Toripalimab plus axitinib versus sunitinib as first-line treatment for advanced renal cell carcinoma: RENOTORCH, a randomized, open-label, phase III study.

BACKGROUND: Immune checkpoint inhibitors in combination with tyrosine kinase inhibitors are standard treatments for advanced clear cell renal cell carcinoma (RCC). This phase III RENOTORCH study compared the efficacy and safety of toripalimab plus axitinib versus sunitinib for the first-line treatment of patients with intermediate-/poor-risk advanced RCC. PATIENTS AND METHODS: Patients with intermediate-/poor-risk unresectable or metastatic RCC were randomized in a ratio of 1 : 1 to receive toripalimab (240 mg intravenously once every 3 weeks) plus axitinib (5 mg orally twice daily) or sunitinib [50 mg orally once daily for 4 weeks (6-week cycle) or 2 weeks (3-week cycle)]. The primary endpoint was progression-free survival (PFS) assessed by an independent review committee (IRC). The secondary endpoints were investigator-assessed PFS, overall response rate (ORR), overall survival (OS), and safety. RESULTS: A total of 421 patients were randomized to receive toripalimab plus axitinib (n = 210) or sunitinib (n = 211). With a median follow-up of 14.6 months, toripalimab plus axitinib significantly reduced the risk of disease progression or death by 35% compared with sunitinib as assessed by an IRC [hazard ratio (HR) 0.65, 95% confidence interval (CI) 0.49-0.86; P = 0.0028]. The median PFS was 18.0 months in the toripalimab-axitinib group, whereas it was 9.8 months in the sunitinib group. The IRC-assessed ORR was significantly higher in the toripalimab-axitinib group compared with the sunitinib group (56.7% versus 30.8%; P < 0.0001). An OS trend favoring toripalimab plus axitinib was also observed (HR 0.61, 95% CI 0.40-0.92). Treatment-related grade ≥3 adverse events occurred in 61.5% of patients in the toripalimab-axitinib group and 58.6% of patients in the sunitinib group. CONCLUSION: In patients with previously untreated intermediate-/poor-risk advanced RCC, toripalimab plus axitinib provided significantly longer PFS and higher ORR than sunitinib and had a manageable safety profile TRIAL REGISTRATION: ClinicalTrials.gov NCT04394975.

[Efficacy and safety analysis of an improved overlength biliary stent in the treatment of biliary stricture].

Objective: To evaluate the efficacy and safety of an improved overlength biliary stent in the treatment of bile duct stricture. Methods: Prospective randomized controlled study. Patients with bile duct stricture in Peking University International Hospital from February 2016 to June 2021 were randomly divided into the conventional plastic biliary stents (CPBS) group and the improved overlength biliary stents (IOBS) group by envelope random method. CPBS or IOBS were placed after endoscopic retrograde cholangiopancreatography (ERCP) breast catheterization was successfully conducted and the stenosis length was determined by angiography. The incidence of postoperative complications, median patency time of postoperative stent and reoperation rate within 6 months were compared between the two groups, Kaplan-Meier method was used to draw the survival curve, and log-rank test was conducted to evaluate the safety and efficacy of IOBS in the treatment of bile duct stricture. Results: A total of 90 patients were included. There were 45 patients in IOBS group, including 28 males and 17 females, aged (67.2±11.7) years. There were 45 patients in CPBS group, including 26 males and 19 females, aged (64.6±14.4) years. The patients in the both groups were balanced and comparable. There were no significant differences in success rate of operation, operation time, hospitalization time, operation cost and prospective complication rate between the two groups (all P>0.05). There were no significant differences in the changes of liver function index before and 72 hours after operation between the two groups (both P>0.05). The median patency time of stents in IOBS group was longer than that in CPBS group [M(Q1, Q3), 201(155,246) vs 109(55,167) d, P=0.002].The IOBS group had lower reoperation rate than the CPBS group within 6 months [46.2% (18/39) vs 78.9%(30/38), P=0.003]. Conclusion: IOBS has good safety in the treatment of bile duct stricture and the clinical efficacy is superior to CPBS.

Experimental Evidence of Intrinsic Current Generation by Turbulence in Stationary Tokamak Plasmas.

High-ß_{θe} (a ratio of the electron thermal pressure to the poloidal magnetic pressure) steady-state long-pulse plasmas with steep central electron temperature gradient are achieved in the Experimental Advanced Superconducting Tokamak. An intrinsic current is observed to be modulated by turbulence driven by the electron temperature gradient. This turbulent current is generated in the countercurrent direction and can reach a maximum ratio of 25% of the bootstrap current. Gyrokinetic simulations and experimental observations indicate that the turbulence is the electron temperature gradient mode (ETG). The dominant mechanism for the turbulent current generation is due to the divergence of ETG-driven residual flux of current. Good agreement has been found between experiments and theory for the critical value of the electron temperature gradient triggering ETG and for the level of the turbulent current. The maximum values of turbulent current and electron temperature gradient lead to the destabilization of an m/n=1/1 kink mode, which by counteraction reduces the turbulence level (m and n are the poloidal and toroidal mode number, respectively). These observations suggest that the self-regulation system including turbulence, turbulent current, and kink mode is a contributing mechanism for sustaining the steady-state long-pulse high-ß_{θe} regime.

