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 analyze the necessity of routinely performing foraminoplasty during percutaneous transforaminal endoscopic discectomy (PETD). Methods: A total of 412 patients including 231 males and 181 females with an average age of 39.1±13 (20-80) years were enrolled in the present study. All patients were preoperatively diagnosed with single-segment lumbar disc herniation and underwent PETD by the same surgical group. The affected segments were at L_3-4 in 32 cases, L_4-5 in 289 cases, and L₅S₁ in 91 cases. Among them, 306 cases had no prolapse, 89 had mild up/down prolapse, and 17 had severe prolapse. MRI sagittal imaging was used to measure the height and width of the intervertebral foramen of L_{3, 4}, L_{4, 5} and L₅S₁ segments, the distance between the lower edge of vertebral pedicle and the upper edge of the lower vertebral pedicle and the distance between the point 3 mm to the ventral side of the intervertebral space to the superior articular process. The necessity of performing foraminoplasty was evaluated by measuring the change of intervertebral foramen width using dynamic X-ray and verified during operation. Results: The height of the intervertebral foramen of L_3,4, L_4,5 and L₅S₁ segments were 1.99±0.25, 1.89±0.15 and 1.52±0.26 cm, respectively. The width of the intervertebral foramen was 0.78±0.14, 0.75±0.13 and 0.64±0.13 cm, respectively. The distance between the lower edge of vertebral pedicle and the upper edge of the lower vertebral pedicle were 1.14±0.17, 1.05±0.16, and 0.98±0.19 cm, respectively. The distance between the point 3 mm to the ventral side of the intervertebral space to the superior articular process were 1.11±0.31, 1.17±0.20, and 0.95±0.14 cm, respectively. The width of the intervertebral foramen of the L_{3, 4} and L_4,5 segments was significantly greater at the over-flexion position than at the over-extension position (P<0.05). Intraoperative verification showed that 347 cases (group A) did not need foraminoplasty. However, the other 65 patients (group B) needed foraminoplasty, including 31 at L_{4, 5} segment and 34 at L₅S₁ segment. One patient in group A and one in group B underwent revision operation due to residual intervertebral disc. At 2 years of follow-up, recurrence occurred in 4 patients in group A and 2 patients in group B. The ODI score and JOA score in group A and B were 18%±9%, 24.2±1.3 and 16%±7%, 23.9±1.3, respectively. There were not significantly different between patients in group A and B (t=1.70, P=0.090; t=1.71, P=0.088). The VAS score of lumbar pain of patients in group A was better than that of patients in group B (P<0.05). Conclusion Most of PETD of L₃-S₁ segments can reach the therapeutic target without performing foraminoplasty with half-half technique combined with far lateral access technique. Due to the special anatomical position of L₅-S₁ segment, the probability of performing foraminoplasty during operation is much higher. Performing foraminoplasty or not depends on the preoperative measurement of foramina and verification during the operation.

