Objective: QL1604 is a highly selective, humanized monoclonal antibody against programmed death protein 1. We assessed the efficacy and safety of QL1604 plus chemotherapy as first-line treatment in patients with advanced cervical cancer. Methods: This was a multicenter, open-label, single-arm, phase II study. Patients with advanced cervical cancer and not previously treated with systemic chemotherapy were enrolled to receive QL1604 plus paclitaxel and cisplatin/carboplatin on day 1 of each 21-day cycle for up to 6 cycles, followed by QL1604 maintenance treatment. Results: Forty-six patients were enrolled and the median follow-up duration was 16.5 months. An 84.8% of patients had recurrent disease and 13.0% had stage IVB disease. The objective response rate (ORR) per Response Evaluation Criteria in Advanced Solid Tumors (RECIST) v1.1 was 58.7% (27/46). The immune ORR per immune RECIST was 60.9% (28/46).The median duration of response was 9.6 months (95% confidence interval [CI]=5.5–not estimable). The median progression-free survival was 8.1 months (95% CI=5.7–14.0). Fortyfive (97.8%) patients experienced treatment-related adverse events (TRAEs). The most common grade≥3 TRAEs (>30%) were neutrophil count decrease (50.0%), anemia (32.6%), and white blood cell count decrease (30.4%). Conclusion QL1604 plus paclitaxel-cisplatin/carboplatin showed promising antitumor activity and manageable safety profile as first-line treatment in patients with advanced cervical cancer. Programmed cell death protein 1 inhibitor plus chemotherapy may be a potential treatment option for the patient population who have contraindications or can’t tolerate bevacizumab, which needs to be further verified in phase III confirmatory study.

Objective: QL1604 is a highly selective, humanized monoclonal antibody against programmed death protein 1. We assessed the efficacy and safety of QL1604 plus chemotherapy as first-line treatment in patients with advanced cervical cancer. Methods: This was a multicenter, open-label, single-arm, phase II study. Patients with advanced cervical cancer and not previously treated with systemic chemotherapy were enrolled to receive QL1604 plus paclitaxel and cisplatin/carboplatin on day 1 of each 21-day cycle for up to 6 cycles, followed by QL1604 maintenance treatment. Results: Forty-six patients were enrolled and the median follow-up duration was 16.5 months. An 84.8% of patients had recurrent disease and 13.0% had stage IVB disease. The objective response rate (ORR) per Response Evaluation Criteria in Advanced Solid Tumors (RECIST) v1.1 was 58.7% (27/46). The immune ORR per immune RECIST was 60.9% (28/46).The median duration of response was 9.6 months (95% confidence interval [CI]=5.5–not estimable). The median progression-free survival was 8.1 months (95% CI=5.7–14.0). Fortyfive (97.8%) patients experienced treatment-related adverse events (TRAEs). The most common grade≥3 TRAEs (>30%) were neutrophil count decrease (50.0%), anemia (32.6%), and white blood cell count decrease (30.4%). Conclusion QL1604 plus paclitaxel-cisplatin/carboplatin showed promising antitumor activity and manageable safety profile as first-line treatment in patients with advanced cervical cancer. Programmed cell death protein 1 inhibitor plus chemotherapy may be a potential treatment option for the patient population who have contraindications or can’t tolerate bevacizumab, which needs to be further verified in phase III confirmatory study.

Objective: QL1604 is a highly selective, humanized monoclonal antibody against programmed death protein 1. We assessed the efficacy and safety of QL1604 plus chemotherapy as first-line treatment in patients with advanced cervical cancer. Methods: This was a multicenter, open-label, single-arm, phase II study. Patients with advanced cervical cancer and not previously treated with systemic chemotherapy were enrolled to receive QL1604 plus paclitaxel and cisplatin/carboplatin on day 1 of each 21-day cycle for up to 6 cycles, followed by QL1604 maintenance treatment. Results: Forty-six patients were enrolled and the median follow-up duration was 16.5 months. An 84.8% of patients had recurrent disease and 13.0% had stage IVB disease. The objective response rate (ORR) per Response Evaluation Criteria in Advanced Solid Tumors (RECIST) v1.1 was 58.7% (27/46). The immune ORR per immune RECIST was 60.9% (28/46).The median duration of response was 9.6 months (95% confidence interval [CI]=5.5–not estimable). The median progression-free survival was 8.1 months (95% CI=5.7–14.0). Fortyfive (97.8%) patients experienced treatment-related adverse events (TRAEs). The most common grade≥3 TRAEs (>30%) were neutrophil count decrease (50.0%), anemia (32.6%), and white blood cell count decrease (30.4%). Conclusion QL1604 plus paclitaxel-cisplatin/carboplatin showed promising antitumor activity and manageable safety profile as first-line treatment in patients with advanced cervical cancer. Programmed cell death protein 1 inhibitor plus chemotherapy may be a potential treatment option for the patient population who have contraindications or can’t tolerate bevacizumab, which needs to be further verified in phase III confirmatory study.

