ObjectiveTo investigate the efficacy and safety of Shuganning injection in the treatment of liver injury by observing the clinical outcome of patients with liver injury after treatment with Shuganning injection and comparing it with reduced glutathione （GSH）. MethodsThis study was conducted among 175 patients with liver injury who attended 6 hospitals in China （Beijing YouAn Hospital， Capital Medical University； Nanyang First People’s Hospital； The Second Affiliated Hospital of Xi’an Jiaotong University； The Fifth Medical Center of Chinese PLA General Hospital； The Third Hospital of Hebei Medical University； The Affiliated Hospital of Guizhou Medical University） from April 25， 2019 to February 28， 2022. The patients were divided into experimental group （89 patients treated with Shuganning injection） and control group （86 patients treated with GSH）， and the course of treatment was 4 weeks for both groups. Related indicators were recorded before treatment， after treatment， and after drug withdrawal for 8 weeks， including liver function parameters， blood biochemical parameters， blood lipids， coagulation profiles， liver fibrosis markers， traditional Chinese medicine （TCM） syndrome score， and ultrasound findings， as well as adverse events during treatment. The Wilcoxon rank-sum test was used for comparison of continuous data between two groups， and the chi-square test was used for comparison of categorical data between two groups. The Wilcoxon signed-rank test was used for comparison of observation indicators before treatment， at week 4 of treatment， and after drug withdrawal for 8 weeks. When the efficacy evaluation of TCM syndromes was used as the outcome， a pooled analysis was performed for the effective cases and the markedly effective cases， and a Logistic regression model was used to calculate the odds ratio （OR） and its 95%CI. ResultsAfter 4 weeks of treatment with Shuganning injection， the patients showed significant reductions in TCM syndrome score （P<0.001） and the levels of aspartate aminotransferase， alanine aminotransferase， total bilirubin， and direct bilirubin （all P<0.001） and a significant increase in the level of albumin （P=0.002）， and these significant improvements persisted after drug withdrawal for 8 weeks. Furthermore， compared with the control group， the experimental group had a significantly higher proportion of patients assessed as effective or markedly effective cases （48.31% vs 32.56%， P=0.033）. Compared with the control group， the experimental group had a significantly greater change in TCM syndrome score at weeks 1-4 of treatment and after drug withdrawal for 8 weeks （P<0.05）. At week 4 of treatment， the experimental group had a significantly greater reduction in alanine aminotransferase than the control group （P<0.05）， and at week 8 after drug withdrawal， the experimental group had a significantly greater reduction in alanine aminotransferase and aspartate aminotransferase than the control group （all P<0.05）. One patient in the experimental group （1.12%） experienced an adverse event， which was determined to be associated with the progression of viral hepatitis. ConclusionShuganning injection can effectively improve liver injury， with good long-term efficacy and a low incidence rate of adverse reactions.

AIM: To evaluate clinical efficacy of recombinant human epidermal growth factor(rhEGF)combined with adjuvant amniotic membrane transplantation in corneal alkaline burns. METHODS:In the prospective, randomized controlled study, patients with corneal alkaline burns treated in the hospital were enrolled between November 2022 and November 2024. After emergency treatment, patients were divided into combined treatment group and routine treatment group by random number table method. The routine treatment group was given basic treatment(rhEGF), while combined treatment group additionally underwent adjuvant amniotic membrane transplantation. The clinical efficacy, healing time of corneal epithelium, best corrected visual acuity, VAS scores, corneal neovascularization area, break-up time, score of corneal opacity, and levels of inflammatory factors(IL-6, hs-CRP, TNF-α)in the two groups were observed and compared. RESULTS:There were 110 patients(110 eyes)in this study, including 55 cases(55 eyes)in each group. The combination group had a mean age of 46.82±10.38 y, including 26 males and 29 females. The routine treatment group had a mean age of 45.13±11.57 y, with 31 males and 24 females. The total response rate of combined treatment group [94.5%(52/55)] was significantly higher than that of routine treatment group [81.8%(45/55), P<0.05]. The healing time of corneal epithelium in combined treatment group was significantly shorter than that in routine treatment group(P<0.001), and VAS score for pain severity after treatment was significantly lower than that in routine treatment group(P<0.001). The corneal neovascularization area in combined treatment group was significantly smaller than that in routine treatment group(P<0.001), break-up time was significantly longer than that in routine treatment group(P<0.001),and score of corneal opacity was significantly lower than that in routine treatment group(P<0.001). After treatment, levels of inflammatory factors in combined treatment group were significantly lower than those in routine treatment group(all P<0.05). CONCLUSION:Adjuvant amniotic membrane transplantation combined with rhEGF presents prominent clinical advantages in the treatment of alkaline corneal burns. It can enhance therapeutic efficacy, accelerate wound healing, relieve pain, reduce corneal neovascularization, prolong tear film break-up time, alleviate corneal opacification, and reduce the levels of inflammatory factors.

