On-site supervision is a risk-based regulatory system that requires the scientific development of supervision plans for quality risks and hidden dangers in pharmaceutical enterprises， the rational allocation of supervision resources based on their risk levels， and the implementation of classified supervision measures. In this study， the quality risk monitoring business support system is set up for pharmaceutical enterprises by establishing the quality risk expert database and quality risk monitoring index system for pharmaceutical enterprises based on the difficulty analysis of on-site drug supervision. Based on this support system， the quality risk classification method， the differentiated spot check strategy and business auxiliary visualization system are established. This support system is used to learn the risk level of pharmaceutical enterprises， so as to innovate supervision methods and optimize monitoring strategies. Taking Jiangxi Province as an example， it is verified that the support system can guide the risk assessment of sample enterprises， can improve the targeting of on-site drug supervision in the process of technical review， scheme editing， on-site implementation and comprehensive evaluation， and can effectively improve the quality and efficiency of supervision.

Objective:To evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) on tourniquet-induced hypertension (TIH) in the patients undergoing anterior cruciate ligament reconstruction.Methods:Seventy-four patients of either sex, aged 18-60 yr, of American Society of Anesthesiologists Physical Status classification I or II, with body mass index of 18-30 kg/m 2, undergoing elective anterior cruciate ligament reconstruction under general anesthesia combined with preoperative femoral nerve block, were divided into 2 groups ( n=37 each) using a random number table method: sham stimulation group (group SS) and group taVNS. Group SS received stimulation on the ear lobe and the tail of the helix of the left ear. Group taVNS received stimulation on the cymba concha and the earlobe of the left ear. Both groups received stimulation from 1 h before induction of anesthesia until the end of the procedure (frequency of 30 Hz, pulse width of 300 μs, and amplitude of the strongest current that could be tolerated by the patient in the absence of pain). The tourniquet inflation pressure was 280 mmHg, with an inflation time of 60-90 min. Systolic blood pressure, diastolic blood pressure and heart rate were recorded before tourniquet inflation to assess the development of intraoperative TIH. The consumption of intraoperative propofol, remifentanil, nitroglycerin, esmolol, norepinephrine and atropine was recorded, and the occurrence of postoperative nausea and vomiting, skin itching and headache and dizziness was also recorded. Results:Compared with group SS, the incidence of TIH and the number of patients used nitroglycerin were significantly reduced ( P<0.05), and no significant changes were found in the other parameters in group taVNS ( P>0.05). Conclusions:taVNS can decrease the occurrence of TIH in the patients undergoing anterior cruciate ligament reconstruction.

Objective To construct a high-quality practical teaching system of rehabilitation majors for undergraduate based on World Health Organization rehabilitation competence framework(RCF). Methods Using the principles and methods of RCF,the competency requirements for rehabilitation therapy were ana-lyzed and a practical teaching system suitable for undergraduate education in rehabilitation therapy was construct-ed. Results The rehabilitation practice education were constructed as practice courses,clinical practice and social service practice,and the practice education modules and objectives were discussed based on RCF. Conclusion A competency-oriented rehabilitation practice education system has been constructed based on RCF,includ-ing practice courses,clinical practice and social service practice.

