1.Connotation and Prevention Strategies of Traditional Chinese Medicine for Panvascular Diseases
Jie WANG ; Jun LI ; Yan DONG ; Cong CHEN ; Yongmei LIU ; Chao LIU ; Lanchun LIU ; Xuan SUN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):1-14
Panvascular disease, with vascular diseases as the common pathological feature, is mainly manifested as atherosclerosis. Panvascular disease mainly affects the important organs of the heart, brain, kidney, and limbs. It is one of the leading causes of death for Chinese residents at present. Previously, due to the narrow branches of disciplines, too much attention was paid to local lesions, resulting in the neglect of panvascular disease as a systemic one. The fact that panvascular disease has overall pathology and comprehensive and individualized treatment strategies, makes the disease highly compatible with the principles of holism concept and syndrome differentiation and treatment in traditional Chinese medicine (TCM). It is believed that blood stasis is the core pathogenesis of atherosclerosis and is involved in the whole process of atherosclerosis. The theories of ''blood vessel'', ''meridians'', ''visceral manifestation'', and ''organs-meridians'' in TCM are helpful to comprehensively understand the complexity of panvascular diseases. Moreover, those theories can provide systematic treatment strategies. The TCM syndromes of panvascular diseases evolve from ''phlegm, stasis, stagnation, and deficiency''. Panvascular arteriosclerosis is related to the syndrome of ''stasis and phlegm'', and the treatment mainly promotes blood circulation and removes phlegm. There are different specific drugs and mechanisms of action for coronary atherosclerosis, cerebral atherosclerosis, and renal artery atherosclerotic stenosis. Panvascular venous lesions are related to the syndrome of ''deficiency and stasis'' in TCM, and the TCM treatment mainly invigorates Qi and promotes blood circulation, which can inhibit venous thrombosis, improve venous ulcers, and resist venous endothelial damage. Panvascular microcirculatory lesions are inseparable from the ''stagnation and stasis'' in TCM, and the treatment mainly promotes Qi and dredges collaterals, which has a good effect on coronary microvascular lesions, diabetic microvascular lesions, pulmonary microvascular lesions, and pancreatic microvascular lesions. Panvascular lymphatic lesions are related to the syndrome of ''water and stasis'' in TCM. The treatment method focuses on promoting blood circulation and water excretion, which can promote lymphangiogenesis and enhance lymphatic reflux. In addition, the combination of TCM and modern technology, especially the application of artificial intelligence, can improve the efficiency of early identification and personalized treatment, resulting in early screening and comprehensive management of panvascular diseases. Therefore, TCM will play a vital role in the prevention and treatment of panvascular diseases.
2.Connotation and Prevention Strategies of Traditional Chinese Medicine for Panvascular Diseases
Jie WANG ; Jun LI ; Yan DONG ; Cong CHEN ; Yongmei LIU ; Chao LIU ; Lanchun LIU ; Xuan SUN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):1-14
Panvascular disease, with vascular diseases as the common pathological feature, is mainly manifested as atherosclerosis. Panvascular disease mainly affects the important organs of the heart, brain, kidney, and limbs. It is one of the leading causes of death for Chinese residents at present. Previously, due to the narrow branches of disciplines, too much attention was paid to local lesions, resulting in the neglect of panvascular disease as a systemic one. The fact that panvascular disease has overall pathology and comprehensive and individualized treatment strategies, makes the disease highly compatible with the principles of holism concept and syndrome differentiation and treatment in traditional Chinese medicine (TCM). It is believed that blood stasis is the core pathogenesis of atherosclerosis and is involved in the whole process of atherosclerosis. The theories of ''blood vessel'', ''meridians'', ''visceral manifestation'', and ''organs-meridians'' in TCM are helpful to comprehensively understand the complexity of panvascular diseases. Moreover, those theories can provide systematic treatment strategies. The TCM syndromes of panvascular diseases evolve from ''phlegm, stasis, stagnation, and deficiency''. Panvascular arteriosclerosis is related to the syndrome of ''stasis and phlegm'', and the treatment mainly promotes blood circulation and removes phlegm. There are different specific drugs and mechanisms of action for coronary atherosclerosis, cerebral atherosclerosis, and renal artery atherosclerotic stenosis. Panvascular venous lesions are related to the syndrome of ''deficiency and stasis'' in TCM, and the TCM treatment mainly invigorates Qi and promotes blood circulation, which can inhibit venous thrombosis, improve venous ulcers, and resist venous endothelial damage. Panvascular microcirculatory lesions are inseparable from the ''stagnation and stasis'' in TCM, and the treatment mainly promotes Qi and dredges collaterals, which has a good effect on coronary microvascular lesions, diabetic microvascular lesions, pulmonary microvascular lesions, and pancreatic microvascular lesions. Panvascular lymphatic lesions are related to the syndrome of ''water and stasis'' in TCM. The treatment method focuses on promoting blood circulation and water excretion, which can promote lymphangiogenesis and enhance lymphatic reflux. In addition, the combination of TCM and modern technology, especially the application of artificial intelligence, can improve the efficiency of early identification and personalized treatment, resulting in early screening and comprehensive management of panvascular diseases. Therefore, TCM will play a vital role in the prevention and treatment of panvascular diseases.
