中药复方、中草药及其有效成分提取物治疗慢性丙型肝炎随机对照试验的系统综述和meta分析

背景：干扰素联合利巴韦林是慢性丙型肝炎的常规治疗方法,然而,该疗法存在一定副作用,对部分患者疗效不佳,且治疗费用昂贵。中医药治疗慢性肝病包括丙型肝炎有大量报道,需要进行系统综述。 目的：运用循证医学系统综述方法评价中草药治疗慢性丙型肝炎的疗效和安全性。 检索策略：MEDLINE、Cochrane图书馆（2009年第3期）、中国学术期刊全文数据库、中文科技期刊全文数据库、中国生物医学文献数据库、中文生物医学期刊数据库、中医药期刊文献数据库。检索日期截止2009年7月8日。 纳入标准：收集比较中草药与安慰剂、非特异性治疗、干扰素治疗丙型肝炎的随机对照试验。中草药联用干扰素与单用干扰素比较的试验也予以纳入。 资料提取与分析：两人独立提取资料,采用Cochrane协作网提供的软件RevMan 5.017进行资料分析。结局的效应指标为相对危险度或均数差,均以95%可信区间表示。 结果：51篇随机对照试验满足纳入标准,共治疗3 678名病人。所纳入的6篇英文文献质量较高,中文文献质量普遍偏低。在临床症状、肝功能及抗病毒效应的综合疗效分析中,中草药明显优于非特异性治疗,与干扰素疗效相当,中药联合干扰素与单用干扰素比较,差异无统计学意义。中药对血清丙型肝炎病毒（hepatitis C virus, HCV）RNA阴转的效果明显优于非特异性治疗,与干扰素抗病毒治疗比较,差异无统计学意义,而与干扰素合用的疗效优于单用干扰素;中药及其与抗病毒药物合用的抗HCV抗体阴转疗效均优于单用干扰素治疗。在改善肝功能指标上中药显著优于安慰剂、非特异性治疗,且与干扰素抗病毒治疗比较,差异无统计学意义,但与抗病毒治疗联合使用则优于单用抗病毒治疗。随访的疗效分析表明上述效应具有持续性。中药注射剂及抗病毒治疗均有一定的副作用,个别患者有较严重的副作用。 结论：纳入本系统综述的部分中草药治疗慢性丙型肝炎具有改善症状、促进肝功能恢复和清除血清HCV标志物的作用。但是由于中文发表的临床试验质量较低,对那些疗效较好的中药制剂需要作进一步的验证,试验的设计及报告应按照国际规范执行。     

Disease-syndrome combination clinical study of psoriasis: Present status, advantages, and prospects

Psoriasis is an immune-abnormal,chronic,proliferative skin disease determined by polygenic inheritance and induced by a number of environmental factors.It causes worldwide concern because of its high-prevalence,harmful and incurable characteristics.Over the years,Chinese medicine(CM) treatment of psoriasis has accumulated a wealth of clinical experience.Disease-syndrome combination, which achieves more satisfactory clinical effect,is the basis to highlight the special CM advantages in treating psoriasis.In this paper,we review the advantages of treating psoriasis with the combination of disease and syndrome,analyze the prospects of research on treating psoriasis combining disease with syndrome.We also make a point that there are several key points for the clinical research of combination of disease and syndrome.It can be expected that carrying out clinical research on the combination of disease and syndrome will help improve the clinical efficacy of medical treatment of psoriasis,which will be the main direction of research in the future.     

Efficacy of externally applied Chinese herbal drugs in treating psoriasis: A systematic review

Objective:To assess the efficacy and safety of external application of Chinese herbal drugs(exCHD) in the treatment of psoriasis.Methods:Literature regarding randomized clinical trials(RCTs) of psoriasis treatments with ex-CHD,either alone or combined with Western medicine(WM) or physiotherapy,controlled by untreated,placebo or WM treatment were found in electronic databases,including PubMed/MEDLINE, EMBASE,Cochrane Library,Cochrane Central Register of Controlled Trials,China Biology Medicine Disc(CBM), Chinese National Knowledge Infrastructure(CNKI),Wanfang database and VIP database from their inception through July 2011.Study selection,data extraction,quality assessment,and data analyses were conducted according to the Cochrane standards.Results:A total of 10 randomized trials(involving 1,435 patients) were included.Because both test and control drugs used in the RCTs were different from each other,the effects can only be described singly and calculated.Regarding the total effective rate for the treatment of psoriasis,exCHD in combination with ultraviolet radiation b(UVB) or narrow band ultraviolet radiation b(NB-UVB),which was reported in 6 trials,was superior to UVB alone.One study reported that ex-CHD and externally applied WM had equivalent effects.In another study,ex-CHD showed better results than placebo.However,another two comparisons of ex-CHD and WM(all in combining with oral WM) showed uncertain outcomes.Nine trials reported adverse reactions.Of these,7 RCTs included statistical analysis.The results showed that the sideeffects that occurred in ex-CHD combined with UVB were less severe than those caused by UVB alone,but the incidence was roughly the same as WM.Conclusion:The evidence supporting the efficacy of ex-CHD with respect to treating psoriasis is quite limited and must be strengthened by high-quality studies.     

