1.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
2.Association of Overlapped and Un-overlapped Comorbidities with COVID-19 Severity and Treatment Outcomes: A Retrospective Cohort Study from Nine Provinces in China.
Yan MA ; Dong Shan ZHU ; Ren Bo CHEN ; Nan Nan SHI ; Si Hong LIU ; Yi Pin FAN ; Gui Hui WU ; Pu Ye YANG ; Jiang Feng BAI ; Hong CHEN ; Li Ying CHEN ; Qiao FENG ; Tuan Mao GUO ; Yong HOU ; Gui Fen HU ; Xiao Mei HU ; Yun Hong HU ; Jin HUANG ; Qiu Hua HUANG ; Shao Zhen HUANG ; Liang JI ; Hai Hao JIN ; Xiao LEI ; Chun Yan LI ; Min Qing LI ; Qun Tang LI ; Xian Yong LI ; Hong De LIU ; Jin Ping LIU ; Zhang LIU ; Yu Ting MA ; Ya MAO ; Liu Fen MO ; Hui NA ; Jing Wei WANG ; Fang Li SONG ; Sheng SUN ; Dong Ting WANG ; Ming Xuan WANG ; Xiao Yan WANG ; Yin Zhen WANG ; Yu Dong WANG ; Wei WU ; Lan Ping WU ; Yan Hua XIAO ; Hai Jun XIE ; Hong Ming XU ; Shou Fang XU ; Rui Xia XUE ; Chun YANG ; Kai Jun YANG ; Sheng Li YUAN ; Gong Qi ZHANG ; Jin Bo ZHANG ; Lin Song ZHANG ; Shu Sen ZHAO ; Wan Ying ZHAO ; Kai ZHENG ; Ying Chun ZHOU ; Jun Teng ZHU ; Tian Qing ZHU ; Hua Min ZHANG ; Yan Ping WANG ; Yong Yan WANG
Biomedical and Environmental Sciences 2020;33(12):893-905
Objective:
Several COVID-19 patients have overlapping comorbidities. The independent role of each component contributing to the risk of COVID-19 is unknown, and how some non-cardiometabolic comorbidities affect the risk of COVID-19 remains unclear.
Methods:
A retrospective follow-up design was adopted. A total of 1,160 laboratory-confirmed patients were enrolled from nine provinces in China. Data on comorbidities were obtained from the patients' medical records. Multivariable logistic regression models were used to estimate the odds ratio (
Results:
Overall, 158 (13.6%) patients were diagnosed with severe illness and 32 (2.7%) had unfavorable outcomes. Hypertension (2.87, 1.30-6.32), type 2 diabetes (T2DM) (3.57, 2.32-5.49), cardiovascular disease (CVD) (3.78, 1.81-7.89), fatty liver disease (7.53, 1.96-28.96), hyperlipidemia (2.15, 1.26-3.67), other lung diseases (6.00, 3.01-11.96), and electrolyte imbalance (10.40, 3.00-26.10) were independently linked to increased odds of being severely ill. T2DM (6.07, 2.89-12.75), CVD (8.47, 6.03-11.89), and electrolyte imbalance (19.44, 11.47-32.96) were also strong predictors of unfavorable outcomes. Women with comorbidities were more likely to have severe disease on admission (5.46, 3.25-9.19), while men with comorbidities were more likely to have unfavorable treatment outcomes (6.58, 1.46-29.64) within two weeks.
Conclusion
Besides hypertension, diabetes, and CVD, fatty liver disease, hyperlipidemia, other lung diseases, and electrolyte imbalance were independent risk factors for COVID-19 severity and poor treatment outcome. Women with comorbidities were more likely to have severe disease, while men with comorbidities were more likely to have unfavorable treatment outcomes.
