ObjectiveTo elucidate the chemical composition of Danshenyin and its blood components in rats after oral administration. MethodsUltra performance liquid chromatography-quadrupole-time-of-flight tandem mass spectrometry（UPLC-Q-TOF-MS/MS） coupled with PeakView 1.2 software was used to systematically characterize and identify the components of Danshenyin aqueous extract and its migratory components in rat blood after oral administration based on the retention time， quasi-molecular ion peaks， secondary fragmentation ions， and literature reports， and a preliminary compounds identification of Salviae Miltiorrhizae Radix et Rhizoma aqueous extract， the co-decoction of Santali Albi Lignum and Amomi Fructus was carried out to attribute the chemical constituents of the aqueous extract of Danshenyin. ResultsA total of 73 compounds， including 21 phenolic acids， 23 diterpenes， 6 flavonoids， 7 organic acids， 3 volatile oils and 13 others， were identified from the aqueous extract of Danshenyin. And 36 prototypes and 15 metabolites were identified in rat plasma， the major metabolic pathways included reduction， hydration， hydroxylation， demethylation， methylation， sulfation and others， these metabolites were mainly derived from tanshinones and salvianolic acids. ConclusionThe main blood components of the aqueous extract of Danshenyin are salvianolic acids and tanshinones， which may be the material basis of the efficacy. This study can provide reference for pharmacological research， quality control， and clinical application of Danshenyin.

Objective:To evaluate the clinical value of holographic imaging-based digital localization technology in robot-assisted partial nephrectomy（RAPN）for the treatment of completely endophytic renal tumors.Methods:A retrospective analysis was conducted on the clinical data of 23 patients with completely endophytic renal tumors who underwent RAPN at the First Affiliated Hospital of Xiamen University between December 2022 and December 2024. Patients were divided into two groups based on the use of holographic imaging：the holographic imaging group（16 cases）and the conventional group（7 cases）. There was no statistically significant difference between the holographic imaging group and the conventional group in terms of age［（41.9 ± 13.4）years vs.（46.9 ± 13.4）years］，body mass index［（25.6 ± 4.8）kg/m2 vs.（24.7 ± 3.1）kg/m2］，maximum tumor diameter［（3.1 ± 0.9）cm vs.（3.0 ± 9.0）cm］，tumor volume［（13.2 ± 9.0）cm3 vs.（34.9 ± 9.9）cm3］，R.E.N.A.L. score［（9.4 ± 1.2）points vs.（9.9 ± 0.7）points］，PADUA score［（10.4 ± 0.7）points vs.（9.4 ± 0.7）points］，proportion of T 1a stage patients［12 cases（75.0%）vs. 6 cases（85.7%）］and preoperative serum creatinine［（67.4 ± 9.5）μmol/L vs.（78.0 ± 16.0）μmol/L］. In the holographic group，holographic models were reconstructed based on preoperative enhanced CT or MRI images and used for preoperative planning and intraoperative localization. In the conventional group，surgeons relied on preoperative CT or MRI images for cognitive fusion during RAPN. Perioperative parameters such as warm ischemia time，operative time，tumor localization time，positive surgical margin rate，and renal function were compared between the two groups. Results:The operative time in the holographic group was significantly shorter than that in the conventional group［（152.8 ± 12.9）min vs.（218.4 ± 105.5）min， P = 0.001］. Warm ischemia time［（26.9 ± 3.4）min vs.（30.7 ± 3.8）min， P < 0.001］，localization time［（4.2 ± 0.9）min vs.（8.9 ± 1.7）min， P < 0.001］，and estimated blood loss［（47.0 ± 17.7）ml vs.（128.6 ± 87.8）ml， P < 0.001］were also significantly lower in the holographic group. In the conventional group，one patient underwent radical nephrectomy，while no patient in the holographic imaging group required conversion to radical nephrectomy. No cases of positive surgical margins were identified in either group. Serum creatinine levels measured one month after surgery showed no statistically significant differences between the two groups［（79.5 ± 15.7）μmol /L vs.（104.9 ± 22.5）μmol /L］. Conclusions:The application of holographic imaging-based digital localization technology in RAPN for completely endophytic renal tumors significantly reduces operative time，localization time，warm ischemia time，and intraoperative blood loss. This technology improves surgical efficiency and success rates，offering distinct clinical advantages.

