A meta-analysis of Chinese herbal medicines for vascular dementia

OBJECTIVE： To investigate the efficacy and safety of Chinese herbal medicines in the treatment of patients with vascular dementia. DATA RETRIEVAL： We retrieved publications from Cochrane Library （2004 to July 2011）, PubMed （1966 to July 2011）, the Chinese Science and Technique Journals Database （1977 to July 2011）, the China National Knowledge Infrastructure （1979 to July 2011）, Google Scholar （July 2011）, and the Chinese Biomedical Database （1977 to July 2011） using the key words ＂Chinese medicine OR Chinese herbal medicine＂ and ＂vascular dementia OR mild cognition impair OR multi-infarct dementia OR small-vessel dementia OR strategic infarct dementia OR hypoperfusion dementia OR hemorrhagic dementia OR hereditary vascular dementia＂. SELECTION CRITERIA： Randomized controlled trials comparing Chinese herbal medicines with placebo/western medicine in the treatment of patients with vascular dementia were included. Diagnostic standards included Diagnostic and Statistical Manual of Mental Disorders-IV, and National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherche et I＇Enseignement en Neurosciences. Two participants independently conducted literature screening, quality evaluation and data extraction. The quality of each trial was assessed according to the Cochrane Reviewers＇ Handbook 5.0. MAIN OUTCOME MEASURES： Effective rate, Mini-Mental State Examination scores, Hasegawa Dementia Scale scores, and incidence of adverse reactions. RESULTS： We identified 1 143 articles discussing the effects of Chinese medicine on vascular dementia. Thirty-one of these were included in the analysis. These studies involved a total of 2 868 participants （1 605 patients took Chinese medicine decoctions （treatment group）; 1 263 patients took western medicine or placebo）. The results of our meta-analysis revealed that Chinese herbal remedies in the treatment group were more efficacious than the control intervention （relative risk （RR） = 1.27; 95% confidence interval （C/）： 1.18-1.38, P 〈 0.01）. Mini-Mental State Examination scores were higher in patients taking Chinese herbal medicines than in those in the control group （weighted mean difference （WMD） = 2.83; 95%CI： 2.55-3.12, P 〈 0.01）. Patients in the treatment group showed better disease amelioration than those in the control group （Hasegawa Dementia Scale scores; WMD = 2.41, 95%CI： 1.48-3.34, P 〈 0.01）. There were also considerably fewer adverse reactions among those in the treatment group compared with those in the control group （RR = 0.20, 95%CI： 0.08-0.47, P 〈 0.01）. CONCLUSION： Chinese herbal medicine appears to be safer and more effective than control measures in the treatment of vascular dementia. However, the included trials were generally low in quality. More well-designed, high-quality trials are needed to provide better evidence for the assessment of the efficacy and safety of Chinese medicines for vascular dementia.

Pharmacokinetics of Two Ingredients of the Compound Chinese Herbal Medicine Transdermal Preparation in Cows

The topical administration of the compound Chinese herbal medicine transdermal preparation has been widely used in treating the mastitis of cows. In order to understand the metabolic process, four cows suffering from clinical mastitis were selected for the pharmacokinetic study. The transdermal preparation was applied to the diseased part of breast. Then the plasma and milk samples were collected respectively at 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, and 36 h, The concentrations of baicalin and phillyrin in plasma and milk were determined by HPLC and the data of time-concentrations were analyzed by the pharmacokinetic software. The results showed that two ingredients in the plasma were not detectable, but they in the milk had linear relationship with the time. The peak concentration of baicalin [（2.84 ±0.15）μg mL^-1] appeared at （4.93 ± 0.35） h, AUC0.1OQ was （27.32 ± 7.91） mg L^-1 h^-1, and the mean retention time was （28.31 ±0.49） h. The peak concentration of phillyrin [（0.49 ± 0.41） μg mL^-1] achieved at （3.68 ± 3.14） h, AUC0-LOQ was （4.10± 0.31） mg L^-1 h^-1, and the mean retention time was （14.52 ± 0.02） h. These suggested that two ingredients had slow absorbing speed and high absorbing degree. They could not be eliminated in a short time, thus exerted the topical curative effect.

