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Paediatrica Indonesiana
Original Article
Comparative efficacy of artesunate and
sulphadoxine-pyrimethamine combination with
artesunate and amodiaquine combination in
uncomplicated falciparum malaria in children
Jose Meky Mandei, Novie Homenta Rampengan, Suryadi Nicolaas, Napoleon Tatura,
Ari Lukas Runtunuwu, Tony Homenta Rampengan
Abstract
Conclusion The combination of artesunate and sulpha-
Background Malaria is still an important cause of mortality
doxine-pyrimethamine and combination of artesunate and morbidity in children and adults in tropical countries. and amodiaquine were found to be equally effective in the Multidrug resistance againts chloroquine and sulphadox- treatment of uncomplicated falciparum malaria in children ine-pyrimethamine had brought to an introduction of [Paediatr Indones 2008;48:240-5].
artemisinin-based combination.
Objective To assess the alternative treatment of uncompli-
Keywords: uncomplicated falciparum malaria, arte-
cated falciparum malaria in children using artesunate and sunate, sulphadoxine-pyrimethamine, amodiaquine. sulphadoxine-pyrimethamine combination comparing to
artesunate and amodiaquine combination.
Methods This is a single-blind randomized trial. Sixty-
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Malaria is an important cause of mortality NJEZGD\IRUWKUHHGD\VZLWKDQDGGLWLRQDOVXOSKDGR[LQH S\ULPHWKDPLQH S\ULPHWKDPLQH  PJNJEZ  VLQJOH PLOOLRQLQGLYLGXDOVDUHLQIHFWHG GRVHRQWKHILUVWGD\ZKLOHFKLOGUHQZHUHWUHDWHGZLWK ZLWK PDODULD HYHU\ \HDU ZKHUH  PLOOLRQ RI WKHP DUWHVXQDWHDQGDPRGLDTXLQHEDVHPJNJEZGD\IRUWKH lived in highly endemic area in Africa. Infection due ILUVWWZRGD\VWKHQPJNJEZGD\RQWKHWKLUGGD\%RG\ temperature and parasite count were recorded everyday for at least seven days. The outcomes were fever clearance time, parasite clearance time, cure rate and side effects. Sta- From the Department of Child Health, Medical School, Sam Ratulangi tistical analysis was performed using the student t-test.
Results The statistical analysis showed that there were
no difference between these two groups either in fever
Reprint request to: Jose Meky Mandei, MD, Department of Child Health,
Medical School, Sam Ratulangi University, Prof. R.D. Kandou General
FOHDUDQFH WLPH 3!  RU LQ SDUDVLWH FOHDUDQFH WLPH +RVSLWDO-O5D\D7DQDZDQJNR0DQDGR,QGRQHVLD7HOS 3! 7KHFXUHUDWHZDVLQERWKJURXSV9RPLW- ing was found in one patient treated with artesunate and 240‡Paediatr Indones, Vol. 48, No. 4, July 2008
Jose Meky Mandei et al: Artesunate and sulphadoxine-pyrimethamine vs artesunate and amodiaquine in falciparum malaria WRPDODULDFDXVHVDQHVWLPDWLRQRIRQHWRPLOOLRQ This study assessed the alternative treatment for morbidity worldwide each year, mainly in tropical uncomplicated falciparum malaria in children using developing countries. ,Q ,QGRQHVLD  PLOOLRQ artesunate and sulphadoxine-pyrimethamine combi- malaria cases were reported with annual death of nation compared with artesunate and amodiaquine  ,W LV HVWLPDWHG WKDW  RI WKH ,QGRQHVLD population live in a high risk area to be infected with malaria. Most malaria-associated deaths are due to Plasmodium falciparum FKLOGUHQ XQGHU WKH DJH RI five and non-immune travelers are especially vul- This study was a single-blind randomized trial. nerable to severe infection. Falciparum malaria is Subjects were uncomplicated falciparum malaria an acute or chronic infection caused by Plasmodium patients admitted to Prof. R. D. Kandou General falciparum, characterized by recurrent fever, anemia +RVSLWDO0DQDGRVLQFH1RYHPEHUXQWLO0DUFK and hepatosplenomegaly.4,5 The diagnosis of malaria is 7KHVWXG\ZDVDSSURYHGE\(WKLFV&RPPLWWHHRI established by clinical manifestations and identifica- Prof. R.D. Kandou General Hospital, Manado.
