Characteristics of children and adolescents first prescribed proton pump inhibitors or histamine-2-receptor antagonists: an observational cohort study

Objective: To describe the characteristics of pediatric patients prescribed proton pump inhibitors (PPIs) vs those of pediatric patients prescribed histamine-2-receptor antagonists (H₂RAs).

Methods: Observational studies were conducted using The Health Improvement Network (THIN) and the PHARMO Database Network. Patients aged 0–18 years who were first prescribed a PPI or H₂RA between October 1, 2009 and September 30, 2012 (THIN) or between September 1, 2008 and August 31, 2011 (PHARMO) were included. Patient characteristics were identified and compared between the PPI and H₂RA cohorts using odds ratios (ORs) and 95% confidence intervals (CIs) adjusted for age and sex.

Results: The mean age (years) was higher in the PPI than in the H₂RA cohorts (THIN 12.3 [n?=?8204] vs 5.4 [n?=?7937], PHARMO 11.0 [n?=?15 362] vs 7.1 [n?=?6168]). Previous respiratory disease was more common in the PPI than in the H₂RA cohort in THIN (OR?=?1.19, 95% CI?=?1.08–1.30), as were asthma and respiratory medication use in PHARMO (OR?=?1.27, 95% CI?=?1.12–1.45 and OR?=?1.23, 95% CI?=?1.10–1.38, respectively) and oral corticosteroid use in both databases (OR?=?1.45, 95% CI?=?1.10–1.92 [THIN]; OR?=?2.80, 95% CI?=?2.11–3.71 [PHARMO]). Non-steroidal anti-inflammatory drugs, antibiotics, and oral contraceptives were also more common in PPI than in H₂RA cohorts in both databases.

Conclusions: Pediatric patients receiving PPIs and those receiving H₂RAs may represent different patient populations. PPIs may be more commonly prescribed than H₂RAs among patients with respiratory diseases.     

川芎嗪合普米克治疗儿童哮喘30例临床观察

目的:观察川芎嗪联合普米克治疗儿童哮喘的临床疗效。方法:56例儿童哮喘随机分为治疗组(30例)和对照组(26例),治疗组采用川芎嗪静脉滴注、普米克雾化吸入治疗,对照组采用普米克雾化吸入治疗,观察两组患儿症状、体征恢复情况。结果:治疗组控制12例,显效9例,好转7例,无效2例,总显效率为70.00%;对照组控制5例,显效6例,好转12例,无效3例,总显效率为42.31%。两组有显著性差异(P<0.05)。结论:川芎嗪静脉滴注结合普米克雾化吸入能有效地治疗儿童哮喘。     

中西医结合治疗小儿哮喘的现代理念与临床实践

目的:探讨中西医结合治疗小儿哮喘的疗效及机理。方法:63例患儿随机分为观察组31例和对照组32例,两组患儿在急性期均采用吸氧、吸入万托林、吸入及全身应用糖皮质激素、氨茶碱、防治感染及对症、支持治疗;缓解期均采用糖皮质吸入疗法及万托林按需吸入治疗。观察组则根据辨证分为肺气虚弱、脾虚气弱及肾虚不纳3型,在西医治疗的基础上分别给予玉屏风散、六君子汤及金匮肾气丸(或六味地黄丸)加减治疗。结果:观察组与对照组在治疗1年时,其哮喘急性发作平均次数分别为(0.81±0.63)次和(1.88±0.87)次,经统计学处理,P<0.01;因哮喘急性发作而住院平均次数分别为(0.06±0.24)次和(0.15±0.45)次,经统计学处理,P<0.05;PEF达正常预计值人数分别为30人和25人,经统计学处理,P<0.05。结论:中西医结合治疗小儿哮喘,其疗效显著优于单纯西医治疗。治疗机理推测可能与中药能调节全身的炎症细胞与炎症因子水平有关。     

Non-interaction of ketotifen and theophylline in children with asthma – an acute study

Summary Six asthmatic children participated in an acute crossover randomized study. They received a single dose of aminophylline syrup 6 mg/kg after having received ketotifen syrup 1 mg b.i.d. or place-bo for 8 days. Ketotifen did not significantly affect the heart rate, pulse pressure or such pharmacokinetic parameters of theophylline as peak serum level, time to peak, half life and AUC. Thus, ketotifen had no significant effect on the disposition of theophylline.     

沙美特罗/丙酸氟替卡松对哮喘儿童肺功能的改善及临床意义

目的:观察沙美特罗/丙酸氟替卡松对哮喘儿童肺功能改善情况。方法:采用德国Jaeger公司的MasterscreenIOS测定仪,对61例支气管哮喘患儿在沙美特罗/丙酸氟替卡松治疗前后进行通气肺功能(F-V)和脉冲振荡(IOS)检测。观察用力肺活量(FVC)、第一秒用力呼气容积(FEV1)、最大呼气流速(PEF)、呼出25%肺活量时最大呼气流量(FEF25)、呼出50%肺活量时最大呼气流量(FEF50)、呼出75%肺活量时最大呼气流量(FEF75);呼吸阻抗(Zrs)、气道总阻力(R5)、中心气道阻力(R20)、响应频率(Fres)。结果:沙美特罗/丙酸氟替卡松治疗后FVC、FEV1、PEF均明显升高(P<0.001),而Zrs、R5、R20、Fres均明显降低(P<0.05),两者检查结果均有显著统计学意义。结论:吸入沙美特罗/丙酸氟替卡松能改善哮喘儿童的肺通气功能,降低气道阻力,是治疗儿童哮喘的理想药物之一。     

