1.Clinical efficacy of extended abdominal wall resection combined with reconstruction for abdo-minal wall aggressive fibromatosis
Zhen REN ; Lisheng WU ; Wenxiu HAN ; Bo HAO ; Xiaohan WEI ; Hu LIU ; Shuhan WANG ; Chen PAN ; Pengfei JI ; Baichuan ZHOU
Chinese Journal of Digestive Surgery 2025;24(9):1186-1190
Objective:To investigate the clinical efficacy of extended abdominal wall resec-tion combined with reconstruction for abdominal wall aggressive fibromatosis (AF).Methods:The retrospective and descriptive study was conducted. The clinical data of 70 patients with abdominal wall AF who were admitted to 3 medical centers, including The First Affiliated Hospital of the University of Science and Technology of China, between January 2009 and July 2024 were collected. There were 6 males and 64 females, aged (36±13)years. All patients underwent extended abdominal wall resection combined with abdominal wall reconstruction. Observation indicators: (1) surgical situations; (2) tumor recurrence and postoperative complications. Comparisons of measurement data with skewed distribution between groups was conducted using the Mann-Whitney U test. Comparison of count data between groups was conducted using the chi-square test. Results:(1)Surgical situations. All 70 patients underwent extended abdominal wall resection combined with abdominal wall recons-truction. The operation time was 90(91)minutes and duration of postoperative hospital stay was 10(6)days. Of the 70 patients, 41 patients underwent abdominal wall AF resection plus polypropylene mesh abdominal wall reconstruction, with a defect area of 60(54)cm2. The mesh placement method was uniformly Sublay repair. The remaining 29 patients underwent abdominal wall AF resection plus direct suture repair, with a defect area of 34(31)cm2. There was a significant difference in the abdominal wall defect area between the two groups ( U=291.00, P<0.05). All 70 patients achieved R 0 resection. The distance from surgical margin to tumor edge was 2-3 cm in 39 cases and >3 cm in 31 cases. (2) Tumor recurrence and postoperative complications. All 70 patients were followed up for 78(90)months. During follow-up, 10 patients developed tumor recurrence (5 cases with mesh reinforced abdominal wall reconstruction and 5 cases with direct suture repair). Among them, one case was monitored, one case underwent radiotherapy, and neither received further surgical treatment. The remaining 8 patients underwent repeat R 0 resection, and no further recurrence occurred. There was no significant difference in recurrence rate between the patients with mesh reconstruction and patients with direct suture repair ( χ2=0.06, P>0.05). The postoperative recurrence rate was 9.7%(3/31) in patients with the distance from surgical margin to tumor edge >3 cm, versus 17.9%(7/39) in patients with the distance from surgical margin to tumor edge of 2-3 cm, showing no significant difference between them ( χ2=0.97, P>0.05). Sixty patients had no tumor recurrence. During follow-up, none of the 70 patients developed incisional hernia. Two patients experienced postoperative wound infection, and 6 cases developed postoperative chronic pain. Conclusion:Extended abdominal wall resection combined with reconstruction is safe and feasible for abdominal wall AF.
