Objective:To assess the efficacy and safety of Gongxuening Capsules in reducing post-abortion bleeding following artificial abortion.Methods:A multicenter, randomized, double-blind study was conducted. From May 31, 2022 to March 31, 2023, 484 women who underwent vacuum aspiration abortion for early intrauterine pregnancy were enrolled in 11 centers and randomly assigned to control group and the study group at a 1∶1 ratio using a center-block randomization method. Control group were administered a placebo of Gongxuening Capsules for 9 d, while the study group received the actual Gongxuening Capsules for the same duration. The outcomes measured included vaginal bleeding volume, duration of vaginal bleeding, endometrial thickness, time to menstrual recovery, and complications.Results:1) A total of 484 subjects were enrolled, and 472 completed the study. Totally 450 subjects were included in the efficacy analysis set, with 224 in control group and 226 in the study group; 468 subjects were included in the safety analysis set, with 236 in control group and 232 in the study group. The baseline characteristics of the two groups were comparable (all P>0.05). 2) The vaginal bleeding volume was lower in the study group [(13.30±12.14) mL] than in control group [(19.00±17.67) mL, P<0.001]. The proportion of subjects in the study group with bleeding days less than 4 d [29.65% (67/226)] was higher than that in control group [19.20% (43/224), P=0.010]. 3) No significant differences were observed between the two groups in terms of time to menstrual recovery and endometrial thickness (all P>0.05). 4) In the study group, 3 subjects experienced non-therapeutic-related complications, while 11 subjects in control group. The incidence of complications was lower in the study group [1.29% (3/232)] than in control group [4.66% (11/236), P=0.033]. Conclusion:The administration of Gongxuening Capsules to women following artificial abortion significantly reduced vaginal bleeding volume and was associated with good safety, with the treatment being well-tolerated by the subjects.

Objective:To develop a pre-processing workflow of real world data (RWD) derived from multicenter clinical laboratories so that the level of data standardization can be improved, and subsequently to produce more robust real world evidence (RWE).Methods:Purpose sampling was used to invite senior experts with experience in clinical research utilizing RWD, covering the fields of clinical laboratory, epidemiology, biostatistics, and clinical medicine. In-depth, semi-structured individual interviews were conducted and thematic analysis was used to analyze the collected data.Results:The in-depth interviews were completed in 16 experts. The experts unanimously agreed that pre-processing RWD derived from multicenter clinical laboratories is necessary prior to its application in research. Based on experts' insights, a comprehensive pre-processing workflow for RWD was constructed, comprising six key steps: ①developing a variable list based on research questions and distributing it to each clinical laboratory; ②conducting an initial quality assessment of RWD based on existing quality control results in clinical laboratories; ③cleaning the data; ④determining whether RWD (including categorical and continuous variables) is heterogeneity among different clinical laboratories; ⑤exploring potential sources of heterogeneity;⑥pre-processing RWD based on identified causes contributing to heterogeneity.Conclusion:The pre-processing workflow of RWD was established, to provide a methodological reference for controlling systematic errors in RWD derived from multicenter clinical laboratories, thereby enhancing the validity of RWE.

