全球精选文摘 - Denosumab对类风湿关节炎的结构损害、骨密度和骨转换的疗效：一项为期12个月的多中心、随机、双盲、安慰剂对照的II期临床试验

Denosumab Treatment Effects on Structural Damage, Bone Mineral Density, and Bone Turnover in Rheumatoid Arthritis: A Twelve-Month, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Clinical Trial

Cohen SB, Dore RK, Lane NE 2009/7/24 12:13:21

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Arthritis and Rheum, 2009,

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Objective:
RANKL is essential for osteoclast development, activation, and survival. Denosumab is a fully human monoclonal IgG2 antibody that binds RANKL, inhibiting its activity. The aim of this multicenter, randomized, double-blind, placebo-controlled, phase II study was to evaluate the effects of denosumab on structural damage in patients with rheumatoid arthritis (RA) receiving methotrexate treatment.

Methods:
RA patients received subcutaneous placebo (n=75), denosumab 60mg (n=71), or denosumab 180mg (n=72) injections every 6 months for 12 months. The primary end point was the change from baseline in the magnetic resonance imaging (MRI) erosion score at 6 months.

Results:
At 6 months, the increase in the MRI erosion score from baseline was lower in the 60-mg denosumab group (mean change 0.13; P=0.118) and significantly lower in the 180-mg denosumab group (mean change 0.06; P=0.007) than in the placebo group (mean change 1.75). A significant difference in the modified Sharp erosion score was observed as early as 6 months in the 180-mg denosumab group (P=0.019) as compared with placebo, and at 12 months, both the 60-mg (P=0.012) and the 180-mg (P=0.007) denosumab groups were significantly different from the placebo group. Denosumab caused sustained suppression of markers of bone turnover. There was no evidence of an effect of denosumab on joint space narrowing or on measures of RA disease activity. Rates of adverse events were comparable between the denosumab and placebo groups.

Conclusion:
Addition of twice-yearly injections of denosumab to ongoing methotrexate treatment inhibited structural damage in patients with RA for up to 12 months, with no increase in the rates of adverse events as compared with placebo.

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高血压	慢性阻塞性肺病
脂肪性肝病	糖尿病
卒中	肺癌
冠心病	子宫内膜异位症
结直肠癌	乳腺癌
心力衰竭

病例分析 [栏目介绍]

呼吸急促伴精神状态改变——《西氏内科学》病例

摘自：《西氏内科学》，第23版

患者男性，36岁，幼年有吸入性肺损伤史，因呼吸急促和精神状态改变来我院就诊。患者睡眠和运动时，吸氧流量基值为2 L/min，每天均进行肺功能康复训练。患者居住在美国中西部，入院5天前曾离家乘船来这里看望其兄弟。入院前一天，患者呼吸急促加剧，自觉发热并注意到其慢性咳嗽稍加重，但痰液无变化。当天晚上，家人注意到患者更加急躁并有点偏执。由于症状加重，患者于次日送我院就诊。

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