Article(id=1291339190042611731, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291339070622396983, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.03.002, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1723651200000, receivedDateStr=2024-08-15, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785808854828, onlineDateStr=2026-08-04, pubDate=1739721600000, pubDateStr=2025-02-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785808854828, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785808854828, creator=13041195026, updateTime=1785808854828, updator=13041195026, issue=Issue{id=1291339070622396983, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='3', pageStart='301', pageEnd='450', issueExtLink='null', onlineDate='null', pubDate='1739721600000', pubDateStr='2025-02-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785808826353, creator='13041195026', updateTime=1785808826353, updator='13041195026', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=306, endPage=310, ext={EN=ArticleExt(id=1291339190277492756, articleId=1291339190042611731, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of Morinda officinalis oligosaccharides in the continuation treatment of mild and moderate depression, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
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.
, authors=Ke XU
1, Li-wei CAI
1, Shu-zhe ZHOU
1, Hong SANG
2, Guo-zhen FAN
3, Feng TIAN
4, Xiu-zhen WANG
5, Yan WEI
6, Jian-guo ZHU
6, Yu-xin LI
7, Shao-xiao YAN
8, Ling ZHANG
9, Ying HAI
10, Zhi-jie JIA
10, Zhan-min WANG
11, Xue-qin YU
12, Hong-ming WANG
13, Bin WU
14, Chang LIU
15, Xue-qin SONG
16, Mao-sheng FANG
17, Chao-ying WANG
18, Wei-feng MI
1, Hong-yan ZHANG
1, authorsList=Ke XU, Li-wei CAI, Shu-zhe ZHOU, Hong SANG, Guo-zhen FAN, Feng TIAN, Xiu-zhen WANG, Yan WEI, Jian-guo ZHU, Yu-xin LI, Shao-xiao YAN, Ling ZHANG, Ying HAI, Zhi-jie JIA, Zhan-min WANG, Xue-qin YU, Hong-ming WANG, Bin WU, Chang LIU, Xue-qin SONG, Mao-sheng FANG, Chao-ying WANG, Wei-feng MI, Hong-yan ZHANG, authorCompany=null, correspAuthors=Wei-feng MI, Hong-yan ZHANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291339190701117461, articleId=1291339190042611731, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=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, columnId=1246531407485489349, journalTitle=中国临床药理学杂志, columnName=临床与基础桥接研究, runingTitle=null, highlight=null, articleAbstract=
目的 观察巴戟天寡糖胶囊用于治疗轻、中度抑郁症患者的24周维持期的疗效和安全性。
方法 本研究为巴戟天寡糖Ⅳ期临床研究的维持期研究部分，以轻、中度抑郁症患者为研究对象，受试者完成巴戟天寡糖8周急性期和24周巩固期治疗后，将继续给予巴戟天寡糖胶囊24周。急性期第1～2周为初始剂量治疗（巴戟天寡糖300 mg·d-1），若第2周末HAMD-17减分率<30%则进入增量治疗（巴戟天寡糖600 mg·d-1），若第2周末HAMD-17减分率≥30%则维持初始剂量。巩固期继续使用急性期后6周的剂量。维持期0~16周维持巩固期剂量不变，17~24周剂量减半。比较患者治疗前后汉密尔顿抑郁量表（HAMD-17）、汉密尔顿焦虑量表（HAMA）、临床总体印象量表-严重度（CGI-S）和亚利桑那性体验量表（ASEX）评分的变化，记录患者临床痊愈率、复发率及复发时间，观察患者治疗相关不良事件的发生情况。
结果 治疗前后HAMA评分分别为（3.64±2.51）和（2.84±2.60）分，在统计学上差异有统计学意义（P<0.05）。治疗前后HAMD-17评分分别为（4.00±2.13）和（3.90±4.09）分，CGI-S评分分别为（1.02±0.51）和（0.90±0.79）分，ASEX评分分别为（16.15±5.65）和（15.95±5.70）分，在统计学上差异均无统计学意义（均P>0.05）。用药24周末患者痊愈率为84.21%（96例/114例），复发率为6.14%（7例/114例），复发时间为（82.14±39.66）d。不良事件发生率为33.05%（39例/118例）。
结论 巴戟天寡糖胶囊能用于轻、中度抑郁症的维持期治疗，且具有良好的耐受性和安全性。
, authors=许珂
1, 蔡丽伟
1, 周书喆
1, 桑红
2, 樊国珍
3, 田峰
4, 王秀珍
5, 魏琰
6, 朱建国
6, 李玉欣
7, 闫少校
8, 张玲
9, 海英
10, 贾智捷
10, 王占敏
11, 余雪芹
12, 王洪明
13, 吴斌
14, 刘畅
15, 宋学勤
16, 房茂胜
17, 王超英
18, 宓为峰
1, 张鸿燕
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许珂（1981-），女，主治医师，主要从事精神障碍方面的工作
蔡丽伟（1983-），男，主治医师，主要从事精神障碍方面的工作
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1.北京大学 第六医院，北京大学 精神卫生研究所，国家卫生健康委员会精神卫生学重点实验室，国家精神心理疾病临床医学研究中心 国家药物临床试验机构办公室，北京 100191, bio={"content":"
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1.北京大学 第六医院，北京大学 精神卫生研究所，国家卫生健康委员会精神卫生学重点实验室，国家精神心理疾病临床医学研究中心 国家药物临床试验机构办公室，北京 100191)])]), Author(id=1291339194887032914, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339190042611731, orderNo=1, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1291339194975113300, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339190042611731, authorId=1291339194887032914, language=EN, stringName=Li-wei CAI, firstName=Li-wei, middleName=null, lastName=CAI, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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蔡丽伟（1983-），男，主治医师，主要从事精神障碍方面的工作
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1.北京大学 第六医院，北京大学 精神卫生研究所，国家卫生健康委员会精神卫生学重点实验室，国家精神心理疾病临床医学研究中心 国家药物临床试验机构办公室，北京 100191)])]), Author(id=1291339195377766487, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339190042611731, orderNo=2, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1291339195549732953, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339190042611731, authorId=1291339195377766487, language=EN, stringName=Shu-zhe ZHOU, firstName=Shu-zhe, middleName=null, lastName=ZHOU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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1.Office of Good Clinical Practice, Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health, National Clinical Research Center for Mental Disorders, Beijing 100191, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1291339195625230426, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339190042611731, authorId=1291339195377766487, language=CN, stringName=周书喆, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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1.北京大学 第六医院，北京大学 精神卫生研究所，国家卫生健康委员会精神卫生学重点实验室，国家精神心理疾病临床医学研究中心 国家药物临床试验机构办公室，北京 100191)])]), Author(id=1291339195700727900, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339190042611731, orderNo=3, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1291339195981746270, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339190042611731, authorId=1291339195700727900, language=EN, stringName=Hong SANG, firstName=Hong, middleName=null, lastName=SANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
