To introduce the general thinking, guidelines, work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition, and to summarize and figure out the main characteristics on dosage forms, physico-chemical testing, microbial and biological testing, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily promote the harmonization and unification with the ICH guidelines； further enhance the overall capacity of TCM quality control, actively implement the 3 R principles on animal experiments, and practice the concept of environmental-friendly； replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug safety control This paper aims to provide a full-view perspective for the comprehensive, correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.

Gastric cancer has high incidence and mortality rate. Chemotherapy is the first-line treatment for gastric cancer and has achieved considerable success. However, due to genetic variations and tumor heterogeneity, the effectiveness of chemothrapy drugs varies among different patients. Therefore, accurate assessment of patient’s sensitivity to chemotherapy drugs is crucial for personalized treatment. Gastric cancer organoids serve as effective tools for predicting patient’s sensitivity to chemotherapy drugs. This review summarizes the applications and related research progress of gastric cancer organoids in determining chemotherapy drug sensitivity, discusses the strengths and limitations of organoid models, and proposes outlooks for future research directions, hoping that organoids can provide more effective personalized treatment options and a greater range of drug choices for gastric cancer treatment.

OBJECTIVE To observe the clinical efficacy of Erdong Xiaoke Formula in the treatment of type 2 diabetes dry eyes with yin deficiency and heat excess syndrome and its effect on serum interleukin 17(IL-17)and interleukin 1β(IL-1β),and to ex-plore the therapeutic mechanism of Erdong Xiaoke Formula.METHODS 110 cases of type 2 diabetes patients with dry eyes of yin deficiency and heat excess syndrome from Jiangsu Province Hospital of Chinese Medicine were enrolled and randomly divided into a treatment group and a control group,55 cases each.5 cases dropped out of the treatment group and 4 cases dropped out of the control group.The control group was given a basic hypoglycemic regimen combined with topical sodium hyaluronate eye drops.The treatment group was given Erdong Xiaoke Formula in addition to the treatment in the control group.The treatment course for both groups was 4 weeks.Changes in TCM syndrome scores of the two groups of patients were observed before and after treatment,and the clinical effica-cy of TCM was evaluated.Blood glucose and pancreatic islet function-related indicators[fasting blood glucose(FBG),fasting insulin(FINS),fasting C-peptide(FCP),postprandial 2 h blood glucose(PBG),insulin secretion function index(HOMA-β),insulin re-sistance index(HOMA)-IR)],ocular surface indicators[tear break up time(BUT),corneal sodium fluorescein staining(FL),Schirmer Ⅰ test(SⅠT)],and inflammation-related indicators(IL-17,IL-1β)were detected.The occurrence of adverse reactions in the two groups of patients was observed during the treatment period.RESULTS After treatment,the total scores of TCM syn-dromes in both groups were significantly reduced(P＜0.01),the treatment group was better than the control group(P＜0.01),and the total effective rate of TCM syndromes in the treatment group was higher than that of the control group(P＜0.01);SⅠT and BUT of pa-tients in both groups increased significantly(P＜0.01),and the treatment group was better than the control group(P＜0.05,P＜0.01);the FL of patients in both groups significantly reduced(P＜0.01),and there was no significant difference between the groups;the ser-um IL-17 and IL-1β of the patients in the treatment group decreased significantly(P＜0.01),which was significantly better than that of the control group(P＜0.05).There were no significant changes in blood glucose and pancreatic islet function-related indicators in the two groups before and after treatment(P＞0.05).During the treatment,no obvious adverse reactions were observed in the two groups.CONCLUSION Erdong Xiaoke Formula can improve SⅠT,BUT,FL and eye symptoms in patients with diabetic dry eye,effectively treat diabetic dry eye,and reduce ocular surface inflammation.Its mechanism may be related to reducing serum inflammato-ry factors IL-17 and IL-1β.

Objective:To compare the clinical efficacy of neoadjuvant chemoradiotherapy (nCRT) and neoadjuvant chemo-immunotherapy (nCIT) for locally advanced esophageal squamous cell carcinoma (ESCC).Methods:Clinical data of patients who received nCRT or nCIT followed by esophagectomy for locally advanced ESCC between January 2010 and December 2022 were retrospectively collected from Zhejiang Cancer Hospital, with 155 patients in the nCRT group and 470 patients in the nCIT group. Propensity score matching (PSM) was performed in the two groups. After PSM, 120 patients were allocated to the nCRT group and 192 patients to the nCIT group. The pathological response and disease recurrence were compared between the two groups after PSM. Log rank test were used to compare the survival outcomes before and after PSM. Univariate and multivariate Cox regression analyses were performed to identify the prognostic factors for locally advanced ESCC.Results:After PSM, the R0 resection rate in the nCRT group and the nCIT group was 93.3% (112/120) and 93.8% (180/192), respectively, with no statistical significance ( P=0.884). However, the pathological complete response rate in the nCRT group [36.7% (44/120)] was higher than that in the nCIT group [21.4% (41/192), P=0.003]. For patients with R0 resection, the major recurrence pattern was distant metastasis [18.8% (21/112)] in the nCRT group, while the pattern was locoregional recurrence [12.2% (22/180)] in the nCIT group. The 3-year disease-free survival rates were 52.7% and 66.1% ( P=0.022) and the 3-year overall survival rates were 59.2% and 75.5% ( P=0.002) in the nCRT and nCIT groups, respectively. Multivariate Cox regression analysis also revealed that the neoadjuvant therapy mode was an independent prognostic factor for patients with locally advanced ESCC. Compared with nCRT, nCIT could significantly prolong disease-free survival ( HR=0.58, 95% CI: 0.40-0.86) and overall survival ( HR=0.53, 95% CI: 0.35-0.79). Conclusion:These results suggest that nCIT could significantly improve disease-free survival rate and overall survival rate over nCRT in locally advanced ESCC, even with lower pathological complete response rate.

