Integrative analysis of bone-formation associated genes and immune cell infiltration in osteoporosis, and the prediction of active ingredients in targeted traditional Chinese medicine

Objective To explore the differential expression and mechanisms of bone formation-related genes in osteoporosis(OP)leveraging bioinformatics and machine learning methodologies;and to predict the active ingredients of targeted traditional Chinese medicine(TCM)herbs.Methods The Gene Expression Omnibus(GEO)and GeneCards databases were employed to conduct a comprehensive screening of genes and disease-associated loci pertinent to the pathogenesis of OP.The R package was utilized as the analytical tool for the identification of differentially expressed genes.Least absolute shrinkage and selection operator(LASSO)logis-tic regression analysis and support vector machine-recursive feature elimination(SVM-RFE)algorithm were employed in defining the genetic signature specific to OP.Gene Ontology(GO)and Kyoto Encyclopedia of Genes and Genomes(KEGG)pathway enrichment analyses for the selected pivotal genes were conducted.The cell-type identification by estimating rela-tive subsets of RNA transcripts(CIBERSORT)algorithm was leveraged to examine the infiltra-tion patterns of immune cells;with Spearman’s rank correlation analysis utilized to assess the relationship between the expression levels of the genes and the presence of immune cells.Coremine Medical Database was used to screen out potential TCM herbs for the treatment of OP.Comparative Toxicogenomics Database(CTD)was employed for forecasting the TCM ac-tive ingredients targeting the key genes.AutoDock Vina 1.2.2 and GROMACS 2020 softwares were employed to conclude analysis results;facilitating the exploration of binding affinity and conformational dynamics between the TCM active ingredients and their biological targets.Results Ten genes were identified by intersecting the results from the GEO and GeneCards databases.Through the application of LASSO regression and SVM-RFE algorithm;four piv-otal genes were selected:coat protein(CP);kallikrein 3(KLK3);polymeraseγ(POLG);and transient receptor potential vanilloid 4(TRPV4).GO and KEGG pathway enrichment analy-ses revealed that these trait genes were predominantly engaged in the regulation of defense response activation;maintenance of cellular metal ion balance;and the production of chemokine ligand 5.These genes were notably associated with signaling pathways such as ferroptosis;porphyrin metabolism;and base excision repair.Immune infiltration analysis showed that key genes were highly correlated with immune cells.Macrophage M0;M1;M2;and resting dendritic cell were significantly different between groups;and there were signifi-cant differences between different groups(P<0.05).The interaction counts of resveratrol;curcumin;and quercetin with KLK3 were 7;3;and 2;respectively.It shows that the interac-tions of resveratrol;curcumin;and quercetin with KLK3 were substantial.Molecular docking and molecular dynamics simulations further confirmed the robust binding affinity of these bioactive compounds to the target genes.Conclusion Pivotal genes including CP;KLK3;POLG;and TRPV4;exhibited commendable significant prognostic value;and played a crucial role in the diagnostic assessment of OP.Resveratrol;curcumin;and quercetin;natural compounds found in TCM;showed promise in their potential to effectively modulate the bone-forming gene KLK3.This study provides a sci-entific basis for the interpretation of the pathogenesis of OP and the development of clinical drugs.

Core outcome set for stable angina pectoris in traditional Chinese medicine(COS-SAP-TCM)

Objective:This study aimed to develop a core outcome set(COS)for use in future studies of stable angina pectoris(SAP)in traditional Chinese medicine(TCM).Methods:Systematic literature reviews and qualitative interviews with cardiologists and patients with SAP treated using TCM were conducted to generate a set of outcomes.Outcomes were prioritized by stakeholders via two rounds of an online Delphi survey and face-to-face consensus meetings.Following the final consensus meeting,a final COS was generated.Results:An initial set of 324 outcomes was identified.A preliminary list of 65 outcomes was employed in the Delphi study.In total,223 participants from seven stakeholder groups were invited to score outcomes in the first Delphi round:87 completed round 1 and 47 completed round 2.Thirty-one participants attended the consensus meeting and agreed on a final core set of outcomes comprising six items across four domains:frequency of angina attack,duration of angina attack,Seattle angina questionnaire,total exercise duration in the exercise treadmill test,cardiovascular events,and QT interval on electrocardiography.Conclusions:The COS developed in this study provides the minimum requirements for measurement and reporting in future TCM clinical trials for the treatment of SAP.The employment of this COS may reduce heterogeneity across trials and facilitate evidencebased decision-making for stakeholders.

