Prospective placebo-controlled double-blind study using a bacterial lysate in infections of the respiratory tract and ENT region in children

94 children suffering from frequent infections of the respiratory tract and of the ear, nose and throat were treated under double-blind conditions with either a bacterial lysate (n = 45) or a placebo (n = 49). During the 6 months of the trial both treatments brought about a significant decrease in the incidence and duration of these infections as well as in the duration of concomitant antibiotherapy in comparison to the corresponding prior 6-month reference period. As these positive results recorded under the bacterial lysate and the placebo could not be differentiated statistically, the influence of meteorological and epidemiological factors as well as of the age of the children is discussed.     

A prospective, double-blind, placebo-controlled trial of iv immunoglobulin and trimethoprim-sulfamethoxazole in children with recurrent respiratory tract infections

In a prospective, double-blind, placebo-controlled study of iv immunoglobulin (IVIG) and trimethoprim-sulfamethoxazole (TMS), 130 children less than 8 years of age were referred for recurrent bacterial respiratory tract infections, as judged by the referring physician. Of the 130 children referred, only 24 continued to have bacterial respiratory infections over a 4-month observation period. They were randomized and 23/24 treated for 4 months during the winter-spring season. The 7 children given placebo for both IVIG and TMS continued to have bacterial respiratory infections, while 14 of 16 children given active therapy with either IVIG or TMS became infection-free ( p = 0.002). No relation to IgG subclass level or between the two modalities of treatment was found. We conclude that most infection-prone children suffer from viral infections and are given antibiotics unnecessarily. Of the small group of children that have documented, repeated bacterial infections, prophylactic therapy with either IVIG or TMS can substantially diminish the number of infections. Children, IgG subclasses, iv, immunoglobulins, recurrent respiratory tract infections, trimethoprim-sulfamethoxazole     

维生素A在小儿呼吸道感染性疾病中的应用

维生素A作为一种最早被认识并应用于临床的维生素 ,有维持上皮完整性、提高机体免疫力及抗感染的作用 ,被称为“抗感染维生素”而用于防治小儿呼吸道感染性疾病。但是它的缺乏与感染之间的关系及其抗感染的机制尚没有统一的结论。该文就维生素A与呼吸道感染性疾病的相关性及其在呼吸道感染性疾病中的应用综述如下。     

The effect of vitamin C on upper respiratory infections in adolescent swimmers: a randomized trial

The risk of upper respiratory infections (URIs) is increased in people who are under heavy physical stress, including recreational and competitive swimmers. Additional treatment options are needed, especially in the younger age group. The aim of this study was to determine whether 1 g/day vitamin C supplementation affects the rate, length, or severity of URIs in adolescent swimmers. We carried out a randomized, double-blind, placebo-controlled trial during three winter months, among 39 competitive young swimmers (mean age 13.8 ± 1.6 years) in Jerusalem, Israel. Vitamin C had no effect on the incidence of URIs (rate ratio = 1.01; 95% confidence interval (CI) = 0.70–1.46). The duration of respiratory infections was 22% shorter in vitamin C group, but the difference was not statistically significant. However, we found a significant interaction between vitamin C effect and sex, so that vitamin C shortened the duration of infections in male swimmers by 47% (95% CI: −80% to −14%), but had no effect on female swimmers (difference in duration: +17%; 95% CI: −38% to +71%). The effect of vitamin C on the severity of URIs was also different between male and female swimmers, so that vitamin C was beneficial for males, but not for females. Our study indicates that vitamin C does not affect the rate of respiratory infections in competitive swimmers. Nevertheless, we found that vitamin C decreased the duration and severity of respiratory infections in male swimmers, but not in females. This finding warrants further research.     

Clinical and immunologic effects of sublingual immunotherapy in asthmatic children sensitized to mites: a double-blind, randomized, placebo-controlled study

