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

End-stage renal disease(ESRD) patients with malignant renal tumor has its unique clinicopathological characteristics, and there are currently few domestic related studies. A retrospective analysis was performed on the clinical data of 16 ESRD patients with malignant renal tumor in Jiangxi Provincial People's Hospital. Their ages ranged from 20 to 70 yrs (mean 47.6 yrs). Most of the patients were asymptomatic and all underwent radical nephrectomy or radical nephroureterectomy. Clear cell carcinoma occurred in 11 cases, and papillary renal cell carcinoma in 2 cases. The vast majority of 13 cases were low-stage, low-grade tumors. All 13 cases were followed up for an average of 43.7 months and no recurrence or metastasis was found. In addition, the patients of renal sarcomatoid carcinoma, renal pelvis carcinoma and renal sarcoma survived for 2 to 20 months with poor prognosis.

Objective: To evaluate the effect of traditional Chinese medicine (TCM) on anthracycline-induced car-diotoxicity (AIC) in animal models. Methods: Separate systematic searches for preclinical studies were performed in the PubMed, EMBASE, Web of Science, Chinese National Knowledge Infrastructure, Chinese Biomedical Database, Chinese Sci-entific Journal Database, and Wanfang Data from inception to August 2019. The primary outcomes were echocardiography, serum assays for myocardial enzymograms, histological assessments, and electro-cardiograms. The secondary outcomes mainly included body weight and safety evaluations. The protocol is registered on PROSPERO (CRD42019145819). RevMan (V.5.3) was used for meta-analysis. Results: We identified 10 studies from 9 international scientific publications describing the efficacy of TCM on AIC animal models. All the included studies reported that, compared with animal model without any intervention, TCM significantly improved ventricular function, cardiac biomarkers, electrocardio-graph results, and cardiac fibrosis. Improved survival rates and body mass indices were also observed with TCM. We further pooled the available data from four studies (63 animals) for the meta-analysis and the results showed that, compared with models without any intervention, TCM significantly increased the ejection fraction by 14.13％ (95％ CI, 9.96-18.29) and fraction shortening by 8.66％ (95％ CI, 6.05-11.26). Creatine kinase-MB (SMD = -2.49, 95％ CI: -3.12 to -1.85) and lactate dehydrogenase (SMD =-2.78, 95％ CI:-3.45 to-2.12) were also significantly decreased by TCM. Conclusions: TCM is effective in improving AIC in animal models and has tremendous potential to be translated to treat AIC in clinical practice. Additionally, the systematic review and meta-analysis of an-imal experiments may be valuable in enhancing and guiding animal experiments and promoting the transformation of the results.

Objective: To investigate the epidemiological and clinical characteristics of 91 cases of dengue fever outbreak in Jiangxi Province in 2019, and to strengthen the management and prevention of dengue fever. Methods: The clinical data, laboratory results and etiology tests of 91 patients with dengue fever from the Ninth Hospital of Nanchang, Zhangshu People′s Hospital, Fengcheng People′s Hospital and Nanchang County People′s Hospital from July 31, 2019 to September 27, 2019 were retrospectively collected. The t test was used for continuous variables and chi-square test was used for categorical variables. Results: A total of 91 dengue fever patients were reviewed. The patients age ranged from 4 to 87 years old, and the majority were adult patients. Most patients were farmers and they all had mosquito-biting history. Local cases were the major source of this outbreak. The incubation time was (5.19±2.96) days. All patients had fever over 38 ℃. Thirty-eight (41.8%) patients developed rashes, mainly distributed on the limbs and trunk, and 15 patients (16.5%) developed myalgia and fatigue. The incidence of rashes in patients admitted in September was 15.9% (7/44), which was significantly lower than 68.1% (32/47) in July and August (χ²=25.262, P<0.01). The incidence of headache in patients admitted in September was 27.3%(12/44), which was significantly lower than 78.7% (37/47) in July and August (χ² =24.206, P<0.01). Among the 91 patients, 64 (70.3%) patients had white blood cell counts less than 4×10⁹/L, 14(15.4%) patients had platelet counts less than 50×10⁹/L. The positive rate of dengue non-structural protein 1 (NS1) antigen was 100.0%(37/37), the positive rates of dengue antibody IgM and IgG were 50.0%(11/22) and 13.6%(3/22), respectively. Among the 113 serum samples tested for dengue virus RNA, 106 were identified with dengue virus type-1 and two were dengue virus type-2. In 22 patients who received tests within 7 days, the positive rate of NS1 antigen was 100.0% (22/22), the IgM and IgG positive rates were 50.0%(11/22) and 13.6% (3/22), respectively, and 19 patients were infected with dengue type-1. Among the IgM antibody positive cases, the onset days before sampling was (5.09±1.64) days, longer than that of IgM antibody negative cases ((2.82±1.83) days), with statistical significance (t=3.063, P=0.007). The onset time before sampling in dengue virus RNA-positive group was (3.53±1.87) days, which was shorter than that of RNA-negative group ((6.67±0.58) days), and the difference was statistically significant (t=2.839, P=0.013). Conclusions The dengue fever outbreak cases in Jiangxi Province in 2019 have typical clinical manifestations of dengue fever. Using the NS1 antigen test, IgM and IgG antibody tests and real-time fluorescent quantitative polymerase chain reaction for dengue virus genotyping during early onset of the disease can assistant clinicians in clinical management, controlling infectious source and stopping disease transmission.