Objective To investigate the application value of tenofovir alafenamide fumarate (TAF) in elderly patients with chronic hepatitis B (CHB) and its influence on bones and kidneys. Methods A total of 36 CHB patients, aged ≥60 years, who received TAF antiviral therapy in Qingdao Municipal Hospital, The Affiliated Hospital of Qingdao University, Qingdao Sixth People's Hospital, Chengyang People's Hospital, and Jimo People's Hospital from June 2021 to October 2022 were enrolled in this study, and all patients received TAF (25 mg/d) antiviral therapy. Related data were collected at baseline and weeks 24 and 48 of treatment, including virological indicators, biochemical parameters, urinary protein electrophoresis indices, transient elastography (FibroScan), and bone mineral density. Virological indicators included high-sensitivity HBV DNA quantification; biochemical parameters included total bilirubin, direct bilirubin (DBil), indirect bilirubin (IBil), alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, gamma-glutamyl transpeptidase, total bile acid (TBA), glucose, blood urea nitrogen, creatinine, estimated glomerular filtration rate, and cystatin C (Cys C); urinary protein electrophoresis indices included urinary β2 microglobulin (β2-MG), urinary retinol (URBP), and urinary α1 microspherin (α1-MG). The paired t -test was used for comparison of normally distributed continuous data before and after treatment, and the Wilcoxon signed-rank test was used for comparison of non-normally distributed continuous data before and after treatment; the chi-square test or the Fisher's exact test was used for comparison of categorical data. Results A total of 36 CHB patients completed 24 weeks of follow-up. The complete virological response rate after 24 weeks of treatment was higher than that at baseline [83.3% (30/36) vs 77.8% (28/36), χ 2 =0.36, P =0.55], and there were significant reductions in DBil ( t =-2.42, P =0.02) and Cys C ( t =-4.34, P < 0.001) from baseline to week 24. A total of 18 CHB patients completed 48 weeks of follow-up. The complete virological response rate after 48 weeks of treatment was higher than that at baseline (94.4% vs 77.8%, χ 2 =2.22, P =0.34), and there were significant increases in IBil ( t =2.43, P =0.03), TBA ( Z =-2.24, P =0.03), and bone mineral density T score of lumbar vertebra ( t =2.92, P = 0.01) and femoral neck ( t =2.42, P =0.03) and a significant reduction in liver stiffness measurement ( t =-2.31, P =0.03). There were no significant changes in β2-MG, URBP, and α1-MG after treatment (all P > 0.05). Conclusion TAF has a good antiviral effect in CHB patients aged ≥60 years and can help more CHB patients achieve complete virological response, without causing damage to the kidney, and it can also improve bone mineral density and liver fibrosis degree.