寻常型银屑病发病相关因素及临床疗效分析

目的探讨寻常型银屑病发病相关因素及临床治疗效果,寻找发病规律及优化治疗方案。方法采用EXCEL软件建立寻常型银屑病住院患者数据库,分析新疆医科大学附属中医医院皮肤科2010年1～12月1 074例寻常型银屑病住院患者的临床资料。结果 1 074例患者经过治疗后痊愈和显效324例,总有效率达96%;住院时间16～18d,中药内服+药浴+拔罐+光疗综合治疗组疗效明显高于其他各组(P<0.05)。结论寻常型银屑病住院患者以脾虚湿盛型为主,采用中西医结合、内治外治结合的综合疗法,可提高疗效,缩短疗程。     

Effects and mechanisms of actions of Chinese herbal medicines for asthma

Asthma is a chronic inflammatory disorder of airways that affects approximately 300 million adults and children worldwide.Most therapy currently uses bronchodilators and corticosteroids.Systemic side effects from chronic use of these drugs are concern.Chinese medicine(CM)has a long history of human use in China and other Asian countries and well received by the patients.But as one component of Western integrative medicine(WIM),it is required that CM use is supported by scientific evidence.On the other hand,there are also suggestions that Western standardized medicine should consider personalized practice.In recent years there have been an increasing studies to narrow the gap between CM,the personalized medicine and Western medicine,evidence based medicine.This communication reviews several CM studies published in the English language in details by reviewing the effects and mechanisms of actions on asthma from clinic and experimental studies. Chinese herbal medicines exhibit broad actions on multiple asthma pathologic mechanisms.These mechanisms may involve antiinflammatory and immunomodulatory effects,inhibiting airway remodeling and normalization of hypothalamus,pituitary and adrenal(HPA)-axis disturbances.However,the mechanisms of actions of Chinese herbal medicines for asthma are not fully understood.More controlled clinical studies are warranted and some anti-asthma CM may be proved to be effective when used as monotherapy or complementary asthma therapies.     

Review of the Regulations for Clinical Research in Herbal Medicines in USA

In 2012,USA Food and Drug Administration（FDA） approved 39 new drugs,however,there are only two botanical drugs（one topical and one oral）approved by FDA since the publication of the FDA＇s industry guidelines for the botanical drug product in June 2004.The approval shows the Western guideline can be used for herbal medicines,authors investigate current regulation on herbal medicine clinical research,identify challenges conducting clinical trials,and seek to produce some guidance for potential investigators and sponsors considering a clinical trial in this area.Key words were formulated for searching on Medline and FDA website to locate relevant regulations for clinical research in herbal medicines to understand current environment for herbal medicine usage and examine the barriers affecting herbal medicine in clinical trials.Authors critically explore case study of the 1st FDA approved botanical drugs,Veregen（sinecatechins）,green tea leaves extract,a topical cream for perianal and genital condyloma.In consideration of current regulation environment in USA,based on the findings and analysis through the literature review and Veregen case study,authors produce and propose a Checklist for New Drug Application of Herbal Medicines for potential investigators and sponsors considerina in a herbal medicine clinical trial.     

Effect of Chinese herbal medicine combined with acitretin capsule in treating psoriasis of blood-heat syndrome type

Objective:To observe the clinical curative effect of Chinese herbal medicine combined with acitretin capsule in treating psoriasis of blood-heat syndrome(P-BH).Methods:Eighty patients of P-BH were randomly assigned to two groups,39 in Group A and 41 in Group B.Both was treated with Chinese herbal medicines for clearing heat,cooling blood and removing toxic substance,and acitretin capsule was given to Group A additionally,with 8 weeks as one therapeutic course.The clinical curative effect was compared bet...     

