OBJECTIVE: To evaluate the efficacy and safety of Shexiang Tongxin Dropping Pill (STDP) in treating stable angina patients with phlegm-heat and blood-stasis syndrome by exercise duration and metabolic equivalents. METHODS: This multicenter, randomized, double-blind, placebo-controlled clinical trial enrolled stable angina patients with phlegm-heat and blood-stasis syndrome from 22 hospitals. They were randomized 1:1 to STDP (35 mg/pill, 6 pills per day) or placebo for 56 days. The primary outcome was the exercise duration and metabolic equivalents (METs) assessed by the standard Bruce exercise treadmill test after 56 days of treatment. The secondary outcomes included the total angina symptom score, Chinese medicine (CM) symptom scores, Seattle Angina Questionnaire (SAQ) scores, changes in ST-T on electrocardiogram and adverse events (AEs). RESULTS: This trial enrolled 309 patients, including 155 and 154 in the STDP and placebo groups, respectively. STDP significantly prolonged exercise duration with an increase of 51.0 s, compared to a decrease of 12.0 s with placebo (change rate: -11.1% vs. 3.2%, P<0.01). The increase in METs was significantly greater in the STDP group than in the placebo group (change: -0.4 vs. 0.0, change rate: -5.0% vs. 0.0%, P<0.01). The improvement of total angina symptom scores (25.0% vs. 0.0%), CM symptom scores (38.7% vs. 11.8%), reduction of nitroglycerin consumption (100.0% vs. 11.3%), and all domains of SAQ, were significantly greater with STDP than placebo (all P<0.01). The changes in Q-T intervals at 28 and 56 days from baseline were similar between the two groups (both P>0.05). Twenty-five participants (16.3%) with STDP and 16 (10.5%) with placebo experienced AEs (P=0.131), with no serious AEs observed. CONCLUSION STDP could improve exercise tolerance in patients with stable angina and phlegm-heat and blood stasis syndrome, with a favorable safety profile. (Registration No. ChiCTR-IPR-15006020).
Humans ; Double-Blind Method ; Drugs, Chinese Herbal/adverse effects* ; Male ; Female ; Middle Aged ; Angina, Stable/physiopathology* ; Aged ; Syndrome ; Treatment Outcome ; Placebos ; Tablets

AIM To evaluate the chemical constituent consistency in formula granules and traditional decoctions of Gouteng Jiangya Formula.METHODS HPLC characteristic chromatograms were established,the analysis was performed on a 30 ℃ thermostatic YMC-Triart C18 column(4.6 mm× 250 mm,5 μm),with the mobile phase comprising of acetonitrile-0.2％phosphoric acid flowing at 1.0 mL/min in a gradient elution manner,and the detection wavelength was set at 240 nm.Puerarin was used as an internal standard to calculate the relative correction factors of 3'-methoxy puerarin,puerarin apioside,magnolflorine,paeoniflora,daidzin,baicalin,palmatine,berberine,wogonoside and benzoylpaeoniflorin,after which the content detemination was made by quantitative analysis of multi-components by single-marker(QAMS).RESULTS The characteristic chromatograms of 9 batches of formula granules and 15 bacthes of traditional decoctions demonstrated the similarities of more than 0.90 at the detection wavelengths of 192,210,240,260,280,300,320,360 nm,along with similar total peak areas.Eleven constituents showed good linear relationships within their own ranges(r＞0.999 0),whose average recoveries were 97.27％-101.64％with the RSDs of 0.36％-1.11％,the result obtained by QAMS and external standard method demonstrated no significant differences(P＞0.05).The contents of various constituents in the formula granules approximated those in the traditional decoctions.CONCLUSION The consistent kinds and contents of various constituents are obversable in formula granules and traditional decoctions of Gouteng Jiangya Formula,which can provide a reference for the reasonable clinical application of this formula.

AIM To evaluate the chemical constituent consistency in formula granules and traditional decoctions of Gouteng Jiangya Formula.METHODS HPLC characteristic chromatograms were established,the analysis was performed on a 30 ℃ thermostatic YMC-Triart C18 column(4.6 mm× 250 mm,5 μm),with the mobile phase comprising of acetonitrile-0.2％phosphoric acid flowing at 1.0 mL/min in a gradient elution manner,and the detection wavelength was set at 240 nm.Puerarin was used as an internal standard to calculate the relative correction factors of 3'-methoxy puerarin,puerarin apioside,magnolflorine,paeoniflora,daidzin,baicalin,palmatine,berberine,wogonoside and benzoylpaeoniflorin,after which the content detemination was made by quantitative analysis of multi-components by single-marker(QAMS).RESULTS The characteristic chromatograms of 9 batches of formula granules and 15 bacthes of traditional decoctions demonstrated the similarities of more than 0.90 at the detection wavelengths of 192,210,240,260,280,300,320,360 nm,along with similar total peak areas.Eleven constituents showed good linear relationships within their own ranges(r＞0.999 0),whose average recoveries were 97.27％-101.64％with the RSDs of 0.36％-1.11％,the result obtained by QAMS and external standard method demonstrated no significant differences(P＞0.05).The contents of various constituents in the formula granules approximated those in the traditional decoctions.CONCLUSION The consistent kinds and contents of various constituents are obversable in formula granules and traditional decoctions of Gouteng Jiangya Formula,which can provide a reference for the reasonable clinical application of this formula.