OBJECTIVE To evaluate the efficacy and safety of sacituzumab tirumotecan combined with bevacizumab for the treatment of human epidermal growth factor receptor 2-negative （HER2－） breast cancer with brain metastases.METHODS Clinical data of 90 patients with HER2－ breast cancer with brain metastases treated at the First Affiliated Hospital of Nanyang Medical College from December 2024 to November 2025 were retrospectively collected. According to the treatment regimens， the patients were divided into a control group （ n ＝55） and an experimental group （ n ＝35）. Patients in the experimental group received sacituzumab tirumotecan combined with bevacizumab， whereas those in the control group received conventional systemic therapy， including albumin-bound paclitaxel-based regimens， capecitabine-based regimens， or gemcitabine/vinorelbine combined with platinum-based regimens. Short-term efficacy， progression-free survival （PFS）， brain metastasis-related efficacy， adverse events， treatment discontinuation due to adverse events， and treatment-related deaths were compared between the two groups.RESULTS The objective response rate （ORR）， disease control rate， median PFS， intracranial disease control rate， and proportion of patients with improvement in neurological symptoms in the experimental group were significantly higher than in the control group （ P ＜0.05）. Stratified analysis showed that PFS of the experimental group was significantly longer than the control group among patients with Breast-Graded Prognostic Assessment scores ≥2.0 and ＜2.0 （ P ＜0.05）. There were no statistically significant differences in the proportion of patients with glucocorticoid dose reduction/discontinuation， the incidence of adverse events of different grades， or the rate of treatment discontinuation due to adverse events between the two groups （ P ＞0.05）. No treatment-related deaths occurred in either group.CONCLUSIONS Compared with conventional systemic therapy， sacituzumab tirumotecan combined with bevacizumab can improve the ORR and prolong PFS in patients with HER2－ breast cancer with brain metastases， with an overall manageable safety profile.