Fecal incontinence is a common but refractory anorectal disorder,seriously affecting the quality of life of patients. Although there are many methods for the treatment of fecal incontinence, the efficacy is uncertain and the mechanism of action is not fully clear. This article summarizes several commonly used modeling method of typical fecal incontinence models at home and abroad, and explores in depth, laying the foundation for further studies on fecal incontinence.

Objective To establish the item pool of quality of life questionnaire of Chinese medicine for postoperative patients with colorectal cancer;To conduct preliminary item screening. Methods With the guidance of Chinese culture background and TCM theory, systematic retrospective studies on medical records, interviews, TCM syndrome entries, and entries from EORTC QLQ-CR38 were used, and theoretical structure was extracted to form the primary item pool. Item selection and entry were optimized through the investigation, and the item pool was established through expert consultation. Results Item pool was composed of 70 entries, and the pre-questionnaire scale was formed. Conclusion Extraction of item pool ensures the reliability and scientificity of soft index, also has the characteristics of Chinese medicine.

Traditional Chinese surgical treatment "suture-dragging" therapy is based on medical thread therapy and tight seton drainage in combination of minimal invasive surgical principle. It can preserve the integrity of anal sphincter musculature involved in fistulous tract or abscess and maintain anal function. This article not only describes in detail about the operation points and mechanisms of "suture-dragging" therapy of anorectal fistula, but also reviews the application and modification of anorectal disease.
Abscess ; Drainage ; Humans ; Rectal Fistula ; Suture Techniques ; Sutures

Objective To investigate the impact of paced QRS duration (pQRSd) on heart function in patients with right ventricular apical pacing. Methods Seventy-six patients with Ⅲ° atrioventricular block received pacemaker treatment were enrolled and randomized into group A (pQRSd < 190 ms, n = 52) and group B(pQRSd≥ 190 ms, n = 24). The concentration of brain natriuretic peptide (BNP),parameters of left atrial diameter (LAD), left ventricular ejection fracetion (LVEF), left ventricular end diastolic diameter (LVEDD), left ventricular end systolic dimension (LVEDD) were measured before operation, at 12 months and 24 months after implanting, respectively. The parameters of echocardiography assay, the concentration of BNP and the incidence of heart failure event after implantation were compared between two groups. Results At 12 months after implanting, LVEF of the patients in the group B decreased significantly compared with that of group A (P < 0.05). However, the echocardiography paramenters and the concentration of BNP were not significantly different between the two groups (P > 0.05). At 24 months after implanting, LAD、LVEDD、LVESD of group B increased significantly compared with those of group A [LAD,( 44.5 ± 6.2) mm vs (41.6 ± 5.1) mm, LVEDD, (52.7 ± 9.3) mm vs (48.2 ± 7.5) mm, LVESD, (37.5 ± 5.6) mm vs (33.8 ± 4.9)mm, each P < 0.05, respectively]. The concentration of BNP of group B increased significantly [(408.2 ± 102.1)ng / L vs (243.7 ± 92.8)ng / L, P < 0.001], and LVEF of the patients in group B decreased significantly compared with those of group A [(46.3 ± 6.8)% vs (51.6 ± 5.2)%, P < 0.001], respectively. No significant difference in the incidence of heart failure event (41.7% vs 26.9%, P > 0.05)between two groups during 24-month follow-up. Conclusion The prolonged paced QRS duration has a detrimental effect on long-term cardiac function during RVA pacing in patients with Ⅲ°atrioventricular block.

OBJECTIVETo study the role of integrin-linked kinase (ILK) on the proliferation and differentiation of human fibroblast in hypertrophic scar and its effect on the scar formation.

METHODSThe human scar fibroblasts were isolated and cultured in vitro. The cells were divided into 4 groups. (1) control group: only contains DMEM; (2) jetPRIME group: DMEM with 200 microl jetPRIME buffer and 4 microl jetPRIME; (3) ILK siRNA group: DMEM and ILK siRNA; (4) ILK cDNA group: DMEM and ILK cDNA. The cell proliferation was detected by XTT assay and the mRNA and protein expressions of ILK and alpha-SMA were detected by Real-time qPCR and Western blot.

