Article(id=1236331161891426660, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236331158678597790, articleNumber=null, orderNo=null, doi=null, 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=1678636800000, acceptedDateStr=2023-03-13, onlineDate=1772693918917, onlineDateStr=2026-03-05, pubDate=1698595200000, pubDateStr=2023-10-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772693918917, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772693918917, creator=13701087609, updateTime=1772693918917, updator=13701087609, issue=Issue{id=1236331158678597790, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='20', pageStart='2009', pageEnd='2120', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772693918151, creator=13701087609, updateTime=1772694963216, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236335542061814375, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236331158678597790, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236335542061814376, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236331158678597790, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=2087, endPage=2092, ext={EN=ArticleExt(id=1236331162117919087, articleId=1236331161891426660, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Evaluation of efficacy and safety of Jiuwei Zhike mixture in the treatment of wind-heat cough syndrome of acute bronchitis, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To evaluate the clinical safety and effectiveness of Jiuwei Zhike mixture in the treatment of wind-heat cough syndrome of acute bronchitis.
Methods: A randomized, double-blind, double-simulation, placebo and positive drug controlled, multi-center clinical trial design was adopted. The selected disease was acute bronchitis (wind-heat cough syndrome). Seven hundred subjects from 10 research centers were planned to be included and divided into treatment group, positive drug control group and placebo group in a ratio of 3∶1∶1. The patients took Jiuwei Zhike mixture+Jizhi syrup simulation agent, Jiuwei Zhike mixture simulation agent+Jizhi syrup, or Jiuwei Zhike mixture simulation agent+Jizhi syrup simulation agent for 7 d.
Results: Jiuwei Zhike mixture took effect on acute bronchitis (wind-heat cough syndrome) from the 3rd day of administration. By the 7th day of administration, 54.7% of the subjects' cough symptoms completely disappeared (49.2% in the positive drug group and 15.1% in the placebo group), with a clinical recovery rate of about 51.6% (43.5% in the positive drug group and 13.7% in the placebo group), and a total effective rate of 93.4% (87.1% in the positive drug group and 41.9% in the placebo group). And it had a significant improvement effect on the symptoms of the disease.
Conclusion: Jiuwei Zhike mixture is safe and effective in treating acute bronchitis (wind-heat cough syndrome) and its curative effect is not inferior to Jizhi syrup and superior to placebo.
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目的： 评价九味止咳口服液治疗急性支气管炎风热咳嗽证的临床安全性和有效性。
方法： 采用随机、双盲双模拟、安慰剂及阳性药对照、多中心临床试验设计，所选病症为急性支气管炎（风热咳嗽证），计划纳入10家研究中心700例受试者，按3∶1∶1的比例分为试验组、阳性药物对照组和安慰剂组。分别服用九味止咳口服液+急支糖浆模拟剂、九味止咳口服液模拟剂+急支糖浆、九味止咳口服液模拟剂+急支糖浆模拟剂，疗程为7 d。
结果： 九味止咳口服液对于急性支气管炎（风热咳嗽证）从服药d 3开始起效，服药至d 7，54.7%的受试者咳嗽症状完全消失（阳性药组49.2%，安慰剂组15.1%），临床痊愈率约为51.6%（阳性药组43.5%，安慰剂组13.7%），总有效率为93.4%（阳性药组87.1%，安慰剂组41.9%），对疾病的各种单项症状均有显著的改善作用。
结论： 九味止咳口服液治疗急性支气管炎（风热咳嗽证）安全、有效。九味止咳口服液疗效非劣效于急支糖浆，优于安慰剂。
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张薇，女，主治医师，主要从事中药新药开发与研究。联系电话：(0512)62956088，E-mail: zhangwei.lc@youseen.com。
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张薇，女，主治医师，主要从事中药新药开发与研究。联系电话：(0512)62956088，E-mail: zhangwei.lc@youseen.com。
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