Objective:To evaluate the clinical value of holographic imaging-based digital localization technology in robot-assisted partial nephrectomy（RAPN）for the treatment of completely endophytic renal tumors.Methods:A retrospective analysis was conducted on the clinical data of 23 patients with completely endophytic renal tumors who underwent RAPN at the First Affiliated Hospital of Xiamen University between December 2022 and December 2024. Patients were divided into two groups based on the use of holographic imaging：the holographic imaging group（16 cases）and the conventional group（7 cases）. There was no statistically significant difference between the holographic imaging group and the conventional group in terms of age［（41.9 ± 13.4）years vs.（46.9 ± 13.4）years］，body mass index［（25.6 ± 4.8）kg/m2 vs.（24.7 ± 3.1）kg/m2］，maximum tumor diameter［（3.1 ± 0.9）cm vs.（3.0 ± 9.0）cm］，tumor volume［（13.2 ± 9.0）cm3 vs.（34.9 ± 9.9）cm3］，R.E.N.A.L. score［（9.4 ± 1.2）points vs.（9.9 ± 0.7）points］，PADUA score［（10.4 ± 0.7）points vs.（9.4 ± 0.7）points］，proportion of T 1a stage patients［12 cases（75.0%）vs. 6 cases（85.7%）］and preoperative serum creatinine［（67.4 ± 9.5）μmol/L vs.（78.0 ± 16.0）μmol/L］. In the holographic group，holographic models were reconstructed based on preoperative enhanced CT or MRI images and used for preoperative planning and intraoperative localization. In the conventional group，surgeons relied on preoperative CT or MRI images for cognitive fusion during RAPN. Perioperative parameters such as warm ischemia time，operative time，tumor localization time，positive surgical margin rate，and renal function were compared between the two groups. Results:The operative time in the holographic group was significantly shorter than that in the conventional group［（152.8 ± 12.9）min vs.（218.4 ± 105.5）min， P = 0.001］. Warm ischemia time［（26.9 ± 3.4）min vs.（30.7 ± 3.8）min， P < 0.001］，localization time［（4.2 ± 0.9）min vs.（8.9 ± 1.7）min， P < 0.001］，and estimated blood loss［（47.0 ± 17.7）ml vs.（128.6 ± 87.8）ml， P < 0.001］were also significantly lower in the holographic group. In the conventional group，one patient underwent radical nephrectomy，while no patient in the holographic imaging group required conversion to radical nephrectomy. No cases of positive surgical margins were identified in either group. Serum creatinine levels measured one month after surgery showed no statistically significant differences between the two groups［（79.5 ± 15.7）μmol /L vs.（104.9 ± 22.5）μmol /L］. Conclusions:The application of holographic imaging-based digital localization technology in RAPN for completely endophytic renal tumors significantly reduces operative time，localization time，warm ischemia time，and intraoperative blood loss. This technology improves surgical efficiency and success rates，offering distinct clinical advantages.