3.Comparison of clinical characteristics between primary bilateral macronodular adrenal hyperplasia and adrenal cortisol-producing adenoma
Bing LI ; Ming-Xiu YANG ; Huai-Jin XU ; Jing-Xuan WANG ; Qing-Zheng WU ; Ya-Jing WANG ; Yi-Jun LI ; Kang CHEN ; Yu CHENG ; Qi NI ; Ya-Qi YIN ; Li ZANG ; Qing-Hua GUO ; Jian-Ming BA ; Wei-Jun GU ; Jing-Tao DOU ; Zhao-Hui LYU ; Yi-Ming MU
Medical Journal of Chinese People's Liberation Army 2025;50(7):779-785
Objective To comparatively analyze the clinical characteristics of primary bilateral macronodular adrenal hyperplasia(PBMAH)and adrenal cortisol-producing Adenoma(CPA),and enhance the understanding of two diseases.Methods The clinical data of 85 PBMAH patients(PBMAH group)and 195 CPA patients(CPA group)diagnosed at Department of Endocrinology,the First Medical Center of Chinese PLA General Hospital,from September 2014 to August 2024 were retrospectively analyzed.The demographic characteristics,comorbidities,biochemical indicators,adrenocorticotropic hormone-cortisol(ACTH-F)levels,and adrenal imaging features and treatment conditions were compared between the two groups.Results(1)General characteristics:Compared with CPA group,PBMAH group had older age at diagnosis and a higher proportion of male patients.(2)Clinical characteristics:Compared with CPA group,PBMAH group had a longer disease duration,a higher proportion of subclinical Cushing's syndrome(CS),and a higher proportion of hypertension,impaired glucose tolerance/diabetes,bone mass reduction or osteoporosis,with higher serum potassium levels,and the differences were statistically significant(P<0.01).(3)Hormone levels:Both PBMAH and CPA groups showed ACTH-F rhythm disorder,significantly increased cortisol levels and suppressed ACTH.Compared with PBMAH group,CPA group had stronger autonomous cortisol secretion ability,manifested by increased midnight serum cortisol(F0:00),16:00 serum cortisol(F16:00),24-hour urinary free cortisol(24 h UFC)levels and lower 8:00 serum ACTH(ACTH8:00)and 16:00 serum ACTH(ACTH16:00)(P<0.01).After low-dose dexamethasone suppression test(LDDST),CPA group showed lower suppression rates of ACTH and cortisol,and higher proportions of paradoxical elevation in serum cortisol and 24 h UFC compared with PBMAH(P<0.01).Conclusions PBMAH has a longer disease course and higher proportions of comorbid metabolic disorders than CPA,mostly manifested as subclinical Cushing's syndrome.CPA has stronger autonomous cortisol secretion ability,with cortisol less likely to be suppressed after LDDST and more obvious paradoxical elevation of cortisol and 24 h UFC.
