Article(id=1317115190924128839, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1317115107243573307, articleNumber=null, orderNo=null, doi=10.13193/j.issn.1673-7717.2026.04.001, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1791954332333, onlineDateStr=2026-10-14, pubDate=1775750400000, pubDateStr=2026-04-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1791954332333, onlineIssueDateStr=2026-10-14, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1791954332333, creator=13701087609, updateTime=1791954332333, updator=13701087609, issue=Issue{id=1317115107243573307, tenantId=1146029695717560320, journalId=1255847919539208197, year='2026', volume='44', issue='4', pageStart='1', pageEnd='258', issueExtLink='null', onlineDate='null', pubDate='1775750400000', pubDateStr='2026-04-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1791954312382, creator='13701087609', updateTime=1791958738709, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1317133672680116252, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1317115107243573307, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1317133672680116253, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1317115107243573307, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1, endPage=6, ext={EN=ArticleExt(id=1317115191091901000, articleId=1317115190924128839, tenantId=1146029695717560320, journalId=1255847919539208197, language=EN, title=A Multicenter，Randomized，Placebo-Controlled Clinical Study on Clinical Efficacy of Simo Decoction Oral Liquid（四磨汤口服液）in Treatment of Functional Constipation（Qi Stagnation Constipation）, columnId=1317115107864330300, journalTitle=Chinese Archives of Traditional Chinese Medicine, columnName=New Opinion of Ph. D. Supervisor, runingTitle=null, highlight=null, articleAbstract=
Objective To explore the clinical efficacy and safety of Simo Decoction Oral Liquid（四磨汤口服液）in the treatment of functional constipation（Qi stagnation constipation）.
Method A multicenter, randomized, double-blind and placebocontrolled design was used to randomly divide 80 patients with functional constipation（Qi stagnation constipation）in 7 hospitals from March 2022 to June 2023 into two groups, 40 cases in the experimental group were given oral administration of Simo Decoction Oral Liquid, and 40 cases in the control group were given Simo Decoction Oral Liquid simulant. Both groups took the medicine two sticks for each time, twice a day, and the course was 8 weeks. The response rate of complete spontaneous defecation（CSBM）, the improvement of bowel movement - related symptoms, the scores of TCMsyndromes, the number of emergency drugs taken and the adverse reactions of the two groups were observed.
Result The overall CSBM response rate in the experimental group（FAS: 77.50%；PPS: 83.80%）was better than that in the control group（FAS: 22.50%；PPS: 17.10%）, with a statistically significant difference（P<0.001）. The weekly CSBMresponse rate of the experimental group（FAS: 82.5%）was significantly better than that of the control group（FAS: 22.50%）, with a statistically significant difference（P<0.001）. The change value of CSBMin the experimental group（FAS: 2.95±1.79）was higher than that of the control group（FAS: 0.74±1.53）, and the difference was statistically significant（P<0.001）. The abdominal pain in defecation, abdominal distension, effortful defecation and medication assisted defecation frequency, the primary symptoms（abdominal distension and unpleasant defecation）and the secondary symptoms（intestinal sounding and fullness in the chest and ribs points）of TCMsyndromes, as well as the amount of emergency medication intake before and after the treatment in the experimental group were better than those in the control group, with a statistically significant difference（P<0.05）. No adverse reactions related to the study drug occurred in neither group, the incidence of adverse reactions was 0.
Conclusion The total CSBMresponse rate of functional constipation（Qi stagnation constipation）treated with Simo Tang Oral Liquid was more than 50% higher than that of the control group, and it significantly improved the bowel movement-related symptoms such as abdominal pain, abdominal distention, unpleasant defecation, bowel sound, and chest and rib tightness, and the medication was safe.