基于析因设计的中药熏蒸治疗血热型银屑病研究

[目的]通过析因设计探究中药熏蒸治疗血热型银屑病的临床疗效。[方法]按两因素三水平的析因设计方法进行分析,两因素即温度组、时间组,三水平即温度组(38、40、42℃)、时间组(20、25、30 min),采集90例住院患者,随机分为9组进行试验,疗程均为2周。[结果]不同温度、时间组合对中药熏蒸治疗血热型银屑病的疗效影响大小为:42℃×25 min42℃×30 min42℃×20 min40℃×25 min40℃×20 min38℃×30 min40℃×30 min38℃×20 min38℃×25 min。在时间与温度的交互作用统计分析结果中,提示时间、温度之间的交互作用无统计学意义(P0.05),但就温度的单独效应结果来看,差异有统计学意义(P0.05),即不同的温度对银屑病面积与严重性指数(PASI)评分下降值具有显著影响。进一步分析,42℃温度条件下对PASI评分降低影响更为显著。[结论]中药熏蒸对血热型银屑病有良好的治疗效果,42℃×25 min组合的疗效明显优于其他组合,且无明显不良反应。     

英国人用传统草药药品政策分析

英国是欧盟中第一个启动对传统医药进行立法管理的国家。根据《欧盟传统草药指令》,英国制订了《英国人用传统草药产品法规2005》、《英国传统草药登记方案》等一系列有关传统草药管理的法规、指南等,从传统草药药品的申报、零售、批发、进口及生产各个环节进行管理,以保证安全、有效和质量可控。以英国传统草药登记程序、豁免条件等内容为切入点,对英国人用传统草药药品的相关政策进行分析,为意欲进入欧盟市场的中医药科研单位及制药企业提供参考。     

中草药临床研究的评价

补充替代医学正被广泛应用,并呈现出良好的增长趋势。随着寻求补充替代医学疗法的人口比例的增长,无论是补充替代医学被单独使用,还是与传统的对抗疗法联合应用,对补充替代医学临床报告质量的研究变得日益迫切。大部分这种质量研究是针对那些主要目的在于为临床医师提供参考的临床研究报告,我们发现,在解释临床研究的结果及其意义时,人们不得不面对其方法学质量低劣的问题。如何解决这个问题,将是我们面临的巨大挑战。临床医师要有效地利用这些科学研究的文献,就必须熟悉循证医学的基本原则。本文的目的在于向临床医师介绍临床研究评价的概念,使他们在阅读研究论文时能带着评判的眼光,以便更好地评价论文中的研究结果,并将其合理地运用到自己的日常医疗实践中去。本文主要讨论了以下六个方面的问题:(1)循证医学的基本原理;(2)临床研究的类型;(3)证据的分级;(4)应用临床试验报告统一标准评价随机对照试验报告的质量;(5)随机对照试验方法学质量的评分;(6)中草药临床研究质量评价的有关问题。     

植物药预防尿路结石

对有预防尿路结石作用的植物药进行综述：(1)中草药,包括泽泻、胖大海、金钱草、中国米糠、玉米须及芭蕉芯;(2)国外的植物药,包括Herniaria hirsuta,Phyllantus niruri,Costus spiralis Roscce,Aerva lanata,Vediuppu chunnam,Dolichos biflorus,Cyclea peltata,Rotuls squstica lour,Ammi visnaga.     

中药复方预防流感样症状：一项随机双盲临床试验

Objective: To investigate the efficacy of a herbal formula in the prevention of influenza or influenza-like syndrome among elderies residing in old-people''s home in Hong Kong. The secondary objectives are to investigate the quality of life (QOL) and symptomology changes among the herbal users and to evaluate the safety of this formula. Methods:In ten old people''s home or community centres in New Territories, Hong Kong, 740 eligible subjects agreed to join the study and were randomized to receive a herbal formula or a placebo on alternate days over 8 weeks. Among those 740 participants, 113 had provided blood samples for immunological assessments before and after the study drug. Assessments were done at 0, 4, 8 and 12 weeks. Participants were instructed to keep a daily record of body temperature and any symptoms as sore throat, myalgia, running nose or cough, and to report to assessor accordingly. Those reporting body temperature of 37.8 ℃ and above would be visited and a proper nasopharyngeal swab be taken for viral study. Results: Seventy-two participants developed influenza-like-symptoms but none of them was proven influenza in their nasopharyngeal swabs, 40 of these patients belonged to the herbal group and 32 to the placebo group, without significant differences between groups. The difference on the changes in QOL between the two groups was not statistically significant. However, in the immunological study, the natural killer cell absolute count was significantly increased in the herbal group compared with the placebo group (463±253 vs 413±198, P<0.05). Conclusions: The herbal preparation was not effective compared with placebo in the prevention of influenza-like syndrome. It was however safe and possibly supporting immunological responses.     

