1.Clinical research report on Chinese patent medicines and classic traditional Chinese medicine prescriptions (2023)
Xiaolei WU ; Haiyin HU ; Yuetong WANG ; Fauci Alice Josephine ; Yazi ZHANG ; Wenting SONG ; Fengwen YANG ; Boli ZHANG ; Junhua ZHANG ; Zhaochen JI
Digital Chinese Medicine 2025;8(2):123-136
Objective:
Randomized controlled trials (RCTs) of Chinese patent medicines and classic traditional Chinese medicine prescriptions were systematically reviewed from both Chinese and English journals published in 2023. A preliminary summary and evaluation were conducted on the generation and translation of clinical evidence for these treatments. This analysis aims to inform future research on clinical efficacy evaluation and guide the rational application of evidence.
Methods:
RCTs of Chinese patent medicines and classic traditional Chinese prescriptions published in 2023 were comprehensively retrieved from the Artificial Intelligence Clinical Evidence Database for Chinese Patent Medicine (AICED-CPM), with supplementary searches conducted in China National Knowledge Infrastructure (CNKI), Wanfang Data, Chinese Science and Technology Journal Database (VIP), Chinese Biomedical Literature Database (SinoMed), Cochrane Library, PubMed, Embase, and Web of Science. The study characteristics and methodological quality of these RCTs were systematically analyzed and evaluated.
Results:
A total of 1 443 RCTs of Chinese patent medicines were included, comprising 1 399 Chinese articles and 44 English articles. Additionally, 334 RCTs of classic traditional Chinese medicine prescriptions were found, with 331 published in Chinese and 3 in English. 196 567 participants were included, covering 585 types of Chinese patent medicines (487 oral, 61 injectable, and 37 topical) and 179 classic traditional Chinese medicine prescriptions. The involved studies encompassed 22 types of diseases, with research primarily focusing on diseases of the circulatory system, the respiratory system, and the genitourinary system. The sample sizes ranged from 18 to 3 777 participants, and most studies were conducted at a single center. Methodologically, the implementation of allocation concealment and blinding remained insufficiently emphasized.
Conclusion
Overall, compared with 2022, both the number of RCT publications and their methodological quality have improved in 2023, with heightened attention to research on diseases of the genitourinary system. However, quality control and standardized management in the design and implementation processes still require enhancement to produce more high-quality clinical evidence and accelerate the translation and application of this evidence.
2.Influence of long-term spaceflight on human speed perception characteristics
Duming WANG ; Xinqi ZHANG ; Yu TIAN ; Xiaolei SONG ; Xianliang GE ; Lidong WANG ; Rui ZHAO ; Zongxiao SUN ; Chunhui WANG
Space Medicine & Medical Engineering 2025;36(1):7-14
Objective Accurate speed perception is crucial for tasks such as man-controlled rendezvous and docking,and teleoperation of space manipulator.Therefore,it is necessary to conduct in-orbit experiments to explore the influence of long-term spaceflight on human speed perception characteristics.Methods The Time-to-Collision(TTC)paradigm was selected to develop experimental software,using a tablet computer for stimulus presentation.Human speed perception characteristics were evaluated based on the subjects'keystroke response data on the keyboard.Through ground-based experiments,the usability and reliability of the paradigm were explored,and the gravity internal model effect was quantitatively analyzed.Through in-orbit experiments on space station tasks,the influence of long-term spaceflight on human speed perception characteristics was further investigated.Results Under the 1G environment on the ground,the TTC paradigm has a high test-retest reliability(r>0.8),and indicators such as average deviation rate and absolute value of average deviation rate show no practice effect.In addition,ground experiments found that compared to vertical upward movement,vertical downward movement is estimated to be faster(i.e.,keystroke time is advanced),showing the existence of the gravity internal model effect.In the microgravity environment of spaceflight,there are no significant differences in average deviation rate and absolute value of average deviation rate among three stages(pre-flight,in-flight,post-flight)and seven tests,indicating that no obvious changes in astronauts'speed perception ability were found at the existing test time points and paradigms.However,the gravity internal model effect(difference between vertical downward and vertical upward)showed a trend of fading in the early stage of astronauts entering orbit.Conclusion Based on the computer screen TTC estimation paradigm,no significant changes in human speed perception ability were found during long-term spaceflight,but microgravity may weaken the human brain's gravity internal model.
