The Chinese Pharmacopoeia is the legal technical standard which should be followed during the research, production, use, and administration of drugs. At present, the new edition of the Chinese Pharmacopoeia is planned to be promulgated and implemented. This article summarizes and analyzes the main characteristics and the content of updates and amendments of the Chinese Pharmacopoeia 2025 Edition(Volume Ⅰ), to provide a reference for the correct understanding and accurate implementation the new edition of the pharmacopoeia.

ObjectiveTo evaluate the clinical efficacy of Xu's Shenqiyizhu （SQYZ） decoction combined with chemotherapy in the treatment of cancer-related fatigue （CRF） of stagnated-toxin spleen deficiency type after gastric cancer surgery and explore its possible mechanism. MethodsFifty postoperative gastric cancer patients with CRF of stagnated-toxin spleen deficiency type were selected and randomly divided into an experimental group and a control group by using a random number table，with 25 cases in each group. The control group was treated with FLOT chemotherapy （50 mg·m^-2 docetaxel （iv drip on day 1） + 85 mg·m^-2 oxaliplatin （iv drip on day 1） + 200 mg·m^-2 calcium folinate （iv drip on day 1） + 2 600 mg·m^-2 fluorouracil （iv drip for 24 h on day 1），once every three weeks） and basic and symptomatic supportive treatment. The experimental group was treated with Xu's SQYZ decoction （decocted twice，200 mL taken orally twice a day） in addition to the treatment of the control group. One course of treatment lasted for three weeks，with a total of four courses conducted. Observation was performed on the piper fatigue scale （PFS） scores，karnofsky performance status （KPS） scores，European Organization for Research and Treatment of cancer quality of life questionnaire （EORTC QLQ-C30） scores，traditional Chinese medicine syndrome scores，and serum levels of tumor necrosis factor-α （TNF-α），interferon-γ （IFN-γ），and interleukin-6 （IL-6）detected via enzyme linked immunosorbent assay （ELISA） before and after treatment in the two groups. The safety test results before and after treatment for the two groups of patients，as well as the occurrence of adverse events during treatment， were recorded. Transcriptome sequencing data of peripheral blood samples from gastric adenocarcinoma patients and normal individuals were downloaded from the gene expression omnibus （GEO） database，and differentially expressed genes between the tumor and normal groups were identified. Differential gene enrichment analysis was made based on the Kyoto Encyclopedia of Genes and Genomes （KEGG） and Gene Ontology （GO）. The CRF relevance scores of genes were retrieved from the GeneCards database. Results① Compared with that before treatment，the total PFS score in the experimental group was significantly reduced （P<0.05）. Compared with the control group after treatment，the experimental group showed significantly reduced total PFS score （P<0.05）. ② Compared with that before treatment，the KPS score in the experimental group decreased significantly （P<0.05）. Compared with the control group after treatment，the experimental group exhibited a significantly decreased KPS score （P<0.05）. The experimental group demonstrated significantly increased functional scores （physical function，role function，emotional function，social function，and overall health） （P<0.05） and significantly reduced symptom scores （fatigue，shortness of breath，loss of appetite，constipation，and diarrhea） of the EORTC QLQ-C30 scale after treatment compared with before treatment. Compared with the control group after treatment，the experimental group presented significantly increased functional scores （physical function，emotional function，social function，and overall health） （P<0.05） and significantly reduced symptom scores （fatigue，nausea and vomiting，shortness of breath，loss of appetite，and diarrhea） of the EORTC QLQ-C30 scale （P<0.05）. Compared with those before treatment，the traditional Chinese medicine syndrome scores （eating too little and poor digestion，fatigue and weakness，postprandial bloating，abnormal bowel movements，lassitude and weakness，and total score） in the experimental group were significantly reduced （P<0.05）. Compared with the control group after treatment，the experimental group had significantly reduced traditional Chinese medicine syndrome scores （eating too little and poor digestion，fatigue and weakness，nausea and vomiting，and sallow complexion） （P<0.05）， which indicated better efficacy in the experimental group than in the control group （χ²=7.996，P<0.05）. The serum levels of TNF-α，IL-6，and IFN-γ were significantly correlated with each other （P<0.01）. Compared with those before treatment，the levels of serum cytokines TNF-α，IL-6，and IFN-γ in the experimental group were significantly reduced （P<0.05）. Compared with the control group after treatment，the experimental group showed significantly reduced serum levels of cytokines TNF-α，IL-6，and IFN-γ （P<0.05）. ③ There were no significant intra-group and inter-group differences in the safety test results of the two groups before and after treatment. During the treatment period，there was no significant difference in the incidence of adverse reactions between the two groups of patients. ④ Compared with the normal group，the tumor group exhibited a total of 328 significantly up-regulated genes in the peripheral blood （P<0.05），and KEGG and GO analyses showed that they were significantly enriched in signaling pathways such as TNF （P<0.05）. ⑤ TNF，IL6，IFNG， and other cytokine encoding genes may be key pathogenic genes for CRF. ConclusionXu's SQYZ decoction can alleviate symptoms such as fatigue in postoperative chemotherapy patients with gastric cancer and improve their functional status and quality of life. Its mechanism may be related to improving cytokine imbalance.