固本止哮汤治疗小儿缓解期哮喘40例临床观察

目的探讨固本止哮汤对缓解期支气管哮喘患儿的临床治疗效果。方法将80例支气管哮喘缓解期患儿分为两组,固本止哮汤口服治疗组和对照组各40例。临床治疗2月后随访2年,观察患儿疗效和血清免疫球蛋白IgG、IgE、T细胞亚群的变化。结果治疗前后的自身对照,治疗组每年的哮喘复发次数较治疗前明显减少,患儿T淋巴细胞亚群CD8明显增加,CD4/CD8细胞比值降低(P0.05)。结论固本止哮汤治疗缓解期支气管哮喘患儿临床效果明显。     

Sustained effects in hypercholesterolaemic patients on combined simvastatin/ezetimibe treatment: observational cohort study in clinical practice

ABSTRACT

Background: In order to reduce individual cardiovascular risk, many patients require life-long lipid-lowering therapy, often as a drug combination approach. We aimed to describe the usage pattern, effectiveness and tolerability of long-term treatment with lipid-lowering agents, with particular focus on an oral combination of simvastatin (SIM 10, 20, 40 or 80?mg) plus ezetimibe (EZ 10?mg).

Methods: A prospective, observational study in 512 general practices throughout Germany. From a sample of patients at moderate or high cardiovascular risk who had previously taken part in a half-year study of an SIM/EZ combination, 5485 patients were documented after 1 year of treatment (mean 58?±?16 weeks) with regard to lipid parameters, adverse drug reactions (ADRs) and adverse events.

Results: At the start of follow-up, 78.6% of patients were still on the SIM/EZ combination. At the end of follow-up, mean low density lipoprotein cholesterol (LDL-C) in patients on the combination versus those on other lipid-lowering therapy was reduced by 29.3 vs. 17.6% compared with baseline, total cholesterol by 23.1 vs. 14.5%, mean high density lipoprotein cholesterol (HDL-C) was increased by 15.9 vs. 13.4%, and mean triglycerides were reduced by 16.1 vs. 7.9%. Individual LDL-C targets were achieved by 56.6% on the SIM/EZ combination versus 35.9% on other therapy. In the long term (but not the short term), low acceptance of nutrition counselling as rated by the physician was associated with poor lipid levels. ADRs during follow-up occurred in 18 patients (0.3%; all cases non-serious), with seven cases of myalgia, and three cases each of nausea or arthralgia.

Conclusions: This observational study showed that long-term therapy with the SIM/EZ combination resulted in sustained beneficial effects on serum lipids and was well-tolerated. Compared to patients with therapy discontinuations or switches, those remaining on the combination had better outcomes regarding lipid status.     

哮喘清合剂联合小剂量西药防治小儿支气管哮喘发作的临床研究

目的 探讨哮喘清合剂联合小剂量西药防小儿支气管哮喘发作的临床疗效.方法 选择2010年1月至2011年7月间在我院就诊治疗的小儿支气管哮喘患者100例,随机分为2组,实验组50例,口服哮喘清合剂加用小剂量西药;对照组50例,吸入糖皮质激素和(或)孟鲁斯特钠咀嚼片,观察3个月为一个疗程.同时在发作期、缓解期及一个疗程结束后分别作嗜酸粒细胞计数(EOS)、呼出气一氧化氮检测(FeNO)及肺功能观察不同时期的变化.比较两组的总有效率.结果 实验组与对照组的总有效率分别为94.0%、74.0%,两组总有效率比较差异有统计学意义(P<0.05).观察各指标间差异有统计学意义.结论 哮喘清合剂联合小剂量西药可以快速防治小儿支气管哮喘的发作控制病情及各指标改善明显,提高了总有效率.     

二陈汤合三子养亲汤加减治疗小儿哮喘190例疗效观察

目的观察二陈汤合三子养亲汤加减治疗小儿哮喘临床效果。方法280例哮喘患儿随机分为对照组90例和治疗组190例。对照组给予抗生素、抗病毒、平喘、祛痰以及糖皮质激素药物,治疗组在对照组的基础上给予二陈汤合三子养亲汤加减。治疗6d后统计疗效。结果治疗组总有效率97.9%,对照组总有效率94.4%,2组差异有统计意义（P〈0.05）,治疗组疗效优于对照组。结论在运用西药的基础上加用二陈汤合三子养亲汤加减治疗小儿哮喘,能起到利气化痰、治肺定喘、燥湿健脾之功。     

Conventional and sustained-release valproate in children with newly diagnosed epilepsy: a randomized and crossover study comparing clinical effects, patient preference and pharmacokinetics