3.Prognostic analysis of male patients with breast cancer after mastectomy based on SEER database
Wenjie NI ; Linan SONG ; Hui YANG ; Xiaolei LIU ; Xiaofeng MU
Chinese Journal of Radiation Oncology 2024;33(10):922-927
Objective:To analyze the survival and prognostic factors of male patients with breast cancer after mastectomy.Methods:Male patients with invasive breast ductal cancer who underwent mastectomy from January 1, 2000 to December 31, 2018 were selected from the Surveillance, Epidemiology, and End Results (SEER) database. Survival analysis was performed by Kaplan-Meier method, and compared by log-rank test. Prognostic factors were identified by Cox proportional hazards regression analysis.Results:A total of 1231 cases were included, with an onset age of (67 ± 12) years. The proportion of stage I-II was 81.1%. The 10-year cancer-specific survival (CSS) rates for stage IA, IIA, IIB, IIIA, IIIB, and IIIC patients were 85.4%, 84.9%, 69.0%, 68.1%, 51.9%, and 48.3%, respectively (all P<0.001). For stage IA-IIB patients, the 10-year CSS rate was 79.2% in the postoperative radiotherapy group, compared to 83.0% in the non-radiotherapy group ( P=0.019). For stage IIIA-IIIC patients, the 10-year CSS rate was 61.7% in the postoperative radiotherapy group, compared to 52.9% in the non-radiotherapy group ( P=0.021). For stage IA-IIB patients, the 10-year CSS rate was 83.8% in the postoperative chemotherapy group, compared to 79.8% in the non-chemotherapy group ( P=0.342). For stage IIIA-IIIC patients, the 10-year CSS rate was 59.7% in the postoperative chemotherapy group, compared to 54.1% in the non-chemotherapy group ( P=0.052). Multivariate analysis showed that younger age, married and grade I-II differentiation were favorable prognostic factors. The earlier the tumor staging, the better the prognosis. Conclusions:Postoperative radiotherapy can improve the CSS of stage III male patients with breast cancer. Younger age, married, grade I-II differentiation are favorable prognostic factors. The earlier the tumor staging, the better the prognosis.
4.Application value of percutaneous coronary intervention in elderly patients with sarcopenia and ischemic cardiomyopathy
Xiaolei ZHU ; Song PENG ; Jing LIU
Journal of Clinical Medicine in Practice 2024;28(22):93-98
Objective To explore the application value of percutaneous coronary intervention (PCI) in the treatment of elderly patients with sarcopenia and ischemic cardiomyopathy (ICM). Methods A total of 129 elderly patients with sarcopenia and ICM were selected as study subjects and randomly divided into conventional group (64 patients) and combined group (65 patients) using a random number table method. After screening based on exclusion criteria, 55 patients were ultimately included in each group. The conventional group received conventional drug therapy, while the combined group received PCI in addition to conventional therapy. Subjective symptoms, blood pressure [systolic blood pressure (SBP), diastolic blood pressure (DBP)], New York Heart Association (NYHA) functional class, Canadian Cardiovascular Society (CCS) angina class, left ventricular function indicators [left ventricular end-diastolic diameter (LVEDD), left ventricular ejection fraction (LVEF), left ventricular end-systolic diameter (LVESD)], serological indicators [N-terminal pro-brain natriuretic peptide (NT-proBNP), cardiac troponin T (cTnT), creatine kinase-MB (CK-MB)], and 6-minute walk distance (6MWD) were compared between the two groups at admission and 1-, 3-, and 6-month after discharge. Additionally, the incidence of major adverse cardiovascular events (MACE) was observed in both groups. Results All 55 patients in the combined group underwent PCI with implantation of 1 stent to 3 stents, with an average of (1.78±0.36) stents implanted per patient, and the surgical success rate was 100.00%. At 1-, 3-, and 6-month after discharge, the scores for chest pain, palpitations, chest distress, and fatigue, as well as SBP, DBP, NYHA functional class, and CCS angina class, were lower in both groups compared to admission. Furthermore, these indicators were lower in the combined group than in the conventional group at 3 and 6 months after discharge (
5.Establishment of characteristic chromatogram and determination of three constituents for modified Huoxiang Zhengqi pills
Yichang ZHANG ; Xiaolei FAN ; Defang SONG
China Pharmacist 2024;27(7):1115-1124
Objective To establish the characteristic chromatogram for modified Huoxiang Zhengqi pills and determine the content of three components based on HPLC.Methods The analysis of methanol extract of this preparation was performed on a Agilent TC-C18 column(250 mm×4.6 mm,5 μm)at 30℃,with mobile phase comprising of acetonitrile-0.1%phosphoric acid flowing at 1.0 mL/min in a gradient elution manner,and the detection wavelength was set at 254 nm and 284 nm.Results Three components(hesperidin,magnolol and honokiol)showed good linearity within the range of 2.715-434.400 μg/mL,2.760-176.600 μg/mL and 2.623-167.900 μg/mL(r=1.000 0),whose average recoveries were 99.2%,96.3%and 95.9%,with the RSD of 1.5%,1.3%and 1.8%(n=9),respectively.The established characteristic chromatogram controlled the 7 main Chinese medicinal herbs in the formulation,which provided a basis for evaluating the quality of raw materials,feedings,processes and preparations of different enterprises as a whole.Conclusion This method is accurate,reliable and has good repeatability,and can be used for the quality control of modified Huoxiang Zhengqi pills.