BACKGROUND: Chronic kidney disease (CKD)-associated anemia (CKD-anemia) is associated with poor survival, and hemoglobin targets are often not achieved with current therapies. Phase 3 trials have demonstrated the treatment efficacy of roxadustat for CKD-anemia. This phase 4 study aims to evaluate the long-term (52-week) safety and effectiveness of roxadustat in a broad real-world patient population with CKD-anemia with and without dialysis in China. METHODS: This Phase 4 multicenter, open-label, prospective study, conducted from 24 November 2020 to 11 November 2022, evaluated the long-term safety and effectiveness of roxadustat for CKD-anemia in China. Patients aged ≥18 years with CKD-anemia with or without dialysis were included. The initial oral dose was 70-120 mg (weight-based followed by dose adjustment) over 52 weeks. The primary endpoint was safety based on adverse events (AEs). The secondary endpoints were hemoglobin changes from baseline and the proportion of patients who achieved mean hemoglobin ≥100 g/L. Effectiveness evaluable populations 1 (EE1) and EE2 included roxadustat-naïve and previously roxadustat-treated patients, respectively. The safety analysis set (SAF) included all patients who received ≥1 occasion. RESULTS: The EE1, EE2, and SAF populations included 1804, 193, and 2021 patients, respectively. In the SAF, the mean age was 50 ± 14 years, and 1087 patients (53.8%) were male. Mean baseline hemoglobin was 96.9 ± 14.0 g/L in EE1 and 100.3 ± 12.9 g/L in EE2. In EE1, the mean (95% confidence interval) hemoglobin changes from baseline over weeks 24-36 and 36-52 were 14.2 (13.5-14.9) g/L and 14.3 (13.5-15.0) g/L, respectively. Over weeks 24-36 and 36-52, 83.3% and 86.1% of patients in EE1 and 82.7% and 84.7% in EE2 achieved mean hemoglobin ≥100 g/L, respectively. In the SAF, 1643 (81.3%) patients experienced treatment-emergent AEs (TEAEs). Overall, 219 (10.8%) patients experienced drug-related TEAEs. Thirty-eight (1.9%) patients died of TEAEs (unrelated to the study drug). Vascular access thrombosis was uncommon. CONCLUSIONS: Roxadustat (52 weeks) increased hemoglobin and maintained the treatment target in Chinese patients with CKD-anemia with acceptable safety, supporting its use in real-world settings. REGISTRATION Chinese Clinical Trial Registry ( www.chictr.org.cn ) ChiCTR2100046322; CDE ( www.chinadrugtrials.org.cn ) CTR20201568.
