二甲双胍治疗氨磺必利所致高催乳素血症的临床试验
Metformin in the Treatment of Amisulpride-Induced Hyperprolactinemia: A Clinical Trial.
作者信息
Zhu Cuifang, Li Ruofan, Ju Mingliang, Xiao Xudong, Yuan Ti-Fei, Jin Zhixing, Zhao Jing
机构信息
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
出版信息
Front Mol Neurosci. 2022 May 26;15:892477. doi: 10.3389/fnmol.2022.892477. eCollection 2022.
OBJECTIVE
To evaluate the efficacy and safety of metformin in the treatment of amisulpride-induced hyperprolactinemia.
METHODS
A total of 86 schizophrenic patients who developed hyperprolactinemia after taking amisulpride were screened and randomly assigned to the metformin group (42 patients) and placebo group (44 patients) and followed up for eight weeks. The patients' serum prolactin levels, blood glucose and lipids were measured at the baseline and the end of the intervention. The treatment emergent symptom scale (TESS) was also assessed.
RESULTS
After eight weeks of intervention, serum prolactin levels in the metformin group decreased from (1737.360 ± 626.918) mIU/L at baseline to (1618.625 ± 640.865) mIU/L, whereas serum prolactin levels in the placebo group increased from (2676.470 ± 1269.234) mIU/L at baseline to (2860.933 ± 1317.376) mIU/L. There was a significant difference in prolactin changes (F = 9.982, = 0.002) between the two groups. There was no significant difference in the incidence of adverse drug reactions ( > 0.05) between the two groups.
CONCLUSION
Metformin is able to improve amisulpride-induced hyperprolactinemia with its safety.
目的
评估二甲双胍治疗氨磺必利所致高催乳素血症的疗效和安全性。
方法
共筛选出86例服用氨磺必利后出现高催乳素血症的精神分裂症患者，随机分为二甲双胍组（42例）和安慰剂组（44例），随访8周。在干预基线和结束时测量患者的血清催乳素水平、血糖和血脂。同时评估治疗中出现的症状量表（TESS）。
结果
干预8周后，二甲双胍组血清催乳素水平从基线时的（1737.360±626.918）mIU/L降至（1618.625±640.865）mIU/L，而安慰剂组血清催乳素水平从基线时的（2676.470±1269.234）mIU/L升至（2860.933±1317.376）mIU/L。两组催乳素变化有显著差异（F = 9.982，P = 0.002）。两组药物不良反应发生率无显著差异（P＞0.05）。
结论
二甲双胍能够安全地改善氨磺必利所致的高催乳素血症。
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