4.Effects of mircoRNA-874-3p on biological behavior of lung adenocarcinoma cells through targeted regulation of plakophilin 3 and its mechanism
Fan CHEN ; Zhao-Hu TENG ; Tao FANG ; Jun-Xu REN ; Jing ZHANG ; Xue LI ; Yi-Xuan WANG ; Xu LIN ; Jing-Fang WU
Acta Anatomica Sinica 2025;56(2):188-201
Objective The study aims to investigate the impact of microRNA-874-3p(miR-874-3p)regulation of plakophilin 3(PKP3)on the malignant biological behavior of lung adenocarcinoma cells and its underlying mechanism.Methods Immunohistochemistry and immunocytochemistry were used to detect the expression of PKP3 in lung adenocarcinoma tissue microarray and lung adenocarcinoma cell line A549 cells respectively,and the relationship between PKP3 and clinicopathological features of lung adenocarcinoma patients was analyzed.Select lung adenocarcinoma cell line A549,the experiment was divided into A549 cell group(blank control group),miR-NC group(transfected with miR-NC)and miR-mimics group(transfected with miR-874-3p mimics),sh-NC group(control group transfected with PKP3 silencing plasmid),sh-PKP3 group(transfected with PKP3 silencing plasmid),miR+pcDNA-PKP3 group(transfected with miR-874-3P mimics+pcDNA-PKP3,rescue group)and miR+pcDNA-NC group(transfected with miR-874-3p mimics+pcDNA-NC).The proliferation,invasion,migration and apoptosis of cells in each group were detected.ENCORI database was used to predict the upstream gene of PKP3,and dual luciferase assay was used to detect the targeting relationship between miR-874-3p and PKP3.MAPK/mTOR pathway-related proteins were detected by Western blotting.Results The expression of PKP3 in lung adenocarcinoma tissue was significantly higher than that in adjacent tissues.The high expression of PKP3 was related to clinical stage,tumor size,and lymph node metastasis(P<0.05).Compared with the human normal lung epithelial cells(BEAS-2B),the expression of PKP3 in A549 cells increased significantly,and the expression of miR-874-3p decreased(P<0.05).Overexpression of miR-874-3p decreased the PKP3 expression level(P<0.05).Compared with the control group,both overexpression of miR-874-3p and silenced PKP3 inhibited the cloning and invasion ability of A549 cells,caused cell cycle arrest,and decreased the expression levels of cyclin dependent kinase 4(CDK4),cyclin D1,cyclin E1 proteins in A549 cells(P<0.05).The expressions of Bax protein and Caspase-3 protein were up-regulated(P<0.05),and apoptosis increased.Overexpression of PKP3 could reverse the biological behavior of overexpression of miR-874-3p.Overexpression of miR-874-3p and silencing of PKP3 significantly decreased the expressions of P38 MAPK and mTOR phosphorylated proteins.Conclusion MiR-874-3p can negatively regulate PKP3 expression and inhibit the malignant biological behavior of A549 cells through MAPK/mTOR pathway.
5.Teaching practice of movable virtual reality equipment in human anatomy classroom teaching
Ping LIU ; Xuan FANG ; Hui-Ru DING ; Li-Ju LUAN ; Yan ZHANG ; Jun WANG ; Huai-Cun LIU ; Wei-Guang ZHANG
Acta Anatomica Sinica 2025;56(5):607-611
Objective To explore the integration value of mobile virtual reality devices in the classroom teaching of human anatomy,and to evaluate their potential impact on the in-depth construction of human anatomy knowledge,the cultivation of spatial cognitive ability,and the transformation of teaching paradigms from the perspectives of cognitive load theory and situated learning.Methods The undergraduate students majoring in clinical medicine in Peking University were selected as the research objects.Among them,students in grade 2019 were the control group,and students in grade 2022 were the experimental group,introducing movable virtual anatomy equipment and other teaching auxiliary method in theory and practice courses.The final exam scores of the two groups of students were compared,and a questionnaire survey was conducted for the experimental group after the course,and the survey result were statistically analyzed.Results The final examination result showed that the average score of the experimental group was 82.47±10.19,and the average score of the control group was 74.82±16.56,which was significantly higher in the experimental group than in the control group,with statistical significance(P<0.05).The questionnaire survey result showed that compared with traditional classroom teaching,94.62%of students preferred the new auxiliary teaching mode such as VR,96.77%of students believed that VR assisted teaching could achieve the traditional teaching effect or better,95.7%of them think that it improved students' interest in learning human anatomy,and 98.92%thought that it improved students' knowledge of anatomy.Conclusion The application of mobile virtual reality devices in anatomy classroom teaching provides immersive and interactive 3D visualization teaching scenarios,effectively reducing students' cognitive load on abstract and complex anatomical structures,promoting spatial understanding and knowledge internalization,significantly improving teaching effectiveness and self-learning ability,thus changing the traditional anatomy teaching mode and laying a solid foundation for the development of future medical education and the cultivation of medical talents.
