BACKGROUND: LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer. METHODS: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels. RESULTS: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]). CONCLUSION: LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile. TRIAL REGISTRATION ClinicalTrials.gov, NCT04563936.
Humans ; Male ; Antineoplastic Agents, Hormonal/therapeutic use* ; East Asian People ; Gonadotropin-Releasing Hormone/agonists* ; Goserelin/therapeutic use* ; Prostate-Specific Antigen ; Prostatic Neoplasms/drug therapy* ; Testosterone

Abstract OBJECTIVE To analyze the inflammation-related molecular targets of Pien Tze Huang in the treatment of hepatocellular carcinoma and to preliminary explore its mechanism. METHODS Obtain the ingredients and targets of Pien Tze Huang through TCMSP and BATMAN databases. Obtain the disease targets of hepatocellular carcinoma through Genecards, OMIM and TCGA databases. Take the intersection of compound targets and disease targets to get Pien Tze Huang’s target for the treatment of hepatocellular carcinoma. Obtain the related genes of inflammation pathway from the GSEA database, and then analyze the correlation between Pien Tze Huang’s therapeutic targets for hepatocellular carcinoma and inflammation-related genes to screen out inflammation-related targets, and explore the mechanism through GO and KEGG enrichment analysis. Then, single-factor cox analysis and LASSO regression were performed to construct related prognostic models. The 10 core targets were screened out through the protein-protein interaction(PPI) network. The model gene and the core target were intersected. The core compounds were screened out through the drug-compound-target network. Perform molecular docking verification between the core compound and the target. Construct a nomogram to assess the prognosis of patients. RESULTS Obtained 162 Pien Tze Huang targets, 522 hepatocellular carcinoma targets, 20 Pien Tze Huang therapeutic targets for hepatocellular carcinoma, and 16 inflammation-related targets. The enrichment analysis of GO and KEGG showed that their effects were mainly through biological functions such as monooxygenase activity, oxidoreductase activity, and chemical carcinogenesis-receptor activation. The ROC curve of the prognosis model calculated AUC as 0.780 in 1 year, 0.688 in 3 years, and 0.642 in 5 years, indicating that the model was reliable. The prognostic model intersects with the core target of PPI to get 5 targets: PON1, IGF2, NQO1, CCNB1 and IGFBP3. The nomogram was constructed using CCNB1, NQO1, and T staging, and its c-index was 0.726, indicating the reliability of the model. The drug-compound-target network suggested that quercetin was the core compound and targets the above two genes. CONCLUSION Pien Tze Huang’s treatment of hepatocellular carcinoma mainly uses quercetin to target CCNB1 and NQO1 to exert anti-inflammatory effects, and its prognostic model can be used to predict the survival of patients.

OBJECTIVE：To analysis the correlation between chrom aticity value and quality index of Atractylodis chinensis decoction piece powder stir-fired with bran ，and to determine its processing time. METHODS ：The processed samples of 16 batches of A. chinensis decoction piece stir-fired with bran （S0-S15，S0 is the raw product of A. chinensis ）were prepared ，and chromaticity values of all samples were determined ，such as lightness value （L*），yellow blue value （b*），red green value （a*）. UPLC fingerprint of sample were analyzed ，and the contents of extract and volatile oil were also determined. Pearson correlation was used to analyze the correlation between the chromaticity value and quality index （relative peak area of each chromatographic peak in UPLC fingerprint ，water-soluble extract content ，alcohol-soluble extract content and volatile oil content ）. Multivariate statistical analysis （principal component analysis ，cluster analysis ，partial least squares discriminant analysis ）was carried out with chromaticity value and quality index ，and the processing time of A. chinensis decoction piece stir-fired with bran was determined by grey correlation method. RESULTS ：In the process of bran frying ，with the extension of processing time ，L* and b* of decoction pieces powder decreased ，and a* increased first and then decreased ；relative areas of peak 1 and peak 2 increased first and then decreased，while relative areas of peak 3（5-hydroxymethyl furfural ）increased，and the areas of the other peaks decreased. The content of the extract did not change significantly with time ，and the content of the volatile oil decreased. The results of correlation analysis showed that the relative peak area of peak 2-27，alcohol-soluble extract content and volatile oil content had a certain correlation with the chromaticity value ，while the relative peak area of peak 1 and water-soluble extract content had no linear correlation with the chromaticity value. Results of multivariate statistical analysis showed that the samples were divided into mild （S0-S5），excessive （S12-S15），moderate （S6-processing time of 18-33 min）. The results of grey correlation method showed that the processing time of A. chinensis decoction piece stir-fired w ith bran should be controlled in the range of 18-24 min，and the optimal processing time was 18 min. CONCLUSIONS ：There is a correlation between chromaticity value of A. chinensis decoction piece powder stir-fired with bran and the relative peak area of 27 chromatographic peaks ，and content of extract and volatile oil. It is suggested that the processing time should be 18 min.

