Applicability comparison between Chinese dry eye questionnaire and ocular surface disease index questionnaire among college students / 国际眼科杂志(Guoji Yanke Zazhi)

AIM: To evaluate the applicability of Chinese dry eye questionnaire in college students using the ocular surface disease index(OSDI)questionnaire as a reference.METHODS: Cross-sectional study. A total of 711 college students from Nanyang Medical College were enrolled in the study and assessed for dry eye condition using OSDI questionnaire and Chinese dry eye questionnaire. The response rate of each question in the two questionnaires was counted. Cronbach α was calculated to evaluate the internal consistency of both questionnaires. Correlation between the total scores of the two questionnaires was analyzed to evaluate the criterion validity. Based on OSDI scores, the discriminant validity of Chinese dry eye questionnaire was evaluated; receiver operating characteristic(ROC)curves was plotted for Chinese dry eye questionnaire scores, area under the ROC curve(AUC)was calculated, and diagnostic thresholds and corresponding sensitivity and specificity were also analyzed.RESULT: The response rates of the 12 questions on the OSDI questionnaire were 33.2%-100.0%, while it was 100.0% for each question on the Chinese dry eye questionnaire. The Cronbach α values of OSDI questionnaire and Chinese dry eye questionnaire were 0.905 and 0.789, respectively. The Chinese dry eye questionnaire score was positively correlated with the OSDI score(rs=0.712, P<0.001). According to OSDI questionnaire scores, dry eye severity was divided into normal group, mild dry eye group, moderate dry eye group and severe dry eye group. The scores of Chinese dry eye questionnaire in these groups were 4.00(2.00, 6.00), 9.00(7.00, 11.00), 12.00(9.00, 14.00)and 16.00(13.50, 22.00), respectively, which increased with the severity of dry eye, and the overall difference was statistically significant(P<0.001), as well as pairwise comparison between groups(P<0.05). The AUCs of Chinese dry eye questionnaire in distinguishing normal population from dry eye population, mild dry eye from moderate dry eye, moderate dry eye from severe dry eye were 0.862, 0.661 and 0.769, respectively, and the diagnostic thresholds were 6.5, 11.5 and 14.5, respectively.CONCLUSION:Chinese dry eye questionnaire has an equivalent reliability, validity, discriminant ability and better response rate for dry eye screening and epidemiological survey among college students in China compared with OSDI questionnaire.

Regularity of prescriptions for sick sinus syndrome based on latent structure combined with association rules / 中国中药杂志

This study aims to mine the regularity of traditional Chinese medicine(TCM) prescriptions for sick sinus syndrome(SSS) and provide a reference for clinical syndrome differentiation and treatment. The relevant papers were retrieved from CNKI, Wanfang, VIP, and SinoMed with the time interval from inception to January 31, 2023. The relevant information from qualified papers was extracted to establish a library. Lantern 5.0 and Rstudio were used to analyze the latent structure and association rules of TCMs with the frequency ≥3%, which combined with frequency descriptions, were used to explore the rules of TCM prescriptions for SSS. A total of 192 TCM prescriptions were included, involving 115 TCMs with the cumulative frequency of 1 816. High-frequency TCMs include Aconiti Lateralis Radix Praeparata, Ginseng Radix et Rhizoma, Glycyrrhizae Radix et Rhizoma, Astragali Radix, and Salviae Miltiorrhizae Radix et Rhizoma. The high-frequency medicines mainly had the effects of tonifying, releasing exterior with pungent-warm, and activating blood and resolving stasis. The analysis of the latent structure model yielded 13 hidden variables, 26 hidden classes, 8 comprehensive cluster models, and 21 core prescriptions. Accordingly, the common syndromes of SSS were inferred as heart-Yang Qi deficiency, heart-spleen Yang deficiency, heart-kidney Yang deficiency, Yang deficiency and blood stasis, both Qi and Yin deficiency and blood stasis, and Yin and Yang deficiency. The analysis of association rules predicted 30 strong association rules, among which Ginseng Radix et Rhizoma-Aconiti Lateralis Radix Praeparata had the highest support. SSS is a syndrome with Yang deficiency and Qi deficiency as the root causes and cold, phlegm, and stasis as the manifestations. The clinical treatment of SSS should focus on warming Yang and replenishing Qi, which should be supplemented with the therapies of activating blood and resolving stasis, warming interior and dissipating cold, or regulating Qi movement for resolving phlegm according to the patients' syndromes.

Network Meta-analysis of efficacy and safety of different traditional Chinese medicine injections in treating post-acute myocardial infarction heart failure / 中国中药杂志