6.Mouth breathing and functional speech sound disorders in children: A correlational analysis
Yanna WANG ; Xuan LI ; Jun WANG ; Xing JIN ; Xinyi HU ; Tongjie YAO ; Ping WAN
Chinese Journal of Physical Medicine and Rehabilitation 2025;47(7):619-623
Objective:To explore the association between mouth breathing (MB) and functional speech sound disorders (FSSDs) in children, aiming to establish a novel theoretical basis for FSSD interventions.Methods:Eighty-nine children with an FSSD aged 4-12 years formed the FSSD group, while eighty-five age-matched healthy children served as controls. Their clinical data were processed using independent sample t-tests and chi-square tests to test for any significant differences between the two groups in terms of gender, age, mouth breathing status, post-frenotomy condition, Mandarin exposure before age 4, and delayed speech onset. Multivariate logistic regressions were evaluated to identify risk factors for FSSD in such children and to seek any association between mouth brea-thing and FSSD.Results:The regression analysis identified the following risk factors for childhood FSSD, ranked by odds ratio ( OR) magnitude: mouth breathing (adjusted OR=22.168, 95% CI=7.849-62.608, P≤0.01), delayed speech onset (adjusted OR=20.091, 95% CI=4.812-83.878, P≤0.01), age (a protective effect) (adjusted OR=0.979, 95% CI=0.962-0.997, P≤0.05). Univariate analysis of mouth breathing and associated factors revealed significant associations of FSSD with mouth breathing (χ 2=52.15, P≤0.01) and delayed speech onset (χ 2=25.873, P≤0.01). Conclusions:The significant risk factors for childhood functional speech sound disorders are mouth breathing (showing the highest adjusted OR), delayed speech onset and age. These findings suggest that early screening and therapeutic interventions for mouth breathing should be clinically prioritized to minimize FSSD risk.
7.Epidemiological characteristics and spatial clustering of dental fluorosis in children aged 8 - 12 in Guizhou Province from 2019 to 2022
Huiyi SHI ; Xuan LI ; Jing GAO ; Boyou ZHANG ; Cuisang WANG ; Demei ZHOU ; Jun LI ; Guanghong YANG ; Hongbing YE
Chinese Journal of Endemiology 2025;44(2):112-118
Objective:To analyze the epidemiological characteristics, spatial clustering, and correlation between dental fluorosis detection rates and meteorological factors in children aged 8 - 12 years old in 37 counties (cities, districts, hereinafter referred to as counties) affected by coal-burning-borne endemic fluorosis in Guizhou Province, and to provide a scientific basis for prevention and control of the disease.Methods:Monitoring data on dental fluorosis in children aged 8 - 12 years old from 2019 to 2022 were collected from the National Health Security Information System for Endemic Diseases. Meteorological data, including annual average temperature, annual average precipitation, annual sunshine hours, and annual average relative humidity, were obtained from the Guizhou Provincial Bureau of Statistics. Descriptive epidemiology, analytical epidemiology, and spatial correlation analysis methods were used to analyze the data. Visual maps were created based on the clustering levels of annual dental fluorosis detection rates (high-high, low-low, high-low, low-high). Spatial autocorrelation and meteorological factors were used to analyze the epidemiological characteristics, spatial clustering, and the impact of meteorological factors on dental fluorosis.Results:From 2019 to 2022, a total of 3 649 161 children aged 8 - 12 in the counties affected by coal-burning-borne endemic fluorosis were monitored, and 115 793 children were diagnosed with dental fluorosis, with a detection rate of 3.17%. The detection rates were 4.73% (45 093/954 338) in 2019, 3.35% (31 424/938 445) in 2020, 2.86% (21 727/760 195) in 2021, and 1.76% (17 549/996 183) in 2022, respectively. The dental fluorosis indices were 0.09, 0.07, 0.06, and 0.03, respectively. The number of counties with detection rates > 6% was 7, 5, 5, and 0 in 2019 - 2022, respectively. Dafang County consistently had the highest detection rates, with rates of 10.06% (6 783/67 408), 10.07% (1 955/19 421), 13.54% (4 017/29 667), and 4.83% (3 284/76 206) in 2019 - 2022, respectively. The Moran's I indices for dental fluorosis detection rates were 0.45, 0.53, 0.53, and 0.53 in 2019 - 2022, with Z = 4.29, 5.07, 5.31, and 5.10, respectively ( P < 0.05), indicating global spatial