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 investigate the seroepidemiological status of Toxoplasma gondii among humans, dogs and cats and its influencing factors in three counties of Yunnan Province, and to assess the risk of dogs and cats transmitting Toxoplasma gondii to humans and causing disease and epidemics. Methods:Three pestis foci of demestic rodent in Mile City, Mang City and Lianghe County in Yunnan Province were selected as the investigation areas, and blood samples of humans, dogs and cats from 16 natural villages were collected. Serum IgG antibodies against Toxoplasma gondii were detected by indirect enzyme-linked immunosorbent assay, and the influencing factors were analyzed by logistic regression. Results:A total of 368 human serum samples, 307 dog serum samples, and 12 cat serum samples were tested. The positive rates of serum IgG antibodies against Toxoplasma gondii in humans, dogs and cats were 54.62% (201/368), 90.88% (279/307), and 91.67% (11/12), respectively. Logistic regression analysis showed that the risk of Toxoplasma gondii infection (serum IgG antibodies positive) in humans of Mang City and Lianghe County were 8.20 times ( AOR = 8.20, 95% CI: 4.38 - 15.36) and 2.22 times ( AOR = 2.22, 95% CI: 1.24 - 3.97) higher than those in Mile City, respectively, and the risk of Toxoplasma gondii infection (serum IgG antibodies positive) in humans in the age group of 30 - < 40 years old decreased by 57% compared to the age group of 30 years old ( AOR = 0.43, 95% CI: 0.19 - 0.98, P < 0.10). The risk of Toxoplasma gondii infection (serum IgG antibodies positive) in dogs of Lianghe County was 89% lower than that in Mile City ( AOR = 0.11, 95% CI: 0.02 - 0.47). The risk of Toxoplasma gondii infection(serum IgG antibodies positive) in dogs aged 2 years old and older was 2.05 times higher than that in dogs aged younger than 2 years old ( AOR = 2.05, 95% CI: 0.91 - 4.64, P < 0.10). Conclusions:The positive rates of serum IgG antibodies against Toxoplasma gondii in humans, dogs and cats in the three counties where the three pestis foci of demestic rodent are located in Yunnan Province is relatively high. The risk of Toxoplasma gondii infection (serum IgG antibodies positive) in humans, dogs is related to the region and age. The risk of dogs and cats transmitting Toxoplasma gondii to humans and other animals is relatively high. It is necessary to strengthen monitoring in key regions, carry out health education, and take corresponding health measures.

Objective To explore the application effect of negative pressure sealing drainage combined with active factor dressing and flap transfer in Gustilo Ⅲ type tibiofibular fractures.Methods From March 2019 to March 2022,92 patients with Gustilo type Ⅲ tibiofibular fracture admitted to the Department of Orthopaedics of the Third People's Hospital of Zhangjiagang City were randomly divided into the experimental group(internal and external fixation+flap transfer+negative pressure sealing drainage+active factor dressing,n=46)and the control group(internal and external fixation+flap transfer+conventional dressing change+active factor dressing,n=46),and the clinical indexes,clinical efficacy,ankle joint function,lower limb function and complications were compared.Result The hospital stay time(25.32±8.36)d,the flap healing time(9.69±1.24)d,the fracture healing time(8.24±1.84)month and the wound healing time(14.24±3.84)d of the experimental group were shorter than those of the control group(43.44±11.84)d,(11.53±2.07)d and(9.12±2.50)month,(50.11±5.12)d(P＜0.05).The total effective rate of the experimental group(93.48％,43 cases/46 cases)was higher than that of the control group(71.74％,33 cases/46 cases,P＜0.05).The ankle pain scores of both groups after treatment were lower than before treatment,and the experimental group was lower than the control group,and the scores of ankle function and stability,the scores of American Association of Foot and Ankle Surgery(AOFAS)and the knee joint score of American Hospital for Special Surgery(HSS)after treatment were higher in both groups than before treatment,and the experimental group was higher than the control group(P＜0.05).The total complication rate of the experimental group(4.34％,2 cases/46 cases)was lower than that of the control group(17.39％,8 cases/46 cases,P＜0.05).Conclusion The application of negative pressure closed drainage combined with active factor dressing in Gustilo typeⅢ tibia and fibula fracture is effective,can promote postoperative wound recovery,improve ankle and lower limb function,and the incidence of complications is low.

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.

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 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.

Objective:To study influence of renal sympathetic denervation (RDN)on cardiac function of dogs with heart failure (HF).Methods:A total of 40 dogs were randomly and equally divided into RDN group [received bilat- eral renal artery radiofrequency ablation (RFA)]and model group (only received femoral puncture).Pacemaker was implanted in every dog,and dog HF model was established using rapid right ventricular pacing.Cardiac and re-nal function indexes,BNP and sympathetic activity index levels were observed and compared between two groups be- fore RFA/sham operation,instant and four weeks after model establishment.Results:After operation four weeks, compared with model group,there were significant reductions in levels of epinephrine (E)[(362.69±42.54)ng/ml vs.(290.36±42.32)ng/ml],renin (R)[(305.46± 39.68)ng/ml vs.(230.04±32.80)ng/ml],aldosterone (AD)[(408.00±38.56)ng/ml vs.(246.00± 48.37)ng/ml],angiotensin Ⅱ (ATⅡ)[(280.00±48.08)pg/ml vs.(172.00±25.04)pg/ml]and norepinephrine (NE)[(425.65±50.54)ng/ml vs.(316.76±46.29)ng/ml]in RDN group (P<0.05 all);there were significant reductions in HR,respiratory rate (RR)and BNP level in RDN group,P<0.05 all;there were significant rise in SBP,LVEF,CO,CI,left ventricular pressure maximal rising rate (+dp/dtmax),left ventricular pressure maximal dropping rate (-dp/dtmax)and left ventricular end-systolic pressure (LVESP),and significant reductions in left ventricular end-systolic dimension (LVESd),left ventricular end-diastolic dimension (LVEDd)and left ventricular end-diastolic pressure (LVEDP)in RDN group,P<0.05 all.Conclusion:RDN can decrease renal sympathetic activity,improve heart function,inhibit myocardial remode- ling,its therapeutic effect is significant