三联疗法治疗寻常型银屑病疗效观察

目的观察复方甘草酸苷片、NB-UVB照射和中药药浴三种疗法联合治疗寻常型银屑病的疗效。方法将120例寻常型银屑病患者随机分为治疗组(60例,复方甘草酸苷片、NB-UVB照射和中药药浴联合治疗)和对照组(60例,复方甘草酸苷片联合NB-UVB照射治疗),观察两组疗效和安全性。结果治疗组有效率为91.7%,对照组为77.7%,两组有效率差异有统计学意义(P<0.05)。结论复方甘草酸苷片、NB-UVB照射和中药药浴三种疗法联合治疗寻常型银屑病疗效高、安全性好。     

浅谈中医临床研究中存在的几个问题

中医临床研究结果是中医疗效的反映,是中医走向现代化、国际化必不可少的环节,其可信度直接决定了中医进步的步伐。从研究者的素质、大型多中心临床研究的匮乏及研究中的不良风气3方面讨论了中医临床研究中存在的问题及解决的办法。     

中医药疗效评价量表研制现状及分析

目的：了解目前国内中医药疗效评价量表研制现状和存在的不足。方法：采用文献分析法检索中国生物医学文献数据库、中国学术期刊网络出版总库（医药卫生科技）和重庆维普中文科技期刊数据库（医药卫生）,纳入以研制中医药疗效评价量表为目的的文献,包括报告关于量表理论框架构建或条目筛选或考评的文献。结果：共有60篇文献（包含36个量表）符合纳入标准。各量表的首篇文献发表于2005～2011年,涉及心脑血管疾病、消化系统疾病、呼吸系统疾病等。纳入的36个量表中有13个（36.1%）研究定义了量表欲测量的概念;有30个（83.3%）量表报告了量表维度,其中最少为2个维度,最多为7个维度。在涉及量表条目筛选及（或）考评的32个研究中,量表条目数为10～52条。14个（43.8%）研究报告了量表填写方式,其中以由受访者自填方式为最多。24个（75%）量表文献描述了答案设置类型,以5级Likert尺度法为最多。10个（31.5%）研究描述了量表的计分方法。所有量表均无关于测量回忆跨度的描述。涉及考评的29个量表研究中,10个（34.4%）研究同时报告了量表的全量表和（或）分量表的Cronbachα系数、重测信度、结构效度及反应度。28个研究报告了全量表和（或）分量表的Cronbachα系数,其中15个量表同时报告了重测信度。27个研究评价了量表的结构效度,11个研究报告了内容效度,13个研究进行了区分效度的评价,16个研究评价了量表的反应度,16个研究评价了量表的可行性。结论：研究调查结果表明,尽管绝大多数研究者遵循量表研制的基本步骤进行量表研制,但在具体的实施过程中仍有不足之处,主要包括缺乏对量表测量概念的界定、对量表考评指标理解存在偏差、忽略量表填写方式及回忆跨度等描述。     

关于草药标准化的研究综述

由于自然产品有化学多样性的特点,使之具有很高的实用性,无论是作为纯天然化合物或是标准化植物提取物,它们都为新药的开发提供了很多可能。与现代西药比较,草药通常被用于治疗慢性疾病。规范化操作可保证植物的一个或多个活性成分及化合物的含量。在新药研发方面,植物药的开发成本较低且资源丰富,但植物的生长环境和基因等因素会在很大程度上影响植物提取物的生物化学成分。植物药的生产要求源植物在基因方面的单种栽培完全符合标准条件,以保证其生物化学指标的一致性,并可以优化植物药的安全性和有效性。本文旨在讨论如何改进植物药提取的规范化操作方法以及如何有效制备质量及效果稳定的植物药。     

中草药治疗银屑病致药物性肝病34例临床分析

目的分析中草药治疗银屑病所致药物性肝病的临床特点,提高对药物性肝病的认识.方法回顾性总结我院收治的34例中草药治疗银屑病所致药物性肝病患者临床资料,对损肝药物、临床特点、并发症及预后等方面进行分析.结果34例患者临床主要症状多表现为乏力、纳差、恶心、尿液发黄;实验室检查可有谷丙转氨酶(ALT)、血清总胆红素(TB)升高、凝血酶原活动度降低表现.所致药物性肝病以药物性肝炎常见,占67.6%,肝硬化占26.5%,肝衰竭占5.9%,常见并发症有腹水、电解质紊乱、原发性腹膜炎、胸腔积液、肝性脑病、上消化道出血.本组患者死亡率为2.9%.结论中草药治疗银屑病所致药物性肝病临床并不少见,长期服用可致肝硬化,重者可导致肝衰竭甚至死亡,用药过程中应密切监测肝功能.     

中药熏洗治疗老年性阴道炎临床疗效评价

目的 :观察我研究所用中药方剂熏洗治疗老年性阴道炎的疗效。方法 :将 97例患者随机分成中药熏洗治疗组与西药治疗组 ,所有病人均在治疗 1个疗程后 2周复查以比较疗效 ,并比较痊愈 3mon后的复发率。结果 :中药熏洗治疗组与西药治疗组治疗 1个疗程后治愈率分别为 92 .96 %与 92 .31% ,痊愈 3mon后的复发率分别为8.4 5 %与 7.6 9% ,两组之间均无显著性差异 (P >0 .0 5 )。结论 :该中药方剂熏洗治疗老年性阴道炎疗效好 ,值得临床推广     

中西医结合临床理论的建立与发展

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