Profiled polyethylene terephthalate filaments that incorporate collagen and calcium phosphate enhance ligamentisation and bone formation.

Polyethylene terephthalate (PET) artificial ligaments offer an unlimited source of ligaments without donor-site-related morbidity and with good mechanical properties for a rapid return to sporting activities. Developing PET artificial ligaments with excellent ligamentisation and ligament-bone healing is still a considerable challenge. This study aimed to investigate the effects of the profiled PET/collagen/calcium phosphate (PET/C/CaP) ligament upon cell growth, ligamentisation and ligament-bone healing in vitro and in vivo. Profiled PET/C/CaP filaments were made by melt-spinning process with 2 % CaP hybrid spinning and collagen coating. Rat mesenchymal stem cells (MSCs) were cultured on the profiled PET/C filaments for cytotoxicity, viability, scanning electron microscopy (SEM) and ligament-related gene expression analysis. MSCs' osteogenic capacity on the profiled PET/CaP filaments was identified by detecting osteogenic gene expression and alizarin red S staining. For in vivo verification, an animal study was performed to evaluate the effect of the profiled PET/C/CaP ligament in a rabbit knee medial collateral ligament reinforcement reconstruction model. The graft ligamentisation and bone formation were investigated by SEM, histology, microcomputed tomography and mechanical tests. The profiled PET/C filaments enhanced MSC proliferation and ligament-related gene expression. Furthermore, they enhanced osteogenic gene expression, alkaline phosphatase activity and mineralisation of MSCs. The in vivo study indicated that the profiled PET/C/CaP ligament enhanced ligamentous matrix remodelling and bone formation. Therefore, their use is an effective strategy for promoting MSCs' ligamentous and osteogenic potential in vitro and enhancing ligamentous matrix remodelling and bone formation in vivo.

[Effects of cinepazide maleate injection on blood pressure in patients with acute ischemic stroke and hypertension].

Objective: To investigate the blood pressure change in patients with acute ischemic stroke (AIS) and hypertension treated with cinepazide maleate injection. Methods: This was a subgroup analysis of post-marketing clinical confirmation study of cinepazide maleate injection for acute ischemic stroke: a randomized, double-blinded, multicenter, placebo-parallel controlled trial, which conducted in China from August 2016 to February 2019. Eligible patients fulfilled the inclusive criteria of acute anterior circulation ischemic stroke with National Institutes of Health Stroke Scale (NIHSS) scores of 7-25. The primary endpoints were mean blood pressure of AIS patients treated with cinepazide maleate or control, which were assessed during the treatment period (14 days), and the proportion of the patients with normal blood pressure was analyzed after the treatment period. Furthermore, a subgroup analysis was performed to investigate a possible effect of the history of hypertension on outcomes. Results: This analysis included 809 patients with hypertension. There was no significant difference in patients blood pressure and the proportion of patients with normal blood pressure (60.5% vs. 59.0%,P>0.05) between cinepazide maleate group and control group. Conclusion: Administration of cinepazide maleate injection does not affect the management of clinical blood pressure in patients with AIS.

[Endoscopic retrograde cholangiopancreatography in patients after bilioenteric anstomosis].

OBJECTIVE: To distinguish clinical features, safety and efficiency of endoscopic retrograde cholangiopancreatography (ERCP) in patients after bilioenteric anstomosis based on retrospectively analyzed clinical data and endoscopy procedures. METHODS: Data extracted from patients after bilioenteric anstomosis due to biliary disease treated with ERCP from January 2005 to December 2021 in the Department of Gastroenterology, Peking University Third Hospital were retrospectively analyzed. Clinical data and endoscopic pictures were reevaluated and analyzed. The patients were divided into three groups, including the patients with choledochoduodenostomy (CDD), Roux-en-Y hepaticojejunostomy (RYHJ) and Whipple. Differences between ERCP success and failure were conducted. RESULTS: In the study, 89 cases with 132 ERCP procedures were involved, 9-80 years old, median 57 years old, containing 4 CDD, 30 RYHJ, 54 Whipple and 1 bile duct ileocecal anastomosis patients; The time between ERCP and surgery were 30 (1-40), 2.75 (0.5-14), 2 (0.3-19), and 10 years, respectively; The time between surgery and symptom were 240 (3-360), 12 (1-156), 22 (0-216), and 60 months, respectively. Fifty percent of CDD could succeed only under local anaesthesia, RYHJ (96.7%) and Whipple (100.0%) needed under general anaesthesia (P < 0.001). Successful first entry rates of CDD, RYHJ and Whipple were 100.0%, 40.0% and 77.8%, respectively. After changing the endoscopy type, successful entry rate could increase to 43.3% of RYHJ and 83.3% of Whipple. The successful entry rate of different anastomotic methods was significant (P < 0.001). The cannulation success rates of CDD, RYHJ and Whipple were 100.0%, 53.8% and 86.7% respectively, with significant difference between the groups (P=0.031). ERCP success rates of CDD, RYHJ and Whipple were 100.0%, 33.3% and 78.8% respectively, with significant difference between the groups (P < 0.001). Complications were found in 23.9% (21/88) patients, including infection (14.8%), pancreatitis (9.2%), bleeding (3.4%), and perforation (2.3%) ranked by incidence. Causes of ERCP in post bilioenteric anstomosis were anastomotic stenosis (50.0%, benign 39.3%, malignant 10.7%), choledocholithiasis (37.5%) and reflux cholangitis (12.5%). Anastomotic method was the only predicting factor of ERCP success in patients after bilioenteric anstomosis (OR=7, 95%CI: 2.591-18.912, P < 0.001). CONCLUSION: ERCP in post bilioenteric anstomosis patients with gastrointestinal reconstruction need general anaesthe-sia, with good safety and efficiency. The successful rate of RYHJ was significantly lower than Whipple. Anastomotic method was the only predicting factor of ERCP success.