Objective:To observe and evaluate the clinical efficacy and safety of albumin-bound paclitaxel as first-line treatment for patients with advanced pancreatic cancer in China, and to explore the prognosis-related molecules in pancreatic cancer based on next-generation sequencing (NGS) of tumor tissues.Methods:From December 2018 to December 2020, patients with locally advanced or metastatic pancreatic cancer were recruited to accept albumin-bound paclitaxel as first-line treatment in the oncology departments of 24 hospitals in East China. The primary endpoints were overall survival (OS) and treatment related adverse events, and the secondary endpoint was progression-free survival (PFS). Adverse effects were graded using Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0). NGS sequencing on the primary or metastatic tissue samples of pancreatic cancer obtained through surgical resection or biopsy was performed.Results:This study recruited 229 patients, including 70 patients with locally advanced pancreatic cancer (LAPC) and 159 patients with metastatic pancreatic cancer (mPC). The disease control rate was 79.9% and the objective response rate is 36.3%.The common adverse effects during treatment were anaemia (159 cases), leucopenia (170 cases), neutropenia (169 cases), increased aminotransferases (110 cases), and thrombocytopenia (95 cases), and the incidence of grade 3-4 neutropenia is 12.2% (28/229). The median follow-up time was 21.2 months (95% CI: 18.5-23.1 months). The median PFS (mPFS) was 5.3 months (95% CI: 4.37-4.07 months) and the median OS (mOS) was 11.2 months (95% CI: 9.5-12.9 months). The mPFS of patients with LAPC was 7.4 months (95% CI: 6.6-11.2 months), and their mOS was 15.5 months (95% CI: 12.6-NA months). The mPFS of patients with mPC was 3.9 months (95% CI: 3.4-5.1 months), and their mOS was 9.3 months (95% CI: 8.0-10.8 months). Multivariate Cox regression analysis showed that clinical stage ( HR=1.47, 95% CI: 1.06-2.04), primary tumor site ( HR=0.64, 95% CI: 0.48-0.86), Eastern Cooperative Oncology Group Performance Status (ECOG PS) score ( HR=2.66, 95% CI: 1.53-4.65), and whether to combine radiotherapy ( HR=0.65, 95% CI: 0.42-1.00) were independent influencing factors for the PFS of these patients. The primary tumor site ( HR=0.68, 95% CI: 0.48-0.95), ECOG score ( HR=5.82, 95% CI: 3.14-10.82), and whether to combine radiotherapy ( HR=0.58, 95% CI: 0.35-0.96) were independent influencing factors of the OS of these patients. The most frequent gene mutations in these advanced stage pancreatic patients were KRAS (89.66%), TP53 (77.01%), CDKN2A (32.18%), and SMAD4 (21.84%) by NGS of tumor tissues from 87 pancreatic cancer patients with sufficient specimens. Further analysis revealed that mutations in CDKN2B, PTEN, FGF6, and RBBP8 genes were significantly associated with an increased risk of death ( P＜0.05). Conclusion:Albumin-bound paclitaxel as first-line treatment demonstrated feasible anti-tumor efficacy and manageable safety for patients with advanced pancreatic cancer in China.

Objective:To observe and evaluate the clinical efficacy and safety of albumin-bound paclitaxel as first-line treatment for patients with advanced pancreatic cancer in China, and to explore the prognosis-related molecules in pancreatic cancer based on next-generation sequencing (NGS) of tumor tissues.Methods:From December 2018 to December 2020, patients with locally advanced or metastatic pancreatic cancer were recruited to accept albumin-bound paclitaxel as first-line treatment in the oncology departments of 24 hospitals in East China. The primary endpoints were overall survival (OS) and treatment related adverse events, and the secondary endpoint was progression-free survival (PFS). Adverse effects were graded using Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0). NGS sequencing on the primary or metastatic tissue samples of pancreatic cancer obtained through surgical resection or biopsy was performed.Results:This study recruited 229 patients, including 70 patients with locally advanced pancreatic cancer (LAPC) and 159 patients with metastatic pancreatic cancer (mPC). The disease control rate was 79.9% and the objective response rate is 36.3%.The common adverse effects during treatment were anaemia (159 cases), leucopenia (170 cases), neutropenia (169 cases), increased aminotransferases (110 cases), and thrombocytopenia (95 cases), and the incidence of grade 3-4 neutropenia is 12.2% (28/229). The median follow-up time was 21.2 months (95% CI: 18.5-23.1 months). The median PFS (mPFS) was 5.3 months (95% CI: 4.37-4.07 months) and the median OS (mOS) was 11.2 months (95% CI: 9.5-12.9 months). The mPFS of patients with LAPC was 7.4 months (95% CI: 6.6-11.2 months), and their mOS was 15.5 months (95% CI: 12.6-NA months). The mPFS of patients with mPC was 3.9 months (95% CI: 3.4-5.1 months), and their mOS was 9.3 months (95% CI: 8.0-10.8 months). Multivariate Cox regression analysis showed that clinical stage ( HR=1.47, 95% CI: 1.06-2.04), primary tumor site ( HR=0.64, 95% CI: 0.48-0.86), Eastern Cooperative Oncology Group Performance Status (ECOG PS) score ( HR=2.66, 95% CI: 1.53-4.65), and whether to combine radiotherapy ( HR=0.65, 95% CI: 0.42-1.00) were independent influencing factors for the PFS of these patients. The primary tumor site ( HR=0.68, 95% CI: 0.48-0.95), ECOG score ( HR=5.82, 95% CI: 3.14-10.82), and whether to combine radiotherapy ( HR=0.58, 95% CI: 0.35-0.96) were independent influencing factors of the OS of these patients. The most frequent gene mutations in these advanced stage pancreatic patients were KRAS (89.66%), TP53 (77.01%), CDKN2A (32.18%), and SMAD4 (21.84%) by NGS of tumor tissues from 87 pancreatic cancer patients with sufficient specimens. Further analysis revealed that mutations in CDKN2B, PTEN, FGF6, and RBBP8 genes were significantly associated with an increased risk of death ( P＜0.05). Conclusion:Albumin-bound paclitaxel as first-line treatment demonstrated feasible anti-tumor efficacy and manageable safety for patients with advanced pancreatic cancer in China.

