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

Debates persist regarding the efficacy and safety of azvudine, particularly its real-world outcomes. This study involved patients aged ≥60 years who were admitted to 25 hospitals in mainland China with confirmed SARS-CoV-2 infection between December 1, 2022, and February 28, 2023. Efficacy outcomes were all-cause mortality during hospitalization, the proportion of patients discharged with recovery, time to nucleic acid-negative conversion (T _NANC), time to symptom improvement (T _SI), and time of hospital stay (T _HS). Safety was also assessed. Among the 5884 participants identified, 1999 received azvudine, and 1999 matched controls were included after exclusion and propensity score matching. Azvudine recipients exhibited lower all-cause mortality compared with controls in the overall population (13.3% vs. 17.1%, RR, 0.78; 95% CI, 0.67-0.90; P = 0.001) and in the severe subgroup (25.7% vs. 33.7%; RR, 0.76; 95% CI, 0.66-0.88; P < 0.001). A higher proportion of patients discharged with recovery, and a shorter T _NANC were associated with azvudine recipients, especially in the severe subgroup. The incidence of adverse events in azvudine recipients was comparable to that in the control group (2.3% vs. 1.7%, P = 0.170). In conclusion, azvudine showed efficacy and safety in older patients hospitalized with COVID-19 during the SARS-CoV-2 omicron wave in China.

OBJECTIVES: To explore the efficacy of DSA-guided intrathecal drug delivery system combined with Zi Wu Liu Zhu Acupoint Therapy for management of cancer pain and provide reference for its standardized clinical application. Methods and. RESULTS: Recommendations were formulated based on literature review and expert group discussion, and consensus was reached following expert consultation. The consensus recommendations are comprehensive, covering the entire treatment procedures from preoperative assessment and preparation, surgical operation process, postoperative management and traditional Chinese medicine treatment to individualized treatment planning. The study results showed that the treatment plans combining traditional Chinese with Western medicine effectively alleviated cancer pain, reduced the use of opioid drugs, and significantly improved the quality of life and enhanced immune function of the patients. Postoperative follow-up suggested good treatment tolerance among the patients without serious complications. CONCLUSIONS The formulated consensus is comprehensive and can provide reference for clinicians to use DSA-guided intrathecal drug delivery system combined with Zi Wu Liu Zhu Acupoint Therapy. The combined treatment has a high clinical value with a good safety profile for management of cancer pain.
Humans ; Medicine, Chinese Traditional ; Cancer Pain/therapy* ; Drugs, Chinese Herbal/therapeutic use* ; Drug Delivery Systems ; Pain Management/methods* ; China

Objective To compare the application effects of plankton multiplex polymerase chain reac-tion-capillary electrophoresis(PCR-CE),SYBR Green Ⅰ real-time quantitative PCR(qPCR)and microwave digestion-vacuum filtration-automated scanning electron microscopy(MD-VF-Auto SEM)in the diagnosis of drowning.Methods Lung,liver and kidney tissues from 212 drowned corpses and 30 non-drowned corpses were examined respectively by the three drowning-related plankton testing methods,and the detection rates of plankton in each tissue by three methods were compared.Results In drowned corpses,the total detection rates of PCR-CE,qPCR,and MD-VF-Auto SEM were 93.9%,96.2%,and 95.3%,respectively,with no statistically significant difference(P>0.05).The detection rate of lung tissue by MD-VF-Auto SEM(100%)was higher than those of PCR-CE and qPCR(P<0.05),and there was no significant difference in the detection rates of the three methods in liver or kidney tissues(P>0.05).In non-drowning corpses,a small number of diatoms(less than 10 cells/10 g)were detected by MD-VF-Auto SEM method,only in liver and kidney tissues,while the other two methods yielded negative results for all tissues.Conclusion All three methods have good efficacy in the examination of drowned corpses.The MD-VF-Auto SEM method directly observes diatom morpho-logical characteristics through scanning electron microscopy,and the qualitative and quantitative analy-ses are intuitive and accurate.It has great advantages in the examination of difficult degradation samples.The PCR-CE method and qPCR method have a low sample demand(0.5 g),are easy to operate and have short detection time(4-7 h).They are easy to be applied in the grassroots depart-ments and are suitable for the rapid determination of drowned corpses in routin cases.The combina-tion of the two DNA methods with the MD-VF-Auto SEM method can increase the detection rate of plankton,ensuring the reliability of examination results.This combined use is of significant importance in the application of drowning diagnosis.

