Zandifar Atefeh, Badrfam Rahim, Sanjari Moghaddam Hossein, Akhondzadeh Shahin
Imam Ali Hospital, Alborz University of Medical Sciences, Karaj, Iran.
Psychiatry and Psychology Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Iran J Psychiatry. 2022 Jan;17(1):14-23. doi: 10.18502/ijps.v17i1.8045.
Spironolactone (C24H32O4S), a potent mineralocorticoid receptor (MR) inhibitor, is a potassium-sparing diuretic that is traditionally used to treat fluid build-up in the body or for its anti-androgenic properties. This study is a double-blind, placebo-controlled, randomized clinical trial assessing the beneficial effects of spironolactone in addition to risperidone in improving negative symptoms of schizophrenia. 40 patients with chronic schizophrenia, aged 18-60 years, were assigned to two groups: risperidone + spironolactone or risperidone + placebo. Risperidone was administered to both the spironolactone and placebo groups with a dose up to 6 mg/day throughout the trial. Spironolactone (C24H32O4S) was ordered 100 mg/day for the full 8-week course of the study. Patients were rated on the Positive and Negative Syndrome Scale (PANSS) at four time points: baseline, weeks two, four, and eight. The PANSS negative subscale score was the main objective. PANSS negative, positive, and total scores showed significantly greater improvements in the spironolactone relative to the placebo group from baseline to the trial endpoint (P (Cohen's d): 0.004 (0.96), 0.007 (0.90), and 0.042 (0.66), respectively). Similarly, ANOVA also presented significant time × treatment interaction effect for spironolactone on PANSS negative (F = 9.04; ηp2 = 0.19; df = 1.38; P = 0.002), positive (F = 3.43; ηp2 = 0.08; df = 2.72; P = 0.023), and total (F = 3.94; ηp2 = 0.09; df = 2.05; P = 0.022) scores. However, spironolactone did not cause significant decrease in the general psychiatric pathology score of PANSS. Our findings suggest the efficacy and safety of spironolactone as an adjunctive therapy to risperidone in improving the symptoms of schizophrenia.
螺内酯（C₂₄H₃₂O₄S）是一种强效的盐皮质激素受体（MR）抑制剂，是一种保钾利尿剂，传统上用于治疗体内液体潴留或因其抗雄激素特性而使用。本研究是一项双盲、安慰剂对照、随机临床试验，评估螺内酯联合利培酮对改善精神分裂症阴性症状的有益效果。40名年龄在18至60岁之间的慢性精神分裂症患者被分为两组：利培酮 + 螺内酯组或利培酮 + 安慰剂组。在整个试验过程中，利培酮给予螺内酯组和安慰剂组，剂量最高达6毫克/天。在为期8周的整个研究过程中，螺内酯（C₂₄H₃₂O₄S）的服用剂量为每日100毫克。在四个时间点对患者进行阳性和阴性症状量表（PANSS）评分：基线、第2周、第4周和第8周。PANSS阴性分量表评分是主要观察指标。从基线到试验终点，与安慰剂组相比，螺内酯组的PANSS阴性、阳性和总分改善显著更大（P（科恩d值）：分别为0.004（0.96）、0.007（0.90）和0.042（0.66））。同样，方差分析也显示螺内酯对PANSS阴性（F = 9.04；ηp² = 0.19；自由度 = 1.38；P = 0.002）、阳性（F = 3.43；ηp² = 0.08；自由度 = 2.72；P = 0.023）和总分（F = 3.94；ηp² = 0.09；自由度 = 2.05；P = 0.022）有显著的时间×治疗交互作用。然而，螺内酯并未导致PANSS的总体精神病理评分显著降低。我们的研究结果表明，螺内酯作为利培酮的辅助治疗药物，在改善精神分裂症症状方面具有有效性和安全性。
