中医药治疗艾滋病免疫重建不良的临床研究证据分析

目的 系统分析中医药治疗艾滋病免疫重建不良的临床研究证据特征及分布,总结改善艾滋病免疫重建不良有效干预的研究现状与不足。方法 检索中国知识资源总库、中国学术期刊数据库、中文科技期刊数据库、中国生物医学文献数据库、PubMed、Web of Science、EMbase、Cochrane Library数据库,纳入建库起至2022年12月31日期间中医药治疗艾滋病免疫重建不良的临床研究,以证据图和图表形式呈现临床研究证据特征及分布。结果 共纳入文献71篇,包括干预性研究文献52篇,观察性研究文献14篇,系统评价/Meta分析4篇,专家共识1篇。年度发文量总体呈上升趋势;47.17%的干预性研究样本量<50例;最常用的艾滋病免疫重建不良诊断标准是cART时间>24个月（37.14%）,CD4细胞计数<350个/μL(23.81%);干预性研究均为中西医协同治疗,90.38%的干预疗程≥6个月,结局指标对淋巴细胞分类计数关注最多（55频次）;随机对照试验文献质量较低;系统评价/Meta分析文献质量极低。结论 中医药治疗艾滋病免疫重建不良的临床研究质量较低,未来需加强临床诊疗...     

中药保留灌肠治疗溃疡性结肠炎疗效的系统评价

[目的]运用系统评价方法,综合评价中药保留灌肠治疗溃疡性结肠炎的临床疗效.[方法]计算机检索1990～2010年中国生物医学文献数据库(sinomed)、CNKI数据库和万方数据知识服务平台,收集中药保留灌肠与西药灌肠治疗溃疡性结肠炎的随机对照试验( RCT),按照纳入与排除标准选择文献、评价质量并提取资料后,采用RevMan 5.1软件进行Meta分析.[结果]最终纳入15篇RCT试验,除1篇中质量外,其余14篇均属低质量文献.中药保留灌肠治疗溃疡性结肠炎的临床疗效优于西药对照组,2组差异有统计学意义.敏感性分析显示评价结果较为稳定;漏斗图图形不对称,提示存在发表性偏倚.共有9篇文献描述了不良反应.[结论]中药保留灌肠治疗溃疡性结肠炎有一定疗效,但因纳入试验的方法学质量存在一些不足之处,可能影响到结果的真实性,因此尚需开展更多设计严谨,大样本、多中心的随机对照试验来确认.     

中医药治疗肠易激综合征临床随机对照研究文献评价

肠易激综合征 ( IBS)是由腹部不适或腹痛伴排便异常组成的一组肠功能紊乱综合征 ,无任何器质性或异常的生化指标。为了解 IBS中医药治疗临床试验的科研设计和论文撰写现状 ,同时发现存在的问题 ,以期能改进和提高临床研究水平 ,我们对近年来中医药治疗 IBS的临床文献进行检索 ,并按循证医学 ( EBM)的要求 ,对其中的随机对照试验 ( RCT)文献进行方法学评价。1　材料与方法1 .1　研究材料 :自 1 995年 1月～ 2 0 0 0年 1 2月在国内各种医学期刊上公开发表的中医药及中西医结合治疗 IBS临床文献。光盘检索 ,数据库为中国生物医学文献光…     

雷公藤制剂治疗类风湿关节炎随机对照试验文献方法学质量评价

目的 调查并评价雷公藤制剂治疗类风湿关节炎(RA)随机对照试验的方法学运用情况，为改进和提高临床试验水平及进行进一步的系统评价提供参考。方法 检索中国生物医学文献光盘数据库(CBMdisc，1978—2000年)及中医药科技文献数据库(TCMLRS，1984—2000年)中收入的以雷公藤制剂为主要干预措施治疗RA的随机对照试验，采用广州中医药大学循证医学方法研究课题组制定的《中医药治疗性文献系统性评价质量评价及信息采集表》对纳入文献进行方法学质量评价，同时运用日前国际上较通用的Jadad量表对文献质量计分。结果 27篇随机对照文献被纳入评价。有26％的文献描述了随机方法，仅有1篇文献有随机分配方案隐匿的描述。6篇文献采用了盲法。89％的文献Jadad计分低于3分，属于低质量的研究。另外，虽然所有文献均有疾病的诊断标准，但只有37％的文献提供了相应的纳入或(和)排除标准。21％的研究未提供药物安全性方面的情况。结论 本次调查的雷公藤制剂治疗RA随机对照试验在方法质量方面存在许多不足之处，因此仍有必要强测随机、对照、盲法等原则在随机对照试验研究中的正确运用。     