tion of parasites on peripheral blood patients.6-8 The inclusion criteria were uncomplicated falci- Malaria infection rate had been increasing in re- SDUXPPDODULDSDWLHQWVDJHGVL[PRQWKVWR\HDUVROG cent years and its treatment has been hampered by the ZLWKKLVWRU\RIIHYHU •oC) in more than 48 hours, increasingly resistance of the parasites to antimalarial P. falciparum monoinfection on thick blood film, no his- drugs. Chloroquine and sulphadoxine-pyrimethamine tory of allergic reaction to the study drug, no history of resistance in falciparum malaria is well advanced, many treatment with artesunate, amodiaquine, sulphadoxine- patients treated with these will not benefits from the pyrimethamine or other antibiotics act as antimalarial treatment and sometimes even die.9 According to Pedo- ZLWKLQWKHSDVWGD\VDQGZKRVHSDUHQWVRUJXDUGLDQ man Penatalaksanaan Kasus Malaria di Indonesia in year of had given a written informed consent. We excluded WKHILUVWOLQHWUHDWPHQWRIXQFRPSOLFDWHGIDOFLSDU- severely sick patients with (not able to drink, severe um malaria is artesunate and amodiaquine combination YRPLWLQJPRUHWKDQWZLFHZLWKLQSUHYLRXVKRXUV plus primaquine.In Indonesia, the first report of chlo- repeated generalized convulsion, lethargy or uncon- roquine resistance in falciparum malaria was from East scious state), severe malnutrition, and any evidence .DOLPDQWDQLQ8QWLOFKORURTXLQHUHVLVWDQFH of chronic disease or other acute infection. was only in East Kalimantan and Irian Jaya. Since that, Drop out was defined as termination from the many provinces in Indonesia reported chloroquine re- study due to any reason such as repeated vomiting, sistance. The first report sulphadoxine-pyrimethamine unable to consume drug orally, hypersensitivity reac- resistance in falciparum malaria was from Irian Jaya. Study tion, worsening of the condition, evidence of mixed LQ 0DQDGR -DQXDU\  ² 'HFHPEHU   IRXQG infection on follow-up, or patient moved to other area. resistance II (R II) to sulphadoxine-pyrimethamine Patients who failed to respond the given treatment (FansidarR LQILYHSDWLHQWV  IURPSDWLHQWV ZHUH WUHDWHG ZLWK TXLQLQH ZLWK WKH GRVH RI  PJ Rampengan et al from their study, found resistance II Uncomplicated falciparum malaria was defined Started from all the facts mentioned, an alterna- as patient with falciparum malaria without complica- tive antimalarial drugs to treat and prevent resistance tion and do not fit the criteria of severe malaria from to Plasmodium falciparum is needed. Plasmodium WHO. Parasite count was measured as the number falciparum resistance had reported from almost all RISDUDVLWHVSHUOHXNRF\WHVRQDWKLFNEORRGILOP antimalarial, except artemisinin and its derivates. DVVXPLQJDWRWDOOHXNRF\WHVFRXQWRI—O2QO\ Recently WHO formulated a policy that elevates asexual parasites were measured (schizon, trophozoid combination antimalarial therapy to preferred first or ring forms), while gametocytes were not measured. therapy for all malaria infections in areas where Fever clearance time was defined as the time taken Plasmodium falciparum is the predominant infecting IRU D[LOODU\·V WHPSHUDWXUH WR IHOO EHORZ oC and UHPDLQHG IRU DW OHDVW  KRXUV 3DUDVLWH FOHDUDQFH Paediatr Indones, Vol. 48, No. 4, July 2008‡241
