直肠应用蒿甲醚与静脉注射奎宁治疗乌干达儿童脑疟疾的随机临床研究

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Objective: To compare the efficacy and safety of rectal artemether with intrav enous quinine in the treatment of cerebral malaria in children. Design: Randomis ed, single blind, clinical trial. Setting: Acute care unit at Mulago Hospital, U ganda’s national referral and teaching hospital in Kampala. Participants: 103 ch ildren aged 6 months to 5 years with cerebral malaria. Intervention: Patients we re randomised to either intravenous quinine or rectal artemether for seven days. Main outcome measures: Time to clearance of parasites and fever; time to regain ing consciousness, starting oral intake, and sitting unaided; and adverse effects. Results: The difference in parasitological and clinical outco mes 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 24.1(SD 18.9 hours, P = 0.08; time to regaining consciousness 30.1 (SD 24.1) hours v 22.67 (SD 18.5) hours, P = 0.1 0; time 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 group than in the artemether group ( 10/52 v 6/51; relative risk 1.29, 95%confidence interval 0.84 to 2.01). No seri ous immediate adverse effects occurred. Conclusion: Rectal artemether is effecti ve and well tolerated and could be used as treatment for cerebral malaria. Objective: To compare the efficacy and safety of rectal artemether with intrav enous quinine in the treatment of cerebral malaria in children. Design: Randomis ed, single blind, clinical trial. Setting: Acute care unit at Mulago Hospital, U ganda’s national referral and teaching hospital in Kampala. Participants: 103 ch ildren aged 6 months to 5 years with cerebral malaria. Intervention: Patients we re randomized to either intravenous quinine or rectal artemether for seven days. Main outcome measures: Time to clearance of parasites and fever; time to Results: The difference in parasitological and clinical outco mes 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 24.1 (SD 18.9 hours, P = 0.08; time to regaining consciousness 30.1 Mortality was higher in the quinine group than in the artemether group (10: 2.67 (SD 18.5) hours, P = 0.1 0; time to starting oral intake 37.9 (SD 27.0) hours v 30.3 / 52 v 6/51; relative risk 1.29, 95% confidence interval 0.84 to 2.01). No serious immediate adverse effects occurred. Conclusion: Rectal artemether is effecti ve and well tolerated and could be used as treatment for cerebral malaria.
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