This study aims to systematically review the efficacy and safety of different traditional Chinese medicine injections combined with conventional treatment for patients with post-acute myocardial infarction heart failure. The relevant randomized controlled trial(RCT) was retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, and Cochrane Library with the time interval from inception to May 13, 2023. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies. Network Meta-analysis was then performed in RevMan 5.3 and Stata 15.1. A total of 68 RCTs involving 11 traditional Chinese medicine injections and 5 995 patients were included. The results were explained based on the surface under the cumulative ranking curve(SUCRA).(1) In terms of reducing major adverse cardiovascular event(MACE), the therapies followed the trend of Xinmailong Injection+conventional treatment(83.8%) > Yiqi Fumai Injection+conventional treatment(57.1%) > Xuebijing Injection+conventional treatment(56.6%) > Shenmai Injection+conventional treatment(53.1%) > Shenfu Injection+conventional treatment(45.3%) > conventional treatment(4.0%).(2) In terms of increasing left ventricular ejection fraction(LVEF), the therapies followed the trend of Yiqi Fumai Injection+conventional treatment(84.0%) > Shenmai Injection+conventional treatment(69.6%) > Shenfu Injection+conventional treatment(62.7%) > Xinmailong Injection+conventional treatment(61.6%) > Shuxuening Injection+conventional treatment(54.8%) > Shenqi Fuzheng Injection+conventional treatment(46.7%) > Shengmai Injection+conventional treatment(45.9%) > Breviscapine Injection+conventional treatment(39.9%) > Danhong Injection+conventional treatment(38.8%) > Huangqi Injection+conventional treatment(38.7%) > conventional treatment(7.3%).(3) In terms of reducing B-type natriuretic peptide(BNP), the therapies followed the trend of Xinmailong Injection+conventional treatment(98.6%) > Shenmai Injection+conventional treatment(57.7%) > Shenfu Injection+conventional treatment(52.5%) > Shengmai Injection+conventional treatment(30.1%) > conventional treatment(11.0%).(4) In terms of reducing cardiac troponin Ⅰ(cTnⅠ), the therapies followed the trend of Shenmai Injection+conventional treatment(92.3%) > Yiqi Fumai Injection+conventional treatment(61.5%) > Shenfu Injection+conventional treatment(51.2%) > Shengmai Injection+conventional treatment(48.1%) > Xinmailong Injection+conventional treatment(26.6%) > conventional treatment(20.3%).(5) In terms of reducing high-sensitivity C-reactive protein(hs-CRP), the therapies followed the trend of Shenmai Injection+conventional treatment(79.9%) > Xinmailong Injection+conventional treatment(68.1%) > Shenfu Injection+conventional treatment(63.1%) > Xuebijing Injection+conventional treatment(56.7%) > Shengmai Injection+conventional treatment(51.1%) > Shenqi Fuzheng Injection+conventional treatment(42.8%) > Huangqi Injection+conventional treatment(34.7%) > conventional treatment(3.5%).(6) A total of 22 RCTs reported the occurrence of adverse reactions, mainly involving the damage of the circulatory system, digestive system, and coagulation function. The current evidence suggested that Xinmailong Injection+conventional treatment may have the best therapeutic effect in reducing MACE and BNP; Yiqi Fumai Injection+conventional treatment may be the best in increasing LVEF; Shenmai Injection+conventional treatment may be the best in reducing cTnI and hs-CRP. The safety needs further quantitative research and analysis. However, more high-quality RCT is required to validate the above conclusions due to limitations in the quality and quantity of the included studies.

Outcome indicators in clinical trials on traditional Chinese medicine treatment of microvascular angina / 中国中药杂志

This study reviewed the current status of the use of outcome indicators in randomized controlled trial(RCT) on traditional Chinese medicine(TCM) treatment of microvascular angina(MVA) and analyzed the existing problems and possible solutions, aiming to provide a basis for the design of high-quality RCT and the establishment of core outcome sets for MVA. CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, Web of Science, and 2 clinical trial registries were searched for the RCT on TCM treatment of MVA according to pre-defined criteria. The Cochrane's risk of bias assessment tool was used to evaluate the methodological quality of the included RCT and the use of outcome indicators was summarized. A total of 69 RCTs were included, from which 100 outcome indicators were extracted, with the frequency of 430. The extracted outcome indicators belonged to 8 domains: response rate, symptoms and signs, physical and chemical examinations, TCM efficacy, safety, quality of life, economic evaluation, and long-term prognosis. The indicators of physical and chemical examinations were the most(70 indicators with the frequency of 211), followed by those of response rate(7 indicators with the frequency of 73) and symptoms and signs(7 indicators with the frequency of 54). The outcome indicators with higher frequency were adverse reactions, angina attack frequency, clinical efficacy, endothelin-1, total duration of treadmill exercise, and hypersensitive C-reactive protein. The RCT on TCM treatment of MVA had the following problems: irregular reporting of adverse reactions, diverse indicators with low frequency, lack of attention to the application of endpoint indicators, insufficient use of TCM differentiation and efficacy indicators, non-standard evaluation criteria and failure to reflect the basic characteristics of TCM. A unified MVA syndrome differentiation standard should be established, on the basis of which an MVA treatment efficacy evaluation system and core outcome indicator set that highlights the characteristics of TCM with patient-reported outcomes as the starting point should be established to improve the clinical research and research value.

Sacubitril/valsartan attenuates left ventricular remodeling and improve cardiac function by upregulating apelin/APJ pathway in rats with heart failure / 中华心血管病杂志

Objective: To investigate the effect and mechanism of sacubitril/valsartan on left ventricular remodeling and cardiac function in rats with heart failure. Methods: A total of 46 SPF-grade male Wistar rats weighed 300-350 g were acclimatized to the laboratory for 7 days. Rats were then divided into 4 groups: the heart failure group (n=12, intraperitoneal injection of adriamycin hydrochloride 2.5 mg/kg once a week for 6 consecutive weeks, establishing a model of heart failure); heart failure+sacubitril/valsartan group (treatment group, n=12, intragastric administration with sacubitril/valsartan 1 week before the first injection of adriamycin, at a dose of 60 mg·kg-1·d-1 for 7 weeks); heart failure+sacubitril/valsartan+APJ antagonist F13A group (F13A group, n=12, adriamycin and sacubitril/valsartan, intraperitoneal injection of 100 μg·kg-1·d-1 APJ antagonist F13A for 7 weeks) and control group (n=10, intraperitoneal injection of equal volume of normal saline). One week after the last injection of adriamycin or saline, transthoracic echocardiography was performed to detect the cardiac structure and function, and then the rats were executed, blood and left ventricular specimens were obtained for further analysis. Hematoxylin-eosin staining and Masson trichrome staining were performed to analyze the left ventricular pathological change and myocardial fibrosis. TUNEL staining was performed to detect cardiomyocyte apoptosis. mRNA expression of left ventricular myocardial apelin and APJ was detected by RT-qRCR. ELISA was performed to detect plasma apelin-12 concentration. The protein expression of left ventricular myocardial apelin and APJ was detected by Western blot. Results: Seven rats survived in the heart failure group, 10 in the treatment group, and 8 in the F13A group. Echocardiography showed that the left ventricular end-diastolic diameter (LVEDD) and the left ventricular end-systolic diameter (LVESD) were higher (both P<0.05), while the left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) were lower in the heart failure group than in the control group (both P<0.05). Compared with the heart failure group, rats in the treatment group were featured with lower LVEDD and LVESD (both P<0.05), higher LVEF and LVFS (both P<0.05), these beneficial effects were reversed in rats assigned to F13A group (all P<0.05 vs. treatment group). The results of HE staining showed that the cardiomyocytes of rats in the control group were arranged neatly and densely structured, the cardiomyocytes in the heart failure group were arranged in disorder, distorted and the gap between cells was increased, the cardiomyocytes in the treatment group were slightly neat and dense, and cardiomyocytes in the F13A group were featured similarly as the heart failure group. Masson staining showed that there were small amount of collagen fibers in the left ventricular myocardial interstitium of the control group, while left ventricular myocardial fibrosis was significantly increased, and collagen volume fraction (CVF) was significantly higher in the heart failure group than that of the control group (P<0.05). Compared with the heart failure group, the left ventricular myocardial fibrosis and the CVF were reduced in the treatment group (both P<0.05), these effects were reversed in the F13A group (all P<0.05 vs. treatment group). TUNEL staining showed that the apoptosis index (AI) of cardiomyocytes in rats was higher in the heart failure group compared with the control group (P<0.05), which was reduced in the treatment group (P<0.05 vs. heart failure group), this effect again was reversed in the F13A group (P<0.05 vs. treatment group). The results of RT-qPCR and Western blot showed that the mRNA and protein levels of apelin and APJ in left ventricular myocardial tissue of rats were downregulated in heart failure group (all P<0.05) compared with the control group. Compared with the heart failure group, the mRNA and protein levels of apelin and APJ were upregulated in the treatment group (all P<0.05), these effects were reversed in the F13A group (all P<0.05 vs. treatment group). ELISA test showed that the plasma apelin concentration of rats was lower in the heart failure group compared with the control group (P<0.05); compared with the heart failure group, the plasma apelin concentration of rats was higher in the treatment group (P<0.05), this effect was reversed in the F13A group (P<0.05 vs. treatment group). Conclusion: Sacubitril/valsartan can partially reverse left ventricular remodeling and improve cardiac function in rats with heart failure through modulating Apelin/APJ pathways.