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

OBJECTIVE: Meta-analysis of the clinical efficacy of plate and external fixator fixation in the treatment of AO-C type distal radius fractures. METHODS: PubMed, Embase, Cochrane Medical Library, Web of Science, CNKI, Wanfang, VIP and SinoMed databases were searched for all literature on randomized controlled clinical trials of AO-C distal radius fractures. The search time limits were from each database. The database will be established until June 30, 2023. The included studies were extracted according to the Cochrane Handbook (Version 6.3, 2022) for information extraction and literature quality evaluation. RevMan 5.4 was used to evaluate the risk of Publication bias, test heterogeneity and Perform Meta-analysis. The outcome indicators were:imaging anatomy indicators (volar inclination angle, ulnar deviation angle, radial height), wrist joint mobility (flexion, extension, rotation, ulnar deviation), complication rate, and comparison of surgical treatments (operative blood loss, operation time, hospitalization time, fracture healing time) and wrist joint function scores and related scales. RESULTS: (1) A total of 28 studies were included, with a total of 2 192 patients, including 1 096 cases in the plate internal fixation group and 1 096 cases in the external fixation group.(2) Meta analysis results showed:the surgical treatment situation of the external fixation group:surgical blood loss MD=-37.93, 95%CI(-48.54, -27.31), P<0.000 01;operation time MD=-31.58, 95%CI(-48.96, -14.20), P<0.000 4;hospitalization time MD=-4.58, 95%CI(-5.44, -3.71), P<0.000 01;the fracture healing time MD=-0.88, 95%CI(-1.35, -0.41), P<0.000 2, which were significantly better than that of the plate internal fixation group(P<0.05).(3) The two groups:palmar inclination angle MD=-0.17, 95%CI(-0.95, 0.61), P=0.68;ulnar declination MD=0.22, 95%CI(-0.73, 1.17), P=0.65, radial height MD=-0.24, 95%CI(-1.15, 0.67), P=0.60;flexion and extension MD=-5.63, 95%CI(-11.85, 0.58), P=0.08;rotation MD=-5.80, 95%CI(-12.77, 1.17), P=0.10, radioulnar deviation MD=-2.86, 95%CI(-10.87, 5.15), P=0.48;complication rate RR=0.96, 95%CI(0.63, 1.46), P=0.83;Gartland-Werley clinical wrist score MD=0.13, 95%CI(-0.80, 1.06), P=0.78;excellent and good rate of Gartland-Werley wrist clinical score RR=0.93, 95%CI(0.87, 1.01), P=0.08;excellent and good rate of Cooney wrist score RR=0.99, 95%CI(0.62, 1.59), P=0.98;wrist DASH score MD=-4.67, 95%CI(-14.96, 5.62), P=0.37;the differences were not significant (P>0.05). CONCLUSION Compared with internal fixation with plate, external fixation can significantly reduce the amount of surgical bleeding, shorten the operation time, hospitalization time and fracture healing time, and its imaging anatomical indicators, wrist mobility, and complications can be significantly reduced in treating AO-C distal radius fractures. Rates and wrist function scores were equivalent.
Humans ; External Fixators ; Bone Plates ; Radius Fractures/surgery* ; Fracture Fixation/methods* ; Fracture Fixation, Internal ; Wrist Fractures

Objective To investigate the effect of basic helix-loop-helix family member E40 (BHLHE40) on the invasion and migration of osteosarcoma (OS) cells, and to explore the role of the phosphatidylinositol 3-kinase/protein kinase B (PI3K/AKT) signaling pathway in the biological behavior of OS mediated by BHLHE40, providing a scientific basis for targeted therapy of OS. Methods On the basis of clinical OS samples and OS cell lines, the expression differences of BHLHE40 between OS and adjacent tissues, as well as those between OS cells and normal osteoblast cell lines, were analyzed. BHLHE40 knockdown OS cells were obtained through shRNA transfection. The effects of BHLHE40 on OS cell proliferation, migration, and invasion were examined using CCK-8, EdU staining, wound healing, and Transwell assays. The involvement of the PI3K/AKT signaling pathway was assessed by Western blotting. Further validation was conducted in vivo experiments. Results The expression of BHLHE40 was significantly higher in OS tissues compared to adjacent tissues. In OS cell lines, BHLHE40 protein expression levels were increased compared to normal osteoblasts, and the cell line with the highest BHLHE40 expression was selected for subsequent knockdown experiments. Compared with the knockdown control group, the BHLHE40 knockdown group exhibited reduced cell viability, EdU-positive cell count, colony number, cell migration, and invasion abilities, along with downregulation of phosphorylated PI3K(p-PI3K)/PI3K and p-AKT/AKT protein expression. The aforementioned functions of BHLHE40 were also reproduced in in vivo experiments. Conclusion BHLHE40 is highly expressed in OS tissues, and its knockdown can significantly inhibit OS cell proliferation, migration, and invasion, while reducing PI3K/AKT signaling pathway activity. This suggests that BHLHE40 could serve as a novel therapeutic target for OS.
Osteosarcoma/metabolism* ; Humans ; Proto-Oncogene Proteins c-akt/genetics* ; Cell Proliferation/genetics* ; Cell Movement/genetics* ; Signal Transduction/genetics* ; Phosphatidylinositol 3-Kinases/genetics* ; Cell Line, Tumor ; Animals ; Neoplasm Invasiveness ; Basic Helix-Loop-Helix Transcription Factors/metabolism* ; Bone Neoplasms/metabolism* ; Mice ; Gene Knockdown Techniques ; Male ; Female ; Mice, Nude

