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1.
王勤  刘爽  倪训业 《河北医学》2010,16(1):12-14
目的:探讨氯吡格雷联合阿司匹林治疗非ST段抬高急性冠脉综合征(ACS)患者的临床治疗效果。方法:选择本科住院施行保守治疗的不稳定心绞痛/非ST段升高的急性心肌梗塞患者122例,其中联合治疗组62例,对照组60例,所有患者均给予皮下注射低分子肝素连用8d,然后停用抗凝治疗。所有患者在继续接受包括阿司匹林(阿司匹林100m/d,首剂300mg)的标准治疗的同时,联合治疗组加用氯吡格雷(首剂300 mg,以后75mg/d)口服,连续给药至1年。结果:对两组患者进行比较,平均随访18个月,联合治疗组近期总心脏事件发生率为19.4%(12/62);对照组为26.7%(16/60)。两组比较,差异有统计学意义(P〈0.05)。结论:氯吡格雷联合阿司匹林用于保守治疗非ST段抬高急性冠脉综合征的疗效好,总心脏事件发生率低。  相似文献   

2.
氨甲喋呤联合米非司酮治疗异位妊娠的Meta分析   总被引:13,自引:0,他引:13  
目的评价氨甲喋呤联合米非司酮治疗异位妊娠的有效性和安全性。方法按照循证医学的要求全面检索中国知识期刊网(1994.1-2005.5)、中国生物医学光盘数据库(1995.1-2005.5)及Pubmed(1995.1-2005.5),收集氨甲喋呤联合米非司酮与单用氨甲喋呤治疗异位妊娠的随机对照试验。结果检索到符合纳入标准的随机对照试验文章23篇,共1706例病人。Meta分析结果显示,氨甲喋呤联合米非司酮能有效治疗异位妊娠[OR合并=2.84,95%CI(2.18,3.69),P=0.0000]。在森林图中,OR合并的95%CI横线落在无效竖线右侧,可认为氨甲喋呤联合米非司酮治疗异位妊娠有效。结论目前较低质量研究的Meta分析提示,氨甲喋呤联合米非司酮治疗异位妊娠与单用氨甲喋呤比较,疗效的差异有高度显著性;在森林图中,,OR合并的95%CI横线落在无效竖线右侧,可认为氨甲喋呤联合米非司酮治疗异位妊娠有效,安全性可能较高,副作用较小,但还需要严格设计的、大样本的随机双盲对照试验来进一步验证和支持。  相似文献   

3.
In the second of four articles, the authors discuss the "estimation" approach to interpreting study results. Whereas, in hypothesis testing, study results lead the reader to reject or accept a null hypothesis, in estimation the reader can assess whether a result is strong or weak, definitive or not. A confidence interval, based on the observed result and the size of the sample, is calculated. It provides a range of probabilities within which the true probability would lie 95% or 90% of the time, depending on the precision desired. It also provides a way of determining whether the sample is large enough to make the trial definitive. If the lower boundary of a confidence interval is above the threshold considered clinically significant, then the trial is positive and definitive, if the lower boundary is somewhat below the threshold, the trial is positive, but studies with larger samples are needed. Similarly, if the upper boundary of a confidence interval is below the threshold considered significant, the trial is negative and definitive. However, a negative result with a confidence interval that crosses the threshold means that trials with larger samples are needed to make a definitive determination of clinical importance.  相似文献   