Meta-analysis of efficacy and safety of Xinmailong Injection in treatment of heart failure after acute myocardial infarction / 中国中药杂志

To systematically evaluate the clinical efficacy and safety of Xinmailong Injection in the treatment of heart failure after acute myocardial infarction. Seven Chinese and English databases, namely CNKI, VIP, Wanfang, SinoMed and PubMed, EMbase, Cochrane Library, were retrieved from the establishment of the database to March 2020. Randomized controlled trials for Xinmailong Injection in the treatment of heart failure after acute myocardial infarction were screened out. Cochrane collaboration network bias risk assessment tool was used to evaluate the literature quality of the studies included, and RevMan 5.3 software was used for Meta-analysis. A total of 926 relevant literatures were retrieved, and 12 studies were finally included, involving 972 patients, including 486 patients in the treatment group and 486 patients in the control group. The quality of the literatures included was generally low. The results of Meta-analysis showed that Xinmailong Injection combined with Western medicine could decrease the levels of BNP(SMD=-5.90, 95%CI[-8.45,-3.36], P<0.000 01) and NT-proBNP(SMD=-2.28, 95%CI[-3.13,-1.43], P<0.000 01) and decrease the levels of cTnI(SMD=-2.91, 95%CI[-4.21,-1.60], P<0.000 1), increase LVEF(MD=4.67, 95%CI[4.19, 5.16], P<0.000 01), increased 6 MWT(MD=73.90, 95%CI[67.51, 80.28], P<0.000 01], decreased LVEDD(MD=-5.46, 95%CI[-9.66,-1.25], P=0.01), reduce the level of serum inflammatory factor(hs-CRP, CRP, IL-6). In terms of safety, less adverse reactions occurred in the study, with no impact on the treatment. The results showed that clinical use of Xinmailong Injection combined with Western medicine in the treatment of heart failure after acute myocardial infarction can further alleviate clinical symptoms and relevant indexes, with less adverse reactions. However, due to the limitations in quantity and quality of the clinical studies included, the positive results can only be used as a hint and reference for clinical diagnosis and treatment, and more high-quality studies are needed to further confirm its efficacy.

Analysis of Medication Rules of Coronary Heart Disease with Heart Failure of Qi Deficiency and Blood Stasis Syndrome Based on Literature Research / 中国实验方剂学杂志

Objective:To systematically sort out and summarize the medication rules of clinical prescriptions for coronary heart disease with heart failure of Qi deficiency and blood stasis syndrome，and to provide reference for selecting prescriptions and medications for the treatment of coronary heart disease （CHD） with traditional Chinese medicine （TCM）. Method:All relevant literature concerning the treatment of CHD with compound TCM prescriptions for Qi deficiency and blood statis syndrome from 2000 to 2020 were retrieved from the China National Knowledge Network （CNKI），WanFang database （WanFang），and VIP journal database （VIP），and the names of prescriptions and drug components were extracted，followed by the frequency of drug use and drug category. Association rules of high-frequency drugs were analyzed by SPSS 18.0，and systematic clustering analysis was conducted by SPSS 21.0. Result:Finally，41 qualified literature articles covering 35 prescriptons and 66 drugs were included in the study. The total frequency of the drugs was 433 times. Among them，there were a total of 25 traditional Chinese medicines with a frequency of ≥5 times. The top 3 frequently used Chinese medicines were Astragali Radix （8.8%），Salviae Miltiorrhizae Radix et Rhizoma （7.2%），Chuanxiong Rhizoma （5.8%）. A total of 15 types of drugs were involved，among which tonic drugs （31.4%），blood promoting and blood stasis drugs （28.2%），and hydration and dampening drugs （7.6%） were used most frequently. The association rule analysis of traditional Chinese medicines with frequency of ≥ 5 showed that there were 13 pairs of binomial associations in 25 traditional Chinese medicines，with Astragali Radix in combination with Salviae Miltiorrhizae Radix et Rhizoma，Chuanxiong Rhizoma，Carthami Flos，et al. There were 8 groups of three associations，with Astragali Radix，Salviae Miltiorrhizae Radix et Rhizoma，and Chuanxiong Rhizoma as the main combinations. A systematic clustering analysis showed that the clustering effect was best when the 25 traditional Chinese medicines were clustered into 5 categories. Conclusion:The treatment of coronary heart disease with heart failure of Qi deficiency and blood stasis syndrome is based on replenishing qi and activating blood circulation，supplemented by warming yang，diuresis，and phlegm-resolving drugs，which can enhance the clinical efficacy. Two basic prescriptions of Buyang Huanwutang and Si junzitang are extracted. Other combinations of prescriptions and drugs can provide references for the clinical treatment of coronary heart disease with heart failure.

