The purpose of this clinical trial was to evaluate the effect of estrogen supplementation on bone mineral density in adolescent girls who received depot medroxyprogesterone acetate for contraception. One hundred twent...The purpose of this clinical trial was to evaluate the effect of estrogen supplementation on bone mineral density in adolescent girls who received depot medroxyprogesterone acetate for contraception. One hundred twenty- three adolescents who began receiving depot medroxyprogesterone acetate injections every 12 weeks were assigned randomly to receive monthly injections of estradiol cypionate or placebo. The main outcome was bone mineral density that was measured by dual energy x- ray absorptiometry for 12 (n = 69) to 24 (n = 36) months. Participants, technicians, and physicians were blinded to estrogen treatment. Over the 24- month period, the percentage of change from baseline bone mineral density at the lumbar spine was 2.8% in the estradiol cypionate group versus - 1.8% in the placebo group (P <.001). At the femoral neck, the percentage of change from baseline bone mineral density was 4.7% in the estradiol cypionate group versus - 5.1% in the placebo group (P <.001). Our results suggest that estrogen supplementation is protective of bone in adolescent girls who receive depot medroxyprogesterone acetate injections.展开更多
Objective. -To investigate the efficacy and tolerability of almotriptan 12.5 mg in migraine patients who respond poorly to sumatriptan 50 mg. Background. -Poor response to sumatriptan therapy for acute migraine attack...Objective. -To investigate the efficacy and tolerability of almotriptan 12.5 mg in migraine patients who respond poorly to sumatriptan 50 mg. Background. -Poor response to sumatriptan therapy for acute migraine attacks has been documented in the literature, but few controlled trials have investigated the efficacy of an alternative triptan in this subgroup of patients. Methods. -Patients with an International Headache Society diagnosis of migraine who self-described as experiencing at least two unsatisfactory responses to sumatriptan treated their first migraine attack with open-label sumatriptan 50 mg. Patients who did not achieve 2-hour pain relief (improvement of headache from moderate/severe to mild/no headache) were then randomized to treat their second attack with almotriptan 12.5 mg or placebo under double-blind conditions. Results. -In the first attack, 221 of 302 participants (73%) did not achieve 2-hour pain relief with sumatriptan and were randomized to treatment of their second attack with almotriptan 12.5 mg or placebo. Of the 198 sumatriptan nonresponders who treated their second attack (99 almotriptan; 99 placebo), 70%had severe headache pain at baseline. Two-hour pain-relief rates were significantly higher with almotriptan compared to placebo (47.5%vs 23.2%; P < .001). A significant treatment effect for almotriptan was also seen in pain-free rates at 2 hours (33.3%vs 14.1%; P < .005) and sustained freedom from pain (20.9%vs 9.0%; P < .05). In the second attack, 7.1%of patients in the almotriptan group experienced adverse events compared to 5.1%in the placebo group (P=.77). Conclusions. -Almotriptan 12.5 mg is an effective and well-tolerated alternative for patients who respond poorly to sumatriptan 50 mg. A poor response to one triptan does not predict a poor response to other agents in that class.展开更多
Background: Capillary leak syndrome is a life-threatening complication after cardiopulmonary bypass (CPB), with an incidence of about 4-37%in children worldwide. On the basis of previous results, we undertook a random...Background: Capillary leak syndrome is a life-threatening complication after cardiopulmonary bypass (CPB), with an incidence of about 4-37%in children worldwide. On the basis of previous results, we undertook a randomised controlled study to investigate the priming with plasma rich in the C4A isotype of complement component 4 on the incidence of capillary leak syndrome in children with C4A deficiency. Methods: In