中医药治疗冠心病室性早搏的系统评价

目的评价中医药治疗冠心病室性早搏的有效性及安全性。方法计算机检索了PubMed、Cochrane图书馆临床试验注册数据库,中国生物医学文献数据库(Web版)、中文生物医学期刊数据库(Web版)CMCC、VIP中文科技期刊数据库(Web版)、CNKI中国期刊全文数据库(Web版)、万方数据库,筛选出中医药治疗冠心病室性早搏的随机对照试验(RCT)或半随机对照试验。用Jadad评分对纳入研究的质量进行评价,RevMan5.1.4软件进行Meta分析。结果共收集中医药治疗冠心病室性早搏文献486篇,经过初筛和严格评价,纳入研究14个,共1 560例,治疗组901例,对照组659例。纳入研究的Jadad评分≥3分。对14项研究的临床疗效有效率合并效应量的检验,PP分析结果:RR(random)=1.25,95%CI[1.13,1.37],有统计学意义(P<0.0001);ITT分析结果:RR(fixed)=1.26,95%CI[1.17,1.36],有统计学意义(P<0.0001)。结论根据当前研究提示,中医药治疗冠心病室性早搏可能是有效的,但尚需更多高质量研究以增加证据的强度。     

全程新辅助治疗局部进展期直肠癌疗效和安全性的Meta分析

目的 比较全程新辅助治疗(TNT)和新辅助放化疗(nCRT)治疗中低位局部进展期直肠癌的疗效和安全性.方法 全面检索中文数据库(中国知网、万方、中国生物医学文献数据库)和英文数据库(PubMed、Embase)公开发表的有关TNT和nCRT治疗局部进展期直肠癌疗效和安全性的临床研究.随机对照研究的质量评价采用Cochr...     

中医药治疗急性胰腺炎临床试验的质量评价

目的评价中医药治疗AP的临床随机对照试验的方法学质量.方法通过计算机检索获得1995年～ 2004年发表的有关中医药治疗AP的临床随机对照试验文献,按照随机对照试验设计质量评价标准和循证医学原则对文献的方法学质量进行评价.结果中医药治疗AP的临床随机对照试验共94篇,分布在61种杂志上.其中8篇有明确的纳入标准,12篇有明确的排除标准,33篇单组样本量大于50例,4篇对不良反应进行了描述,2篇提及随访.结论中医药治疗AP的临床随机对照试验的方法学质量尚低,还不能为临床应用提供可靠的依据.     

中医药治疗肝硬化腹水随机对照临床试验质量评价

目的:评价中医药治疗肝硬化腹水随机对照临床试验的质量。方法:检索国内外数据库中有关中医药治疗肝硬化腹水随机对照临床试验的文献,参照Cochrane手册有关临床试验评价标准对其进行分析和质量评价。结果:通过筛选最终纳入560篇相关临床试验文献进行研究,发现样本量在60例以上的临床研究仅占13.57%;所有临床试验均选择阳性药作为对照;只有52篇文献报道的试验选用了低偏倚风险的随机方法,且普遍缺乏对随机分配的隐藏;实施盲法的临床试验文献只有6篇;326篇文献描述了使用的统计方法;518篇文献进行了组间均衡性的比较;大多数临床试验过程中缺乏对不良反应的监测以及对病例随访/脱失的记录。结论:目前国内外已报道的中医药治疗肝硬化腹水的随机对照临床试验数量较多,但大部分质量偏低,亟需依据临床试验评价标准来开展相关试验,以提高临床试验质量,增强证据力度。     

补肾活血中药治疗女性抗精子抗体阳性不孕的文献系统评价

目的评价补肾活血中药治疗肾虚血瘀型抗精子抗体阳性不孕的效果和安全性。方法通过计算机检索中国期刊全文数据库、中国引文数据库、中文科技期刊数据库、会议论文及手工检索所选中文献的参考文献,比较中医药与西医治疗的随机对照试验结果。对纳入研究的数量与质量进行循证医学评价,并用RevMan4.2软件进行Meta分析。结果有7篇文献满足标准,与避孕套隔绝及强的松、泼尼松、地塞米松等激素或其他西药治疗相比,补肾活血中药治疗抗精子抗体阳性不孕症,在不孕妇女的妊娠率及抗体转阴率方面效果较好,经Meta分析,差异有统计学意义。结论中医药治疗肾虚血瘀型抗精子抗体阳性不孕可能有效,但因检索到的文献方法学质量不高,存在发表偏倚,故其有效性尚需更有力的证据来证明。     

