舍曲林治疗创伤后应激障碍的疗效和安全性:一项随机对照试验。

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布雷迪K, T Pearlstein, Asnis通用,贝克D, Rothbaum B,赛克斯CR, Farfel通用

舍曲林治疗创伤后应激障碍的疗效和安全性:一项随机对照试验。

《美国医学协会杂志》上。2000年4月12日,283 (14):1837 - 44。

PubMed ID
10770145 (在PubMed
]
文摘

背景:尽管高患病率、长期性和相关疾病的创伤后应激障碍(PTSD)在社区里,很少有安慰剂对照研究评估这个障碍药物治疗的疗效。目的:确定盐酸舍曲林治疗有效地减少创伤后应激障碍的症状温和的严重性。设计:Twelve-week、双盲、安慰剂对照试验之前两周,单盲安慰剂引入期,1996年5月至1997年6月进行。设置:门诊精神病诊所8学术医学中心临床研究中心和6。必威国际app病人:共有187名门诊病人与精神疾病诊断与统计手册修订第三版PTSD的诊断和临床医生管理PTSD规模第2部分(CAPS-2)最低总严重程度至少50分的基线(平均年龄,40年;意味着疾病的持续时间,12年;73%是女性;和61.5%经验的身体或性侵犯)。干预:病人被随机分为急性与盐酸舍曲林治疗灵活的每日剂量50到200 mg / d, 1周后在25 mg / d (n = 94);或安慰剂(n = 93)。 MAIN OUTCOME MEASURES: Baseline-to-end-point changes in CAPS-2 total severity score, Impact of Event Scale total score (IES), and Clinical Global Impression-Severity (CGI-S), and CGI-Improvement (CGI-I) ratings, compared by treatment vs placebo groups. Results Sertraline treatment yielded significantly greater improvement than placebo on 3 of the 4 primary outcome measures (mean change from baseline to end point for CAPS-2 total score, -33.0 vs -23.2 [P =.02], and for CGI-S, -1.2 vs -0.8 [P=.01]; mean CGI-I score at end point, 2.5 vs 3.0 [P=.02]), with the fourth measure, the IES total score, showing a trend toward significance (mean change from baseline to end point, -16.2 vs -12.1; P=.07). Using a conservative last-observation-carried-forward analysis, treatment with sertraline resulted in a responder rate of 53% at study end point compared with 32% for placebo (P=.008, with responder defined as >30% reduction from baseline in CAPS-2 total severity score and a CGI-I score of 1 [very much improved], or 2 [much improved]). Significant (P<.05) efficacy was evident for sertraline from week 2 on the CAPS-2 total severity score. Sertraline had significant efficacy vs placebo on the CAPS-2 PTSD symptom clusters of avoidance/numbing (P=.02) and increased arousal (P=.03) but not on reexperiencing/intrusion (P=.14). Sertraline was well tolerated, with insomnia the only adverse effect reported significantly more often than placebo (16.0% vs 4.3%; P=.01). CONCLUSIONS: Our data suggest that sertraline is a safe, well-tolerated, and effective treatment for PTSD.

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