Humans ; Male ; Female ; Anemia/etiology* ; Middle Aged ; Renal Insufficiency, Chronic/complications* ; Glycine/adverse effects* ; Isoquinolines/adverse effects* ; Aged ; Prospective Studies ; Adult ; Hemoglobins/metabolism* ; Treatment Outcome ; China ; Registries ; East Asian People

OBJECTIVE: To investigate the impact of early antimicrobial therapy on the prognosis of patients with suspected sepsis in emergency and outpatient settings. METHODS: A prospective cohort study was conducted. Patients with suspected sepsis admitted to the emergency department of Taizhou Hospital, Zhejiang Province, from May 1, 2022, to July 31, 2023, were enrolled. Participants were divided into an early group (0-1 hour) and a delayed group (> 1 hour) according to duration from admission to antimicrobial administration. General information, initial vital signs, laboratory parameters within 24 hours after admission, disease severity scores, vasoactive drug usage, and clinical outcomes of the patient were collected. Kaplan-Meier survival curve was used to analyze 28-day survival. Multivariate Cox proportional hazards regression was performed to identify independent risk factors for prognosis of the patients with suspected sepsis in emergency and outpatient settings. Sensitivity analyses were conducted through subgroup analyses. RESULTS: A total of 143 patients with suspected sepsis were enrolled in the analysis, with 66 patients in the early group and 77 in the delayed group. No statistically significant differences were observed in baseline characteristics (age, gender, vital signs, laboratory parameters, disease severity scores) or clinical outcomes [vasoactive drug usage rate, mechanical ventilation duration, length of intensive care unit (ICU) stay, total hospitalization duration] between the two groups. The 28-day mortality, multidrug resistance rate and sepsis confirmation rate did not differ significantly between the early group and delay group [28-day mortality: 18.2% (12/66) vs. 20.8% (16/77), multidrug resistance rate: 3.0% (2/66) vs. 2.6% (2/77), sepsis confirmation rate: 87.9% (58/66) vs. 88.3% (68/77), all P > 0.05]. Kaplan-Meier survival curve analysis showed no difference in 28-day cumulative survival between the two groups (Log-Rank test: χ² = 2.528, P = 0.112). Multivariate Cox proportional hazards regression identified vasoactive drug usage [hazard ration (HR) = 2.465, 95% confidence interval (95%CI) was 1.019-5.961, P = 0.045] and endotracheal intubation (HR = 5.516, 95%CI was 2.195-13.858, P < 0.001) as independent risk factors for 28-day death of the patients with suspected sepsis in emergency and outpatient settings. Further exploration of the impact of early antimicrobial therapy on 28-day death in different subgroups of the patients with suspected sepsis in emergency and outpatient settings was conducted through subgroup analysis. The results showed that in the patients with different ages (< 60 years old: HR = 1.214, 95%CI was 0.535-2.751, P = 0.643; ≥ 60 years old: HR = 2.085, 95%CI was 0.233-18.668, P = 0.511), sequential organ failure assessment (SOFA) scores (< 6: HR = 1.411, 95%CI was 0.482-4.128, P = 0.530; ≥ 6: HR = 0.869, 95%CI was 0.292-2.587, P = 0.801), shock indexes (< 1: HR = 1.095, 95%CI was 0.390-3.077, P = 0.863; ≥ 1: HR = 1.364, 95%CI was 0.458-4.059, P = 0.577) and whether diagnosed with sepsis or not (yes: HR = 0.943, 95%CI was 0.059-15.091, P = 0.967; no: HR = 1.207, 95%CI was 0.554-2.628, P = 0.636) subgroups, early usage of antibiotics had not shown any advantage in improving prognosis compared with delayed usage. CONCLUSION Early antimicrobial therapy does not improve the prognosis of patients with suspected sepsis in emergency and outpatient settings.
Humans ; Sepsis/drug therapy* ; Prospective Studies ; Prognosis ; Emergency Service, Hospital ; Outpatients ; Female ; Male ; Anti-Infective Agents/therapeutic use* ; Middle Aged ; Aged ; Proportional Hazards Models ; Treatment Outcome

Objective:To evaluate the efficacy and safety of fronto-orbital plasty using premature frontal suture osteotomy with frontoparietal transposition for the treatment of metopic synostosis.Methods:Retrospective analysis was performed on the clinical data of children with metopic synostosis who were treated in the Department of Burns and Plastic Surgery, Children’ s Hospital of Nanjing Medical University from January 2015 to October 2023 with fronto-orbital plasty, which involved premature frontal suture osteotomy with frontoparietal transposition. The frontal and parietal bones were divided into two bones, then the supraorbital bridge was cut off and the premature frontal suture was removed. The parietal bone block was then placed on the upper edge of the orbital bone, followed by the placement of the two pieces of the frontal bone on the upper edge of the parietal bone. Finally, all bone blocks were secured using absorbable plates. Pre-and post-operative CT scans and reconstructions were performed to measure changes in cranial cavity volume, and complications such as cerebrospinal fluid leakage, infection, and recurrence of metopic synostosis were followed up.Results:A total of 5 patients with metopic synostosis were enrolled, 4 males and 1 female, aged 5 to 14 months. The operation time was 4.5 to 5.5 hours, and the intraoperative blood loss was 50 to 150 ml. All patients completed the treatment without serious complications. The cranial cavity volume increased by 48.53 to 172.00 cm 3 after the operation. Follow-up was conducted for 3 to 6 months, and the trigonocephaly was completely improved without any serious complications. Short-term follow-up indicated stable craniofacial morphology. Conclusion:Fronto-orbital plasty using premature frontal suture osteotomy with frontoparietal transposition is an effective and safe treatment for metopic synostosis. The procedure has a low risk of recurrence and complications, and the result are positive. Recurrence was scarce in the short term, and the long-term situation needs to be observed.