Objective Renal vascular injury,especially thrombotic microangiopathy (TMA),is an important prognostic factors in pat.ients with lupus nephritis.TMA is most likely to be associated with proliferative lupus nephritis.This single-center retrospective study was conducted in order to explore the characteristics and prognosis of patients with TMA associated with proliferative lupus nephritis.Methods From January 2013 to June 2016,146 hospitalized patients with lupus nephritis underwent renal biopsy in the Department of Rheumatology,South Campus,Ren Ji Hospital,of which 108 were proliferative nephritis including 32 with TMA and 76 without TMA.All the clinical records were collected.All data were analyzed by Graphpad 5.0 or SPSS 22.0 statistical software analysis.Nonparametric test,t test and Fisher test were used for comparison between the two groups.Predictors were analyzed by multiple factors regression analysis,survival curve was analyzed by Kaplan-Meire method.Results Patients with TMA were found to have higher levels of creatinine (Cr) [93.5 (69.0,179.8) μmol/L vs 73.0 (56.3,116.3) μmol/L,U=833,P=0.010 1],B-type brain natriuretic peptide (BNP) [177(93.2,619) pg/ml vs 87.5(28.5,255) pg/ml,U=765,P=0.004 6],24-hour urinary protein [4.98 (1.99,7.62) g vs 2.83 (1.71,4.38) g,U=875,P=0.022] and highersystemic lupus erythematosus disease activity index (SLEDAI) [16(13.25,18) vs 12(10.25,14),U=559,P＜0.000 1],as well as lower complement [C3:(0.37±0.15) g/L vs (0.52±0.20) g/L,t=3.713,P=0.000 3;C4:0.056 (0.035,0.140) g/L vs 0.088(0.053,0.167) g/L,U=912,P=0.047 9],albumin (Alb) [(24±6) g/L vs (28±6) g/L,t=3.416,P=0.000 9] and hemoglobin (Hb) [(88±19) g/L vs (99±21) g/L,t=2.627,P=0.015 7].They were more prone to hypertension [(24/32,75％) vs (35/76,46％),x2=7.613,P=0.006 4],had less glomerular sclerosis [0(0,0.038)％ vs 7(0,17)％,U=848,P=0.007 7] and higher acute score [16(14.25,19.75) vs 13(10,15),U=612,P＜0.000 1];while these patients received higher doses of corticosteroid therapy,and more patients were treated with cyclophosphamide for induction therapy.Multivariate regression analysis showed that Cr (OR =1.008,P=0.033) and SLEDAI (OR =1.272,P=0.003) scores might be predictors of TMA in patients with proliferative lupus nephritis.During follow up,6 and 2 patientsin two groups progressed to end-stage renal disease (ESRD),respectively (P=0.010 4).Univariate analysisfound that patients progressed to ESRD were more likely to have TMA[(6/8,75％) vs (23/85,27％),x2=7.831,P=0.010 4],and had more crescents[54.5(12,83.5)％ vs 20(6,41)％,U=183,P=0.032].Higher activity indices (AI) [(20±6) vs (14±4),t=3.489,P=0.000 7],Cr [286(214.5,395) μmol/L vs 76(59,115.5) μmol/L,U=19,P＜0.000 1] and BNP [456(192.3,1 060) vs 110(45.38,275.5),U=116.5,P=0.002 4],as well as lower Hb [(71±12) vs (97±19),t=3.776,P=0.000 3] and platelets (PLT) [(130±71)×109/L vs (196±76)×109/L,t=2.399,P=0.018 5] were observed in these patients.Conclusion This study has shown that patients with proliferative lupus nephritis with renal TMA have a higher level of Cr and more active disease state,requiring more aggressive immunosuppressive therapy and more likely to progress to ESRD.So renal TMA may be one of the risk factors of renal survival in these patients.