Objective:To assess the preliminary efficacy and safety of modified Société Internationale d′Oncologie Pédiatrique Epithelial Liver Tumor Study Group (SIOPEL)-4 protocol for pediatric hepatoblastoma (HB) with lung metastases.Methods:This prospective cohort study enrolled 27 newly diagnosed pediatric HB with lung metastases who received the modified SIOPEL-4 protocol at Shanghai Children′s Medical Center, Shanghai Jiao Tong University School of Medicine, and Shanghai Children′s Hospital between January 2020 to December 2023. Clinical characteristics, lung response rates to induction chemotherapy, treatment outcomes, prognostic factors and sever chemotherapy toxicities at different stages were analyzed. Survival analysis was performed by Kaplan-Meier method. Univariate prognostic analysis was conducted by Log-Rank test.Results:Of the 27 patients, there were 17 males and 10 females, with the age of 21 (15, 33) months. During the follow-up of 31 (12, 45) months for 17 continuous complete remission patients, 4 cases disease progression (2 cases death) and 6 cases relapse were observed. The 2-year event free survival (EFS) and overall survival (OS) rate was (58±11)% and (89±7)%, respectively. All the 27 patients had response to block 1-3 induction chemotherapy (cisplatin+doxorubicin), with 14 cases (52%) achieving complete response and 13 cases (48%) achieving partial response of lung metastatic lesions, the 2-year EFS rate was (81±12)% and (34±14)%, respectively ( χ 2=6.76, P=0.009), the 2-year OS rate was 100% and (79±13)%, respectively ( χ2=2.12, P=0.145). Patients with caudate lobe tumors or ≥10 pulmonary metastatic nodules had significantly lower EFS rates ( χ2=5.36, 7.84, P=0.021, 0.005, respectively). The incidence of grade 3/4 neutropenia after block 1-3 induction chemotherapy, CD (carboplatin+doxorubicin), and VI (vincristine+irinotecan) consolidation chemotherapy was 90% (73/81), 75% (58/77), and 31% (11/35), respectively. The incidence of grade 3/4 thrombocytopenia was 77% (62/81), 69% (53/77), and 14% (5/35), respectively. The incidence of grade 3/4 infections was 64% (52/81), 25% (19/77), and 20% (7/35), respectively. The differences between the groups were statistically significant ( χ2=43.51, 42.69, 33.00, all P<0.001). Two patients (10%) of the 20 evaluable patients for ototoxicity occurred grade 3 and higher hearing impairment, with 1 patient requiring a hearing aid. Conclusions:The modified SIOPEL-4 regimen shows good preliminary efficacy and safety in treating pediatric HB with lung metastases. The prognosis for patients with residual lesions in the lungs after induction chemotherapy needs to be improved. Attention should be given to the ototoxicity induced by high-dose cisplatin chemotherapy.

Objective:To develop a pre-processing workflow of real world data (RWD) derived from multicenter clinical laboratories so that the level of data standardization can be improved, and subsequently to produce more robust real world evidence (RWE).Methods:Purpose sampling was used to invite senior experts with experience in clinical research utilizing RWD, covering the fields of clinical laboratory, epidemiology, biostatistics, and clinical medicine. In-depth, semi-structured individual interviews were conducted and thematic analysis was used to analyze the collected data.Results:The in-depth interviews were completed in 16 experts. The experts unanimously agreed that pre-processing RWD derived from multicenter clinical laboratories is necessary prior to its application in research. Based on experts' insights, a comprehensive pre-processing workflow for RWD was constructed, comprising six key steps: ①developing a variable list based on research questions and distributing it to each clinical laboratory; ②conducting an initial quality assessment of RWD based on existing quality control results in clinical laboratories; ③cleaning the data; ④determining whether RWD (including categorical and continuous variables) is heterogeneity among different clinical laboratories; ⑤exploring potential sources of heterogeneity;⑥pre-processing RWD based on identified causes contributing to heterogeneity.Conclusion:The pre-processing workflow of RWD was established, to provide a methodological reference for controlling systematic errors in RWD derived from multicenter clinical laboratories, thereby enhancing the validity of RWE.

Objective:To construct a humanistic care nursing program for adult ICU patients, providing guidance for the clinical practice of humanistic care in ICUs.Methods:Based on a literature review and clinical practice experience, a preliminary humanistic care nursing program for adult ICU patients was drafted. From August to September 2024, the Delphi method was used to conduct two rounds of expert consultation with 16 experts to revise the content of each item and the overall program, resulting in the final version of the humanistic care nursing program for ICU adult patients. The experts' engagement was measured by the effective response rate of the questionnaires, their authority by the expert authority coefficient, and the coordination of expert opinions by the Kendall's coefficient of concordance.Results:The effective response rate for the Delphi expert consultation questionnaires was 100.00% (16/16) in both rounds. The expert authority coefficients were 0.872 and 0.875, respectively. After the second round of consultation, the Kendall's coefficients for the importance, applicability, and feasibility of each level of item ranged from 0.119 to 0.313 ( P<0.05). The final humanistic care nursing program for adult ICU patients included three first-level items, 12 second-level items, and 55 third-level items. Conclusions:The humanistic care nursing program for adult ICU patients constructed in this study is scientific, targeted, and feasible, providing guidance for the clinical practice of humanistic care in ICU settings.