4.
T F Imperiale  A S Petrulis 《JAMA》1991,266(2):260-264
BACKGROUND.--Pregnancy-induced hypertension (PIH), defined as either isolated hypertension after the 20th week of gestation or hypertension with proteinuria (preeclampsia), occurs in 5% to 15% of pregnancies and is associated with maternal and neonatal morbidity. Previous clinical trials with small numbers of patients have suggested that aspirin in doses of 60 to 150 mg/d during the second and third trimesters reduces the risk of PIH and improves maternal and neonatal outcomes. OBJECTIVE.--We performed a meta-analysis of the six published controlled trials to estimate more precisely (1) the magnitude of protection of aspirin from PIH; (2) the effect of aspirin on severe low-birth-weight infants, cesarean section, and perinatal mortality; and (3) the risk of adverse effects. METHODS.--We critically and independently evaluated study methods, assigned a quality score to each trial, and abstracted quantitative outcomes data. For each outcome, both relative risk (RR) and the number needed to be treated were calculated. RESULTS.--Among 394 subjects from six trials, the RR of PIH among women who took aspirin was 0.35 (95% confidence interval [CI], 0.22 to 0.55) and the number needed to be treated was 4.4, meaning that between four and five high-risk women would need to be treated with aspirin to prevent one case of PIH. Aspirin reduced the risk of severe low birth weight among newborns by 44% (RR = 0.56; 95% CI, 0.36 to 0.88) and reduced the risk of cesarean section by 66% overall (RR = 0.34; 95% CI, 0.25 to 0.48), although the specific indications for cesarean section were generally not described. There was no effect on fetal and neonatal death (RR = 0.88; 95% CI, 0.32 to 2.46), and there were no maternal or neonatal adverse effects associated with taking aspirin. CONCLUSION.--This meta-analysis suggests that low-dose aspirin reduces the risks of PIH and severe low birth weight, with no observed risk of maternal or neonatal adverse effects.  相似文献   

5.
Context  Following percutaneous coronary intervention (PCI), short-term clopidogrel therapy in addition to aspirin leads to greater protection from thrombotic complications than aspirin alone. However, the optimal duration of combination oral antiplatelet therapy is unknown. Also, although current clinical data suggest a benefit for beginning therapy with a clopidogrel loading dose prior to PCI, the practical application of this therapy has not been prospectively studied. Objectives  To evaluate the benefit of long-term (12-month) treatment with clopidogrel after PCI and to determine the benefit of initiating clopidogrel with a preprocedure loading dose, both in addition to aspirin therapy. Design, Setting, and Participants  The Clopidogrel for the Reduction of Events During Observation (CREDO) trial, a randomized, double-blind, placebo-controlled trial conducted among 2116 patients who were to undergo elective PCI or were deemed at high likelihood of undergoing PCI, enrolled at 99 centers in North America from June 1999 through April 2001. Interventions  Patients were randomly assigned to receive a 300-mg clopidogrel loading dose (n = 1053) or placebo (n = 1063) 3 to 24 hours before PCI. Thereafter, all patients received clopidogrel, 75 mg/d, through day 28. From day 29 through 12 months, patients in the loading-dose group received clopidogrel, 75 mg/d, and those in the control group received placebo. Both groups received aspirin throughout the study. Main Outcome Measures  One-year incidence of the composite of death, myocardial infarction (MI), or stroke in the intent-to-treat population; 28-day incidence of the composite of death, MI, or urgent target vessel revascularization in the per-protocol population. Results  At 1 year, long-term clopidogrel therapy was associated with a 26.9% relative reduction in the combined risk of death, MI, or stroke (95% confidence interval [CI], 3.9%-44.4%; P = .02; absolute reduction, 3%). Clopidogrel pretreatment did not significantly reduce the combined risk of death, MI, or urgent target vessel revascularization at 28 days (reduction, 18.5%; 95% CI, -14.2% to 41.8%; P = .23). However, in a prespecified subgroup analysis, patients who received clopidogrel at least 6 hours before PCI experienced a relative risk reduction of 38.6% (95% CI, -1.6% to 62.9%; P = .051) for this end point compared with no reduction with treatment less than 6 hours before PCI. Risk of major bleeding at 1 year increased, but not significantly (8.8% with clopidogrel vs 6.7% with placebo; P = .07). Conclusions  Following PCI, long-term (1-year) clopidogrel therapy significantly reduced the risk of adverse ischemic events. A loading dose of clopidogrel given at least 3 hours before the procedure did not reduce events at 28 days, but subgroup analyses suggest that longer intervals between the loading dose and PCI may reduce events.   相似文献   