Objective To discuss the etiology and clinical characteristics of human rhinovirus (HRV) as pathogen of central nervous system infection .Methods Two hundred and five cerebrospinal fluid (CSF) specimens were collected from children with fever and convulsions who were admitted to the pediatric intensive care unit with suspicion of central nervous system infection from June 2011 to December 2012 .Genome Lab Genetic Analysis System (GeXP) was applied to detect HRV from CSF .Specimens with positive results were amplified by nested reverse transcription‐polymerase chain reaction and followed by gene sequencing . Clinical data of HRV positive cases were analyzed . Results Of the 205 CSF specimens ,7 samples were positive for HRV ,which were composed of 2 HRV‐A ,1 HRV‐B and 4 HRV‐C (including 1 HRV‐Ca) .There were 6 boys and 1 girl among the 7 positive cases for HRV .Six children were less than 3 years old ,except one was 9 years old .The onset time was mainly concentrated between September and October . The main clinical manifestations were fever and convulsions . The clinical diagnosis before the pathogen confirmation included viral encephalitis ,epilepsy ,febrile convulsion ,benign infantile convulsions with mild gastroenteritis (CwG ) and hand‐foot‐and‐mouth disease ( HFMD ) . Although the disease severity of the 7 cases varied ,all ended with favorable prognosis .Conclusions HRV is one of pathogens of viral central nervous system infection .All types of HRV can cause central nervous system infection ,among which HRV‐C accounts for the majority .The clinical manifestations of HRV central nervous system infection could mimic febrile convulsion ,CwG and HFMD .

To investigate the anti-inflammatory, analgesia and antipyretic effects of Chaige Qingre granules. Meth-ods:Kunming mice were used to make auricle swelling model by dimthylphenanthrene, and the auricle swelling degree was measured to test the anti-inflammatory effect of Chaige Qingre granules. Mice were used to make pain models by acetic acid, and the body twis-ting of the mice was counted to observe the analgesia effect of the granules. The fever model in rats was induced by yeast, and the body temperature of the rats was measured to investigate the antipyretic effects of the granules. Results:Chaige Qingre granules could relieve the auricle swelling degree significantly, and the inhibition rate was 46. 3% in the high dose group. High and middle dose groups could reduce the body twisting frequency with the inhibition rate of 51. 1% and 61. 8%, respectively. Every Chaige Qingre granules group could lower the body temperature after one hour of the administration, and the temperature could be reduced 0. 56 degrees Celsius in the high dose group. Conclusion:Chaige Qingre granules can effectively inhibit auricle swelling degree, relieve pain and reduce heat.

Objective To compare the safety and efficacy between flexible ureteroscope lithtripsy (FURL) and percutaneous nephrolithotomy (PCNL) in treating the renal calculus.Methods From Jan.2012 to Oct.2013,120 male and 87 female patients with renal calculus were accepted FURL (n =108)or PCNL (n=99) in our hospital.In FURL group,108 cases were classified according to the diameter of the stone,including 33 patients with the diameter of renal stone more than 20mm (range 20-39 mm,mean 29.2±5.6 mm)and 75 patients with the diameter of renal stone less than 20 mm (range 13-19 mm,mean 16.8± 1.3 mm).In PCNL group,99 cases were also classified according to the diameter of the stone,including 51 patients with the diameter of renal stone more than 20 mm (range 20-45 mm,mean 30.4±6.6 mm)and 48 patients with the diameter of renal stone less than 20 mm (range 14-19 mm,mean 17.2±1.4mm).There were no significant differences between the groups FURL and PCNL in the stone size(P＞0.05).Demographic data,operative duration,postoperative hospital stay,complication rate,and stone-free rate were recorded and compared.Results The overall stone free rate in group FURL was significantly lower 80.6％ (87/108) than that in group PCNL 91.9％ (91/99) (P＜0.05).In those patients with the diameter of stones less than 20 mm,the stone free rate was 88.0％ (66/75) in group FURL vs 93.8％ (45/48) in group PCNL (P＞0.05).The operative time was 30-65 (mean 49.5±6.9) min and 30-65 (mean 46.9±7.2) min in FURL and PCNL group,respectively (P＞0.05).In those patients with the diameter of stones more than 20 mm,the stone free rate was 63.6％ (21/33) in group FURL,which was lower than that in group PCNL 90.2％ (46/51) (P＜0.05).The operative time was 60-115 min (85.0±16.3) min and 30-95 min (68.3± 16.7) min in FURL and PCNL group,respectively (P＜0.05).The overall complication rate was significantly lower in group FURL 2.8％ (3/108) compared to group PCNL 8.1％ (8/99) (P＜0.05).Postoperative hospitalization stay were 2-6 d (3.5±1.4) d and 3-9 d (5.8±1.9) d in FURL and PCNL group,respectively (P＜0.05).Conclusions Both PCNL and FURS are efficacy and safe surgical alteration for patients with renal calculus.As to the FURS,its merits were faster recovery,less invasiveness than those in PCNL.Therefore,it can be considered as the first-line treatment for renal calculus ＜20 mm.However,for renal calculus ≥20 mm stones,FURS is still effective.