Objective To investigate the safety of the laparoscopic pancreaticoduodenectomy (LPD) in 70 years of age or older patients.Methods The retrospective cohort study was conducted.The clinicopathological data of 40 patients (age ≥70 years old) who underwent pancreaticoduodenectomy in the West China Hospital of Sichuan University between January 2012 and December 2016 were collected.Twenty patients undergoing LPD were allocated into the LPD group,and 20 receiving open pancreaticoduodenectomy (OPD) who were selected by random number table during the same period were allocated into the OPD group.Observation indicators included:(1) intraoperative situations;(2) postoperative situations;(3) follow-up situation.Follow-up using outpatient examination and telephone interview was performed to detect the patients' survival after discharge and tumor recurrence and metastasis up to March 2017.Measurement data with normal distribution was represented as x±s,and comparison between groups were evaluated with the t test.Measurement data with skewed distribution were described as median (range) and comparison between groups was analyzed using the nonparametric test.Comparison of count data was analyzed using the chi-square test.Comparison of ranked data was analyzed by non parametric test.Results (1) Intraoperative situations:1 patient in the LPD group was converted to open surgery,with a conversive rate of 5.0％ (1/20).Operative time and volume of intraoperative blood loss were (463 ± 10) minutes,210.5 mL (152.5-300.0 mL) in the LPD group and (332± 25) minutes,420.0 mL (350.1-493.8 mL) in the OPD group,showing statistically significant differences between the 2 groups (t =5.48,Z =-3.98,P＜0.05).Cases with intraoperative blood transfusion and pylorus preservation were respectively 4,14 in the LPD group and 6,10 in the OPD group,showing no statistically significant difference between the 2 groups (x2=0.53,1.67,P＞0.05).The results of intraoperative rapid frozen pathological examination showed negative margin of the 40 patients.(2) Postoperative situations:cases in ICU,cases with postoperative analgesia,time for out-of-bed activity,time to anal exsufflation and time for intake were 17,7,(2.2±0.7)days,(4.2± 0.9)days,(4.8±0.7)days in the LPD group and 6,15,(3.6±0.8)days,(5.7±0.9)days,(7.1 ± 2.7)days in the OPD group,showing statistically significant differences between the 2 groups (x2 =12.34,6.47,t=-6.18,-6.55,-3.65,P＜0.05).Pancreatic fistula,delayed gastric emptying (Grade B),postoperative bleeding (Grade B),biliary fistula,pulmonary infection,intestinal obstruction,wound infection,reoperation and major complication were respectively detected in 2,3,1,1,3,1,0,2,3 patients of the LPD group and 2,4,1,1,4,1,2,3,4 in patients of the OPD group,showing no statistically significant difference between the 2 groups (x2 =0.00,0.17,0.00,0.00,0.17,0.00,2.11,0.23,0.17,P＞0.05).Results of postoperative pathological examination showed that duodenal adenocarcinoma,ampullary carcinoma,lower bile duct carcinoma,pancreatic ductal adenocarcinoma and pancreatic cystic tumor were respectively detected in 8,2,5,3,2 patients of the LPD group and 10,2,4,2,2 patients of the OPD group,showing no statistically significant difference between the 2 groups (x2 =0.53,P＞0.05).Duration of postoperative hospital stay in the LPD and OPD groups were (19± 13) days and (15±7) days,respectively,showing no statistically significant difference between the 2 groups (t =1.28,P＞ 0.05).Results of postoperative oncology showed that tumor diameter,number of lymph node dissected,number of positive lymph nodes,cases with negative margin,cases in T1N0M0,T2N0M0,T3N0M0,T3N1M0,T4N0M0,T4N1M0 of TNM staging were respectively (2.4±0.7)cm,15.4±2.3,2,20,2,7,8,2,1,0 in the LPD group and (2.8±0.9)cm,14.4±2.5,3,20,1,8,5,2,3,1 in the OPD group,with no statistically significant difference between the 2 groups (t =-1.64,1.32,x2 =0.23,0.00,Z =-0.69,P＞ 0.05).(3) Follow-up situation:1 patient died respectively in both groups within the postoperative 30 days.Thirty-eight patients were followed up for 1-26 months,with a median time of 14 months.During follow-up,2 patients had tumor recurrence and 1 died of myocardial infarction in the LPD group;3 had tumor recurrence and 1 died of tumor recurrence in the OPD group.Conclusion LPD in 70 years of age or older patients is not only safe and feasible,but also significantly reduce volume of intraoperative blood loss and demand of analgesia,as well as quickly resume normal diet and activities.

