Objective To investigate the impact of social psychological factors on adherence among subjects with chronic diseases during the early phase of new drug clinical trials and propose strategies to optimize trial outcomes.Methods Between December 2020 to December 2023,observational datas were collected from subjects participating in new drug clinical trials in the Frist Hospital of Jiaxing,including customized sociodemographic informations,Eysenck personality questionnaire(EPQ)survey results,symptom checklist 90(SCL-90)scores,Beck anxiety inventory(BAI)scores,Beck depression inventory(BDI)scores.The SCL-90 was further categorized into ten factor scores,and the EPQ was evaluated based on four dimensional standard T-scores.Univariate and multivariate Logistic regression analyses were conducted to identify the related factors.Results Univariate analyses showed that gender,willingness to go out,EPQ_T neuroticism,SCL-90,SCL somatic,SCL obsessive compulsive,SCL interpersonal,SCL depression,SCL anxiety,SCL psychoticism,SCL other,BAI scores,and BDI scores were associated with adherence in subjects with chronic diseases.Multivariate analysis confirmed that a higher willingness to go out,elevated BAI and BDI scores were positively associated with non-adherence risk,whereas an increase in the SCL-90 somatization factor scores were inversely related to adherence risk in subjects with chronic diseases.Conclusion Identifying and managing anxiety and depression among subjects with chronic diseases,as well as understanding their outdoor plans,are crucial for enhancing adherence during the early stages of new drug clinical trials.In certain instances,subjects with chronic diseases heightened awareness of bodily discomfort may paradoxically promote adherence.

Objective:Tumor-treating fields (TTFields) is a kind of non-invasive anti-mitotic tumor therapy, which has been approved for patients with newly diagnosed and recurrent glioblastoma. This study aims to explore the efficacy and safety of TTFields in high-grade gliomas in clinical practice settings.Methods:The clinical data of 15 patients with recurrent glioma and 9 patients with newly diagnosed high-grade glioma admitted to our center from April 2019 to January 2021 were retrospectively analyzed. All patients accepted TTFields≥1 month. Follow-up was performed for 5.3 months (ranged from 2.3 to 10.7 months); Response Assessment in Neuro-Oncology Working Group (RANO) criteria was used to evaluate the glioma responses. The progression-free survival (PFS) and overall survival (OS) were calculated according to Kaplan-Meier method. Common Terminology Criteria for Adverse Events v5.0 (CTCAE v5.0) and TTFields related skin adverse reaction (dAE) criteria were used to evaluate the adverse events. Quality of life questionnaire-core 30 (QLQ-C30) and QLQ-brain cancer module (QLQ-BN20) questionnaires were used to evaluate the health-related quality of life (HRQoL). Treatment compliance was evaluated by data on the use of NovoTTF-200A devices, and calculated as a percentage of daily TTFields usage.Results:The median duration of TTFields was 4.2 months (ranged from 1.0 to 10.7 months), with a median compliance rate of 91.5% (67.0%-97.0%). TTFields was used alone in 2 patients and used with combination of chemotherapy in 22 patients. From follow-up to April 2021, 14 patients had stable symptoms and 10 had disease progression (8 died). The median PFS and OS of recurrent patients were 5.9 months ( 95%CI: 3.3-8.6 months) and 8.5 months ( 95%CI: 3.2-13.8 months), respectively; and the median PFS and OS of newly diagnosed patients were both 10.7 months (without 95%CI). The common adverse events included grading 1 dAE (58.3%) and grading 2 dAE (12.5%), without grading 3 or 4 dAE, manifested as contact or allergic dermatitis, erosion, folliculitis and ulcers. And 87.5% patients had stable HRQoL. Conclusions:The preliminary results showed that the survival of recurrent high-grade glioma patients treated by TTFields is similar to that reported in foreign literature; and the newly diagnosed patients need further survival follow-up. The patients' treatment compliance and safety are good. The dAE incidence (grading 1-2) is higher than that reported in the literature, and the toxicity was acceptable.

