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Effect.veness and Safet. of 9-m.nt. t.eat.0}nt.Regim.n for m.lt.drug-Resist.nt.t.berculosis in t.e Philippines

Journal of t.berculosis Research 2022年第2期10卷 75-86页

作者： Vivian S. Lofranco vincent m. balanag Jr Lawrence O. Raym.nd Noel G. m.calalad Alex Golubkov mary rosary t. santiag. Anna m.rie Celina G. Garfin Nat.onal Cent.r for Pulm.nary Research-Lung Cent.r of t.e Philippines Quezon City Philippines Nat.onal t. Reference Laborat.ry-Research Inst.t.t. for t.opical m.dicine Muntinlupa City Philippines Global Healt. Bureau Infectious Diseases Office TB Division U.S. Agency for International Development (USAID) Washington USA Disease Prevent.on and Cont.ol-Depart.0}nt.of Healt. Manila Philippines

Background: t.e Philippines has a burden of drug-resist.nt.t.berculosis (DR-t.). One of t.e key challenges in t.e program.at.c m.nagem.nt.of DR-t. (Pm.t. is t.e high rat. of loss t. follow-up (38% in t.e 2010 cohort.. An urgent.need for a short.r, m.re t.lerable, less expensive t.eat.0}nt.regim.n exist.. t.e aim.of t.e operat.onal st.dy is t. det.rm.ne t.e efficacy and safet. of t.e short.t.eat.0}nt.regim.n am.ng drug resist.nt.t.. m.t.ods: t.is is a prospect.ve single-arm.cohort.st.dy evaluat.ng t.e effect.veness and safet. of a short.r 9 - 11-m.nt. t.eat.0}nt.regim.n (9m.R) for rifam.icin-resist.nt.m.lt.-drug resist.nt.t. (RR/m.R-t.) in 10 Pm.t.facilit.es. All eligible consent.ng adult.pat.ent. wit. rifam.icin-resist.nt.t. were enrolled and received t.e st.ndardized 9-m.nt. t.eat.0}nt.regim.n (9m.R), including inject.bles, wit. a follow-up aft.r 12 m.nt.s of t.eat.0}nt.com.let.on. Result.: A t.t.l of 329 pat.ent. were enrolled from.July 2015 t. Decem.er 2016. At.t.e 6t. m.nt. post.enrollm.nt. 256 (77.8%) of t.em.had cult.re-negat.ve t.st.result.. t.e end-of-t.eat.0}nt.success rat. was 74.1% (224 [68.0%] were cured and 20 [6.1%] com.let.d t.e t.eat.0}nt.. On t.e ot.er hand, 10 (3.0%) died, 41 (12.5%) lost.t. follow-up, 33 (10.0%) wit.drawn, 1 (0.3%) t.eat.0}nt.failure. In t.e 12t. m.nt. aft.r 9m.R com.let.on, am.ng t.e 244 pat.ent. wit. successful t.eat.0}nt. 198 (81.1%) had cult.re-negat.ve result., while t.ere were 46 pat.ent. whose cult.re t.st. were not.done. One pat.ent.developed t. relapse wit. fluoroquinolone resist.nce. t.e m.jorit. of t.e adverse event. were m.ld t.at.occurred m.st.y during t.e first.6 m.nt.s of t.eat.0}nt. Conclusion: t.e 9-m.nt. t.eat.0}nt.regim.n had a high t.eat.0}nt.success rat. wit. a favorable safet. profile. t.e loss t. follow-up was reduced;however, it.was st.ll a challenge. t.e int.oduct.on of t.e 9m.R via operat.onal research had a m.jor im.act.on building nat.onal capacit. and infrast.uct.re for t.e program.at.c adopt.on of a new regim.n.

关键词： m.R-t. Short.t.eat.0}nt.Regim.n t.eat.0}nt.Out.om.s Prospect.ve St.dies

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Int.rim.Out.om.s and Adverse Event. am.ng Drug-Resist.nt.t.berculosis Pat.ent. t.eat.d wit. Bedaquiline in t.e Philippines

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Journal of t.berculosis Research 2022年第2期10卷 61-74页

作者： Vivian S. Lofranco m.ria Rhoda A. t.rres-Cervas Kat.erine A. Asence Khrizza m.rianne A. Del m.ndo vincent m. balanag.mary rosary t. santiag. Anna m.rie Celina G. Garfin Nat.onal Cent.r for Pulm.nary Research Lung Center of the Philippines Quezon City Philippines t.e Global Fund Project Philippine Business for Social Progress Manila Philippine Nat.onal t.berculosis Cont.ol Program.m.nagem.nt.Office Department of Health Manila Philippines Disease Prevent.on and Cont.ol Bureau Department of Health Manila Philippines

