Treatment of adult varicella with oral acyclovir. A randomized, placebo-controlled trial.

OBJECTIVE: To assess the efficacy of oral acyclovir in treating adults with varicella and to describe the natural history of adult varicella. DESIGN: Double-blind, placebo-controlled randomized trial. SETTING: A naval hospital. PATIENTS: One hundred forty-eight of 206 consecutive adult active duty Navy and Marine Corps personnel who were hospitalized for isolation and inpatient therapy of varicella and who could be treated within 72 hours of rash onset completed the study. The diagnosis of varicella was confirmed by acute and convalescent serology in 143 of 144 patients with available paired sera. INTERVENTION: Patients were randomly assigned to receive either acyclovir, 800 mg orally five times per day for 7 days, or an identical placebo. Separate randomization codes were used for patients presenting within 24 hours of rash onset and for those presenting 25 to 72 hours after rash onset. MEASUREMENTS: Daily lesion counts, symptom scores, temperature measurements, and laboratory tests were used to monitor the course of the illness. RESULTS: Early treatment (initiated within 24 hours of rash onset) reduced the total time to (100%) crusting from 7.4 to 5.6 days (P = 0.001) and reduced the maximum number of lesions by 46% (P = 0.04). Duration of fever and severity of symptoms were also reduced by early therapy. Late therapy (25 to 72 hours after rash onset) had no effect on the course of illness. Only four patients had pneumonia, and no encephalitis or mortality was noted. CONCLUSIONS: Early therapy with oral acyclovir decreases the time to cutaneous healing of adult varicella, decreases the duration of fever, and lessens symptoms. Initiation of therapy after the first day of illness is of no value in uncomplicated cases of adult varicella. The low frequency of serious complications of varicella (pneumonia, encephalitis, or death) precluded any evaluation of the possible effect of acyclovir on these outcomes.     

A randomized, double-blind study comparing 5 days oral gemifloxacin with 7 days oral levofloxacin in patients with acute exacerbation of chronic bronchitis

OBJECTIVE: To demonstrate that 5 days of treatment with a new fluoroquinolone, gemifloxacin, is at least as effective as 7 days of treatment with levofloxacin in adult patients with acute exacerbation of chronic bronchitis (AECB). DESIGN: Randomized, double-blind, double dummy, multicentre, parallel group study SETTING: Sixty different medical centers in US, UK and Germany. MATERIAL AND METHODS: A total of 360 adults (>40 years of age) with AECB were randomly assigned to receive gemifloxacin 320 mg once daily for 5 days or levofloxacin 500mg once daily for 7 days. The primary efficacy parameter was a clinical response at follow-up (Days 14-21). RESULTS: In total, 335/360 patients completed the study (93.1%). Seven patients receiving gemifloxacin withdrew from the study compared to 18 patients receiving levofloxacin; this difference was statistically significant (Fisher's exact test: p=0.02). In the intent-to-treat (ITT) population, the clinical success rate at follow-up (Days 14-21) was 85.2% (155/182) with gemifloxacin and 78.1% (139/178) with levofloxacin. Clinical success rate in the per-protocol (PP) population was 88.2% (134/152) with gemifloxacin and 85.1% (126/148) with levofloxacin. At long-term follow-up (Days 28-35), the clinical success rates in the PP population were 83.7% (123/147) with gemifloxacin and 78.4% (109/139) with levofloxacin. The difference in success rates was 5.26% (95% CI: -3.83, 14.34). CONCLUSION: The clinical efficacy of gemifloxacin 320 mg once daily for 5 days in AECB was at least as good as levofloxacin 500 mg once daily for 7 days. Fewer withdrawals and superior clinical efficacy at long-term follow-up were also seen with gemifloxacin.     

