中药配方颗粒临床应用国际专家共识

中药配方颗粒以中医药理论为指导,结合现代制剂新技术,选定最佳工艺,经现代化的制药技术提取、浓缩、干燥、制粒,精制而成。中药配方颗粒稳定、安全、便捷、有效。中药配方颗粒产业链相较于中药饮片可以实现从田间到车间的全程化、过程化控制,在药材来源、饮片炮制、加工工艺、质量检测、产品的销售流通等环节实现标准化管理。中药配方颗粒可部分替代中成药。目前中药配方颗粒仅涵盖常用的800余种中药,因此对许多临床并不常用的中药品种,中药配方颗粒并不能取代饮片。临床研究与动物实验中大量使用配方颗粒,从而使得科研人员不再对中药饮片进行提取与质量控制。应尽快从提高生产工艺、建立质量标准、完善监管制度、拓展临床应用等方面解决困扰配方颗粒发展所面临的问题。

Systematic review of Chinese herbal medicine for functional constipation

Constipation is a common gastrointestinal complaint in clinical practice,affecting an estimated 27% of the population.Many patients are disappointed by current conventional treatments and,therefore,seek help from complementary and alternative medicine(CAM).Traditional Chinese medicine,is the most important part of CAM and has been practiced for treating diseases and promoting the health of humans for thousands of years,and has become a popular alternative choice.Although there are many Chinese herbal medicine(CHM) interventions available,and some have been verif ied by clinical trials,their eff icacy and safety are still questioned by both patients and health care providers worldwide.The purposes of this review are,f irst,to appraise the qualities of individual study designs in the new Cochrane approach.Second,the benefits of individual CHM interventions or individual types of CHM intervention for the treatment of functional constipation are analyzed.Finally,valid and comprehensive conclusions are drawn,if applicable,in order to make clinical recommendations.

Impact of psychological stress on irritable bowel syndrome

Psychological stress is an important factor for the development of irritable bowel syndrome(IBS). More and more clinical and experimental evidence showed that IBS is a combination of irritable bowel and irritable brain. In the present review we discuss the potential role of psychological stress in the pathogenesis of IBS and provide comprehensive approaches in clinical treatment. Evidence from clinical and experimental studies showed that psychological stresses have marked impact on intestinal sensitivity, motility, secretion and permeability, and the underlying mechanism has a close correlation with mucosal immune activation, alterations in central nervous system, peripheral neurons and gastrointestinal microbiota. Stress-induced alterations in neuro-endocrine-immune pathways acts on the gut-brain axis and microbiota-gut-brain axis, and cause symptom flare-ups or exaggeration in IBS. IBS is a stresssensitive disorder, therefore, the treatment of IBS should focus on managing stress and stress-induced responses. Now, non-pharmacological approaches and pharmacological strategies that target on stress-related alterations, such as antidepressants, antipsychotics, miscellaneous agents, 5-HT synthesis inhibitors, selective 5-HT reuptake inhibitors, and specific 5-HT receptor antagonists or agonists have shown a critical role in IBS management. A integrative approach for IBS management is a necessary.

Key factors in developing the trinitrobenzene sulfonic acid-induced post-inflammatory irritable bowel syndrome model in rats

AIM:To investigate the key factors in developing the trinitrobenzene sulfonic acid(TNBS)-induced postinflammatory irritable bowel syndrome(PI-IBS)model in rats. METHODS:TNBS was administered to rats at the following conditions:(1)with different doses(20,10,5 mg/0.8 mL per rat);(2)with same dose in different concentrations(20 mg/rat,25,50 mg/mL);(3)in different ethanol percentage(25%,50%);and(4)at depth either 4 cm or 8 cm from anus.At 5 d and 4 wk after TNBS administration,inflammation severity and inflammation resolution were evaluated.At 4 and 8 wk after TNBS application,visceral hyperalgesia and enterochromaffin(EC)cell hyperplasia were assayed by abdominal withdrawal reflex test,silver staining and capillary electrophoresis. RESULTS:Our results showed that:(1)TNBS induced dose-dependent acute inflammation and inflammation resolution.At 5 d post TNBS,the pathological score and myeloperoxidase(MPO)activity in all TNBS treated rats were significantly elevated compared to that of the control(9.48±1.86,8.18±0.67,5.78± 0.77 vs 0,and 3.55±1.11,1.80±0.82,0.97±0.08 unit/mg vs 0.14±0.01 unit/mg,P<0.05).At 4 wk post TNBS,the pathological score in high and median dose TNBS-treated rats were still significantly higher than that of the control(1.52±0.38 and 0.80±0.35 vs 0,P<0.05);(2)Intracolonic TNBS administration position affected the persistence of visceral hyperalgesia.At 4 wk post TNBS,abdominal withdrawal reflex (AWR)threshold pressure in all TNBS-treated groups were decreased compared to that of the control(21.52 ±1.73 and 27.10±1.94 mmHg vs 34.44±1.89 mmHg,P<0.05).At 8 wk post TNBS,AWR threshold pressure in 8 cm administration group was still significantly decreased(23.33±1.33 mmHg vs 36.79±2.29 mmHg,P<0.05);(3)Ethanol percentage affected the TNBS-induced inflammation severity and visceral hyperalgesia.In TNBS-25%ethanol-treated group,the pathological score and MPO activity were significantly lowered compared to that of the TNBS-50%ethanoltreated group,while AWR threshold pressure were significantly elevated(36.33±0.61 mmHg vs 23.33±1.33 mmHg,P<0.05);and(4)TNBS(5 mg/0.8 mL per rat, in 50%ethanol,8 cm from anus)-treated rats recovered completely from the inflammation with acquired visceral hyperalgesia and EC cell hyperplasia at 4 wk after TNBS administration.CONCLUSION:TNBS dosage,concentration,intraco-lonic administration position,and ethanol percentage play important roles in developing visceral hyperalgesia and EC cell hyperplasia of TNBS-induced PI-IBS rats.