a hospital in Wuhan, China, we randomly assigned 116 neonates, infants, and children lacking complement component C4A to receive C4A-free or C4A-rich plasma priming (n=58 each, 20 mL/kg). The primary outcome was capillary leak syndrome, identified as an increased transvascular escape rate of Evans blue dye from plasma. Concentrations of activated complement components C4 and C3, inflammatory mediators interleukin 6, interleukin 8, tumour necrosis factor (TNF)-α, plasma protein, and PaO2/FIO2 ratios (ratio of the partial arterial pressure of oxygen to the fractional concentration of oxygen in inspired air) were measured before and 4 h after CPB. Analysis was by intention to treat. Findings: Three (5%) patients given C4A-rich plasma priming had capillary leak syndrome compared with 56 (97%)-given C4A-free plasma (p < 0.0001). At 4 h after CPB, activated C4, interleukin 6, interleukin 8, and TNFαconcentrations were higher, whereas PaO2/FIO2 ratios and plasma protein concentrations were significantly lower in the C4A-free group than changes in the C4A-rich group. Activated C3 rose equally in both groups. Activated C4 significantly correlated with interleukin 6, interleukin 8, and TNFαconcentrations; PaO2/FIO2 ratios; and the escape rate of Evans blue dye at 4 h after CPB. Two patients in the C4A-free group died of respiratory and renal failure on day 3 after CPB. Interpretation: In paediatric patients with C4A deficiency, C4A-rich plasma priming reduces the incidence of CPB-related capillary leak syndrome by blocking the activated C4 increase and attenuating the systemic inflammatory response after CPB.展开更多
Colonoscopy is often disturbed by poor patient tolerance; benzodiazepines or opiates are routinely used to overcome such problems, despite the possibility of undesired effects. Tramadol, an opiate analogue with potent...Colonoscopy is often disturbed by poor patient tolerance; benzodiazepines or opiates are routinely used to overcome such problems, despite the possibility of undesired effects. Tramadol, an opiate analogue with potentially fewer side effects, has not been tested yet to this end. The aim of the study was therefore to evaluate the efficacy of tramadol as a premedication for the colonoscopic procedure. Fifty patients were randomly allocated to receive an i.v. infusion of 100 ml saline, with 100 mg tramadol or alone, before endoscopy. At the end of the procedure patients were asked to score the discomfort experienced and to give an exam evaluation. The endoscopist also analyzed his performance. Tramadol patients reported a pain score of 39 ±10 (mean ±SE), compared to 45 ±8 for the placebo group (P=0.25); the evaluation of endoscopy was also similar (tramadol, 66 ±12; placebo, 70 ±9; P=0.15). The endoscopist also reported a similar score (65 ±4 after tramadol; 69 ±4 after placebo; P=0.2). No significant sex or age related differences were detected. We conclude that tramadol, at least as a monotherapy, seems scarcely effective for controlling pain evoked by colonoscopy.展开更多
Background: Recently, polyethylene glycol (PEG 3350) has been suggested as a good alternative laxative to lactulose as a treatment option in paediatric constipation. However, no large randomised controlled trials exis...Background: Recently, polyethylene glycol (PEG 3350) has been suggested as a good alternative laxative to lactulose as a treatment option in paediatric constipation. However, no large randomised controlled trials exist evaluating the efficacy of either laxative. Aims: To compare PEG 3350 (Transipeg: polyethylene glycol with electrolytes) with lactulose in paediatric constipation and evaluate clinical efficacy/side effects. Patients: One hundred patients (aged 6 months-15 years) with paediatric constipation were included in an eight week double blinded , randomised, controlled trial. Methods: After faecal disimpaction, patients < 6 years of age received PEG 3350 (2.95 g/sachet) or lactulose (6 g/sachet) while children ≥6 years started with 2 sachets/day. Primary outcome measures were: de fecation