autocorrelation (positive) and spatial clustering of dental fluorosis detection rates. The number of counties with "high-high" clustering of detection rates was 7, 7, 6, and 7 in 2019 - 2022, mainly concentrated in the northwestern region, including Qixingguan District, Nayong County, Dafang County, Zhijin County, and Jinsha County of Bijie City. "Low-high" clustering areas were distributed in Zhongshan District of Liupanshui City in 2019, 2020, and 2022. The detection rate of dental fluorosis was associated with local annual average temperature (°C) and annual precipitation (mm) ( r = - 0.393, - 0.337, P = 0.016, 0.041). Conclusions:From 2019 to 2022, the detection rate of dental fluorosis in children aged 8 - 12 in coal-burning-borne endemic fluorosis areas in Guizhou Province has been decreasing year by year, and it shows spatial clustering. The high clustering area is in the northwest of Guizhou Province, which should be regarded as a key prevention and control area for coal-burning-borne fluorosis in the future. At the same time, areas with lower temperatures and precipitation should also strengthen prevention and control efforts.
8.Analysis of the effect of dosimeter wearing position on effective dose estimation among interventional radiology workers
Xuanrong ZHANG ; Wen GUO ; Xian XUE ; Pin GAO ; Kaiyi WANG ; Xuan ZHANG ; Yanqiu DING ; Xiao LUO ; Wenfang MENG ; Jun CHAO
Chinese Journal of Radiological Health 2025;34(5):687-694
Objective To evaluate the influence of the wearing position of dosimeters outside lead aprons on effective dose estimation for interventional radiology workers, analyze the differences between single and double dosimeter methods in effective dose estimation, and provide a reference for the personal dose monitoring of interventional radiology workers. Methods This study employed a combined approach of on-site monitoring and Monte Carlo simulation to evaluate the impact of the wearing position of dosimeters outside lead aprons on effective dose estimation, as well as the differences between effective doses measured using single and double dosimeters. Interventional radiology workers wore dosimeters at three positions: the neck outside the lead collar, the left chest outside the lead apron, and inside the lead apron. Effective doses were estimated using the single and double dosimeter methods specified in GBZ 128-2019 Specifications for individual monitoring of occupational external exposure, and the impact of different wearing positions on the estimation results was compared. Geant4 Monte Carlo simulations were used to model dose distributions at the neck outside the lead collar and at the left chest outside the lead apron for operators performing cardiovascular interventions under tube voltages of 70, 80, 90, and 100 kVp and exposure angles of posteroanterior (PA), anteroposterior (AP), and left anterior oblique 45° (LAO45°) positions. The study assessed the impact of dosimeter wearing position on effective dose estimation. Results Monte Carlo simulations demonstrated that neck doses consistently exceeded left chest doses across different tube voltages and exposure angles, with neck-to-chest dose ratios of 0.80-0.90. Under identical tube voltage conditions, AP showed the highest doses, followed by LAO45°, and PA demonstrated the lowest doses. The single and double dosimeter methods exhibited consistent patterns in effective dose estimation. Single dosimeter method generally yielded higher effective doses with relative deviations of 9.9% to 83%, though these deviations decreased under high tube voltages. Field monitoring data indicated that most interventional radiology workers maintained relative deviations between single and double dosimeter calculations below 6%, with neck-to-chest dose ratios of 0.95-1.1. The estimation patterns remained consistent across both methods, though single dosimeter method showed slightly higher results. Conclusion Under PA, AP, or LAO45°, the doses at the neck consistently exceeded those at the left chest. Therefore, when wearing lead protective equipment, the dosimeter should be properly positioned at the neck outside the lead collar to accurately reflect the radiation doses of surgeons. Some interventional radiology workers improperly positioned the dosimeter (intended at the neck outside the lead collar) at the left chest outside the lead apron, and this may result in an underestimation of the effective dose.