Efficacy of nebulized fluticasone propionate compared with oral prednisolone in children with an acute exacerbation of asthma

The aim of the present study was to investigate the efficacy and safety of nebulized fluticasone propionate (FP Nebules) compared with oral soluble prednisolone in children with an acute exacerbation of asthma. The study used an international, multi-centre, randomized, double-blind, parallel group design. Three hundred and twenty-one patients, aged 4-16 years old, who presented with an acute exacerbation of asthma, were randomly allocated to either nebulized FP (1 mg b.d.) or oral prednisolone (2 mg kg(-1) day(-1) for 4 days then 1 mg kg(-1) day(-1) for 3 days) for 7 days. Patients in the FP group showed a significantly greater increase in diary card morning peak expiratory flow (PEF) over 7 days compared with patients in the prednisolone group (difference = 9.51 min(-1), CI = 2.1, 16.8, P = 0.034). Similar increases for both treatments were shown for evening PEF. Clinic PEF improved with both treatments, but was significantly greater in patients taking FP after 7 days (difference = 11.41 min(-1), CI = 2.8, 20.0, P = 0.029). Both treatments reduced symptom scores to a similar extent. The two treatments were well tolerated, and there was no difference in the incidence of adverse events. The present study demonstrated that nebulized FP is at least as effective as oral prednisolone in the treatment of children presenting with an acute exacerbation of asthma.     

Randomized, placebo-controlled clinical trial of oral azithromycin prophylaxis against respiratory infections in a high-risk, young adult population.

Military Special Forces trainees undergo intense psychological and physical stressors that often lead to respiratory infection. During 1998-2000, 477 Navy Special Forces trainees were enrolled in a double-blind trial of oral azithromycin (1 g given weekly) plus a placebo injection, compared with benzathine penicillin G (1.2 million U) plus azithromycin placebo tablets. Among the 464 subjects with complete data, 44 developed acute respiratory infection (20 with pneumonia) during the 2 weeks of most intense training; of these subjects, 12 (27.3%) had evidence of Chlamydia pneumoniae infection and 7 (15.9%) had evidence of Mycoplasma pneumoniae infection. Trainees who received azithromycin were less likely than were trainees who received benzathine penicillin G to develop acute respiratory infection (risk ratio, 0.50; 95% confidence interval [CI], 0.28-0.92) and less likely at the end of training to report episodes of breathing difficulty (odds ratio [OR], 0.59; 95% CI, 0.34-1.01) or sore throat (OR, 0.66; 95% CI, 0.41-1.05). Compared with benzathine penicillin G prophylaxis, weekly oral azithromycin was superior in preventing respiratory infection in this population at transient high risk.     

Prospective randomized trial comparing oxygen administration during nasal flexible bronchoscopy : oral vs nasal delivery.

STUDY OBJECTIVES: To determine the optimal method of delivering supplemental oxygen during flexible bronchoscopy (FB). DESIGN: Prospective study. SETTING: University medical center. PATIENTS: Ninety-seven consecutive patients undergoing outpatient nasal FB during a 7-month period. INTERVENTION: During FB, delivery of oxygen was alternated weekly and administered by nasal cannula either nasally (52 patients) or orally (45 patients). Prior to the procedure, patients completed a questionnaire regarding oral or nasal breathing preferences, history of sinus disease, allergy history, and perceived degree of nasal congestion. RESULTS: Comparison of oxygen delivery groups demonstrated no significant difference in oxygen requirements (4.1 L/min nasal vs 3.8 L/min oral, p = 0.63), overall saturation nadir (90.9% nasal vs 91.4% oral, p = 0.85), or average saturation (95.8% nasal vs 95.7% oral, p = 0.57). No correlation between subjective symptoms or sinus or allergy history was found for oxygen requirements, average saturation, or saturation nadir. CONCLUSIONS: These data suggest that during nasal FB, no discernible difference exists between administration of oxygen using cannulas placed either nasally or orally.     