and encopresis frequency/week and successful treatment after eight weeks. Success was defined as a defecation frequency ≥3/week and encopresis ≤1 every two weeks. Secondary outcome measures were side effects after eight weeks of treatment. Results: A total of 91 patients (49 male) completed the study. A significant increase in defeca tion frequency (PEG 3350: 3 prev 7 post treatment/week; lactulose: 3 prev 6 post/week) and a significant decrease in encopresis frequency (PEG 3350: 10 prev 3 post/week; lactulose: 8 prev 3 post/week) was found in both groups (NS). However, success was significantly higher in the PEG group (56%) compared with the lactulose group (29%). PEG 3350 patients reported less abdominal pain, straining, and pain at defecation than children using lactulose. However, bad taste was reported significantly more often in the PEG group. Conclusions: PEG 3350 (0.26 (0.11) g/kg), compared with lactulose (0.66 (0.32) g/kg), provided a higher success rate with fewer side effects. PEG 3350 should be the laxative of first choice in childhood constipation.展开更多
文摘The purpose of this clinical trial was to evaluate the effect of estrogen supplementation on bone mineral density in adolescent girls who received depot medroxyprogesterone acetate for contraception. One hundred twenty- three adolescents who began receiving depot medroxyprogesterone acetate injections every 12 weeks were assigned randomly to receive monthly injections of estradiol cypionate or placebo. The main outcome was bone mineral density that was measured by dual energy x- ray absorptiometry for 12 (n = 69) to 24 (n = 36) months. Participants, technicians, and physicians were blinded to estrogen treatment. Over the 24- month period, the percentage of change from baseline bone mineral density at the lumbar spine was 2.8% in the estradiol cypionate group versus - 1.8% in the placebo group (P <.001). At the femoral neck, the percentage of change from baseline bone mineral density was 4.7% in the estradiol cypionate group versus - 5.1% in the placebo group (P <.001). Our results suggest that estrogen supplementation is protective of bone in adolescent girls who receive depot medroxyprogesterone acetate injections.
文摘Objective. -To investigate the efficacy and tolerability of almotriptan 12.5 mg in migraine patients who respond poorly to sumatriptan 50 mg. Background. -Poor response to sumatriptan therapy for acute migraine attacks has been documented in the literature, but few controlled trials have investigated the efficacy of an alternative triptan in this subgroup of patients. Methods. -Patients with an International Headache Society diagnosis of migraine who self-described as experiencing at least two unsatisfactory responses to sumatriptan treated their first migraine attack with open-label sumatriptan 50 mg. Patients who did not achieve 2-hour pain relief (improvement of headache from moderate/severe to mild/no headache) were then randomized to treat their second attack with almotriptan 12.5 mg or placebo under double-blind conditions. Results. -In the first attack, 221 of 302 participants (73%) did not achieve 2-hour pain relief with sumatriptan and were randomized to treatment of their second attack with almotriptan 12.5 mg or placebo. Of the 198 sumatriptan nonresponders who treated their second attack (99 almotriptan; 99 placebo), 70%had severe headache pain at baseline. Two-hour pain-relief rates were significantly higher with almotriptan compared to placebo (47.5%vs 23.2%; P < .001). A significant treatment effect for almotriptan was also seen in pain-free rates at 2 hours (33.3%vs 14.1%; P < .005) and sustained freedom from pain (20.9%vs 9.0%; P < .05). In the second attack, 7.1%of patients in the almotriptan group experienced adverse events compared to 5.1%in the placebo group (P=.77). Conclusions. -Almotriptan 12.5 mg is an effective and well-tolerated alternative for patients who respond poorly to sumatriptan 50 mg. A poor response to one triptan does not predict a poor response to other agents in that class.