Objective To explore preliminarily the effects of preoperative depression condition in patients with breast cancer on the efficacy of intravenous analgesia with dezocine and the serum level of 5 hydroxytryptamine.Methods Sixty patients with breast cancer were assessed with Hamilton depression scale (HAMD).The total patients were divided into three groups according to HAMD scores,including normal group (26 cases),suspicious group (22 cases),and depression group (12 cases).The postoperative analgesia was facilitated with patients intravenous control analgesia with dezocine and the postoperative pain was assessed by visual analogue scale (VAS) at 2 hours,12 hours,and 24 hours.Yhe serum concentration of 5 hydroxytryptamine was measured by enzyme-linked immunosorbent assays before anesthesia,2 hours after surgery beginning,and 24 hours after surgery.Results The postoperative VAS at 12 hours and 24 hours in suspicious group and in depression group were higher than those in normal group (P ＜ 0.05).There was no statistical difference between depression and suspicious groups (P ＞ 0.05).The serum concentrations of 5 hydroxytryptamine in three groups increased obviously at 2 hours after surgery beginning (P＜0.05),and then decreased at 24 hours postoperation.The serum concentrations of 5 hydroxytryptamine in suspicious group and depression group at three measurement point were significantly lower than those in normal group (P ＜0.05).The serum concentrations of 5 hydroxytryptamine in depression group at three measurement point were significantly lower than those in suspicious group (P ＜ 0.05).Conclusions Under this preliminary study condition,the preoperative severity of the depression in patients with breast cancer may affect the analgesia effect of patients intravenous control analgesia with dezocine and maybe have some relationships with serum levels of 5 hydroxytryptamine.

Objective To explore the feasibility of employing a risk category system in evaluating the treatment outcome of locoregionally advanced nasopharyngeal carcinoma (NPC) treated by intensitymodulated radiation therapy (IMRT) alone,and offering evidence for relevant perspective studies.Methods Totally 185 locoregionally advanced NPC patients were divided into high-risk and low-risk groups for evaluation and comparison.The patients who met at least one of the following criteria were defined as high-risk group and others as low-risk group:GTVnx ＞ 30 cm3;Clinical stage T4N2M0;multiple neck node metastases with 1 node size ＞4 cm,and N3 with any T stage.Results With a median follow up of 110.9 months (6.7-152.4 months),the 5-year overall survival,locoregional relapse-free survival,distant metastasis-free survival for the high-risk group vs.the low-risk group were 61.0％ vs.90.5％ (x2 =30.298,P＜0.05),78.3％ vs.91.5％ (x2 =6.352,P＜0.05)and 71.6％ vs.92.0％ (x2 =16.346,P ＜0.05).Conclusions As a simple and practicable method,the risk category system is helpful for discriminating locoregionally advanced nasopharyngeal carcinoma with different risk-group of treatment failure and in further perspective clinical research.

Objective To determine the median effective concentration (EC50) of epidural lidocaine inhibiting herpetic neuralgia.Methods The patients with thoracic or lumbar herpetic neuralgia,aged 20-60 yr,with body mass index of 18-25 kg/m2,of ASA physical status Ⅰ or Ⅱ,were included in the study.Epidural catheter was placed under the guidance of the digital subtraction angiography (DSA).An injection of iohexol mixed with lidocaine was given under the guidance of DSA to make sure that drug solution covered all the injured nerve roots.The initial concentration of lidocaine was 0.37％.The concentration was determined by up-and-down sequential allocation.Each time the concentration of lidocaine increased/decreased in the next patient depending on whether or not the analgesia was effective.The ratio between the two successive concentrations was 1.06.Effective analgesia was defined as VAS score ≤ 1 within 30 min after administration.The EC50 and 95 ％ confidence interval of lidocaine inhibiting herpetic neuralgia were calculated using Dixon formula.Results The EC50 of lidocaine inhibiting herpetic neuralgia was 0.199 ％ and the 95 ％ confidence interval was 0.168 ％-0.216 ％.Conclusion The EC50 of epidural lidocaine required to inhibit herpetic neuralgia is 0.199％.