Background::Atopic dermatitis (AD) affects approximately 10% of adults worldwide. CM310 is a humanized monoclonal antibody targeting interleukin-4 receptor alpha that blocks interleukin-4 and interleukin-13 signaling. This trial aimed to evaluate the efficacy and safety of CM310 in Chinese adults with moderate-to-severe AD.Methods::This multicenter, randomized, double-blind, placebo-controlled, phase 2b trial was conducted in 21 medical institutions in China from February to November 2021. Totally 120 eligible patients were enrolled and randomized (1:1:1) to receive subcutaneous injections of 300 mg CM310, 150 mg CM310, or placebo every 2 weeks for 16 weeks, followed by an 8-week follow-up period. The primary endpoint was the proportion of patients achieving ≥75% improvement in the Eczema Area and Severity Index (EASI-75) score from baseline at week 16. Safety and pharmacodynamics were also studied.Results::At week 16, the proportion of EASI-75 responders from baseline was significantly higher in the CM310 groups (70% [28/40] for high-dose and 65% [26/40] for low-dose) than that in the placebo group (20%[8/40]). The differences in EASI-75 response rate were 50% (high vs. placebo, 95% CI 31%–69%) and 45% (low vs. placebo, 95% CI 26%–64%), with both P values <0.0001. CM310 at both doses also significantly improved the EASI score, Investigator’s Global Assessment score, daily peak pruritus Numerical Rating Scale, AD-affected body surface area, and Dermatology Life Quality Index compared with placebo. CM310 treatment reduced levels of thymus and activation-regulated chemokine, total immunoglobulin E, lactate dehydrogenase, and blood eosinophils. The incidence of treatment-emergent adverse events (TEAEs) was similar among all three groups, with the most common TEAEs reported being upper respiratory tract infection, atopic dermatitis, hyperlipidemia, and hyperuricemia. No severe adverse events were deemed to be attributed to CM310. Conclusion::CM310 at 150 mg and 300 mg every 2 weeks demonstrated significant efficacy and was well-tolerated in adults with moderate-to-severe AD.Trial Registration::ClinicalTrials.gov, NCT04805411.

Objective:To analyze the occurrence and clinical features of liver injury induced by dandelion, a food-medicine homologous traditional Chinese medicine.Methods:The patients with liver injury caused by taking dandelion, who were admitted to the Department of Infectious Diseases, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School from January 1, 2017 to December 31, 2023, were enrolled in this study. The electronic medical records of the patients were retrieved, and the patients′ general information, using of dandelion, combined medication, clinical manifestations, and liver biochemical test results were recorded. The causal relationship between dandelion and the liver injury were evaluated, and the clinical manifestations, classification, severity, treatment and prognosis of liver injury were analyzed.Results:A total of 13 patients were enrolled in the study, including 8 females and 5 males. The age ranged from 29 to 78 years. Nine patients took dandelion by themselves, and 4 according to the doctor′s advice. The administration methods included dandelion root tea drink, whole herb tea drink, and powder drink mixed in water. Most patients′ liver injury occurred within 90 days after taking dandelion. The main clinical manifestations were yellowish staining of skin and sclera, dark urine, abdominal distension, abdominal pain, loss of appetite, etc. The laboratory tests showed that serum aminotransferase and bilirubin increased in 13 patients, alkaline phosphatase increased in 12 patients, and plasma ammonia increased in 5 patients. The causality evaluation results showed "probable related" in 8 cases and "highly probable related" in 5 cases. The clinical classification showed that 11 patients were of hepatocellular type and 2 of mixed type. The severity was mainly grade 2 (8 of 13 patients). Two patients with grade 3 and 2 patients with grade 4 developed liver failure. After symptomatic treatments, 11 patients′ liver function returned to normal or were improved; 2 patients′ condition progressed, of which 1 patient survived after liver transplantation and 1 patient died.Conclusions:Dandelion can cause liver injury, mostly occurring within 90 days after administration, with moderate severity. After stopping dandelion and giving symptomatic treatments, most patients have a good prognosis, but there is a risk of liver failure and death.

