Drug Clinical Trial Institution, the First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, China.
Department of Hematology, the First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, China.
Ann Hematol. 2023 Jul;102(7):1927-1937. doi: 10.1007/s00277-023-05277-4. Epub 2023 May 22.
Hemophilia patients enrolled in clinical trials often exhibit various physical and psychological symptoms. However, little is known about anxiety and depression among them. This study assessed the effects of depression and anxiety on hemophilia patients enrolled in clinical trials and identified risk factors for these disorders. A multi-center, cohort study was conducted from January to December 2022. Sixty-nine hemophilia patients who enrolled in clinical trials participated at baseline (T1, prior to treatment initiation) and completed the informed consent. Risk factors were measured at baseline to predict depression and anxiety at 3 months (T2). Sixty-four hemophilia patients were included in the final analysis. More hemophilia patients had moderate-severe depression (28 [43.75%]) and anxiety (16 [25.00%]) at T2 than at T1 (12 [18.75]), (5 [7.81%]). Depression was aggravated in 23 (35.94%) patients and anxiety was aggravated in 12 (18.75%) patients. Frequently acquired medical information (OR 11.378, CI 1.319-98.114, P = 0.027), baseline GAD-7 (OR 1.341, CI 1.015-1.772, P = 0. 039) and PHQ-9 (OR 1.465, CI 1.039-2.065, P = 0.029) are important factors predicting depression and anxiety in hemophilia patients. Hemophilia patients enrolled in a clinical trial have significant anxiety and depression. The frequency of acquiring medical information and the baseline PHQ-9 and GAD-7 scores were risk factors for anxiety and depression. Thus, hemophilia patients should receive education regarding clinical trials and undergo evaluations of their anxiety and depression; these changes will enable prompt detection of their psychological burden and identify potential psychological intervention strategies.
参加临床试验的血友病患者常表现出各种躯体和心理症状，但对他们的焦虑和抑郁知之甚少。本研究评估了抑郁和焦虑对参加临床试验的血友病患者的影响，并确定了这些疾病的危险因素。一项多中心队列研究于 2022 年 1 月至 12 月进行。69 名参加临床试验的血友病患者在基线（T1，治疗开始前）时入组并签署了知情同意书。在基线时测量了危险因素，以预测 3 个月（T2）时的抑郁和焦虑。最终有 64 名血友病患者纳入了最终分析。与 T1 时相比，更多的血友病患者在 T2 时出现中度至重度抑郁（28 [43.75%]）和焦虑（16 [25.00%]）（12 [18.75%]），（5 [7.81%]）。23 名（35.94%）患者的抑郁加重，12 名（18.75%）患者的焦虑加重。经常获取医疗信息（OR 11.378，CI 1.319-98.114，P = 0.027）、基线 GAD-7（OR 1.341，CI 1.015-1.772，P = 0.039）和 PHQ-9（OR 1.465，CI 1.039-2.065，P = 0.029）是预测血友病患者抑郁和焦虑的重要因素。参加临床试验的血友病患者有明显的焦虑和抑郁。获取医疗信息的频率以及基线 PHQ-9 和 GAD-7 评分是焦虑和抑郁的危险因素。因此，血友病患者应接受有关临床试验的教育，并对其焦虑和抑郁进行评估；这些变化将能够及时发现他们的心理负担，并确定潜在的心理干预策略。