Jose Meky Mandei et al: Artesunate and sulphadoxine-pyrimethamine vs artesunate and amodiaquine in falciparum malaria time was defined as the time taken for clearance of during study period. Seventy-one falciparum malaria asexual parasites from peripheral blood film detectable patients were enrolled and randomly allocated into by microscope and remained cleared during follow-up period. Resistance was defined as absence of asexual Thirty-three children were treated with artesu- parasitaemia RQGD\UHDSSHDULQJRQGD\ HDUO\ nate and sulphadoxine-pyrimethamine combination 5, RURQGD\ ODWH5, UHGXFWLRQLQDVH[XDO DQG  FKLOGUHQ ZHUH WUHDWHG ZLWK DUWHVXQDWH DQG parasitaemiaEHORZRIGD\FRXQWRQGD\ZLWK amodiaquine. Tables 1, 2, and 3 show that the demo-
asexual parasitaemiaRQGD\ 5,, SDUDVLWHVGHQVLW\ JUDSKLFFOLQLFDODQGODERUDWRU\GDWDRIWKHJURXSV On admission, a standardized medical history &XUHUDWHRQWKHWZRJURXSVZDV2Q was taken and clinical examination performed. The day seven, there was no parasites found in these two children were weighed, axillary temperatures taken, groups. No serious side effects during seven days and capillary blood specimen was taken by venipunc- observation in the two groups. Only one child had ture for malaria films, hemoglobin, leukocyte, hema- repeated vomiting after consuming artesunate and tocrit, platelet, and liver function test (ALT, AST). Enrolled patients were randomly assigned to either receive artesunate and sulphadoxine-pyrimethamine combination (group I) or artesunate and amodiaquine Table 12CVKGPVUFKUVTKDWVKQPCEEQTFKPIEJCTCEVGTKUVKEUQHUWDLGEVU
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combination (group II). Doses were given according to ERG\ZHLJKWDUWHVXQDWHPJNJEZGD\IRUGD\VDQG VXOSKDGR[LQHS\ULPHWKDPLQH S\ULPHWKDPLQH PJNJEZ VLQJOHGRVHRQWKHILUVWGD\IRUJURXS,DQG DUWHVXQDWHPJNJEZGD\IRUGD\VDQGDPRGLDTXLQH EDVHPJNJEZGD\IRUWKHILUVWGD\VWKHQPJ NJEZGD\RQWKHWKLUGGD\IRUJURXS,,$OOGRVHVZHUH directly observed and repeated if vomiting occurred ZLWKLQPLQXWHV$IWHUWUHDWPHQWRQGD\FKLOGUHQ were assessed clinically and parasitologically on day Table 22CVKGPVUFKUVTKDWVKQPDCUGFQPENKPKEOCPKHGUVCVKQPUCPF
WR%RG\WHPSHUDWXUHVZHUHPHDVXUHGRQ DQGHDFKGD\3DUDVLWHFRXQWZDV #TVGUWPCVG52 #TVGUWPCVG#OQFKCSWKPG 'DWD ZHUH DQDO\]HG XVLQJ 6366 YHUVLRQ  Statistical analysis was performed using the student Eighty-three falciparum malaria patients were admitted in Prof. R. D. Kandou General Hospital, Manado Table 3.CDQTCVQT[ſPFKPIUQPCFOKUUKQP
242‡Paediatr Indones, Vol. 48, No. 4, July 2008
Jose Meky Mandei et al: Artesunate and sulphadoxine-pyrimethamine vs artesunate and amodiaquine in falciparum malaria Discussion
nate and sulphadoxine-pyrimethamine combination appeared slightly more efficacious than artesunate The characteristics of both groups in this study were in and amodiaquine combination. Koram et alfound general similar. In general the clinical manifestations that artesunate and lumefantrin combination (Coar- and laboratory findings were similar to that previously tem) and artesunate and amodiaquine combination had rapid parasite clearance time than using single After treatment, in artesunate and sulphadox- antimalarial (chloroquine alone or sulphadoxine- ine-pyrimethamine combination group had fever clearance time shorter than in artesunate and amo- Cure rates on day seven in both artesunate diaquine combination group. Although this study and sulphadoxine-pyrimethamine combination had a difference on fever clearance time, but there and artesunate and amodiaquine combination were was no statistically difference between the two groups HTXDO  3DUDVLWHVHQVLWLYLW\FOLQLFDODQGSDUD- 3! 