Effects of Fermented Nano Chinese Herbal Medicines Replacing Antibiotics on Production Performance and Carcass Quality of Growing-Finishing Pigs

[Objectives]To study the effects of fermented nano Chinese herbal medicines replacing antibiotics on the production performance and carcass quality of growing-finishing pigs.[Methods]200 healthy and disease-free Duroc-Landrace-Yorkshire(DLY)growing-finishing pigs with similar birth time(45±2 d)and body weight of about 31.5 kg were randomly divided into group A(fed with non-antibiotic basal diet),group B(fed with antibiotic basal diet),group C(fed with non-antibiotic basal diet+0.1%fermented nano Chinese herbal medicine preparation),group D(fed with non-antibiotic basal diet+0.3%fermented nano Chinese herbal medicine preparation)and group E(fed with non-antibiotic basal diet+0.5%fermented nano Chinese herbal medicine preparation).The experiment lasted for 90 d.At the end of the experiment,the production performance and carcass indicators were measured.[Results]Compared with group A,the final weight,average daily gain(ADG)and average daily feed intake(ADFI)of groups B,C,D and E were extremely significantly increased(P<0.01),while the feed-to-gain ratio(F/G)was extremely significantly decreased(P<0.01).Compared with group B,the ADG of group E was significantly increased(P<0.05),while the F/G was significantly decreased(P<0.05).Compared with group A,the slaughter rate and carcass length of pigs in groups B,C,D and E were extremely significantly increased(P<0.01);compared with group B,the slaughter rate of groups D and E was extremely significantly increased(P<0.01).[Conclusions]The fermented nano Chinese herbal medicine preparation has better effects in promoting growth than that of antibiotic additives,and it can significantly improve the carcass quality of growing-finishing pigs.

Administration of modified Gegen Qinlian decoction for hemorrhagic chronic radiation proctitis: A case report and review of literature

BACKGROUND Hemorrhagic chronic radiation proctitis(CRP) is a common late complication of irradiation of the pelvis and seriously impairs life quality. There is no standard treatment for hemorrhagic CRP. Medical treatment, interventional treatment, and surgery are available, but they are limited in their applications due to nondefinite efficacy or side effects. Chinese herbal medicine(CHM), as a complementary or alternative therapy, may provide another option for hemorrhagic CRP treatment.CASE SUMMARY A 51-year-old woman with cervical cancer received intensity-modulated radiation therapy and brachytherapy with a total dose of 93 Gy fifteen days after hysterectomy and bilateral adnexectomy. She received six additional cycles of chemotherapy with carboplatin and paclitaxel. Nine months after radiotherapy treatment, she mainly complained of 5-6 times diarrhea daily and bloody purulent stools for over 10 d. After colonoscopy examinations, she was diagnosed with hemorrhagic CRP with a giant ulcer. After assessment, she received CHM treatment. The specific regimen was 150 mL of modified Gegen Qinlian decoction(GQD) used as a retention enema for 1 mo, followed by replacement with oral administration of 150 mL of modified GQD three times per day for 5 mo. After the whole treatment, her diarrhea reduced to 1-2 times a day. Her rectal tenesmus and mild pain in lower abdomen disappeared. Both colonoscopy and magnetic resonance imaging confirmed its significant improvement. During treatment,there were no side effects, such as liver and renal function damage.CONCLUSION Modified GQD may be another effective and safe option for hemorrhagic CRP patients with giant ulcers.

