中国临床药理学杂志2025，Vol.41Issue(3)：306-310,5.DOI:10.13699/j.cnki.1001-6821.2025.03.002
巴戟天寡糖胶囊用于轻、中度抑郁症患者维持期治疗的临床研究
Clinical trial of Morinda officinalis oligosaccharides in the continuation treatment of mild and moderate depression
摘要
Abstract
Objective To evaluate the efficacy and safety of Morinda officinalis oligoes(MOs)capsules in the 24-week maintenance phase treatment of mild and moderate depression.Methods This study was the maintenance phase part of phase Ⅳ clinical trial for MOs capsules.Patients who was diagnosed as mild or moderate depressive episode were included into this study.Participants who were finished MOs capsules'8-week acute phase and 24-week continuation phase would go on to take MOs capsules for 24 weeks.During the acute phase,patients would take the start treatment dosage MOs capsules 300 mg qd for 2 weeks.On the final of week two,if HAMD-17 reduce rate＜30％,patients would take an increased dosage treatment about MOs capsules 600 mg qd,and if HAMD-17 reduce rate ≥ 30％,patients would continue the start treatment dosage.The dosage remained unchanged during the first 16 weeks in maintenance phase,and from week 17 to week 24 the dosage would be cut to the half.The changes from baseline to endpoint of Hamilton Depression Scale(HAMD),Hamilton Anxiety Scale(HAMA),Clinical Global Impression-Severity(CGI-S)and Arizona Sexual Experience Scale(ASEX)were evaluated,and recovery rate,relapse rate,relapse time were reported.The incidence of adverse events was reported.Results The scores of HAMA at baseline and after treatment were(3.64±2.51)and(2.84±2.60)points,the difference was statistical significant(P＜0.05).The scores of HAMD-17 at baseline and after treatment were(4.00±2.13)and(3.90±4.09)points,CGI-S were(1.02±0.51)and(0.90±0.79)points,scores of ASEX were(16.15±5.65)and(15.95±5.70)points,the differences were not statistical significant(P＞0.05).After 24-week's treatment,the recovery rate was 84.21％(96 cases/114 cases),the relapse rate was 6.14％(7 cases/114 cases),the relapse time was(82.14±39.66)d.The incidence of treatment-related adverse events was 33.05％(39 cases/118 cases).Conclusion MOs capsules can be used for the maintenance treatment of mild or moderate depression,and were well tolerated and safe.关键词
巴戟天寡糖胶囊/抑郁症/临床疗效/安全性/维持期Key words
Morinda officinalis oligose capsule/depression/clinical efficacy/safety/maintenance phase分类
医药卫生引用本文复制引用
许珂,李玉欣,闫少校,张玲,海英,贾智捷,王占敏,余雪芹,王洪明,吴斌,刘畅,蔡丽伟,宋学勤,房茂胜,王超英,宓为峰,张鸿燕,周书喆,桑红,樊国珍,田峰,王秀珍,魏琰,朱建国..巴戟天寡糖胶囊用于轻、中度抑郁症患者维持期治疗的临床研究[J].中国临床药理学杂志,2025,41(3):306-310,5.基金项目
国家"重大新药创制"科技重大专项课题资助项目(2014ZX09301307014) （2014ZX09301307014）