6.
C D Naylor  S B Jaglal 《JAMA》1990,264(6):697-702
Evidence of the potential impact of intravenous thrombolytic therapy on short-term revascularization rates among patients with acute myocardial infarction was sought. Because nonrandomized comparisons with conventional treatment would be subject to various confounders, a meta-analysis of randomized controlled trials was performed. Seven trials were included, applying standard doses of either tissue plasminogen activator or streptokinase without an aggressive revascularization protocol. Follow-up ranged from 14 to 30 days. The revascularization rates among treated patients in all trials were lower than in the conservative arm of the Thrombolysis in Myocardial Infarction Phase II trial, which established the current procedural benchmarks for postthrombolysis management. However, the aggregate volume of bypass surgery and angioplasty in patients treated with tissue plasminogen activator was more than double that of controls (odds ratio, 2.25; 95% confidence interval, 1.31 to 3.94), with a smaller but still significant increase for streptokinase-treated patients (odds ratio, 1.66; 95% confidence interval, 1.08 to 2.59). Combining all trials, the increase in mechanical revascularization was 80% (95% confidence interval, 33% to 144%). Thus, for patterns of practice currently accepted in North America, intravenous thrombolysis for myocardial infarction leads to a significant short-term increase in clinical and angiographic indications for revascularization as compared with conventional treatment.  相似文献   

7.
目的:分析服用抗血小板药物心脑血管病病人血栓弹力图(TEG)结果,为临床治疗提供参考。方法:收集因心脑血管疾病住院病人249例,根据其服用抗血小板药物情况分为阿司匹林组(AA组,n=141)、氯吡格雷组(ADP组,n=20)、阿司匹林+氯吡格雷联合组(双联组,n=88),用血栓弹力图仪检测病人血小板抑制率,分析3组抗血小板治疗的疗效差异。结果:双联组的AA途径和ADP受体途径血小板抑制率分别为(88.47±19.69)%和(68.08±28.12)%,均高于AA组的(77.71±29.7)%和ADP组的(52.57±26.97)%(P<0.01和P<0.05)。双联组的阿司匹林抵抗和氯吡格雷抵抗发生率分别为6.82%和11.36%,均低于AA组的21.99%和ADP组的30%(P<0.01和P>0.05)。结论:采用TEG仪检测心脑血管病病人的血小板聚集抑制率有利于指导临床制定个体化的抗血小板治疗方案。阿司匹林对心脑血管病人血小板聚集的抑制作用强于氯吡格雷。接受标准剂量抗血小板治疗的心脑血管病病人存在抗血小板抵抗;阿司匹林与氯吡格雷联用抗血小板有协同作用。  相似文献   

8.
文微微 《当代医学》2014,(2):151-152
目的观察急性脑梗死早期使用氯吡格雷联合阿司匹林用药方法、疗效。方法105例急性脑梗死患者随机分为三组,对照组予阿司匹林口服治疗,治疗组1予氯吡格雷联合阿司匹林口服治疗,治疗组2-经确诊即予氯吡格雷联合阿司匹林嚼服治疗,三组疗程均为14d。观察三组治疗前后NIHSS总评分比较及疗效总有效率比较。结果治疗后NIHSS评分均有不同程度的改善,治疗组1治疗效果显著优于对照组,治疗组2治疗效果显著优于治疗组1(P〈0.05);临床总有效率各组差异亦有统计学意义(P〈0.05)。结论氯吡格雷联合阿司匹林治疗急性脑梗死疗效优于单用阿司匹林,而确诊后立即嚼服作用优于常规口服,急性脑梗死早期尽早发挥双抗治疗的作用会使患者获得更大的受益。  相似文献   

