1.Clinical Observation on Acupuncture Combined with Guanxinning Tablets in the Treatment of Heart Vessel Obstruction Type of Chest Obstruction Syndrome
Rui LEI ; Ping YAN ; Hui-Min DING ; Hua YU
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(4):937-943
Objective To observe the clinical efficacy of acupuncture combined with Guanxinning Tablets in the treatment of heart vessel obstruction type of chest obstruction syndrome.Methods Eighty patients with heart vessel obstruction type of chest obstruction syndrome were randomly divided into the observation group and the control group,with 40 cases in each group,the control group was given conventional western medicine treatment,the observation group was given acupuncture combined with Guanxinning Tablets on the basis of the treatment in the control group,and the patients in the two groups were treated continuously for 30 days.The clinical efficacy of the two groups was evaluated after 1 month of treatment.After 1 month of treatment,the clinical efficacy of the two groups was evaluated.The changes in the traditional Chinese medicine(TCM)scores,including chest tightness,palpitations,stabbing pains in the chest,and dark complexion,as well as the frequency and duration of angina pectoris were observed before and after the treatment in the two groups.The changes of serum monocyte chemotactic factor 1(MPC-1),hs-CRP,tumor necrosis factor α(TNF-α),mitogen-activated protein kinase(MAPK),and Toll-like receptor 4(TLR4)were observed before and after treatment in the two groups.Results(1)The total effective rate was 95.00%(38/40)in the observation group and 75.00%(30/40)in the control group.The efficacy of the observation group was superior to that of the control group,and the difference was statistically significant(P<0.05).(2)After treatment,the TCM syndrome scores of patients in the two groups,including chest tightness and palpitations,chest tingling,and dark complexion,were significantly improved,and the observation group was significantly superior to the control group in improving the TCM syndrome scores of chest tightness and palpitations,chest tingling,and dark complexion,and the difference was statistically significant(P<0.05).(3)After treatment,the frequency and duration of angina attacks in the two groups were significantly improved,and the observation group was significantly superior to the control group in improving the frequency and duration of angina attacks,and the difference was statistically significant(P<0.05).(4)After treatment,the serum hs-CRP,MPC-1,and TNF-α levels of patients in the two groups were significantly improved(P<0.05),and the observation group was significantly superior to the control group in improving the serum hs-CRP,MPC-1 and TNF-α levels,and the difference was statistically significant(P<0.05).(5)After treatment,the serum MAPK and TLR4 levels of patients in the two groups were significantly improved(P<0.05),and the observation group was significantly superior to the control group in improving serum MAPK and TLR4 levels,and the difference was statistically significant(P<0.05).Conclusion Acupuncture combined with Guanxinning Tablets for the treatment of heart vessel obstruction type of chest obstruction syndrome can significantly improve the clinical symptoms of the patients,effectively alleviate the body's inflammatory response,reduce the level of serum MAPK and TLR4,and the clinical efficacy is remarkable.
2.Bioequivalence study of buspirone hydrochloride tablets in Chinese healthy subjects
Ping LU ; Rui WANG ; Hui-Hui WU ; Hai-Yan LIU ; Ge-Fei HE ; Shun-Zhi ZHANG ; Wei WU
The Chinese Journal of Clinical Pharmacology 2024;40(5):723-727
Objective To study the pharmacokinetic characteristics of buspirone hydrochloride tablets in healthy adult populations under conditions of fasting and postprandial administration.Methods A single-center,randomized,three-cycle partially repeated crossover trial design was adopted,and 36 subjects were enrolled on fasting/postprandial,one tablet of the test preparation was taken in one cycle,one tablet of reference preparation(5 mg of buspirone tablets)was taken once in each of 2 cycles,the drug concentration of buspirone in plasma was determined by liquid chromatography-tandem mass spectrometry,and the pharmacokinetic parameters were calculated by WinNonlin software.Results Main pharmacokinetics of buspirone after oral administration of test and reference preparations in fasting group,the Cmax was(285.72±286.08)and(308.94±341.03)pg·mL-1;AUC0-t were(577.09±491.10)and(618.62±642.56)pg·mL-1·h;AUC0-∞ were(586.85±510.04)and(655.92±687.95)pg·mL-1·h;tmax was 0.75(0.33-4.00)and 0.75(0.33-1.75)h.Main pharmacokinetics of buspirone after oral administration of test and reference preparations in the postprandial group,the Cmax were(676.36±603.64)and(760.33±610.27)pg·mL-1;AUC0-t were(1 755.58±1 001.69)and(1 743.00±1 073.33)pg·h·mL-1;AUC0-∞ were(1 839.97±1 044.60)and(1 818.00±1 106.95)pg·mL-1·h;tmax was 1.25(0.25-4.50)and 1.00(0.25-3.50)h.The 90%confidence intervals of the AUC0-t and AUC0-∞ geometric mean ratios of the test preparation and the reference preparation in the fasting test and the postprandial test all fell between 80.00%and 125.00%,and the 95%upper confidence limit of of Cmax was ≤0 and geometric mean ratios point estimates fall between 80.00%and 125.00%.Conclusion Two kinds of buspirone hydrochloride are bioequivalent in Chinese healthy adult subject.