Correlations Between Severity of Heart Failure Related to Coronary Heart Disease of Qi Deficiency and Blood Stasis Syndrome and Biological Indexes / 中国实验方剂学杂志

Objective:To explore the correlations of the severity of heart failure related to coronary heart disease arising from Qi deficiency and blood stasis with cardiac function indexes， energy metabolism indexes， coagulation function indexes， and inflammatory factors， in order to provide a scientific basis for further research on the biological foundation of this disease. Method:Two hundred patients with heart failure related to coronary heart disease of Qi deficiency and blood stasis syndrome were collected and then classified into mild， moderate and severe groups according to their scores of Qi deficiency and blood stasis syndrome. Meanwhile， 40 healthy persons confirmed by physical examination during the same period were included into the control group. Such biological indexes as cardiac function indexes， energy metabolism indexes， coagulation function indexes， and inflammatory factors were determined in patients of each group for comparison. Then the Spearman rank correlation analysis was conducted to figure out the correlations between differential indexes and the severity of Qi deficiency and blood stasis syndrome， followed by the determination of risk factors for the severity of Qi deficiency and blood stasis syndrome by ordered logistic regression analysis. Result:The cardiac function indexes， energy metabolism indexes， coagulation function indexes， and inflammatory factors in patients with heart failure related to coronary heart disease arising from Qi deficiency and blood stasis varied significantly. There were significant statistical differences in the levels of N-terminal pro-B-type natriuretic peptide （NT-ProBNP）， 6-minute walk test （6MWT）， heart-type fatty acid-binging protein （H-FABP）， prothrombin time （PT）， activated partial thromboplastin time （APTT）， tumor necrosis factor-<italic>α</italic> （TNF-<italic>α</italic>）， and nitric oxide （NO） among the mild， moderate， and severe groups （<italic>P</italic><0.05）. The severity of Qi deficiency and blood stasis syndrome was positively correlated with NT-ProBNP （<italic>r</italic>=0.144）， PT （<italic>r</italic>=0.173）， and APTT （<italic>r</italic>=0.144）， but negatively with 6MWT （<italic>r</italic>=-0.287）. The 6MWT［odds ratio（OR）=0.995， 95% confidence interval（CI） 0.991-0.998），<italic>P</italic><0.01］ and APTT（OR=1.088，95%CI 1.021-1.157，<italic>P</italic><0.01） were independent risk factors affecting the severity of heart failure related to coronary heart disease arising from Qi deficiency and blood stasis. Conclusion:The severity of heart failure related to coronary heart disease of Qi deficiency and blood stasis syndrome is closely related to NT-ProBNP， 6MWT， H-FABP， PT， APTT， TNF-<italic>α</italic>， and NO. Moreover， 6MWT and APTT can be used as independent risk factors to evaluate the severity of patients with heart failure related to coronary heart disease due to Qi deficiency and blood stasis.

Systematic review and Meta-analysis of efficacy and safety of Toutongning Capsules in treatment of tension-type headache / 中国中药杂志

This study aims to systematically evaluate the clinical efficacy and safety of Toutongning Capsules in the treatment of tension-type headache(TTH), so as to provide a corresponding basis for clinical treatment. Eight commonly used medical research databases and two clinical trial registration systems were retrieved with the time interval from the establishment of the database or system to November 2020. The randomized controlled trials of Toutongning Capsules in the treatment of TTH were screened out according to the pre-set criteria. The quality of the included papers was evaluated by the bias risk assessment tool in Cochrane Reviewers Handbook 6.1 and the data were statistically analyzed by RevMan v5.4 provided by Cochrane collaboration. A total of 13 studies were included and the quality of methodology was generally low. Meta-analysis showed that Toutongning Capsules assisted with western medicine therapy can effectively reduce the pain intensity(MD_(VAS)=-1.94,95%CI[-2.50,-1.38],P<0.000 01;MD_(NRS)=-0.83,95%CI[-0.86,-0.80],P<0.000 01), headache duration(SMD=-0.98,95%CI[-1.17,-0.79],P<0.000 01), headache frequency(MD=-1.01,95%CI[-1.16,-0.85],P<0.000 01), headache index(MD=-11.13,95%CI[-12.10,-10.16],P<0.000 01), anxiety and depression scale score(MD_(HAMA)=-4.02,95%CI[-6.58,-1.46],P=0.002;MD_(HAMD)=-2.67,95%CI[-4.04,-1.29],P=0.000 1), while Toutongning Capsules as monotherapy only reduced the headache score(MD=-2.24,95%CI[-2.97,-1.51],P<0.000 01). The available clinical studies demonstrate that Toutongning Capsules combined with western medicine in the treatment of TTH can improve the related outcome indicators, but the clinical safety and efficacy of Toutongning Capsules alone remain unclear. Due to the small number and low quality of the included studies, large-sample, multi-center, high-quality and strictly designed randomized controlled trials are still needed to verify the clinical efficacy in the future.