Adult
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Aged
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COVID-19/virology*
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China/epidemiology*
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Comorbidity
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Female
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Humans
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Male
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Middle Aged
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Retrospective Studies
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Severity of Illness Index
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Treatment Outcome
4.Study on optineurin gene polymorphism in Chinese patients with primary open angle glaucoma
Si-ying, LIANG ; Li-na, HUANG ; Fang-wei, YING ; Jing, HE ; Teng-liang, WEN
Chinese Journal of Experimental Ophthalmology 2013;31(9):863-866
Background Primary open angle glaucoma(POAG) is a common type of glaucoma.It has been well known that a lot of factors are associated with the pathogenesis of POAG,but genetic factor plays a critical role.Optineurin (OPTN)gene is the second confirmed POAG-relevant gene,and screening its mutation in the population contribute to the deeply understanding of the pathogenesis of POAG.Objective The present study was to investigate the association between sequence variants of OPTN gene and POAG in Chinese patients.Methods DNA was isolated from peripheral blood of 100 POAG patients and 60 cataract individuals.The coding exons of OPTN gene were amplified by PCR.PCR products were then sequenced directly to assay the variants and contrasted to original sequence in GenBank.This study was approved by the Ethical Committee of Shenzhen Eye Hospital.All the subjects signed the written inform consent.Results A case-controlled study was designed.The mean intraocular pressure (IOP)of the POAG patients was (29.0±6.5)mmHg,and that of the cataract patients was (13.7 ±2.4)mmHg.Variant of synonymous coding T34T was found in 60 POAG patients.Genetic type frequencies of AA,GA and GG were 10%,50% and 40% in the POAG patients,and those of cataract patients were 0,25% and 75% respectively,showing significant difference between them (x2 =20.416,P =0.000).The allele frequencies of A and G were 35% and 65% in the POAG patients,and those of cataract patients were 12.5% and 87.5%,with a statistically significant difference (x2 = 19.464,P =0.000).The sequence changes of non-synonymous coding variants (M98K,691-692insA G,R545Q,H486R) were also found in both POAG and cataract patients,but no significant difference was seen in the genetype and allele frequencies between two groups (P>0.05).Conclusions No obvious association of OPTN gene variant with POAG is verified.The variant of T34T maybe increase the risk of POAG.
5.Study on mechanism of traditional Chinese medicines reducing phlegm and resolving masses in treatment of goiter.
Peng CUI ; Ying-Na WANG ; Tian-Shu GAO ; Teng-Che QI ; Lan MEI ; Hui-Si YIN
China Journal of Chinese Materia Medica 2012;37(22):3451-3456
OBJECTIVETo discuss the mechanism of traditional Chinese medicines reducing phlegm and resolving masses in treatment of iodine deficiency-induced goiter by observing the expression of growth factors and the balance-regulating mechanism of proliferation and apoptosis.
METHOD180 four-week-old Wistar rats were selected to establish the iodine deficiency model. After the modeling, the rats were randomly divided into six groups: the normal control group, the model control group, the iodine group, the phlegm compound group, the L-T4 group and the phlegm compound and L-T4 group. At the 21st day and 77th day after administration, 15 rats in each group were killed to collect specimens. Doses were calculated and adjusted according to body surface area and body weight. TT3, TT4 radioimmunoassay, TSH, immunoradiometric method were adopted. Fas, FasL and PCNA protein expressions are detected using immunohistochemical methods.
RESULTCompared with the normal group and the model group, the expressions of fas and FasL in the phlegm Group significantly increased, the expressions of fas and FasL in the phlegm and L-T4 group were also increased significantly. The expression of fas in the L-T4 Group was significantly lower than that of the L-T4 group and the phlegm compound and L-T4 group. Compared with the normal group, the expression of PCNA of the phlegm group and the phlegm and L-T4 group was significantly lower. Compared with the model group, the expression of PCNA of the iodine group, the phlegm groups and the phlegm and L-T4 group were significantly lower. Compared with the normal group, the expression of VEGF in the iodine group significantly decreased after treatment. Compared with the iodine group, the expression of VEGF in the phlegm group and the L-T4 group significantly reduced. Compared with the normal group, the expression of TGF-beta1 in the model group and the phlegm group significantly increased. Compared with model group, the expression of TGF-beta1 in the iodine group significantly reduced. Compared with the phlegm group, the expression of TGF-beta1 in the phlegm compound and L-T4 group was significantly reduced.
CONCLUSIONTraditional Chinese medicines reducing phlegm and resolving masses can completely recover goiter by promoting apoptosis of thyroid cells, inhibiting their proliferation and the expression of growth factors and enhancing the expression of TGF-beta, without causing injury on thyroid cells.