[Applied anatomical study and clinical application of the caudate lobe boundary and ductal system of the liver].

Objective: To explore the relationship between the hepatic caudate lobe boundary and the ductal system so as to guide the identification of the anatomical relationship during liver surgery. Methods: The specific parts were observed and the liver parenchyma was removed according to 41 cadaveric liver autopsy specimens. The critical relationship between the hepatic caudate lobe and other ducts was observed to explore the reticular duct structure. Results: The plane formed by the hepatic hilar plate and Arantius ligament served as the boundary between the caudate lobe and other hepatic lobes. The caudate lobe hepatic portal vein was composed of numerous small branches from its left and right branches. The portal vein adjacent to the vena cava was mainly derived from the left branch, and to a lesser extent from the right branch. Blood was drained straight from the caudate lobe vein into the inferior vena cava via the short hepatic vein. There were three or four bile duct branches in the caudate lobe. The main source of arterial blood flow were the left and right branches of the hepatic artery. An avascular zone of loose connective tissue was found between the caudate lobe and the retrohepatic inferior vena cava. Conclusion: The hepatic caudate lobe is an independent lobe. During hepatic caudate lobe surgery, the plane formed by the hepatic hilar plate and Arantius ligament can serve as the boundary between the caudate lobe and other hepatic lobes and be used for anatomical site identification. The duct system of the caudate lobe's is complicated, but it also has its own distinct regularity.

Pan-Asian adapted ESMO Clinical Practice Guidelines for the management of patients with intermediate and advanced/relapsed hepatocellular carcinoma: a TOS-ESMO initiative endorsed by CSCO, ISMPO, JSMO, KSMO, MOS and SSO.

The most recent version of the European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for the diagnosis, treatment and follow-up of hepatocellular carcinoma (HCC) was published in 2018, and covered the diagnosis, management, treatment and follow-up of early, intermediate and advanced disease. At the ESMO Asia Meeting in November 2018 it was decided by both the ESMO and the Taiwan Oncology Society (TOS) to convene a special guidelines meeting immediately after the Taiwan Joint Cancer Conference (TJCC) in May 2019 in Taipei. The aim was to adapt the ESMO 2018 guidelines to take into account both the ethnic and the geographic differences in practice associated with the treatment of HCC in Asian patients. These guidelines represent the consensus opinions reached by experts in the treatment of patients with intermediate and advanced/relapsed HCC representing the oncology societies of Taiwan (TOS), China (CSCO), India (ISMPO) Japan (JSMO), Korea (KSMO), Malaysia (MOS) and Singapore (SSO). The voting was based on scientific evidence, and was independent of the current treatment practices, the drug availability and reimbursement situations in the individual participating Asian countries.

Prospective randomized controlled trial comparing treatment efficacy and tolerance of picosecond alexandrite laser with a diffractive lens array and triple combination cream in female asian patients with melasma.

BACKGROUND: Recent evidence suggests melasma to be a photoaging disorder. Triple combination creams (TCC: fluocinolone acetonide 0.01%, hydroquinone 4% and tretinoin 0.05%) remain the gold standard treatment. Picosecond alexandrite laser treatment using a diffractive lens array (DLA) has been identified to be effective for improving photoaging conditions. OBJECTIVE: We aimed to compare the efficacy and tolerance of the picosecond alexandrite laser with those of DLA and TCC in female Asian patients with melasma. METHODS: Twenty-nine patients were randomly assigned to group A1 (3 laser sessions at 4-week intervals), A2 (5 laser sessions at 4-week intervals) or B (TCC daily for at least 8 weeks and then tapered until the final evaluation). The Melasma Area, Severity Index (MASI) score and VISIA were assessed at baseline, week 12 and week 20. By week 20, the follow-up periods for groups A1 and A2 were 3 months and 1 month, respectively. RESULTS: Nine, 11 and 6 participants in groups A1, A2 and B completed the study, respectively. MASI scores were significantly improved in all 3 groups at weeks 12 and 20. In groups A1, A2 and B, the improvement rates at week 20 were 53%, 38% and 50%, respectively. VISIA® analysis additionally revealed a significant improvement in spots, porphyria, pores and brown spots after 3 laser sessions (P < 0.05). Group A2 showed greater improvements than group A1 in terms of spots, wrinkles and pores; however, only red areas were significantly different (P < 0.001). All side-effects in the 3 groups were transient and gradually subsided after 1-3 months. CONCLUSION: Picosecond alexandrite laser treatment using DLA showed comparable efficacy with TCC for the treatment of melasma. Improvements in texture, spots, wrinkles and pores were observed in the laser groups. Patients with melasma lesions that exhibit telangiectasia may benefit from additional laser treatment sessions.