Ureteral artery fistula (UAF) is a rare complication after long-term indwelling of ureteral stent. In this study, two cases were presented. Both of them underwent pelvic tumor surgery and radiotherapy, and had a history of cutaneous terminal ureterostomy and long-term indwelling of ureteral stents. The first case, a 52-year-old female, was admitted to hospital because of intermittent bleeding from ureteral dermostomy for 1 week on April 2, 2020. CT examination revealed hematocele in the left upper urinary tract, and left nephrectomy was performed.However, bleeding still presented and the distal ureteral resection was performed at the same time, and partial ureteral was ligated. Postoperative diagnostic was ureteral artery fistula. After 8 months of follow-up, no recurrent bleeding presented. Another case, a 82-year-old male, was admitted to hospital because of bleeding at the ureteral dermostomy for an hour on June 15, 2020. Contrast enhanced CT examination revealed intersecting of the left ureter and common iliac artery, and interventional surgery was performed, by which UAF was diagnosed. Embolization of left internal iliac artery and stent implantation of common iliac artery and external iliac artery were performed intraoperatively. The bleeding stopped immediately after the operation, and there was no further bleeding during follow-up of 6 months.

Objective:To investigate the clinical impact factors of liver regeneration after hemihepatectomy in patients with hepatocellular carcinoma (HCC).Methods:Patients who underwent hemihepatectomy due to HCC from Sep 2013 to Sep 2018 were included in the study. Liver volumes were calculated by perioperative simulations to analyze the influencing factors of postoperative liver regeneration, and to compare the albumin bilirubin (ABLI) score and the end-stage liver disease (MELD) score at weeks 1, 5, 9, and 13 after operation.Results:A total of 163 patients were included, of which 13 developed postoperative liver failure. The median liver regeneration rates at 1, 5, 9 and 13 weeks after operation were 22.0%, 32.2%, 33.7% and 35.4%, respectively. Multivariate analysis showed that remnant liver volume (RLV) <611.1 cm 3, %RLV and liver cirrhosis were the influencing factors of liver regeneration. ALBI score and MELD score were lower in the low regeneration group compared to the high regeneration group in the first 5 weeks after operation. Conclusion:RLV and cirrhosis are influential factors in postoperative liver regeneration. Liver regeneration proceeded rapidly within 1 week and slowed down until week 5.

BACKGROUND: Benvitimod cream, a novel synthetic small molecule, was effective in treating mild-to-moderate plaque psoriasis. We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in patients with mild-to-moderate plaque psoriasis. METHODS: We randomly assigned 686 patients (2:1:1) to receive 1% benvitimod cream, 0.005% calcipotriol ointment or placebo twice a day for 12 weeks. The primary efficacy end points were the percentage of patients with a 75% or greater reduction from baseline in the psoriasis area and severity index (PASI 75) score and with a score of 0 or 1 in static physician's global assessment (sPGA) at week 12. RESULTS: The results showed that 50.4% of patients in the benvitimod group achieved PASI 75, which was significantly higher than that in the calcipotriol (38.5%, P < 0.05) and placebo (13.9%, P < 0.05) groups. The proportion of patients achieving an sPGA score 0 or 1 was 66.3% in the benvitimod group and 63.9% in the calcipotriol group, which were both significantly higher than that in the placebo group (34%, P < 0.05). In the long-term follow-up study, 50.8% of patients experienced recurrence. After retreatment with 1% benvitimod, 73.3% of patients achieved an sPGA score of 0 or 1 again at week 52. Adverse events included application site irritation, follicular papules, and contact dermatitis. No systemic adverse reactions were reported. CONCLUSION: During this 12-week study, benvitimod cream was demonstrated with high effectiveness and safety in patients with mild-to-moderate plaque psoriasis. TRIAL REGISTRATION Chinese Clinical Trial Registry (ChiCTR), ChiCTR-TRC-13003259; http://www.chictr.org.cn/showprojen.aspx?proj=6300.
Double-Blind Method ; Follow-Up Studies ; Humans ; Ointments ; Psoriasis/drug therapy* ; Resorcinols ; Severity of Illness Index ; Stilbenes ; Treatment Outcome

