随机临床试验:直肠内给予青蒿素甲醚和静脉滴注奎宁治疗乌干达患儿脑型疟疾的比较

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Objective: To compare the efficacy and safety of rectal artemether with intrav enous quinine in the reatment of cerebral malaria in children.Design: Randomised, single blind, clinical trial.Setting: Acute care unit at ulago Hospital, Uganda’s national referral and teaching hospital in Kampala.Participants: 103 children aged 6 onths o 5 years with cerebral malaria.Intervention: Patients were randomised to either intravenous quinine or rectal rtemether for seven days.Main outcome measures: Time to clearance of parasites and fever; time to regaining onsciousness, starting oral intake, and sitting unaided; and adverse effects.Results: The difference in arasitological nd clinical outcomes between rectal artemether and intravenous quinine did not reach significance (parasite clearance time 54.2 (SD 33.6) hours v 55.0 (SD 24.3) hours, P = 0.90; fever clearance time 33.2 (SD 21.9) hours v 4.1SD 18.9 hours, P = 0.08; time to regaining consciousness 30.1 (SD 24.1) hours v 22.67 (SD 18.5) hours, P = 0.10; ime to starting oral intake 37.9 (SD 27.0) hours v 30.3 (SD 21.1) hours, P = 0.14)-.Mortality was higher in the quinine roup than in the artemether group (10/52 v 6/51; relative risk 1.29, 95%confidence interval 0.84 to 2.01).No serious mmediate adverse effects occurred.Conclusion: Rectal artemether is effective and well tolerated and could be used s reatment for cerebral malaria. Objective: To compare the efficacy and safety of rectal artemether with intrav enous quinine in the reatment of cerebral malaria in children. Design: Randomized, single blind, clinical trial. Set: Acute care unit at ulago Hospital, Uganda’s national referral and teaching hospital in Kampala.Participants: 103 children aged 6 onths o 5 years with cerebral malaria.Intervention: Patients were randomized to either intravenous quinine or rectal rtemether for seven days. Main outcome measures: Time to clearance of parasites and fever; time to regaining onsciousness, starting oral intake, and sitting unaided; and adverse effects. Results: The difference in arasitological nd clinical outcomes between rectal artemether and intravenous quinine did not reach significance (para 24, 0.90; fever clearance time 33.2 (SD 21.9) hours v 4.1SD 18.9 hours, P = 0.08; time to regaining consciousness 30.1 (SD 24.1) hours v 22.67 P = 0.10; ime to starting oral intake 37.9 (SD 27.0) hours v 30.3 (SD 21.1) hours, P = 0.14) -. Mortality was higher in the quinine roup than in the artemether group (10/52 v 6/51; relative risk 1.29, 95% confidence interval 0.84 to 2.01) .No serious mrait over effects occurred. Conlusion: Rectal artemether is effective and well tolerated and could be used reatment for cerebral malaria.
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