9.
Anand SS  Yusuf S 《JAMA》1999,282(21):2058-2067
CONTEXT: Despite years of use in coronary artery disease (CAD) and several studies of its effectiveness, the role of oral anticoagulants (OAs) remains controversial. OBJECTIVE: To determine the effects of long-term OA therapy, stratified by the intensities of anticoagulation and aspirin therapy, on outcomes in patients with CAD. DATA SOURCES: Studies were identified by MEDLINE, EMBASE, and CURRENT CONTENTS searches (1960-July 1999) and by reviewing reference lists and inquiring with experts and pharmaceutical companies. STUDY SELECTION: Studies were included if they were published between 1960 and July 1999, were randomized, had recruited patients with CAD, who had used OA therapy for at least 3 months. Of 43 articles identified, 30 articles (31 trials) were analyzed. DATA EXTRACTION: Information on type, duration, and method of monitoring OA therapy, as well as rates of death, myocardial infarction (MI), thromboembolic complications, stroke, and bleeding were abstracted by 2 independent observers. DATA SYNTHESIS: With high-intensity (international normalized ratio [INR], 2.8-4.8) OAs vs control (16 trials, 10056 patients), clear reductions in mortality (odds reduction [ORed], 22%; 95% confidence interval [CI], 13%-31%), MIs (ORed, 42%; 95% CI, 34%-48%), and thromboembolic complications including stroke (ORed, 63%; 95% CI, 53-71%) were observed, but were associated with a 6.0-fold (95% CI, 4.4- to 8.2-fold) increase in major bleeding. For moderate OAs (INR, 2-3) vs control (4 trials, 1365 patients) the ORed for death was 18% (95% CI, -6% to 37%); for MI, 52% (95% CI, 37%-64%); and for stroke, 53% (95% CI, 19%-73%), but it increased bleeding by 7.7-fold (95% CI, 3.3- to 18-fold). For moderate- to high-intensity OAs (INR, > or =2) vs aspirin (7 trials, 3457 patients), no reduction in death, MI, or stroke was observed, and it was associated with a 2.4-fold (95% CI, 1.6- to 3.6-fold) increase in major bleeding. For moderate- to high-intensity OAs and aspirin vs aspirin alone (3 trials, 480 patients), the ORed for death, MI, or stroke was 56% (95% CI, 17%-77%) and major bleeding increased by 1.9-fold (0.6- to 6.0-fold). For low-intensity OAs (INR, <2.0) and aspirin vs aspirin alone (3 trials, 8435 patients), no significant reduction in death, MI, or stroke was observed, and major bleeding increased by 1.3-fold (95% CI, 1.0- to 1.8-fold). CONCLUSIONS: Among patients with CAD, high-intensity and moderate-intensity OA are effective in reducing MI and stroke but increase the risk of bleeding. In the presence of aspirin, low-intensity OA does not appear to be superior to aspirin alone, while moderate- to high-intensity OA and aspirin vs aspirin alone appears promising and the bleeding risk is modest, but this requires confirmation from ongoing trials.  相似文献   

10.
刘刚  李胜利  费素娟 《吉林医学》2011,(19):3927-3929
目的:对以康复新液为基础的灌肠治疗溃疡性结肠炎的疗效进行系统性分析。方法:应用Meta分析方法对国内有关康复新液为基础的灌肠疗法治疗溃疡性结肠炎的随机对照实验进行定量综合分析。结果:共有8项随机对照实验纳入研究,经Meta分析其合并OR值为0.18(95%CI:0.11~0.32),统计检验Z=6.06,P<0.01。结论:当前研究显示,康复新液灌肠治疗溃疡性结肠炎的疗效明显优于传统药物。  相似文献   

11.

Background

To study the efficacy and safety of cilostazol on ischemic stroke prevention and treatment, systematic reviews of related clinical randomized controlled trials were analyzed.

Methods

We searched the main databases for eligible trials including literature from January 1966 to November 2012 in MEDLINE, reports from 1980 to November 2012 in EMBASE, and all the studies published in EBSCO, Springer, Ovid, and Cochrane library citations. We also searched for keywords, including cilostazol and aspirin. RewMan 5.0 software was used to conduct the meta-analysis.