RESULTS(1) XTT results showed that the cellular proliferation level after 48 h in four groups were 0.820 +/- 0.065, 0.873 +/- 0.041, 0.554 +/- 0.013 and 1.296 +/- 0.094, respectively. The cellular proliferation curve showed that the cellular proliferation level was very flat in ILK siRNA group while the cellular proliferation level gradually increased from 12 h. 48 h after transfection, the cellular proliferation level in ILK siRNA group was significant lower than those in other groups (P value were 0.021, 0.034, 0), while the cellular proliferation level in ILK cDNA group was the highest among all 4 groups (P value were 0.017, 0.009, 0). (2) The Real-time qPCR showed that the expressions of ILK mRNA and alpha-SMA mRNA were 0.693 +/- 0.412 and 0.422 +/- 0.037 in control group, were 0.621 +/- 0.183 and 0.388 +/- 0.005 in jetPRIME group, were 0.052 +/- 0.019 and 0.073 +/- 0.023 in ILK siRNA group, were 240.193 +/- 35.170 and 138.056 +/- 24.060 in ILK cDNA group. The expressions of ILK mRNA and alpha-SMA mRNA in ILK siRNA group were significantly lower than those in other three groups (P < 0.05). And the expressions of ILK mRNA and alpha-SMA mRNA in ILK cDNA group were significantly higher than those in other three groups (P < 0.05). (3) The Western blot also showed that the expression of ILK and alpha-SMA proteins were decreased in ILK siRNA group and increased in ILK cDNA group.

CONCLUSIONILK may promote the proliferation and differentiation of human scar fibroblast. It may play an important role in scar formation and contracture.

Actins ; metabolism ; Adolescent ; Adult ; Cell Differentiation ; drug effects ; Cell Proliferation ; drug effects ; Cells, Cultured ; Cicatrix, Hypertrophic ; metabolism ; Female ; Fibroblasts ; cytology ; drug effects ; metabolism ; Humans ; Male ; Middle Aged ; Protein-Serine-Threonine Kinases ; pharmacology ; RNA, Messenger ; genetics ; Transfection ; Young Adult

Objective To observe the effects of lung protective ventilation strategy (LPVS) on inflammatory mediators in bronchial alveolar lavage fluid (BALF) in pulmonary and extrapulmonary acute respiratory distress syndrome(ARDS).Methods All of 62 extrapulmonary ARDS(ARDSexp) cases and 60 pulmonary ARDS (ARDSp) cases were divided into observation group and control group by table of random digit.ARDSexp and ARDSp observation group were received LPVS treatment [tidal volume 6-8 ml/kg,positive end expiratory pressure (PEEP) 5-15 cm H2O (1 cm H2O =0.098 kPa)],and ARDSexp and ARDSp control group were received the routine ventilation strategy (tidal volume 10-12 ml/kg,PEEP 4-8 cm H2O).All groups were treated with the same conventional therapy of ARDS,same model and parameter of mechanical ventilation.The level of tumor necrosis factor (TNF)-α,interleukin (IL)-6,IL-8 in BALF were tested by enzyme linked immunosorbent assay on the 1st,4th,7th day in each group.The oxygenation index was tested at 8 o'clock each morning.Results There were 4 ARDSexp cases and 6 ARDSp cases who were expelled,because of death within 7 days.ARDSexp observation group was in 28 cases,ARDSexp control group was in 30 cases,ARDSp observation group was in 28 cases,ARDSp control group was in 26 cases.The oxygenation index had no significant difference between ARDSexp and ARDSp observation group and corresponding ARDSexp and ARDSp control group on the 1st and 2nd day (P ＞ 0.05).But the oxygenation index in ARDSexp and ARDSp observation group were significantly higher than that in ARDSexp and ARDSp control group from 3rd to 7th day (P ＜ 0.05).The oxygenation index in ARDSexp observation group was significantly higher than that in ARDSp observation group except 1st day (P ＜0.05).The oxygenation index in ARDSexp and ARDSp observation group were significantly better with the time passing (P ＜ 0.05).The BALF levels of TNF-α,IL-6 and IL-8 in ARDSexp and ARDSp observation group were significantly lower than those in corresponding ARDSexp and ARDSp control group on the 4th and 7th day (P＜ 0.05).The BALF levels of TNF-α,IL-6 and IL-8 in ARDSexp observation group and ARDSexp control group were significantly lower than those in corresponding ARDSp observation group and ARDSp control group (P＜ 0.05).The BALF levels of TNF-α,IL-6 and IL-8 in ARDSexp and ARDSp observation group were decreased significantly with the time passing (P ＜0.05).Conclusion It is more reasonable to decrease the BALF levels of inflammatory mediators,increase oxygenation index for ARDS patients to with LPVS treatment,then for ARDSexp patients obviously.