Systematic review and Meta-analysis of efficacy and safety of gastrodin in treatment of tension-type headache / 中国中药杂志

The efficacy of gastrodin as a Chinese herbal medicine extract in the treatment of tension-type headache has been confirmed. This paper systematically reviewed the efficacy and safety of gastrodin in the treatment of tension-type headache, aiming to provide a new choice for the treatment of this disease. In this study, four Chinese databases, four English databases and two trial registries were searched from the date of establishment to September 2020. The related randomized controlled trials(RCTs) were screened out according to the predetermined criteria. The bias risk assessment tool developed by Cochrane collaboration was used to evaluate the quality of the reports. RevMan 5.4.1 was used for Meta-analysis, and GRADE system for the evidence-based evaluation on the quality of outcome indicators. A total of 177 articles were retrieved and 8 articles were finally included for analysis, with a total sample size of 1 091 cases, which included 565 cases in the treatment group and 526 cases in the control group. The overall quality of included stu-dies was not high. The results of Meta-analysis are as follows:(1)In terms of headache frequency, gastrodin group was better than wes-tern medicine group(MD=-2.90, 95%CI[-3.76,-2.03], P<0.000 01).(2)In terms of number of abnormal blood vessels in TCD, gastrodin group was better than western medicine group(MD=-88.96, 95%CI[-102.36,-75.55], P<0.000 01).(3)In terms of effective rate, gastrodin group was better than western medicine group(RR=1.47, 95%CI[1.29, 1.68], P<0.000 01). The results of subgroup analysis are as follows:(1)Effective rate based on age, for the patients upper age limit 40-46 years old, gastro-din group was better than western medicine group(RR=1.69, 95%CI[1.50, 1.90], P<0.000 01); for the patients upper age limit 55-60 years old, gastrodin group was better than western medicine group(RR=1.27, 95%CI[1.16, 1.38], P<0.000 01).(2)Effective rate based on dosage form, both the gastrodin capsules and injection groups were better than western medicine group(RR_(capsules)=1.42, 95%CI[1.08, 1.88], P=0.01; RR_(injection)=1.50, 95%CI[1.26, 1.77], P<0.000 01). GRADE evaluation showed that the above outcomes had low quality of evidence. Only one article detailed the occurrence of adverse reactions and thus the present study cannot make a positive conclusion on the safety of gastrodin in the treatment of tension-type headache. The small number and low quality of the included reports affected the reliability of the results. In the future, more high-quality randomized controlled trails are needed to improve the evaluation on the efficacy and safety of gastrodin in the treatment of tension-type headache.

Outcome indicators in randomized controlled trials on traditional Chinese medicine intervention for tension-type headache in recent five years / 中国中药杂志

To evaluate the application of outcome indicators in randomized controlled trials(RCTs) concerning the treatment of tension-type headache(TTH) with traditional Chinese medicine(TCM) in recent five years, so as to provide a basis for the study of core outcome set(COS) for TCM intervention in TTH. The RCTs on TCM treatment of TTH in recent five years were systematically retrieved from CNKI, Wanfang, VIP, CBM, EMbase, PubMed, Cochrane Library, Web of Science, ClinicalTrials.gov and China Clinical Trial Registry. After literature screening, data extraction and evaluation of the risk of bias, the outcome indicators in the included RCTs were subjected to qualitative analysis. The preliminary search yielded 19 042 articles, and 10 983 were left after the elimination of duplication. Finally, 52 RCTs(48 in Chinese and 4 in English) were included for qualitative analysis. The outcome indicators of RCTs included in this study were classified into seven domains: TCM syndrome, symptom and sign, physical and chemical detection, quality of life, long-term prognosis, economic evaluation, and safety event. The findings demonstrated that headache characteristic index in the symptom and sign domain was the index with the highest reporting frequency and reporting rate. Seventeen RCTs used TCM syndrome score as the outcome indicator. Further analysis revealed that there existed such problems in research design as non-distinction between primary and secondary outcome indicators, great difference in the adopted measurement tools for outcome indicators, and the neglect of measurement time of outcome indicators. Moreover, the syndrome indicators reflecting TCM advantages, objective evaluation indicators, safety and health-economic indicators were lacking. These limitations have affected the quality and reliability of RCTs on TTH treatment with TCM. It is suggested that the efficacy and characteristics of TCM should be combined into current clinical research, and the COS in RCTs regarding TCM treatment of TTH should be established according to internationally recognized standard procedures.

Screening and bioinformatic analysis of differentially expressed miRNAs in serum of patients with pneumoconiosis / 中国职业医学

OBJECTIVE: To screen the differentially expressed microRNA(miRNA) in the serum of patients with occupational pneumoconiosis(hereinafter referred to as pneumoconiosis), and explore their potential target genes and related transcription factors using bioinformatics analysis. METHODS: The pneumoconiosis and miRNA related reports were searched from the Google academic website. The miRNA sequencing or high-throughput microarray data sets based on the serum samplings of pneumoconiosis patients(case group) and normal healthy individuals(control group) were selected to screen for the differentially expressed miRNAs. Serum samples of patients with occupational silicosis and healthy controls were collected, and the relative expression of miRNAs was detected by real-time fluorescence quantitative polymerase chain reaction to verify the differential expression of miRNAs. The target genes of the differentially expressed miRNAs were predicted in the database of miRWalk, analyzed by Gene Ontology(GO) enrichment analysis, Kyoto Encyclopedia of Genes and Genomes(KEGG) signaling pathway prediction. The transcription factor analysis of target genes was carried out by the database for annotation. RESULTS: Seven differentially expressed miRNAs were screened out and verified. Among them, five were up-regulated and two were down-regulated. GO enrichment analysis and KEGG signaling pathway prediction showed that the up-regulated differentially expressed miRNAs were mainly related to RNA polymerase Ⅱ promoter transcription and extracellular matrix, and were mainly involved in the occurrence and development of pulmonary fibrosis through adhesion plaque, protein digestion and absorption, phosphatidylinositol 3-kinase/protein kinase B and transforming growth factor-β signaling pathways. The down-regulated differentially expressed miRNAs were mainly related to the transcription of RNA polymerase Ⅱ promoter and the activity of DNA sequence specific transcription factors, that were mainly involved in the occurrence and development of pulmonary fibrosis through the signaling pathway of related hormone release. Transcription factor annotation results showed that SMAD family member 3, proto-oncogene JUN, forkhead box O1, early growth factor 1, β-catenin and other transcription factors may have an important relationship with the occurrence and development of pneumoconiosis. CONCLUSION: The seven miRNAs were differentially expressed in the serum of patients with pneumoconiosis. These miRNAs could be used as potential biomarkers for understanding the pathogenesis, the early diagnosis and treatment pneumoconiosis.

