Assessment of emphysema-modifying therapy is difficult, but newer outcome measures offer advantages over traditional methods. The EXAcerbations and Computed Tomography scan as Lung End-points (EXACTLE) trial explored the use of computed tomography (CT) densitometry and exacerbations for the assessment of the therapeutic effect of augmentation therapy in subjects with a 1 -antitrypsin (a 1 -AT) deficiency.In total, 77 subjects (protease inhibitor type Z) were randomised to weekly infusions of 60 mg?kg -1 human a 1 -AT (Prolastin1) or placebo for 2-2.5 yrs. The primary end-point was change in CT lung density, and an exploratory approach was adopted to identify optimal methodology, including two methods of adjustment for lung volume variability and two statistical approaches.Other end-points were exacerbations, health status and physiological indices. CT was more sensitive than other measures of emphysema progression, and the changes in CT and forced expiratory volume in 1 s were correlated. All methods of densitometric analysis concordantly showed a trend suggestive of treatment benefit (p-values for Prolastin1 versus placebo ranged 0.049-0.084). Exacerbation frequency was unaltered by treatment, but a reduction in exacerbation severity was observed.In patients with a 1 -AT deficiency, CT is a more sensitive outcome measure of emphysemamodifying therapy than physiology and health status, and demonstrates a trend of treatment benefit from a 1 -AT augmentation.
This paper addresses two questions: 1) What is the relation of hemoglobin in the second gestational month to preterm birth and low birth weight? 2) How does the relation differ when hemoglobin in the fifth or eighth month or the lowest pregnancy hemoglobin are examined in place of first trimester values? These relations were examined prospectively in 829 women from Shanghai, China in 1991-1992. The population was nearly homogeneous by race, parity, antenatal care, and smoking. Rates of birth outcomes were compared between hemoglobin categories based on 10 g/liter groupings, with 110-119 g/liter as the reference group. Rates of low birth weight and preterm birth (but not small-for-gestational age) were related to early pregnancy hemoglobin concentration in a U-shaped manner. The relative risks (95% confidence intervals) for preterm birth in women by g/liter of hemoglobin were 2.52 (0.95-6.64) for > or = 130 g/liter, 1.11 (0.41-2.99) for 120-129 g/liter, 1.64 (0.77-3.47) for 100-109 g/liter, 2.63 (1.17-5.90) for 90-99 g/liter, and 3.73 (1.36-10.23) for 60-89 g/liter. Use of hemoglobin values in the fifth or eighth month attenuated the association with preterm birth. When lowest pregnancy hemoglobin values were used, the association of anemia with both outcomes was obscured, and risk of preterm birth at high hemoglobin values increased dramatically.
Grip strength can be considered a sensitive tool for assessing clinically relevant changes in patients with CIDP. Its use in daily practice is suggested.
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