Pharmacokinetics of ibuprofen in febrile children

Summary Ibuprofen may be an alternative to acetaminophen to control fever in children but little is known about its pharmacokinetics in pediatric patients. We studied 17 patients (age 3–10 yr) with fever; the most prevalent diagnoses were streptococcal pharyngitis and otitis media. Ibuprofen liquid was given as a single dose, 5 mg/kg (9 patients) or 10 mg/kg (8 patients). Multiple blood samples were collected over 8 hours and analyzed by HPLC.The maximum observed serum concentrations of ibuprofen ranged from 17–42 m·ml^–1 at 5 mg·kg^–1 and 25–53 m·ml^–1 at 10 mg·kg^–1 doses. Pharmacokinetics did not appear to be affected by ibuprofen dose. Mean t_max, oral clearance and elimination half life were 1.1 h, 1.2 ml·min^–1·kg^–1, and 1.6 h, respectively in patients at 5 mg·kg^–1 doses; the corresponding values were 1.2 h, 1.4 ml·min^–1·kg^–1, and 1.6 h in those receiving 10 mg·kg^–1 doses. There was no relationship between age and ibuprofen kinetics. No adverse effects occurred in any patients.These data suggest that ibuprofen pharmacokinetics may not be affected by dose between 5 and 10 mg/kg or age between 3 and 10 years.     

布洛芬混悬液治疗小儿发热疗效观察

目的观察布洛芬混悬液治疗小儿发热的临床疗效与安全性。方法 203例高热患儿随机分为观察组102例和对照组101例。观察组给予布洛芬混悬液治疗;对照组给予对乙酰氨基酚混悬剂治疗。观察2组疗效及安全性。结果 观察组退热效果评分为(2.88±0.17)分高于对照组的(2.62±0.37)分,总有效率98.0%高于对照组的91.1%,差异均有统计学意义(P<0.05)。2组治疗后体温均较治疗前降低,且观察组不同时段的退热效果均优于对照组,差异有统计学意义(P<0.01)。结论布洛芬混悬液退热疗效好,作用强,持续时间长,口服方便,不良反应少,可作为儿科退热的常用药物之一。     

Evaluation of ibuprofen versus aspirin and paracetamol on efficacy and comfort in children with fever

Objective: We compared efficacy and impact on the comfort of ibuprofen (7.5 mg/kg per dose), aspirin (10 mg/kg/dose) and paracetamol (10 mg/kg per dose) on children with fever aged 6–24 months in an open, randomised study with three parallel groups. Methods: The main criterion for efficacy was area under the curve (AUC) of percentage temperature reduction. Comfort was assessed on scores depending on general behaviour and degree of relief. General behaviour was assessed on a verbal scale and on a visual analogue scale (VAS) and the degree of relief was assessed in relation to baseline on a verbal scale. Results: The efficacy of ibuprofen was better than that of aspirin or paracetamol. In spite of more adverse events, the comfort scores were significantly in favour of ibuprofen 6 h after the first dose of treatment. Received: 29 March 1996 / Accepted in revised form: 2 August 1996     

对乙酰氨基酚和布洛芬均引起儿童急性荨麻疹不良反应1例

目的 探讨退热药物对乙酰氨基酚和布洛芬引起儿童急性荨麻疹的不良反应的发生及有效治疗方法。方法 临床药师全程开展药学服务,分析1例3岁患儿使用对乙酰氨基酚和布洛芬退热治疗后均出现急性荨麻疹的临床案例,并进行相关讨论。结果 患儿出现急性荨麻疹后,口服地氯雷他定干混悬剂抗过敏、地塞米松抗炎抗过敏和抗病毒药物治疗,最终患儿症状好转。结论 乙酰氨基酚和布洛芬同致急性荨麻疹的不良反应报道较为少见但仍存在,患儿用药后需密切观察,出现急性荨麻疹时可予抗过敏治疗。临床药师进行药物相关性不良反应的评分和分析,旨在为临床合理用药提供参考。     

布洛芬对急性上呼吸道感染患儿的退热效果

目的:观察布洛芬混悬液的退热效果.方法:选择有高热症状的急性上呼吸道感染患儿100例,随机分为两组,分别用布洛芬混悬液(56例)和对乙酰氨基酚口服溶液(44例)治疗,记录首次给药后0.5、1.0、1.5、2.0、3.0、4.0、5.0和6.0 h的体温变化.结果:布洛芬组和对乙酰氨基酚组体温降低1.5 ℃所需的平均时间分别为(110±78)min、(119±82)min,比例分别为83.9%和84.1%(P＞0.05).体温恢复正常时间分别为(110±76)min、(124±78)min(P＞0.05),比例分别为87.5%和68.2%(P＜0.05).前2 h两组体温下降相似,在3.0、4.0、5.0和6.0 h布洛芬组平均体温下降大于对乙酰氨基酚组,体温正常化维持时间更长.结论:布洛芬退热疗效优于对乙酰氨基酚.     