[Clinical practice guideline for migraine with traditional Chinese medicine(draft version for comments)].

The present clinical practice guideline was written by experts organized by the special group of key projects in the 13 th five-year plan period of the China Academy of Chinese Medical Sciences based on the standards and procedures of World Health Orga-nization Handbook for Guideline Development, with "evidence-based, consensus-based, and experience-based principle" as a guide. On the basis of practice in traditional Chinese medicine(TCM) and clinical research for migraine, following the idea and method of evidence-based medicine, as well as the expert experience, the current best evidence and patients' values, the internationally recognized evidence quality evaluation methods and recommendation grading system were combined with the prescription record of classical TCM, TCM expert experience, and modern clinical research evidences. The acupuncture therapy, classic prescriptions and Chinese patent medicines used in the treatment of migraine in acute stage and preventive treatment were summarized to obtain five classic prescriptions(Chuanxiong Chatiao Powder, Chuanxiong Dingtong Yin, Sanpian Decoction, Xuefu Zhuyu Decoction, and Tongqiao Huoxue Decoction), and four Chinese patent medicines(Zhengtian Pills, Toutongning Capsules, Tongtian Oral Liquid, and Yangxue Qingnao Granules/Pills), and the common problems in their clinical application were analyzed. The purpose of this guideline is to standardize the treatment of migraine with TCM, reduce the frequency and severity of migraine attacks, and improve the patients' quality of life. It provides the clinical basis for the TCM treatment of migraine, and ensures the safety, effectiveness, practicability and scientificity of the treatment, so as to promote the TCM treatment of migraine. Due to the influence of region, nationality, race and other factors of the users, the detailed implementation of the guideline should be determined according to the actual situation.

[Network Meta-analysis of oral Chinese patent medicine in treatment of migraine].

To systemically assess the clinical efficacy of oral Chinese patent medicine for migraine by using network Meta-analysis. Four Chinese databases(CNKI, VIP, WanFang, CBM), three English databases(Medline, EMbase, Cochrane Library) and ClinicalTrials.gov were systematically and comprehensively retrieved from the establishment of each database to April 24, 2020. Rando-mized controlled trial(RCT) on oral Chinese patent medicine combined with Flunarizine for migraine were screened out according to inclusion criteria and exclusion criteria. Literature screening and data extraction were conducted independently by 2 researchers. The included studies were evaluated with the Cochrane bias risk assessment tool. Data analysis was conducted by using Stata 16.0 software. Finally, a total of 52 RCTs were included, involving 11 kinds of oral Chinese patent medicines. The results of the network Meta-analysis showed that in terms of headache frequency, the order of efficacy was: Flunarizine combined with Tongtian Oral Liquid>combined with Zhengtian Pills>combined with Toutongning Capsules>combined with Yangxue Qingnao Granules>combined with Tianshu Capsules>combined with Xuefu Zhuyu Capsules>combined with Danzhen Toutong Capsules>combined with Chuanxiong Qingnao Granules>combined with Songling Xuemaikang Capsules. In terms of headache intensity, the order of efficacy was: Flunarizine combined with Tongtian Oral Liquid>combined with Zhengtian Pills>combined with Danzhen Toutong Capsules>combined with Tianshu Capsules>combined with Toutongning Capsules>combined with Chuanxiong Qingnao Granules>combined with Yuntongding Capsules>combined with Yang-xue Qingnao Granules>combined with Danqi Soft Capsules. In terms of headache lasting time, the order of efficacy was: Flunarizine combined with Tongtian Oral Liquid>combined with Yangxue Qingnao Granules>combined with Toutongning Capsules>combined with Zhengtian Pills>combined with Danzhen Toutong Capsules>combined with Tianshu Capsules>combined with Xuefu Zhuyu Capsules>combined with Yuntongding Capsules>combined with Chuanxiong Qingnao Granules>combined with Songling Xuemaikang Capsules. The results showed that oral Chinese patent medicines combined with Flunarizine were effective in improving the clinical efficacy for migraine. Due to the differences in the number and quality of studies included in studies of different Chinese patent medicines, and the lack of direct comparison of Chinese patent medicines, the results of the above order of Chinese patent medicines need to be demonstrated in future multi-center, large-sample, and double-blind randomized trial.

[Systematic review and Meta-analysis on randomized controlled trial of efficacy and safety for acupuncture versus Flunarizine in treatment of migraine].

To systematically evaluate the efficacy and safety of acupuncture versus Flunarizine hydrochloride in the treatment of migraine. Four Chinese databases(CNKI, VIP, WanFang, CBM), three English databases(Cochrane Library, EMbase, Medline) and ClinicalTrail.gov were systematically and comprehensively retrieved. The retrieval time was from the establishment of each database to January 8, 2020. Randomized controlled trial(RCT) for acupuncture versus Flunarizine in the treatment of migraine were screened out according to inclusion criteria and exclusion criteria. The included studies were evaluated with the Cochrane bias risk assessment tool. The included studies was conducted by RevMan 5.3, and the outcome indicators were evaluated for evidence quality and strength of recommendation by the GRADE system. A total of 1 033 literatures were retrieved, and 23 studies were finally included. Except for 4 multiarm tests, the total sample size was 1 548, including 785 in acupuncture group and 763 in Flunarizine group. The overall quality of the included studies was not high. Meta-analysis results showed that the acupuncture group was superior to the Flunarizine group in reduction of headache frequency(SMD=-1.00, 95%CI[-1.45,-0.54], P<0.000 1). In reduction of headache intensity, acupuncture group was superior to Flunarizine group(SMD=-1.05, 95%CI[-1.41,-0.68], P<0.000 01). In reduction of headache duration, acupuncture group was superior to Flunarizine group(SMD=-1.42, 95%CI[-1.83,-1.02], P<0.000 1). The acupuncture group was superior to Flunarizine group(MD=-0.17, 95%CI[-0.21,-0.13], P<0.000 01) in reduction of the painkillers taking frequency. The acupuncture group was superior to Flunarizine group(SMD=-0.94, 95%CI[-1.35,-0.52], P<0.000 1) in allevia-tion of paroxysmal symptoms, such as nausea and vomiting. The GRADE system showed that the evidence level of the above indicators was extremely low, and the strength of recommendation was low. As for the occurrence of adverse reactions, the adverse reactions reported in the acupuncture group included in the study were all mild adverse reactions, like drowsiness, subcutaneous bleeding, local pain, subcutaneous hematoma and dizziness needle. The available evidence showed that acupuncture has a better efficacy than Flunarizine hydrochloride in the treatment of migraine in adult patients. However, due to the high bias risk in the included studies, the conclusions of this study shall be adopted with caution, and more high-quality studies shall be carried out for verification in the future.