  Objective  To study the demographic and clinical characteristics, correlation of genotype and phenotype and treatment of Blau syndrome to facilitate early diagnosis and timely treatment of Blau syndrome.  Methods  Seventy-two patients with Blau syndrome from 11 centers from May 2006 to April 2022 were retrospectively analyzed, and their general information, clinical data, laboratory examination and treatment medication were collected.  Results  The distribution of patients with Blau syndrome was uniform in geographical north and south of China, and there was no obvious gender bias. The mean age of onset was (14.30±12.81) months, and the age of diagnosis was (55.18±36.22) months. 35% of patients with Blau syndrome happened before 1 year old, and all patients developed before 5 years old. 87.50% (63/72) had granulomatous arthritis, 65.28% (47/72) had rash, 36.11% (26/72) had ocular involvement, 27.78% (20/72) had fever, and 15.28% (11/72) had pulmonary involvement. Arthritic manifestations of Blau syndrome were most at risk, followed by rash, ocular involvement, and fever.The first 25 months of the disease, the risk of developing a rash was the greatest. The risk of developing arthritis was the greatest between 25 months and 84 months. The main mutations were p.R334Q and p.R334W, and patients with p.R334Q mutation had relatively high incidence of fever (35.71%[5/14] vs. 14.29%[1/7], P=0.43) and ocular involvement (42.86%[6/14]vs. 28.57%[2/7], P=0.51). There was a relatively high incidence of rash (85.71%[6/7] vs. 64.29%[9/14], P=0.59) in patients with the p.R334W mutation. Forty-five patients(62.50%)were treated with a combina-tion of glucocorticoid and methotrexate. Twenty-two patients were treated with tumor necrosis factor antagonist in addition to glucocorticoid and methotrexate.  Conclusions  The risk of different clinical manifestations of Blau syndrome from high to low was arthritis, followed by rash, ocular involvement and fever. The main treatment was glucocorticoid combined with methotrexate, to which biological agents could be added.

Objective:To explore the effect of family integrated care (FIC) combined with intelligent health education platform in health education for elderly patients with stroke.Methods:Eighty patients with stroke were included from the Department of Neurology of the Second Affiliated Hospital of Chongqing Medical University from June 2019 to May 2020. They were divided into the experimental group and the control group ( n=40, respectively) by the random number table method. Patients in the control group received routine FIC in the Department of Neurology. Additional intelligent health education platform was provided for the experimental group to carry out intensive education. The modified Barthel index scale, self-care compliance scale and hospital anxiety and depression scale (HADS) were used before and after the intervention to evaluate patient′s self-care ability, self-care compliance and the degree of anxiety and depression. Results:Finally, 39 patients in the experimental group (1 case lost to followed-up) and 37 patients in the control group (3 cases lost to followed-up) completed the study. After the intervention, the scores of the modified Barthel index and self-care compliance scale of the experimental group were significantly higher than those of the control group [(65.9±12.6) vs (60.1±11.9) points, (78.2±13.6) vs (71.4±14.6) points], the HADS score was significantly lower than the control group [(15.18±2.46) vs (19.46±2.40) points] (all P<0.05). The scores of the modified Barthel index scale and self-care compliance scale of the experimental group after the intervention were significantly higher than those before the intervention [(65.9±12.6) vs (40.8±12.5) points, (78.2±13.6) vs (54.6±15.9) points] (all P<0.05), the HADS score was significantly lower than before the intervention [(15.18±2.46) vs (21.74±3.52) points] (all P<0.05). Similarly,the scores of the modified Barthel index and self-care compliance scale of the control group after the intervention were significantly higher than before the intervention [(60.1±11.9) vs (41.6±9.72) points, (71.4±14.6) vs (54.3±14.8) points], the HADS score was significantly lower than before the intervention [(19.46±2.40) vs (21.38±3.09) points] (all P<0.05). Conclusion:FIC combined with intelligent health education platform can significantly improve the self-care ability and self-nursing compliance of elderly stroke patients, and markedly improve the degree of depression and anxiety.

Objective To investigate the efficacy and limitation of endoscopic ultrasonography (EUS) on the diagnosis of gastrointestinal submucosal tumor (SMT) prior to endoscopic resection.Methods Data of 211 patients,who were confirmed as gastrointestinal SMT before operation and received endoscopic resection for gastrointestinal submucosal tumor at Department of Gastroenterology,Shanghai Ruijin Hospital from January 2016 to December 2018 were analyzed.The value and limitation of EUS for SMT were investigated according to the final pathology.Results For the lesion distribution,66 were in esophagus,108 in stomach,2 in duodenum and 35 in rectum.The accuracy of tumor origin by EUS was 99.5％ (210/211).The accuracy of tumor nature by EUS was 75.8％ (160/211).For the lesions originated from different locations,the diagnostic accuracy for lesion originated from esophageal mucosa/submucosa,esophageal muscularis propria,gastric mucosa/submucosa,gastric muscularis propria,duodenal submucosa,rectal mucosa/submucosa by EUS were 90.0％ (54/60),83.3％ (5/6),31.0％ (13/42),89.4％ (59/66),50.0％(1/2),82.9％ (29/35),respectively.With respect to hypoechoic lesions,leiomyoma,leiomyoma/gastrointestinal stromal tumor,and neuroendocrine tumor were the predominant type of tumor originated from esophageal mucosa,gastrointestinal muscularis propria and rectal mucosa/submucosal,respectively.Conclusion Although EUS is indispensible for the diagnosis of gastrointestinal submucosal tumor,it plays a limited role in the differential diagnosis of various lesions originated from gastric mucosa and submucosa.Since part of the submucosal tumors may be potential for malignant development,an diagnosis made by EUS should be more careful.