Immunotherapy through oral routes is thought to be a valuable therapeutic option for asthma. The clinical and immunologic effects of sublingual immunotherapy (SLIT) in children with asthma caused by mites were evaluated in a double-blind, placebo-controlled study for 6 months. Patients (aged 6-12 yr) with mild-to-moderate asthma, with single sensitization to mite allergen, received either SLIT or placebo with a standardized Dermatophagoides pteronyssinus (D.p.)/D. farinae (D.f.) 50/50 extract. The cumulative dose was around 41824 IR, equivalent to 1.7 mg of D.p. and 3.0 mg of D.f. allergen. Symptom and medication scores were assessed throughout the study. Serum total immunoglobulin (Ig)E, eosinophil count, eosinophil cationic protein, specific IgE, specific IgG4, and skin sensitivity were evaluated before starting the treatment and after the treatment period. Twenty patients completed the study. At the beginning of the treatment, no differences were observed between the groups for symptom and medication scores, skin sensitivity, or immunologic parameters. After 6 months of treatment, there was a significant difference in nighttime asthma symptom scores and specific IgG4 (p < 0.05) in the SLIT group compared with the placebo group. Daytime symptom and medication scores, total IgE, eosinophil count, forced expiratory volume in 1 s, and mean evening peak expiratory flow rate reached significant differences in the SLIT group during the treatment period (p < 0.05). No severe adverse effects were reported. Our results revealed that treatment for 6 months with SLIT is clinically effective in decreasing asthmatic symptoms and medication use in children with mild-to-moderate asthma because of mite sensitivity. The clinical usefulness of this form of immunotherapy and the mechanism underlying its immunologic effects deserve further studies.     

人鼻病毒C型在呼吸道感染住院患儿中的流行病学研究

目的 了解苏州地区人鼻病毒C型 （HRV-C）在呼吸道感染 （RTIs）住院患儿中的检出情况、流行特点及临床特征。方法 选取2014年1~12月RTIs住院患儿1702例为研究对象,采集所有患儿鼻咽深部吸取物1702份。采用RT-PCR法检测HRVmRNA;实时荧光定量PCR+高分辨熔链曲线分析对HRV-C进行检测。结果 1702例RTIs患儿中,检出HRV感染244例 （14.34%）,其中HRV-C型69例 （69/244,28.3%）。HRV-C混合感染率为61% （42/69）。HRV-C在每个月份均有检出,其中秋季阳性检出率显著高于春、夏、冬三季 （P < 0.05）;2~5岁患儿HRV-C检出率显著高于其他年龄组 （P < 0.05）。HRV-C感染致大叶性肺炎和哮喘急性发作的比例显著高于HRV-A/B感染 （P < 0.05）;HRV-C感染所致中性粒细胞、CRP升高比例显著高于HRV-A/B感染 （P < 0.05）,但在性别分布和其他临床表现上差异均无统计学意义 （P > 0.05）。结论 HRV-C感染约占HRV感染的1/3,秋季高发,混合感染率高,以2~5岁患儿检出率最高,HRV-C感染患儿的临床表现基本与HRV-A/B感染患儿相似。     

Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial

Background

Several uncontrolled studies of hyperbaric treatment in children with autism have reported clinical improvements; however, this treatment has not been evaluated to date with a controlled study. We performed a multicenter, randomized, double-blind, controlled trial to assess the efficacy of hyperbaric treatment in children with autism.

Methods

62 children with autism recruited from 6 centers, ages 2–7 years (mean 4.92 ± 1.21), were randomly assigned to 40 hourly treatments of either hyperbaric treatment at 1.3 atmosphere (atm) and 24% oxygen ("treatment group", n = 33) or slightly pressurized room air at 1.03 atm and 21% oxygen ("control group", n = 29). Outcome measures included Clinical Global Impression (CGI) scale, Aberrant Behavior Checklist (ABC), and Autism Treatment Evaluation Checklist (ATEC).

Results

After 40 sessions, mean physician CGI scores significantly improved in the treatment group compared to controls in overall functioning (p = 0.0008), receptive language (p < 0.0001), social interaction (p = 0.0473), and eye contact (p = 0.0102); 9/30 children (30%) in the treatment group were rated as "very much improved" or "much improved" compared to 2/26 (8%) of controls (p = 0.0471); 24/30 (80%) in the treatment group improved compared to 10/26 (38%) of controls (p = 0.0024). Mean parental CGI scores significantly improved in the treatment group compared to controls in overall functioning (p = 0.0336), receptive language (p = 0.0168), and eye contact (p = 0.0322). On the ABC, significant improvements were observed in the treatment group in total score, irritability, stereotypy, hyperactivity, and speech (p < 0.03 for each), but not in the control group. In the treatment group compared to the control group, mean changes on the ABC total score and subscales were similar except a greater number of children improved in irritability (p = 0.0311). On the ATEC, sensory/cognitive awareness significantly improved (p = 0.0367) in the treatment group compared to the control group. Post-hoc analysis indicated that children over age 5 and children with lower initial autism severity had the most robust improvements. Hyperbaric treatment was safe and well-tolerated.