2, address=
2.Department of Psychiatry, Changchun Sixth Hospital, Changchun 130052, Jilin Province, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1291339196057243743, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339190042611731, authorId=1291339195700727900, language=CN, stringName=桑红, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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2.长春市第六医院 精神科，吉林 长春 130052, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1291339191229599769, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339190042611731, xref=2., ext=[AuthorCompanyExt(id=1291339191237988378, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339190042611731, companyId=1291339191229599769, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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2.长春市第六医院 精神科，吉林 长春 130052)])]), Author(id=1291339197751742561, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339190042611731, orderNo=4, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1291339197873377379, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339190042611731, authorId=1291339197751742561, language=EN, stringName=Guo-zhen FAN, firstName=Guo-zhen, middleName=null, lastName=FAN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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3.Department of Psychiatry, Jilin Neuropsychiatric Hospital, Songyuan 138001, Jilin Province, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1291339197948874852, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339190042611731, authorId=1291339197751742561, language=CN, stringName=樊国珍, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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1.北京大学 第六医院，北京大学 精神卫生研究所，国家卫生健康委员会精神卫生学重点实验室，国家精神心理疾病临床医学研究中心 国家药物临床试验机构办公室，北京 100191)]), AuthorCompany(id=1291339191229599769, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339190042611731, xref=2., ext=[AuthorCompanyExt(id=1291339191237988378, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339190042611731, companyId=1291339191229599769, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
2.Department of Psychiatry, Changchun Sixth Hospital, Changchun 130052, Jilin Province, China), AuthorCompanyExt(id=1291339191246376987, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339190042611731, companyId=1291339191229599769, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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3.Department of Psychiatry, Jilin Neuropsychiatric Hospital, Songyuan 138001, Jilin Province, China), AuthorCompanyExt(id=1291339191359623198, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339190042611731, companyId=1291339191326068764, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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4.Department of Psychiatry, Second Hospital of Shanxi Medical University, Taiyuan 030001, Shanxi Province, China), AuthorCompanyExt(id=1291339191443509281, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339190042611731, companyId=1291339191426732063, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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5.Department of Psychiatry, Shenyang Mental Health Center, Shenyang 110168, Liaoning Province, China), AuthorCompanyExt(id=1291339191523201060, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339190042611731, companyId=1291339191506423842, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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11.Department of Psychiatry, Rongjun Hospital of Hebei Provence, Shijiazhuang 050899, Hebei Province, China), AuthorCompanyExt(id=1291339193779736630, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339190042611731, companyId=1291339193754570804, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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14.Department of Psychiatry, Xi’an Mental Health Center, Xi’an 710061, Shaanxi Province, China), AuthorCompanyExt(id=1291339194094309439, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339190042611731, companyId=1291339194073337917, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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15.Department of Psychiatry, The Tirst Hospital of Jilin University, Changchun 130061, Jilin Province, China), AuthorCompanyExt(id=1291339194316607554, tenantId=1146029695717560320, journalId=1246415772164075586, articleId=1291339190042611731, companyId=1291339194169806912, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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