Effect and Safety of Herbal Medicine Foot Baths in Patients with Diabetic Peripheral Neuropathy:A Multicenter Double-Blind Randomized Controlled Trial

Objective:To evaluate the effect and safety of foot baths with Tangbi Waixi Decoction(TW)in treating patients with diabetic peripheral neuropathy(DPN).Methods:It is a multicenter double-blinded randomized controlled trial.Participants with DPN were recruited between November 18,2016 and May 30,2018 from 8 hospitals in China.All patients received basic treatments for glycemic management.Patients received foot baths with TW herbal granules either 66.9 g(intervention group)or 6.69 g(control group)for 30 min once a day for 2 weeks and followed by a 2-week rest,as a therapeutic course.If the Toronto Clinical Scoring System total score(TCSS-TS)6 points,the patients received a total of 3 therapeutic courses(for 12 weeks)and were followed up for 12 weeks.The primary outcome was change in TCSS-TS score at 12 and 24 weeks.Secondary outcomes included changes in bilateral motor nerve conduction velocity(MNCV)and sensory nerve conduction velocity(SNCV)of the median and common peroneal nerve.Safety was also assessed.Results:Totally 632 patients were enrolled,and 317 and 315 were randomized to the intervention and control groups,respectively.After the 12-week intervention,patients in both groups showed significant declines in TCSSTS scores,and significant increases in MNCV and SNCV of the median and common peroneal nerves compared with pre-treatment(P<0.05).The reduction of TCSS-TS score at 12 weeks and the increase of SNCV of median nerve at 24 weeks in the control group were greater than those in the intervention group(P<0.05).The number of adverse events did not differ significantly between groups(P>0.05),and no serious adverse event was related with treatment.Conclusion:Treatment of TW foot baths was safe and significantly benefitted patients with DPN.A low dose of TW appeared to be more effective than a high dose.(Registry No.Chi CTR-IOR-16009331)

Tyrosine hydroxylase expression in the midbrain of Parkinson's disease model rats treated with Xifeng Dingchan decoction

This study showed that abnormal behavioral changes were greatly improved in rats displaying Parkinson＇s disease-like symptoms after intragastric administration of Xifeng Dingchan decoction at 15, 7.5, 3.75 g/kg per day. In addition, tyrosine hydroxylase mRNA expression in the substantia nigra of the midbrain was up-regulated, and tyrosine hydroxylase content in the midbrain ventral tegmentum and substantia nigra pars compacta was also increased. The effect of administration of Xifeng Dingchan decoction at 7.5 g/kg per day was similar to that of Madopar at 67.5 mg/kg per day. These results indicate that the therapeutic effect of Xifeng Dingchan decoction on Parkinson＇s disease is associated with the up-regulated protein and mRNA expression of tyrosine hydroxylase in the midbrain.

基于中药监管科学创新技术体系破解国家中药类产品集中带量采购难点

在国家推动药品集中带量采购(以下简称集采)工作常态化背景下,中成药大品种在全国范围内的集采已经落地开展,中药饮片的省际联合采购也正在进行,而未来中药配方颗粒纳入集采也是大势所趋。然而,中药不同于化学药品,其原料来源于天然资源,组成成分复杂、功效主治多样,是一个多功效、多组分的复杂体系,加之中药类产品生产过程复杂,产品质量良莠不齐,生产成本相差悬殊,如何在中药类产品集采中科学评价产品质量,体现优质优价,以及如何科学评估中药类产品的生产成本,制定合理的最高限价,都是中药集采工作执行中亟待解决的难点问题。针对上述难点,笔者提出基于中药监管科学体系,创新制定中药类产品质量等级标准以及构建全产业链溯源与供应保障平台,从而确保中药类产品集采保质、提级、稳供、高质量发展的新思路。