3.National bloodstream infection bacterial resistance surveillance report (2022) : Gram-negative bacteria
Zhiying LIU ; Yunbo CHEN ; Jinru JI ; Chaoqun YING ; Qing YANG ; Haishen KONG ; Haifeng MAO ; Hui DING ; Pengpeng TIAN ; Jiangqin SONG ; Yongyun LIU ; Jiliang WANG ; Yan JIN ; Yuanyuan DAI ; Yizheng ZHOU ; Yan GENG ; Fenghong CHEN ; Lu WANG ; Yanyan LI ; Dan LIU ; Peng ZHANG ; Junmin CAO ; Xiaoyan LI ; Dijing SONG ; Xinhua QIANG ; Yanhong LI ; Qiuying ZHANG ; Guolin LIAO ; Ying HUANG ; Baohua ZHANG ; Liang GUO ; Aiyun LI ; Haiquan KANG ; Donghong HUANG ; Sijin MAN ; Zhuo LI ; Youdong YIN ; Kunpeng LIANG ; Haixin DONG ; Donghua LIU ; Hongyun XU ; Yinqiao DONG ; Rong XU ; Lin ZHENG ; Shuyan HU ; Jian LI ; Qiang LIU ; Liang LUAN ; Jilu SHEN ; Lixia ZHANG ; Bo QUAN ; Xiaoping YAN ; Xiaoyan QI ; Dengyan QIAO ; Weiping LIU ; Xiusan XIA ; Ling MENG ; Jinhua LIANG ; Ping SHEN ; Yonghong XIAO
Chinese Journal of Clinical Infectious Diseases 2024;17(1):42-57
Objective:To report the results of national surveillance on the distribution and antimicrobial resistance profile of clinical Gram-negative bacteria isolates from bloodstream infections in China in 2022.Methods:The clinical isolates of Gram-negative bacteria from blood cultures in member hospitals of national bloodstream infection Bacterial Resistant Investigation Collaborative System(BRICS)were collected during January 2022 to December 2022. Antibiotic susceptibility tests were conducted by agar dilution or broth dilution methods recommended by Clinical and Laboratory Standards Institute(CLSI). WHONET 5.6 and SPSS 25.0 software were used to analyze the data.Results:During the study period,9 035 strains of Gram-negative bacteria were collected from 51 hospitals,of which 7 895(87.4%)were Enterobacteriaceae and 1 140(12.6%)were non-fermenting bacteria. The top 5 bacterial species were Escherichia coli( n=4 510,49.9%), Klebsiella pneumoniae( n=2 340,25.9%), Pseudomonas aeruginosa( n=534,5.9%), Acinetobacter baumannii complex( n=405,4.5%)and Enterobacter cloacae( n=327,3.6%). The ESBLs-producing rates in Escherichia coli, Klebsiella pneumoniae and Proteus spp. were 47.1%(2 095/4 452),21.0%(427/2 033)and 41.1%(58/141),respectively. The prevalence of carbapenem-resistant Escherichia coli(CREC)and carbapenem-resistant Klebsiella pneumoniae(CRKP)were 1.3%(58/4 510)and 13.1%(307/2 340);62.1%(36/58)and 9.8%(30/307)of CREC and CRKP were resistant to ceftazidime/avibactam combination,respectively. The prevalence of carbapenem-resistant Acinetobacter baumannii(CRAB)complex was 59.5%(241/405),while less than 5% of Acinetobacter baumannii complex was resistant to tigecycline and polymyxin B. The prevalence of carbapenem-resistant Pseudomonas aeruginosa(CRPA)was 18.4%(98/534). There were differences in the composition ratio of Gram-negative bacteria in bloodstream infections and the prevalence of main Gram-negative bacteria resistance among different regions,with statistically significant differences in the prevalence of CRKP and CRPA( χ2=20.489 and 20.252, P<0.001). The prevalence of CREC,CRKP,CRPA,CRAB,ESBLs-producing Escherichia coli and Klebsiella pneumoniae were higher in provinicial hospitals than those in municipal hospitals( χ2=11.953,81.183,10.404,5.915,12.415 and 6.459, P<0.01 or <0.05),while the prevalence of CRPA was higher in economically developed regions(per capita GDP ≥ 92 059 Yuan)than that in economically less-developed regions(per capita GDP <92 059 Yuan)( χ2=6.240, P=0.012). Conclusions:The proportion of Gram-negative bacteria in bloodstream infections shows an increasing trend,and Escherichia coli is ranked in the top,while the trend of CRKP decreases continuously with time. Decreasing trends are noted in ESBLs-producing Escherichia coli and Klebsiella pneumoniae. Low prevalence of carbapenem resistance in Escherichia coli and high prevalence in CRAB complex have been observed. The composition ratio and antibacterial spectrum of bloodstream infections in different regions of China are slightly different,and the proportion of main drug resistant bacteria in provincial hospitals is higher than those in municipal hospitals.