Objective To explore the risk factors of venous thromboembolism(VTE)following laparoscopic urological surgery and to construct a predictive model.Methods A retrospective analysis was conducted on the clinical data from 846 laparoscopic surgery patients admitted to the Urology Department of Hainan Cancer Hospital from January 2020 to January 2023.Patients were divided into VTE group(n=64)and non-VTE group(n=782)based on postoperative VTE confirmed by imaging examination.Univariate and multivariate logistic regression analyses were performed to identify independent risk factors for VTE after laparoscopic urological surgery.A predictive model was developed using regression coefficients from the multivariate analysis,and its predictive accuracy was assessed using a nomogram.Additionally,its sensitivity and specificity were evaluated through the construction of a receiver operating characteristic(ROC)curve and a calibration curve.The clinical application of predictive model was evaluated using a decision curve analysis.Results The incidence of VTE after laparoscopic urological surgery was 7.6%(64/864).Significant differences were observed between two groups in age,body mass index(BMI),hypertension,diabetes,malignant tumor,history of abdominal surgery,previous VTE,operation time≥4 h,preoperative fibrinogen levels,preoperative prothrombin time,postoperative D-dimer(D-D)levels,Caprini score and postoperative immobilization time(P<0.05).Increasing age,higher BMI,history of malignancy,abdominal surgery,and previous VTE,longer operation and postoperative immobilization time,and higher postoperative D-D levels and Caprini score were identified as independent risk factors for the development of VTE after urological laparoscopy(P<0.05).Based on the regression coefficients between independent risk factors,a predictive model was constructed as P=ex/(1+ex),where X=0.054×age+0.105×BMI+0.902×history of abdominal surgery+1.172×previous VTE+0.787×operation time+1.546×malignant tumor+0.867×postoperative D-D+1.303×Caprini score+0.544×postoperative immobilization time-13.888.The model demonstrated a discriminant evaluation C-index of 0.827,and the area under the ROC curve for the combined independent risk factors is 0.827(95%CI 0.776-0.878),with a sensitivity of 64.1%,and specificity of 87.7%.Calibration and decision curves indicated that high predictive accuracy and clinical application of the model.Conclusions Increasing age,higher BMI,history of malignancy,abdominal surgery,and previous VTE,longer operation and postoperative immobilization time,and higher postoperative D-D and Caprini score are independent risk factors for the development of VTE after urological laparoscopy.

Objective To investigate the dynamic changes of N-terminal pro-brain natriuretic peptide(NT-proBNP)and high-sensitivity cardiac troponin T(hs-cTnT)during gestation period in women with heart disease,and to evaluate their predictive value for adverse pregnancy outcomes.Methods A total of 221 pregnant women with heart disease undergoing peripartum management were enrolled and divided into adverse outcome group(n=68)and favorable outcome group(n=153)based on pregnancy outcomes.General clinical data and pregnancy outcomes were compared between two groups.Levels of NT-proBNP and hs-cTnT were measured during early pregnancy,mid-pregnan-cy as well as late pregnancy and within 24 hours postpartum.The predictive value of NT-proBNP and hs-cTnT for adverse pregnancy outcomes was evaluated using receiver operating characteristic(ROC)curve analysis.Multivariate Logistic regression analysis was used to screen independent risk factors for adverse pregnancy outcomes.Results There was a statistically significant difference in the New York Heart Association(NYHA)cardiac function classification,left ventricular ejection fraction(LVEF)and pulmonary artery systolic pressure(PASP)between two groups(P＜0.001).In the early stage of pregnancy,the second stage of pregnancy,the third stage of pregnancy and at 24 hours after delivery,the levels of NT-proBNP and hs-cTnT in the adverse outcome group were higher than those in the favorable outcome group,and the differences were statistically significant(P＜0.001).The incidence of maternal complications in the adverse outcome group was higher than that in the favorable outcome group,and the difference was statistically significant(P＜0.01 or P＜0.001).The rates of preterm birth,low birth weight and neonatal asphyxia in the adverse outcome group were higher than those in the favorable outcome group,and the differences were statistically significant(P＜0.01 or P＜0.001).The ROC curve analysis showed that the area under the curve(AUC)of NT-proBNP was 0.892(95％CI,0.845 to 0.939),the AUC of hs-cTnT was 0.857(95％CI,0.802 to 0.912),and the AUC of the combined detection of the two was 0.924(95％CI,0.885 to0.963).The NT-proBNP＞986.5 pg/mL(OR=6.85,95％CI,3.24 to 14.46)and hs-cTnT＞15.8 ng/L(OR=5.62,95％CI,3.24 to 14.46)in the third trimester 2.86 to 11.05)and NYHA class Ⅲ to Ⅳ(OR=4.28,95％CI,1.96 to 9.35)were independent risk factors for adverse pregnancy outcomes.Conclusion The levels of NT-proBNP and hs-cTnT during the perina-tal period in patients with pregnancy complicated with heart disease show dynamic changes.Monito-ring two indicators has important clinical value for predicting adverse pregnancy outcomes.