Objective: To understand the epidemiological characteristics of product-related injuries among children in Changshan County from 2011 to 2017 and to provide evidence for targeted intervention. Methods: The surveillance data of product-related injuries among children aged below 18 years from 2011 to 2017 was collected from three sentinel hospitals in Changshan County. The characteristics of product-related injuries among children were analyzed,especially those injuries caused by furniture,stationery and sporting goods,commodities and toys. Results: A total of 5 111 product-related injury cases among children were reported,accounting for 13.49% of product-related injury cases of all age. There were 3 138 boys and 1 973 girls,accounting for 61.40% and 38.60%. There were 2 973 cases less than 10 years old,accounting for 58.17%. The main causes of product-related injuries were road traffic injury（49.46%）,blunt（16.02%）,stab/cut（12.39%）and fall（10.37%）. The main categories of products included transportation equipments（not including motor vehicles,36.83%）,motor vehicles（17.82%）,furniture（12.23%）,stationery and sporting goods（8.45%）,commodities（4.89%）and toys（3.25%）. Stab/cut（53.01%）was the main cause of commodities related injuries;blunt was the main cause of furniture,stationery and sporting goods and toys. The stationery and sporting goods related injuries occurred mainly in schools/public places（64.57%）and sports venues（18.48%）when engaging in sports（54.13%）;furniture,commodities and toys related injuries injured cases occurred at home when engaging in leisure activities. Commodities mainly resulted in sharp/bite/open wound（51.50%）;furniture,stationery and sporting goods and toys mainly resulted in bruises. Most cases were injured in head,slight and allowed home after treated. Conclusion The product-related injuries among children in Changshan County are more boys. The products mainly involve transportation equipments（not including motor vehicles）,motor vehicles,furniture,stationery and sporting goods,commodities and toys,with emphasis on the latter four categories in the prevention of product-related child injury.

Objective: To explore the correlation between standard remnant liver volume(SRLV) and post-hepatectomy liver failure (PHLF)in patients with hepatocellular carcinoma(HCC)and cirrhotic livers.Methods:In total,181 patients who underwent hemihepa-tectomy in Affiliated Tumor Hospital of Guangxi Medical University from September 2013 to August 2016 were enrolled in the study. Total liver,tumor,remnant liver,and resected liver volumes were measured using the Myrian liver surgical planning system before sur-gery. Intraoperative resected liver volume (including resected normal liver and tumor volumes) were collected using the drainage method.The patients were divided into the PHLF(22 cases)and non-PHLF groups(159 cases)according to whether PHLF occurred based on the"50/50"criteria.The risk factors of PHLF were then explored.The cut-off of SRLV and efficiency of predicting PHLF were analyzed in the subgroup of patients with cirrhotic livers.The grade of liver cirrhosis was retrospectively analyzed using helical comput-ed tomography(CT).Results:Twenty-two of the 181 patients developed PHLF and one died of it.Preoperative total bilirubin levels and SRLV were identified as independent factors for predicting PHLF using a Logistic regression model.In total,102 patients with cirrhotic livers were selected in subgroup analysis based on postoperative cirrhotic pathology.Eighteen patients developed PHLF and one died of PHLF in the subgroup.Using receiver-operating characteristic(ROC)curve analysis,340 mL/m2was the cut-off of SRLV for patients with HCC and cirrhotic livers(area under the curve:0.861,P<0.01;sensitivity and specialty rates were 94.4% and 74.7%,respectively). Eighty-four cases were of grade Ⅰ or Ⅱ cirrhosis,18 cases were of grade Ⅲ cirrhosis,and there were no cases of grade Ⅳ cirrhosis based on retrospective analysis using helical CT.Conclusions:Patients with cirrhotic livers with an anticipated SRLV of≤340 Ml/m2after he-patic resection are at increased risk for PHLF after emihepatectomy.