4.Effects of Rosa roxburghii Radix on ulcerative colitis in rats based on pyroptosis and neutrophil extracellular traps
Yi-Ping YAN ; Yun-Zhi CHEN ; Qian LI ; Bo-Yang CHEN ; Zhi-Liang FAN ; Shuai CHEN ; Yi-Hui CHAI ; Zhong QIN
Chinese Traditional Patent Medicine 2024;46(3):780-788
AIM To explore the effects of Rosa roxburghii Radix on ulcerative colitis(UC)in rats based on pyroptosis and neutrophil extracellular traps(NETs).METHODS Rats were randomly divided into the normal group and the model group.The successfully established UC rat models by trinitrobenzene sulfonic acid(TNBS)/ethanol enema were then randomly divided into the model group,the sulfasalazine group(0.3 g/kg)and the low,medium and high dose R.roxburghii Radix groups(2,4,8 g/kg),followed by dosing of corresponding drugs by gavage.21 days later,the rats had their disease activity index(DAI)score calculated;their pathological changes of colon tissue observed by HE staining;their levels of serum interleukin(IL)-18,IL-1β and myeloperoxidase(MPO)detected by ELISA;and their protein expressions of NE,MPO,NLRP3,caspase-1 and GSDMD in colon tissue detected by Western blot and immunohistochemistry.RESULTS Compared with the normal group,the model group displayed increased DAI score(P<0.01),increased serum levels of IL-1β,IL-18 and MPO(P<0.01),and increased protein expressions of NE,MPO,caspase-1,NLRP3 and GSDMD in colon tissue(P<0.01).Compared with the model group,the groups intervened with sulfasalazine,or medium,or high dose R.roxburghii Radix demonstrated with decreased DAI scores(P<0.05,P<0.01),decreased serum levels of IL-1β,IL-18 and MPO(P<0.01),and decreased protein expressions of NE,MPO,caspase-1,NLRP3 and GSDMD in colon tissue(P<0.05,P<0.01).CONCLUSION R.roxburghii Radix may alleviate the inflammatory reaction in a rat model of UC and improve its pathological injury of colon via regulating pyroptosis and NETs.
