OBJECTIVES: To assess the effectiveness of influenza vaccine in reducing the occurrence of acute otitis media in infants and children.
SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, LILACS, Web of Science, the WHO International Clinical Trials Registry Platform, and ClinicalTrials.gov (15 February 2017). We also searched the reference lists of included studies to identify any additional trials.
SELECTION CRITERIA: Randomised controlled trials comparing influenza vaccine with placebo or no treatment in infants and children aged younger than six years. We included children of either sex and of any ethnicity, with or without a history of recurrent AOM.
DATA COLLECTION AND ANALYSIS: Two review authors independently screened studies, assessed trial quality, and extracted data. We performed statistical analyses using the random-effects and fixed-effect models and expressed the results as risk ratio (RR), risk difference (RD), and number needed to treat for an additional beneficial outcome (NNTB) for dichotomous outcomes, with 95% confidence intervals (CI).
MAIN RESULTS: We included 11 trials (6 trials in high-income countries and 5 multicentre trials in high-, middle-, and low-income countries) involving 17,123 children aged 6 months to 6 years. Eight trials recruited participants from a healthcare setting. Ten trials (and all four trials that contributed to the primary outcome) declared funding from vaccine manufacturers. Four trials reported adequate allocation concealment, and 10 trials reported adequate blinding of participants and personnel. Attrition was low for eight trials included in the analysis.The primary outcome showed a small reduction in at least one episode of AOM over at least six months of follow-up (4 trials, 3134 children; RR 0.84, 95% CI 0.69 to 1.02; RD -0.04, 95% CI -0.08 to -0.00; NNTB 25, 95% CI 12.5 to 100; low-quality evidence).The subgroup analyses (i.e. number of courses and types of vaccine administered) showed no differences.There was a reduction in the use of antibiotics in vaccinated children (2 trials, 1223 children; RR 0.70, 95% CI 0.59 to 0.83; RD -0.11, 95% CI -0.16 to -0.06; moderate-quality evidence).We were unable to demonstrate whether there was any difference in the utilisation of health care. The use of influenza vaccine resulted in a significant increase in fever (7 trials, 10,615 children; RR 1.15, 95% CI 1.06 to 1.24; RD 0.02, 95% CI 0.00 to 0.04; low-quality evidence), rhinorrhoea (6 trials, 10,563 children; RR 1.17, 95% CI 1.07 to 1.29; RD 0.09, 95% CI 0.01 to 0.16; low-quality evidence), but no difference in pharyngitis. No major adverse events were reported.Differing from the protocol, the original publication of the review included a subgroup analysis of AOM episodes by season, and the secondary outcome 'types of influenza vaccine' was changed to a subgroup analysis. For this update, we removed the subgroup analyses for trial setting, season, and utilisation of health care due to the small number of trials involved. We removed Belshe 2000 from primary and secondary outcomes (courses of vaccine and types of vaccine) because it reported episodes of AOM per person. We did not perform a subgroup analysis by type of adverse event. We have reported each type of adverse event as a separate analysis.
AUTHORS' CONCLUSIONS: Influenza vaccine results in a small reduction in AOM. The observed reduction in the use of antibiotics needs to be considered in light of current recommended practices aimed at avoiding antibiotic overuse. Safety data from these trials were limited. The benefits may not justify the use of influenza vaccine without taking into account the vaccine efficacy in reducing influenza and safety data. We judged the quality of the evidence to be low to moderate. Additional research is needed.
MATERIALS AND METHODS: This is a retrospective cross-sectional study which was carried out at department of O&G, Putrajaya Hospital. A total of 120 cases of ovarian mass in pregnancy between Jan 2000-December 2014 were evaluated. 115 patients had undergone laparoscopy cystectomy/salpingo-oophorectomy. Women's age, parity, gestational age, surgical technique, operative findings and time, estimated blood loss, postoperative hospital stay, post operative pain score, usage of analgesia, complications of surgery, outcome of the pregnancy and histopathology reports were evaluated.
MEASUREMENT AND MAIN RESULTS: Outcome of the pregnancy and post operative pain score and usage of analgesic were evaluated. The mean gestational week at the time of surgery was 14 weeks 1 day (±2 weeks 1 day). The duration of surgery was 87.4 mins (±34.8 mins) with average blood loss of 110.3 ml (±32.0). Median size of ovarian cyst was 6 cm (IQR 2 cm). 2 cases converted to laparotomy. Only 2 cases were reported with second trimester loss which was diagnosed after 4 weeks and 10 weeks respectively. 5 women received tocolytic agent post operatively, all of them delivered at term.The mean length of hospitalization was 1.51 day (±0.597). The average gestational age of delivery was 37.78 (±3.42) mean birth weight 2.97 kg (±0.65 kg). There was one intrauterine growth restriction baby with birth weight of 1.89 kg at 35 weeks of gestation and another baby with bladder exstrophy with ambiguous genitalia which was not related to surgery. The mean of pain score was 1.5 (±1.6) over 10. 87.9% of the women had mild pain which only 64.6% require paracetamol or no analgesia.
CONCLUSION: Majority of women with ovarian masses in pregnancy can be treated with ensured safety and reduced morbidity using the endoscopic approach.
METHODS: This research aims to compare evaluation practice on biosimilar and novel BTPs at the Biological Product Registration Section in Malaysia. Evaluation activities were studied in terms of evaluation questions, evaluation timeline, nonclinical and clinical requirements, and local requirements on product label (including package insert). Six biosimilar product dossiers and 6 novel BTP dossiers evaluated in 2013-2015 were sampled. Parameters for comparison were determined and analyzed using data collection forms. Specific to the biosimilar products, the evaluation practice on labels and package inserts were dissected and described in a qualitative arm of this research.
RESULTS: Generally, the registration requirements of novel BTPs and biosimilar products are in agreement with international regulatory practices. However, some labeling and package insert requirements, and registration conditions are unique to the Malaysian regulatory context.
CONCLUSIONS: Study findings revealed some similarities and differences in current evaluation practice (timeline and requirements) for biosimilar versus novel BTPs. The findings of this research also provide an insight on current evaluation practice on biosimilar product labeling.