文摘Background: Capillary leak syndrome is a life-threatening complication after cardiopulmonary bypass (CPB), with an incidence of about 4-37%in children worldwide. On the basis of previous results, we undertook a randomised controlled study to investigate the priming with plasma rich in the C4A isotype of complement component 4 on the incidence of capillary leak syndrome in children with C4A deficiency. Methods: In a hospital in Wuhan, China, we randomly assigned 116 neonates, infants, and children lacking complement component C4A to receive C4A-free or C4A-rich plasma priming (n=58 each, 20 mL/kg). The primary outcome was capillary leak syndrome, identified as an increased transvascular escape rate of Evans blue dye from plasma. Concentrations of activated complement components C4 and C3, inflammatory mediators interleukin 6, interleukin 8, tumour necrosis factor (TNF)-α, plasma protein, and PaO2/FIO2 ratios (ratio of the partial arterial pressure of oxygen to the fractional concentration of oxygen in inspired air) were measured before and 4 h after CPB. Analysis was by intention to treat. Findings: Three (5%) patients given C4A-rich plasma priming had capillary leak syndrome compared with 56 (97%)-given C4A-free plasma (p < 0.0001). At 4 h after CPB, activated C4, interleukin 6, interleukin 8, and TNFαconcentrations were higher, whereas PaO2/FIO2 ratios and plasma protein concentrations were significantly lower in the C4A-free group than changes in the C4A-rich group. Activated C3 rose equally in both groups. Activated C4 significantly correlated with interleukin 6, interleukin 8, and TNFαconcentrations; PaO2/FIO2 ratios; and the escape rate of Evans blue dye at 4 h after CPB. Two patients in the C4A-free group died of respiratory and renal failure on day 3 after CPB. Interpretation: In paediatric patients with C4A deficiency, C4A-rich plasma priming reduces the incidence of CPB-related capillary leak syndrome by blocking the activated C4 increase and attenuating the systemic inflammatory response after CPB.
文摘Colonoscopy is often disturbed by poor patient tolerance; benzodiazepines or opiates are routinely used to overcome such problems, despite the possibility of undesired effects. Tramadol, an opiate analogue with potentially fewer side effects, has not been tested yet to this end. The aim of the study was therefore to evaluate the efficacy of tramadol as a premedication for the colonoscopic procedure. Fifty patients were randomly allocated to receive an i.v. infusion of 100 ml saline, with 100 mg tramadol or alone, before endoscopy. At the end of the procedure patients were asked to score the discomfort experienced and to give an exam evaluation. The endoscopist also analyzed his performance. Tramadol patients reported a pain score of 39 ±10 (mean ±SE), compared to 45 ±8 for the placebo group (P=0.25); the evaluation of endoscopy was also similar (tramadol, 66 ±12; placebo, 70 ±9; P=0.15). The endoscopist also reported a similar score (65 ±4 after tramadol; 69 ±4 after placebo; P=0.2). No significant sex or age related differences were detected. We conclude that tramadol, at least as a monotherapy, seems scarcely effective for controlling pain evoked by colonoscopy.
文摘Background: Recently, polyethylene glycol (PEG 3350) has been suggested as a good alternative laxative to lactulose as a treatment option in paediatric constipation. However, no large randomised controlled trials exist evaluating the efficacy of either laxative. Aims: To compare PEG 3350 (Transipeg: polyethylene glycol with electrolytes) with lactulose in paediatric constipation and evaluate clinical efficacy/side effects. Patients: One hundred patients (aged 6 months-15 years) with paediatric constipation were included in an eight week double blinded , randomised, controlled trial. Methods: After faecal disimpaction, patients < 6 years of age received PEG 3350 (2.95 g/sachet) or lactulose (6 g/sachet) while children ≥6 years started with 2 sachets/day. Primary outcome measures were: de fecation and encopresis frequency/week and successful treatment after eight weeks. Success was defined as a defecation frequency ≥3/week and encopresis ≤1 every two weeks. Secondary outcome measures were side effects after eight weeks of treatment. Results: A total of 91 patients (49 male) completed the study. A significant increase in defeca tion frequency (PEG 3350: 3 prev 7 post treatment/week; lactulose: 3 prev 6 post/week) and a significant decrease in encopresis frequency (PEG 3350: 10 prev 3 post/week; lactulose: 8 prev 3 post/week) was found in both groups (NS). However, success was significantly higher in the PEG group (56%) compared with the lactulose group (29%). PEG 3350 patients reported less abdominal pain, straining, and pain at defecation than children using lactulose. However, bad taste was reported significantly more often in the PEG group. Conclusions: PEG 3350 (0.26 (0.11) g/kg), compared with lactulose (0.66 (0.32) g/kg), provided a higher success rate with fewer side effects. PEG 3350 should be the laxative of first choice in childhood constipation.