[Systematic review and Meta-analysis on efficacy and safety of Yangxue Qingnao Granules in treatment of migraine].

To evaluate the efficacy and safety of Yangxue Qingnao Granules alone or combined with calcium channel blocker in treatment of migraine. In this study, four Chinese databases(CNKI, VIP, WanFang, CBM), three English databases(Cochrane Library, EMbase, Medline) and clinical trials registration center(ClinicalTrials.gov) were retrieved. The retrieval time was from the establishment of each database to January 8, 2020. According to the set inclusion criteria and exclusion criteria,the randomized controlled trial(RCT) of Yangxue Qingnao Granules alone or combined with calcium channel blocker was selected. The "Cochrane bias risk assessment" tool was used to evaluate the quality of the included studies. RevMan 5.3 was used to conduct Meta-analysis of the included studies and grade system was used to evaluate the evidence quality of the outcome indicators. A total of 583 documents were retrieved and finally included in 23 studies, with a total sample size of 2 308 cases, 1 171 cases in the treatment group and 1 137 cases in the control group. The overall quality of the research included was not high. Meta-analysis showed that,(1)in terms of effective rate, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(RR=1.24, 95%CI[1.17, 1.32], P<0.000 01), and there was no significant difference between Yangxue Qingnao Granules and calcium channel blocker(RR=1.36, 95%CI[0.91, 2.03], P=0.14).(2)In terms of reducing headache frequency, when the unit of headache frequency was times per month, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(MD=-1.39, 95%CI[-1.83,-0.95], P<0.000 01), when the unit of headache frequency was times daily, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(MD=-2.08, 95%CI[-2.34,-1.82], P<0.000 01).(3)In terms of headache intensity, when headache intensity was scored by pain intensity, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(MD=-0.70, 95%CI[-0.81,-0.59], P<0.000 01), when headache intensity was scored by VAS score, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(MD=-1.59, 95%CI[-2.13,-1.06], P<0.000 01).(4)In terms of reducing headache duration, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(SMD=-3.13, 95%CI[-4.12,-2.15], P<0.000 01). GRADE system showed that the evidence level of the above outcome indicators was low and extremely low. Twelve cases of adverse reactions were reported, all of which were mild. The results showed that the combination of Yang-xue Qingnao Granules can improve the effective rate, reduce the headache frequency, the headache intensity and the headache duration, and had good safety and low incidence of adverse reactions compared with the single calcium channel blocker. However, there was no difference in the effective rate between Yangxue Qingnao Granules alone and calcium channel blocker. In view of the low quality of this study, which affects the reliability of the conclusion, it is necessary to use the conclusion of this study carefully, and more high-quality randomized controlled trials are needed to further verify in the future.

[Selection principles and analysis of common prescriptions in clinical practice guidelines of traditional Chinese medicine--case example of migraine].

In this study, common prescriptions were retrieved from existing data in multiple ways to determine the selection principle of common formulas in traditional Chinese medicine(TCM) clinical practice guidelines. Taking the selection of common prescriptions in the clinical practice guidelines of TCM for migraine as an example, we searched common prescriptions for migraines from National Essential Medicine List, the National Drug Catalog for Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance, Chinese Pharmacopoeia, three teaching materials and two clinical practice guidelines, and we also electronically searched CNKI, VIP, WanFang about famous clinical experience for migraine published from 1990 to 2019. At the same time, 32 prescriptions commonly used by experts in the clinical questionnaire survey were collected to summarize and analyze the TCM clinically applicable syndrome types and medication rules of the included prescriptions and medicines. From the National Essential Medicine List, the National Drug Catalog for Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance, Chinese Pharmacopoeia, we got 12 Chinese patent medicines. From the teaching materials, we got 9 prescriptions. From the clinical practice guidelines, we got 8 prescriptions. We got 3 prescriptions from the experience of famous experts and got 4 prescriptions from experts in the clinical questionnaire survey. A total of 24 prescriptions were included from the above results. External wind syndrome, syndrome of blood stasis and brain blocking, and syndrome of liver Yang transforming into wind were the common syndrome types in the treatment of migraine. Chuanxiong Rhizoma and Angelicae Dahuricae Radix were the most common Chinese herbs in the prescriptions. Chuanxiong Rhizoma-Angelicae Dahuricae Radix was the most common drug pair for the treatment of migraine. By retrieving the data such as the famous clinical experience and teaching materials, we systematically summarized the prescriptions in the treatment of migraine in this study, which can provide a basis for the selection of traditional Chinese medicines in clinical practice guidelines.

[Systematic review of efficacy and safety of Xinmailong Injection in treatment of coronary heart disease complicated with heart failure].