近20年中医药治疗冠心病的知识图谱分析

目的:对中医药治疗冠心病领域的文献进行知识图谱分析,以探索本领域的发展进程、研究热点和前沿趋势。方法:检索中国知网(CNKI)、万方数据库(WanFang Data)、维普中文科技期刊数据库(VIP),并筛选来源于《中文核心期刊要目总览》中的相关文献,采用CiteSpace 5.8.2软件对纳入的文献进行作者共现分析及关键词共现、聚类、突现分析。结果:共纳入4 841篇文献,研究的内容以临床研究和基础研究为主,同时也包括数据挖掘、网络药理和理论探讨等;研究团队主要来自陈可冀、王阶、刘建勋、王伟、谢雁鸣等科研团队;研究热点是活血化瘀方剂、中药药对、中药提取物、中成药、生物学研究。结论:通过知识图谱分析直观地展示了近20年中医药治疗冠心病的现状,未来应利用新技术和方法从多个角度阐述中医药治疗冠心病的作用机制,增加对冠心病更多证型的多中心随机对照试验,进行多途径、多学科、多领域的合作,建立具有中医特色的冠心病诊疗及评价系统。     

Myocardial infarction secondary prevention study (MISPS)

Background Traditional Chinese medicine (TCM), especially herbal medicine, has been widely used in China and now is also being increasingly used in other countries for the treatment of cardiovascular diseases. Although many studies have demonstrated that certain Chinese herbal products are effective and safe for the treatment of cardiovascular diseases, most of these lack sufficient quality. Therefore, large randomized clinical trials and further scientific research to determine its safety, effectiveness are necessary.QiShen YiQi Dripping Pills (QSYQDP) is a herbal preparation clinically used in the treatment and prevention of coronary artery disease. Preliminary observations have shown its safety and effectiveness. Methods/Design This randomized, controlled trial will recruit 3600 patients with a history of myocardial infarction. Patients will be randomized into two groups by a Centr-Randomized System. One group receives QSYQDP, the other group receive aspirin. This trial protocol will describe eligibility criteria, detailed information on the treatment definition, blinding, endpoints, statistical methods, sample size determination, data management, legal aspects, and the current status of the trial. Discussion This trial is one of the first randomized, controlled clinical trial to evaluate the efficacy and safety of traditional Chinese herbal medicine in the treatment and secondary prevention of coronary artery disease. The results of this study should help to define the role of TCM in modern medical care, as well as to provide the management strategy for CAD patients in China and other countries.     

Quality of reporting of randomized controlled trials of herbal medicine interventions

Background

Public interest in herbal medicines has generated an increasing number of trials evaluating their efficacy. Trials with poor methodologic quality have exaggerated estimates of treatment effect, and incomplete reporting of trials causes difficulties in assessing trial methodologic quality. The objective of this project was to examine the quality of reporting of randomized controlled intervention trials of herbal medicine.

Methods

MEDLINE (1966 to September 2003) was searched for randomized controlled trials of 10 herbal medicines. Two individuals (J. G. and J. D.) independently assessed trials using the Consolidated Standard of Reporting Trials checklist. Disagreements were resolved by consensus. The mean number of checklist items reported across all and for individual herbal medicines was calculated. The influence of decade of publication and species of herbal medicine tested was explored using an analysis of variance.

Results

A total of 206 randomized controlled trials of herbal medicine were included. Interrater reliability on reporting quality assessment was high. A total of 45% of items were reported across all trials. The quality of reporting improved across decades from the 1970s to the 2000s. Individual herbal species differed in the total number of items reported, with echinacea, ginkgo, St. John’s wort, and kava trials reporting the most items.

Conclusions

Important methodologic components of randomized controlled trials of herbal medicines are incompletely reported including allocation concealment, method used to generate the allocation sequence, and whether an intention-to-treat analysis was used. Also, key information unique to these trials may be missing, such as percentage of active constituents and type or form of the herbal medicine preparation. We suggest trialists consult a recent extension of the Consolidated Standard of Reporting Trials statement specific to herbal medicine trials when designing and reporting randomized controlled intervention trials of herbal medicines.     

