Gill D, Hatcher S
Cochrane Depression and Neurosis Collaborative Review Group, Institute of Health Sciences, PO BOX 777, Oxford, UK, OX3 7LF. david.
Cochrane Database Syst Rev. 2000(2):CD001312. doi: 10.1002/14651858.CD001312.
To determine whether antidepressants are clinically effective and acceptable for the treatment of depression in people who also have a physical illness.
Medline, Cochrane Library Trials Register and Cochrane Depression and Neurosis Group Trials Register were all systematically searched, supplemented by hand searches of two journals and reference searching.
All relevant randomised trials comparing any antidepressant drug (as defined in the British National Formulary) with placebo or no treatment, in patients of either sex over 16, who have been diagnosed as depressed by any criterion, and have a specified physical disorder (for example cancer, myocardial infarction). "Functional" disorders where there is no generally agreed physical pathology (e.g. irritable bowel syndrome) were excluded. The main outcome measures are numbers of individuals who recover/improve at the end of the trial and, as a proxy for treatment acceptability, numbers who complete treatment.
Data was extracted independently by the reviewers onto data collection forms and differences settled by discussion.
18 studies were included, covering 838 patients with a range of physical diseases (cancer 2, diabetes 1, head injury 1, heart 1, HIV 5, lung 1, multiple sclerosis 1, renal 1, stroke 3, mixed 2). Depression was diagnosed clinically in 3 studies, otherwise by structured interview or checklist. Only 5 studies described how they performed randomisation. 1 study compared drug with no treatment, and the rest with placebo: all of the latter said they were double blind. 6 studies used SSRIs, 3 atypical antidepressants, and the remainder tricyclics. Patients treated with antidepressants were significantly more likely to improve than those given placebo (13 studies, OR 0.37, 95% CI 0.27-0.51) or no treatment (1 study, OR 3.45, 95% CI 11.1-1.10). About 4 patients would need to be treated with antidepressants to produce one recovery from depression which would not have occurred had they been given placebo (NNT 4.2, 95% CI 3.2-6.4). Most antidepressants (tricyclics and SSRIs together, 15 trials ) produced a small but significant increase in dropout (OR 1.66, 95% CI 1.14-2.40. NNH 9.8, 95% CI 5.4-42.9). The "atypical" antidepressant mianserinproduced significantly less dropout than placebo. Only 2 studies used numerical scales designed to measure effects on function and quality of life; in HIV (Karnofsky scale), drug was better than no treatment; in lung disease (Sickness Impact Profile), drug was not significantly different from placebo. Only 7 studies reported looking for changes in the physical disease. Antidepressants produced no change in immune function in HIV relative to placebo (2 studies) or no treatment (1 study). Relative to placebo, antidepressants produced no change in cardiovascular function in heart disease, in respiratory function in lung disease, or in vital signs or laboratory tests in cancer (1 study each). Nortriptyline produced worse control in diabetes. Trends towards tricyclics being more effective than SSRIs, but also more likely to produce dropout were noted, but these are based on non-randomised comparisons between trials.
REVIEWER'S CONCLUSIONS: The review provides evidence that antidepressants, significantly more frequently than either placebo or no treatment, cause improvement in depression in patients with a wide range of physical diseases. About 4 patients would need to be treated with antidepressants to produce one recovery from depression which would not have occurred had they been given placebo (NNT 4.2, 95% CI 3.2-6.4). Antidepressants seem reasonably acceptable to patients, in that about 10 patients would need to be treated with antidepressants to produce one dropout from treatment which would not have occurred had they been given placebo (NNH 9.8, 95% CI 5.4-42.9). (ABSTRACT TRUNCATED)
确定抗抑郁药对同时患有躯体疾病的抑郁症患者的治疗在临床上是否有效且可接受。
系统检索了医学文献数据库(Medline)、考克兰图书馆试验注册库以及考克兰抑郁与神经症小组试验注册库,并辅以对两份期刊的手工检索和参考文献检索。
所有相关随机试验,比较任何抗抑郁药物(如英国国家处方集所定义)与安慰剂或不治疗,受试对象为16岁以上的任何性别患者,这些患者已根据任何标准被诊断为抑郁症,且患有特定的躯体疾病(如癌症、心肌梗死)。排除没有普遍认可的躯体病理学依据的“功能性”疾病(如肠易激综合征)。主要结局指标为试验结束时康复/改善的个体数量,以及作为治疗可接受性替代指标的完成治疗的个体数量。
评审人员独立将数据提取到数据收集表格上,并通过讨论解决分歧。
纳入18项研究,涉及838例患有一系列躯体疾病的患者(癌症2例、糖尿病1例、头部损伤1例、心脏病1例、艾滋病病毒感染5例、肺部疾病1例、多发性硬化症1例、肾脏疾病1例、中风3例、混合型2例)。3项研究通过临床诊断抑郁症,其他研究则通过结构化访谈或清单进行诊断。只有5项研究描述了随机分组的方法。1项研究比较了药物与不治疗,其余研究比较了药物与安慰剂:后者均称采用双盲法。6项研究使用了选择性5-羟色胺再摄取抑制剂(SSRI),3项使用非典型抗抑郁药,其余使用三环类抗抑郁药。接受抗抑郁药治疗的患者比接受安慰剂治疗(13项研究,比值比0.37,95%可信区间0.27 - 0.51)或不治疗(1项研究,比值比3.45,95%可信区间1.10 - 11.1)的患者显著更有可能改善。大约需要4例患者接受抗抑郁药治疗才能使1例患者从抑郁症中康复,而若给予安慰剂则不会发生这种康复(需治人数4.2,95%可信区间3.2 - 6.4)。大多数抗抑郁药(三环类和SSRI合计,15项试验)导致脱落率小幅但显著增加(比值比1.66,95%可信区间1.14 - 2.40。需治伤害人数9.8,95%可信区间5.4 - 42.9)。“非典型”抗抑郁药米安色林导致的脱落率显著低于安慰剂。只有2项研究使用了旨在测量对功能和生活质量影响的数字量表;在艾滋病病毒感染患者中(卡诺夫斯基量表),药物治疗优于不治疗;在肺部疾病患者中(疾病影响概况量表),药物治疗与安慰剂无显著差异。只有7项研究报告了观察躯体疾病变化的情况。相对于安慰剂(2项研究)或不治疗(1项研究),抗抑郁药对艾滋病病毒感染患者的免疫功能无影响。相对于安慰剂,抗抑郁药对心脏病患者的心血管功能、肺部疾病患者的呼吸功能、癌症患者的生命体征或实验室检查均无影响(每项各1项研究)。去甲替林对糖尿病的控制效果较差。有迹象表明三环类抗抑郁药比SSRI更有效,但也更有可能导致脱落,但这些是基于试验间的非随机比较得出的。
本综述提供的证据表明,与安慰剂或不治疗相比,抗抑郁药能显著更频繁地使患有多种躯体疾病的患者的抑郁症得到改善。大约需要4例患者接受抗抑郁药治疗才能使1例患者从抑郁症中康复,而若给予安慰剂则不会发生这种康复(需治人数4.2,95%可信区间3.2 - 6.4)。抗抑郁药对患者似乎具有合理的可接受性,因为大约需要10例患者接受抗抑郁药治疗才会导致1例患者退出治疗,而若给予安慰剂则不会发生这种情况(需治伤害人数9.8,95%可信区间5.4 - 42.9)。(摘要截选)