5.Efficacy and safety of recombinant human anti-SARS-CoV-2 monoclonal antibody injection(F61 injection)in the treatment of patients with COVID-19 combined with renal damage:a randomized controlled exploratory clinical study
Ding-Hua CHEN ; Chao-Fan LI ; Yue NIU ; Li ZHANG ; Yong WANG ; Zhe FENG ; Han-Yu ZHU ; Jian-Hui ZHOU ; Zhe-Yi DONG ; Shu-Wei DUAN ; Hong WANG ; Meng-Jie HUANG ; Yuan-Da WANG ; Shuo-Yuan CONG ; Sai PAN ; Jing ZHOU ; Xue-Feng SUN ; Guang-Yan CAI ; Ping LI ; Xiang-Mei CHEN
Chinese Journal of Infection Control 2024;23(3):257-264
Objective To explore the efficacy and safety of recombinant human anti-severe acute respiratory syn-drome coronavirus 2(anti-SARS-CoV-2)monoclonal antibody injection(F61 injection)in the treatment of patients with coronavirus disease 2019(COVID-19)combined with renal damage.Methods Patients with COVID-19 and renal damage who visited the PLA General Hospital from January to February 2023 were selected.Subjects were randomly divided into two groups.Control group was treated with conventional anti-COVID-19 therapy,while trial group was treated with conventional anti-COVID-19 therapy combined with F61 injection.A 15-day follow-up was conducted after drug administration.Clinical symptoms,laboratory tests,electrocardiogram,and chest CT of pa-tients were performed to analyze the efficacy and safety of F61 injection.Results Twelve subjects(7 in trial group and 5 in control group)were included in study.Neither group had any clinical progression or death cases.The ave-rage time for negative conversion of nucleic acid of SARS-CoV-2 in control group and trial group were 3.2 days and 1.57 days(P=0.046),respectively.The scores of COVID-19 related target symptom in the trial group on the 3rd and 5th day after medication were both lower than those of the control group(both P<0.05).According to the clinical staging and World Health Organization 10-point graded disease progression scale,both groups of subjects improved but didn't show statistical differences(P>0.05).For safety,trial group didn't present any infusion-re-lated adverse event.Subjects in both groups demonstrated varying degrees of elevated blood glucose,elevated urine glucose,elevated urobilinogen,positive urine casts,and cardiac arrhythmia,but the differences were not statistica-lly significant(all P>0.05).Conclusion F61 injection has initially demonstrated safety and clinical benefit in trea-ting patients with COVID-19 combined with renal damage.As the domestically produced drug,it has good clinical accessibility and may provide more options for clinical practice.
6.Metabonomic study of blood of mice with high-voltage electrical injury
Si-Yu CHEN ; Hui WANG ; Yan LUO ; Jia-Wen TAO ; Wen-Juan ZHANG ; Yang YUE ; Zheng-Ping YU ; Hui-Feng PI
Journal of Regional Anatomy and Operative Surgery 2024;33(2):100-106
Objective To explore the changes of metabonomics in blood of mice after high-voltage electric shock,then screen out the significantly changed differential metabolites and metabolic pathways.Methods The head of C57BL/6J mice was subjected to high-voltage electric shock(electric shock group)or exposed to acoustic and optical stimulation of high-voltage electric(control group),then the whole blood from mice were collected to separate serum.The dual platform combined metabonomic analysis based on gas chromatography-mass spectrometer(GC-MS)and liquid chromatography-mass spectrometer(LC-MS)was performed and orthogonal partial least squares discriminant analysis(OPLS-DA)was used to screen the differential metabolites and related metabolic pathways.Results A total of 415 differential metabolites were screened out in metabonomics in blood of mice after high-voltage electric shock,including 187 up-regulated and 228 down-regulated metabolites.These differentially metabolites were significantly enriched in metabolic pathways including central carbon metabolism in cancer,glucagon signaling pathway,etc.Conclusion By establishing the model of high-voltage electrical injury on experimental mice,this study reveals the significant change of metabolite content and metabolic pathway in blood by high-voltage electrical injury.Which provides a basis for the damage of blood metabolic activity by high-voltage electrical injury,and suggests the potential harm of high-voltage electrical injury to blood metabolic activity in the whole body.
7.Hepatic lipidomics study in chronic cadmium-exposed mice
Rong-Rong HAO ; Ling LI ; Li TIAN ; Jia XIE ; Meng-Yan CHEN ; Zheng-Ping YU ; Hui-Feng PI
Journal of Regional Anatomy and Operative Surgery 2024;33(3):194-200
Objective To study the change of lipidomics in chronic cadmium-exposed mice,thereby screening out lipid subclasses,lipid molecules and enriched metabolic pathways with significant differences.Methods Twelve SPF male C57BL/6J mice(8 weeks old)were randomly divided into the control group(normal water feeding)and the experimental group[cadmium water(0.6 mg/L of CdCl2)feeding],with 6 mice in each group.Mice were sacrificed after 6 months of cadmium exposure,and fresh liver tissues were collected immediately.Lipid oil red O staining and lipidomics analysis were performed on liver tissue.Results Compared with the control group,the liver tissue of mice in the experimental group did not appear red after lipid oil red O staining.Seventeen lipid subclasses with significant differences and 144 lipid molecules with significant differences were screened out by lipidomics.These lipid molecules with significant differences were enriched in glycerophospholipid metabolism,linoleic acid metabolism,alpha-linolenic acid metabolism,glycosylphosphati-dylinositol biosynthesis,glycerolipid metabolism and arachidonic acid metabolism by KEGG.Conclusion This study reveals that chronic cadmium exposure can induce the disorder of lipid subclasses and lipid metabolites in the liver of mice,which provides a basis for understanding the non-alcoholic fatty liver disease caused by chronic cadmium exposure.
