Objective:To assess the clinical effectiveness and safety of Omalizumab for treating pediatric allergic asthma in real world in China.Methods:The clinical data of children aged 6 to 11 years with allergic asthma who received Omalizumab treatment in 17 hospitals in China between July 6, 2018 and September 30, 2020 were retrospectively analyzed.Such information as the demographic characteristics, allergic history, family history, total immunoglobulin E (IgE) levels, specific IgE levels, skin prick test, exhaled nitric oxide (FeNO) levels, eosinophil (EOS) counts, and comorbidities at baseline were collected.Descriptive analysis of the Omalizumab treatment mode was made, and the difference in the first dose, injection frequency and course of treatment between the Omalizumab treatment mode and the mode recommended in the instruction was investigated.Global Evaluation of Treatment Effectiveness (GETE) analysis was made after Omalizumab treatment.The moderate-to-severe asthma exacerbation rate, inhaled corticosteroid (ICS) dose, lung functions were compared before and after Omalizumab treatment.Changes in the Childhood Asthma Control Test (C-ACT) and Pediatric Asthma Quality of Life Questionnaire (PAQLQ) results from baseline to 4, 8, 12, 16, 24, and 52 weeks after Omalizumab treatment were studied.The commodity improvement was assessed.The adverse event (AE) and serious adverse event (SAE) were analyzed for the evaluation of Omalizumab treatment safety.The difference in the annual rate of moderate-to-severe asthma exacerbation and ICS reduction was investigated by using t test.The significance level was set to 0.05.Other parameters were all subject to descriptive analysis.A total of 200 allergic asthma patients were enrolled, including 75.5% ( n=151) males and 24.5% ( n=49) females.The patients aged (8.20±1.81) years. Results:The median total IgE level of the 200 patients was 513.5 (24.4-11 600.0) IU/mL.Their median treatment time with Omalizumab was 112 (1-666) days.Their first dose of Omalizumab was 300 (150-600) mg.Of the 200 cases, 114 cases (57.0%) followed the first Omalizumab dosage recommended in the instruction.After 4-6 months of Omalizumab treatment, 88.5% of the patients enrolled ( n=117) responded to Omalizumab.After 4 weeks of treatment with Omalizumab, asthma was well-controlled, with an increased C-ACT score [from (22.70±3.70) points to (18.90±3.74) points at baseline]. Four-six months after Omalizumab administration, the annual rate of moderate-to-severe asthma exacerbation had a reduction of (2.00±5.68) per patient year( t=4.702 5, P<0.001), the median ICS daily dose was lowered [0 (0-240) μg vs. 160 (50-4 000) μg at baseline] ( P<0.001), the PAQLQ score was improved [(154.90±8.57) points vs. (122.80±27.15) points at baseline], and the forced expiratory volume in one second % predicted (FEV 1%pred) was increased [(92.80±10.50)% vs. (89.70±18.17)% at baseline]. In patients with available evaluations for comorbidities, including allergic rhinitis, atopic dermatitis or eczema, urticaria, allergic conjunctivitis and sinusitis, 92.8%-100.0% showed improved symptoms.A total of 124 AE were reported in 58 (29.0%) of the 200 patients, and the annual incidence was 0(0-15.1) per patient year.In 53 patients who suffered AE, 44 patients (83.0%) and 9 patients (17.0%) reported mild and moderate AE, respectively.No severe AE were observed in patients.The annual incidence of SAE was 0(0-1.9) per patient year.Most common drug-related AE were abdominal pain (2 patients, 1.0%) and fever (2 patients, 1.0%). No patient withdrew Omalizumab due to AE. Conclusions:Omalizumab shows good effectiveness and safety for the treatment of asthma in children.It can reduce the moderate-to-severe asthma exacerbation rate, reduce the ICS dose, improve asthma control levels, and improve lung functions and quality of life of patients.