Azvudine and nirmatrelvir/ritonavir (Paxlovid) are recommended for COVID-19 treatment in China, but their safety and efficacy in the elderly population are not fully known. In this multicenter, retrospective, cohort study, we identified 5131 elderly hospitalized COVID-19 patients from 32,864 COVID-19 patients admitted to nine hospitals in Henan Province, China, from December 5, 2022, to January 31, 2023. The primary outcome was all-cause death, and the secondary outcome was composite disease progression. Propensity score matching (PSM) was performed to control for confounding factors, including demographics, vaccination status, comorbidities, and laboratory tests. After 2:1 PSM, 1786 elderly patients receiving azvudine and 893 elderly patients receiving Paxlovid were included. Kaplan-Meier and Cox regression analyses revealed that compared with Paxlovid group, azvudine could significantly reduce the risk of all-cause death (log-rank P = 0.002; HR: 0.71, 95% CI: 0.573-0.883, P = 0.002), but there was no difference in composite disease progression (log-rank P = 0.52; HR: 1.05, 95% CI: 0.877-1.260, P = 0.588). Four sensitivity analyses verified the robustness of above results. Subgroup analysis suggested that a greater benefit of azvudine over Paxlovid was observed in elderly patients with primary malignant tumors (P for interaction = 0.005, HR: 0.32, 95% CI: 0.18-0.57) compared to patients without primary malignant tumors. Safety analysis revealed that azvudine treatment had a lower incidence of adverse events and higher lymphocyte levels than Paxlovid treatment. In conclusion, azvudine treatment is not inferior to Paxlovid treatment in terms of all-cause death, composite disease progression and adverse events in elderly hospitalized COVID-19 patients.

Objective To investigate the changes in the serum levels of visinin-like protein 1 （VILIP-1） and fibrinogen-like protein 2（FGL2） and their correlation with the degree of neurological deficits and prognosis in patients with acute cerebral hemorrhage. Methods A total of 121 patients with acute cerebral hemorrhage who received treatment in our hospital were enrolled as observation group， and 121 individuals who underwent physical examination during the same period of time were enrolled as control group. The serum levels of VILIP-1 and FGL2 were measured， and their correlation with the degree of neurological deficits was analyzed； a logistic regression analysis was used to investigate the influencing factors for poor prognosis in patients with acute cerebral hemorrhage；the value of the serum levels of VILIP-1 and FGL2 in predicting the prognosis of patients with acute cerebral hemorrhage was analyzed. Results The observation group had significantly higher serum levels of VILIP-1 and FGL2 than the control group（P<0.05），and the serum levels of VILIP-1 and FGL2 were positively correlated with the neurological function of patients（P<0.05）.Compared with the good prognosis group， the poor prognosis group had significantly higher proportion of patients with hyperglycemia， serum levels of VILIP-1 and FGL2， and NHISS score （P<0.05）. Serum VILIP-1 and FGL2 were independent risk factors for poor prognosis in patients with acute cerebral hemorrhage （P<0.05），and the combination of serum VILIP-1 and FGL2 had a higher predictive value than each indicator alone （P<0.05）. Conclusion There are increases in the serum levels of VILIP-1 and FGL2 in patients with acute cerebral hemorrhage， which are positively correlated with neurological function and are risk factors for poor prognosis in patients with acute cerebral hemorrhage， and the combination of the two indicators has a higher predictive value for the prognosis of patients with acute cerebral hemorrhage.
Prognosis