Effect of traditional Chinese medicine on rheumatoid arthritis bone destruction:A systematic review and meta-analysis

Objective:To systematically evaluate the efficacy of Traditional Chinese medicine for improving bone damage in rheumatoid arthritis(RA),and provide guidance for clinical treatment.Methods:computer retrieval China hownet database(CNKI),Chinese biomedical literature retrieval(SinoMed),ten thousand Data knowledge service system(WanFang Data),VIP full-text database(VIP),PubMed,MedLine and the cochrane library,collect relevant Chinese medicine for the treatment of rheumatoid arthritis,bone destruction randomized controlled trial(RCT),screening from built by researchers at the two libraries to literature in February 2020,to extract the required indicators,and incorporated into RevMan 5.2 analysis.Results:a total of 1291 patients were included in 14 RCTS.The results of meta-analysis showed that compared with the control group,The traditional Chinese medicine treatment group could improve the 25-hydroxyvitamin D of patients with RA bone damage,which was better than the western medicine control group,and the difference was statistically significant.TCM treatment group can improve the balance between osteoblasts and osteoclasts(nuclear factor B receptor activating factor;Bone mineral density;Bone alkaline phosphatase;Bone protectin;(osteocalcin),and was superior to the western medicine control group,the difference was statistically significant;(3)traditional Chinese medicine treatment group can improve RA patients with bone destruction of the balance of osteoblast and osteoclast(Ⅰtype collagen amino terminal propeptide before;Carboxy-terminal peptide of collagen;The effect of nuclear factor B receptor activator factor and bone protectin was similar to that of the western medicine control group,and the difference was not statistically significant.Conclusion:At present,the existing evidence can prove that Traditional Chinese Medicine in the treatment of rheumatoid arthritis bone damage has an exact effect,regulate the function of osteoblasts and osteoclasts,improve the level of bone metabolism of patients,prevent the progress of bone damage.

The mechanism and traditional Chinese medicine research of bone destruction and hypercalcemia in multiple myeloma

Multiple myeloma is a malignant proliferative disease of plasma cells. Its main feature is the malignant proliferation of monoclonal plasma cells and the secretion of a large number of monoclonal immunoglobulins. Because of the uncontrolled proliferation, extensive infiltration of malignant plasma cells, and the appearance and deposition of a large number of monoclonal immunoglobulins, normal polyclonal plasma cell proliferation and polyclonal immunoglobulin secretion are inhibited. It can cause extensive bone destruction, hypercalcemia, repeated infection, renal insufficiency, high viscosity syndrome and other clinical manifestations, which can alsolead to adverse consequences.In view of these unique clinical manifestations and pathological features of multiple myeloma, we systematically expounded the pathological characteristics of multiple myeloma and the treatment of traditional Chinese medicine from extensive bone destruction and hypercalcemia on the basis of Chinese and Western medicine. In order to provide theoretical support and clinical guidance for the treatment of multiple bone marrow tumors with bone destruction and hypercalcemia.

Review for treatment and signaling pathway regulation of kidney-tonifying traditional Chinese medicine on osteoporosis

The treatment and signaling pathway regulation effects of kidney-tonifying traditional Chinese medicine on osteoporosis have been widely studied,but without a systematic summary currently.This review comprehensively collected and analyzed the traditional Chinese medicine on the treatment and signaling pathway regulation of osteoporosis in recent ten years,such as Epimedium,Drynariae Rhizoma,Cnidium,Eucommia,Psoralen and Dipsacus.Based on the existing findings,we concluded the following conclusions:(1)kidney-tonifying traditional Chinese medicine treats osteoporosis mainly through BMP-Smads,Wnt/β-catenin,MAPK,PI3K/AKT signaling pathway to promote osteoblast bone formation and through OPG/RANKL/RANK,estrogen,CTSK signaling pathway to inhibit osteoclasts of bone resorption.(1)Epimedium,Drynariae Rhizoma,Cnidium and Psoralen up-regulate the key proteins and genes of BMP-Smads and Wnt/β-catenin signaling pathways to promote bone formation.(2)Epimedium,Drynariae Rhizoma,Cnidium,Eucommia,Psoralen,Dipsacusinhibit the bone resorption by mediating the OPG/RANKL/RANK signaling pathway.(2)Kidney-tonifying traditional Chinese medicine prevent and treat osteoporosis through a variety of ways:Icariin,Naringin,Osthol,Psoralen can regulate BMP-Smads,Wnt/β-catenin signaling pathway to promote bone formation,but also activate OPG/RANKL/RANK,CTSK and other signaling pathway to inhibit bone resorption.(3)The crosstalk of the signaling pathways and the animal experiments of the traditional Chinese medicine on the prevention and treatment of osteoporosis as well as their multi-target mechanism and comprehensive regulation need further clarification.