Objective:To assess the prognosis of sinonasal adenoid cystic carcinoma with hard palatine invasion treated by transnasal endoscopic total maxillectomy. Methods:Clinical data of twenty-six patients with sinonasal adenoid cystic carcinoma invading hard palatine treated by transnasal endoscopic total maxillectomy between May 2014 and December 2020 was analyzed retrospectively. Survival rate, local recurrence and distant metastasis were analyzed using Kaplan-Meier method. Cox regression was used to investigate the prognosis factors. Masticatory function after maxillectomy has also been assessed using the questionnaire of patients' satisfaction about masticatory function. Results:Margins in 8 patients（30%） were positive. The median time of follow-up was 38 months（6 to 85 months）. Twenty-five patients recurred. Four patients died of distant metastasis. The 5-year overall survival rate and relapse-free survival rate was 79.5% and 89.1%, respectively. Independent predictors of outcome on multivariate analysis were positive margin（P=0.018）, recurrence（P=0.006） and distant metastasis（P=0.04）. Conclusion:Transnasal endoscopic total maxillectomy could be performed for the treatment of the sinonasal adenoid cystic carcinoma with hard palatine invasion. Positive margin, local recurrence and distant metastasis were important predictors for patients' prognosis.
Humans ; Carcinoma, Adenoid Cystic/pathology* ; Paranasal Sinus Neoplasms/pathology* ; Retrospective Studies ; Neoplasm Recurrence, Local/pathology* ; Prognosis

Humans ; Waldenstrom Macroglobulinemia/genetics* ; East Asian People ; Chromosome Aberrations ; Lymphoma

ObjectiveTo evaluate the reliability of Foot Posture Index (FPI-6) for Chinese adolescent idiopathic scoliosis (AIS) patients. MethodsFrom July, 2021 to April, 2022, 35 AIS patients were recruited from Guangdong Second Hospital of Traditional Chinese Medicine and non-specially. They were evaluated with FPI-6 by two raters on the same days, and by one of the raters a week later. The intra-class correlation coefficient (ICC) of inter-rater and test-retest was calculated and Bland-Altman diagram was drawn; the correlation among the items score and total score was analyzed with Spearman correlation coefficient. ResultsThe ICCs were above 0.75 except talar head palpation, and eversion and inversion of the calcaneus. There was no significant difference in foot posture classification among the three evaluation results (χ² = 4.000, P > 0.05). There was a significant positive correlation between each item score and total score (r > 0.3, P < 0.01). ConclusionFPI-6 is reliable for people with mild AIS.

Objective:To investigate the feasibility of endoscopic salvage surgery for patients with rT2 recurrent nasopharyngeal carcinoma (rNPC) and to analyze their prognostic factors.Methods:The clinical data of 33 patients with rT2 rNPC who underwent endoscopic extended nasopharyngectomy in Eye & ENT Hospital Affiliated to Fudan University from January 2015 to July 2020 were analyzed, including 29 males (87.9%) and 4 females (12.1%), aging (51.7±10.6) years. The clinicopathological characteristics of these patients were recorded and analyzed, in terms of gender, sex, alcohol and cigarette use, interval between primary treatment to recurrence, adjuvant therapy, lymph node metastasis, internal carotid artery (ICA) invasion, necrosis, margin and reconstruction materials. Kaplan Meier analysis was used to plot the overall survival rate and progression free survival rate curve, Log-rank test was used to analyze the prognostic factors among patients, and multivariate Cox proportional hazards regression was used to determine the independent risk factors of tumor progression free survival.Results:Among 33 patients with rT2 rNPC, the recurrence interval of 24 patients with rNPC after primary radiotherapy was more than 2 years. A total of 25 patients received primary radiotherapy and adjuvant chemotherapy at the same time. There were 6 cases with cervical lymph node metastasis, 12 cases with ICA invasion, 8 cases with positive surgical margin, 7 cases underwent ICA embolization before operation. A total of 18 cases underwent pedicled tissue flap repairment after operation, including 12 pedicled nasal septal mucosa flaps and 6 temporalis muscle flaps. The median follow-up time was 15 months. Five patients died because of disease progression (in 2 cases), post surgical ICA hemorrhage (in 1 case), liver metastasis (in 1 case) and dysphagia (in 1 case). The 1-year, 2-year and 3-year overall survival rates of all patients were 93.9%, 81.8% and 81.8%, respectively. The 1-year, 2-year and 3-year progression free survival rates were 74.7%, 59.7% and 40.9%, respectively. Log-rank statistical analysis showed that the positive surgical margin ( P=0.060) and recurrence interval ( P=0.151) were possibly related to the prognosis of rT2 rNPC. Multivariate Cox regression analysis showed that the positive surgical margin was an independent risk factor for patients with rT2 rNPC ( P=0.034). Nasopharynx hemorrhage occurred in 4 patients, skull base bone necrosis occurred in 2 patients, trismus occurred in 3 patients, and no obvious brain complications occurred in 7 patients with ICA embolization. Conclusion:Endoscopic salvage surgery for rT2 rNPC is a safe and effective surgical option, but the long-term effect still needs long-term follow-up in bulk cases.