Results

Our search yielded five eligible trials. The effects of cilostazol and aspirin on ischemic stroke prevention and treatment were almost equal (combined odds ratio (OR) 0.78, 95% confidence interval (CI) (0.59, 1.04)). Additionally, both magnetic resonance angiography (MRA) and transcranial Doppler (TCD) examination showed that cilostazol could significantly decrease the incidence of intracranial artery stenosis exacerbation (MRA: combined OR 0.22, 95% CI (0.07, 0.68); TCD: combined OR 0.17, 95% CI (0.05, 0.51)). In terms of adverse reactions, there were slightly fewer incidences of major bleeding with cilostazol than with aspirin (combined OR 0.38, 95% CI (0.24, 0.60)), and there was no difference in the number of heart palpitations between cilostazol and aspirin. However, the incidence of gastrointestinal disorders, dizziness, and headaches caused by cilostazol was greater.

Conclusions

Cilostazol might be a more effective and safer alternative to aspirin for patients with ischemic stroke. Further studies are required to confirm whether cilostazol is a suitable therapeutic option for secondary stroke prevention in larger cohorts of patients with ischemic stroke.  相似文献   

12.
目的观察抗血小板药物阿司匹林、氯吡格雷及两药合用对兔动脉粥样硬化病变进展的抑制作用.方法将49只雄性日本大耳白兔随机分为正常对照组(n=9)、模型对照组(n=10)、阿司匹林组(n=10)、氯吡格雷组(n=10)及合用组(n=10).后4组建立高胆固醇饲料并免疫损伤诱发的主动脉粥样硬化模型.测血清血脂和C反应蛋白(CRP)浓度.观察主动脉组织病理形态学改变并定量分析病变程度,免疫组织化学方法测定斑块部位的巨噬细胞和平滑肌细胞阳性百分率.结果阿司匹林和氯吡格雷均能明显减轻动脉粥样硬化病变,降低血清CRP浓度,减少巨噬细胞阳性细胞百分率,增加平滑肌细胞阳性细胞百分率,联合用药作用增强(P<0.05~0.01),两药之间差异无显著性(P>0.05).结论氯吡格雷与阿司匹林均有抑制内膜增生和动脉粥样硬化病变进展的作用,联合使用抗动脉粥样硬化效果更佳.  相似文献   

13.
S MacMahon  R Collins  R Peto  R W Koster  S Yusuf 《JAMA》1988,260(13):1910-1916
The effects of prophylactic lidocaine hydrochloride on early ventricular fibrillation and death in patients with suspected acute myocardial infarction were investigated in an overview of 14 randomized trials. During follow-up intervals of one to four hours in the trials of intramuscular lidocaine infusion (6961 patients) and 24 to 48 hours in the trials of intravenous lidocaine injection (2194 patients), a total of 103 cases of ventricular fibrillation and 137 deaths were recorded. Overall, allocation to lidocaine was associated with a reduction in the odds of ventricular fibrillation of about one third, with a 95% confidence interval that ranged from a 3% to a 56% reduction. There was no evidence of any beneficial effect on early mortality; indeed, the odds of early death were about one third greater among patients allocated lidocaine, though this difference was not statistically significant (95% confidence interval, 2% reduction to 95% increase). Because of the small numbers of reported events, the short follow-up periods, and the unavailability of data for some specific causes of death, even an overview of all the trial results does not provide good evidence as to whether prophylactic lidocaine is likely to be helpful or harmful. To answer this question reliably, future trials will need to involve large numbers of patients and prolonged follow-up.  相似文献   

14.
目的探讨氯吡格雷与阿司匹林联合应用治疗不稳定型心绞痛(UAP)的临床疗效和安全性。方法 187例UAP患者随机分成治疗组(96例)和对照组(91例),均常规应用抗心绞痛药物治疗。治疗组在常规治疗的同时,首次给负荷剂量的氯吡格雷300mg口服,继之75mg口服。治疗期间记录两组心绞痛的发作情况、12导联心电图变化及药物主要不良反应等。结果 UAP患者中、高危险组,与单用阿司匹林相比,联合氯吡格雷使临床症状改善的总有效率分别提高26.2%和25.1%;治疗组心血管事件的发生率比对照组下降11.5%,均未见严重不良反应。结论氯吡格雷与阿司匹林联合应用治疗UAP疗效满意,优于单独应用阿司匹林的常规治疗效果。  相似文献   