Object.ves: t.is st.dy aim.d t. assess t.e int.rim.out.om.s for drug-resist.nt.t.berculosis (DR-t.) pat.ent. t.eat.d wit. bedaquiline regim.n under t.e operat.onal research condit.ons com.ared t. DR-t. pat.ent. t.eat.d wit.out.bedaquiline in t.eir regim.n, and t. describe t.e adverse event. t.at.occurred am.ng pat.ent. t.eat.d wit. bedaquiline in t.e Philippines. Design: Pat.ent. who were t.eat.d wit. a bedaquiline-cont.ining regim.n from.June 2016 t. m.y 2017 were included in t.is st.dy as t.e int.rvent.on group, while pat.ent. who were t.eat.d wit.out.bedaquiline regim.n from.January 2013 t. m.y 2016 were included as t.e com.arison group. t.e int.rim.t.eat.0}nt.out.om.s were com.ared using Chi-square t.st. t.e analysis of t.m. t. cult.re conversion wit.in 6 m.nt.s of t.eat.0}nt.was conduct.d. A Cox proport.onal hazard m.del was const.uct.d t. ident.fy t.e variables associat.d wit. a favorable int.rim.t.eat.0}nt.out.om.. t.e R program.was used for st.t.st.cal analysis. Result.: On t.e 6t. m.nt. of t.eat.0}nt. t.e cult.re conversion for pat.ent. t.eat.d wit. a bedaquiline-cont.ining regim.n was significant.y higher t.an wit. t.e com.arison group [63/75 (84.0%) vs 84/117 (71.8%), p = 0.012)]. Nearly 15% of t.e pat.ent. t.eat.d wit. bedaquiline were lost.t. follow-up. Frequent.adverse event. included vom.t.ng, dizziness, nausea, joint.pain, and abdom.nal pain. Conclusion: t.e pat.ent. who were t.eat.d wit. bedaquiline-cont.ining regim.n have bet.er int.rim.t.eat.0}nt.out.om.s t.an t.ose t.eat.d wit.out.bedaquiline, but.t.e proport.on of pat.ent. who were lost.t. follow-up rem.ins subst.nt.al.

关键词： Operat.onal Research New Ant.-t. Drug Regim.n Drug Int.rim.Out.om.s Adverse Event.

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t.e Int.oduct.on of Bedaquiline Regim.n for Drug-Resist.nt.t.berculosis in t.e Philippines: An Operat.onal St.dy

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Journal of t.berculosis Research 2022年第4期10卷 205-219页

作者： vincent m. balanag Jr. Vivian S. Lofranco m.riquit. J. m.nt.la mary rosary t. santiag. Pat.ice Jam.e E. Cabasis Arnyl G. Aranet. Anna m.rie Celina G. Garfin Lung Cent.r of t.e Philippines National Center for Pulmonary Research Quezon Philippines Depart.0}nt.of Healt. National Tuberculosis Control Program Management Office Manila Philippines Philippine Business for Social Progress The Global Fund Project Manila Philippines Depart.0}nt.of Healt. Disease Prevention and Control Bureau Manila Philippines

Object.ves: Bedaquiline (BDQ) is t.e first.new ant.-t.berculosis (t.) drug int.oduced t. t.e m.rket.aft.r 45 years. Recent.st.dies have shown t.e pot.nt.al benefit. of adding bedaquiline t. regim.ns for drug-resist.nt.t. (DR-t.). In search of m.re effect.ve regim.ns for DR-t., bedaquiline was int.oduced in t.e t. program.in t.e Philippines under operat.onal research t. assess it. effect.veness, safet., and t.lerabilit. when given wit. background regim.ns am.ng pat.ent. wit. m.lt.-or ext.nsively DR-t. (m.R/XDR-t.). Design: A prospect.ve cohort.st.dy of pat.ent. wit. m.R/XDR-t. was given wit. a bedaquiline-cont.ining regim.n from.June 2016 t. m.y 2017. Dem.graphic dat., presence of com.rbidit.es, and m.crobiologic profile on ent.y were recorded. Bedaquiline was adm.nist.red at.t.e recom.ended dose of 400 m. once daily for 14 days, t.en 200 m. t.ree t.m.s a week for 22 weeks t.get.er wit. World Healt. Organizat.on (WHO)-com.liant.background regim.n. t.e t.m. t. cult.re conversion, int.rim.out.om.s at.t.e 6t. m.nt. of t.eat.0}nt. end-of-t.eat.0}nt.out.om.s, and post.t.eat.0}nt.follow-up out.om.s aft.r one year was det.rm.ned. t.e frequency and severit. of adverse event. (SAE) were recorded as part.of pharm.covigilance. Result.: Sevent.-five pat.ent. were given wit. bedaquiline-cont.ining regim.n during t.e st.dy period. Fort.-t.o (56.0%) had second-line inject.ble resist.nce, 23 (30.7%) had fluoroquinolone-resist.nce, 6 (8.0%) had m.R-t., and 4 (5.3%) had XDR-t.. In t.e 6t. m.nt. of post.enrolm.nt. 79% were cult.re-negat.ve. t.e t.eat.0}nt.success rat. was 65.3% (37 were cured and 12 com.let.d t.eat.0}nt., 7 (9.3%) died, 17 (22.7%) lost.t. follow-up, and 2 (2.7%) were wit.drawn from.t.eat.0}nt. Adverse event. included vom.t.ng (80%), dizziness (69%), nausea (52%), cough (44%), and headache (36%). t.e post.t.eat.0}nt.follow-up of 49 pat.ent. in t.e 12t. m.nt. showed 92% were cult.re-negat.ve while 8% of t.C were not.done. Conclusion: Bedaquiline-cont.ining regim.ns for pat.ent.

关键词： Bedaquiline Drug-Resist.nt.t. XDR-t.

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