[Characteristics of benign and malignant lesions of ampullary polyps and the accuracy of forceps biopsy].

OBJECTIVE: To distinguish the endoscopic and clinical features of ampullary polyps, to investigate the endoscopic cancer risk factors of ampullary polyps based on the compared differences of benign lesions and adenocarcinoma, and to assess the accuracy of forceps biopsy. METHODS: Authors retrospectively analyzed the data extracted from patients treated with endoscopic papillectomy (EP) from January 2009 to May 2019 in the Department of Gastroenterology, Peking University Third Hospital. Endoscopic pictures and pathology reports were reevaluated and analyzed. Differences between benign and cancer groups were conducted. RESULTS: In the study, 42 cases were involved, 35 to 83 years old, containing 83.3% older than 50 years old patients. The histological types were as follows, 2 for inflammatory polyps (4.8%), 1 for neuroendocrine tumor (2.4%), 1 for hyperplastic polyp (2.4%), 5 for grade Ⅰ adenoma (11.9%), 10 for grade Ⅱ adenoma (23.8%), 4 for grade Ⅲ adenoma (9.5%) and 19 for adenocarcinoma (45.2%), and 90.5% were adenoma or adenocarcinoma. The average age of benign group (inflammatory polyps and adenomas) was (56.7±9.2), which was significantly younger than that of adenocarcinoma group [(66.0±9.8), P=0.004]. Tumor diameter in adenocarcinoma group[(2.3±0.8) cm] was significantly larger than that in benign group[(1.6±0.6) cm, P=0.002]. Benign lesions only showed Yamada type Ⅰ(57.1%)and type Ⅱ(42.9%). The percentage of Yamada type Ⅰ (36.8%)and type Ⅱ(31.6%) in adenocarcinoma group was lower than that in benign group. Moreover, Yamada type Ⅲ (31.5%) was only found in the adenocarcinoma group. Significant differences were observed between the two groups in Yamada types (P=0.046). Most of the benign lesions had clear boundary(18/21, 85.7%). The percentage of clear boundary in adenocarcinoma group (2/19, 10.5%) was significantly lower than that in the benign group (P < 0.001). No significant differences were investigated in color (P=0.353) and surface (P=0.324) between benign and adenocarcinoma lesions. Pooling age, lesion diameter, Yamada type and clear boundary into Logistic regression analysis, only age (OR=1.186, 95%CI 1.025-1.373, P=0.022) and clear boundary (OR=66.218, 95%CI 3.421-1 281.840, P=0.006) were the independent cancer risk factors. Only 2 (10.5%) in the 19 cancer patients had positive biopsy results before EP. As compared with post-EP, 55.3% (21/38) biopsies were under-estimated, including 17 (17/19, 89.5%) adenocarcinomas and 4 (4/10, 40%) grade Ⅱ adenomas. CONCLUSION: adenoma and adenocarcinoma were the major histological type of ampullary po-lyps. Age and unclear boundary were the independent risk factors of ampullary adenocarcinoma. Forceps biopsy was not enough for ampullary polyp differentiation.

[Efficacy and safety of low-intensity pulsed ultrasound at different intervals by mechanical force in treating erectile dysfunction: a preliminary study].

Objective: To study the efficacy and safety of low-intensity pulsed ultrasound (LIPUS) at different intervals by mechanical force in treating erectile dysfunction (ED). Method: Forty patients with mild to moderate ED were randomized in a 1∶1 ratio to receive 16-treatment sessions of LIPUS in group A and group B, applied 3 times per week and 2 times per week, respectively. End-point assessments were made at 8th week after treatment. Efficacy were evaluated using International Index of Erectile Function-Erectile Function domain score (IIEF-EF), Erectile Hardness Score (EHS), Self-Esteem and Relationship Questionnaire (SEAR), Sexual Encounter Profile (SEP), Global Assessment Question (GAQ), and pain were assessed by Visual Analogue Score (VAS).Treatment response was confirmed by a minimal clinically importance difference (MCID) at 8th week. Results: Compared with baseline, IIEF-EF score [(17.1±5.48 vs 23.4±3.75, P<0.05) and (18.9±4.34 vs 24.1±4.32, P<0.05)], proportion of EHS 4 [(0 vs 40%, P<0.05) and (16.7% vs 55.6%, P<0.05)], and Overall Relationship score [(50.6 vs 67.5, P<0.05) and (44.4 vs 70.1, P<0.05)] were significantly improved at 8th week in two groups, respectively. Compared with baseline, the positive responses to SEP-3 increased significantly at 8th week in two groups (50.0% vs 80.0%,P<0.05) and (44.4% vs 88.9%, P<0.05), respectively. The positive responses to GAQ-2 were 90.0% and 88.9% at 8th week in two groups, respectively. There were no significant differences in IIEF-EF, EHS, SEAR, SEP and GAQ at 8th week between two groups. There was no significant difference in treatment response using MCID between two groups at end-point (80.5% vs 77.5%). The treatment duration for full sessions were 2.5 weeks less in group A than group B. No adverse effects were reported in all cases. Conclusion: LIPUS at two different intervals is effective and safe for mild to moderate ED, and the regimen at 3 times per week can achieve quite good effect in relatively short duration,while the long-term effects is still be clarified in further study.