2.Clinical efficacy of extended abdominal wall resection combined with reconstruction for abdo-minal wall aggressive fibromatosis
Zhen REN ; Lisheng WU ; Wenxiu HAN ; Bo HAO ; Xiaohan WEI ; Hu LIU ; Shuhan WANG ; Chen PAN ; Pengfei JI ; Baichuan ZHOU
Chinese Journal of Digestive Surgery 2025;24(9):1186-1190
Objective:To investigate the clinical efficacy of extended abdominal wall resec-tion combined with reconstruction for abdominal wall aggressive fibromatosis (AF).Methods:The retrospective and descriptive study was conducted. The clinical data of 70 patients with abdominal wall AF who were admitted to 3 medical centers, including The First Affiliated Hospital of the University of Science and Technology of China, between January 2009 and July 2024 were collected. There were 6 males and 64 females, aged (36±13)years. All patients underwent extended abdominal wall resection combined with abdominal wall reconstruction. Observation indicators: (1) surgical situations; (2) tumor recurrence and postoperative complications. Comparisons of measurement data with skewed distribution between groups was conducted using the Mann-Whitney U test. Comparison of count data between groups was conducted using the chi-square test. Results:(1)Surgical situations. All 70 patients underwent extended abdominal wall resection combined with abdominal wall recons-truction. The operation time was 90(91)minutes and duration of postoperative hospital stay was 10(6)days. Of the 70 patients, 41 patients underwent abdominal wall AF resection plus polypropylene mesh abdominal wall reconstruction, with a defect area of 60(54)cm2. The mesh placement method was uniformly Sublay repair. The remaining 29 patients underwent abdominal wall AF resection plus direct suture repair, with a defect area of 34(31)cm2. There was a significant difference in the abdominal wall defect area between the two groups ( U=291.00, P<0.05). All 70 patients achieved R 0 resection. The distance from surgical margin to tumor edge was 2-3 cm in 39 cases and >3 cm in 31 cases. (2) Tumor recurrence and postoperative complications. All 70 patients were followed up for 78(90)months. During follow-up, 10 patients developed tumor recurrence (5 cases with mesh reinforced abdominal wall reconstruction and 5 cases with direct suture repair). Among them, one case was monitored, one case underwent radiotherapy, and neither received further surgical treatment. The remaining 8 patients underwent repeat R 0 resection, and no further recurrence occurred. There was no significant difference in recurrence rate between the patients with mesh reconstruction and patients with direct suture repair ( χ2=0.06, P>0.05). The postoperative recurrence rate was 9.7%(3/31) in patients with the distance from surgical margin to tumor edge >3 cm, versus 17.9%(7/39) in patients with the distance from surgical margin to tumor edge of 2-3 cm, showing no significant difference between them ( χ2=0.97, P>0.05). Sixty patients had no tumor recurrence. During follow-up, none of the 70 patients developed incisional hernia. Two patients experienced postoperative wound infection, and 6 cases developed postoperative chronic pain. Conclusion:Extended abdominal wall resection combined with reconstruction is safe and feasible for abdominal wall AF.
3.Predictive value of toe-to-room temperature gradient for 28 d mortality in sepsis patients:a single center prospective observational clinical study
Lu-Lan LI ; Yi-Lin LIU ; Yong LIU ; Shao-Wu CHEN ; Hong-Bin HU ; Zhen-Hua ZENG
Medical Journal of Chinese People's Liberation Army 2025;50(5):536-544
Objective To investigate the predictive value of temperature gradients on the mortality of sepsis patients and their correlation with fluid input.Methods By means of a prospective observational method,154 patients with sepsis or septic shock admitted to the Department of Critical Care Medicine at Nanfang Hospital,Southern Medical University from November 2019 to November 2021 were included as research subjects.They were divided into a survivor group(n=118)and a non-survivor group(n=36)according to whether they survived within 28 days.The core-to-toe temperature gradient(CTTG)and toe-to-room temperature gradient(TRTG)were monitored and calculated immediately upon admission to the intensive care unit(ICU)and 6 hours after admission.Receiver operating characteristic(ROC)curve was used to explore the predictive value of temperature gradients on mortality,and multivariate Cox regression analysis was performed to explore the risk factors of 28-day mortality in sepsis patients.The results were verified through survival analysis.Correlation analysis and multivariate analysis of variance were used to explore the correlation between temperature gradients and fluid input,as well as noradrenaline doses.Results Among the 154 patients,118 survived within 28 days(survivor group),and 36 died(non-survivor group).ROC curve and multivariate Cox regression analysis showed that a toe-to-room temperature gradient of≤5.35℃within 6 hours after admission was a risk factor for 28-day mortality.Compared with patients with a high toe-to-room temperature gradient(>5.35℃),patients with a low toe-to-room temperature gradient(≤5.35℃)had a 2.74-fold increase in the risk of 28-day mortality(P=0.004,95%CI 1.54,9.12).The CTTG and TRTG upon admission to the ICU and 6 hours after admission were not significantly associated with fluid input or noradrenaline doses(P>0.05).Conclusions A toe-to-room temperature gradient of less than or equal to 5.35℃within 6 hours after ICU admission is a risk factor for 28-day mortality in sepsis patients.The improvement of temperature gradients at different time points is not associated with fluid input.