Objective:To explore the characteristics of latent profiles of health literacy in elderly patients with multiple chronic conditions (MCCs), and to analyze the impacts of the profiles on patients′ health promoting lifestyle, and to provide reference for developing intervention strategies.Methods:From July 2022 to May 2023, elderly patients with multiple chronic conditions in Nanfang Hospital, Southern Medical University were selected as the survey subjects by cross-sectional survey method. The General Information Questionnaire, All Aspects of Health Literacy Scale and Health Promoting Lifestyle Profile-Ⅱ were used for investigation. The latent profile analysis was conducted with the 11 entries of health literacy in elderly patients with MCCs as the explicit indicators. The difference of clinical data in potential profiles of health literacy were compared, and regression mixture model was implemented to analyze the impacts of different profiles on health promoting lifestyle of patients.Results:Totally 198 valid questionnaires [127 males and 71 females with 60-80(64.57 ± 4.60) years old] were collected, with the effective recovery rate of 94.3%. The latent profiles of health literacy in elderly patients with MCCs was divided into 3 profiles, high literacy and high efficiency in health information application group 51 cases (25.8%), moderate literacy and moderate efficiency in health information application group 87 cases (43.9%), low literacy and low efficiency in health information application group 60 cases (30.3%). Education level [high school or technical secondary school: OR(95% CI)=0.134(0.034-0.531), college degree or above: OR(95% CI)=0.056(0.005-0.670)], per capita monthly income of families [3 000-5 000yuan: OR(95% CI)=0.176(0.052-0.593), >5 000 yuan: OR(95% CI)=0.095(0.024-0.370)], years of illness [>5years: OR(95% CI)=0.204(0.053-0.787)], and number of co-occurring diseases [4-5kinds: OR(95% CI)=3.500(1.324-4.252)] were the influencing factors of high literacy and high efficiency in health information application group (all P<0.05). Per capita monthly income of families [3 000-5 000yuan: OR(95% CI)=0.336(0.150-0.752)] and years of illness[1-5years: OR(95% CI)=0.266(0.098-0.721)] were the influencing factors of moderate literacy and moderate efficiency in health information application group (all P<0.05). There were statistically significant difference in the total score of Health Promoting Lifestyle Profile-Ⅱ and the scores of each dimension among elderly patients with MCCs between 3 latent profiles ( F=32.12-81.04, all P<0.05). Conclusions:The health literacy of elderly patients with MCCs is significantly heterogeneous, and there are significant differences in health promoting lifestyle among the profiles. Medical staff should formulate personalized intervention strategies based on the classification characteristics of health literacy of MCCs elderly patients to improve their health promoting lifestyle.