6.Clinical characteristics and influencing factors of adverse outcomes in pregnancy complicated by primary Sj?gren's syndrome
Shiqi YANG ; Fei CHEN ; Weizhang LIANG ; Ruirui LI ; Xiaolei SONG ; Fang HE
Chinese Journal of Perinatal Medicine 2024;27(8):643-648
Objective:To explore the clinical characteristics of pregnancy complicated by primary Sj?gren's syndrome (pSS) and the related factors of adverse outcomes in pregnant women with pSS.Methods:A retrospective analysis was conducted on the clinical data of 32 pregnancies complicated by pSS treated in the Department of Obstetrics at the Third Affiliated Hospital of Guangzhou Medical University from February 2017 to August 2022. The patients were divided into two groups according to whether they had perinatal adverse outcomes: an adverse outcome group ( n=20) and a favorable outcome group ( n=12). The clinical characteristics of the two groups were compared with two independant sample t-test, Mann-Whitney U test, and Fisher's exact test, and multivariate logistic regression analysis was used to analyze the related factors of adverse outcomes in pregnant women with pSS. Results:(1) The average maternal age of the 32 pSS pregnancies was (32.9±4.6) years, the pre-pregnancy body mass index was (21.1±3.8) kg/m 2, and the median gestational age at delivery was 37.8 (35.4-38.5) weeks. There were 18 women (56.3%, 18/32) were diagnosed before pregnancy and 14 women (43.7%, 14/32) during pregnancy. Out of the 32 pregnancies, 25 (79.1%, 25/32) received therapy with glucocorticoids and/or hydroxychloroquine during pregnancy, whereas seven (21.9%, 7/32) had no medication during pregnancy. (2) The main adverse maternal outcomes included oligohydramnios (25%, 8/32), hypertensive disorder of pregnancy (18.8%, 6/32), preterm birth (18.8%, 6/32), fetal growth restriction (15.6%, 5/32), miscarriage (12.5%, 4/32), gestational diabetes mellitus (9.4%, 3/32), and postpartum hemorrhage (3.1%, 1/32). (3) Adverse neonatal outcomes included low birth weight infants in seven cases (25.0%, 7/28), neonatal asphyxia in seven cases (25.0%, 7/28), and two cases of congenital heart block (7.1%, 2/28). (4) The rate of diagnosis before pregnancy in the favorable outcome group was higher than the adverse outcome group [10/12 vs. 40.0%(8/20), Fisher's exact test, P=0.028]. There were no significant differences between the two groups concerning maternal age, pre-pregnancy BMI, weight gain during pregnancy, parity, rates of positivity for autoantibodies (antinuclear antibody, Sj?gren-specific antibody A, Sj?gren-specific antibody B, anti-Ro-52), and proportion of drug treatment (glucocorticoids, hydroxychloroquine) (all P>0.05). (5) Multivariate logistic regression analysis showed that diagnosis before pregnancy ( OR=0.02, 95% CI: 0.00-0.62, P=0.024) and positive Sj?gren-specific antibody B ( OR=0.01,95% CI: 0.00-0.75, P=0.038) were the protective factors. Conclusions:The clinical manifestations of pSS among pregnant women are varied and atypical,often with insidious onset. For pregnant women with pSS, being diagnosed before pregnancy, positive Sj?gren-specific antibody B may reduce adverse outcomes. It is important to address pre-pregnancy examination, early diagnosis and timely intervention to reduce the occurrence of adverse outcomes in pregnant women with pSS.