4.Establishment of preparation process and quality standard for Zhenggu Pills
Wen-ming ZHANG ; Zi-fang FENG ; Li-hong GU ; Ping QIN ; Zhen-hua BIAN ; Min-min HU ; Xiao-wei CHEN
Chinese Traditional Patent Medicine 2025;47(9):2863-2869
AIM To establish the preparation process and quality standard for Zhenggu Pills.METHODS With decoction time,decoction frequency and water addition as influencing factors,comprehensive score for extract yield and transfer rates of epicatechin and naringin as an evaluation index,the decoction process was optimized by orthogonal test.With sugarless paste relative density,medicinal powder fineness,sugarless paste-corn starch ratio,drying temperature and drying time as influencing factors,soft material traits,pill formability,moisture and disintegration time limit as evaluation indices,the formability process was optimized by single factor test.TLC was adopted in the qualitative identification of Dipsaci Radix,salt-processed Psoraleae Fructus,cooked Rhei Radix et Rhizoma and Notoginseng Radix et Rhizoma.HPLC was used for the content determination of paeoniflorin and naringin.RESULTS The optimal decoction process was determined to be 0.5 h for decoction time,two times for decoction frequency,and 10 times for water addition,the comprehensive score was 0.93.The optimal formability process was determined to be 1.21-1.22 for sugarless paste relative density,80 mesh for medicinal powder fineness,1∶0.17-1∶0.18 for sugarless paste-corn starch ratio,70 ℃ for drying temperature,and 24 h for drying time,good soft material traits and pill formability were observable,and moisture and disintegration time limit accored with 2020 edition of Chinese Pharmacopoeia requirements.The TLC spots were clear without negative interference.Two constituents showed good linear relationships within 61.30-490.41 μg/mL(r=0.999 8)and 3.27-26.18 μg/mL(r=0.999 8),whose average recoveries were 100.15%and 98.15%with the RSDs of 0.55%and 2.30%,respectively.CONCLUSION This stable,reliable and specific method can be used for the production and quality evaluation of Zhenggu Pills.
5.Interpretation of"Guideline 9213 for validation,verification,and transfer of microbiological analytical methods"in Chinese Pharmacopoeia 2025 Edition
Yan YANG ; Hong SHAO ; Shujuan WANG ; Rong FU ; Qian YANG ; Junhao CHEN ; Zhen SHEN ; Chunyan AN ; Yiling FAN ; Meicheng YANG ; Jun ZHANG ; Changqin HU
Drug Standards of China 2025;26(5):462-467
The Chinese Pharmacopoeia 2025 Edition added the 9213 Guideline for validation,verification,and transfer of microbiological analytical methods.Based on the characteristics of pharmaceutical microbiological analyt-ical methods and practical applications,it specified definitions of relevant terms and application scenarios,estab-lished technical indicators and acceptance criteria for methodological evaluation,and introduced key statistical tools and evaluation principles.This article systematically elaborates on the drafting background and process of the Guideline,and interprets its key content,aiming to offer theoretical guidance and practical reference for relevant practitioners in applying this guideline.This guideline strengthens the foundation of pharmaceutical microbial analytical methods in China and enhances the scientificity and accuracy of the pharmaceutical microbial standards system.
6.Prognostic factors and survival analysis in rectal cancer patients with poor response to neoadjuvant therapy
Hongbo LI ; Yi QIAN ; Kexuan LI ; Chen WANG ; Zhen SUN ; Xiyu SUN ; Lai XU ; Guannan ZHANG ; Bin WU ; Guole LIN ; Junyang LU ; Ke HU ; Yi XIAO
Chinese Journal of Gastrointestinal Surgery 2025;28(1):48-57
Objective:To compare the impact of different treatment strategies on the survival outcomes in rectal cancer patients with poor response to neoadjuvant therapy, and to explore the survival-related influencing factors.Methods:A retrospective cohort study was conducted. Between January 2018 and November 2022, the clinical, pathological, and follow-up data of 106 rectal cancer patients who received neoadjuvant therapy and were evaluated as grade 4 or 5 based on the Magnetic Resonance Tumor Regression Grade (mrTRG) from the rectal cancer database at Peking Union Medical College Hospital were retrospectively collected. Based on the post-neoadjuvant therapy assessment, patients were classified into three groups: the chemotherapy-radiotherapy group (23 patients), the consolidation therapy group (18 patients), and the standard treatment group (65 patients). General condition, pathological findings, selection of neoadjuvant therapy, comorbidities, as well as 3-year expected DMFS and OS were observed in the three groups.Results:All 106 patients were followed up, with a median follow-up time of 28 (21, 38) months. The overall 3-year DMFS rate was 60%, and the 3-year OS rate was 74%. The 3-year DMFS in the standard treatment and consolidation therapy groups were 74% and 72%, respectively; the 3-year OS were 84%, 81%, respectively. The Log-rank test showed that there was no significant difference in the 3-year expected DMFS and OS between the standard treatment group and the consolidation therapy group (both P>0.05), but both groups had better survival outcomes than the chemotherapy-radiotherapy group (10% and 39%, respectively; all P<0.001). Multivariate Cox regression analysis indicated that the chemotherapy-radiotherapy only regimen was an independent risk factor for DMFS (HR=12.425, 95% CI: 4.436–34.594, P<0.001), and the independent risk factors for OS were chemotherapy-radiotherapy only regimen (HR=8.991, 95%CI:2.220–36.403, P=0.002) and age≥65 years (HR=3.495, 95%CI: 1.017–12.009, P=0.047). Stratified analysis showed that chemotherapy-radiotherapy only regimen was the independent risk factors for DMFS and OS in patients with extramural vascular invasion (EMVI) positive ( n=66) and mesorectal fascial invasion (MRF) positive (n=56) (all P<0.05). Whether consolidation therapy was added to the standard neoadjuvant treatment regimen was not an independent factor affecting 3-year expected DMFS or OS in rectal cancer patients with poor response to neoadjuvant therapy. Further comparisons between the standard neoadjuvant treatment and consolidation therapy groups showed no statistically significant differences in spincter-preservation rate or postoperative complication rates (both P>0.05). However, the consolidation therapy group had a longer interval between the end of radiotherapy and surgery [80.1 (50.8, 109.4) days vs. 61.8 (48.8, 74.8) days, P<0.001], and a higher incidence of chemotherapy-related adverse effects ([10/18] vs. 26.2% [17/65], P=0.018). Conclusion:In rectal cancer patients with poor response to neoadjuvant therapy and clear adverse prognostic features before surgery (locally advanced stage, MRF positive or EMVI positive), the addition of short- or long-course chemotherapy-based systemic therapy does not provide short- or long-term survival benefits. Moreover, an extended chemotherapy duration increases the incidence of chemotherapy-related adverse effects.
7.Prognostic Significance of Endothelial Activation and Stress Index in Mantle Cell Lymphoma
Xin-Yue ZHOU ; Zhi-Qin YANG ; Jin HU ; Feng-Yi LU ; Qian-Nan HAN ; Huan-Huan ZHAO ; Wen-Xia GAO ; Yu-Han MA ; Hu-Jun LI ; Zhen-Yu LI ; Kai-Lin XU ; Wei CHEN
Journal of Experimental Hematology 2025;33(4):1051-1056
Objective:To investigate the predictive value of endothelial activation and stress index(EASIX)for the prognosis of patients with mantle cell lymphoma(MCL).Methods:A retrospective analysis was conducted to assess prognosis and compare the clinical features of patients diagnosed with MCL who were admitted to the Affiliated Hospital of Xuzhou Medical University from January 2010 to June 2023,had therapeutic indications and received standard treatment.Results:A total of 66 patients were included and divided into high EASIX group and low EASIX group,according to a cutoff value of 0.97 determined by the receiver operating characteristic(ROC)curve.Multivariate Cox regression analysis showed that prealbumin<0.2 g/L,high EASIX,and ECOG PS score ≥2 were independent risk factors influencing overall survival(OS)in MCL patients.The median OS of patients in the high and low EASIX group was 13.0 and 37.5 months,and the median progression-free survival was 8.8 and 26.0 months,respectively.The proportions of patients with ECOG PS score ≥2 and prealbumin<0.2 g/L at onset significantly increased in the high EASIX group compared to those in the low EASIX group.Conclusion:At the time of initial diagnosis,EASIX can serve as an independent prognostic indicator impacting OS in patients with MCL.Furthermore,patients in the high EASIX group experience a poorer prognosis and shorter survival duration compared with those in the low EASIX group.