OBJECTIVES: To study the protective effect of melatonin (Mel) against oxygen-induced retinopathy (OIR) in neonatal mice and the role of the HMGB1/NF-κB/NLRP3 axis. METHODS: Neonatal C57BL/6J mice, aged 7 days, were randomly divided into a control group, a model group (OIR group), and a Mel treatment group (OIR+Mel group), with 9 mice in each group. The hyperoxia induction method was used to establish a model of OIR. Hematoxylin and eosin staining and retinal flat-mount preparation were used to observe retinal structure and neovascularization. Immunofluorescent staining was used to measure the expression of proteins and inflammatory factors associated with the HMGB1/NF-κB/NLRP3 axis and lymphocyte antigen 6G. Colorimetry was used to measure the activity of myeloperoxidase. RESULTS: The OIR group had destruction of retinal structure with a large perfusion-free area and neovascularization, while the OIR+Mel group had improvement in destruction of retinal structure with reductions in neovascularization and perfusion-free area. Compared with the control group, the OIR group had significant increases in the expression of proteins and inflammatory factors associated with the HMGB1/NF-κB/NLRP3 axis, the expression of lymphocyte antigen 6G, and the activity of myeloperoxidase (P<0.05). Compared with the OIR group, the OIR+Mel group had significant reductions in the above indices (P<0.05). Compared with the control group, the OIR group had significant reductions in the expression of melatonin receptors in the retina (P<0.05). Compared with the OIR group, the OIR+Mel group had significant increases in the expression of melatonin receptors (P<0.05). CONCLUSIONS Mel can alleviate OIR-induced retinal damage in neonatal mice by inhibiting the HMGB1/NF-κB/NLRP3 axis and may exert an effect through the melatonin receptor pathway.
Animals ; Mice ; HMGB1 Protein ; Melatonin/therapeutic use* ; Mice, Inbred C57BL ; NF-kappa B ; NLR Family, Pyrin Domain-Containing 3 Protein ; Oxygen/adverse effects* ; Peroxidase ; Receptors, Melatonin ; Retinal Diseases/drug therapy*

Humans ; Stroke, Lacunar ; Mendelian Randomization Analysis ; Leukocytes ; Telomere/genetics* ; Genome-Wide Association Study ; Polymorphism, Single Nucleotide

OBJECTIVE: To investigate the effect of hydronidone on CCl₄-induced liver fibrosis in rats and explore the possible mechanism. METHODS: Sixty-six male SD rats were randomized into 5 groups, including a control group (n=10), a liver fibrosis model group (n=20), 2 hydronidone dose groups (100 and 250 mg/kg; n=12), and a pirfenidone (250 mg/kg) treatment group (n= 12). Rat models of liver fibrosis were established by subcutaneous injection of CCl₄ in all but the control group. Hydronidone and pirfenidone were given daily at the indicated doses by intragastric administration for 6 weeks. After the treatments, serum samples were collected from the rats for detecting liver function parameters, and hydroxyproline content in the liver tissue was determined. Inflammation and fibrosis in the liver tissue were observed using HE staining and Sirius Red staining. In the cell experiment, human hepatic stellate cell line LX-2 was stimulated with TGF-β1 and treated with hydronidone or pirfenidone, and the expression levels of α-SMA, collagen type I and phosphorylated Smad3, phosphorylated p38, phosphorylated ERK1/2 and phosphorylated Akt were detected with Western blotting. RESULTS: In the rat models of liver fibrosis, treatment with hydronidone obviously improved the liver functions, reduced the content of hydroxyproline in the liver tissue, and significantly alleviated liver fibrosis (P < 0.05). In LX-2 cells, hydronidone dose-dependently decreased the expression levels of α-SMA and collagen type I. In TGF- β1-stimulated cells, the phosphorylation levels of Smad3, P38, ERK, and Akt increased progressively with the extension of the treatment time, but this effect was significantly attenuated by treatment with hydronidone (P < 0.05). CONCLUSION Hydronidone can inhibit the phosphorylation of the proteins in the TGF-β signaling pathway, thereby preventing TGF-β1-mediated activation of hepatic stellate cells, which may be a possible mechanism by which hydronidone alleviates CCl₄-induced liver fibrosis in rats.
Animals ; Male ; Rats ; Carbon Tetrachloride/metabolism* ; Collagen Type I ; Hepatic Stellate Cells/pathology* ; Hydroxyproline/therapeutic use* ; Liver Cirrhosis ; Phosphorylation ; Proto-Oncogene Proteins c-akt/metabolism* ; Rats, Sprague-Dawley ; Signal Transduction ; Smad Proteins/metabolism* ; Transforming Growth Factor beta1/metabolism*