8.National bloodstream infection bacterial resistance surveillance report(2022): Gram-positive bacteria
Chaoqun YING ; Yunbo CHEN ; Jinru JI ; Zhiying LIU ; Qing YANG ; Haishen KONG ; Haifeng MAO ; Hui DING ; Pengpeng TIAN ; Jiangqin SONG ; Yongyun LIU ; Jiliang WANG ; Yan JIN ; Yuanyuan DAI ; Yizheng ZHOU ; Yan GENG ; Fenghong CHEN ; Lu WANG ; Yanyan LI ; Dan LIU ; Peng ZHANG ; Junmin CAO ; Xiaoyan LI ; Dijing SONG ; Xinhua QIANG ; Yanhong LI ; Qiuying ZHANG ; Guolin LIAO ; Ying HUANG ; Baohua ZHANG ; Liang GUO ; Aiyun LI ; Haiquan KANG ; Donghong HUANG ; Sijin MAN ; Zhuo LI ; Youdong YIN ; Kunpeng LIANG ; Haixin DONG ; Donghua LIU ; Hongyun XU ; Yinqiao DONG ; Rong XU ; Lin ZHENG ; Shuyan HU ; Jian LI ; Qiang LIU ; Liang LUAN ; Jilu SHEN ; Lixia ZHANG ; Bo QUAN ; Xiaoping YAN ; Xiaoyan QI ; Dengyan QIAO ; Weiping LIU ; Xiusan XIA ; Ling MENG ; Jinhua LIANG ; Ping SHEN ; Yonghong XIAO
Chinese Journal of Clinical Infectious Diseases 2024;17(2):99-112
Objective:To report the results of national surveillance on the distribution and antimicrobial resistance profile of clinical Gram-positive bacteria isolates from bloodstream infections in China in 2022.Methods:The clinical isolates of Gram-positive bacteria from blood cultures in member hospitals of National Bloodstream Infection Bacterial Resistant Investigation Collaborative System(BRICS)were collected during January 2022 to December 2022. Antibiotic susceptibility tests were conducted by agar dilution or broth dilution methods recommended by Clinical and Laboratory Standards Institute(CLSI). WHONET 5.6 and SPSS 25.0 software were used to analyze the data.Results:A total of 3 163 strains of Gram-positive pathogens were collected from 51 member units,and the top five bacteria were Staphylococcus aureus( n=1 147,36.3%),coagulase-negative Staphylococci( n=928,29.3%), Enterococcus faecalis( n=369,11.7%), Enterococcus faecium( n=296,9.4%)and alpha-hemolyticus Streptococci( n=192,6.1%). The detection rates of methicillin-resistant Staphylococcus aureus(MRSA)and methicillin-resistant coagulase-negative Staphylococci(MRCNS)were 26.4%(303/1 147)and 66.7%(619/928),respectively. No glycopeptide and daptomycin-resistant Staphylococci were detected. The sensitivity rates of Staphylococcus aureus to cefpirome,rifampin,compound sulfamethoxazole,linezolid,minocycline and tigecycline were all >95.0%. Enterococcus faecium was more prevalent than Enterococcus faecalis. The resistance rates of Enterococcus faecium to vancomycin and teicoplanin were both 0.5%(2/369),and no vancomycin-resistant Enterococcus faecium was detected. The detection rate of MRSA in southern China was significantly lower than that in other regions( χ2=14.578, P=0.002),while the detection rate of MRCNS in northern China was significantly higher than that in other regions( χ2=15.195, P=0.002). The detection rates of MRSA and MRCNS in provincial hospitals were higher than those in municipal hospitals( χ2=13.519 and 12.136, P<0.001). The detection rates of MRSA and MRCNS in economically more advanced regions(per capita GDP≥92 059 Yuan in 2022)were higher than those in economically less advanced regions(per capita GDP<92 059 Yuan)( χ2=9.969 and 7.606, P=0.002和0.006). Conclusions:Among the Gram-positive pathogens causing bloodstream infections in China, Staphylococci is the most common while the MRSA incidence decreases continuously with time;the detection rate of Enterococcus faecium exceeds that of Enterococcus faecalis. The overall prevalence of vancomycin-resistant Enterococci is still at a low level. The composition ratio of Gram-positive pathogens and resistant profiles varies slightly across regions of China,with the prevalence of MRSA and MRCNS being more pronounced in provincial hospitals and areas with a per capita GDP≥92 059 yuan.