ObjectiveTo systematically evaluate the safety of Tianzhi granules used in the treatment of mild-to-moderate vascular dementia. MethodA randomized， double-blind， double-simulated， positive drug/placebo parallel controlled multi-center phase Ⅳ clinical trial and an open multi-center phase Ⅳ clinical trial of Tianzhi granules in the treatment of mild-to-moderate vascular dementia were conducted. Safety data of 1 492 patients were included and analyzed according to inclusion and exclusion criteria. The main evaluation measures were the incidence rate of adverse events/adverse reactions， laboratory indicators， vital signs， and electrocardiogram （ECG） results. ResultA total of six adverse events possibly related to the test drug occurred in 520 patients of the double-blind trial， and the symptoms were all mild and recovered. The incidence of adverse events was not statistically different among Tianzhi granules， donepezil， and placebo groups. Nine adverse events possibly related to the test drug were observed in 972 patients of the open trial， and the symptoms were mild and recovered. Laboratory tests （blood routine， urine routine， liver function， kidney function， and coagulation） and vital signs were compared before treatment （baseline） and after treatment of 12 and 24 weeks， respectively. There was no statistical significance in the main indicators before and after treatment. In the double-blinded trial， there was no significant difference in safety indicators between different groups before and after treatment. The most frequent adverse reaction was gastrointestinal discomfort， with an incidence rate of 6.64‰. ConclusionAdverse reactions occasionally occur in patients using Tianzhi granules， and it is safe to use Tianzhi granules to treat mild-to-moderate vascular dementia clinically.

OBJECTIVE To explore the effect of Shilinqing granules on calcium oxalate nephrolithiasis in rats and its potential mechanisms through the silence information regulator 1 （SIRT1）/nuclear factor-κB （NF-κB）/nucleotide-binding domain leucine-rich repeat and pyrin domain-containing receptor 3 （NLRP3） signaling pathway. METHODS Sixty male SD rats were randomly assigned to control group， model group， and low- ， medium- ， high-dose groups of Shilinqing granules （6.5， 13， 26 g/kg， calculated based on crude drug）， and high-dose of Shilinqing granules+inhibitor group （Shilinqing granules 26 g/kg+SIRT1 inhibitor nicotinamide 5 mg/kg）， with 10 rats in each group. Except for the control group， the remaining groups of rats were given 1% ethylene glycol solution to drink freely and were intubated with 2% ammonium chloride solution 2 mL （once a day， for 4 weeks） to construct a calcium oxalate nephrolithiasis model. At the same time of modeling， the administration groups were intubated or （and） intraperitoneally injected with the corresponding drug solutions， while the control and the model groups were intubated with physiological saline and intraperitoneally injected with dimethyl sulfoxide. The body weight， kidney index， urine/ blood biochemical indicators [24-hour urine volume， urine pH， urinary calcium ion （Ca2+） and urinary oxalic acid （Ox） content， as well as blood creatinine （Scr）， blood urea nitrogen （BUN）， blood Ca2+ content]， serum inflammatory indicators [levels of interleukin-1β （IL-1β）， IL-18]， pathological changes in renal tissue， calcium oxalate crystallization， and crystal scoring were observed. The protein expressions of SIRT1， NLRP3， and NF-κB in renal tissue were detected. RESULTS Compared with the control group， the model group had severe renal tissue damage and a large number of calcium oxalate crystals， with significant decrease or downregulation in body weight， 24-hour urine volume， urine pH， and protein expression of SIRT1 in renal tissue （P＜ 0.05）； crystal score， kidney index， urinary contents of Ca2+ and Ox， serum contents of Scr， BUN and Ca2+， and serum levels of IL- 1β and IL-18， as well as the protein expressions of NF-κB， NLRP3 in renal tissue were significantly increased or upregulated （P＜0.05）. The pathological changes in the rats of 2024ZY2045） each dose group of Shilinqing granules were improved， the calcium oxalate crystals were reduced， and all quantitative indicators were significantly improved as compared with the model group （P＜0.05）； while the SIRT1 inhibitor could significantly reverse the improving effects of high-dose of Shilinqing granules on the above indicators （P＜0.05）. CONCLUSIONS Shilinqing granules can inhibit the formation of calcium oxalate nephrolithiasis in rats， reduce the levels of inflammatory indicators and its mechanism may be related to upregulating protein expression of SIRT1， and downregulating protein expressions of NF-κB and NLRP3.