Objective:To retrieve, evaluate, and integrate evidence on the humanistic care practice of physical restraints for adult patients in the ICU to inform the management of physical restraints for clinical ICU patients.Methods:Expert consensus, group standards, systematic reviews, clinical decisions, best practices, guidelines, evidence summaries, and other types of literature related to the humanistic care of physical restraints for adult patients in the ICU were electronically searched in Chinese and English databases, relevant association websites, and guideline websites. The search period was from database establishment to August 31, 2024. Evidence was extracted and summarized according to themes after an independent literature quality assessment by two researchers.Results:A total of 15 articles were included, including four guidelines, one group standard, three best practices, five systematic reviews, and two expert consensus. Literature reading, evidence extraction and categorization resulted in seven themes of 39 best evidence on respecting patients' personality and dignity, attending to patients' physical needs, attending to patients' psychological needs, attending to patients' social and cultural needs, establishing good communication and trusting relationships, attending to patients' family and social support, and providing comprehensive nursing services.Conclusions:The best evidence summarized in this study may provide an evidence-based basis for the proper use of physical restraints by ICU medical and nursing staff to ensure patient safety and improve the ICU patient experience.

Objective:To explore the lived experiences of family members of terminal ICU patients regarding their humanistic care needs and provide theoretical foundations for developing nursing care plans tailored to their needs.Methods:This study was a descriptive qualitative study. From April to December 2023, 16 family members of terminally ill ICU patients in Shanghai East Hospital, Tongji University were selected for semi-structured interviews using purposive sampling method, and the interview data were qualitatively analyzed using Colaizzi 7-step analysis.Results:The humanistic care needs of family members of terminally ill ICU patients can be categorized into five themes, namely, the need to know the condition at the first time; the need to participate in treatment and decision-making; the need to respect the wishes of terminally ill patients; the need for psychological care; and the need for social support.Conclusions:The humanistic care needs of family members of terminal ICU patients remain largely unmet. Nursing professionals should consider these needs and preferences and provide family members with professional guidance to help them establish positive coping mechanisms.

Purpose To investigate the expression of LAMB3 and ITGB4 in esophageal squamous cell carcinoma(ESCC)and analyze their associations with clinicopathological features.Methods Bioinformatics was used to assess the expression of LAMB3 and ITGB4 in pan-cancer and ESCC.Immunohistochemistry was performed to evaluate their expression and distribution in ESCC tissues,and correlations clinicopathological features were analyzed.Follow-up data were collected to construct Kaplan-Meier survival curves,and Cox regression analysis was proformed to determine their prognostic significance.Results Bioinformatics analysis showed that LAMB3 and ITGB4 were highly expressed in ES-CC tissues(P＜0.001).Immunohistochemistry confirmed that both proteins were localized in the cytoplasm and membrane of tumor cells.High LAMB3 expression was significantly associated with poor differentiation(P＜0.001),lymph node metastasis(P=0.015),and T staging(P＜0.001).High ITGB4 expression was significantly correlated with poor differentiation(P=0.004)and advanced T staging(P=0.004).Cox regression analysis identified high ex-pression of LAMB3 and ITGB4 as independent prognostic factors for overall survival[HR=4.97(95％CI:2.73-9.02);HR=2.33(95％CI:1.36-3.99)].Conclusion LAMB3 and ITGB4 are highly expressed in ESCC.High LAMB3 expression is associated with tumor differentiation,lymph node metastasis,and T staging,while high ITGB4 expression is correlated with tumor differentiation and T staging.Patients with high expression of LAMB3 or ITGB4 have poorer overall survival,suggesting that these proteins may serve as prognostic biomarkers for unfavorable outcome in ESCC.