Objective:The study aims to explore the clinical and biological characteristics of patients with non-IgM lymphoplasmacytic lymphoma (LPL) .Methods:The clinical data of 340 patients with LPL admitted to the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College were collected retrospectively, including 23 cases of the non-IgM LPL and 317 cases of the Waldenstr?m's macroglobulinemia (WM) , from July 1993 to August 2020. The clinical and biological characteristics of the two groups were compared.Results:Among 23 patients with the non-IgM type LPL, two patients secreted monoclonal IgA, 14 patients secreted monoclonal IgG, and seven patients did not secrete monoclonal immunoglobulin. The median age of the non-IgM LPL and WM were both 62 (35-81) years old. Compared with the WM group, the proportion of women (56.5% vs 27.3%, P=0.007) , the proportion of splenomegaly (60.1% vs 43.8%, P=0.100) , and the proportion of extranodal invasion (21.7% vs 12.3%, P=0.672) in non-IgM LPL group were higher. Eighteen patients were tested for MYD88 gene mutation, and the overall mutation rate of MYD88 was 55.6%. In the non-IgM LPL group, a total of 17 patients received treatment, which had a comparable proportion (94.4% vs 92.7%, P=0.488) to the WM group. Sixteen patients were evaluated for efficacy, and the overall remission rate of the first-line treatment was 87.5%. The median follow-up time was 33.9 (3.5-125.1) months, and the median PFS and OS were both not reached. The 3-year PFS and OS rates were 71.4% and 68.9%, respectively. In the WM group, the median PFS was 66.2 months and the median OS was 78.1 months. Compared with the WM group, in the non-IgM group no significant differences in PFS ( P=0.340) and OS ( P=0.544) were seen. Conclusion:The clinical and biological characteristics of the non-IgM LPL and WM patients were similar. However, the proportion of women and extranodal involvement were higher in the non-IgM LPL group. The survival and prognosis of the non-IgM LPL patients were similar to those of the WM patients.