Objective:To explore the clinical application effect of allogeneic acellular dermal matrix (ADM) in the repair of asymmetric nail fold deformity after complete syndactyly surgery in children.Methods:A retrospective analysis was conducted on the clinical data of children with secondary asymmetric nail fold deformity after complete syndactyly surgery treated at the Department of Burn and Plastic Surgery, Children’s Hospital of Nanjing Medical University, from January 2022 to December 2023. The patients required a secondary surgical repair due to insufficient soft tissue capacity with or without scar contracture, causing asymmetry of the nail fold after finger separation at the distal end following syndactyly surgery. During the operation, continuous Z-plasty was designed along the original surgical scar axis and incised towards the proximal end of the lateral nail fold, followed by thorough scar release. Scar debulking surgery was performed if there was significant local scar hyperplasia. A tunnel was created from the incision site near the lateral nail fold to reach the fingertip subcutaneously. ADM was filled into this tunnel until a satisfactory appearance of the lateral nail fold was achieved. The flaps were then closed by cross-suturing. Regular follow-up observations were conducted on the incision healing, scar, and appearance of the finger, and aesthetic evaluation according to Bulic’s standards was performed, classifying them into four grades: excellent, good, fair, and poor.Results:The study enrolled 12 patients, and nail fold asymmetry appeared 3 to 6 months after surgery, with 8 males and 4 females, ranging from 1 to 9 years old (average age 4.6 years). Affected digits included both hands in 7 cases and one hand in 5 cases, totaling 38 fingers. All 12 cases including 25 fingers presented with insufficient distal capacity in their fingers; seven cases including 16 fingers also had scar contracture resulting in poor appearance. All procedures were successfully performed. Post-operatively, one case of necrosis at the tip of the scar flap was observed after 12 days of removing the dressing but healed after dressing changes, and no infections or flap necrosis occurred in the remaining patients, with the incisions healing primarily. Follow-up periods ranged from 1 to 24 months, with an average duration of 13.6 months. All patients achieved the restoration of soft tissue capacity in the finger lateral nail fold, varying degrees of correction for asymmetrical nail fold deformities, and complete release for scar contracture, with 7 fingers in 4 cases rated as excellent, 12 fingers in 5 cases as good, 4 fingers in 2 cases as fair, and 2 fingers in one case as poor in evaluation of fingertip appearance.Conclusion:The use of ADM for filling is effective in restoring soft tissue capacity and correcting asymmetrical deformities caused by secondary nail fold abnormalities after complete syndactyly repair surgery in children. It has shown good clinical outcomes with minimal complications.