Objective To explore the efficacy of DSA-guided intrathecal drug delivery system combined with Zi Wu Liu Zhu Acupoint Therapy for management of cancer pain and provide reference for its standardized clinical application.Methods and Results Recommendations were formulated based on literature review and expert group discussion,and consensus was reached following expert consultation.The consensus recommendations are comprehensive,covering the entire treatment procedures from preoperative assessment and preparation,surgical operation process,postoperative management and traditional Chinese medicine treatment to individualized treatment planning.The study results showed that the treatment plans combining traditional Chinese with Western medicine effectively alleviated cancer pain,reduced the use of opioid drugs,and significantly improved the quality of life and enhanced immune function of the patients.Postoperative follow-up suggested good treatment tolerance among the patients without serious complications.Conclusion The formulated consensus is comprehensive and can provide reference for clinicians to use DSA-guided intrathecal drug delivery system combined with Zi Wu Liu Zhu Acupoint Therapy.The combined treatment has a high clinical value with a good safety profile for management of cancer pain.

AIM To establish an HPLC method for the simultaneous content determination of gallic acid,protocatechuic acid,morroniside,loganin,sweroside,paeoniflorin,hypericin,astragalin,salvianolic acid B,salvianolic acid A,epimedin C and icariin in Bushen Huoxue Sanjie Capsules.METHODS The analysis was performed on a 30℃thermostatic Agilent 5 TC-C18 column(250 mm×4.6 mm,5 μm),with the 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 240 nm.RESULTS Twelve constituents showed good linear relationships within their own ranges(r≥0.999 8),whose average recoveries were 97.11%-101.14%with the RSDs of 0.60%-2.65%.CONCLUSION This simple,accurate and reproducible method can be used for the quality control of Bushen Huoxue Sanjie Capsules.

Objective:To explore the clinical application value of neutrophil extracellular traps(NETs)in the evaluation of psoriasis patients.Methods:Peripheral blood(2 ml)of 63 patients with psoriasis and 27 healthy controls were collected,neutrophils were isolated by density gradient method,and the formation of NETs was observed by immunofluorescence staining.Calculated the pro-portion and fluorescence intensity of NETs,and analyzed their correlation with clinical classification,severity and serological indica-tors.Skin lesions of 5 patients with psoriasis were collected,and the NETs were observed by immunofluorescence method.Results:Proportion and fluorescence intensity of spontaneous NETs in patients with psoriasis were significantly higher than those in healthy con-trols,and were positively correlated with the PASI scores.Production of NETs in psoriasis patients with metabolic abnormalities or TNF-α abnormalities was higher than that in psoriasis patients without metabolic abnormalities or TNF-α normalcy.Expressions of NETs in psoriatic lesions were increased.Conclusion:Levels of NETs are correlated with disease severity of psoriasis and patients with metabolic abnormalities,and may be used as a clinical indicator to reflect the inflammatory state of psoriasis and metabolic comor-bidity of psoriasis for disease evaluation.

Objective This study aimed to explore the effect of pituitary tumor-transforming gene 1(PTT-G1)on the invasion and proliferation of oral squamous cell carcinoma(OSCC)cell lines under the action of miR-362-3p.Methods The bioinformatics online database was used to query the expression of PTTG1 in head and neck squamous cell carcinoma(HNSCC).The expression of PTTG1 in the Cal-27,HN-30,and HOK cell lines was detected by Western blot.A wound-healing assay was used to determine the effect of PTTG1 on the migration ability of the OSCC cells.The Transwell assay was used to examine the changes in cell-invasion ability.5-ethynyl-2'-deoxyuridine(EdU)cell-proliferation assay was used to detect changes in cell-proliferation ability.Bioinformatics approach predicted the upstream miRNA of PTTG1.The targeting relationship between miR-362-3p and PTTG1 was examined by the dual luciferase assay,and quantitative real-time polymerase chain reaction(qRT-PCR)was used to determine the expression of miRNA in OSCC tissues.Results The ENCORI database showed that PTTG1 expression was up-regulated in OSCC tissues.Western blot confirmed that PTTG1 expression was up-regulated in Cal-27 and HN-30 cells than HOK cells.PTTG1 knockout can inhibit the migration,invasion,and prolif-eration of Cal-27 and HN-30 cells(P<0.05).Bioinformatics prediction websites predicted that the upstream miRNA of PTTG1 was miR-362-3p,and PTTG1 can bind to miR-362-3p.Results of qRT-PCR showed that miR-362-3p expression was downregulated in OSCC tissues compared with normal tissue(P<0.05).Transwell and EdU experiments confirmed that miR-362-3p knockdown can promote the invasion and proliferation of Cal-27 and HN-30 after PTTG1 knockdown.Conclusion miR-362-3p can inhibit the invasion and proliferation of Cal-27 and HN-30 cells by targeting PTTG1.