7KLVILQGLQJVKRZVWKDWERWKDUWHVXQDWH sitology responses were classified based on WHO. and sulphadoxine-pyrimethamine combination and From this classification, this study concluded that artesunate and amodiaquine combination had rapid these two artemisinin-based combination therapies elimination of fever in falciparum malaria patients. were equally efficacious in therapy uncomplicated Van den Broek et alfound rapid elimination of fever falciparum malaria in children. Guthmann et al26 o& DWGD\RQHDQGGD\WZRZDVDQG found that the very low proportion of failures in LQWKHDUWHVXQDWHDQGDPRGLDTXLQHFRPELQD- both artesunate and sulphadoxine-pyrimethamine WLRQJURXSDQGDQGLQWKHDUWHVXQDWHDQG combination and artesunate and amodiaquine com- sulphadoxine-pyrimethamine combination group, bination than amodiaquine alone or sulphadoxine- and on day three all but one (in artesunate and sul- phadoxine-pyrimethamine combination group) were Side effects during seven days observation in the free from fever. Tambajongin her study found that two groups occurred in one child, in artesunate and the fever had decreased rapidly in artemisinin group amodiaquine combination group. She had vomited (artemeter). Dorsey et al found significant decrease PLQXWHVDIWHUFRQVXPLQJWKHVHGUXJVDQGWKHQWKH of fever in malaria patients which used artesunate drugs were given again but then she vomited again. and sulphadoxine-pyrimethamine combination and Those drugs were changed to other antimalarial artesunate and amodiaquine combination than using (quinine sulphate) via nasogastric tube. This side sulphadoxine-pyrimethamine alone. Koram et al  effect maybe caused by amodiaquine which is in the on their study in Ghana, found that artesunate and combination of the drugs. Amodiaquine was an anti- lumefantrin combination (Coartem) and artesu- malarial 4-aminoquinolines group which its structure nate and amodiaquine combination had rapid fever and activity is equal to chloroquine. This drug had elimination than those using chloroquine alone or equal side effect to chloroquine including nausea and vomiting. Dorsey et alon their study in Uganda Although there was difference in parasite clear- RQFKLOGUHQZLWKXQFRPSOLFDWHGfalciparum ma- ance time in this study, but there was no statistically laria which treated with sulphadoxine-pyimrthamine GLIIHUHQFH EHWZHHQ WKLV WZR JURXSV 3!  7KLV alone, combination with artesunate or amodiaquine, result shows that therapy for the uncomplicated found no patients had severe side effect and less than falciparum malaria patients used artesunate and  YRPLWHG 7KH VHUXP FRQFHQWUDWLRQ RI DPRGL- sulphadoxine-pyrimethamine combination and arte- aquine, artesunate or sulphadoxine-pyrimethamine sunate and amodiaquine combination were equally was not measured in this study from the start, this efficacious on parasite clearance time. Tambajong found parasite clearance time were more rapid in We conclude that artesunate and sulphadoxine- artemisinin-based combination therapy than without pyrimethamine combination and artesunate and using that combination. Van den Broek et al  in Su- amodiaquine combination was found equally effective dan, who also used the same combination in his study, in treatment of uncomplicated falciparum malaria in found rapid parasite clearance time. However, artesu- Paediatr Indones, Vol. 48, No. 4, July 2008‡243
Jose Meky Mandei et al: Artesunate and sulphadoxine-pyrimethamine vs artesunate and amodiaquine in falciparum malaria Acknowledgments
