Introduction: This manuscript aims to provide a protocol of systematic review to assess the safety and effectiveness of Chinese herbal medicine(CHM) for the treatment of ulcerative colitis(UC). Although CHM has been w...Introduction: This manuscript aims to provide a protocol of systematic review to assess the safety and effectiveness of Chinese herbal medicine(CHM) for the treatment of ulcerative colitis(UC). Although CHM has been widely used for UC, its effectiveness and safety has not yet been well defined and analyzed.Methods and analysis: Seven electronic databases were searched, including China National Knowledge Infrastructure(CNKI), Chinese Biomedical literature(CBL), VIP database, Cochrane Library, MEDLINE, PubMed and China Journals Full-text Database. Related Chinese literature will be searched in other Chinese databases. All relevant randomized controlled literature of publication type will be included.Assessment of risk of bias, data synthesis and subgroup analysis will be carried out using Review Manager 5.2.Ethics and dissemination: The results of the systematic review will be disseminated via publication in a peer-reviewed journal and presented at a relevant conference.展开更多
Background: Ma-Zi-Ren-Wan(MZRW) is a classic Chinese formula for treating human constipation. It is comprised of six herbs.Our previous studies have shown its great therapeutic effect. The absorbed compounds had been ...Background: Ma-Zi-Ren-Wan(MZRW) is a classic Chinese formula for treating human constipation. It is comprised of six herbs.Our previous studies have shown its great therapeutic effect. The absorbed compounds had been studied in rat, while there was no study about its components in human body.Objectives: To observe the components of MZRW absorbed in health subjects and study the pharmacokinetics of major compounds. At the same time, to observe the renal excretion of MZRW in health subjects based on the quantification of major compounds.Methods: Health adults were randomly assigned to three dose groups(5 g, 7.5 g and 10 g q.d.) of MZRW. Blood samples were collected from the medial cubital vein just before and at 0.25, 0.5, 1, 2, 4, 8 and 12 h after administration. Urine samples were collected at 0 to 3 h, 3 to 6 h, 6 to 9 h and 9 to 12 h after MZRW administration, with the urine volume recorded for each time segment. Plasma and urine samples were analyzed by optimized LC-MSMS(Liquid chromatography-tandem mass spectrometry) method for pharmacokinetics and renal excretion study of MZRW.Results: Ten compounds of MZRW were observed in 23 health subjects. Due to the low concentration in plasma at the current dose, only four compounds(Albiflorin, paeoniflorin, magnolol and rhein) were quantified in the plasma sample. Honokiol, aloe emodin and emodin could only meet the LLOQ at some time points of the high dose group. Hesperidin, naringin and amygdalin could not be detected in plasma sample. While seven compounds(Amygdalin, albiflorin, paeoniflorin, magnolol, honokiol, rhein and aloe emodin) could be quantified in urine, the renal excretion was well studied.Conclusion: MZRW was safe and well tolerated in this clinical study. Albiflorin, paeoniflorin, magnolol and rhein was well quantified in plasma. The renal excretion of paeoniflorin, albiflorin and rhein were dose dependent for doses ranging between 5 and 10 g.展开更多
基金supported by the project of Traditional Chinese Medicine for Inflammatory Bowel Disease:Efficacy Confirmation and Basic Mechanism Study,HKBU/IRMS
文摘Introduction: This manuscript aims to provide a protocol of systematic review to assess the safety and effectiveness of Chinese herbal medicine(CHM) for the treatment of ulcerative colitis(UC). Although CHM has been widely used for UC, its effectiveness and safety has not yet been well defined and analyzed.Methods and analysis: Seven electronic databases were searched, including China National Knowledge Infrastructure(CNKI), Chinese Biomedical literature(CBL), VIP database, Cochrane Library, MEDLINE, PubMed and China Journals Full-text Database. Related Chinese literature will be searched in other Chinese databases. All relevant randomized controlled literature of publication type will be included.Assessment of risk of bias, data synthesis and subgroup analysis will be carried out using Review Manager 5.2.Ethics and dissemination: The results of the systematic review will be disseminated via publication in a peer-reviewed journal and presented at a relevant conference.
基金supported by Hong Kong Baptist University Faculty Research Grant Category Ⅱ. Grant No.: HKBU/ FRG2/13-14/025Shenzhen Science and Technology Innovation Committee JCYJ20140419130444178
文摘Background: Ma-Zi-Ren-Wan(MZRW) is a classic Chinese formula for treating human constipation. It is comprised of six herbs.Our previous studies have shown its great therapeutic effect. The absorbed compounds had been studied in rat, while there was no study about its components in human body.Objectives: To observe the components of MZRW absorbed in health subjects and study the pharmacokinetics of major compounds. At the same time, to observe the renal excretion of MZRW in health subjects based on the quantification of major compounds.Methods: Health adults were randomly assigned to three dose groups(5 g, 7.5 g and 10 g q.d.) of MZRW. Blood samples were collected from the medial cubital vein just before and at 0.25, 0.5, 1, 2, 4, 8 and 12 h after administration. Urine samples were collected at 0 to 3 h, 3 to 6 h, 6 to 9 h and 9 to 12 h after MZRW administration, with the urine volume recorded for each time segment. Plasma and urine samples were analyzed by optimized LC-MSMS(Liquid chromatography-tandem mass spectrometry) method for pharmacokinetics and renal excretion study of MZRW.Results: Ten compounds of MZRW were observed in 23 health subjects. Due to the low concentration in plasma at the current dose, only four compounds(Albiflorin, paeoniflorin, magnolol and rhein) were quantified in the plasma sample. Honokiol, aloe emodin and emodin could only meet the LLOQ at some time points of the high dose group. Hesperidin, naringin and amygdalin could not be detected in plasma sample. While seven compounds(Amygdalin, albiflorin, paeoniflorin, magnolol, honokiol, rhein and aloe emodin) could be quantified in urine, the renal excretion was well studied.Conclusion: MZRW was safe and well tolerated in this clinical study. Albiflorin, paeoniflorin, magnolol and rhein was well quantified in plasma. The renal excretion of paeoniflorin, albiflorin and rhein were dose dependent for doses ranging between 5 and 10 g.