Objective:To analyze the occurrence and clinical features of liver injury induced by dandelion, a food-medicine homologous traditional Chinese medicine.Methods:The patients with liver injury caused by taking dandelion, who were admitted to the Department of Infectious Diseases, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School from January 1, 2017 to December 31, 2023, were enrolled in this study. The electronic medical records of the patients were retrieved, and the patients′ general information, using of dandelion, combined medication, clinical manifestations, and liver biochemical test results were recorded. The causal relationship between dandelion and the liver injury were evaluated, and the clinical manifestations, classification, severity, treatment and prognosis of liver injury were analyzed.Results:A total of 13 patients were enrolled in the study, including 8 females and 5 males. The age ranged from 29 to 78 years. Nine patients took dandelion by themselves, and 4 according to the doctor′s advice. The administration methods included dandelion root tea drink, whole herb tea drink, and powder drink mixed in water. Most patients′ liver injury occurred within 90 days after taking dandelion. The main clinical manifestations were yellowish staining of skin and sclera, dark urine, abdominal distension, abdominal pain, loss of appetite, etc. The laboratory tests showed that serum aminotransferase and bilirubin increased in 13 patients, alkaline phosphatase increased in 12 patients, and plasma ammonia increased in 5 patients. The causality evaluation results showed "probable related" in 8 cases and "highly probable related" in 5 cases. The clinical classification showed that 11 patients were of hepatocellular type and 2 of mixed type. The severity was mainly grade 2 (8 of 13 patients). Two patients with grade 3 and 2 patients with grade 4 developed liver failure. After symptomatic treatments, 11 patients′ liver function returned to normal or were improved; 2 patients′ condition progressed, of which 1 patient survived after liver transplantation and 1 patient died.Conclusions:Dandelion can cause liver injury, mostly occurring within 90 days after administration, with moderate severity. After stopping dandelion and giving symptomatic treatments, most patients have a good prognosis, but there is a risk of liver failure and death.

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

Objective To compare the effects of different statistical protocols on the results of external quality assessment(EQA)of se-men,and select appropriate statistical protocols for the promotion of EQA of semen.Methods Taking sperm concentration as an ex-ample,the semen EQA data of 20 laboratories in Hunan Province in 2022 were selected,and the advantages and disadvantages of the traditional statistical scheme(TSS),robust statistical scheme(RSS)and traditional statistical scheme after eliminating the"outliers"(TSEOS)combined with robust statistical technology were analyzed and compared.Results The"outliers"could not be excluded from the sperm concentration data of the four groups in the TSS,which led to the difference between TSS and RSS or TSEOS.The num-ber of qualified laboratories for TSS and RSS were 19 vs 16,19 vs 16,19 vs 19,and 19 vs 19,respectively.Conclusion The results of RSS are similar to those of TSEOS.Compared with TSS,RSS do not need to remove outlier data steps,and are more suitable for se-men EQA data analysis with small data volume.

Objective:To establish surgical difficulty scoring system of partial nephrectomy based on holographic imaging and explore its application value in partial nephrectomy.Methods:A total of 184 patients including 110 males and 74 females with renal tumors diagnosed as stage cT 1 to cT 2 before surgery in the First Affiliated Hospital of Xiamen University from October 2019 to January 2022 were included. Among the 184 patients, 141 patients were treated with partial nephrectomy and 43 patients were treated with radical nephrectomy (3 partial nephrectomies were finally changed to radical nephrectomies due to vascular and tumor location). 60 patients had hypertension. 24 patients had diabetes. 7 patients had hyperuricemia. The median age was 55(47, 62) years. The median BMI was 23.7(21.8, 26.4) kg/m 2. The median maximum tumor diameter was 3.9(2.9, 5.2) cm. The median preoperative eGFR was 99.7(83.4, 114.2) ml/(min·1.73m 2). The median R. E.N.A.L. score was 8(6, 9). The median PADUA score was 9(8, 10). 153 patients were diagnosed as stage cT 1 and 31 patients were diagnosed as stage cT 2. The hologram reconstruction was performed according to preoperative CT or MRI examination. The maximum diameter of the tumor in the kidney (D), the compression degree of the renal segmental vessels by tumor(C), the area of the renal sinus occupied by tumor(O) and the mass of exophytic rate(M) were comprehensively considered and finally constituted the difficulty scoring system named DCOM score for partial nephrectomy. The DCOM score divided the complexity of tumor surgery into mild (4-6 points), moderate (7-8 points) and high (≥ 9 points). Meanwhile, the MIC (surgical margins are negative, WIT is <20 min, and no major complications)was used to evaluate the overall surgical effect. The DCOM, R. E.N.A.L. and PADUA scores were performed on all patients and compared with each other to evaluate the surgical effect of DCOM score in partial nephrectomy. Results:All surgeries in this study were successfully completed, including 141 partial nephrectomies and 43 radical nephrectomies. The DCOM score was 10(9, 11) for radical nephrectomy and 6(5, 8) for partial nephrectomy, and the difference was statistically significant ( P=0.001). There were 23 patients (37.7%) in highly complex group, 39 patients (88.6%) in moderately complex group and 79 patients (100.0%) in mildly complex group underwent partial nephrectomy, respectively. According to multifactorial analysis, patients in highly and moderately complex group of DCOM score had 8.88 times ( P=0.001) and 1.76 times ( P=0.005) less reach MIC than those in mildly complex group, respectively. Patients in highly and moderately complex group of PADUA score had 4.86 times ( P=0.005)and 3.41 times ( P=0.006)less reach MIC than patients in mildly complex group of DCOM score, respectively. What’s more, patients in moderately complex group of R. E.N.A.L. score had 3.11 times ( P=0.003) less reach MIC than patients in mildly complex group of DCOM score. In the ROC curves to predict MIC achievement, the AUC values of R. E.N.A.L., PADUA and DCOM scores were 0.657, 0.655 and 0.746, respectively. Comparing:R. E.N.A.L. score with DCOM score, the AUC value was statistically significant ( P=0.025). Conclusions The surgical difficulty scoring system (DCOM score) based on holographic imaging can predict the outcome of partial nephrectomy, but further verification is needed.