[Novel compound heterozygous LoF mutations in SRD5A2 may result in disorders of sex development].

Objective: To investigate the novel genetic cause associated with hypospadias and the strategy for preventing offspring genetic defects in these patients. Methods: In March 2019, a patient with gonadal dysplasia (hypospadias associated with cryptorchidism) was referred to Shanghai General Hospital. His secondary sex characters, level of sex hormones and the development of male reproductive system was assessed through physical examination, sex hormone examination, male reproductive system B-ultrasound and computed tomography (CT). Whole-exome sequencing (WES) was preformed to investigate the pathogenic genetic variations associated with hypospadias and cryptorchidism. Also, Sanger sequencing was conducted to verify the WES results in the pedigree. Semen analysis was used to assess the fertility of the proband and the SRD5A2 gene analysis of his spouse was performed to assess the risk of genetic defects in the offspring. Results: The patient suffered from gonadal dysplasia (hypospadias associated with cryptorchidism). Physical examination showed an inverted triangular distribution of pubic hair, small penis and the volume of the testis was 8 ml. Sex hormone examination revealed the level of FSH, LH, Pituitary prolactin (PRL), estrogen (E(2)), testosterone (T), and sex hormone-binding globulin (SHBG) was 25.81 U/L, 10.84 U/L, 21.09 µg/L, 153 pmol/L, 16.95 nmol/L, and 36.15 nmol/L respectively. B-ultrasound and computed tomography (CT) showed left inguinal testis. Also, semen analysis illustrated that the volume was 0.05 ml and sperm concentration<2×10(6)/ml, suggesting oligospermia in this case. WES sequencing and Sanger sequencing showed compound heterozygous LoF mutations in SRD5A2 [NM_000348.3:C.679C>T(p.Arg227Ter) and NM_000348.3:C.16C>T(p.Gln6Ter)] in this patient. And there were no pathogenic genetic variations of SRD5A2 in the spouse. Conclusion: Novel compound heterozygous LoF mutations in SRD5A2[NM_000348.3:C.679C>T(p.Arg227Ter) and NM_000348.3:C.16C>T(p.Gln6Ter)] may be the primary cause of disorders of sex development.

Expression of Wnt-1 and TSLC1 in condyloma acuminatum.

BACKGROUND: Despite its high contagiousness, high recurrence rate and potential for malignant transformation, effective treatments for condyloma acuminatum (CA) have not yet been developed. Accordingly, it is necessary to clarify the mechanisms underlying CA development. AIM: To investigate the expression and significance of the proteins Wnt-1 and TSLC1 in patients with CA and in normal foreskin controls. METHODS: Wnt-1 and TSLC1 were assessed by immunohistochemistry in 45 patients with CA. RESULTS: Positive expression rates of Wnt-1 and TSLC1 were 82.22% (37/45) and 37.78% (17/45), respectively, in CA tissues, and 29.17% (7/24) and 91.67% (22/24), respectively, in normal foreskin controls. Wnt-1 expression intensity in CA was markedly higher (positive to strongly positive) than that in normal controls (negative to weakly positive), whereas TSLC1 expression intensity ranged from weakly positive to positive in CA, and nearly strongly positive in the normal control group. The differences in the positive expression rate and expression intensity of Wnt-1 and TSLC1 between the two groups were statistically significant (P < 0.05). In addition, Wnt-1 and TSLC1 were negatively correlated. (r = -0.336, P < 0.05). CONCLUSIONS: Overexpression of Wnt-1 and low expression of TSLC1 may be associated with the growth of CA. These findings may provide a basis for the development of therapies to prevent recurrence or malignant transformation of CA.

[Long-term effect of risk-adaptive therapy for early stage extranodal NK/T cell lymphoma].