Traditional Chinese medicine manipulative reduction combined with percutaneous vertebroplasty for treating type Ⅲ Kummell's disease: A case report

BACKGROUND A patient with type Ⅲ Kummell’s disease had a ruptured posterior cortex of the fractured vertebral body, which caused spinal cord compression. An open surgery was considered the best choice of operation. However, the patient and her family refused open surgery and instead demanded a minimally invasive surgical treatment such as percutaneous vertebroplasty(PVP). After preoperative discussion, we finally adopted the novel therapy of traditional Chinese medicine manipulative reduction(TCMMR) combined with PVP.CASE SUMMARY A patient with type Ⅲ Kummell’s disease exhibiting bone block-induced spinal cord compression was admitted to our hospital. She suffered from a variety of medical disorders but refused open surgery, and instead asked for PVP surgery. TCMMR, in parallel with PVP, was used to restore the height of the compressed vertebral body and reduce the symptoms of spinal cord compression by the bone block in order to strengthen the vertebral body and prevent further collapse. The surgery was very successful. The height of the compressed vertebra was restored, and the symptom of spinal cord compression by bone block was reduced successfully via TCMMR. The fractured vertebra was solidified by the PVP. The pain visual analog score declined from preoperative 7 scores to postoperative 2 scores, and the Frankel spinal cord scale increased from preoperative D degree to postoperative E degree.CONCLUSION The new method has advantages in treating patients with type Ⅲ Kummell’s disease who cannot be treated with open surgery.

Current status of outcome reporting in randomized controlled trials of traditional Chinese medicine for mammary gland hyperplasia: A systematic review

Objective:To assess outcome indicators in clinical trials and provide a reference for establishing a core outcome set to treat hyperplasia of mammary gland(HMG)with traditional Chinese medicine(TCM).Methods:Eight online databases were searched from their inception to December 31,2022,to assess outcomes reported in randomized controlled trials(RCTs)of HMG treated with TCM.The quality of the included studies was assessed according to the Cochrane Risk of Bias Assessment Tool.All outcomes were extracted,classified,and described.Results:A total of 8249 articles were initially retrieved.Of these,70 articles were eligible and involved 10618 participants with HMG.A total of 17 outcome indicators with a frequency of 271 times were involved and were collected according to six outcome domains.Conclusions:The core outcomes of RCTs of HMG treated with TCM are large and divergent.There are problems in evaluation standards,primary and secondary outcomes,TCM characteristic indicators,long-term prognosis,and standardization of reporting.It is recommended to strengthen the trial design and actively construct the core outcome sets with TCM characteristics for HMG.

Outcome measures in clinical trials of traditional Chinese medicine for stable angina pectoris

Objective:This work aimed to present a descriptive analysis of the outcome measures used in clinical trials of traditional Chinese medicine(TCM)for patients with stable angina pectoris,and to provide baseline data for the development of core outcome sets(COSs)for relevant clinical trials.Methods:Medical databases were searched to identify randomized trials of the effects of TCM for the treatment of stable angina pectoris.Outcome measures of each trial were extracted.Descriptive statistics were used to analyze the baseline characteristics of outcomes in clinical trials of TCM.Results:94 randomized trials(with 9,111 participants)involving 79 different outcomes were identified.The mean number of outcomes was 5(1-21 per trial).The 5 most commonly reported outcomes were efficacy rate of electrocardiogram,efficacy rate of angina pectoris,efficacy rate of TCM syndrome,fasting lipid indices,and withdrawal rate of nitroglycerin.Several challenges were identified:(1)significant heterogeneity of outcomes and differences in the technique and timing of the measurement of the same outcome;(2)transformation of continuous data into categorical data and presented as such in>90% of trials;(3)few trials on the outcomes associated with the advantages and characteristics of TCM;and(4)selective reporting of outcomes.Conclusions:The outcomes used are excessively heterogenous,and the choice of some outcomes(timing and techniques)for measurement is confusing or inappropriate.Hence,developing and implementing a COS is necessary for greater consistency.