falciparum malaria in Africa children. Am J Trop Med Hyg  The authors would like to thanks to Director and Ethics  9RQ6HLGOHLQ/0LOOLJDQ33LQGHU0%RMDQJ.$Q\DOHEHFKL Committee of Prof. R.D. Kandou General Hospital, all patients C, Gosling R, et al. Efficacy of artesunate plus pyrimethamine- sulphadoxine for uncomplicated malaria in Gambian children: double-blind, community-randomised, placebo FRQWUROOHGWULDO/DQFHW References
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Diagnosis and treatment malaria in child. Indian Pediatric  9DQ GHQ %URHN ,9 0DXQJ 8$ 3HWHUV $ /LHP / .DPDO M, Rahman M, et al. Efficacy of chloroquine+sulfadoxine- 7. Stauffer W, Fischer PR. Diagnosis and treatment of malaria pyrimetamine, mefloquine + artesunate and artemether + LQFKLOGUHQ&OLQ,QIHFW'LV lumefantrine combination therapies to treat Plasmodium 8. Leder K, Weller PF. Epidemiology, pathogenesis, clinical falciparum malaria in the Chittagong Hill Tracts, Bangladesh. IHDWXUHVDQGGLDJQRVLVRIPDODULD$YDLODEOHIURPXUOKWWS  9DQGHQ%URHN,$PVDOX5%DODVHJDUDP0+HSSOH3$OHPX 9. Attaran A, Barnes KI, Curtis C, d’Alessandro U,Fanello E, Hussein EB, et al. Efficacy of two artemisinin combination CI,Galinski MR, et al. WHO, the global fund, and medical therapies for uncomplicated falciparum malaria in children PDOSUDFWLFH LQ PDODULD WUHDWPHQW /DQFHW  under 5 years, Malakal, Upper Nile Sudan. Malaria Journal  6XQJNDU 6 3ULEDGL : 5HVLVWHQVL 3ODVPRGLXP IDOVLSDUXP  .RUDP.$$EXDNX%'XDK14XDVKLH1&RPSDUDWLYH WHUKDGDSREDWREDWPDODULD0DM.HG,QGRQHV efficacy of antimalarialdrugs including ACTs in the treatment of uncomplicated malaria among children under 5 years in  5DPSHQJDQ-5DPSHQJDQ7+0DODULDWURSLNDSDGDDQDN \DQJUHVLVWHQ,,WHUKDGDSIDQVLGDU0DM.HG,QGRQHV  7DPEDMRQJ ) 3HUEDQGLQJDQ HILNDVL NRPELQDVL NORURNXLQ dan sulfadoksin-pirimetamin dengan artemeter dan sulfa-  5DPSHQJDQ-0XO\DQWR$.DXQDQJ('5DPSHQJDQ7+ doksin-pirimetamin pada pengobatan malaria tropika tanpa Malaria tropika pada anak yang resisten II terhadap kina komplikasi pada anak. (Thesis). Manado: Universitas Sam VXOIDW0DM)DUPDNRORJLGDQ7HUDSL,QGRQHVLD 9RQ6HLGOHLQ/%RMDQJ.-RQHV3$UDQGRPL]HGFRQWUROOHG  'RUVH\*1MDPD'.DP\D05&DWWDPDQFKL$.\DED\LQ]H trial of artemether benflumetol, a new antimalarial and py- D, Gasasira A, et al 6XOIDGR[LQHS\ULPHWKDPLQH DORQH RU rimetamine sulphadoxine in the treatment of uncomplicated with amodiaquine or artesunate for treatment of uncom- 244‡Paediatr Indones, Vol. 48, No. 4, July 2008
Jose Meky Mandei et al: Artesunate and sulphadoxine-pyrimethamine vs artesunate and amodiaquine in falciparum malaria plicated malaria: a longitudinal randomised trial. Lancet $QJROD7UDQV56RF7URS0HG+\J 7MLWUD(2EDWDQWLPDODULD,Q+DULMDQWR31HGLWRU0DODULD  :RUOG+HDOWK2UJDQL]DWLRQ$VVHVPHQWRIWKHUDSLFHIILFDF\ epidemiologi, patogenesis, manifestasi klinik dan penan- of antimalarial drugs for uncomplicated falciparum malaria. JDQDQ&HWDNDQ,-DNDUWD3HQHUELW%XNX.HGRNWHUDQ(*&  *XWKPDQQ-3$PSXHUR-)RUWHV)YDQ2YHUPHLU&*DERX-  6KDSLUR 7$ *ROGEHUJ '( &KHPRWKHUDS\ RI SURWR]RDO laud V, Tobback S, et al. Antimalarial efficacy of chloroquine, infections: malaria. In: Brunton LL, Lazo JS, Parker KL edi- amodiquine, sulphadoxine-pyrimetamine, and the combina- tors. Goodman and Gilman’s the pharmacological basis of tions of amodiaquine + artesunate and sulfadoxine-pyrimet- WKHUDSHXWLFV 8QLWHG 6WDWHV RI $PHULFD 0F*UDZ+LOO &R amine + artesunate in Huambo and Bie provinces, central Paediatr Indones, Vol. 48, No. 4, July 2008‡245

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