Objective To study the effects of photodynamic therapy (PDT) combined with torasemide on rat glioma by detecting the protein expression of matrix metalloproteinase 2 (MMP2),matrix metalloproteinase 9 (MMP9),sodium-potassium-chloride co-transporter 1 (NKCC1) and vascular endothelial growth factor (VEGF).Methods Male Wistar rats with glioma were randomly divided into four groups,includes control group (sham group,n=15),photodynamic therapy group (PDT group,n=15),torasemide group (T group,n=15) and PDT+T group (n=15).The rats were normally fed in the sham group,were received PDT (80 J/cm2) for 10 min in the PDT group,were received intraperitoneal torasemide 5 mg/kg for 3 days in the T group,and received PDT and torasemide treatment in the PDT+T group.After 2 weeks,5 rats were sacrificed from each group.Peritumoral edema tissues were harvested for the detection of wet-dry-weight ratio (W/D),and the protein expression of MMP2,MMP9,NKCC 1 and VEGF by Western Blot,immunohistochemistry and qRT-PCR.The remaining rats were used for survival time assessment.Results Compared with the sham group,the PDT group showed an increase in W/D (5.17±0.42 vs 4.83±0.38),the expression of NKCC1 (0.54±0.21 vs 0.35±0.12) and VEGF (0.68±0.20 vs 0.42±0.15),and survival time ((32.2±2.9) d vs (25.3±2.6) d) (all P＜0.05),and showed an decrease in the expression of MMP2 (2.76±0.42 vs 1.88±0.17) and MMP9 (2.55±0.38 vs 1.46±0.21) (all P＜0.05).Compared with the PDT group,the T group showed decrease in W/D (3.68±1.04),the expression of NKCC1 (0.22±0.10) and VEGF (0.33±0.14),and survival time ((28.7±2.2) d) (all P＜0.05),and showed increase in the expression of MMP2 (2.71 ±0.35) and MMP9 (2.42±0.36) (all P＜0.05).Compared with the PDT group,the PDT+T group showed decrease in W/D (4.52±0.46),and the expression of NKCC1 (0.30±0.16),VEGF (0.44±0.21),MMP2 (1.84±0.23) and MMP9 (1.53±0.24) (all P＜0.05),and showed increase in survival time ((44.5±2.8) d)(P＜0.05).Conclusion PDT combined with torasemide can reduce PDT induced edema,reduce tumor invasiveness,and prolonged the average survival time of rats.

BACKGROUND:The number of elderly patients with hip fracture is huge, and this population mainly combines with a variety of internal diseases. The general condition was bad. Compared to total hip arthroplasty, bipolar hemiarthroplasty can shorten operation time, reduce the time of anesthesia and improve surgical safety, but the operation using which fixation mode is always controversial.
OBJECTIVE:To compare the safety and curative effects of bipolar hemiarthroplasty with cementless or cement femoral stem prosthesis in elderly patients with osteoporotic complex hip fracture.
METHODS:From June 2007 to June 2010, 198 elderly patients with osteoporotic hip fracture aged more than 75 years old, who were treated with bipolar hemiarthroplasty in the People’s Hospital of Xinjiang Uygur Autonomous Region, China, were enroled in this study. Al patients were divided into cementless group (n=69) and cement group (n=129) according to the type of prognosis. Osteoporosis was treated conventionaly in both groups after replacement. Operation time, intraoperative blood loss, incidence of postoperative hip pain, out of bed activity time post surgery, Harris scores of last folow-up and loosening rate of the prognosis were compared between the two groups.
RESULTS AND CONCLUSION:176 of above 198 cases were folowed up for 48 to 84 months, including 122 in the cement group and 54 in the cementless group. Operation time was longer in the cement group than in the cementless group, but out of bed time was earlier in the cement group than in the cementless group post surgery, and there were significant differences (P < 0.05). The incidences of loosening and hip pain were more in the cement group than in the cementless group post surgery (P < 0.05). No significant difference in intraoperative blood loss and Harris scores of last folow-up was detected between the two groups (P > 0.05). The incidences of loosening rate were 5% and 4% in the cement and cementless groups, respectively, which showed significant differences (P< 0.05). These results indicate that bipolar hemiarthroplasty with or without cement for osteoporotic hip fracture in the elderly can obtain good middle- and long-term effects. Bipolar hemiarthroplasty with cement can reduce the out of bed time, but operation time was longer, and incidences of hip pain and loosening were higher in cement prosthesis than in cementless prosthesis.