OBJECTIVE: The large sample retrospective cohort study were used to compare the diagnostic efficiency of PET/CT with conventional work-up (CWU) for evaluating nasopharyngeal carcinoma (NPC) distant metastasis. METHOD: Five hundred and fourteen patients with NPC were divided into PET/CT group and CWU group according the method of detecting distant metastasis. Chest film, abdominal ultrasonography, and bone scan were used in CWU group. Then the diagnostic efficiency of the two groups was compared. RESULT: Two hundred and sixteen patints were enrolled in PET/CT group and two hundred and nineteen-eight ones in CWU group. There were 28 out of 412 suspicious patients in CWU group were confirmed, another 3 patients confirmed without positive findings, compared with PET/CT group that all 32 suspicious patients were confirmed. The sensitivity and specificity of PET/CT were 100.0% (32/32) and 100.0% (184/184), as compared to 90.3% (28/31) and 94.8% (253/267) with CWU respectively, while there was no statistical significance. Further research found out that the percentage of patients with multiple distant metastatic sites and multiple organ metastases was higher in PET/CT group (P < 0.05), and similarly of patients with distant metastasis in N2-3 stages (P < 0.01). CONCLUSION Our results suggest that PET/CT appears to be slightly superior to conventional work-up in assessment of distant metastasis in NPC patients, but CWU is still a cheap and practical method.
Aged ; Carcinoma ; Cohort Studies ; Female ; Fluorodeoxyglucose F18 ; Humans ; Male ; Middle Aged ; Nasopharyngeal Carcinoma ; Nasopharyngeal Neoplasms ; diagnosis ; secondary ; Positron-Emission Tomography ; methods ; Radiopharmaceuticals ; Retrospective Studies ; Sensitivity and Specificity ; Tomography, X-Ray Computed ; Ultrasonography

Objective To investigate the long-term outcome and prognostic factors of patients with nasopharyngeal carcinoma treated with intensity-modulated radiation therapy (IMRT). Methods From February 2001 to December 2006, 419 patients with nasopharyngeal carcinoma in Cancer Center of Sun yatsen University received IMRT. The number of patients with stage Ⅰ,Ⅱ,Ⅲ and Ⅳ disease was 28, 113, 202 and 76, respectively. In all, 182 and 237 patients received radiotherapy alone and chemoradiotherapy. The prescription doses were as follows:66-70 Gy/25 -30 f to GTV_(nx), 60 -64 Gy/25 -30 f to GTV_(nd), 55 -62 Gy/25 -30 f to CTV_1, and 42 -54 Gy/25 -30 f to CTV_2. Results The median follow-up time was 49 months (6 -94 months). The number of patients with follow-up of 1-, 3-, and 5-year were 419,360 and 166, respectively. Twenty-one, 13 and 57 patients had local recurrence, regional recurrence and distant metastasis, respectively. The 5-year local control (LC) rate, regional control (RC) rate and free from distant metastasis survival rate was 92.7%, 95.8% and 85.5%, respectively. The 5-year disease-free survival (DFS) and disease-specific survival (DSS) was 76. 3% and 84.4%, respectively. In univariate analysis, T stage, primary tumor volume, N stage and volume of cervical nodes before treatment were significant predictors of DFS and DSS, favoring the patients with early T stage (84. 1% vs. 67.6% ,Χ~2 = 12. 16, P = 0. 000 : 92. 1% vs. 75. 1% ,Χ~2 = 14. 86 . P = 0. 000) , primary tumor volume less than 20 cm~3 (89. 1% vs. 62. 9% ,Χ~2 =14. 13,P=0.000;96.2% vs. 72. 1% ,Χ~2 =38. 76,P=0.000), early N stage (81.1% vs. 64. 5%, Χ~2 = 15.49, P = 0. 000; 87. 8% vs. 76. 1%, Χ~2 = 10. 89, P = 0. 001) and volume of cervical nodes less than 5 cm~3 (83. 3% vs. 68. 8%, Χ~2 = 14. 13, P = 0. 000 ; 90. 0% vs. 78. 1%, Χ~2 = 10. 71 ,P =0. 001). Multivariate analysis showed that primary tumor volume (Χ~2 = 26. 81, P = 0. 000 and Χ~2 = 28. 47, P = 0. 000) and N stage (Χ~2 = 4. 92, P = 0. 026 and Χ~2 = 9.50, P = 0. 002) were independent predictive factors for both DFS and DSS. No grade 4 acute and late toxicities were observed. In 243 patients with follow-up time more than 3 years, only 2. 8% suffered from grade 3 late toxicifies. Conclusions IMRT with or without chemotherapy can improve the long-term survival of patients with nasopharyngeal carcinoma, especially in LC and RC. Distant metastasis becomes the main treatment failure. Primary tumor volume and N stage are significant prognostic factors. Acute and late toxicities are acceptable.