Conclusion

Children with autism who received hyperbaric treatment at 1.3 atm and 24% oxygen for 40 hourly sessions had significant improvements in overall functioning, receptive language, social interaction, eye contact, and sensory/cognitive awareness compared to children who received slightly pressurized room air.

Trial Registration

clinicaltrials.gov NCT00335790     

Efficacy and safety of fluticasone propionate hydrofluoroalkane inhalation aerosol in pre-school-age children with asthma: a randomized, double-blind, placebo-controlled study

OBJECTIVE: To evaluate the efficacy and tolerability of fluticasone propionate (FP) hydrofluoroalkane (HFA) in children age 1 to < 4 years with asthma. STUDY DESIGN: Children were assigned (2:1) to receive FP HFA 88 mug (n = 239) or placebo HFA (n = 120) twice daily through a metered-dose inhaler with a valved holding chamber and attached facemask for 12 weeks. The primary efficacy measure was mean percent change from baseline to endpoint in 24-hour daily (composite of daytime and nighttime) asthma symptom scores. RESULTS: The FP-treated children had significantly greater (P < or = .05) reductions in 24-hour daily asthma symptom scores (-53.9% vs -44.1%) and nighttime symptom scores over the entire treatment period compared with the placebo group. Daytime asthma symptom scores and albuterol use were slightly more decreased with FP than with placebo; however, the differences were not statistically significant. Increases in the percentage of symptom-free days were comparable. The percentage of patients who experienced at least 1 adverse event was similar in the 2 groups. Baseline median urinary cortisol excretion values were comparable between the groups, and there was little change from baseline at endpoint. FP plasma concentrations demonstrated that systemic exposure was low. CONCLUSIONS: FP HFA 88 mug twice daily was effective and well tolerated in pre-school-age children with asthma.     

Assessing the effect of docosahexaenoic acid on cognitive functions in healthy, preschool children: a randomized, placebo-controlled, double-blind study

The utility of multicenter cognitive test methodology and resultant outcomes of supplementation with docosahexaenoic acid in healthy 4-year-old children was evaluated in a randomized, placebo-controlled, double-blind study. Subjects received 400-mg/d docosahexaenoic acid (n = 85) or matching placebo (n = 90) in capsules for 4 months. Cognitive tests included the Leiter-R Test of Sustained Attention, Peabody Picture Vocabulary Test, Day-Night Stroop Test, and Conners' Kiddie Continuous Performance Test. The relationship of docosahexaenoic acid levels in capillary whole blood from a subsample (n = 93) with scores on cognitive tests was evaluated. For each test, results indicated that changes from baseline to end of treatment were not statistically significantly different between the docosahexaenoic acid group and the placebo group. Regression analysis, however, yielded a statistically significant positive (P = .018) association between the blood level of docosahexaenoic acid and higher scores on the Peabody Picture Vocabulary Test, a test of listening comprehension and vocabulary acquisition.     

孟鲁司特钠单用于轻度持续哮喘患儿疗效和安全性的随机双盲安慰剂对照试验

目的：研究孟鲁司特钠单用于治疗5~14岁轻度持续哮喘患儿的疗效和安全性。方法：采用安慰剂随机双盲对照试验,对首诊诊断为轻度持续哮喘患儿,采用调查问卷方式采集患儿基线数据,经过2周安慰剂洗脱期,随机分为治疗组和对照组,分别睡前咀嚼口服孟鲁司特钠或安慰剂5 mg·d-1,疗程均为12周。在入组后4、8和12周记录哮喘日记卡内容：日间和夜间哮喘症状评分、β2受体激动剂使用频率、最大呼气峰流速（PEF）、因哮喘急性发作而需急诊或住院治疗的次数等;于治疗后12周检测肺功能指标：FEV1%预计值、FEF25%~75%。结果：2009年9月至2010年9月上海交通大学附属第一人民医院儿科哮喘专科门诊的轻度持续哮喘患儿安慰剂组纳入42例,孟鲁司特钠组纳入89例,至观察终点安慰剂组35例,孟鲁司特钠组77例进入分析。与安慰剂组相比,孟鲁司特钠组的PEF明显改善（P<0.05）;每周日间和夜间哮喘症状平均评分、每月因哮喘发作而需急诊或住院就诊率和每周平均β2受体激动剂使用次数均下降,差异有显著统计学意义（P<0.01）;治疗后12周孟鲁司特钠组FEV1%、FEF25%~75%较安慰剂组显著提高（P<0.05）;研究期间两组患儿均未观察到不良反应事件。结论：孟鲁司特钠单独用于轻度持续性哮喘患儿具有良好的疗效,不良反应少,患儿依从性高。