, authors=Xudong TANG
1, Fang LU
1, Qian YANG
2, Xiaomeng LANG
2, Huiwu LIU
3, Hongmei YAN
3, Zufu YANG
4, Honglei CHEN
4, Haiqing LIANG
5, Yiran LI
5, Luzhou XU
6, Kai ZHENG
6, Xiaojun YANG
7, Wanqun CHEN
7, Hua YANG
8, Hongxia LYU
9, authorsList=Xudong TANG, Fang LU, Qian YANG, Xiaomeng LANG, Huiwu LIU, Hongmei YAN, Zufu YANG, Honglei CHEN, Haiqing LIANG, Yiran LI, Luzhou XU, Kai ZHENG, Xiaojun YANG, Wanqun CHEN, Hua YANG, Hongxia LYU, authorCompany=null, correspAuthors=null, 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=1317115191414862409, articleId=1317115190924128839, tenantId=1146029695717560320, journalId=1255847919539208197, language=CN, title=评价四磨汤口服液治疗功能性便秘（气滞秘）临床疗效的多中心、随机、安慰剂对照临床研究, columnId=1256183426563096985, journalTitle=中华中医药学刊, columnName=博士导师新论, runingTitle=null, highlight=null, articleAbstract=
目的 探索四磨汤口服液治疗功能性便秘（Functional Constipation，FC）（气滞秘）的临床疗效及安全性。
方法 采用多中心、随机、双盲、安慰剂对照设计，将2022年3月—2023年6月在7家医院纳入的功能性便秘（气滞秘）患者（80例）随机分为两组，试验组（40例）给予四磨汤口服液，对照组（40例）给予四磨汤口服液模拟剂，均2支/次，3次/d，疗程8周。观察两组完全自主排便次数（Complete Spontaneous Bowel Movement，CSBM）应答率、排便相关症状改善情况、中医证候积分、应急药物服用数量以及不良反应情况。
结果 试验组的总CSBM应答率[全分析数据集（Full Analysis Set，FAS）：77.50%；符合方案数据集（Per Protocol Set，PPS）：83.80%]高于对照组（FAS：22.50%；PPS：17.10%），差异有极显著统计学意义（P<0.001）；试验组的周CSBM应答率（FAS：82.5%）优于对照组应答率（FAS：22.50%），差异有极显著统计学意义（P<0.001）；试验组的CSBM变化值（FAS：2.95±1.79）高于对照组（FAS：0.74±1.53），差异有极显著统计学意义（P<0.001）。试验组治疗前后腹痛、腹胀、排便费力情况及药物辅助排便次数，中医证候主症腹胀和排便不爽、次症肠鸣和胸肋满闷积分以及应急药物服用数量（FAS）均优于对照组，差异有统计学意义（P<0.05）。两组均无与研究药物相关的不良反应发生，不良反应发生率为0。
结论 采用四磨汤口服液治疗FC（气滞秘）的总CSBM应答率高于对照组50%以上，显著改善腹痛、腹胀、排便不爽、肠鸣和胸肋满闷等排便相关症状，且用药安全。
, authors=唐旭东
1, 陆芳
1, 杨倩
2, 郎晓猛
2, 刘惠武
3, 严红梅
3, 杨祖福
4, 陈洪雷
4, 梁海清
5, 李一然
5, 徐陆周
6, 郑凯
6, 杨小军
7, 陈万群
7, 杨华
8, 吕红霞
9, authorsList=唐旭东, 陆芳, 杨倩, 郎晓猛, 刘惠武, 严红梅, 杨祖福, 陈洪雷, 梁海清, 李一然, 徐陆周, 郑凯, 杨小军, 陈万群, 杨华, 吕红霞, authorCompany=null, correspAuthors=null, authorNote=
唐旭东（1963-），男，江苏沭阳人，主任医师、教授，博士研究生导师，博士，研究方向：中医脾胃理论、中西医结合消化系统疾病的基础与临床、中医临床疗效评价方法学。
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1.Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1319630635933745811, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1317115190924128839, authorId=1319630635745002128, language=CN, stringName=唐旭东, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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唐旭东（1963-），男，江苏沭阳人，主任医师、教授，博士研究生导师，博士，研究方向：中医脾胃理论、中西医结合消化系统疾病的基础与临床、中医临床疗效评价方法学。
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唐旭东（1963-），男，江苏沭阳人，主任医师、教授，博士研究生导师，博士，研究方向：中医脾胃理论、中西医结合消化系统疾病的基础与临床、中医临床疗效评价方法学。
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2.Hebei Provincial Hospital of Traditional Chinese Medicine, Shijiazhuang 050013, Hebei, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1319630636487393949, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1317115190924128839, authorId=1319630636281873050, language=CN, stringName=杨倩, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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