Objective: To explore the evaluation of joint injury by HEAD-US-C (Hemophilic Early Arthropathy Detection with UltraSound in China, HEAD-US-C) in patients with moderate or severe hemophilia A treated with prophylaxis vs on-demand. Methods: The patients from June 2015 to July 2017 with moderate or severe hemophilia A were examined by ultrasound imaging of the elbows, knees and ankles; Meanwhile the HEAD-US-C ultrasound assessment scale and hemophilia joint health score scale 2.1 (HJHS2.1) were used to score the joint status. The correlation between the HEAD-US-C and HJHS score was performed in prophylaxis group and on-demand group patients, respectively. Results: A total of 925 cases of joint ultrasonography were conducted in 70 patients with moderate or severe hemophilia A. Among patients with moderate hemophilia, the median (IQR) of HEAD-US-C score and HJHS score in on-demand group were significantly higher than those in the prophylaxis group[1 (0, 6) vs 0.5 (0, 3) , z=0.177, P=0.046],[2 (0, 4) vs 2 (0, 3) z=0.375, P=0.007], even though there was no significant difference of the median (IQR) number of annualized target joints bleeding episodes between on-demand and prophylaxis groups[1 (0, 7) vs 1 (0, 5) , z=1.271, P=0.137]. Unlike in moderate cases, on-demand treatment group had more annualized target joints bleeding episodes than prophylaxis group among patients with severe hemophilia[3 (0, 8) vs 2 (0, 8) , z=0.780 P=0.037]. The prophylaxis group compared favorably with on-demand therapy group in terms of HEAD-US-C score[1 (0, 6) vs 4 (0, 7) , z=2.189, P=0.008], and HJHS score[2 (0, 5) , 4 (1, 6) , z=3646, P<0.001]for the severe hemophilia patients. The positive correlation between HEAD-US-C score and HJHS score was identified (P<0.05) , whether on-demand treatment or prophylaxis groups. The correlation coefficient between HEAD-US-C score and HJHS score in on-demand treatment and prophylaxis groups were 0.739 (95% CI 0.708-0.708) , 0.865 (95% CI 0.848-0.848) respectively, and 95% CI didn’t overlap (P<0.05) , indicating that the correlation coefficient in prophylaxis group had stronger correlation than that in on-demand group. Conclusions Clinical effects of prophylaxis were significantly better than those of on-demand treatment in patients with moderate or se-vere haemophilia A. HEAD-US-C scoring system could effectively evaluate joints damage in hemophilia A patients treated with on-demand or prophylaxis, companied by significantly positive correlation with HJHS clinical evaluation system, and provided objective index for clinical effect assessment.

Objective To observe the therapeutic effect of Guizhi Decoction plus Yupingfeng Powder for chronic urticaria and its effect on serum total IgE level.Methods One hundred and twenty patients were randomly divided into treatment group,control group 1 and control group 2,40 cases in each group.The treatment group was treated with Guizhi Decoction,Yupingfeng Powder and Loratadine Tablets orally,the control group 1 was given intramuscular injection of Bacillus Calmette-Guerin polysaccharide nucleic acid and oral use of Loratadine Tablets,and the control group 2 was only given oral use of Loratadine Tablets.The course of treatment covered 5 weeks.The levels of serum total IgE in the three groups were determined before and after treatment,and the therapeutic effect was evaluated after treatment.Results (1) The total effective rate was 85.0％ in the treatment group,80.0％ in the control group 1,and 55.0％ in the control group 2.The effect of control group 1 and the treatment group was superior to that of the control group 2 (P＜ 0.05),but the difference was insignificant between the treatment group and control group 1 (P＞ 0.05).(2)Before treatment,the serum total IgE level of the three groups was higher than that of the normal control group (P ＜ 0.05).After treatment,the serum total IgE level of the three groups was obviously decreased (P ＜ 0.05 compared with that before treatment);the inter-group comparison results showed that the effect of the treatment group and control group 1 on decreasing the serum total IgE level was superior to that of the control group 2(P ＜ 0.05),while the effect of the treatment group was similar to that of the control group 1 (P ＞0.05).(3) During the treatment,blood routine examination indexes and hepato-renal function of the three groups showed no abnormal changes,neither adverse reaction was shown.Conclusion Guizhi Decoction plus Yupingfeng Powder exerts certain therapeutic effect for the treatment of chronic urticaria,and can decrease the serum total IgE level,thus to stabilize the curative effect and reduce the recurrence.