Objective:To explore the status of disability, characteristics of unmet needs and services of rehabilitation and their related factors for adults with disabilities (AWDs). Methods:A total of 2 315 498 AWDs were sampled from the provincial level administration data (2019). Multiple response analysis was used to analysis the disability status of AWDs, characteristics of unmet needs and received services of rehabilitation, and related factors were explored with Logistic regression. Results:The distribution of disabilities for AWDs from high to low were physical disabilities (62.2%), visual disabilities (9.9%), intellectual disabilities (8.4%), mental disorders (7.3%), hearing disabilities (6.9%), multiple disabilities (2.8%) and speech disabilities (2.5%). The reporting rate of unmet needs of rehabilitation for AWDs from high to low were assistive devices (49.0%), medicine (33.3%), nursing care (27.7%), functional training (20.2%) and surgery (1.9%). The reporting rate of received service for AWDs from high to low were assistive devices (44.1%), nursing care (26.6%), medicine (25.9%), functional training (22.2%) and surgery (1.3%). The logistic regression model shown that types and severities of disabilities had significant effects on unmet needs and received services of rehabilitation for AWDs (P < 0.001). Conclusion:The reporting of unmet needs for AWDs had been influenced by their functioning and disability. There were gaps between unmet needs and received services. It proposed to develop precise and individualized reporting of unmet needs and service programs for AWDs.

Objective:To explore the status of disability, and characteristics of unmet needs and services of rehabilitation for children with disabilities (CWDs). Methods:A total of 130 290 CWDs administration data of unmet needs and services of rehabilitation at provincial level had been sampled and analyzed. Results:CWDs accounted for 5.33% of the total population with disabilities, in which, 60.4% were boys and 39.6% were girls; 16.3% aged 0 to nine years and 83.7% were seven to 18 years old; 88.4% with agricultural household and 11.6% with non-agricultural household. The distribution of disability severity from severe to mild were 28.3%, 39.5%, 17.7% and 14.6%. The reported unmet needs included assistive devices (40.3%), functional training (37.4%), nursing care (32.2%), medicine (24.9%) and surgery (5.7%). The received services involved in assistive devices (37.9%), functional training (33.7%), nursing care (31.0%), medicine (19.7%) and surgery (2.9%). Logistic Regression model showed that severities of disabilities had significant effects on reported unmet needs and received services (P < 0.001). Conclusion:Implement rehabilitation programs would be tailored to the unmet needs of rehabilitation as CWDs had functioning oriented unmet needs. It proposed to develop individualized and structured rehabilitation services to improve the accessibility and quality of rehabilitation for CWDs.

Objective:To explore the characteristics of unmet needs and services of rehabilitation for people with hearing disability (PHD). Methods:A total of 219 473 PHDs administration data of unmet needs and services of rehabilitation at provincial level were sampled (2019) and analyzed the characteristics of needs and services of rehabilitation with multiple response analysis, and the related factors of needs and services with Logistic regression. Results:There were 47 657 (21.7%) PHDs reported their unmet needs of rehabilitation, from high to low were assistive devices (65.5%), medicine (22.7%), nursing care (19.1%), functional training (16.2%) and surgery (2.2%). There were 34 684 (18.8%) PHDs reported their received services, from high to low were assistive devices (59.8%), medicine (22.5%), functional training (19.7%), nursing care (19.4%) and surgery (1.8%). The logistic regression model showed that age, types of household registration and severities of disabilities related with the reported unmet needs and received services (P < 0.001). Conclusion:PHDs mainly reported unmet needs in the fields of assistive devices, medicine, and rehabilitation training. The reported unmet needs for PHDs had matched the received services structurally. It proposed to use modern science and technology to develop services delivery and to improve accessibility and quality of rehabilitation services.

Objective:To analyze the characteristics of unmet needs and services of rehabilitation for people with intellectual disability (PIDs). Methods:A total of 250 654 PIDs had been sampled and administration data of unmet needs and services of rehabilitation at provincial level had been analyzed the characteristics of unmet needs and services of rehabilitation, and the related factors of needs and services were analyzed with Logistic Regression. Results:The rate of unmet needs reported by PIDs from high to low were nursing (47.8%), medicine (37.2%), functional training (26.1%), assistive devices (19.8%) and surgery (1.3%). The PIDs reported received service of rehabilitation, including nursing care (43.5%), medicine (29.3%), functional training (27.2%), assistive devices (19.6%) and surgery (0.8%). Logistic Regression Model showed that age and severity of disabilities significantly affect the reported the unmet needs and received services (P < 0.001). Conclusion:PIDs reported unmet needs mainly involved in the fields of nursing care, medicine and rehabilitation training and therapy. The unmet needs and received services had similar structure. It proposed to develop rehabilitation services tailored to PIDs' intellectual function and adaptive behaviors to develop services items and to deliver individualized and precise services.