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舍曲林联合黛力新治疗慢性躯体疾病伴抑郁焦虑患者:一项随机对照试验

Sertraline plus deanxit to treat patients with depression and anxiety in chronic somatic diseases: a randomized controlled trial.

作者信息

Wang Limin, Zhong Zhuoyuan, Hu Jingyang, Rong Xiaoming, Liu Jun, Xiao Songhua, Liu Zhonglin

机构信息

Department of Neurology, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangdong Neuroscience Institute, 510080, Guangzhou, Guangdong Province, P P China.

Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, 510120, Guangzhou, China.

出版信息

BMC Psychiatry. 2015 Apr 14;15:84. doi: 10.1186/s12888-015-0449-2.

DOI:10.1186/s12888-015-0449-2
PMID:25879863
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4403889/
Abstract

BACKGROUND

Patients in chronic somatic diseases are often accompanied with depression and anxiety, remission of which may be observed in the third or fourth week after applying common antidepressant medications. We investigate the efficacy and safety of sertraline plus deanxit on patients with depression and anxiety in chronic somatic diseases.

METHODS

75 Patients who met the criteria were randomly assigned to deanxit group or placebo group: sertraline (75 mg/day) plus deanxit (one piece/day) (N = 38), or sertraline (75 mg/day) plus placebo (one piece/day) (N = 37) for 2 weeks, both groups received sertraline (75 mg/day) in the following 2 weeks. Changes from baseline to day 4, day 8, day 15, and day 29 in Hamilton Rating Scale for Depression (HAM-D) and Hamilton Rating Scale for Anxiety (HAM-A) total scores were the efficacy measures. Adverse events were monitored and registered systematically during the trial.

RESULTS

Response rates for HAM-D scores in deanxit group and placebo group were significantly different on day 8(55.26% ± 2.56% VS 24.32% ± 2.19%, p = 0.006) and day 15(78.95% ± 3.89% VS 40.54% ± 4.18%, p = 0.001), while no statistical differences were observed on day 4 and day 29. Respectively, response rates for HAM-A scores on day 4 (34.21% ± 2.21% VS 8.11% ± 1.37%, p = 0.006), day 8 (57.89% ± 3.56% VS 18.92% ± 2.68%, p = 0.001) and day 15 (78.95% ± 4.37% VS 43.24% ± 4.68%, p = 0.002), favoring the deanxit group. However, HAM-A scores were not remarkably different at the end point. The overall safety profile of both groups was favorable with no distinct differences.

CONCLUSIONS

The efficacy was exhibited in the deanxit group, with evidence for similar safety. The rapid onset of sertraline plus short-term deanxit indicated that it might be an inspiring strategy to manage depression and anxiety within the first two weeks in chronic somatic diseases.

摘要

背景

患有慢性躯体疾病的患者常伴有抑郁和焦虑,在使用常见抗抑郁药物后的第三或第四周可能会观察到症状缓解。我们研究了舍曲林联合黛力新对慢性躯体疾病伴抑郁和焦虑患者的疗效及安全性。

方法

75例符合标准的患者被随机分为黛力新组或安慰剂组:舍曲林(75毫克/天)加黛力新(1片/天)(N = 38),或舍曲林(75毫克/天)加安慰剂(1片/天)(N = 37),为期2周,接下来的2周两组均服用舍曲林(75毫克/天)。以汉密尔顿抑郁量表(HAM-D)和汉密尔顿焦虑量表(HAM-A)总分从基线到第4天、第8天、第15天和第29天的变化作为疗效指标。在试验期间系统监测并记录不良事件。

结果

黛力新组和安慰剂组的HAM-D评分有效率在第8天(55.26% ± 2.56% 对 24.32% ± 2.19%,p = 0.006)和第15天(78.95% ± 3.89% 对 40.54% ± 4.18%,p = 0.001)有显著差异,而在第4天和第29天未观察到统计学差异。黛力新组的HAM-A评分有效率在第4天(34.21% ± 2.21% 对 8.11% ± 1.37%,p = 0.006)、第8天(57.89% ± 3.56% 对 18.92% ± 2.68%,p = 0.001)和第15天(78.95% ± 4.37% 对 43.24% ± 4.68%,p = 0.002)也更优,但在终点时HAM-A评分差异不显著。两组的总体安全性良好,无明显差异。

结论

黛力新组显示出疗效,且安全性相似。舍曲林联合短期黛力新起效迅速,表明这可能是在慢性躯体疾病的前两周内管理抑郁和焦虑的一种有效策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2301/4403889/b5f59467b729/12888_2015_449_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2301/4403889/caff936c6fbd/12888_2015_449_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2301/4403889/67841e70f29f/12888_2015_449_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2301/4403889/b5f59467b729/12888_2015_449_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2301/4403889/caff936c6fbd/12888_2015_449_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2301/4403889/67841e70f29f/12888_2015_449_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2301/4403889/b5f59467b729/12888_2015_449_Fig3_HTML.jpg

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