Prescription and treatment rules for the prescriptions containing Poria cocos and Atractylodes macrocephala couplet medicine based on traditional Chinese Medicine inheritance support platform

Objectives:To provide a theoretical basis for the development of the new products of Poria cocos-Atractylodes macrocephala couplet medicine.Methods:All prescription preparations containing Poria cocos and Atractylodes macrocephala were collected from the Drug Standards of the Ministry of Public Health Drug Standard·Traditional Chinese Medicine Set Prescription Preparation(called Traditional Chinese Medicine Set Prescription Preparation for short).After standardization,the information of each prescription preparation was input into the Chinese Traditional Medicine Inheritance Support Platform(V2.5),and the relevant rules of the software were adopted.Data mining methods were used to analyze the frequency of drugs,main symptoms and diseases in prescriptions,and to analyze the regularity of prescriptions.The prescription rules of top 2 high frequency attending syndromes and diseases were analyzed.Results:There were total of 337 prescription preparations containing couplet medicine of Poria cocos and Atractylodes macrocephala,107 kinds of main symptoms and 66 kinds of diseases.The high frequency syndromes were deficiency of Qi and blood and weakness of spleen and stomach,and the high frequency syndromes were anorexia and irregular menstruation.Conclusion:The couplet medicine of Poria cocos-atractylodes macrocephala prescription is mainly used to treat digestive tract diseases and gynecological diseases;it mostly takes tonifying deficiency efficat.It can treat different diseases being compatible with different medicinal materials.The study can provide theoretical basis for clinical application and new drug development of the couplet medicine of Poria cocos-atractylodes macrocephala.

The prognosis and survival of integrated traditional Chinese and western medicine on glioma: a meta-analysis

Objective:To systematically access the effects of integrated traditional Chinese and western medicine treatment versus western medicine treatment alone in glioma.Methods:Published randomized controlled trials were included from electronic databases(Cochrane Library,Pubmed,Embase,Chinese National Knowledge Infrastructure,Wanfang database,Chinese Scientific Journal Database,Chinese Biomedical Literature Database.Deadline on January 30,2020).The Cochrane handbook was referred to evaluate the methodological quality.Curative efficacy,gastrointestinal side effects,bone marrow suppression,survival time and quality of life(Karnofsky)were compared between the two groups.Meta-analysis was conducted using Reveman 5.3 and Stata 14.0 software.Results:Twelve randomized controlled trials involved 886 cases were selected,including 446 cases in the trial group and 440 cases in the control group.The meta-analysis indicated that the overall efficacy of integrated traditional Chinese and western medicine showed significant improvement compared with western medicine alone.The effects included reduced tumor size(RR=1.32,95%CI(1.18,1.49),P<0.05),gastrointestinal adverse reactions(RR=0.42,95%CI(0.30,0.60),P<0.05),bone marrow suppression(RR=0.437,95%CI(0.282,0.677),P<0.05),and improved KPS score(SMD=0.632,95%CI(0.312,0.952),P<0.05).Conclusion:For patients with glioma,integrated traditional Chinese and western medicine treatment can be one of the options for a better treatment.

Review on the research of Chinese medicine promoting tissue regeneration

In the long history of the Chinese nation,traditional Chinese medicine has made great contributions to the protection of the health of the Chinese people.Given that many pathological processes can cause tissue damage,does Chinese medicine also promote tissue regeneration in the process of disease recovery?It has been found from recent research articles that traditional Chinese medicine can promote tissue regeneration in the treatment of diseases.The following is an illustration of the role of Chinese medicine in selected parts of the study.

斑马鱼模型在中医药防治骨质疏松应用的研究进展

随着骨质疏松(osteoporosis,OP)动物模型的不断发展,斑马鱼逐渐成为中医药防治OP的常用动物模型之一。文章整理了近五年来以斑马鱼作为动物模型在OP防治方面的运用,系统综述了不同种类斑马鱼OP模型的建立以及通过斑马鱼对单体中药、中药复方以及中成药对OP防治的药理、毒理的研究进展。以期对OP发病机制以及抗OP药物筛选、研究的动物模型选择提供新的思路与方法。

Treatment of Cerebral Ischemia with Combination of Bone Marrow-Derived Mesenchymal Stem Cells and Chinese Medicine

Many laboratories have been attempting to integrate Chinese medicine（CM） with the research of stem cells in order to explore this promising frontier.Studies on the combination of CM and bone marrow-derived mesenchymal stem cells（BMSCs） have found that some effective components from CM could activate endogenous stem cells and induce stem cells to differentiate into neural-like cells in vitro and promote angiogenesis.This review summarized the latest research findings of BMSCs and their application combined with CM in the treatment of cerebral ischemia.