This study was aimed to investigate the influence on component content indexes,which included chlorogenic acid and luteolin of honeysuckle by the absorption of chemical insecticide thiamethoxam.High-performance liquid chromatography (HPLC) method was used in the analysis of content determination of component content indexes of honeysuckle samples by different concentrations of thiamethoxam.SPSS was used in the statistical analysis.The results showed that compared to samples from the blank control group,the content of chlorogenic acid had the increasing tendency in the honeysuckle groups with different concentrations of thiamethoxam.However,there was no significant difference among different experiment groups.There was no significant difference on luteolin among honeysuckle groups with different concentrations of thiamethoxam and the blank control group.It was concluded that at the recommended dose and high-powered dose of thiamethoxam,there was some influence on the content of chlorogenic acid.However,there was no significant effect on the content of luteoloside.And the quality scores of both contents were within the range defined in the Chinese Pharmacopoeia(2010 edition).

Objective Our retrospective study is aimed to analyze the correlative clinical features of be-tween expressions of miR -135b and miR-141 in colorectal cancer.Methods Clinical data and specimens of patients with colorectal carcinoma at our hospital from 2013 to 2014 were retrospectively collected .The expres-sions of miR-135 b and miR-141 between colon cancer and matched normal colonic tissues were compared .The correlation between the expressions of miR -135 b and miR-141 in colorectal carcinoma and the clinical charac-teristics were discussed .Results A total of 42 patients was retrospective analyzed .The expressions of miR -135b,miR-141 in the colon cancer tissues were obviously higher than that in the normal colonic tissues .The differences of the expression of miR -141 in the colon cancer tissues of different Dukes stages ,degree of differen-tiation,lymph node metastasis and infiltration depth were all significant .The expressions of miR -135 b and miR-141 displayed a positive linear correlation .Conclusion The expressions of miR-135b,miR-141 in colorec-tal cancer are significantly increased ,and the expressions display a remarkable correlation with the Dukes stages , degree of differentiation ,lymph node metastasis and infiltration depth of tumor .The expressions of miR-135 b and miR-141 demonstrate a positive correlation .

This article was aimed to study the dynamics of biocontrol endobacteria in roots, stems and leaves of Panax ginseng and soils adjacent roots. Gradient screening and root irrigation methods were used to develop Rif-resistance bacteria and inoculation. Dilution plate method was used to count the number of them in roots, stems and leaves of P. ginseng and soils adjacent roots. The results showed that bacteria which can endure 120 μg·mL-1 Rif was developed, and no change was found on their antagonistic activity against A lternaria panax Whetz and Phytophthora cactorum. In roots and stems of P. ginseng, ge15 and ge25 showed the highest number in the initial.Then, populations of ge15 and ge25 in ginseng roots and stems decreased to a stable status gradually. In ginseng leaves, populations of ge15 and ge25 increased to the highest 3 days after inoculation, then, populations of them were decreased and kept at certain concentration. In ginseng rhizosphere soil, populations of ge15 showed reciprocating change, and which of ge25 showed increase initial, and then decrease to a stable status. It was concluded that endobacteria can keep a certain population in ginseng roots, stems, and leaves. Biocontrol agents based on them will be helpful for ginseng diseases controlling in the field.

OBJECTIVETo explore the association of fish intake with the risk of renal cancer.

METHODSPubMed, Embase, CNKI and CA databases were searched for case-control studies or cohort studies examining the relationship between fish or fish products intake and renal cancer. Heterogeneity among the selected studies was assessed using I2 score, and the publication bias was assessed using funnel plots.

RESULTSSeventeen articles were included in the analysis with a heterogeneity across the studies (P=0.003, I(2)=52.3%). A random-effects model was used to generate the pooled risk ratio (RR) and 95% confidence interval (CI), and no statistically significant association was found between the risk of renal cancer and fish intake (RR=0.90; 95% CI, 0.78-1.02). In subgroup analysis, no evidence was found that the study design, study region or publication date influenced the results; but in the gender subgroup analysis, fish intake we found to decrease the risk of renal cancer in men but not in women.

CONCLUSIONThe results of meta-analysis do not support an association between fish intake and a lowered risk of renal cancer.

Carcinoma, Renal Cell ; etiology ; Diet ; Female ; Fish Products ; Humans ; Kidney Neoplasms ; etiology ; Male ; Odds Ratio ; Risk Factors