9.Traditional Chinese Medicine Regulates Gut Microbiota in Treatment of Thyroid Diseases via Gut-thyroid Axis: A Review
Shanshan LI ; Dandan WEI ; Yu FU ; Ping WANG ; Hui WANG ; Shuxun YAN
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(19):254-262
Thyroid diseases are common endocrine disorders with high incidence. The diseases are closely related to genetic factors, immune system disorders, and hormone levels. Although modern medical therapies have achieved certain therapeutic effects, the side effects have affected clinical treatment. In recent years, studies have proven that gut microbiota is a key factor affecting thyroid diseases, and increasing studies have referred to the bidirectional information interaction system between the gut and thyroid as the gut-thyroid axis. This study adopts the meridian-collateral theory and the visceral manifestation theory of traditional Chinese medicine (TCM) to explain the functions, physiological characteristics, and pathological mechanisms of the gut and thyroid. Furthermore, this paper clarifies the mechanism of gut microbiota in modulating thyroid homeostasis by inducing inflammation and altering thyroid hormone metabolism from the perspective of molecular biology, clarifying the rationality of the gut-thyroid axis from the perspectives of TCM and Western medicine. Meanwhile, under the guidance of the gut-thyroid axis, increasing studies have been carried out regarding the application of TCM in regulating gut microbiota in the treatment of thyroid diseases. Both the active component emodin and compound prescription Yiqi Huatan Huoxue prescription of Chinese medicine can treat thyroid diseases by regulating the abundance and diversity of gut microbiota and improving the intestinal mucosal barrier. However, the systematic review of the research on TCM treatment of thyroid diseases by regulating gut microbiota remains to be conducted. This study expounds the gut-thyroid axis from both TCM and Western medicine and reviews the research progress in the TCM treatment of thyroid diseases by regulating gut microbiota, aiming to give new insights into the prevention and treatment of thyroid diseases with TCM.
10.Status of Outcome Index in Randomized Controlled Trials of Traditional Chinese Medicine for Treatment of Tic Disorder in Children
Yujing CHEN ; Hui LIU ; Qianfang FU ; Haihong YAN ; Ping RONG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(20):103-110
This study analyzed the outcome index and related design elements of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) in the treatment of children with tic disorder (TD) in the past ten years, so as to provide a basis for the construction of the core index set of TCM in the treatment of children with TD. Eight databases were searched, including four English databases (PubMed, Web of Science, Embase, and Cochrane Library) and four Chinese databases, including China National Knowledge Infrastructure (CNKI), Wanfang Database, VIP Database, and China Biology Medicine disc (CBMdisc), as well as ClinicalTrials.gov and China Clinical Trial Registry. The search time was limited to from January 1, 2013 to October 29, 2023. RCTs on the TD in children treated with TCM were collected. Two researchers independently conducted literature screening, data extraction, and literature quality evaluation and summarized clinical outcome indexes and related trial design elements through qualitative analysis. A total of 67 RCTs were included, including 63 outcome indexes, with a total frequency of 348 times. The related outcome indexes could be divided into six categories: 12 symptom/sign indexes with a frequency of 134 (38.5%), seven TCM symptom/syndrome indexes with a frequency of 31 (8.9%), 33 physical and chemical examination indexes with a frequency of 97 (27.9%), four safety indexes with a frequency of 67 (19.3%), three long-term prognostic indexes with a frequency of 14 (4.0%), and one kind of quality-of-life evaluation index (0.3%). Currently, the RCTs research design of TCM in the treatment of TD in children has not yet formed a unified standard, and there are many problems in the quality of methodology, which reduces the authenticity and reliability of clinical conclusions. There are problems with clinical outcome indexes, such as significant quantity differences, unclear primary and secondary outcome indexes, unreasonable alternative indexes, non-standard TCM syndrome types and TCM evaluation indexes, lack of economic evaluation indexes, and less attention to long-term prognostic indexes and safety indexes. It is suggested that the researchers should design a more rigorous trial scheme and reasonably design the outcome index which is in line with the clinical trial efficacy evaluation of TCM, so as to construct the core index set with the characteristics of TCM for the treatment TD in children.

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