Extending the CONSORT Statement to moxibustion

The STandards for Reporting Interventions in Clinical Trials Of Moxibustion （STRICTOM）, in the form of a checklist and descriptions of checklist items, were designed to improve reporting of moxibustion trials, and thereby facilitating their interpretation and replication. The STRICTOM checklist included 7 items and 16 sub-items. These set out reporting guidelines for the moxibustion rationale, details of moxibustion, treatment regimen, other components of treatment, treatment provider background, control and comparator interventions, and precaution measures. In addition, there were descriptions of each item and examples of good reporting. It is intended that the STRICTOM can be used in conjunction with the main CONSORT Statement, extensions for nonpharmacologic treatment and pragmatic trials, and thereby raise the quality of reporting of clinical trials of moxibustion. Further comments will be solicited from the experts of the CONSORT Group, the STRICTA Group, acupuncture and moxibustion societies, and clinical trial authors for optimizing the STRICTOM.

International expert consensus on clinical application of traditional Chinese medicine formula granules

Guided by the theory of traditional Chinese medicine(TCM),TCM formula granules are made through the optimal process of extraction,concentration,drying,and granulation by combining modern new preparation technologies and pharmaceutical technologies.TCM formula granules are stable,safe,convenient,and effective.Compared with TCM decoction pieces,TCM formula granules can achieve the full process control of its industry chain from field to workshop and standardize the management of the origin of medicinal materials,processing of decoction pieces,processing technology,quality inspection,sales,and products distribution.TCM formula granules can partially replace Chinese patent medicines.Only available for around 800 common varieties of TCM,TCM formula granules cannot replace decoction pieces for many types which are not commonly used in clinical practice.A large number of formula granules are used in clinical and animal studies so that investigators no longer need to extract and control the quality of TCM decoction pieces.How to improve the production process,establish the quality standard,perfect the regulatory system,and expand the clinical application are the problems we need to solve as soon as possible for the better development of formula granules.

Therapeutic implications of antioxidant defense in acute pancreatitis

Acute pancreatitis is an inflammation initially localized in the pancreas,which may be accompanied with severe complications such as multi-organ failure,gastrointestinal hemorrhage and malnutrition.One in ten severe cases of acute pancreatitis develops systemic inflammatory response syndrome.Despite treatment,acute pancreatitis can be a life-threatening disease as its mortality rate amounts to 5%-10%in general,and up to 35%in cases of severe course.[1]Over the years,the role of oxidative stress

Proteome profiling of spinal cord and dorsal root ganglia in rats with trinitrobenzene sulfonic acid-induced colitis

AIM: To investigate proteomic changes in spinal cord and dorsal root ganglia (DRG) of rats with trinitrobenzene sulfonic acid (TNBS)-induced colitis. METHODS: The colonic myeloperoxidase (MPO) activity and tumor necrosis factor-(TNF- ) level were determined. A two-dimensional electrophoresis (2-DE)-based proteomic technique was used to profile the global protein expression changes in the DRG and spinal cord of the rats with acute colitis induced by intracolonic injection of TNBS. RESULTS: TNBS group showed significantly elevated colonic MPO activity and increased TNF-level. The proteins derived from lumbosacral enlargement of the spinal cord and DRG were resolved by 2-DE; and 26 and 19 proteins that displayed significantly different expression levels in the DRG and spinal cord were identified respectively. Altered proteins were found to be involved in a number of biological functions, such as inflammation/immunity, cell signaling, redox regulation, sulfate transport and cellular metabolism. The over-expression of the protein similar to potassium channel tetramerisation domain containing protein 12 (Kctd 12) and low expression of proteasome subunit type-1 (psma) were validated by Western blotting analysis. CONCLUSION: TNBS-induced colitis has a profound impact on protein profiling in the nervous system. This result helps understand the neurological pathogenesis of inflammatory bowel disease.