The Mobilization of Autologous Bone Marrow Stem Cells in the Treatment of Heart Failure with Chinese Medicine

Heart failure （HF） is a severe heart disease. The use of autologous bone marrow stem cells （BMCs） mobilization in the treatment of HF has been a hot topic to research both in Western medicine and Chinese medicine （CM）. There are many clinical trials and experiments on study of BMCs mobilization for HF therapy, including integrative medicine. The effect of BMCs mobilization is favorable for cardiac repair, while some advantages of CM support the advanced study of its application in BMCs mobilization to treat HF. In addition, with mechanisms of autologous BMCs mobilization for the treatment of HF that will be revealed in the future, especially stem cells niches, integrative medicine would play an important role in this clinical thought of therapy model gradually. Simultaneously, CM should adapt the new approaches of stem cells progresses on HF treatment as holding characteristics of itself.

Potential advantages of a combination of Chinese Medicine and bone marrow mesenchymal stem cell transplantation for removing blood stasis and stimulating neogenesis during ischemic stroke treatment

Combined treatment of ischemic stroke with Chinese medicine and exogenous bone marrow mesenchymal stem cell(BMSC) transplantation may improve the removal of blood stasis and stimulation of neogenesis.Chinese medicines that remove blood stasis not only promote blood circulation but also calm the endopathic wind,remove heat,resolve phlegm,remove toxic substances and strengthen body resistance.The medicinal targeting effect of Chinese medicine can promote the homing of BMSCs,and the synergistic therapeutic effects of drugs can contribute to BMSC differentiation.As such,exogenous BMSC transplantation has potential advantages for neogenesis.Chinese medicines and exogenous BMSCs provide complementary functions for the removal of blood stasis and stimulation of neogenesis.Therefore,a combination of Chinese medicine and transplantation of exogenous BMSCs may be particularly suited to ischemic stroke treatment.

中药有效成分结合骨组织工程材料用于骨修复

背景:如何修复骨缺损一直以来是临床难题,中药有效成分在骨修复方面具有良好的生物活性与治疗效果,将中药有效成分与组织工程材料相结合在骨修复领域具有广阔的前景。不同中药有效成分与支架的组合在作用关系方面具有相似之处。目的:搜集常见的中药有效成分与支架材料组合的案例,基于七情配伍的启发将组织工程支架与中药有效成分类比为产生配伍关系的两类中药,以二者的作用关系为纲进行归纳总结。方法:检索1998年1月至2024年1月Pub Med和中国知网数据库中发表的相关文献,英文检索词:“traditional Chinese medicine,Chinese medicine,traditional Chinese medicine monomers,bone defect,bone repair,bone tissue engineering,tissue engineering,scaffold”,中文检索词:“中药,中药有效成分,中药单体,骨组织工程,骨组织工程支架,支架,组织工程,骨缺损,骨修复”,最终纳入88篇文献进行综述分析。结果与结论:(1)组织工程支架材料与中药有效成分各自均在骨修复领域有广泛的运用,二者在成骨方面优势明显但仍有许多缺陷,许多研究致力于将二者制备成复合材料,希望通过二者间的相互作用发挥减毒增效作用。(2)一些药物与材料在成骨、抗菌、促血管生成方面能互相促进,增强原有的效果,受到传统方剂配伍观念的启发,文章将其归纳为“相须”关系,并举实例佐证。(3)一些药物能提高材料的强度,而某些材料能对负载于其上的药物实现缓释控释效果、增加载药量与稳定性,或是进行靶向递送,文章将这种单方面的提升效果归纳为“相使”关系。(4)一些中药与材料搭配使用能减少对方的毒副反应,文章将这种减毒关系归纳为“相畏相杀”。(5)文章得出了一个由七情配伍关系启发、基于作用关系分类的关于中药复合支架的全新视角,将中药传统观念引入组织工程领域,为后续复合支架的研究者提供新的研究思路,并在选材搭配方面提供一定的便利。

