb ntawm cov menyuam yaus. (Jacobson, 2009, Vaccine)

Xyoo 1930, ob tus kws kho mob los ntawm German nroog Lübeck tau txiav txim siab txhaj tshuaj tiv thaiv menyuam yaus tiv thaiv kab mob khaub thuas nrog cov tshuaj tiv thaiv BCG, uas, txawm hais tias muaj txij li xyoo 1921, tsis tau siv tshwj xeeb. Lub sijhawm 12 lub hlis ntawm qhov kev sib tw no, 208 tus menyuam yaus tau kis tus kabmob los ntawm cov tshuaj tiv thaiv thiab 77 tuag. Cov kws kho mob raug ntes thiab raug txim ntawm kev tua neeg.

Qhov no ua rau muaj kev sib tham txog kev siv tib neeg hauv kev sim kho mob.

Xyoo 2008, Tebchaws Meskas tau tso tseg Txoj Kev Tshaj Tawm ntawm Helsinki. (Xwb, Tebchaws Meskas siv Txoj Cai Kho Mob Zoo, uas tsis txwv cov tuam txhab tshuaj ntau npaum li Kev Tshaj Tawm ntawm Helsinki.)

Hauv kev tshawb fawb tshuaj tiv thaiv, saline (isotonic tov) tuaj yeem siv tau, tab sis cov kws tshawb fawb feem ntau xaiv lwm cov tshuaj. Kab lus muab plaub piv txwv:

Hauv kev kawm txog tshuaj tiv thaiv kab mob pneumococcal (PCV9), lwm yam tshuaj tiv thaiv (DTP-Hib) tau siv los ua cov placebo.

Txoj kev tshawb fawb tshuaj tiv thaiv kab mob cholera siv cov tshuaj tiv thaiv E. coli ua cov placebo.

Lwm txoj kev tshawb fawb txog tshuaj tiv thaiv kab mob pneumococcal (PCV23) tau siv tshuaj tiv thaiv kab mob siab A thiab B ua cov placebo.

Hauv kev kawm thib plaub, aluminium hydroxide tov nrog thiomersal (ethylmercury) tau siv los ua cov placebo.

7. Tsis zoo li kev sim tshuaj ntawm ntau cov tshuaj, qhov twg cov placebo muaj pes tsawg leeg tau muab zais, ntau lub tuam txhab tshuaj tiv thaiv tsis zais cov placebo siv. Txhawm rau kom paub nws, tsuas yog nyeem cov ntawv txhaj tshuaj. Nov yog qee qhov piv txwv xwb:

8. Daptacel, diphtheria, tetanus thiab pertussis vaccine (DTaP, Sanofi Pasteur). Peb lwm cov tshuaj tiv thaiv tau siv los ua cov placebo - DTP, DT, thiab tshuaj tiv thaiv kab mob pertussis.

Yog lawm. Kev sim tshuaj tiv thaiv tau siv los ua cov placebo. Cia qhov ntawd tso rau hauv.

9. Infanrix, lwm yam kab mob diphtheria, tetanus thiab pertussis vaccine (DTaP, GlaxoSmithKline). Cov tshuaj tiv thaiv Pediarix tau siv los ua cov placebo. Ntxiv mus, ob pawg tau txais cov tshuaj tiv thaiv no nrog rau kev txhaj tshuaj tiv thaiv kab mob siab B, pneumococcus, kab mob khaub thuas, polio, Haemophilus influenzae, qhua pias, mumps thiab rubella.

10. Pediarix, diphtheria, tetanus, pertussis, kab mob siab B thiab tshuaj tiv thaiv kab mob polio (DtaP-HepB-IPV, GlaxoSmithKline). Cov tshuaj tiv thaiv no tau sim nrog rau cov tshuaj tiv thaiv kab mob haemophilus influenzae. Pawg tswj hwm tau txais cov tshuaj tiv thaiv Infanrix nrog rau cov tshuaj tiv thaiv kab mob polio thiab Haemophilus influenzae.

Ntawd yog, kwv yees hais lus, Infanrix sim siv Pediarix ua cov placebo, thiab Pediarix sim siv Infanrix ua cov placebo. Tag nrho cov no tau flavored nrog kev sib xyaw ntawm ntau cov tshuaj tiv thaiv ntxiv kom tshem tawm tag nrho qhov muaj peev xwm ntawm kev paub qhov txawv ntawm cov tshuaj tiv thaiv uas tau sim.

11. Thawj cov tshuaj tiv thaiv kab mob diphtheria, tetanus thiab pertussis tau tshwm sim ntev ua ntej leej twg cuam tshuam nrog kev sim tshuaj, thiab txawm tias siv cov placebo. Yog li ntawd, nws tuaj yeem sib cav ntawm no tias kev siv cov placebo los kuaj lawv, uas yog, tsis txhaj tshuaj rau qee tus menyuam yaus, yog qhov tsis ncaj ncees. Tab sis txawm tias kev sim tshuaj tiv thaiv tshiab rau cov kab mob tshiab tau siv lwm cov tshuaj tiv thaiv li placebos.

12. Havrix, tshuaj tiv thaiv kab mob siab A (GlaxoSmithKline). Txoj kev tshawb fawb soj ntsuam muaj peb pawg. Thawj tus tau txais Havrix. Qhov thib ob tau txais Havrix + MMR (measles / mumps / rubella vaccine). Qhov thib peb tau txais MMR + kab mob khaub thuas thiab kuj Havrix 42 hnub tom qab.

13. Prevnar, tshuaj tiv thaiv kab mob pneumococcal (PCV7, Wyeth). Kev sim (!) tshuaj tiv thaiv Meningococcus C tau siv los ua cov placebo.

Cov tshuaj tiv thaiv tom ntej no, Prevnar-13 (Pfizer), siv Prevnar ua cov placebo.

14. Cervarix, HPV vaccine (GlaxoSmithKline). Cov placebo yog tshuaj tiv thaiv kab mob siab A thiab txhuas hydroxide.

15. Engerix-B, tshuaj tiv thaiv kab mob siab B (GlaxoSmithKline). Tsis muaj pawg tswj hwm.

16. Recombivax, tshuaj tiv thaiv kab mob siab B (Merck). Tsis muaj pawg tswj hwm.

17. Txhawm rau tso cai rau cov tshuaj tiv thaiv tshiab, nws txaus rau FDA tias nws tsis muaj kev phom sij ntau dua li lwm cov tshuaj tiv thaiv, lossis tshuaj tiv thaiv kev sim, lossis txhuas hydroxide, lossis qee yam tshuaj uas lub tuam txhab kws tshuaj tseem tsis tau tshaj tawm…. Qhov no yog li cas FDA cov kws tshawb fawb txhawj xeeb txog koj cov menyuam txoj kev noj qab haus huv.

Tsis muaj kev tshawb fawb soj ntsuam tau siv tshuaj tiv thaiv, thiab tsis tau siv cov placebo tiag tiag

Yog li ntawd, lwm zaus ib tug neeg hais tias kev txhaj tshuaj tiv thaiv zoo kawg nkaus, nug lawv seb lawv puas muaj kev nyab xeeb zoo li cas piv rau.

Kev txhaj tshuaj muaj kev nyab xeeb tag nrho hauv kev sib piv nrog lwm cov tshuaj tiv thaiv, lossis piv nrog cov tshuaj lom heev.