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疏肝理气法治疗甲状腺癌术后并发性抑郁随机对照临床试验研究。

Research on the soothing Liver - Qi stagnation method in the treatment of postoperative papillary thyroid carcinoma patients' concomitant depression: A randomized controlled clinical trial.

机构信息

Oncology Department, Longhua Hospital Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Department of Oncology and Hematology, Wenzhou Hospital of Integrated Traditional Chinese and Western Medicine, Wenzhou, Zhejiang Province, China.

出版信息

Medicine (Baltimore). 2024 Sep 13;103(37):e39325. doi: 10.1097/MD.0000000000039325.

Abstract

BACKGROUND

Postoperative papillary thyroid carcinoma (P-PTC) patients often grapple with depression fueled by the looming threat of recurrence. While the Liver-Qi stagnation method is frequently employed for depression management, a notable scarcity of clinical trials exists regarding its application in patients with P-PTC and concurrent depression. This study presents a randomized controlled clinical trial, aiming to establish the efficacy of the Liver-Qi stagnation method in alleviating depression in patients with P-PTC.

METHODS

In this randomized controlled clinical trial, P-PTC patients diagnosed with concomitant depression were systematically enrolled. Subjects were randomly assigned to either the control or test group, both receiving standard treatment comprising Levothyroxine sodium tablets and decoction of benefiting Qi and nourishing Yin. Additionally, the test group received supplementation with bupleuri radix-paeoniae alba radix (CH-BS) alongside the baseline therapy. The intervention spanned 12 weeks. Pre- and post-treatment evaluations were conducted using the Hamilton Depression Scale (HAMD), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and Traditional Chinese Medicine (TCM) syndrome score scale. Concurrently, blood inflammatory factors and serum 5-hydroxytryptamine (5-HT) levels were measured to comprehensively assess treatment outcomes.

RESULTS

During the 12-week intervention, the test group demonstrated a significant reduction in HAMD scores compared to the control group (P < .05). Moreover, post-treatment serum 5-HT levels were significantly elevated in the test group compared to the control group (P < .05). Findings gleaned from the EORTC QLQ - C30 revealed a noteworthy improvement in social function and overall quality of life scores within both groups post-treatment in comparison to baseline (P < .05). Concurrently, post-treatment scores for fatigue and insomnia symptoms witnessed a significant decrease compared to baseline (P < .05). Notably, the test group exhibited superior scores in the emotional domain in contrast to the control group (P < .05). Both groups exhibited a substantial decrease in TCM syndrome scores from baseline (P < .05). Noteworthy increases were found in IFN-γ < 2.44 rate (62.86%) and IL-6 < 2.44 rate (74.29%) in the test group compared to pretreatment levels (P < .05).

CONCLUSION

The soothing Liver-Qi stagnation method induces a rise in serum 5-HT levels, reducing depression-related inflammatory factors, culminating in the alleviation of depression for P-PTC.

摘要

背景

甲状腺乳头状癌术后(P-PTC)患者常因复发的潜在威胁而陷入抑郁。虽然肝郁气滞法常用于治疗抑郁症,但在 P-PTC 合并抑郁症患者中的应用,临床研究却相当匮乏。本研究采用随机对照临床试验,旨在确立肝郁气滞法在缓解 P-PTC 患者抑郁症状中的疗效。

方法

本随机对照临床试验纳入了 P-PTC 合并抑郁症的患者。将受试者随机分配到对照组或试验组,两组均接受标准治疗,包括左甲状腺素钠片和益气温阴汤。此外,试验组在基础治疗的基础上还补充使用柴胡白芍(CH-BS)。干预持续 12 周。治疗前后采用汉密尔顿抑郁量表(HAMD)、欧洲癌症研究与治疗组织生活质量问卷(EORTC QLQ-C30)和中医(TCM)证候评分量表进行评估。同时,测量血液炎症因子和血清 5-羟色胺(5-HT)水平,以全面评估治疗效果。

结果

在 12 周的干预过程中,试验组的 HAMD 评分与对照组相比显著降低(P<0.05)。此外,治疗后试验组的血清 5-HT 水平明显高于对照组(P<0.05)。EORTC QLQ-C30 的结果显示,与基线相比,两组治疗后社会功能和总体生活质量评分均显著提高(P<0.05)。同时,与基线相比,治疗后疲劳和失眠症状评分显著降低(P<0.05)。值得注意的是,试验组的情绪领域评分明显优于对照组(P<0.05)。两组的 TCM 证候评分均较基线显著降低(P<0.05)。与治疗前相比,试验组 IFN-γ<2.44 率(62.86%)和 IL-6<2.44 率(74.29%)显著升高(P<0.05)。

结论

疏肝理气法可升高血清 5-HT 水平,降低与抑郁相关的炎症因子,从而缓解 P-PTC 患者的抑郁症状。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1340/11404975/bbd91b7b3a31/medi-103-e39325-g001.jpg

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