2021-2023年某院含毒性饮片中成药分析

目的分析2021-2023年首都医科大学附属北京中医医院(以下简称“本院”)含毒性饮片中成药,为医疗机构合理管理含毒性饮片中成药提供参考。方法收集2021-2023年本院含毒性饮片中成药,统计含毒性饮片中成药品种数、功效、销售金额。结果2021-2023年,本院含毒性饮片中成药共110种,含大毒饮片中成药共10种,其中活血化瘀类中成药居首位;大毒饮片前3位为生草乌、生川乌、马钱子,有毒饮片前5位为朱砂、雄黄、制草乌、附子、全蝎,小毒饮片前3位为苦杏仁、水蛭、土鳖虫。销售金额前15位含毒性饮片中成药品种较稳定,关节克痹丸一直居于首位。结论通过对本院2021-2023年含毒性饮片中成药的分析,探讨保障含毒性饮片中成药安全使用的措施,具有一定可行性和必要性。

国家药品计划抽检品种麸炒薏苡仁质量问题分析及评价

目的:通过国家药品计划抽检工作,对药食两用中药材麸炒薏苡仁的质量进行考察,了解麸炒薏苡仁饮片质量现状及存在的问题,完善麸炒薏苡仁检验标准,为药品监管部门提供技术支持。方法:从全国24个省(市、自治区)的生产和使用环节抽取麸炒薏苡仁样品,按照《中华人民共和国药典》2020年版一部进行性状、水分、灰分、浸出物及含量测定项检验,分析检验数据以评价麸炒薏苡仁饮片的质量状况,并针对检验中发现的问题,开展探索性研究。结果与结论:本次抽验的麸炒薏苡仁样品共计98批次,按现行质量标准检验合格率均为100%。经探索性研究,发现麸炒薏苡仁存在炮制不到位的问题,33批次样品中4批次玉米赤霉烯酮超标;此外,甘油三油酸酯含量测定项限度偏低。通过探索性研究发现麸炒薏苡仁饮片和标准中的问题,结合标准提高工作完善麸炒薏苡仁检验标准。建议增加安全性控制指标及炮制控制指标,并提高含量测定限度。

温经汤对大鼠子宫内膜异位症SPARC介导的上皮-间质转化的影响

目的探讨温经汤对子宫内膜异位症(EMT)大鼠模型富含半胱氨酸的酸性分泌蛋白(SPARC)介导的上皮-间质转化的影响。方法采用手术自体移植子宫内膜块法建立EMT大鼠模型,将建模成功的40只大鼠随机分为模型组(给予质量分数为0.9%的氯化钠溶液10 mL/kg)、孕三烯酮组(给予孕三烯酮溶液0.5 mg/kg)以及温经汤低、中、高剂量组(分别给予温经汤免煎颗粒剂8.19 g/kg、16.38 g/kg、32.76 g/kg),每组各8只,另取7只未手术大鼠作为正常对照组(给予质量分数为0.9%的氯化钠溶液10 mL/kg)。所有大鼠均连续灌胃给药3周后进行取材。腹主动脉取血,采用酶联免疫吸附试验(ELISA)法检测血清中SPARC水平。电子游标卡尺测量异位病灶体积,计算生长抑制率。取下异位病灶组织(正常对照组取下双侧子宫组织)采用免疫组织化学法检测内膜组织中SPARC、锌指转录因子(Snail)、E-钙黏蛋白(E-cadherin)和波形蛋白(Vimentin)的表达,采用Western blot法和RT-qPCR法测定内膜组织中上述因子的蛋白和mRNA相对表达量。结果各治疗组异位病灶的生长抑制率与模型组比较差异均有统计学意义(P<0.05)。与正常对照组比较,模型组血清中SPARC水平显著升高(P<0.05),各治疗组血清中SPARC水平均明显低于模型组(P<0.05)。模型组异位内膜中SPARC、Snail、Vimentin呈高表达,E-cadherin呈低表达,经温经汤治疗后,异位内膜中SPARC、Snail、Vimentin的阳性表达减少,E-cadherin的阳性表达增加。温经汤中、高剂量组和孕三烯酮组异位内膜中SPARC、Snail、Vimentin的蛋白相对表达量均明显低于模型组(P<0.05),E-cadherin的蛋白相对表达量显著高于模型组(P<0.05)。温经汤高剂量组和孕三烯酮组异位内膜中Snail、Vimentin mRNA相对表达量均较模型组显著降低(P<0.05),E-cadherin mRNA相对表达量明显高于模型组(P<0.05)。结论温经汤可以降低EMT大鼠模型血清中SPARC水平,下调异位内膜中SPARC、Snail、Vimentin蛋白和mRNA表达,升高异位内膜中E-cadherin蛋白和mRNA表达,通过调控SPARC介导的上皮-间质转化,从而抑制异位内膜病灶的生长。