Objective:To evaluate the effect of pre-infusion of hypertonic saline on the postoperative cognitive function in elderly patients.Methods:This was a prospective study. Seventy-six patients of both sexes, aged≥60 yr, of American Society of Anesthesiologists Physical Status classification Ⅱ or Ⅲ, who underwent elective shoulder arthroscopic surgery under brachial plexus block combined with general anesthesia from June 2022 to January 2023 in our hospital, were selected and divided into 2 groups ( n=38 each) by the random number table method: hypertonic saline group and normal saline group. At 30 min before anesthesia induction, 3% hypertonic saline of 4 ml/kg was intravenously infused in hypertonic saline group, and normal saline 4 ml/kg was intravenously infused in normal saline group. The occurrence of intraoperative cerebral desaturation events was recorded. Venous blood samples were collected at 24 h postoperatively, and the plasma concentrations of interleukin-1beta (IL-1β), IL-6, tumor necrosis factor-alpha and S-100β were measured by enzyme-linked immunosorbent assay, and the expression of neutrophil CD11b was detected by flow cytometry. Rey auditory verbal learning test, trail making test, digit symbol substitution test, and stroop color-word test were performed at 1 day before surgery and 5 days after surgery, and the postoperative cognitive dysfunction was assessed using the Z-score method. Results:Compared with normal saline group, the concentrations of plasma IL-6, tumor necrosis factor-alpha and S-100β and expression of neutrophil CD11b were significantly decreased in hypertonic saline group, and the incidence of cognitive dysfunction and cerebral desaturation events was decreased in hypertonic saline group ( P<0.05). Conclusions:Pre-infusion of hypertonic saline can reduce inflammatory responses and improve postoperative cognitive function in elderly patients.

Objective:To explore the values of albumin-bilirubin (ALBI) score, carcinoembryonic antigen (CEA) and combination of the two in the prognostic assessment of colorectal cancer patients with postoperative liver metastasis.Methods:The clinicopathological data of 98 colorectal cancer patients with postoperative liver metastasis who were admitted to Lianyungang Oriental Hospital and receiving adjuvant chemotherapy from January 2016 to March 2020 were retrospective analyzed. The data of serum protein, bilirubin, and CEA before chemotherapy were obtained, the relationship between serum protein and bilirubin was analyzed, and the ALBI score was calculated. The ALBI-CEA score was judged according to the ALBI score and the CEA level. ALBI score > -2.60 points was categorized as high ALBI group, and ALBI score ≤ -2.60 points was categorized as low ALBI group; CEA >5 ng/ml was categorized as high CEA group, and CEA ≤5 ng/ml was categorized as low CEA group; patients were categorized into 0, 1, and 2 points groups based on ALBI-CEA score. Overall survival (OS) and progression-free survival (PFS) of ALBI score, CEA and ALBI-CEA score subgroups were analyzed by Kaplan-Meier method; with the actual survival and progress status of the patients as the gold standard, receiver operating characteristic (ROC) curve was used to analyze the effect of 3 indicators to assess patients' OS and PFS, and area under the curve (AUC) was compared; Cox proportional hazards model was used to analyze the influencing factors of OS and PFS.Results:The median albumin and bilirubin levels of the 98 patients were 34.4 g/L (26.8-42.8 g/L) and 16.6 μmol/L (7.6-44.6 μmol/L), and the result of Pearson correlation analysis showed a negative correlation between the levels of albumin and bilirubin ( r = -0.282, P < 0.001). The 3-year OS and PFS rates in the high ALBI group were lower than those in the low ALBI group (OS rate: 9.2% vs. 33.3%, PFS rate: 7.7% vs. 18.2%), and the differences in OS and PFS between the two groups were statistically significant ( χ2 values were 27.64, 23.30, both P < 0.001). The 3-year OS and PFS rates in the high CEA group were lower than those in the low CEA group (OS rate: 7.1% vs. 42.9%, PFS rate: 7.1% vs. 21.4%), and the differences in OS and PFS between the two groups were statistically significant ( χ2 values were 23.71, 17.14, both P < 0.001). The 3-year OS rates in the ALBI-CEA score 0, 1 and 2 points groups were 77.8%, 20.9% and 2.2%, and the 3-year PFS rates were 44.4%, 9.3% and 6.5%, and there were statistical differences in OS and PFS among the three groups ( χ2 values were 102.36, 76.55, both P < 0.001). The ROC curve analysis showed that the AUC of ALBI score, CEA and ALBI-CEA score for assessing OS were 0.688 (95% CI 0.544-0.832), 0.754 (95% CI 0.618-0.890) and 0.828 (95% CI 0.723-0.933) (all P < 0.05), and the AUC for assessing PFS were 0.618 (95% CI 0.436-0.799), 0.646 (95% CI 0.464-0.829) and 0.682 (95% CI 0.494-0.870) (all P > 0.05). Multivariate Cox regression analysis showed that ALBI-CEA score was an independent influencing factor for OS (2 points vs. 0 point: HR = 17.254, 95% CI 8.385-35.504, P < 0.001) and PFS (2 points vs. 0 point: HR = 6.144, 95% CI 3.725-10.134, P < 0.001) of patients. Conclusions:The colorectal cancer patients with liver metastasis and high ALBI-CEA score are at high risk of death and disease progression and have a poor prognosis, and they are recommended to receive intensive treatment.