中药调控线粒体质量控制防治骨质疏松研究进展

骨质疏松症是一种慢性代谢性骨病,主要由成骨细胞和破骨细胞之间的失衡引起。发生骨质疏松后若不及时治疗,则会引发反复骨折的恶性循环,最终导致患者残疾和过早死亡。目前治疗骨质疏松症的方法以抑制骨吸收和促进骨形成药物为主,缺少较好的治疗手段。既往国内外学者研究发现,线粒体质量控制可以通过调节成骨细胞和破骨细胞活性之间的平衡来维持骨稳态。中医通过辨证论治依据患者个人的体质进行综合调理,起到了延缓和治疗骨质疏松进展的作用。同时,研究表明中药通过靶向线粒体质量控制可以调控成骨细胞和破骨细胞以及骨髓间充质干细胞的活性,进而防止骨质疏松的发生,但相关研究缺乏系统阐述。因此,笔者将从中药调控线粒体质量控制防治骨质疏松展开研究,旨在为中药治疗骨质疏松症的新药研发和治疗方式提供新的思路和方法。

fsQCA组态视角下我国中医类医院医疗资源配置效率提升路径分析

目的 探究多重因素协同作用下我国中医类医院医疗资源配置效率提升的优化路径,为中医类医院医疗资源均衡发展提供有力支撑。方法 以数据包络分析法得到的我国31个省(区、市)中医类医院资源配置综合效率值为结果变量,借助模糊集定性比较分析方法,以人均地区生产总值、财政拨款收入占总收入比重、中医执业(助理)医师占执业(助理)医师比重、出院者平均住院日、每千人口总诊疗量、每千人口床位数作为条件变量,探究医疗资源高效配置组态路径。结果 通过对中医类医院医疗资源高效率配置的条件组态进行分析,可归纳为3条等效驱动路径,分别为综合服务能力型、中医优势型及住院驱动型。结论 我国中医类医院医疗资源配置效率整体水平有待提升,未来应努力提高医院综合服务能力和运行效率,充分发挥中医药优势,建设高质量中医人才队伍,合理缩短平均住院日,提高医院床位利用效率。

化脓性骨髓炎病因病机的古代中医文献溯源

化脓性骨髓炎属于中医学“附骨疽”“附骨痈”等范畴,文章通过系统梳理中国古代文献典籍,总结探析从先秦至明清历代医家对于化脓性骨髓炎病因病机的认识,秦汉时期多以“内虚”立论,外感热邪而致病;晋唐时期,认为患者体质素热,风寒外袭未愈,复感湿邪而致病。宋元时期认为,由于脾肾亏虚、外感风、寒、湿、火等邪气,最终导致以痰积、瘀血为病理表现。明清时期,认为病因主要由于肾、脾、肝亏虚,导致风、寒、暑、湿、火侵入,而致此病。最终为现代临床治疗化脓性骨髓炎提供中医辨治思路。

中医药治疗孤独症谱系障碍随机对照试验结局指标分析

[目的]整理中医药治疗孤独症谱系障碍(ASD)的随机对照试验(RCTs)结局指标,分析中存在的问题,为其临床试验设计及构建核心结局指标集提供依据。[方法]计算机检索2018年1月1日至2023年12月31日中国知网(CNKI)、万方数据知识服务平台(WanFang Database)、中国生物医学文献服务系统(SinoMed)、维普中文期刊服务平台(VIP)、PubMed、Web of Science、Embase、The Cochrane Library数据库中医药治疗ASD的RCTs文献,通过文献筛选和资料提取汇总结局指标及其测量工具并进行整理和分析。[结果]共纳入72项研究,总样本量为5207例,单项研究样本量为18~169例,治疗周期为30 d~10个月;12项研究报告了ASD的中医辨证分型,64项研究报告了ASD的西医诊断标准,17项研究报告了中医诊断标准;有41项研究进行了疗效评价,共使用了13种有效率测量工具。所有研究一共涉及54个结局指标,归类进入8个指标域:临床有效率1项;中医病证类1项;症状/体征类共有35项;理化检测类13项,生活质量类3项,安全性事件类1项,远期预后和经济学评估未评估。单项RCT报告指标最少有1个,最多达8个,所有54个结局指标共应用259次,结局指标应用最多的是儿童孤独症评定量表评分(CARS),共计50次,其次是孤独症行为量表评分(ABC)共报道了45次,临床有效率指标共报道了41次。[结论]中医药治疗ASD的RCTs结局指标应用现状在临床研究中存在着试验设计方法学的不足,结局指标数量、选择的差异性大、疗效指标设计要素多,忽视不良结局指标、中医药特色指标不足等问题。研究者在遴选结局指标时,应对各种量表和临床疗效参考标准的质量及其适用性进行合理评估,注重中医病证特点,并选用权威可靠工具,助力构建中医药治疗ASD的核心指标集。