15.
易成文 《中原医刊》2009,36(1):22-23
目的评价应用氯吡格雷与阿司匹林治疗不稳定型心绞痛、(UAP)的疗效及经济学效果。方法运用药物经济学成本-效果分析方法,对氯吡格雷与阿司匹林治疗不稳定型心绞痛(UAP)的疗效及成本进行比较分析,并观察不良反应。结果治疗组与对照组治疗不稳定型心绞痛(UAP)的总有效率分别92.29%和87.50%(P〉0.05),成本-效果比分别为1.101和0.141,治疗组每增加1个效果单位,要比对照组多花23.27元的费用。治疗组与对照组不良反应发生率分别为8.57%和25%。结论氯吡格雷与阿司匹林均能有效治疗不稳定型心绞痛,但阿司匹林的成本-效果比优于氯吡格雷。  相似文献   

16.
目的:研究和探讨氯吡格雷联合小剂量阿司匹林治疗急性缺血性脑卒中患者的疗效及安全性。方法:对156例急性缺血性脑卒中患者随机分为两组,一组患者单用氯吡格雷和另一组患者使用氯吡格雷联合小剂量阿司匹林进行治疗,观察两组患者的疗效及安全性。结果:单用氯吡格雷治疗患者的有效率为83.3%,氯吡格雷联合小剂量阿司匹林治疗患者的有效率为87.2%。联合用药增加了危及治疗患者的生命出血危险(绝对危险增加2.57%)。结论:氯吡格雷联合小剂量阿司匹林治疗急性缺血性脑卒中患者的疗效增加不显著,而增加了出血风险,安全性降低。  相似文献   

17.
Objectives: This systemic review evaluated the efficacy and safety of Chinese herbal medicines (CHMs) in patients with coronary heart disease (CHD) complicated with depression. Methods: All databases were retrieved till September 30, 2014. Randomized controlled trials (RCTs) comparing CHMs with placebo or conventional Western medicine were retrieved. Data extraction, analyses and quality assessment were performed according to the Cochrane standards. RevMan 5.3 was used to synthesize the results. Results: Thirteen RCTs enrolling 1,095 patients were included. Subgroup analysis was used to assess data. In reducing the degree of depression, CHMs showed no statistic difference in the 4th week [mean difference (MD)=–1.06; 95% confidence interval (CI) –2.38 to 0.26; n=501; I2=73%], but it was associated with a statistically significant difference in the 8th week (MD=–1.00; 95% CI –1.64 to –0.36; n=436; I2=48%). Meanwhile, the combination therapy (CHMs together with antidepressants) showed significant statistic differences both in the 4th week (MD=–1.99; 95% CI –3.80 to –0.18; n=90) and in the 8th week (MD=–5.61; 95% CI –6.26 to –4.97; n=242; I2=87%). In CHD-related clinical evaluation, 3 trials reported the intervention group was superior to the control group. Four trials showed adverse events in the intervention group was less than that in the control group. Conclusions: CHMs showed potentially benefits on patients with CHD complicated with depression. Moreover, the effect of CHMs may be similar to or better than antidepressant in certain fields but with less side effects. However, because of small sample size and potential bias of most trials, this result should be interpreted with caution. More rigorous trials with larger sample size and higher quality are warranted to give high quality of evidence to support the use of CHMs for CHD complicated with depression.  相似文献   

