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 uni...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.展开更多
Objectives. -To describe and compare acceptability of treatment and quality of life over 12 cycles in 2 groups of women randomised to continuous combined Climodiè ne (estradiol valerate 2 mg/dienogest 2 mg) or ...Objectives. -To describe and compare acceptability of treatment and quality of life over 12 cycles in 2 groups of women randomised to continuous combined Climodiè ne (estradiol valerate 2 mg/dienogest 2 mg) or cyclic Climè ne (estradiol valerate 2 mg, from D1 to D21/cyproterone acetate 1 mg, from D12 to D21, followed by 7 days off), switching from previous sequential estroprogestative HRT because of side effects. Patients and methods. -One hundred forty three postmenopausal women aged 54.39-years were recruited and randomised to Climè ne (N = 68) or Climodiè ne (N=75)was evaluated by the continuation rate in the 2 groups at the end of the 12 cycles study. Assessment of quality of life was obtained from the responses to the women’ s health questionnaire (WHQ) and to an ad hoc satisfaction questionnaire at baseline, and at the 12th cycle of treatment. Results. -No significant difference in baseline characteristics of volunteers were found in the 2 treatment groups except for the socioeconomic status (more town-dwellers in Climè ne group). Total WHQ score significantly improved after 12 months of treatment with Climè ne and Climè ne respectively decreasing from 68.9 to 64.37(-4.53) and from 69.95 to 62.06(-7.89), with a trend towards higher improvement with Climodiè ne , particularly in the hot flushes subscale. In Climodiè ne group, a significant decrease in sleep problems and cognitive function subscales was found, which is consistent with previous polysomnography and psycho physiological measures data with Climodiè ne . The evolution of Satisfaction Index is positive and of the same magnitude in the 2 groups, showing an improvement at 12 months: respectively -2.79 (P = 0.002) et -2.26 (P = 0.02) for Climè ne and Climodiè ne . Discussion and conclusions. -Even though the benefit/risk ratio of the hormonal substitutive treatment is recognized effective against climateric symptoms which affect the quality of life, this work is the first randomised prospective study on the effects of Climodiè ne on quality of life in postmenopausal women assessed by the French validated version of the world-wide used WHQ. Decreases in “ sleep problems” and “ cognitive function” subscales scores in this study are of a magnitude clinically relevant and consistent with previous data on Climodiè ne impact on postmenopausal symptoms.展开更多
Background-Acute renal failure is a serious complication of cardiac surgery causing high morbidity and mortality. The aim of this study was to evaluate the usefulness of fenoldopam, a specific agonist of the dopamine-...Background-Acute renal failure is a serious complication of cardiac surgery causing high morbidity and mortality. The aim of this study was to evaluate the usefulness of fenoldopam, a specific agonist of the dopamine-1 receptor, in patients at high risk of perioperative renal dysfunction. Methods and Results-A prospective single-center, randomized, double-blind trial was performed after local ethical committee approval and after written consent was obtained from 80 patients undergoing cardiac surgery. Patients received either fenoldopam at 0.05 μg/kg per minute or dopamine at 2.5 μg/kg per minute after the induction of anesthesia for a 24-hour period. All these patients were at high risk of perioperative renal dysfunction as indicated by Continuous Improvement in Cardiac Surgery Program score >10. Primary end point was defined as 25%creatinine increase from baseline levels after cardiac surgery. The 2 groups(fenoldopam versus dopamine) were homogeneous cohorts, and no difference in outcome was observed. Acute renal failure was similar: 17 of 40(42.5%) in the fenoldopam group and 16 of 40(40%) in the dopamine group(P=0.9). Peak postoperative serum creatinine level, intensive care unit and hospital stay, and mortality were also similar in the 2 groups. Conclusions-Despite an increasing number of reports of renal protective properties from fenoldopam, we observed no difference in the clinical outcome compared with dopamine in a high-risk population undergoing cardiac surgery.展开更多
文摘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.
文摘Objectives. -To describe and compare acceptability of treatment and quality of life over 12 cycles in 2 groups of women randomised to continuous combined Climodiè ne (estradiol valerate 2 mg/dienogest 2 mg) or cyclic Climè ne (estradiol valerate 2 mg, from D1 to D21/cyproterone acetate 1 mg, from D12 to D21, followed by 7 days off), switching from previous sequential estroprogestative HRT because of side effects. Patients and methods. -One hundred forty three postmenopausal women aged 54.39-years were recruited and randomised to Climè ne (N = 68) or Climodiè ne (N=75)was evaluated by the continuation rate in the 2 groups at the end of the 12 cycles study. Assessment of quality of life was obtained from the responses to the women’ s health questionnaire (WHQ) and to an ad hoc satisfaction questionnaire at baseline, and at the 12th cycle of treatment. Results. -No significant difference in baseline characteristics of volunteers were found in the 2 treatment groups except for the socioeconomic status (more town-dwellers in Climè ne group). Total WHQ score significantly improved after 12 months of treatment with Climè ne and Climè ne respectively decreasing from 68.9 to 64.37(-4.53) and from 69.95 to 62.06(-7.89), with a trend towards higher improvement with Climodiè ne , particularly in the hot flushes subscale. In Climodiè ne group, a significant decrease in sleep problems and cognitive function subscales was found, which is consistent with previous polysomnography and psycho physiological measures data with Climodiè ne . The evolution of Satisfaction Index is positive and of the same magnitude in the 2 groups, showing an improvement at 12 months: respectively -2.79 (P = 0.002) et -2.26 (P = 0.02) for Climè ne and Climodiè ne . Discussion and conclusions. -Even though the benefit/risk ratio of the hormonal substitutive treatment is recognized effective against climateric symptoms which affect the quality of life, this work is the first randomised prospective study on the effects of Climodiè ne on quality of life in postmenopausal women assessed by the French validated version of the world-wide used WHQ. Decreases in “ sleep problems” and “ cognitive function” subscales scores in this study are of a magnitude clinically relevant and consistent with previous data on Climodiè ne impact on postmenopausal symptoms.
文摘Background-Acute renal failure is a serious complication of cardiac surgery causing high morbidity and mortality. The aim of this study was to evaluate the usefulness of fenoldopam, a specific agonist of the dopamine-1 receptor, in patients at high risk of perioperative renal dysfunction. Methods and Results-A prospective single-center, randomized, double-blind trial was performed after local ethical committee approval and after written consent was obtained from 80 patients undergoing cardiac surgery. Patients received either fenoldopam at 0.05 μg/kg per minute or dopamine at 2.5 μg/kg per minute after the induction of anesthesia for a 24-hour period. All these patients were at high risk of perioperative renal dysfunction as indicated by Continuous Improvement in Cardiac Surgery Program score >10. Primary end point was defined as 25%creatinine increase from baseline levels after cardiac surgery. The 2 groups(fenoldopam versus dopamine) were homogeneous cohorts, and no difference in outcome was observed. Acute renal failure was similar: 17 of 40(42.5%) in the fenoldopam group and 16 of 40(40%) in the dopamine group(P=0.9). Peak postoperative serum creatinine level, intensive care unit and hospital stay, and mortality were also similar in the 2 groups. Conclusions-Despite an increasing number of reports of renal protective properties from fenoldopam, we observed no difference in the clinical outcome compared with dopamine in a high-risk population undergoing cardiac surgery.