Animals ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Gene Expression ; drug effects ; Goiter ; drug therapy ; genetics ; metabolism ; Humans ; Male ; Proliferating Cell Nuclear Antigen ; genetics ; metabolism ; Rats ; Rats, Wistar ; Thyroid Hormones ; secretion ; Vascular Endothelial Growth Factor A ; genetics ; metabolism
6.Clinical analysis of simultaneous bilateral carotid stenting for treating patients with bilateral atherosclerostic carotid stenosis
Hui DONG ; Xiong-Jing JIANG ; Meng PENG ; Wei JI ; Si-Yong TENG ; Hai-Ying WU ; Rui-Tai HUI ; Yue-Jin YANG
Chinese Journal of Cardiology 2012;40(4):278-282
Objective To evaluate the safety and feasibility of simultaneous bilateral carotid stenting for treating patients with bilateral atherosclerostic carotid stenosis.Methods The clinical data of 39 consecutive patients with bilateral atherosclerostic carotid stenosis undergoing simultaneous bilateral carotid artery stenting in Fuwai hospital from January 2005 to December 2009 were collected and analyzed retrospectively.The reduction of the angiographic diameter stenosis after stenting and clinical outcomes of 30 days after stenting including hyperperfusion syndrome,hemodynamic depression,stroke,myocardial infarction and death were assessed.Results The patients were 43 - 78 (65.9 ± 8.5 ) years old,and there were 25 (64.1% )male.Carotid stenting procedure success rate was 100%.Distal embolic protection devices were used in all patients,and 20( 51.3% ) out of 39 patients underwent coronary artery bypass surgery after carotid stenting.The angiographic diameter stenosis reduced from ( 87.0 ± 5.8 ) % to ( 10.2 ± 5.6 ) % after stenting (P<0.01 ).Up to 30 days after carotid artery stenting,the incidence of hyperperfusion syndrome,hemodynamic depression,minor stroke,major stroke,myocardial infarction and death was 2.6% (1/39),28.2%(11/39),5.1% (2/29),0,2.6% (1/39),2.6% (1/39),respectively.Conclusion The data show that simultaneous bilateral carotid stenting is a technically feasible and safe alternative for patients with severe bilateral atherosclerostic carotid stenosis.
7.Preliminary study of the Th17/Treg immunoregulation in patients coinfected with TB and HIV before and after HAART
Ying-Xia LIU ; Gui-Lin YANG ; Yang ZHOU ; Hong-Mei ZHANG ; Jie-Yun ZHANG ; Si-Yuan WANG ; Yan LIU ; Shui-Teng LIU ; Lu-Kun ZHANG ; Hui WANG
Chinese Journal of Experimental and Clinical Virology 2011;25(5):348-350
Objective To study the Th17/Treg (regulatory T cells) immunoregulation in patients coinfected with TB and HIV before and after HAART( highly active anti-retroviral therapy).Methods 10 HIV cases coinfected with TB ( HIV/TB group) and 10 cases infected with HIV only ( HIV group) received HAART.PBMCs were stained and immunophenotyping of Th17( IL-17 expressing T cells) and CD4 + CD25 +T cells (Treg) were analysed by flow cytometry.Results The pre-treatment patients tended to have lower Th17 cells and higher Tregs cells compared to post-treatment( 1.90% ± 0.9% vs.4.65% ± 1.48%,16.48% ±4.91% vs.8.29% ± 3.13% respectively).The percentage of IL-17 before and after HAART were 1.90 ± 0.9% vs.4.65 ± 1.48% respectively in HIV/TB group patients ( P < 0.01 ).The difference between the percentage of IL-17 before and after HAART in the HIV/TB group and the HIV group were 2.65 ± 1.62% vs.0.67% ± 0.46% respectively (P <0.01 ).IL-17 expressing T cells were increased faster after HAART in the former group than the latter.The percentage of Treg before and after HAART were 16.48% ±4.91% vs.8.29% ± 3.13% respectively in HIV/TB group ( P < 0.01 ).The difference between the percentage of Treg before and after HAART in the HIV/TB group and the HIV group were 8.91% ±4.82% vs.2.63% ± 2.34% respectively ( P < 0.01 ).Treg were decreased more rapidly after HAART in the former than the latter.Conclusions TB and HAART both had an effect on the Th17/Treg ratio of HIV/ TB co-infected patients,which can cause increased Th17 expression,the later plays a pro-inflammatory role.TB and HAART can decrease Treg expression and enhance anti-inflammation response.The fact that Th17/Treg disorder are more likely to exist in patients with HIV/TB co-infection after HAART for one month suggests a potential role for Th17/Treg imbalance leading to tuberculosis-associated immune reconstitution inflammatory syndrome during patients receiving HAART period.
8.Acupression combined with manipulation for the treatment of abnormal cervical curvature in teenagers.
Si-Jin HU ; You-Rong YING ; Rang-Teng ZHU ; Hai-Dong SHI
China Journal of Orthopaedics and Traumatology 2010;23(4):314-315
Acupressure
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methods
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Adolescent
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Adult
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Cervical Vertebrae
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pathology
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Female
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Humans
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Male
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Spinal Curvatures
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pathology
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physiopathology
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therapy
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Treatment Outcome
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Young Adult
10.Hypertrophic cardiomyopathy with right aortic arch, right descending aorta, and Kommerell's diverticulum: a case report.
Xiao-han FAN ; Hai-ying WU ; Si-yong TENG
Chinese Journal of Cardiology 2009;37(8):755-756
Cardiomyopathies
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complications
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Diverticulum
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complications
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Hematoma
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complications
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Humans
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Male
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Middle Aged

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