18.
目的探讨氯吡格雷联合阿司匹林治疗急性冠脉综合征(ACS)患者的临床疗效和安全性。方法选择2008年4月-2010年9月住院治疗的89例ACS患者,根据抗血小板药物的差异,将患者分为观察组(氯吡格雷+阿司匹林,n=46)和对照组(阿司匹林组,72=43),比较两组患者临床疗效、肌钙蛋白变化和并发症。结果两组患者临床疗效比较,观察组显效率和总有效率(72.4%、95.2%)高于对照组(62.8%、91.5%),差异有统计学意义(P〈O.05);观察组肌钙蛋白变化显效率和总有效率(分别为77.2%、96.1%)高于对照组(67.4%、89.9%),差异有统计学意义(P〈0.05)。两组患者发生出血情况主要表现为皮下出血点,经减量或停药后自行好转,均未做特殊处理。其中观察组发生3例(6.5%),对照组2例(4.7%),二者相比,差异无统计学意义(P〉0.05)。结论氯吡格雷联合阿司匹林治疗急性冠脉综合征疗效显著,安全性好,可在临床推广应用。  相似文献   

19.
目的血栓弹力图观察我院老年患者服用血小板后抑制率情况。方法检测我院住院和门诊48例老年人血栓弹力图测得AA和ADP途径诱导的血小板抑制率值,并将病人分成阿司匹林组、氯吡格雷组、阿司匹林+氯吡格雷组,与未服用阿司匹林+氯吡格雷组(对照组)26例进行比较。结果48例患者中,阿司匹林组AA诱导的血小板抑制率为86.6±21.2%,氯吡格雷组ADP诱导的血小板抑制率平均值为49.3±23.8%,阿司匹林+氯吡格雷组AA诱导和ADP诱导的血小板抑制率为分别91.8±12.8%和54.2±22.7%,血小板抑制率均显著高于对照组(P〈0.01)。结论阿司匹林能起到很好的抗血小板作用,氯吡格雷稍差,同时服用阿司匹林和氯吡格雷能起到更强的抗血小板作用。  相似文献   

20.
CONTEXT: Initial treatment of major depressive disorder in adolescents may include cognitive-behavioral therapy (CBT) or a selective serotonin reuptake inhibitor (SSRI). However, little is known about their relative or combined effectiveness. OBJECTIVE: To evaluate the effectiveness of 4 treatments among adolescents with major depressive disorder. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial of a volunteer sample of 439 patients between the ages of 12 to 17 years with a primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis of major depressive disorder. The trial was conducted at 13 US academic and community clinics between spring 2000 and summer 2003. INTERVENTIONS: Twelve weeks of (1) fluoxetine alone (10 to 40 mg/d), (2) CBT alone, (3) CBT with fluoxetine (10 to 40 mg/d), or (4) placebo (equivalent to 10 to 40 mg/d). Placebo and fluoxetine alone were administered double-blind; CBT alone and CBT with fluoxetine were administered unblinded. MAIN OUTCOME MEASURES: Children's Depression Rating Scale-Revised total score and, for responder analysis, a (dichotomized) Clinical Global Impressions improvement score. RESULTS: Compared with placebo, the combination of fluoxetine with CBT was statistically significant (P =.001) on the Children's Depression Rating Scale-Revised. Compared with fluoxetine alone (P =.02) and CBT alone (P =.01), treatment of fluoxetine with CBT was superior. Fluoxetine alone is a superior treatment to CBT alone (P =.01). Rates of response for fluoxetine with CBT were 71.0% (95% confidence interval [CI], 62%-80%); fluoxetine alone, 60.6% (95% CI, 51%-70%); CBT alone, 43.2% (95% CI, 34%-52%); and placebo, 34.8% (95% CI, 26%-44%). On the Clinical Global Impressions improvement responder analysis, the 2 fluoxetine-containing conditions were statistically superior to CBT and to placebo. Clinically significant suicidal thinking, which was present in 29% of the sample at baseline, improved significantly in all 4 treatment groups. Fluoxetine with CBT showed the greatest reduction (P =.02). Seven (1.6%) of 439 patients attempted suicide; there were no completed suicides. CONCLUSION: The combination of fluoxetine with CBT offered the most favorable tradeoff between benefit and risk for adolescents with major depressive disorder.  相似文献   

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