9.Prescription pattern of traditional Chinese medicine for treatment of hypertensive left ventricular hypertrophy based on multivariate data mining.
Xuan-Yang WANG ; Yuan GAO ; Bin LI ; Rui YU ; Shi-Yang XIE ; Lu-Ye ZHOU ; Yu-Die SUN ; Ming-Jun ZHU
China Journal of Chinese Materia Medica 2025;50(6):1688-1698
This study explored the prescription pattern of traditional Chinese medicine(TCM) in the treatment of hypertensive left ventricular hypertrophy(LVH), so as to provide a relevant theoretical basis for the clinical diagnosis and treatment of hypertensive LVH. The study systematically searched the databases of CNKI, Wanfang, VIP, and SinoMed to screen out the qualified literature on TCM treatment of hypertensive LVH and used Microsoft Excel 2021 to establish the relevant prescription database. It also counted the frequency, property, flavor, and meridian affiliation of TCM in the prescriptions and classified their efficacy. The study used Lantern 5.0 and Rstudio software to analyze the hidden structural models and association rules of the high-frequency TCM with a frequency of >3.50% and adopted Origin 2024 software to visualize the data, so as to explore the prescription pattern of TCM in treating hypertensive LVH. The results showed that a total of 128 TCM prescriptions were included, involving 163 TCM with a total frequency of 1 242. The high-frequency TCM included Salviae Miltiorrhizae Radix et Rhizoma, Uncariae Ramulus Cum Uncis, Gastrodiae Rhizoma, Poria, and Chuanxiong Rhizoma, with the main efficacy from blood-activating and stasis-resolving herbs, tonic herbs, and liver-calming and wind-extinguishing herbs. The latent structure analysis(LSA) identified 10 latent variables, 20 latent classes, 7 comprehensive clustering models, and 23 core prescriptions. It was speculated that the common syndromes of hypertensive LVH included blood stasis obstructing the collaterals, ascending hyperactivity of liver Yang, Yin deficiency with Yang hyperactivity, and intermingled phlegm and blood stasis. The association rule analysis yielded 33 strong association rules, with the highest comprehensive association rule being Gastrodiae Rhizoma→Uncariae Ramulus Cum Uncis. Hypertensive LVH is characterized by asthenia in origin and asthenia in superficiality, with Yin deficiency and Qi deficiency as the origin and blood stasis and phlegm as the superficiality. Clinical treatment focuses on activating blood circulation, resolving stasis, tonifying Qi, and nourishing Yin, combined with syndrome-specific therapies such as calming wind and stopping convulsions, clearing heat, eliminating dampness and resolving phlegm, and promoting diuresis and reducing swelling.
Drugs, Chinese Herbal/therapeutic use*
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Data Mining
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Humans
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Hypertension/complications*
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Hypertrophy, Left Ventricular/physiopathology*
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Medicine, Chinese Traditional
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Drug Prescriptions
10.Randomized, double-blind, parallel-controlled, multicenter, equivalence clinical trial of Jiuwei Xifeng Granules(Os Draconis replaced by Ostreae Concha) for treating tic disorder in children.
Qiu-Han CAI ; Cheng-Liang ZHONG ; Si-Yuan HU ; Xin-Min LI ; Zhi-Chun XU ; Hui CHEN ; Ying HUA ; Jun-Hong WANG ; Ji-Hong TANG ; Bing-Xiang MA ; Xiu-Xia WANG ; Ai-Zhen WANG ; Meng-Qing WANG ; Wei ZHANG ; Chun WANG ; Yi-Qun TENG ; Yi-Hui SHAN ; Sheng-Xuan GUO
China Journal of Chinese Materia Medica 2025;50(6):1699-1705
Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent
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Child
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Child, Preschool
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Female
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Humans
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Male
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Double-Blind Method
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Drugs, Chinese Herbal/therapeutic use*
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Tic Disorders/drug therapy*
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Treatment Outcome

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