HPA-axis effects of nebulised fluticasone propionate compared with oral prednisolone in childhood asthma

The aim of this study was to compare the effect of 7 days nebulised fluticasone propionate (FP) with oral prednisolone on 24-h urinary-free cortisol excretion, systemic exposure and safety. This was a randomised, double-blind, double-dummy, two-way crossover study. Thirty-one children (19 male, 12 female, mean age 8 years) with stable asthma were randomly assigned to 7 days treatment with either FP Nebules (2 x 0.5 mg/2 ml bd) or prednisolone tablets once daily (2 mg/kg/day for 4 days [maximum 40 mg] followed by 1 mg/kg/day or half the original dose for 3 days [maximum 20 mg]). After a 2-4 week washout period, patients received the second treatment for 7 days, followed by a 2-week follow-up visit. The primary outcome measure was 24-h urinary-free cortisol concentrations corrected for creatinine. Nebulised FP (1 mg bd) had significantly less effect on 24-h urinary-free cortisol excretion than oral prednisolone (8.9 ng/ml for FP and 5.0 ng/ml for prednisolone, P = 0.001). Systemic exposure to FP was also low. In conclusion, FP Nebules had significantly less effect on hypothalamic-pituitary-adrenal axis function than oral prednisolone in asthmatic children when used at doses recommended for the treatment of an acute exacerbation of asthma.     

Response of the jejunal mucosa in adult coeliac disease to oral prednisolone

Five patients with adult coeliac disease were treated with prednisolone for four to five weeks while continuing a normal gluten-containing diet. A prompt histological, ultrastructural and enzymic recovery of the jejunal mucosa in all five was accompanied by an incomplete metabolic response in three of four patients tested. These findings are discussed in relation to the possible immunological pathogenesis of coeliac disease.     

A short course of prednisolone in chronic type B hepatitis. Report of a randomized, double-blind, placebo-controlled trial

Fifteen patients with chronic type B hepatitis were treated with corticosteroids in a randomized, double-blind, placebo-controlled trial lasting 28 days. Ten patients received prednisolone, 60 mg/d for 2 weeks, then 30 mg/d for another 2 weeks; 5 patients received placebo. Serum aminotransferase levels decreased significantly during prednisolone therapy but 4 to 10 weeks after abrupt withdrawal of the drug, they rebounded to levels greater than those before treatment. This exacerbation of disease lasted for several months and was prolonged and symptomatic in 3 patients. Hepatitis B virus levels did not change substantially during treatment. Follow-up examinations showed no improvement in biochemical or serologic features of the disease in any of the 15 patients; follow-up liver biopsies showed a worsening in 4 of 7 treated patients but in 0 of 5 control patients. Thus, a 28-day course of prednisolone produced no beneficial effects in patients with mild-to-moderate chronic type B hepatitis; on the contrary, such treatment may be harmful.     

IL-5、IL-10及FENO三种炎性标记物诊断成人支气管哮喘的临床价值

目的探讨IL-5、IL-10及FENO三种炎性标记物在诊断成人支气管哮喘中的作用及价值,为临床工作提供参考及指导。方法选取2014年10月-2015年12月期间经我院收治的106例成人支气管哮喘患者作为病例组,同时选取同期来我院进行体检的106例健康人群作为对照组,应用酶联免疫吸附法(ELISA)对所有研究对象的血清IL-5、IL-10浓度进行测定,应用FENO测试仪测定其呼出气FENO浓度,比较支气管哮喘组及正常对照组之间的IL-5、IL-10及FENO水平,明确IL-5、IL-10及FENO三种炎性标记物在成人支气管哮喘诊断中的价值。结果病例组及对照组间的IL-5、IL-10及FENO水平存在差异,两组的血清IL-5浓度分别为(23.65±13.86)pg/m L和(11.65±2.79)pg/m L;两组的IL-10浓度分别为(19.78±14.25)pg/m L和(39.21±12.18)pg/m L;两组的FENO水平分别为(63.18±31.62)ug/L和(26.74±18.51)ug/L,两组间差异具有统计学意义(P0.05)。结论 IL-5、IL-10及FENO水平是成人支气管哮喘患者诊断过程中的重要参考指标,对其进行联合检测有利于成人支气管哮喘的早期诊断、预防及个体化治疗的开展。     