中药饮片质量追溯体系的建设及应用

追溯技术广泛应用于中药领域,中药材产品追溯体系逐渐形成,中药饮片的质量追溯管理模式也在不断进步。分析中药饮片质量追溯体系在国内部分省份的建设现状,阐明体系建设的促进方案,提出发挥行业协会积极性、专业性,及时发布法规及追溯标准,建设中药饮片追溯监管服务平台,完善饮片质量监管体系的发展策略。

本草经典理论体系之饮片炮制论

中医临床用药有2个最重要的特色:一是药材炮制成饮片后方能入药,中药的性、味、归经等功效属性均源自饮片;二是饮片需经临床医师辨证论治、复方配伍后使用,这样才能以君、臣、佐、使的和合之力发挥最佳疗效。炮制是形成性、味、归经等中药药性的重要阶段,也是中药临床应用的必经过程。炮制的自身发展也经历了从临床用药需求到药性形成需求的升华,从简单净制处理到水火共制成就药性的演变,从物理变化、化学变化到生物变化的递进,从产地粗加工到减毒增效、改性存效的精妙工艺传承。从炮制称谓演变开始,系统梳理炮制方法变迁、炮制目的演进、炮制工艺的传承,以期勾勒出本草经典中蕴含的中药饮片炮制科学理论。

不同中药炮制措施对中药饮片治疗效果的影响探讨

目的 分析不同中药炮制措施对中药饮片治疗效果的影响。方法 80例接受中药饮片治疗的患者,随机分为对照组与观察组,各40例。对照组在水处理前分档,观察组在水处理前分档联合炮制前分档。对比两组治疗效果及不良反应发生情况。结果 观察组治疗总有效率97.50%高于对照组的82.50%,差异有统计学意义(P<0.05)。观察组不良反应发生率5.00%显著低于对照组的20.00%,差异有统计学意义(P<0.05)。结论 不同的中药炮制措施会对中药饮片的治疗效果产生影响,水处理前分档联合炮制前分档的方式,可以使整体的治疗效果得到提升,并降低不良反应的发生率。

中药罗勒全国6个地方中药饮片炮制规范比较研究

目的:由于各地方中药饮片质量标准不统一,甚至出现矛盾现象,如“各地各法”“一药多法”的现象极为严重,导致各地区炮制规范存在一定的差异性,不仅影响中药饮片的市场流通,而且影响中药饮片的临床应用,在一定程度上妨碍了中医药产业的持续发展。方法:通过对中药材罗勒在全国6个地方中药饮片炮制规范中的差异比较和统计分析,明确各地区炮制规范内容的差异性。结果:罗勒各地方标准存在一定的差异,质量标准不统一。结论:各地方应尽快制定新版炮制规范,以统一的质量标准将其收录并进行有效监管,不仅可以加强对部分中药饮片的监管,还可以满足其临床用药需求。

“十四五”时期国家中医药综合改革示范区构建中药饮片溯源体系实践与探讨——以上海为例

介绍了中药材及中药饮片溯源的重要性,分析目前国家中医药综合改革示范区相关省市在中药材和中药饮片溯源方面开展的工作及问题,探讨上海作为国家中医药综合改革示范区在中药饮片溯源方面开展的实践、经验及面临的问题,提出完善我国构建中药饮片溯源体系的对策及建议。