Objective To evaluate the clinical value of holographic image navigation in urological laparoscopic and robotic surgery.Methods The data of patients were reviewed retrospectively for whom accepted holographic image navigation laparoscopic and robotic surgery from Jan.2019 to Dec.2019 in Beijing United Family Hospital and other 18 medical centers,including 78 cases of renal tumor,2 cases of bladder cancer,2 cases of adrenal gland tumor,1 cases of renal cyst,1 case of prostate cancer,1 case of sweat gland carcinoma with lymph node metastasis,1 case of pelvic metastasis after radical cystectomy.All the patients underwent operations.In the laparoscopic surgery group,there were 27 cases of partial nephrectomy,1 case of radical prostatectomy,2 cases of radical cystectomy and 2 cases of adrenalectomy.In the da Vinci robotic surgery group of 54 cases,there were 51 cases of partial nephrectomy,1 case of retroperitoneal lymph node dissection,1 case of retroperitoneal bilateral renal cyst deroofing and 1 case of resection of pelvic metastasis.There were 41 partial nephrectomy patients with available clinical data for statistic,with a median age of 53.5 years (range 24-76),including 26 males and 15 females.The median R.E.N.A.L score was 7.8 (range 4-11).Before the operation,the engineers established the holographic image based on the contrast CT images and reports.The surgeon applied the holographic image for preoperative planning.During the operation,the navigation was achieved by real time fusing holographic images with the laparoscopic surgery images in the screen.Results All the procedures had been complete uneventfully.The holographic images helped surgeon in understanding the visual three-dimension structure and relation of vessels supplying tumor or resection tissue,lymph nodes and nerves.By manipulating the holographic images extracorporeally,the fused image guide surgeons about location vessel,lymph node and other important structure and then facilitate the delicate dissection.For the 41 cases with available clinical data including 23 cases of robotic-assisted partial nephrectomy and 18 cases of laparoscopic nephrectomy,the median operation time was 140 (range 50-225) min,the median warm ischemia time was 23 (range 14-60) min,the median blood loss was 80(range 5-1 200) ml.In the robotic surgery group,the median operation time was 140 (range 50-215)min,the median warm i schemia time was 21 (range 17-40)min,the median blood loss was 150(range 30-1 200)ml.In the laparoscopic surgery group,the median operation time was 160(range 80-225)min,the median warm ischemia time was 25 (range 14-60)min,the median blood loss was 50 (range 5-1 200) ml.All the patients had no adjacent organ injury during operation.There were 2 cases with Clavien Ⅱ complications.One required transfusion and the other one suffered hematoma post-operation.However,the tumors were located in the renal hilus for these 2 cases and the R.E.N.A.L scores were both 11.Conclusions Holographic image navigation can help location and recognize important anatomic structures during the surgical procedures..This technique will reduce the tissue injury,decrease the complications and improve the success rate of surgery.