Oral vs repository corticosteroid therapy in acute asthma

Acutely ill asthmatic patients treated in the usual fashion in an emergency room setting and discharged within six hours were studied to determine whether therapy with a single injection of a repository corticosteroid (methylprednisolone sodium acetate) could be as effective as a tapering course of oral corticosteroids in decreasing asthma symptomatology and relapse within seven days. Seventeen patients (18 episodes of asthma) formed the study population. Eight episodes occurred in patients who received depot methylprednisolone (group 1) and ten episodes in patients who received oral corticosteroid treatment (group 2). All patients in both groups improved following emergency room treatment. Relapse occurred in two of ten patients in group 2 and none in group 1. Symptoms attributable to asthma recurred in significantly more patients in group 2 than in group 1 (9 vs 0, p less than .01). Side effects from therapy with corticosteroids were rare. This study indicates that intramuscular repository corticosteroids are at least as effective as oral corticosteroids in the management of the acute asthmatic outpatient, with a distinct advantage with regard to patient compliance.     

Influenza vaccination in children with asthma: randomized double-blind placebo-controlled trial

There is little evidence that influenza vaccination reduces asthma exacerbations. We determined whether influenza vaccination is more effective than placebo in 6-18-year-old children with asthma. We performed a randomized, double-blind, placebo-controlled trial. Parenteral vaccination with inactivated influenza vaccine or placebo took place approximately November 1, and children were followed until April 1 of the next year. Airway symptoms were reported in a diary. When symptom scores reached a predefined level, a pharyngeal swab was taken. Primary outcome was the number of asthma exacerbations associated with virologically proven influenza infection. Three hundred forty-nine children were assigned placebo, and 347 were assigned vaccine. Pharyngeal swabs positive for influenza were related to 42 asthma exacerbations, 24 in the vaccine group and 18 in the placebo group, a difference of 33% favoring placebo (31% after adjustment for confounders; 95% confidence interval, -34% to 161%). Influenza-related asthma exacerbations were of similar severity in both groups; they lasted 3.1 days shorter in the vaccine group (95% confidence interval, -6.2 to 0.002 days, p = 0.06). We conclude that influenza vaccination did not result in a significant reduction of the number, severity, or duration of asthma exacerbations caused by influenza. Additional studies are warranted to justify routine influenza vaccination of children with asthma.     

Continuous vs intermittent beta-agonists in the treatment of acute adult asthma: a systematic review with meta-analysis

BACKGROUND: Since the late 1980s, there has been considerable clinical and academic interest in the use of continuous aerosolized bronchodilators for the treatment of patients with acute asthma. These studies have suggested that this therapy is safe, is at least as effective as intermittent nebulization, and may be superior to intermittent nebulization in patients with the most severely impaired pulmonary function. OBJECTIVES: To determine whether continuous nebulization offered an advantage over intermittent nebulization for the treatment of adults with acute asthma in the emergency department (ED). DESIGN: Systematic review of randomized controlled trials of adults with acute asthma. OUTCOMES: Change in pulmonary function tests as primary outcome, and admissions to the hospital and side effects as secondary outcomes. RESULTS: Six studies including 393 adults with acute asthma were selected. No significant differences were demonstrated between the two delivery methods in terms of pulmonary function measures obtained after 1 h of treatment (standardized mean difference [SMD], -0.15; 95% confidence interval [CI], -0.35 to 0.05) and after 2 to 3 h of treatment (SMD, -0.19; 95% CI, -0.39 to 0.01). No significant heterogeneity was demonstrated (p > 0.5). At the end of treatment, there was a significantly greater decrease in pulse rate when the continuous nebulizer was used (weighted mean difference [WMD], -6.82; 95% CI, -8.67 to -3.90 beats/min; chi(2), 2.55; degrees of freedom [df], 4; p = 0.6). Additionally, the analysis showed a significant decrease of serum potassium concentration with the use of intermittent nebulization (WMD, 0.12; 95% CI, 0.24 to 0.01 mmol/L; chi(2), 0.5; df, 2; p = 0.8). However, this finding was obtained on the analysis of only two trials. Finally, at the end of the study period, no significant differences were identified between patients treated with continuous or intermittent nebulization with respect to hospital admission (relative risk, 0.68; 95% CI, 0.33 to 1.38; chi(2), 2.06; df, 1; p = 0.2). CONCLUSIONS: Overall, this review supports the equivalence of continuous and intermittent albuterol nebulization in the treatment of acute adult asthma.