How to establish precise proprietary Chinese medicine in post-marketing reappraisal?

中药的临床疗效和安全性已成为公众关心的重大健康问题.中国食品药品监督管理局已经推动药品公司对中药进行上市后再评价,为药物的疗效和安全性提供更多的证据支持.在本文中,我们提出了一个'精准中药'的概念:i)精确地定义治疗目标;ii)制定计划;iii)控制中药的质量;iv)在临床试验中实施计划;v)研究中药的机制;vi)描述中药的适应症.我们希望这些步骤可以促进中药的上市后再评价.

A clinical pathway for integrative medicine in the treatment of functional constipation in Hong Kong,China

Objective:Functional constipation(FC)is a common intestinal disease worldwide.Despite the presence of criteria such as Roman IV,there is no standardized diagnosis and treatment algorithm in Hong Kong that combines both Western and Chinese medicine approaches.This study integrates current effective and safe diagnosis and treatment methods for FC and provides a clear and scientific pathway for clinical professionals and patients.Methods:A systematic search of the PubMed,Cochrane Library,and China National Knowledge Infrastructure databases was performed from their inception to June 30th,2022,collecting the current evidence about the efficacious integrative management for FC.We organized a meeting of professionals in fields relevant to treatment and management of FC to develop a consensus agreement on clinical pathway process.Results:We developed a clinical pathway for the treatment of FC based on the most recent published guidelines and consultation with experts.This pathway includes a hierarchy of recommendations for every step of the clinical process,including clinical intake,diagnostic examination,recommended labs,diagnostic flowchart,and guidance for selection of therapeutic drugs.Conclusion:This pathway establishes clinical standards for the diagnosis and treatment of FC using Chinese medicine and Western medicine;it will help to provide high-quality medical services in Hong Kong for patients with FC.

Chinese Herbal Medicine for Ulcerative Colitis:A Systematic Review Protocol

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.

Chinese Herbal Medicine for Chemotherapy Induced Gastrointestinal Side Effects: A Systematic Review of Randomized Controlled Trials

Objective: To determine how safe and effective Chinese Herbal Medicine(CHM) is in alleviating the nausea, vomiting, oral ulceration,diarrhea and constipation for cancer patients with chemotherapy.Methods: Data sources: A systematic review of Chinese and English articles using Ovid SP, CNKI, VIP Database and Traditional Chinese Medicine Database System. Study selection: Only randomized controlled trials(RCTs) for the prevention or treatment of any one of gastrointestinal side effects, namely nausea, vomiting, oral ulceration, diarrhea and constipation, of CHM with or without western medicine(WM) vs WM, placebo or no treatment were included. Data Extraction: Independent extraction of articles was first performed by four medical students using predefined data fields. Then, all data, including study quality indicators, was checked by two authors.Results: Eighty-six RCTs involving 7076 cancer patients were found and analyzed in this review. Because of the heterogeneity of study design and low overall methodological quality, only descriptive summaries were performed. Beneficial effects were found in some CHM interventions,regardless of being taken alone or taken with WM. Moreover, none of serious adverse effect was reported. However, same intervention had not been repeatedly investigated by different research teams.Conclusions: Implications of the analysis support the efficacy and safety of CHM for the management of gastrointestinal side effects.However, definite clinical recommendation for particular CHM intervention still cannot be made due to low methodological quality of included studies and lack of duplicated verification. Further large scale and high quality RCTs on the same CHM interventions are suggested.

Novel N-heteroaromatic dyes for textile substrates

This study reports the synthesis and characterization of quinoline derivatives. The synthesized quinoline compounds were applied to the dyeing treatment of acrylic fabrics. The color fastness to washing and light of quinoline compound-dyed fabrics was examined. Human skin HaCaT cell line was also used for the skin cytotoxicity evaluation of the quinoline compound-dyed acrylic fabrics.

Evaluation of the Pharmacokinetics and Renal Excretion of Ma-Zi-Ren-Wan in Health Subjects

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.

CHALLENGES AND OPPORTUNITIES OF CLINICAL STUDY IN CHINESE MEDICINE

Clinical trials are experimental studies done in clinical setting.Such prospective biomedical or behavioral studies on human beings are designed to answer specific questions about interventions,including new treatments and known interventions that warrant further study and comparison.Starting from 1980s,more and more of Chinese