Objective:To compare the clinical efficacy of neoadjuvant chemoradiotherapy (nCRT) and neoadjuvant chemo-immunotherapy (nCIT) for locally advanced esophageal squamous cell carcinoma (ESCC).Methods:Clinical data of patients who received nCRT or nCIT followed by esophagectomy for locally advanced ESCC between January 2010 and December 2022 were retrospectively collected from Zhejiang Cancer Hospital, with 155 patients in the nCRT group and 470 patients in the nCIT group. Propensity score matching (PSM) was performed in the two groups. After PSM, 120 patients were allocated to the nCRT group and 192 patients to the nCIT group. The pathological response and disease recurrence were compared between the two groups after PSM. Log rank test were used to compare the survival outcomes before and after PSM. Univariate and multivariate Cox regression analyses were performed to identify the prognostic factors for locally advanced ESCC.Results:After PSM, the R0 resection rate in the nCRT group and the nCIT group was 93.3% (112/120) and 93.8% (180/192), respectively, with no statistical significance ( P=0.884). However, the pathological complete response rate in the nCRT group [36.7% (44/120)] was higher than that in the nCIT group [21.4% (41/192), P=0.003]. For patients with R0 resection, the major recurrence pattern was distant metastasis [18.8% (21/112)] in the nCRT group, while the pattern was locoregional recurrence [12.2% (22/180)] in the nCIT group. The 3-year disease-free survival rates were 52.7% and 66.1% ( P=0.022) and the 3-year overall survival rates were 59.2% and 75.5% ( P=0.002) in the nCRT and nCIT groups, respectively. Multivariate Cox regression analysis also revealed that the neoadjuvant therapy mode was an independent prognostic factor for patients with locally advanced ESCC. Compared with nCRT, nCIT could significantly prolong disease-free survival ( HR=0.58, 95% CI: 0.40-0.86) and overall survival ( HR=0.53, 95% CI: 0.35-0.79). Conclusion:These results suggest that nCIT could significantly improve disease-free survival rate and overall survival rate over nCRT in locally advanced ESCC, even with lower pathological complete response rate.

Objective:To observe the clinical efficacy of a new type of "firebreak" drainage with skin preservation in the treatment of Fournier's gangrene.Methods:This technique is suitable for patients with perianal necrotizing fasciitis who can tolerate surgery without large area of skin blackness and necrosis. Procedure and key points: (1) The dividing line between inflammatory tissue and normal tissue was determined according to imaging examination and intraoperative exploration; (2) The abscess cavity was cut along the most obvious part of the abscess fluctuation, with a long diameter of 3~4 cm and a short diameter of 1~2 cm; (3) Necrotic tissue was discreetly separated and removed from the main incision to the outer edge of the infection. A fusiform incision was made every 3 to 5 cm, with a long diameter of 2 to 3 cm and a short diameter of 1 cm, and discreetly separated until the normal tissue, and a hose was hung between the adjacent incisions for drainage. (4) Each adjacent edge cut between the stealth separation and hanging hose drainage, forming a "firebreak"; (5) Rinse the wound repeatedly; (6) If the infection invades the rectum, colostomy is performed as required. The case data of 11 patients with perianal necrotizing fasciitis admitted to the Second Affiliated Hospital of Nanjing University of Chinese Medicine from July 2019 to February 2023 were retrospectively analyzed. All patients were treated with emergency surgical debridement by "firebreak" drainage with skin preservation.Results:All 11 cases were cured with 100%. One case underwent multiple operations. The hospitalization time was 11-46 days, with an average of 22 days. The wound healing time was 28-75 days, with an average of 43 days. Except for 1 patient with trauma, all the other patients had no significant anal function injury after surgery. All the 11 patients recovered and were discharged from hospital with a median follow-up of 136 (115-413) days.Conclusions:The "firebreak" drainage based on skin preservation has the advantages of less trauma and faster recovery, and do not cause obvious anal function damage.