Objective: This study aimed to evaluate the role of extended involved-field intensity modulated radiation therapy (IMRT) for patients with early stage extranodal nasal-type NK/T-cell lymphoma (NKTCL) in a single center, and to explore the long-term effect of risk-adaptive therapy. Methods: Among 238 patients with early stage NKTCL, there were 191 in high-risk group [any risk factor of age > 60, elevated serum lactate dehydrogenase (LDH), Eastern Cooperative Oncology Group (ECOG) score≥2, primary tumor invasion, or Ann Arbor stage Ⅱ] and 47 in low-risk group (no risk factor). A total of 204 patients received radiotherapy combined with chemotherapy, 15 received radiotherapy alone and 19 received chemotherapy alone. One-hundred and eighty-six patients had radiotherapy at a dose ≥50 Gy and 159 patients received chemotherapy with asparaginase-based regimen. Results: The 5-year overall survival (OS) rate and progression- free survival (PFS)rate of all patients were 66.2% and 57.5%. Five-year OS and PFS rates in low-risk group were 91.8% and 88.0%, while 59.3% and 49.3% in high-risk group. The survival of patients in low-risk group were better than those in high-risk group (both P<0.001). The five-year OS rate in combined therapy group, radiotherapy group and chemotherapy group were 71.7%, 52.3% and 20.7%, respectively (P<0.001). The five-year PFS rate were 63.5%, 23.3% and 24.1%, respectively (P<0.001). Among 219 patients receiving radiotherapy, the 5-year OS and PFS rate of patients with primary site radiotherapy dose ≥ 50 Gy were 72.6% and 66.1%, higher than those of patients with a dose <50 Gy (57.3% and 30.9%, respectively; P=0.031, P<0.001). In the high-risk group, the 5-year OS and PFS rate of the patients who received radiotherapy combined with more than 4 cycles of chemotherapy were 66.5% and 62.6%, higher than those of patients received less than 4 cycles of chemotherapy (56.7% and 46.4%, P=0.045 and 0.020, respectively). Cox multivariate analysis showed that ECOG score (HR=2.208, P=0.001), primary site (HR=4.887, P<0.001), primary tumor invasion (HR=3.265, P=0.001) and radiation dose (HR=1.895, P=0.011) were independent factors of OS in early NKTCL patients. Conclusion: Extended-involved field IMRT with radiation dose more than 50 Gy was the main treatment for patients with early stage NKTCL. Radiotherapy combined with adequate cycle chemotherapy significantly improved prognosis of high-risk patients.

[Comparative treatment analysis of upper gastroenterology submucosal tumors originating from muscularis propria layer: submucosal tunneling endoscopic resection versus endoscopic submucosal excavation].

OBJECTIVE: To evaluate the efficacy and safety of submucosal tunneling endoscopic resection (STER) and endoscopic submucosal excavation (ESE) for upper gastroenterology submucosal tumors (SMT) originating from the muscularis propria (MP) layer. METHODS: Clinicopathological and endoscopic data of 42 cases with upper gastroenterology tumors originating from the MP layer who were treated with STER (n=28) or ESE (n=14) between April 2013 and December 2016 in Peking University Third Hospital were retrospectively analyzed. The treatment and complications of the two groups were compared. RESULTS: In the study, 42 cases were all resected by therapeutic endoscopy successfully．There was no significant difference (STER vs. ESE) in gender, age, mean tumor size [1.5 (1.0-6.0) cm vs. 1.3 (0.5-2.0) cm, P=0.056]. STER was superior to ESE with reduced sutured time [3.5 (1.0-11.0) min vs. 8.0 (2.0-33.0) min, P=0.006], but more resection time [46.5 (11.0-163.0) min vs.19.5 (6.0-56.0) min, P=0.007]. There was statistical difference between the two groups in resection time or sutured time, but no significant difference (STER vs. ESE) in total operative time [52.0 (14.0-167.0) min vs. 31.5 (10.0-88.0) min, P=0.080]. En bloc resection rates (92.9% vs. 85.7%), hospital stay duration and complications (10.7 vs. 0.0) were similar in the STER and ESE groups. One case developed mediastinal emphysema and 2 pneumonia after operation in STER group, and all of them recovered uneventfully after conservative treatments; There were no complications in the ESE group. After operation, 28 cases of leiomyoma and 14 cases of stromal tumor were diagnosed by routine pathological and immunohistochemical staining. Among them, 6 cases of stromal tumors in group STER were all extremely low risk, 4 cases of stromal tumors in group ESE were extremely low risk, 4 cases of stromal tumors in group ESE were medium risk (the size of the lesion was about 1.0-2.0 cm, and mitotic figures counted (6-8)/50 high power field). The median follow-up time of all the patients was 46.5 (24-60) months, and the shortest follow-up time for medium risk stromal tumors was 32 months. No residual tumor, recurrence and implantation in the tunnel were observed. CONCLUSION: STER or ESE can be used as an effective and safe option for treatment of submucosal tumors originating from the muscularis propria of the upper digestive tract. Compared with STER, ESE had shorter resection time but longer wound closure time. There was no significant difference in total operation time.

[Comparison of the minimally invasive treatments of laparoscopic and endosopic for common bile duct stones after gastrojejunostomy].

