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普伐他汀降低胆固醇随机安慰剂对照试验中心理健康的长期评估。脂质研究调查人员。

Long-term assessment of psychological well-being in a randomized placebo-controlled trial of cholesterol reduction with pravastatin. The LIPID Study Investigators.

作者信息

Stewart R A, Sharples K J, North F M, Menkes D B, Baker J, Simes J

机构信息

Cardiovascular Research Unit, Green Lane Hospital, Private Bag 92189, Auckland 1030, New Zealand.

出版信息

Arch Intern Med. 2000 Nov 13;160(20):3144-52. doi: 10.1001/archinte.160.20.3144.

DOI:10.1001/archinte.160.20.3144
PMID:11074745
Abstract

BACKGROUND

There is controversial evidence that a low serum cholesterol level is associated with an increased risk of depression, suicide, and violence. The aim of this study was to identify or exclude any small or infrequent adverse effect of long-term reduction of serum cholesterol with pravastatin sodium on psychological well-being.

METHODS

The study population consisted of 1130 respondents from a representative sample of 1222 patients with stable coronary artery disease participating in the Long-term Intervention with Pravastatin in Ischaemic Disease (LIPID) study. Subjects were randomized in a double-blind manner to treatment with pravastatin sodium, 40 mg/d (n = 559), or placebo (n = 571) for at least 4 years. Psychological well-being was assessed with a standard self-administered questionnaire at baseline and after 6 months, 1 year, 2 years, and 4 years. The questionnaire assessed anxiety and depression, anger, impulsiveness, alcohol consumption, and adverse life events.

RESULTS

Serum cholesterol levels decreased by an average of 1.3 mmol/L (50 mg/dL) with pravastatin therapy and did not change with placebo. During follow-up there was no significant difference by treatment group in measures of anxiety and depression, anger expression, or impulsiveness (95% confidence interval excluded differences of >0.2 SD) and no difference in the proportion of subjects with excessive alcohol consumption or adverse life events (odds ratio, 1.0; 95% confidence interval, 0.8-1.2). There was no evidence of a treatment effect for persons whose baseline serum cholesterol level was in the lowest 10% (<4.6 mmol/L [178 mg/dL]) or whose scores for anxiety and depression, anger, or impulsiveness were in the highest 10% at baseline. There was no association between change in the serum cholesterol level and measures of anxiety and depression, anger, or impulsiveness during follow-up.

CONCLUSION

Long-term reduction of serum cholesterol with pravastatin has no adverse effect on psychological well-being.

摘要

背景

有证据表明,血清胆固醇水平低与抑郁症、自杀及暴力风险增加有关,但该证据存在争议。本研究旨在确定或排除长期使用普伐他汀钠降低血清胆固醇对心理健康是否存在任何微小或罕见的不良影响。

方法

研究人群包括1222例稳定型冠心病患者代表性样本中的1130名受访者,这些患者参与了缺血性疾病普伐他汀长期干预(LIPID)研究。受试者以双盲方式随机分为两组,分别接受40毫克/天的普伐他汀钠治疗(n = 559)或安慰剂治疗(n = 571),治疗时间至少为4年。在基线时以及6个月、1年、2年和4年后,使用标准的自填问卷对心理健康状况进行评估。该问卷评估焦虑和抑郁、愤怒、冲动、饮酒情况及不良生活事件。

结果

普伐他汀治疗使血清胆固醇水平平均降低1.3毫摩尔/升(50毫克/分升),而安慰剂组血清胆固醇水平未发生变化。在随访期间,治疗组在焦虑和抑郁、愤怒表达或冲动测量方面无显著差异(95%置信区间排除>0.2标准差的差异),在饮酒过量或发生不良生活事件的受试者比例方面也无差异(优势比为1.0;95%置信区间为0.8 - 1.2)。对于基线血清胆固醇水平处于最低10%(<4.6毫摩尔/升[178毫克/分升])或基线时焦虑和抑郁、愤怒或冲动得分处于最高10%的人群,没有证据表明存在治疗效果。随访期间,血清胆固醇水平变化与焦虑和抑郁、愤怒或冲动测量之间没有关联。

结论

长期使用普伐他汀降低血清胆固醇对心理健康没有不良影响。

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