8.Interpretation of"Guideline 9213 for validation,verification,and transfer of microbiological analytical methods"in Chinese Pharmacopoeia 2025 Edition
Yan YANG ; Hong SHAO ; Shujuan WANG ; Rong FU ; Qian YANG ; Junhao CHEN ; Zhen SHEN ; Chunyan AN ; Yiling FAN ; Meicheng YANG ; Jun ZHANG ; Changqin HU
Drug Standards of China 2025;26(5):462-467
The Chinese Pharmacopoeia 2025 Edition added the 9213 Guideline for validation,verification,and transfer of microbiological analytical methods.Based on the characteristics of pharmaceutical microbiological analyt-ical methods and practical applications,it specified definitions of relevant terms and application scenarios,estab-lished technical indicators and acceptance criteria for methodological evaluation,and introduced key statistical tools and evaluation principles.This article systematically elaborates on the drafting background and process of the Guideline,and interprets its key content,aiming to offer theoretical guidance and practical reference for relevant practitioners in applying this guideline.This guideline strengthens the foundation of pharmaceutical microbial analytical methods in China and enhances the scientificity and accuracy of the pharmaceutical microbial standards system.
9.Prognostic factors and survival analysis in rectal cancer patients with poor response to neoadjuvant therapy
Hongbo LI ; Yi QIAN ; Kexuan LI ; Chen WANG ; Zhen SUN ; Xiyu SUN ; Lai XU ; Guannan ZHANG ; Bin WU ; Guole LIN ; Junyang LU ; Ke HU ; Yi XIAO
Chinese Journal of Gastrointestinal Surgery 2025;28(1):48-57
Objective:To compare the impact of different treatment strategies on the survival outcomes in rectal cancer patients with poor response to neoadjuvant therapy, and to explore the survival-related influencing factors.Methods:A retrospective cohort study was conducted. Between January 2018 and November 2022, the clinical, pathological, and follow-up data of 106 rectal cancer patients who received neoadjuvant therapy and were evaluated as grade 4 or 5 based on the Magnetic Resonance Tumor Regression Grade (mrTRG) from the rectal cancer database at Peking Union Medical College Hospital were retrospectively collected. Based on the post-neoadjuvant therapy assessment, patients were classified into three groups: the chemotherapy-radiotherapy group (23 patients), the consolidation therapy group (18 patients), and the standard treatment group (65 patients). General condition, pathological findings, selection of neoadjuvant therapy, comorbidities, as well as 3-year expected DMFS and OS were observed in the three groups.Results:All 106 patients were followed up, with a median follow-up time of 28 (21, 38) months. The overall 3-year DMFS rate was 60%, and the 3-year OS rate was 74%. The 3-year DMFS in the standard treatment and consolidation therapy groups were 74% and 72%, respectively; the 3-year OS were 84%, 81%, respectively. The Log-rank test showed that there was no significant difference in the 3-year expected DMFS and OS between the standard treatment group and the consolidation therapy group (both P>0.05), but both groups had better survival outcomes than the chemotherapy-radiotherapy group (10% and 39%, respectively; all P<0.001). Multivariate Cox regression analysis indicated that the chemotherapy-radiotherapy only regimen was an independent risk factor for DMFS (HR=12.425, 95% CI: 4.436–34.594, P<0.001), and the independent risk factors for OS were chemotherapy-radiotherapy only regimen (HR=8.991, 95%CI:2.220–36.403, P=0.002) and age≥65 years (HR=3.495, 95%CI: 1.017–12.009, P=0.047). Stratified analysis showed that chemotherapy-radiotherapy only regimen was the independent risk factors for DMFS and OS in patients with extramural vascular invasion (EMVI) positive ( n=66) and mesorectal fascial invasion (MRF) positive (n=56) (all P<0.05). Whether consolidation therapy was added to the standard neoadjuvant treatment regimen was not an independent factor affecting 3-year expected DMFS or OS in rectal cancer patients with poor response to neoadjuvant therapy. Further comparisons between the standard neoadjuvant treatment and consolidation therapy groups showed no statistically significant differences in spincter-preservation rate or postoperative complication rates (both P>0.05). However, the consolidation therapy group had a longer interval between the end of radiotherapy and surgery [80.1 (50.8, 109.4) days vs. 61.8 (48.8, 74.8) days, P<0.001], and a higher incidence of chemotherapy-related adverse effects ([10/18] vs. 26.2% [17/65], P=0.018). Conclusion:In rectal cancer patients with poor response to neoadjuvant therapy and clear adverse prognostic features before surgery (locally advanced stage, MRF positive or EMVI positive), the addition of short- or long-course chemotherapy-based systemic therapy does not provide short- or long-term survival benefits. Moreover, an extended chemotherapy duration increases the incidence of chemotherapy-related adverse effects.

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