Efficacy and safety of acupuncture combined with Chinese herbal medicine in the treatment of type 2 diabetes mellitus: A protocol for a systematic review and meta-analysis

Background:Diabetes has become a global public health problem and danger to human health. Diabetes is the main cause of blindness, kidney failure, heart attack, stroke, and lower limb amputation. According to the latest epidemiological survey and research, the overall prevalence of diabetes in mainland China is 11.2%, of which type 2 diabetes mellitus (T2DM) accounts for more than 90% acupuncture combined with Chinese herbal medicine have been widely used in the treatment of T2DM. However, we have not found a meta-analysis of their synergistic effects. Therefore, this systematic review and meta-analysis aims to evaluate the efficacy and safety of acupuncture combined with Chinese herbal medicine in the treatment of T2DM.Method:From inception up to September 20, 2021, the PubMed, Web of Science, Embase, AMED, Cochrane Library, CNKI, VIP, CBM, and Wanfang databases will be searched. The publication date or language will not be limited. We will apply a combination of medical keywords, including “acupuncture”, “Chinese herbal medicine”, and “type 2 diabetes mellitus”. We will also check other ongoing and unpublished studies in the clinical trial registry. At the same time, we will manually search all reference lists from relevant systematic reviews to find other eligible studies. We will use Review Manager software (REVMAN v5.3 Cochrane Collaboration) to meta-analyze the selected literature. The study for acupuncture combined with Chinese herbal medicine in the treatment of T2DM was a randomized controlled study. Two researchers will independently review the research selection, data extraction, and research quality assessments. Finally, we will observe the outcome measures.Results:This study will generate evidence-based data on the treatment of T2DM with acupuncture combined with Chinese herbal medicine and will provide new ideas and treatment modalities to investigate in future research.     

Efficacy and safety of acupuncture combined with Chinese herbal medicine in the treatment of primary liver cancer: A protocol for systematic review and meta-analysis

Background:Primary liver cancer (PLC) is a common cancer, and its morbidity and mortality are ranked 6th and 3rd in the world for malignant tumors, respectively. And this number is still on the rise, seriously endangering people''s health. In recent years, acupuncture combined with Chinese herbal medicine have been widely used in the treatment of PLC, and there are few restrictions. However, we have not found a meta-analysis of their synergistic effects. Therefore, this systematic review and meta-analysis will evaluate the efficacy and acupuncture combined with Chinese herbal medicine in the treatment of primary liver cancer.Method:We will search the following databases from inception up to August 20, 2021: PubMed, Web of Science, Embase, AMED, Cochrane Library, CNKI, VIP, CBM, and Wanfang. There will be no restrictions regarding publication date or language. We will apply a combination of medical keywords and words, including “acupuncture,” “Chinese herbal medicine” and “primary liver cancer”. Additionally, we will manually search all reference lists from relevant systematic reviews to find other eligible studies. We will use the random effects model in REVMAN v5.3 for meta-analysis. The study for acupuncture combined with Chinese herbal medicine in the treatment of PLC was a randomized controlled study. Two researchers will independently review the research selection, data extraction, and research quality assessments. Finally, we will observe the outcome measures.Results:This study will provide evidence-based medical evidence for the treatment of PLC with a combination of acupuncture and Chinese herbal medicine, and provide new ideas and methods for the treatment of PLC.Registration number: INPLASY202180103     

Efficacy and safety of acupuncture combined Chinese herbal medicine for diabetic peripheral neuropathy: A protocol for systematic review and meta-analysis

Background:Acupuncture combined with Chinese herbal medicine has been widely utilized for pain management in patients with diabetic peripheral neuropathy (DPN). However, its results are still inconsistent, and no systematic review has specifically addressed this issue. Thus, this systematic review will comprehensively and systematically investigate the effectiveness and safety of acupuncture combined with Chinese herbal medicine for pain relief in DPN.Methods:Randomized controlled trials on acupuncture combined with Chinese herbal medicine treatment of DPN published before September of 2021 will be searched in 9 databases including Medline, Web of Science, PubMed, Cochrane Library, Excerpta Medica Database, Sinomed, China National Knowledge Infrastructure, WanFang, and China Science and Technology Journal Database. The methodological assessment performed using the risk of bias assessment tool of Cochrane, and the level of evidence quality for the main results will be evaluated by a recommended grading, evaluation, formulation, and evaluation system approach. Bayesian network meta-analysis will be conducted using STATA V.14.0 and WinBUGS V.1.4.3.Results:This study will provide a high-quality comprehensive evaluation of the safety of acupuncture combined with Chinese herbal medicine for treating DPN.Conclusion:This systematic review will evaluate the efficacy and safety of Chinese herbal medicine combined with acupuncture in the treatment of DPN, and provide the latest evidence for clinical application.Ethics and dissemination:The protocol of the systematic review does not require ethical approval because it does not involve humans. This article will be published in peer-reviewed journals and presented at relevant conferences.Registration number: INPLASY2021100004.     