布洛芬混悬液与复方氨基比林治疗小儿发热的疗效比较

目的:观察比较布洛芬混悬液与复方氨基比林的退热疗效.方法:选择有发热症状的患儿200例随机分成两组,分别用布洛芬混悬液和复方氨基比林治疗.结果:两组在第1 h内退热效果和退热速度相同,而布洛芬混悬液在第2 h就能使患儿体温降至接近正常体温,并能维持6～8 h;复方氨基比林未能将体温退至正常,用药3 h后体温有回升趋势.结论:与复方氨基比林比较,布洛芬混悬液退热效果好,维持时间长,不良反应轻微.     

布洛芬混悬液在儿童发热中的应用与疗效

目的观察口服布洛芬混悬液的退热效果。方法将136例发热患儿分为口服2%布洛芬混悬液治疗组70例和肌注复方氨林巴比妥对照组66例,对两组患儿的体温变化及退热效果进行对比分析。结果两组患儿均在给药后30min内体温开始下降,治疗组体温下降明显优于对照组。治疗组用药4h后总有效67例,总有效率为95.7%;对照组总有效57例,总有效率为86.4%;两组比较,差异有统计学意义(P<0.05)。结论口服2%布洛芬混悬液退热起效快,退热效果良好,可作为儿科退热首选用药。     

Section 3 The activity and tolerance of ibuprofen in patients with rheumatism and associated conditions

Summary

Ibuprofen, in a daily dosage range of 600?mg. to 1200?mg., was given to 100 patients suffering from a variety of rheumatic conditions for periods ranging from 1 to 3 months. The drug was found to be effective and well-tolerated by the majority of patients, even by those with associated conditions such as gastro-intestinal disorders which often make treatment difficult with other antirheumatic agents. Side-effects were reported in only 4 patients.     

Assessment of the efficacy and safety of paracetamol, ibuprofen and nimesulide in children with upper respiratory tract infections

Objective: The aim of this study was to assess and compare the efficacy and tolerability of paracetamol, ibuprofen and nimesulide in children with upper respiratory tract infections (URTIs). Methods: Ninety children with acute URTIs and fever were enrolled to the study. The patients were allocated to three groups. The first group was treated with paracetamol 10 mg/kg thrice daily; the second group with ibuprofen 10 mg/kg thrice daily; and the third group received nimesulide 2.5 mg/kg twice daily for 5 days. Results: The anti-pyretic activity of nimesulide was greater and more rapid than either paracetamol or ibuprofen. The number of patients with normal temperature was significantly greater in the first 2 days for the nimesulide group. The improvement in cough for the paracetamol group was better than the others. Conclusion: The results of this study demonstrated that the anti-pyretic effectiveness of nimesulide is better than paracetamol and ibuprofen in febrile children with URTIs. However, new studies in larger paediatric populations are required to explore the anti-inflammatory effect of nimesulide. Received: 20 April 1999 / Accepted in revised form: 13 August 1999     

Flucloxacillin in the treatment of infectious conditions in children

Summary

A multi-centre study was carried out in 107 children with skin and soft-tissue infections (46) or upper respiratory tract infections (61) to assess the effectiveness of flucloxacillin (125?mg. q.d.s. for 5 days). Swabs were taken from the lesion sites before and after treatment for bacteriological assessment and sensitivity of the isolated organisms.

The clinical success rate achieved was 93% in skin and soft-tissue infections and 94% in upper respiratory tract infections and these results correlate closely with the bacteriological findings. The main causative organism in the skin and soft-tissue infections was Staph, aureus which was resistant to benzyl penicillin and to ampicillin in all but 2 cases. All strains proved sensitive to flucloxacillin. Minimal side-effects were reported and the syrup presentation was well accepted.     