Objective:To investigate the efficiency and pharmacoeconomics of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) for mobilization of peripheral blood stem cells (PBSCM) in patients with multiple myeloma (MM).Methods:The data of 91 patients with newly treated MM who were hospitalized in the First Hospital of Jilin University and Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College from January 2015 to October 2017 were retrospectively analyzed. According to the patient's wishes, a high-dose chemotherapy combined with subcutaneous injection of PEG-rhG-CSF or recombinant human granulocyte colony-stimulating factor (rhG-CSF) was used for stem cell mobilization in 42 and 49 patients, respectively. The number of mononuclear cells (MNC) and CD34 + cells collected after mobilization, the maximum absolute neutrophil count (mANC), the cost of mobilization, and the engraftment time of white blood cells and platelets after transplantation were compared between the two groups. Results:The median number of MNC collected after mobilization in the PEG-rhG-CSF group and rhG-CSF group were 5.86×10 8/kg [(1.08-24.54)×10 8/kg] and 6.61×10 8/kg [(0.83-33.80)×10 8/kg], and the difference was not statistically significant ( U = 883.00, P = 0.245); while the median number of CD34 + cells collected after mobilization in the PEG-rhG-CSF group was higher than that in the rhG-CSF group [5.56×10 6/kg (0.94-19.90)×10 6/kg and 4.82×10 6/kg (1.12-14.61)×10 6/kg], and the difference was statistically significant ( U = 732.00, P = 0.038). The median number of mANC during mobilization in the PEG-rhG-CSF group was lower than that in the rhG-CSF group [20.50×10 9/L (7.26-61.30)×10 9/L and 32.08×10 9/L (6.92-69.99)×10 9/L], and the difference was statistically significant ( U = 490.00, P = 0.001). After autologous stem cell transplantation (ASCT), the time-to-recovery of white blood cell count (WBC) to 1.0×10 9/L in the PEG-rhG-CSF group was shorter than that in the rhG-CSF group [(11.59±1.98) d vs. (12.93±2.83) d], and the difference was statistically significant ( t = -2.395, P = 0.019), and the time-to-recovery of platelet count (Plt) to 20.0×10 9/L in the PEG-rhG-CSF group was also shorter than that in the rhG-CSF group [(12.86±2.62) d vs. (14.80±5.47) d], but the difference was not statistically significant ( t = -1.749, P = 0.085). The total mobilization cost of the PEG-rhG-CSF group was not statistically different from that of the rhG-CSF group [(21 405.47±7 365.98) yuan vs. (22 976.83±10 264.34) yuan, t = -0.721, P = 0.474]. Conclusions:PEG-rhG-CSF combined with high-dose chemotherapy is an effective option for PBSCM in MM patients, and its mobilization cost is equivalent to rhG-CSF. Therefore, PEG-rhG-CSF may be a better choice for PBSCM in MM patients.

Objective:To disclose the expression and correlation of E6, E7 and PD-L1 in cervical squamous cell carcinoma (CSCC) tissues and explore the immune regulation of E6, E7 on PD-L1.Methods:The expressions of E6, E7 and PD-L1 in human papillomavirus (HPV) negative normal cervical tissue, cervical intraepithelial neoplasia (CIN) tissue and HPV16, 52 and 58 positive CSCC tissue were detected by Western blot (WB). HPV16 positive CSCC and HPV negative CSCC tissues were used for primary cell isolation, identification and culture. E6, E7 small interfering RNAs (siRNAs) were constructed and transfected into HPV16 positive CSCC cells via liposomes.The expression of PD-L1 in the cells was detected by WB. Plasmids of E6, E7 gene were constructed and overexpressed in HPV negative CSCC cells to detect the expression of PD-L1.Results:The expression of E6, E7 and PD-L1 was not detected in the HPV negative normal cervical. While in the HPV16, 52, 58 positive CSCC tissue group, the expression of all the three were significantly higher than that in the CIN group ( P<0.01). Primary HPV16 positive CSCC and HPV negative CSCC cells were successfully isolated and cultured, which were named as H16CC cell lines and HNCC cell lines respectively. After inhibiting the expression of E6, E7 in H16CC cell lines, the expression of PD-L1 was significantly decreased ( P<0.05). The expression of PD-L1 was significantly increased after the overexpression of E6, E7 in HNCC cell lines ( P<0.05). Conclusions:The expression of PD-L1 is positively correlated with E6, E7, which may regulate the occurrence and development of CSCC by mediating the immune escape mechanism of PD-L1 in CSCC.