Objective To study the differences of clinical manifestations,etiology and hospitalized outcomes of purulent meningitis in preterm and term infants.Method All preterm and term infants with purulent meningitis hospitalized in the Hospital from 2006 to 2015 were enrolled in this study.The data of neonate's condition,maternal condition,clinical manifestations,complications,etiology,treatment and outcomes of the preterm and term infants groups were compared.Result During the study period,44 preterm infants and 118 term infants were included.The time of onset for purulent meningitis of preterm infants group was statistically earlier than that of term infants group [11.2 (3.2,19.8) d vs.14.3 (5.6,23.9) d,P ＜ 0.05].The prognosis of preterm infants group was statistically worse than that of term infants group (P ＜ 0.05).Among them,the incidences of clinical manifestations in preterm infants group compared to term infants group were:fever (54.5％ vs.78.8％),seizure (11.4％ vs.26.3％),lethargy and poor response (59.1％ vs.38.1％),slow weight gain (9.1％ vs.0％),apnea (45.5％ vs.0.8％) and cyanosis (15.9％ vs.4.2％);all the differences between two groups were significant (P ＜ 0.05).The time of onset for purulent meningitis with complications was statistically earlier than those without complications [9.5 (4.1,20.5) d vs.13.8 (5.9,22.0) d,P＜0.05].The duration of treatment for purulent meningitis with complications was longer than that without complications [(42.2 ± 8.8) d vs.(28.7 ± 7.1) d,P ＜ 0.05],and the positive rate of pathogens was also statistically higher than those without complications (73.8％ vs.26.7％,P ＜0.05).Coagulase-negative staphylococcus was the main pathogen for both preterm and term infants group.Klebsiella pneumoniae was more common in preterm infants group than in term infants group (40.0％ vs.10.4％,P ＜0.05).Conclusion Preterm infants with purulent meningitis had early onset time,atypical clinical manifestations,and poor prognosis.The treatment course for purulent meningitis with complications is prolonged.The pathogens for neonatal purulent meningitis have already changed.The detection rate of conditional pathogens is increasing yearly,for which the clinicians should take note seriously.

Objective To investigate the clinical efficacy of auricular point therapy for chronic fatigue syndrome.Methods Eighty patients with chronic fatigue syndrome were randomly allocated to treatment and control groups, 40 cases each. The treatment group received ear acupuncture plus auricular plaster therapy and the control group, conventional acupuncture. The overall symptom was scored, the Fatigue Assessment Instrument (FAI) score was recorded and immunoglobulins (IgA, IgG and IgM) were measured in the two groups before treatment and after four courses.Results There were statistically significant pre-/post-treatment differences in the overall symptom score, the FAI score and immunoglobulins in the two groups (P<0.05). There were statistically significant post-treatment differences in the FAI score, and IgA and IgG between the treatment and control groups (P<0.05). Conclusion Auricular point therapy is an effective way to treat chronic fatigue syndrome.

Objective To observe the effect of combining virtual reality technology with occupational thera-py in treating children with spastic hemiplegia resulting from cerebral palsy. Methods Thirty-eight spastic and hemiplegic children with cerebral palsy were randomly divided into a treatment group ( n=18) and a control group ( n=20) . Both groups received occupational therapy, while the treatment group was additionally provided with virtual reality-based treatment. The sessions lasted 30 min, 6 times a week for 3 months. Before and after the treatment the upper extremity motor function of both groups was assessed using the fine motor quotients of the Peabody developmen-tal motor scale, the Caroll hand function scale and a activities of daily life scale. Results Before the treatment there was no significant difference between the two groups in terms of any of the measurements. After the 3 months, significant improvement was observed in both groups, but the improvement of the treatment group was significantly greater than that of the control group. Conclusion Virtual reality technology can further improve the motor function of the upper ex-tremities and ability in the activities of daily life beyond that achievable through occupational therapy alone.