102例儿童传染性单核细胞增多症治疗分析

目的:探讨儿童传染性单核细胞增多症的(IM)临床特点,分析IM的误诊原因,以提高诊治技术。方法:收集102例IM患儿的临床资料,并按年龄分成三组,进行回顾性分析。结果:102例就诊患者临床表现多样,临床表现以发热、咽峡炎、淋巴结肿大及肝肿大为主。年龄越小临床表现越不典型,其中有22例入院完善相关检查后才明确诊断。入院后予以抗病毒治疗对控制病情有一定疗效。结论:儿童传染性单核细胞增多症临床表现多样,常侵犯全身多个器官,掌握该病的临床特点,做到早期诊断、早期治疗,对提高儿童身体素质有重要作用。     

Section 3 Clinical experience with ibuprofen in the treatment of rheumatic diseases

Summary

Ibuprofen in a dosage of 1200?mg. daily was shown in an open study of 247 patients to be effective in the treatment of rheumatoid arthritis, ankylosing spondylitis and non-articular rheumatism. Side-effects were minimal and particularly noteworthy was the absence of gastro-intestinal symptoms in 26 patients with known peptic ulceration who were treated with the drug.     

Section 3 Algodystrophies in the upper and lower limbs treated with ibuprofen

Summary

Fifty patients suffering from painful conditions in the upper and lower limbs arising from a variety of different causes were treated with 1000?mg. to 1200?mg. ibuprofen daily for periods up to 6 months. Treatment was found to be effective in terms of pain relief and the drug was well tolerated, only 2 patients developing side-effects.     

Analgesic efficacy of ibuprofen alone and in combination with codeine or caffeine in post-surgical pain: a meta-analysis

Objective: To estimate the analgesic effect of ibuprofen and to test whether codeine and caffeine enhance its effect on post-surgical pain. Method: Systematic overview of the literature and meta-analysis of published randomised, controlled trials. Results: Ibuprofen is effective in dental pain, episiotomy pain and other post-operative pain. There is a dose–response relationship over the range 50–400 mg. The difference in total pain-relief score relative to placebo was 19–31%. On average, patients were over three times more likely to obtain moderate to excellent pain relief with ibuprofen than with placebo (response-rate ratio = 3.45) and the number needed to treat was 2.44. Codeine 60 mg enhanced the analgesic effect of ibuprofen 400 mg by about 8% in the total pain-relief scale, but it also increased its adverse effects. The additive effect of caffeine was inconsistent. Conclusion: Ibuprofen is an effective analgesic in postoperative pain. Codeine 60 mg adds to the analgesic effect of ibuprofen 400 mg. Any additive caffeine effect requires validation. Received: 5 February 1997 / Accepted in revised form: 11 August 1997     

Systematic review and meta-analysis of the clinical safety and tolerability of ibuprofen compared with paracetamol in paediatric pain and fever

ABSTRACT

Objective: The main aim of this review was to compare the tolerability and safety between ibuprofen and paracetamol when used as anti-pyretic and analgesic agents in children up to 18 years of age.

Methods: MEDLINE (1950 to November 2008), EMBASE (1980 to November 2008), The Cochrane Library (2007, Issue 3), ACP Journal Club (1991 to November 2007) and Pascal (1987 to November 2007) were searched for randomised controlled trails (RCTs) (comparing ibuprofen and/or paracetamol with placebo), controlled observational studies and large case series comprised more than 1000 participants.

Main outcome measures: Adverse events (AEs) requiring discontinuation of medication; systemic reactions related to ibuprofen or paracetamol; serious AEs that are fatal, life-threatening or require hospitalisation; and serious AEs not requiring hospitalisation.

Results: A total of 24 RCTs examined either ibuprofen and/or paracetamol versus placebo for AE data. Twelve other studies meeting our criteria were also included for AE data. Meta-analysis of systemic reactions demonstrated that tolerability and safety of ibuprofen was similar to placebo, as was paracetamol: ibuprofen versus placebo relative risk (RR) 1.39 (95% CI: 0.92, 2.10); paracetamol versus placebo RR 1.57 (95% CI 0.74, 3.33). A total of 2937 systemic AEs occurred in 21?305 patients taking ibuprofen compared with 1466 systemic AEs in 11?164 patients taking paracetamol: RR 1.03 (95% CI 0.98, 1.10). There was no significant difference between the two groups. Narrative analysis of AE data identified conflicting evidence regarding hepatic injury with paracetamol and group A streptococcal infections with ibuprofen or paracetamol treatment.