7.The differences in the growth of transplanted hepatocellular carcinoma and the efficacy of TACE in experimental rats with different liver backgrounds
Hang ZHAO ; Xiaolei SONG ; Xuan ZHENG ; Yujie ZHANG ; Jun ZHOU
Journal of Interventional Radiology 2024;33(10):1095-1100
Objective To explore the difference of various indicators in the growth of transplanted liver cancer in experimental rats with the background of normal liver,fatty liver and liver cirrhosis,and to discuss the difference in the curative effect after TACE.Methods Walker-256 ascites tumor cells were implanted into the rats with normal liver,fatty liver,and cirrhosis liver separately to establish the experimental liver cancer models.TACE treatment was performed for all experimental rats.All the indicators related to tumor growth and the curative effect of TACE were compared among the three groups of rats with different liver backgrounds.Results In terms of the liver volume,there were differences among the three groups,but the differences were not statistically significant(P>0.05).No statistically significant differences in the preoperative liver functions existed among the three groups,but some indicators of postoperative liver functions in the fatty liver group were significantly higher than those in the cirrhosis group,and the differences were statistically significant(P<0.05).No significant differences in microvessel density were observed among the three groups(P>0.05).However,in the same group statistically significant differences in the above indexes existed between the preoperative values and the preoperative ones(P<0.05).Conclusion The results of this study indicate that during the growing period of tumor the following three changes can be observed:① There are differences in tumor volume.Cirrhosis may inhibit tumor growth in the early stage,but in the later stage the cachexia of cirrhosis rats may accelerate tumor growth;② There were no significant differences in liver functions between fatty liver and cirrhosis;and ③ There was no significant difference in microvessel density among the rats with different liver backgrounds.However,with the tumor growing,the microvessel density will be slightly increased.After TACE treatment the following three changes can be observed:① There is no significant difference in tumor volume;② Fatty liver rats have more liver function reserve capacity when compared with cirrhotic rats;③ There is no obvious change in microvessel density,although the embolization treatment can stimulate the proliferation of the microvessel.
8.Mental health disparities in people living with human immunodeficiency virus: A cross-sectional study on physician-patient concordance and treatment regimens
Jinchuan SHI ; Zhongdong ZHANG ; Junyan ZHANG ; Yishu ZHANG ; Jiating QIU ; Fang LIU ; Daoyuan SONG ; Yanfang MA ; Lianmei ZHONG ; Hongxing WANG ; Xiaolei LIU
Chinese Medical Journal 2024;137(18):2223-2232
Background::Human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) can profoundly affect the mental health of the people living with HIV (PLWH), with higher rates of anxiety, depression, and sleep disturbances. The disparities in neuropsychological problems evaluated by physicians and self-assessed by patients are still unknown.Methods::A total of 5000 PLWH and 500 physicians from 167 hospitals were enrolled in this cross-sectional study from September 2022 to February 2023. 4-Item Patient Health Questionnaire (PHQ-4) was used for the evaluation of depressive issues and anxiety issues by PLWH. Each physician assessed 10 PLWH under their care for the presence of depressive or anxiety issues. The primary outcomes of this study are the concordance rates on the depressive issues and anxiety issues evaluation between physicians and PLWH. The Cohen’s kappa test was used to assess the agreement between physicians and PLWH.Results::The concordance rate for the evaluation of depressive issues is 73.84% (95% confidence interval [CI]: 72.60-75.04%), and it is significantly different from the expected rate of 80% ( P <0.001). Similarly, the concordance rate for the evaluation of anxiety issues is 71.74% (95% CI: 70.47-72.97%), which is significantly different from the expected rate of 80% as per the null hypothesis ( P <0.001). The overestimation rate by physicians on depressive issues is 12.20% (95% CI: 11.32-13.14%), and for anxiety issues is 12.76% (95% CI: 11.86-13.71%). The mismatch rate for depressive issues is 26.16% (95% CI: 24.96-27.40%), and for anxiety issues is 28.26% (95% CI: 27.02-29.53%). The underestimation rate by physicians on depressive issues is 13.96% (95% CI: 13.03-14.95%), and for anxiety issues is 15.50% (95% CI: 14.52-16.53%). For the treatment regiments, PLWH sustained on innovative treatment regimen (IR) related to a lower prevalence of depressive issues (odds ratio [OR] = 0.71, 95% CI: 0.59-0.87, P = 0.003) and a lower prevalence of anxiety issues (OR = 0.63, 95% CI: 0.52-0.76, P <0.001). PLWH switch from conventional treatment regimen (CR) to IR also related to a lower prevalence of depressive issues (OR = 0.79, 95% CI: 0.64-0.98) and a lower prevalence of anxiety issues (OR = 0.81, 95% CI: 0.67-0.99). Conclusion::Nearly one in three PLWH had their condition misjudged by their physicians. The findings underscore the need for improved communication and standardized assessment protocols in the care of PLWH, especially during the acute phase of HIV infection.