Is there a role for herbal medicine in the treatment of pancreatic cancer?. Highlights from the "44th ASCO Annual Meeting". Chicago, IL, USA. May 30 - June 3, 2008

One of the greatest challenges in the treatment of pancreatic cancer remains its inherent lack of beneficial response to cytotoxic chemotherapy. According to the encyclopedic knowledge on herbal medicine regimen and clinical experience accumulated for centuries, traditional Chinese medicine can provide new avenues for alternative treatments of pancreatic diseases. Chinese herbal extracts have been widely used for the treatment of various cancers, but objective information on their efficacy in pancreatic cancer is lacking. This article provides a summary of herbal medicine, presented at the Annual Meeting of ASCO, 2008. The clinical applications of these active compounds warrant further investigation in randomized, controlled clinical trials.     

Different Chinese herbal medicine therapy for idiopathic thrombocytopenic purpura: A protocol for systematic review and Bayesian network meta-analysis

Background:Idiopathic thrombocytopenic purpura (ITP) is a common immune system and blood system disease in clinical practice, and it is a hemorrhagic disease caused by immune factors causing platelet destruction and decreasing number of platelets. There is currently no effective treatment plan for ITP. At this stage, glucocorticoid and gamma globulin are mostly used in the treatment of ITP, and some patients use splenectomy to achieve therapeutic purposes, but the various treatment methods are inadequate. At this stage, a large number of randomized controlled studies have reported that Chinese herbal medicine has achieved good curative effect in the treatment of ITP. However, due to the variety of Chinese herbal medicine, there has been no evidence of the effectiveness and safety of Chinese herbal medicine in the treatment of ITP. Because of the above reasons, this study uses the network meta-analysis method based on Bayesian method to compare the clinical efficacy and safety of different kinds of Chinese herbal medicine in the treatment of ITP through direct and indirect comparison, in order to provide evidence-based medical support for the treatment of ITP with Chinese herbal medicine.Methods:This study uses the method of combining free words with theme words, and using computer to retrieve PubMed, EMbase, The Cochrane Library, WANFANG Database, CNKI, and VIP Database, etc, to collect the randomized control studies on Chinese herbal medicine in the treatment of ITP. The retrieval time is from the establishment of each database to January 2021, and the retrieval languages are Chinese and English. Two researchers independently read the title, abstract and full text of the article to determine whether it is included in the literature; In the event of a disagreement, a third researcher will join the discussion to resolve the disagreement; For the literature that lacks information, trying to contact the original author of the document to supplement it. The literature quality evaluation carried out by using the Stata 14.0 software to draw network and funnel plots, in accordance with the quality evaluation criteria of version 5.1.0 of the Cochrane System Evaluation Manual. Statistical analysis is performed by using ADDIS 1.16.8 software based on the Bayesian model.Results:This study will compare the clinical efficacy and safety of different types of Chinese herbal medicine in the treatment of idiopathic thrombocytopenic purpura through the method of network meta-analysis, and rank the different types of Chinese herbal medicine according to their effectiveness, and the results will be published in a peer-reviewed, high-quality academic journal.Conclusion:This study will find effective and safe Chinese herbal medicine for clinical treatment of ITP from the perspective of evidence-based medicine, and benefit more ITP patients.     

Preventive effect and safety of Chinese herbal medicine mouthwash in chemotherapy-induced oral mucositis: A protocol for systematic review and meta analysis

Background:Oral mucositis (OM), one of the most common side effects for cancer patients who have undergone chemotherapy, can cause severe impairment to patients’ functional ability and impact their quality of life, resulting in delayed and/or incomplete treatment. Traditional Chinese medicine offers empirical herbal decoctions to gargle for the prevention of chemotherapy-induced OM; however, evidence for its clinical efficacy and safety is lacking. Therefore, we provide a protocol to evaluate the preventive effect and safety of Chinese herbal medicine mouthwash in chemotherapy-induced OM.Methods:We will comprehensively retrieve relevant articles published till August 15, 2020, in the following electronic databases: the Cochrane Library, PubMed, EMBASE, Chinese National Knowledge Infrastructure Database, Chinese Biomedical Literature Database, Chinese Science and Technique Journals Database, and the Wan-fang Database. Only randomized controlled trials will be included. We will use the criteria provided by the Cochrane Handbook for quality assessment and risk assessment of the included studies and use the RevMan 5.3 software for meta-analysis of the preventive effect and safety.Results:This study will assess the preventive effect and safety of Chinese herbal medicine mouthwash in chemotherapy-induced OM.Conclusion:This systematic review will provide evidence-based medical corroboration for the clinical application of the Chinese herbal medicine mouthwash in chemotherapy-induced OM.PROSPERO registration number:CRD42020206614.