Long non-coding RNAs(lncRNAs)play an indispensable role in the occurrence and development of ovarian cancer(OC).However,the potential involvement of lncRNAs in the progression of OC is largely unknown.To investigate the detailed roles and mechanisms of RAD51 homolog B-antisense 1(RAD51B-AS1),a novel lncRNA in OC,reverse transcription-quantitative polymerase chain reaction(RT-qPCR)was performed to verify the expression of RAD51B-AS1.Cellular proliferation,metastasis,and apoptosis were detected using the cell counting kit-8(CCK-8),colony-formation,transwell,and flow cytometry assays.Mouse xenograft models were established for the detection of tumorigenesis.The results revealed that RAD51B-AS1 was significantly upregulated in a highly metastatic human OC cell line and OC tissues.RAD51B-AS1 significantly increased the proliferation and metastasis of OC cells and enhanced their resistance to anoikis.Biogenetics prediction analysis revealed that the only target gene of RAD51B-AS1 was RAD51B.Subsequent gene function experiments revealed that RAD51B exerts the same biological effects as RAD51B-AS1.Rescue experiments demonstrated that the malignant biological behaviors promoted by RAD51B-AS1 overexpression were partially or completely reversed by RAD51B silencing in vitro and in vivo.Thus,RAD51B-AS1 promotes the malignant biological behaviors of OC and activates the protein kinase B(Akt)/B cell lymphoma protein-2(Bcl-2)signaling pathway,and these effects may be associated with the positive regulation of RAD51B expression.RAD51B-AS1 is expected to serve as a novel molecular biomarker for the diagnosis and prediction of poor prognosis in OC,and as a potential therapeutic target for disease management.

Background::Psychological stress has been reported to be a potential risk factor for hypertension among females, but it remains unclear whether spousal chronic stress levels alter the risk of hypertension among women. We examined the associations between stress within the family and hypertension among married women.Methods::Reproductive-aged women who were planning for pregnancy and their husbands were recruited from the National Free Pre-pregnancy Checkup Projects (NFPCP) across 31 provinces in China in 2016 and 2017. Perceived stress of wives or husbands was measured with a 5-point Likert-type scale, and assessed from three domains: work/life-related stress, economic stress, and overall stress. Multivariable-adjusted logistic regression models were used to assess the associations between stress status and the prevalence of hypertension.Results::Of 10,027,644 couples, 261,098 (2.60%) women had hypertension. The results showed that higher stress levels among themselves or their husbands were associated with a higher prevalence of hypertension in women ( Pfor trend <0.001). Compared with non-stressed participants, female participants with the highest stress themselves were at a greater risk of hypertension, with adjusted odds ratio (OR) of 1.31 (95% confidence interval [CI]: 1.25-1.37); and compared with participants whose husbands had no stress, those whose husbands had the highest stress level were at a higher risk of hypertension with adjusted OR of 1.24 (95% CI: 1.20-1.29). Moreover, compared with non-stressed status for both couples, only-wife-stressed, only-husband-stressed, and both-stressed couples were found to be significantly associated with increased risks of wives’ hypertension, with adjusted ORs of 1.28 (95% CI: 1.25-1.31), 1.19 (95% CI: 1.17-1.21), and 1.28 (95% CI: 1.26-1.31), respectively. Conclusion::Moderate to severe stress in both spouses might be associated with female hypertension prevalence, which highlights the importance of paying attention to the psychological stresses of couples within the family.

Objective To explore the objective indicators of tongue and pulse manifestations in patients with endometriosis diseases by collecting the data of tongue and pulse manifestations of patients with endometriosis diseases by digital tongue and pulse diagnostic instrument. Methods The endometriosis disease group included 72 patients with endometriosis diseases who were treated in Department of Gynecology (Professor ZHANG Tingting),Yueyang Hospital of Integrated Traditional Chinese and Western Medicine from Jun. 1,2021 to Sep. 15,2022. The normal group included 35 healthy adult women recruited by the Physical Examination Center of Shuguang Hospital,Shanghai University of Traditional Chinese Medicine. Results In terms of age,there was no significant difference between the endometriotic disease group and normal group (P>0.05). In terms of tongue color,the values of zhiCon,zhiASM,zhiENT,zhiMEAN,zhiClrB,zhiClrI,zhiClrLa,zhiClrCb,and zhiClrLb in the endometriosis disease group were significantly different from those in the normal group (all P<0.05),while there were no significant differences in the values of zhiClrR,zhiClrG,zhiClrS,zhiClrL,zhiClrY,or zhiClrCr between the 2 groups (all P>0.05). In terms of tongue coating color,the values of taiClrR,taiClrB,taiClrI,taiClrS,taiClrLa,taiClrLb,taiClrCr,and taiClrCb in the endometriosis disease group were significantly different from those in the normal group (all P<0.05),while there were no significant differences in the values of taiClrG,taiClrL,or taiClrY (all P>0.05). In terms of texture and thickness of tongue coating,there were no significant differences in the values of perAll,perPart,taiCon,taiASM,taiENT,or taiMEAN between the 2 groups (all P>0.05). In terms of pulse manifestation,the values of h3,h4,h5,t4,h3/h1,and h4/h1 in the endometriosis disease group were significantly different from those in the normal group (all P<0.05),while there were no significant differences in the values of h1,t,t1,or t5 (all P>0.05). Conclusion There are significant differences in tongue and pulse indicators between patients with endometriosis diseases and healthy individuals. It can provide objective indicators for further research on the pathogenesis changes and clinical differentiation of endometriosis diseases.