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51.
A randomized,double-blind crossover trial of paracetamol 1000 mg four times daily vs ibuprofen 600 mg: effect on swelling and other postoperative events after third molar surgery
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AIMS: To evaluate the effect of a 3-day regimen of ibuprofen 600 mg x 4 on acute postoperative swelling and pain and other inflammatory events after third molar surgery compared with a traditional regimen of paracetamol 1000 mg x 4. METHODS: A controlled, randomized, double-blind, cross-over study where 36 patients (26 females, 10 males) with mean age 23 (range 19-27) years acted as their own controls. All patients were subjected to surgical removal of bilateral third molars. After one operation the patients received tablets of ibuprofen 600 mg x 4 for 3 days. After the other operation they received an identical regimen of paracetamol 1000 mg tablets. Swelling was objectively measured (mm) with a standardized face bow and the patients scored their pain intensity (PI) on a 100-mm visual analogue scale. RESULTS: There was no statistically significant difference between paracetamol and ibuprofen treatment with respect to effect on acute postoperative swelling. Swelling after paracetamol on the third postoperative day was 1.8% less than that after ibuprofen. Mean (95% CI) difference between treatments was -0.3 (-4.7, 4.1) mm. On the sixth postoperative day swelling after ibuprofen was 2.3% less than that after paracetamol. Mean (95% CI) between treatments was 0.2 (-2.4, 2.8) mm. There was no statistically significant difference in pain intensity between the paracetamol and the ibuprofen regimen on the day of surgery. The mean (95% CI) difference between the treatments for summed pain intensity on the day of surgery (SUMPI 3.5-11) was 3.31 (-47.7, 54.3) mm. Two patients developed fibrinolysis of the blood clot (dry socket) after receiving ibuprofen while none did this after paracetamol treatment. There was no noticeable difference between treatments with respect to appearance of haematomas/ecchymoses or adverse effects which all were classified as mild to moderate. CONCLUSIONS: A 3-day regimen of ibuprofen 600 mg x 4 daily does not offer any clinical advantages compared with a traditional paracetamol regimen 1000 mg x 4 daily with respect to alleviation of acute postoperative swelling and pain after third molar surgery. 相似文献
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采用FID气相色谱仪,Bp 20 毛细管柱(25 m ×3.2 m m ,膜厚1.0 μm ),二阶程序升温分离布洛芬凝胶中的薄荷脑,基质不干扰测定,以正辛醇为内标。线性范围在220~600 μg/m l。平均回收率99.5% ,RSD 0.5% 。 相似文献
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以布洛芬、盐酸伪麻为主药,以黄原胶、预胶化淀粉、Tween-80等为稳定剂制备布洛伪麻混悬液,并进行了一系列体外性质的考察及初步临床观察。结果显示,本品具有性质稳定、起效快、适口性强等优点,拟作为医院新制剂开发应用。 相似文献
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Desfrere L Zohar S Morville P Brunhes A Chevret S Pons G Moriette G Rey E Treluyer JM 《Journal of clinical pharmacy and therapeutics》2005,30(2):121-132
OBJECTIVE: Intravenous ibuprofen (IBU) has been found to be as effective as indomethacin for the treatment of patent ductus arteriosus (PDA) in preterm infants and has been associated with fewer adverse effects in comparative phase III studies. The dose regimen used (10-5-5 mg/kg/day) was based on limited pharmacokinetic data and no phase II study was available to determine the optimal dose of IBU for this indication. The present study was designed to determine the minimum effective dose regimen (MEDR) of IBU (one course) required to close ductus arteriosus in preterm infants. METHOD: A double-blind dose-finding study was conducted using the continual reassessment method, a Bayesian sequential design. Two distinct target closure rates were initially chosen according to postmenstrual age (PMA) at birth: 80% in infants with a PMA of 27-29 weeks, and 50% in infants with a PMA < 27 weeks. Forty neonates (20 in each PMA group) with PDA were treated between days 3 and 5 of life. Four different dose regimens were tested: loading doses of 5, 10, 15 or 20 mg/kg, followed by two doses (1/2 loading dose) at 24-h intervals. Efficacy was evaluated by echocardiography 24 h after the third infusion. RESULTS: In infants with a PMA of 27-29 weeks, the estimated MEDR was 10-5-5 mg/kg with a final estimated probability of success of 77% (95% credibility interval: 56-92%). The 15-7.5-7.5 mg/kg dose regimen had a better estimated probability of success (88%, 95% credibility interval: 68-97%), but resulted in more minor renal adverse effects. In contrast, in infants with a PMA < 27 weeks, the estimated MEDR was 20-10-10 mg/kg with an estimated probability of success of 54.8% (95% credibility interval: 22-84%), whereas the conventional dose regimen resulted in a low estimated probability of success (30.6%, 95% credibility interval: 13-56%). In these infants, compared with those with a PMA of 27-29 weeks, minor renal adverse effects were more frequent from the 10-5-5 mg/kg/day dose regimen and did not appear to be clearly dose related. CONCLUSION: This study confirms that the currently recommended dose regimen (10-5-5 mg/kg) of IBU is associated with a high closure rate (80%) and few adverse effects in premature infants with a PMA of 27-29 weeks. The failure rate was much higher below 27 weeks. A higher dose regimen (20-10-10 mg/kg) might achieve a higher closure rate. However, tolerability and safety of this dose regimen should be assessed in a larger population before considering the use of these doses for ductus arteriosus closure. 相似文献
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Mahé I Mouly S Mahé E Diemer M Knellwolf AL Simoneau G Caulin C Bergmann JF 《Fundamental & clinical pharmacology》2001,15(1):61-63
In a short-term gastro-duodenal endoscopic study in 12 healthy volunteers, the gastrotoxicity was not different after intake of diclofenac-K 12.5 mg (0.33) or ibuprofen 200 mg (0.42, P=0.66) but significantly higher after aspirin 500 mg (2.67, P=0.002). 相似文献
58.
Background aim of the studyPatent ductus arteriosus (PDA), a common finding among premature infants, is conventionally treated by intravenous indomethacin. Intravenous ibuprofen was recently shown to be as effective and to have fewer adverse reactions in preterm infants. If equally effective, then oral ibuprofen for PDA closure would have several important advantages over the intravenous route. This study was designed to determine whether oral ibuprofen treatment is efficacious and safe in closure of a PDA in premature infants.Patients and methodsThirty-three premature group I (study group) were treated with ibuprofen 10 mg/kg administered through a feeding tube. Thirty-three premature group II (control group) receive placebo the two imaging procedures were again performed 24 h after each ibuprofen dose. When the PDA was still hemodynamically significant, as demonstrated by echocardiography, and there was no evidence of deterioration in brain ultrasonography, a second dose of ibuprofen 5 mg/kg (placebo for control) was administered. A third equivalent dose was given after another 24 h if necessary. Cranial ultrasound was repeated 1 week after the last ibuprofen dose and again before discharge from the ward. Hematochemical analysis was preformed daily in the unit during the first days of life.ResultsIn the study group the rate of PDA closure was 93.9% (31 of 33 cases) while in the control group the rate of PDA closure was 30.3% (10 of 33 cases) with significant difference in between. There was no reopening of the ductus after closure had been achieved. No infant required surgical ligation of the ductus in study group while in the control group 24.2% (8 of 33 cases) were required surgical ligation (Table 2). Twenty-one newborns were treated with 1 dose of ibuprofen, 9 were treated with 2 doses, and the remaining 3 were treated with 3 doses.ConclusionOral ibuprofen is an effective and safe alternative to intravenous ibuprofen for PDA closure in premature infants. 相似文献
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