Objective:To evaluate the efficacy and safety of fronto-orbital plasty using premature frontal suture osteotomy with frontoparietal transposition for the treatment of metopic synostosis.Methods:Retrospective analysis was performed on the clinical data of children with metopic synostosis who were treated in the Department of Burns and Plastic Surgery, Children’ s Hospital of Nanjing Medical University from January 2015 to October 2023 with fronto-orbital plasty, which involved premature frontal suture osteotomy with frontoparietal transposition. The frontal and parietal bones were divided into two bones, then the supraorbital bridge was cut off and the premature frontal suture was removed. The parietal bone block was then placed on the upper edge of the orbital bone, followed by the placement of the two pieces of the frontal bone on the upper edge of the parietal bone. Finally, all bone blocks were secured using absorbable plates. Pre-and post-operative CT scans and reconstructions were performed to measure changes in cranial cavity volume, and complications such as cerebrospinal fluid leakage, infection, and recurrence of metopic synostosis were followed up.Results:A total of 5 patients with metopic synostosis were enrolled, 4 males and 1 female, aged 5 to 14 months. The operation time was 4.5 to 5.5 hours, and the intraoperative blood loss was 50 to 150 ml. All patients completed the treatment without serious complications. The cranial cavity volume increased by 48.53 to 172.00 cm 3 after the operation. Follow-up was conducted for 3 to 6 months, and the trigonocephaly was completely improved without any serious complications. Short-term follow-up indicated stable craniofacial morphology. Conclusion:Fronto-orbital plasty using premature frontal suture osteotomy with frontoparietal transposition is an effective and safe treatment for metopic synostosis. The procedure has a low risk of recurrence and complications, and the result are positive. Recurrence was scarce in the short term, and the long-term situation needs to be observed.

Objective:To explore the clinical application effect of allogeneic acellular dermal matrix (ADM) in the repair of asymmetric nail fold deformity after complete syndactyly surgery in children.Methods:A retrospective analysis was conducted on the clinical data of children with secondary asymmetric nail fold deformity after complete syndactyly surgery treated at the Department of Burn and Plastic Surgery, Children’s Hospital of Nanjing Medical University, from January 2022 to December 2023. The patients required a secondary surgical repair due to insufficient soft tissue capacity with or without scar contracture, causing asymmetry of the nail fold after finger separation at the distal end following syndactyly surgery. During the operation, continuous Z-plasty was designed along the original surgical scar axis and incised towards the proximal end of the lateral nail fold, followed by thorough scar release. Scar debulking surgery was performed if there was significant local scar hyperplasia. A tunnel was created from the incision site near the lateral nail fold to reach the fingertip subcutaneously. ADM was filled into this tunnel until a satisfactory appearance of the lateral nail fold was achieved. The flaps were then closed by cross-suturing. Regular follow-up observations were conducted on the incision healing, scar, and appearance of the finger, and aesthetic evaluation according to Bulic’s standards was performed, classifying them into four grades: excellent, good, fair, and poor.Results:The study enrolled 12 patients, and nail fold asymmetry appeared 3 to 6 months after surgery, with 8 males and 4 females, ranging from 1 to 9 years old (average age 4.6 years). Affected digits included both hands in 7 cases and one hand in 5 cases, totaling 38 fingers. All 12 cases including 25 fingers presented with insufficient distal capacity in their fingers; seven cases including 16 fingers also had scar contracture resulting in poor appearance. All procedures were successfully performed. Post-operatively, one case of necrosis at the tip of the scar flap was observed after 12 days of removing the dressing but healed after dressing changes, and no infections or flap necrosis occurred in the remaining patients, with the incisions healing primarily. Follow-up periods ranged from 1 to 24 months, with an average duration of 13.6 months. All patients achieved the restoration of soft tissue capacity in the finger lateral nail fold, varying degrees of correction for asymmetrical nail fold deformities, and complete release for scar contracture, with 7 fingers in 4 cases rated as excellent, 12 fingers in 5 cases as good, 4 fingers in 2 cases as fair, and 2 fingers in one case as poor in evaluation of fingertip appearance.Conclusion:The use of ADM for filling is effective in restoring soft tissue capacity and correcting asymmetrical deformities caused by secondary nail fold abnormalities after complete syndactyly repair surgery in children. It has shown good clinical outcomes with minimal complications.