OBJECTIVE: To explore the feasibility and to compare the merits and demerits of laparoscopic and endoscopic approach in removing common bile duct stones in patients with gastrojejunostomy after gastrectomy. METHODS: Between January 2012 and December 2016, 25 patients with common bile duct stones after gastrojejunostomy received laparoscopic or endoscopic treatment in our centers. They were divided into laparoscopic group and endoscopic group based on treatment approaches for common bile duct stones, including 15 patients in laparoscopic group and 10 in endoscopic group. The clinical characteristics and outcomes between the two groups were retrospectively analyzed. RESULTS: Among the 25 patients with gastrojejunostomy, the method of reconstruction was Billroth II in 21 patients and Roux-en-Y in 4 patients. Six patients received laparoscopic or endoscopic treatment during the acute cholangitis state. Among the laparoscopic group, 5 patients with stones more than 1 cm, 7 patients with multiple stones, while in the endoscopic group, 3 patients with stones more than 1 cm and 4 patients with multiple stones. Fourteen patients in the laparoscopic group with coexisting gallbladder stones, and 6 of their common bile duct stones were successfully removed by transcystic approach without T tube drainage. Stone removals were successful in 4 patients of the endoscopic group by a single performance, including 3 patients with single small stone and one patient with multiple small stones. Two patients in the laparoscopic group were converted to open surgery for severe adhesion and one patient in the endoscopic group turned to laparoscopic operation for failing of finding papilla in the Roux-en-Y anastomotic status. The median hospital stays were 12 d and 10 d, respectively in the laparoscopic and endoscopic group. There were 3 patients with postoperative complications, including one patient with paralytic ileus in the laparoscopic group and 2 patients with biliary pancreatitis or bacteremia in the endoscopic group, and all of them recovered uneventfully with conservative treatment. CONCLUSION: Both laparoscopic and endoscopic approaches are feasible for removing stones in the common bile duct in patients with gastrojejunostomy after gastrectomy, and they complement each other. In addition, both techniques are difficult to conduct, and a technical competence should be considered in selection of each method.

[Clinical characteristics and analysis of prognostic factors of 222 patients diagnosed with Hodgkin's lymphoma].

Objective: To analyze the clinical characteristics and prognostic factors of patients with Hodgkin's lymphoma(HL). Methods: The clinical data of HL patients who were newly treated in Guizhou Cancer Hospital from August 2007 to March 2019 was retrospectively collected, and the efficacy and prognostic factors were analyzed. Results: The clinical data of a total of 222 patients were analyzed in this study. The 5-year progression-free survival (PFS) and overall survival (OS)rate of them were 82.8% and 81.3%, respectively. The 5-year PFS rate and OS rate of early (stage Ⅰ-Ⅱ) HL were 87.3% and 86.1%, respectively, and the 5-year PFS rate and OS rate of progressive (stage Ⅲ-Ⅳ) HL were 77.9% and 76.3%, respectively. Among the 118 patients with early Hodgkin's lymphoma, the complete remission(CR) rate of chemotherapy alone was 55.6%(15/27), and chemotherapy plus radiotherapy was 86.8% (79/91), the difference between which was statistically significant (P<0.05). Compared with chemotherapy plus radiotherapy in early stage patients, 5-year PFS (93.0%) and 5-year OS (92.0%) rate in patients with chemotherapy plus radiotherapy were better than those with chemotherapy alone which were 63.7% and 62.1%, respectively. Multivariate analysis showed that age, LDH, ABVD cycle number and chemoradiotherapy were independent prognostic factors for 5-year OS and PFS rate in HL patients. The adverse reactions were increased level Ⅰ-Ⅱ aminotransferase with an incidence of 47.7% (106/222), decreased level Ⅰ-Ⅱ neutrophils with an absolute value of 54.1% (120/222), and decreased level Ⅲ-Ⅳ neutrophils with an absolute value of 45.9% (102/222). No adverse cardiac and pulmonary reactions or secondary tumors associated with chemotherapy was found in all patients. Conclusions: HL is a type of malignant tumor with good prognosis, and the short-term and long-term efficacy of chemotherapy combined with radiotherapy in early patients is better than that of chemotherapy alone. Age, LDH, ABVD cycle number and chemoradiotherapy are associated with prognosis in patients with Hodgkin's lymphoma. Adverse reactions can be tolerated.

[Clinical analysis of FRAX in the assessment of fracture risk in patients with rheumatic disease in three medical center].

Objective: The aim is to analyze the fracture risk in rheumatic patients by fracture risk assessment tool (FRAX), which is recommended by World Health Organization (WHO), so that we can prevent the occurrence of osteoporotic fracture earlier. Methods: Totally 617 participants, 204 out-patients with rheumatism, 204 in-patients with rheumatism and 209 healthy controls, from March to October in 2018 of Fourth Medical Center of PLA General Hospital, Jishuitan Hospital and China-Japan Friendship Hospital, were enrolled in this study. The probability of hip fracture (PHF) and major osteoporotic fracture (PMOF) in 10 years with FRAX were compared, and the differences between taking sleroids or not and with or without bone mass density (BMD) of femoral neck were evaluated. Correlation analysis was conducted between PHF, PMOF and clinical information, including age, disease duration, gender, steroid usage, osteocalcin, P1NP and ß-crosslaps. Results: There was no significant difference in PMOF within 10 years (3.455±2.690 vs 2.973±2.149 vs 3.323±1.828) among the three groups (P>0.05), but the PHF (0.986±1.619 vs 0.515±0.873 vs 0.149±0.311) was different (P<0.05). PHF and PMOF increased gradually with age. PMOF of patients without glucocorticoid therapy in 10 years was lower than that of patients with glucocorticoid (3.554±2.584 vs 2.857±2.238, P<0.05). There is no difference between the results of FRAX calculated with BMD or not (3.012±2.231 vs 3.207±2.601, P>0.05). PHF and PMOF were positively correlated with age, course of disease, glucocorticoid use and osteocalcin level, while PHF was negatively correlated with TP1NP among in-patients. Conclusion: The prevalence of 10-year hip fracture calculated by FRAX in rheumatism patients is higher than that of healthy group. FRAX can be used to calculate fracture risk without BMD. Combination of FRAX and bone turnover markers may be more effective in prediction of osteoporotic fracture in rheumatic patients.