To systematically evaluate the efficacy and safety of Xinmailong Injection in the treatment of coronary heart disease complicated with heart failure. Seven databases,namely CNKI, VIP,WanFang,SinoMed,PubMed,EMbase,Cochrane Library, were retrieved by computer for collecting the randomized controlled trials about Xinmailong Injection in the treatment of coronary heart disease complicated with heart failure. The literatures were screened out, data was extracted, and the methodological quality evaluation was conducted by 2 researchers independently according to inclusion and exclusion criteria. RevMan 5.3 software was used for Meta-analysis and corresponding description analysis. A total of 19 studies involving 1 922 patients were included, including 967 cases in the trial group and 955 cases in the control group. All the clinical studies showed a low quality. Meta-analysis results showed that Xinmailong Injection combined with conventional treatment could better reduce the BNP level(SMD=-3.34, 95%CI[-4.06,-2.63]) in patients of coronary heart disease complicated with heart failure or NT-proBNP level, improve the cardiac function(RR=1.23,95%CI[1.18,1.29]) and LVEF(MD=6.85,95%CI[4.93,8.76]),increase 6 MWT(MD=24.34, 95%CI[16.05, 32.64]) and VEGF(MD=26.39,95%CI[24.30,28.49]),and decreased LVEDD(MD=-4.06, 95%CI[-6.33,-1.80]). And subgroup analysis suggested that the course of treatment may be related to the increase of LVEF. This study found that Xinmailong Injection for coronary heart disease complicated with heart failure can further alleviate clinical symptoms and relevant indicators, with no serious adverse reaction. However, it still needs the support of well-designed multicenter, double-blind and high-quality clinical trials.

Systematic review and Meta-analysis on efficacy and safety of Yangxue Qingnao Granules in treatment of migraine / 中国中药杂志

To evaluate the efficacy and safety of Yangxue Qingnao Granules alone or combined with calcium channel blocker in treatment of migraine. In this study, four Chinese databases(CNKI, VIP, WanFang, CBM), three English databases(Cochrane Library, EMbase, Medline) and clinical trials registration center(ClinicalTrials.gov) were retrieved. The retrieval time was from the establishment of each database to January 8, 2020. According to the set inclusion criteria and exclusion criteria,the randomized controlled trial(RCT) of Yangxue Qingnao Granules alone or combined with calcium channel blocker was selected. The "Cochrane bias risk assessment" tool was used to evaluate the quality of the included studies. RevMan 5.3 was used to conduct Meta-analysis of the included studies and grade system was used to evaluate the evidence quality of the outcome indicators. A total of 583 documents were retrieved and finally included in 23 studies, with a total sample size of 2 308 cases, 1 171 cases in the treatment group and 1 137 cases in the control group. The overall quality of the research included was not high. Meta-analysis showed that,(1)in terms of effective rate, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(RR=1.24, 95%CI[1.17, 1.32], P<0.000 01), and there was no significant difference between Yangxue Qingnao Granules and calcium channel blocker(RR=1.36, 95%CI[0.91, 2.03], P=0.14).(2)In terms of reducing headache frequency, when the unit of headache frequency was times per month, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(MD=-1.39, 95%CI[-1.83,-0.95], P<0.000 01), when the unit of headache frequency was times daily, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(MD=-2.08, 95%CI[-2.34,-1.82], P<0.000 01).(3)In terms of headache intensity, when headache intensity was scored by pain intensity, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(MD=-0.70, 95%CI[-0.81,-0.59], P<0.000 01), when headache intensity was scored by VAS score, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(MD=-1.59, 95%CI[-2.13,-1.06], P<0.000 01).(4)In terms of reducing headache duration, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(SMD=-3.13, 95%CI[-4.12,-2.15], P<0.000 01). GRADE system showed that the evidence level of the above outcome indicators was low and extremely low. Twelve cases of adverse reactions were reported, all of which were mild. The results showed that the combination of Yang-xue Qingnao Granules can improve the effective rate, reduce the headache frequency, the headache intensity and the headache duration, and had good safety and low incidence of adverse reactions compared with the single calcium channel blocker. However, there was no difference in the effective rate between Yangxue Qingnao Granules alone and calcium channel blocker. In view of the low quality of this study, which affects the reliability of the conclusion, it is necessary to use the conclusion of this study carefully, and more high-quality randomized controlled trials are needed to further verify in the future.

Systematic review and Meta-analysis on randomized controlled trial of efficacy and safety for acupuncture versus Flunarizine in treatment of migraine / 中国中药杂志

To systematically evaluate the efficacy and safety of acupuncture versus Flunarizine hydrochloride in the treatment of migraine. Four Chinese databases(CNKI, VIP, WanFang, CBM), three English databases(Cochrane Library, EMbase, Medline) and ClinicalTrail.gov were systematically and comprehensively retrieved. The retrieval time was from the establishment of each database to January 8, 2020. Randomized controlled trial(RCT) for acupuncture versus Flunarizine in the treatment of migraine were screened out according to inclusion criteria and exclusion criteria. The included studies were evaluated with the Cochrane bias risk assessment tool. The included studies was conducted by RevMan 5.3, and the outcome indicators were evaluated for evidence quality and strength of recommendation by the GRADE system. A total of 1 033 literatures were retrieved, and 23 studies were finally included. Except for 4 multiarm tests, the total sample size was 1 548, including 785 in acupuncture group and 763 in Flunarizine group. The overall quality of the included studies was not high. Meta-analysis results showed that the acupuncture group was superior to the Flunarizine group in reduction of headache frequency(SMD=-1.00, 95%CI[-1.45,-0.54], P<0.000 1). In reduction of headache intensity, acupuncture group was superior to Flunarizine group(SMD=-1.05, 95%CI[-1.41,-0.68], P<0.000 01). In reduction of headache duration, acupuncture group was superior to Flunarizine group(SMD=-1.42, 95%CI[-1.83,-1.02], P<0.000 1). The acupuncture group was superior to Flunarizine group(MD=-0.17, 95%CI[-0.21,-0.13], P<0.000 01) in reduction of the painkillers taking frequency. The acupuncture group was superior to Flunarizine group(SMD=-0.94, 95%CI[-1.35,-0.52], P<0.000 1) in allevia-tion of paroxysmal symptoms, such as nausea and vomiting. The GRADE system showed that the evidence level of the above indicators was extremely low, and the strength of recommendation was low. As for the occurrence of adverse reactions, the adverse reactions reported in the acupuncture group included in the study were all mild adverse reactions, like drowsiness, subcutaneous bleeding, local pain, subcutaneous hematoma and dizziness needle. The available evidence showed that acupuncture has a better efficacy than Flunarizine hydrochloride in the treatment of migraine in adult patients. However, due to the high bias risk in the included studies, the conclusions of this study shall be adopted with caution, and more high-quality studies shall be carried out for verification in the future.