3种中药配方颗粒全生产链的污染微生物考察

目的:对郁金、桑叶、蝉蜕中药配方颗粒生产全过程污染微生物进行考察,建立数据库,探索中药配方颗粒生产过程微生物关键控制点及控制措施,为企业提供示范性研究,为制定标准、改进生产工艺提供依据,填补质量全过程控制的空白。方法:对3种中药配方颗粒的原材料、中间产品、成品按照《中国药典》2020年版进行分析检测,采用质谱技术对负载微生物进行鉴定,分析研究从药材原料到中药配方颗粒成品的外源性污染微生物的程度及容易污染微生物的种类。结果:3种中药配方颗粒的原材料(中药饮片)微生物污染较严重,原材料的耐热芽孢杆菌即使经过工艺处理后,仍能在中间产品、成品中检出,并造成部分批次需氧菌总数结果超出限度规定;中间产品、成品中还检出来源于人和动物肠道中的屎肠球菌。结论:①加强中药饮片的微生物污染控制,有利于降低终端产品的微生物负载;②3种中药配方颗粒的生产工艺存在芽孢类微生物污染的风险,需优化生产工艺参数来降低微生物负载;③药品生产企业需加强对产品全过程控制,降低微生物污染风险。

基于虚拟仿真技术的微生物限度检查教学资源建设

针对中药饮片微生物限度检查实训教学中遇到的问题,以学生为中心,创设职业情境,设计开发虚拟仿真实训教学软件及配套数字化活页式实训手册。高质量的数字教学资源,能够增强学生学习体验感,引导学生积极探索与思考,提高学生创新能力。

门诊中药房中药饮片调剂差错原因分析及防范措施研究

分析门诊中药房中药饮片调剂差错的发生原因及防范措施。选取2022年8月—2023年8月盐城市中医院门诊中药房出现的82例中药饮片调剂差错事件,对差错原因进行分析,并提出防范对策。结果显示,82例门诊中药房中药饮片调剂差错事件中包含处方审方差错1例,药品漏配46例,药品错配11例,药品多配两例,剂量误差20例,药品发错两例。研究发现,门诊中药房中药饮片调剂差错出现的原因比较复杂,医院应加大对门诊中药房调剂人员的培训力度,提高处方开具规范性,加强处方监督,合理排班,从而降低门诊中药房中药饮片调剂差错率。

传统经验鉴定法应用于中药饮片鉴定中的效果

目的对中药饮片采用传统经验鉴定法取得的鉴定效果进行探究。方法研究时间为2023年1—11月;研究对象为中药饮片,包括茯苓、杜仲、松贝、西洋参、西红花、黄连、天麻、柴胡、乳香、车前子、鸡血藤、蛤蚧。比较传统经验鉴定法与现代鉴定结果的鉴定准确率。结果传统经验鉴定法与现代鉴定法相比较,中药饮片鉴定准确率无显著差异(P>0.05)。结论中药饮片鉴定中使用传统经验鉴定法与现代鉴定法,在准确率方面相当,相关人员可以根据实际工作需要选择合适的鉴定方法。

政策工具视角下三明市取消中药饮片加成政策文本分析

目的基于政策工具和政策目标2个维度,分析三明市取消中药饮片加成的政策文本特点,积累取消中药饮片加成经验,并提出思考。方法采用文献研究法并结合内容分析,构建政策工具和目标二维分析框架,对2013年1月—2023年4月三明市公开发表的有关取消中药饮片加成政策的26份政策文件进行编码分析。结果共计编码87条,需求型、供给型、环境型占比分别为16.09%、34.49%、49.42%,偏向于使用供给型和环境型政策工具;政策目标有一定倾向,“保证中药饮片质量”“完善中药饮片价格机制”“规范中药饮片使用”“强化组织实施,落实政府投入责任”占比分别为11.49%、39.08%、18.39%、31.03%。结论创新使用市场塑造等需求型工具,高质量推进饮片生产链发展;兼顾地域经济水平,将价格主动权归还市场,优化中药饮片行业市场结构,配合宣传措施,促进政策落实;改革药学人员人事薪酬制度,规范医疗行为。