Conclusions: Ibuprofen, paracetamol and placebo have similar tolerability and safety profiles in terms of gastrointestinal symptoms, asthma and renal adverse effects. While the study data investigated here may not reflect over-the-counter use, these results are still relevant in the context of any safety concerns relating to general ibuprofen or paracetamol treatment in children.     

小儿唇腭裂术后不同方法镇痛的临床观察

目的探讨不同镇痛方式在小儿唇腭裂手术后应用的效果。方法择期唇腭裂手术患儿40例。随机分为布洛芬混悬液口服组和对乙酰氨基酚栓塞肛组,每组20例。应用视图疼痛评分（LPS）观察术后镇痛效果。记录两组患儿术前、术后6、12、24h的HR、MAP、RR、SpO2等临床指标。观察并记录术后恶心呕吐、胃肠道出血、皮疹、水肿、血尿及呼吸抑制等不良反应。结果口服组和塞肛组术后镇痛效果无差异（P〉0.05）。两组患儿HR、MAP、RR、SpO2术后各时点之间、各时点与术前比较差异无统计学意义（P〉0.05）。塞肛组较口服组不良反应发生率少（13%vs33%）。结论小儿唇腭裂手术后,布洛芬混悬液口服和对乙酰氨基酚栓塞肛的给药方式都有满意的镇痛效果,但对乙酰氨基酚栓塞肛方式不良反应少,更安全和可行。     

表现为不明原因发热的传染病患者38例临床分析

目的对表现为不明原因发热（FUO）的传染病患者38例进行分析,以利于非传染病收治科室防控传染病。方法采用回顾性分析的方法,对首诊我院呼吸内科247例FUO患者最后确诊为国家法定报告传染病的38例患者的临床资料、疾病谱、确诊方法及治疗情况进行分析。结果传染病患者占FUO的15.4％：肺结核占传染病患者首位,占42.1％;传播途径明确占传染病患者的47.3％。最终通过化验检查、侵袭性病理检查及诊断性治疗而明确诊断。结论在收治以FUO为表现的患者时,应警惕并排除传染性疾病的可能。通过仔细采集病史,进行相关病原学化验检查,必要时给予侵袭性病理检查和诊断性治疗即可明确诊断。     

The efficacy and tolerance to three doses of diltiazem in elderly patients with stable angina

Summary Twelve patients aged 71–82 years with chronic stable angina were treated with the calcium antagonist diltiazem in three successive doses, 180, 270 and 360 mg/day each over two weeks.Exercise tolerance increased and trinitrin consumption fell on the first dose but showed no further change on the higher doses. Heart rates at rest and on maximal treadmill exercise were significantly reduced on the highest dose only.Adverse effects were experienced by 1, 3 and 8 subjects respectively on the three doses. The most frequent was constipation which was of sufficient severity to cause three to withdraw from treatment. It is concluded that, of the three doses studied, the optimal daily dose of diltiazem for elderly patients is 180 mg/day.     

Metabolism of paracetamol in children with chronic liver disease

Objective: To study the metabolism of single doses of paracetamol in paediatric patients with chronic liver disease admitted to a hospital liver disease clinic. Results: Thirteen paediatric patients, aged 7 months to 12 years, with chronic liver disease of varying severity were studied. In these children, paracetamol elimination half-life was negatively correlated with serum albumin and positively with prothrombin time, as previously reported in adults with liver disease. The rate constant of glucuronide formation was higher in the children with liver disease compared to the value reported in healthy children of similar ages. The rate constant of the formation of paracetamol sulphate was no different from that in normal children. The 36 h urinary paracetamol glucuronide to sulphate ratio was 1.4 (95% CI 0.8 to 1.7). This mean ratio was higher than in healthy children (0.81 and 0.75) but not significantly so, probably because of a Type 1 error due to the inevitable small sample size arising from the nature of the population being studied. Conclusion: The present study provides reassuring additional data to indicate that, at least for single doses, there is no cause for concern in the use of paracetamol in children with chronic liver disease. Received: 13 April 1995 /Accepted in revised form: 15 September 1995