Objective It has been suggested that sustained-release valproate (VPA) formulations may be more effective and better tolerated than conventional VPA due to better compliance and lower fluctuations in VPA serum concentrations, but comparative trials with conventional VPA in children are scarce. This randomized and crossover trial compared the efficacy (complete control of seizures), the tolerability, and the patient (or parents) preference of conventional VPA twice daily (CVbid) with those of sustained-release chrono VPA twice daily (ChVbid), once daily in the morning (ChVom) or once daily in the evening (ChVoe) in monotherapy.Methods The study was carried out in 48 children (29 girls), aged 5–14 years, with newly diagnosed partial epilepsy (n=26), or idiopathic generalized epilepsy (n=22). The study duration was 16 months (four phases of 4 months each). VPA pharmacokinetics data were also compared in the different regimens. Mean VPA dosage was of approximately 870 mg/day (approximately 22 mg/kg/day) and mean VPA concentration was of approximately 89 mg/l at 12 h post-dose and of 54 mg/l at 24 h post-dose.Results By intention in treatment there were no significant differences in efficacy (73%, 83%, 77% and 75%, respectively) or in adverse reaction frequency (56%, 58%, 67% and 46%, respectively). There were significant differences, however, in patient (or parents) preference, the order being ChVoe (31%) > ChVom (25%) > CVbid (17%) > ChVbid (8%). The mean VPA serum concentration fluctuation between 4 h and 0 h post-morning-dose was nonsignificantly lower after CVbid than after ChVbid. Fluctuation was significantly higher after ChVom than after CVbid or ChVbid. The mean VPA serum concentration difference between 12 h and 24 h post-dose was approximately 40 mg/l.Conclusion Although our results should be confirmed by a larger study, they suggest that the efficacy and tolerability of chrono valproate is similar to that of conventional valproate, and that the main advantage is the once-daily administration.     

天灸疗法佐治儿童支气管哮喘合并过敏性鼻炎42例疗效观察

目的 探讨天灸疗法联合吸入激素治疗轻、中度儿童哮喘合并过敏性鼻炎的临床疗效。方法 将80例轻、中度哮喘合并过敏性鼻炎儿童随机分为治疗组和对照组。对照组雾化吸入布地奈德气雾剂和沙丁胺醇气雾剂，治疗组在此基础上加用天灸疗法。治疗1个疗程后观察两组布地奈德每天吸入总剂量和每天平均剂量减量情况，对两组总有效率和总治愈率进行统计学分析。结果 治疗组在加用天灸疗法后布地奈德吸入量减少幅度与对照组比较，差异有高度统计意义（P〈0．01）；两组总有效率和治愈率比较亦有统计意义（P〈0．05或P〈0.01）。结论 天灸疗法联合布地奈德气雾剂治疗儿童轻、中度哮喘合并过敏性鼻炎，不仅能明显缓解哮喘和鼻炎症状，还可减少糖皮质激素吸入量，取得了满意的疗效且无不良反应。     

中西医结合治疗小儿哮喘急性发作50例临床体会

目的观察中西医结合治疗小儿哮喘的临床疗效。方法将85例小儿支气管哮喘急性发作患儿随机分为中西医结合治疗组（50例）和单纯西药对照组（35例）。对照组予西药治疗，治疗组在对照组的基础上加用加味麻杏石甘汤，10d后统计疗效。结果治疗组总有效率为90％，对照组的总有效率为80％，经统计学处理，2组差异有统计意义（P〈0．05）。结论中西医结合治疗小儿支气管哮喘疗效确切。     

Intra-articular administration of hylan G-F 20 in patients with symptomatic hip osteoarthritis: tolerability and effectiveness in a large cohort study in clinical practice

ABSTRACT

Objective: This prospective, observational, open study aimed to assess the efficacy and safety of hylan G-F 20 in a large cohort of patients with symptomatic hip osteoarthritis (OA), and identify predictors of clinical response.

Research design and methods: Patients presenting with symptomatic hip OA received one 2?mL intra-articular (IA) injection of hylan G-F 20 under ultrasound guidance. Patients were followed-up every 3 months for a total of 12 months and were offered an optional, additional injection at each follow-up visit if symptomatically justified. At each visit, pain scores (100?mm visual analogue scale [VAS]), Lequesne index scores, NSAID intake, and physician and patient global assessments scores were recorded. Adverse events (AEs) were recorded throughout the study.

Main outcome measures; results: 250 patients completed the 12 month follow-up and received a total of 734 injections. Statistically significant reductions in VAS pain scores, Lequesne index scores and NSAID usage were reported at all time-points (?p < 0.05). No systemic, serious or severe side effects were observed. Fifty-two local AEs were reported (7.08% per injection) all of which were mild and transient. One predictor of clinical response was identified, with patients?<?75 years of age reporting better outcomes.

Conclusions: This study supports the safety, tolerability and effectiveness of hylan G-F 20 in the treatment of symptomatic hip OA. Hylan G-F 20 may also offer economic benefits due to a reduction in NSAID usage and the resultant reduction in management costs of NSAID related side-effects. These data reflect those obtained in previous studies of hylan G-F 20 in patients with knee OA.