Precisely delivering combinational therapeutic agents has become a crucial challenge for anti-tumor treatment. In this study, a novel redox-responsive polymeric prodrug (molecular weight, MW: 93.5 kDa) was produced by reversible addition-fragmentation chain transfer (RAFT) polymerization. The amphiphilic block polymer-doxorubicin (DOX) prodrug was employed to deliver a hydrophobic photosensitizer (PS), chlorin e6 (Ce6), and the as-prepared nanoscale system [NPs(Ce6)] was investigated as a chemo-photodynamic anti-cancer agent. The glutathione (GSH)-cleavable disulfide bond was inserted into the backbone of the polymer for biodegradation inside tumor cells, and DOX conjugated onto the polymer with a disulfide bond was successfully released intracellularly. NPs(Ce6) released DOX and Ce6 with their original molecular structures and degraded into segments with low MWs of 41.2 kDa in the presence of GSH. NPs(Ce6) showed a chemo-photodynamic therapeutic effect to kill 4T1 murine breast cancer cells, which was confirmed from a collapsed cell morphology, a lifted level in the intracellular reactive oxygen species, a reduced viability and induced apoptosis. Moreover, ex vivo fluorescence images indicated that NPs(Ce6) retained in the tumor, and exhibited a remarkable in vivo anticancer efficacy. The combinational therapy showed a significantly increased tumor growth inhibition (TGI, 58.53%). Therefore, the redox-responsive, amphiphilic block polymeric prodrug could have a great potential as a chemo-photodynamic anti-cancer agent.

Objective:To explore the dance movement therapy on nutritional status and muscle strength in older patients with sarcopenia.Methods:A total of 35 older sarcopenia patients from May 2019 to April 2020 in Nanfang Hospital, Southern Medical University were enrolled as the intervention group with dance movement therapy; another 35 older sarcopenia patients from May 2018 to April 2019 were selected as control group with routine exercise intervention. Nutritional indicators and muscle strength were compared between two groups on admission, at 1, 3, 6 months after intervention.Results:At 3, 6 months after intervention, hemoglobin and body mass index were (124.10 ± 16.59) g/L, (128.33 ± 14.50) g/L and (21.40 ± 1.87) kg/m 2, (21.40 ± 1.87) kg/m 2 in the intervention group, higher than in the control group (116.03 ± 12.23) g/L, (120.09 ± 11.34) g/L and (20.03 ± 1.93) kg/m 2, (19.97 ± 1.99) kg/m 2. The differences were statistically significant ( t values were 2.17-2.84, all P<0.05). At 6 months after intervention, serum albumin was (33.73 ± 5.23) g/L in the intervention group, significantly higher than that in the control group (30.88 ± 5.17) g/L, the difference was statistically significant ( t=2.16, P<0.05). At 3, 6 months after intervention, muscle strength were (21.63 ± 1.54) kg, (23.17 ± 1.72) kg and short physical performance battery scores were 7.83 ± 1.56, 7.47 ± 1.59 in the intervention group, significantly higher than in the control group (19.66 ± 2.50) kg, (20.91 ± 2.83) kg and 6.59 ± 1.64, 5.97 ± 1.49, the differences were statistically significant ( t values were 3.05-3.83, all P<0.05). At 6 months after intervention, appendicular skeletal muscle mass index (ASMI) was (6.03 ± 1.47) kg/m 2 in the intervention group, significantly higher than (5.13 ± 1.36) kg/m 2 in the control group, the difference was statistically significant ( t=2.52, P<0.05). Conclusions:Dance movement therapy can improve the nutritional status and muscle strength of older patients with sarcopenia.