Objective To investigate the expression of microRNA(miR)-15b and miR-503 in peripheral blood in patients with depression and their relationship with cognitive function.Methods A total of 103 patients with depression admitted and diagnosed in Shaoxing Seventh People's Hospital from January 2023 to June 2024 were set as study group,and 94 healthy participants were selected as control group.The cognitive function of patients with depression was evaluated by Montreal cognitive assessment(MoCA),and the patients in study group were divided into normal cognitive function group(n=68)and cognitive dysfunction group(n=35).Pearson method was used to analyze the correlation between the expression level of miR-15b,miR-503 and cognitive function;The diagnostic value of miR-15b and miR-503 for cognitive dysfunction in patients with depression was analyzed by using receiver operating characteristic(ROC)curve.Results miR-15b and miR-503 in the peripheral blood of study group were lower than those of control group(P＜0.05),miR-15b and miR-503 in the peripheral blood of cognitive dysfunction group were lower than those of normal cognitive function group(P＜0.05),the scores of MoCA and mini-mental state examination in normal cognitive function group were higher than those in cognitive dysfunction group(P＜0.05);The results of Pearson analysis showed that the levels of miR-15b and miR-503 in peripheral blood of patients with depression were significantly positively correlated with MoCA scores(r=0.635,0.668,P＜0.05);The area under the curve(AUC)of miR-15b level alone in diagnosing cognitive dysfunction in patients with depression was 0.836(95％CI:0.750-0.902),the sensitivity and specificity were 77.14％and 89.71％respectively;The AUC of miR-503 level alone in diagnosing cognitive dysfunction in patients with depression was 0.892(95％CI:0.816-0.945),the sensitivity and specificity were 80.00％and 88.24％respectively;The AUC for the combined diagnosis of miR-15b and miR-503 was significantly greater than the AUC for miR-15b and miR-503 alone.Conclusion The expression of miR-15b and miR-503 is decreased in patients with depression,and they are of high diagnostic value for cognitive dysfunction in patients with depression.

Objective:To investigate the effect of preoperative patellar tilt angle on postoperative outcome of total knee arthroplasty (TKA).Methods:A total of 277 patients with knee osteoarthritis who underwent TKA without patellar replacement in the First Affiliated Hospital of Nanjing Medical University from October 2020 to September 2022 were retrospectively analyzed. There were 72 males and 205 females, aged 69.16±6.77 years (range, 52-87 years), body mass index 27.01±3.81 kg/m 2 (range 18.14-39.01 kg/m 2). The patients were divided into three groups according to the preoperative tilt angle of the patella: tilt angle<5° for mild tilt group, 5°≤tilt angle<10° for moderate tilt group, and tilt angle≥10° for severe tilt group. There were 103 cases in the mild group, 137 cases in the moderate group, and 37 cases in the severe group. The preoperative and postoperative visual analogue scale (VAS), Hospital for Special Surgery (HSS) score and Feller's score of patella were compared. Results:All patients were followed up for 15.73±3.06 months (range, 12-22 months). The patellar tilt angle was 6.86°±3.55° preoperatively and 3.63°±2.61° postoperatively ( t=19.086, P<0.001). The patellar tilt angle of mild group, moderate group and severe group decreased after operation, and the difference was statistically significant compared with that before operation ( P<0.05). The anterior knee VAS of the three groups decreased after operation, and the differences were statistically significant compared with those before operation. The anterior knee VAS at 3, 6, and 12 months after operation were lower than those before operation. The differences between groups at 6 and 12 months postoperatively were statistically significant ( P<0.05), with anterior knee VAS scores of 2.59±0.55 and 2.03±0.55 in the severe group being greater than those of 2.15±0.38 and 1.57±0.50 in the mild group and 2.19±0.49 and 1.67± 0.61 in the moderate group. The HSS score of the three groups was increased after operation, and the difference was statistically significant compared with that before operation ( P<0.05), and the HSS scores at 3, 6 and 12 months after operation were higher than those before operation. There were significant differences at 6 and 12 months after operation ( P<0.05), the HSS scores of the severe group were 86.27±2.04 and 87.73±2.28, which were lower than those of the mild group 89.02±2.33 and 89.83±1.48, and the moderate group 88.77±2.83 and 89.52±1.95. Postoperative patellar Feller score increased in all three groups, and the difference was statistically significant compared with that before operation ( P<0.05), the patellar Feller score at 3, 6 and 12 months after operation was higher than that before operation. There were significant differences at 6 and 12 months after operation ( P<0.05), the patellar Feller scores in the severe group were 18.32±1.99 and 20.32±1.60, which were lower than those in the mild group 20.92±1.01 and 23.07±1.39 and the moderate group 20.91±1.95 and 22.69±1.59. Conclusion:In TKA patients without patella replacement, the increase of patellar tilt angle before operation can lead to anterior knee pain and reduced knee function.