Objective To evaluate the value of L-(methyl-11C)-labeled methionine positron emissions tomography (MET PET) and MRI in target volume delineation for postoperative radiotherapy for brain high grade glioma (HGG).Methods Thirty-seven patients with supratentorial HGG were included.Both MRI and MET PET scan were performed in the same treatment position for all patients.The consistency to determine residual tumor between MRI and MET PET was analyzed.Imaging data of MET PET and MRI were coregistered using the BrainLAB image fusion software.The extension of the volume with high uptake (VMET) on MET PET were compared quantitately with the enhancing area on MRI T1W gadolinium enhancement (VGd) and the hyperintensity area on MRI T2W (VT2).Results Both MET PET and MRI were positive for 19 patients and negative for 7 patients.The consistency between these two scans was 70.3%.MET PET was integrated with MRI in 30 patients with positive MET uptake.VMET were partially or entirely outside VGd in 29 patients and VT2 in 17 patients, whereas VGd and VT2 were partially or entirely outside VMET in all patients.The maximal distance from the margin of VMET to VGd was ≥ 2.0 cm in 50%patients and the corresponding distance of VMET to VT2 was ≥ 1.0 cm in 33% patients.Conclusions The differences are existing between MET PET and MRI in determination and identification of the location and extension of residual tumor for patients with HGG.The integration of MET PET and MRI can accurately delineate radiation target volume.

Objective To compare the onset time, duration and adverse effects of stellate ganglion block (SGB) with different concentrations of lidocaine. Methods Two hundred and forty ASA Ⅰ or Ⅱ patients (97 male, 143 female) aged 37-76 yr weighing 48-79 kg were randomly divided into 3 groups ( n = 80 each): group A, B and C received unilateral SGB with 8 ml of 0.6%, 0.8% and 1.0% lidocaine respectively. Unilateral SGB was performed by the same anesthesiologist in all patients. Successful SGB was verified by Homer's syndrome. The onset time, duration and adverse effects were recorded. Results Homer's syndrome was observed in all patients. There was no significant difference in onset time among the 3 groups. The duration of action was significantly longer in group B and C than in group A and in group C than in group B. There was no significant difference in the adverse effects including recurrent laryngeal nerve block, brachial plexus block, local anesthetic intoxication and transient loss of consciousness among the 3 groups. Conclusion SGB can be induced with either 0.6%, 0.8% or 1.0% lidocaine with comparable effectiveness. We suggest using lower concentration of lidocaine.

Objective To evaluate the effect of intensity-modulated radiation therapy(IMRT) on parotid function in nasopharyngeal carcinoma(NPC). Methods Eighty-three NPC patients received prima-ry IMRT between 2001 and 2003. Xerostomia before radiotherapy, at the end of radiotherapy, at 6-month, 1-,2-,3-,4- and 5-year after radiotherapy were investigated, respectively. The relation between xerostomia and parotid dose distribution was analyzed. Results Of all the patients,4,31,31 and 17 had stage Ⅰ,Ⅱ,Ⅲ and ⅣA disease, respectively. Sixteen patients received chemo-radiotherapy. The median followed-up time was 65 months. The 5-year local control and regional control rate were 96% and 95% ,respectively. The 5-year overall survival rate was 80%. The mild xerostomia rate at the seven time points was 42%, 51%, 71%, 77%, 58%, 38% and 26%. The corresponding moderate xerostomia rate was 52%, 53%, 21%,8%, 3%, 2% and 2%, respectively. No serious xerostomia was observed. The mean dose of the bilateral parotid glands was 34.34 Gy. Xerostomia at 6-month after radiotherapy was positively correlated with the mean dose of the parotid glands, and D50 was the independent factor in predicting the xerostomia. Parotid function was well protected when the mean dose and D50 were no more than 33 Gy and 29 Gy,respectively. Conclusions IMRT can improve the local-regional control of NPC and protect the parotid glands from radiation-induced in-jury.