Significant microbiological effect of inhaled tobramycin in young children with cystic fibrosis

We conducted a double-blind, placebo-controlled, multicenter, randomized trial to test the hypothesis that 300 mg of tobramycin solution for inhalation administered twice daily for 28 days would be safe and result in a profound decrease in Pseudomonas aeruginosa (Pa) density from the lower airway of young children with cystic fibrosis. Ninety-eight subjects were to be randomized; however, the trial was stopped early because of evidence of a significant microbiological treatment effect. Twenty-one children under age 6 years were randomized (8 active; 13 placebo) and underwent bronchoalveolar lavage at baseline and on Day 28. There was a significant difference between treatment groups in the reduction in Pa density; no Pa was detected on Day 28 in 8 of 8 active group patients compared with 1 of 13 placebo group patients. We observed no differences between treatment groups for clinical indices, markers of inflammation, or incidence of adverse events. No abnormalities in serum creatinine or audiometry and no episodes of significant bronchospasm were observed in association with active treatment. We conclude that 28 days of tobramycin solution for inhalation of 300 mg twice daily is safe and effective for significant reduction of lower airway Pa density in young children with cystic fibrosis.     

Systematic overview of quality of life studies for breast cancer

BACKGROUND: The concept of quality of life (QOL) is essentially subjective, determined from the patient's point of view. Thus, an appropriate investigation and analysis of QOL as an indicator of medical treatment outcome is a task of some difficulty. The physician-led QOL assessment studies to date in Japan have suffered from insufficient knowledge and understanding of the diverse factors contributing to QOL, thereby contributing to a dearth of quality studies. Given this background, the Japanese Breast Cancer Society has established a Task Force for the development of guidelines to properly conduct QOL assessment studies. The present article reports the results of a large-scale systematic overview of QOL assessment studies for breast cancer patients that was undertaken as one part of this project. METHODS: Six databases were used in this overview: MEDLINE, CINAHL, CANCERLIT, EMBASE, PsychINFO, and Japan Centra Revuo Medicina. The search period was 1982-1999 for CINAHL, and 1990-1999 for the others. Following a check of the titles, important information was recorded on relevance and data collection forms. RESULTS: A systematic search was conducted of the literature on QOL assessment studies for breast cancer patients, and 1,954 articles were extracted from a check of titles. Using the relevance and data collection forms, the number of articles was further narrowed to 126. These articles were then classified according to the type and design of the study, the number of QOL and psychological measures used, frequency of use of each measure, and study focus and type of intervention. The results were then compiled. CONCLUSION: To date there have been almost no appropriate systematic overviews or guidelines issued for QOL assessment studies related to breast cancer, even on the international level. The results of the present study may contribute high-quality QOL information for evidence-based medicine, as it continues to gain global prevalence.     

中医疗效系统评价体系的研究

临床疗效是中医药学生存和发展的基础,建立中医临床疗效系统评价体系,对于科学、客观、系统地开展中医临床疗效的评价具有重要意义。本文研究并探讨了建立中医临床疗效系统评价体系所需达到的目标和发展思路,提出了建立该系统的重点任务及关键技术。     

情志疾病的中医药防治研究与养生保健理论与方法的研究——中医现代化临床研究(二)

本文针对现代生活对人们健康危害严重的情志疾病，指出应该发掘中医对情志致病的发病机理，探索情志的伤脏规律，从而建立科学的中医学防治情志疾病的疗效评价方法。和有效的防治药物及方案；同时以老年人和更年期妇女两大人群为重点研究对象，研究了养生保健方法在解决老龄化相关疾病，亚健康状态所要达到的目标和发展思路，本文对此列出了与之对应的相关重点任务和关键技术。     

Magnesium sulphate in the treatment of eclampsia and pre-eclampsia: an overview of the evidence from randomised trials

Objective To evaluate the effectiveness of magnesium sulphate in the treatment of eclampsia and pre-eclampsia by a systematic quantitative overview of controlled clinical trials.
Design Online searching of the MEDLINE database between 1966 and 1995, and scanning of the bibliography of known primary studies and review articles on the use of magnesium sulphate in eclampsia and pre-eclampsia. Study selection, study quality assessment and data extraction were performed independently by two reviewers under masked conditions. Where possible outcome data from trials were pooled and summarised using the Mantel-Haenszel method.
Participants One thousand seven hundred and forty-three women with eclampsia and 2390 with pre-eclampsia included in nine randomised trials that evaluated the effects of magnesium sulphate.
Main outcome measures Seizure activity and maternal death.
Results In eclampsia, recurrence of seizures was less common with magnesium sulphate therapy compared with phenytoin (odds ratio [OR] 0.27, 95% CI 0.17.0.45,   P = 0.00  ) and diazepam (OR 0–41, 95% CI 0.30–0.57,   P = 0.00  ). As indicated by the point estimate, there was a trend towards a reduction in maternal mortality with magnesium sulphate in eclampsia (OR 0.51,95% CI 0.24–1.07,   P = 0.10  versus phenytoin; OR 0.78, 95% CI 0.41–1.45,   P = 0.52  versus diazepam). When used for seizure prophylaxis in pre-eclampsia, magnesium sulphate was found to be more effective than phenytoin (OR 0.15, 95% CI 0.03–0.72,   P = 0.01  ).
Conclusion Magnesium sulphate is a superior drug in preventing the recurrence of seizures in eclampsia and in seizure prophylaxis in pre-eclampsia.     

Antenatal screening for cystic fibrosis

Objective To assess the practicality of implementing antenatal screening for cystic fibrosis in Yorkshire.
Design Prospective study in which all pregnant women were offered testing for the AF508 mutation which accounts for about 85 % of carriers in Yorkshire. The reproductive partners of those found to be cystic fibrosis carriers were then tested and any carrier referred for genetic counselling.
Setting Antenatal clinics in two hospitals and eight general practices.
Population Six thousand and seventy-one pregnant women.
Results A total of 3773 women (62 %) accepted the screening offer. This was a lower uptake rate than in other published UK studies: Aberdeen (85–91%), Manchester (85%), Edinburgh (76–84%) and Oxford (67%). Nonetheless there were large and statistically significant differences in the uptake rate between centres within the study: 78% and 60% for the two hospitals and 67% for the general practices. One hundred and thirty women (3.4%) were found to be carriers and three carrier couples were identified. The median time interval for the laboratory to produce a result was five days and the cost was £16 on average.
Conclusions Antenatal screening for cystic fibrosis does not pose any special practical difficulties. It would be feasible to introduce it into routine practice in Yorkshire.