Objective:To assess the efficacy and safety of Gongxuening Capsules in reducing post-abortion bleeding following artificial abortion.Methods:A multicenter, randomized, double-blind study was conducted. From May 31, 2022 to March 31, 2023, 484 women who underwent vacuum aspiration abortion for early intrauterine pregnancy were enrolled in 11 centers and randomly assigned to control group and the study group at a 1∶1 ratio using a center-block randomization method. Control group were administered a placebo of Gongxuening Capsules for 9 d, while the study group received the actual Gongxuening Capsules for the same duration. The outcomes measured included vaginal bleeding volume, duration of vaginal bleeding, endometrial thickness, time to menstrual recovery, and complications.Results:1) A total of 484 subjects were enrolled, and 472 completed the study. Totally 450 subjects were included in the efficacy analysis set, with 224 in control group and 226 in the study group; 468 subjects were included in the safety analysis set, with 236 in control group and 232 in the study group. The baseline characteristics of the two groups were comparable (all P>0.05). 2) The vaginal bleeding volume was lower in the study group [(13.30±12.14) mL] than in control group [(19.00±17.67) mL, P<0.001]. The proportion of subjects in the study group with bleeding days less than 4 d [29.65% (67/226)] was higher than that in control group [19.20% (43/224), P=0.010]. 3) No significant differences were observed between the two groups in terms of time to menstrual recovery and endometrial thickness (all P>0.05). 4) In the study group, 3 subjects experienced non-therapeutic-related complications, while 11 subjects in control group. The incidence of complications was lower in the study group [1.29% (3/232)] than in control group [4.66% (11/236), P=0.033]. Conclusion:The administration of Gongxuening Capsules to women following artificial abortion significantly reduced vaginal bleeding volume and was associated with good safety, with the treatment being well-tolerated by the subjects.

BACKGROUND:Studies have shown that different durations of pressure application on normal muscles can produce varying physiological responses.OBJECTIVE:To explore the expression levels of inflammatory factors tumor necrosis factor α and nuclear κB in skeletal muscle under different pressure durations.METHODS:Twenty healthy male SPF-grade Sprague-Dawley rats were randomly divided into four groups:control group,10-second pressure group,20-second pressure group,and 30-second pressure group.The right leg of each rat was used for the experiment.The control group received no intervention,while rats in each pressure group were anesthetized by intraperitoneal injection of 2%pentobarbital sodium(35 mg/kg),and the thin femoral muscle of the rats was pressed continuously at a constant pressure of 200 kPa using a homemade mechanical pressure device for 10,20,and 30 seconds,respectively.Muscle tissue at the pressing site of the right hind limb was collected immediately after pressure.Hematoxylin-eosin staining was used to observe the morphological changes of skeletal muscle tissues and changes in the cross-sectional area of muscle fibers,and immunohistochemistry was used to detect the expression levels of tumor necrosis factor α and nuclear factor κB in rat skeletal muscle.RESULTS AND CONCLUSION:Hematoxylin-eosin staining results revealed that the pressure groups showed loosely arranged skeletal muscle fibers,reduced cross-sectional area and diameter,and enlarged intermuscular spaces.Compared with the control group,the cross-sectional area of muscle fibers was significantly reduced in the pressure groups(P<0.05),but there was no significant difference between the three pressure groups(P>0.05).The 10-second pressure group showed no significant presence of red blood cells in the interstitial spaces,while the 20-second pressure group exhibited a small amount of red blood cells,and the 30-second pressure group showed capillary dilation with red blood cells in the interstitial spaces.The expression level of tumor necrosis factor α in the 30-second pressure group was significantly higher than that in the control group(P<0.05).The expression level of nuclear factor κB in skeletal muscle showed no significant difference among groups(P>0.05).To conclude,skeletal muscle undergoes morphological changes and reduced cross-sectional area after pressure at 200 kPa,but there is no significant difference among the 10-,20-,and 30-second pressure groups.As the duration of pressure increases to 30 seconds,the inflammatory factor tumor necrosis factor α is activated,but nuclear factor κB remains unaffected,suggesting that inflammatory factors may express under short-term pressure,while transcription factors show no significant change.