[Comparison of endoscopic features between colorectal sessile serrated adenoma/polyp with or without cytologic dysplasia and hyperplastic polyp].

Objective: To investigate the morphological features of colorectal sessile serrated adenoma/polyp (SSA/P) and hyperplastic polyp (HP) by white light endoscope (WLE) and Image enhancement endoscope (IEE) . Methods: The data of 7 384 patients who underwent colonoscopy at the Center of Digestive Endoscopy, Peking University International Hospital from August 1, 2016 to February 29, 2018 were analyzed retrospectively. WLE and IEE[Fuji intelligent chromo endoscopy (FICE) or Blue Laser Imaging (BLI) ]were used to compare the morphological features of SSA/P with HP, SSA/P-CD(+)with SSA/P-CD(-). The diagnostic values of endoscopic features in SSA/P and SSA/P-CD(+)were analyzed. Results: A total of 3 401 polyps were detected in 7 384 patients, including 164 SSA/Ps (135 patients). During the same period, there were 270 HPs (223 patients) in accordance with the admission criteria. Compared with HP group, SSA/P group was more common in the right colon with a diameter>5 mm and more likely to be manifested as: Ⅱ-O pit pattern, surface mucus, cumulus-like surface, irregular morphology, VMV, redness, and also more likely to be associated with colon adenoma, colon cancer elsewhere in the colorectum. The differences were statistically significant (P<0.01). Compared with SSA/P-CD(-)group, SSA/P-CD(+)group was more common in the right colon with a diameter>5 mm and more likely to be manifested as: Ⅱ-O pit pattern, surface mucus, cumulus-like surface, irregular morphology, VMV. The differences were statistically significant (P<0.001). The differential diagnosis between SSA/P and HP was predicted by combining any two endoscopic morphological features (right colon, Ⅱ-O pit pattern, surface mucus, cumulus surface, irregular morphology, VMV, diameter>5 mm, at least 2 of 7 endoscopic features). The sensitivity, specificity, accuracy, positive likelihood ratio and negative likelihood ratio were 59.15%, 95.56%, 81.80%, 13.32 and 0.43, respectively. Similarly, the differential diagnosis between SSA/P-CD(+) and HP was predicted. The sensitivity, specificity, accuracy, positive likelihood ratio and negative likelihood ratio were 92.16%, 95.56%, 95.02%, 20.76 and 0.08, respectively. Conclusion: Comprehensive analysis of the WLE and FICE/BLI morphological features of the lesions can effectively distinguish SSA/P from HP, especially SSA/P-CD(+) from HP.

[Correlation between multi-slice spiral CT determined epicardial adipose tissue volume and atrial fibrillation].

Objective: To determine the relationship between volume of epicardial adipose tissue (EAT) and atrial fibrillation (AF) . Methods: A total of 207 patients who hospitalized in the Department of Cardiology, Nantong University Affiliated Hospital from January 2016 to June 2018 were included in this study. They were divided into two groups, including AF group (n=125) and sinus rhythm group (n=82). The AF group included 80 paroxysmal AF (PAF) and 45 persistent AF (PeAF) patients. Total EAT and left atrial EAT (LA-EAT) volume were measured using 256 rows of multi-slice spiral CT in all patients. Echocardiographic derived left ventricular ejection fraction (LVEF) and left atrial diameter (LAD) were analyzed. Hospholipase A2 and blood lipids were examined in all patients. The baseline data and EAT volume of all groups were compared. The multivariate logistic regression was used to analyze the risk factors related to the occurrence of AF. The correlation between total EAT volume and LA-EAT volume and LAD were analyzed by Pearson correlation. Result: The volume of total EAT in patients with sinus rhythm, AF, PAF and PeAF were (92.2±32.1), (136.0±46.0), (134.2±46.3) and (140.1±52.6)cm(3), respectively. The volume of LA-EAT in patients with sinus rhythm, AF, PeAF and PAF were (27.1±7.5), (39.2±19.2), (35.9± 17.0) and (45.1±21.5)cm(3), respectively. Total EAT and LA-EAT volume were significantly larger in PAF and PeAF groups than in sinus rhythm group (all P<0.01). The LA-EAT volume was larger in PeAF group than in PAF group (P<0.01), but total EAT volume was similar between two groups (P>0.05). Logistic regression analysis showed that total EAT volume (OR=1.202, 95%CI 1.083-1.334, P=0.001), LA-EAT volume (OR=1.051, 95%CI 1.003-1.101, P=0.037) and LAD (OR=1.019, 95%CI 1.005-1.032, P=0.006) were the independent related factors of AF. Pearson correlation analysis showed that the total EAT volume was positively correlated with LAD (r=0.466, P<0.01) and LA-EAT volume was positively correlated with LAD (r=0.290, P<0.01). Conclusion: The volume of total EAT and LA-EAT measured by 256-row multi-slice spiral CT is significantly correlated with the incidence of AF.