9.Influences of Pinocembrin on inflammatory injury in rats with acute myocardial infarction by inhibiting TLR4/NF-κB/NLRP3 signaling pathway
Shuxia YAO ; Xuan SHI ; Song HAN ; Xiaolei YANG ; Lei WANG
Chinese Journal of Immunology 2024;40(12):2525-2530
Objective:To investigate the influences of Pinocembrin on inflammatory injury in rats with acute myocardial in-farction(AMI)by regulating TLR4/NF-κB/NLRP3 signaling pathway.Methods:The AMI model was established by coronary liga-tion,and the rats were grouped into Sham group,AMI group,Pinocembrin group(5 mg/kg tail vein injection),TLR4 inhibitor group(TAK-242 group,2.0 mg/kg tail vein injection),the levels of cardiac function indexes(LVEF,LVEDD,LVESD,FS)and serum LDH,cTnⅠ,IL-6,IL-β and TNF-α were detected in rats,TTC staining,HE staining and Masson staining were applied to observe myocardial infarction and myocardial histopathological changes in rats,cardiomyocyte apoptosis was detected by TUNEL method,im-munohistochemistry and Western blot were applied to detect TLR4/NF-κB/NLRP3 pathway-related proteins in rat myocardial tissue.Results:Compared with Sham group,the myocardial infarction area increased,the number of myocardial cells decreased,some myo-cardial fibers were broken,inflammatory cells infiltrated,collagen fibers increased,and the apoptosis rate was obviously increased in AMI group(P<0.05),LVEDD,LVESD,serum LDH,cTnⅠ,IL-6,IL-β,TNF-α levels,myocardial tissue TLR4,MyD88,p-NF-κB p65,NLRP3,Caspase-1 expression levels were obviously increased(P<0.05),while LVEF and FS were obviously decreased(P<0.05);compared with AMI group,the myocardial infarction area of the Pinocembrin group and the TAK-242 group were reduced,the cell damage and inflammatory infiltration were reduced,the necrotic cells were obviously reduced,and the apoptosis rate was obvious-ly reduced(P<0.05),LVEDD,LVESD,serum LDH,cTnⅠ,IL-6,IL-β,TNF-α levels,myocardial tissue TLR4,MyD88,p-NF-κB p65,NLRP3,Caspase-1 expression levels were decreased(P<0.05),LVEF and FS were obviously increased(P<0.05);there was no obvious difference in each index between Pinocembrin group and TAK-242 group(P>0.05).Conclusion:Pinocembrin may at-tenuate myocardial inflammatory injury caused by AMI by inhibiting TLR4/NF-κB/NLRP3 signaling pathway.
10.Progress in role of intercellular mitochondrial transfer in diabetes and its complications
Haiyan WANG ; Wenting SONG ; Meng ZHAO ; Dong WANG ; Xiaolei WANG ; Qiu LI
Chinese Journal of Pathophysiology 2023;39(12):2251-2258
Diabetes mellitus is a metabolic disorder characterized by hyperglycemia and has become a com-mon chronic disease worldwide.Mitochondria play key roles in energy production,signal transduction and apoptosis.Mi-tochondrial dysfunction is an important factor that promotes the development of diabetes and its complications.Maintaining mitochondrial function is expected to have a therapeutic effect on diabetes and its complications.Mitochondria can be transferred between cells,replacing dysfunctional mitochondria with exogenous healthy mitochondria and thereby reversing cell damage.Mitochondrial transfer through actin-based tunnel nanotubes,extracellular vesicles,connexins,cell fusion and extrusion has been shown to restore the bioenergetics of damaged mammalian cells.In addition,mitochondrial trans-plantation,which is an innovative strategy to treat mitochondrial diseases by increasing and replacing mitochondria,has at-tracted increasing attention.This article focuses on improving mitochondrial function in damaged cells as an entry point for the treatment of diabetes and its complications,focusing on the role of mitochondrial transfer among cells in diabetes and its complications.


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