Objective: To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia (ChP) 2025 Edition, and explore its novel requirements in risk-based pharmaceutical product lifecycle management.
Methods: A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview, international harmonization of microbiological standards, risk-based quality management system, and novel tools and methods with Chinese characteristics.
Results: The ChP 2025 edition demonstrates three prominent features in microbiological-related standards: enhanced international harmonization, introduced emerging molecular biological technologies, and established a risk-based microbiological quality control system.
Conclusion: The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system, which significantly improves the scientificity, standardization and applicability of the standards, providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.

BACKGROUND: The global rise in diabetes prevalence is a pressing concern. Despite initiatives like "The Healthy Beijing Action 2020-2030" advocating for increased awareness, treatment, and control, the specific situation in Beijing remains unexplored. This study aimed to analyze the trends in diabetes prevalence, awareness, treatment, and control among Beijing adults. METHODS: Through a stratified multistage probability cluster sampling method, a series of representative cross-sectional surveys were conducted in Beijing from 2005 to 2022, targeting adults aged 18-79 years. A face-to-face questionnaire, along with body measurements and laboratory tests, were administered to 111,943 participants. Data from all survey were age- and/or gender-standardized based on the 2020 Beijing census population. Annual percentage rate change (APC) or average annual percentage rate change (AAPC) was calculated to determine prevalence trends over time. Complex sampling logistic regression models were employed to explore the relationship between various characteristics and diabetes. RESULTS: From 2005 to 2022, the total prevalence of diabetes among Beijing adults aged 18-79 years increased from 9.6% (95% CI: 8.8-10.4%) to 13.9% (95% CI: 13.1-14.7%), with an APC/AAPC of 2.1% (95% CI: 1.1-3.2%, P <0.05). Significant increases were observed among adults aged 18-39 years and rural residents. Undiagnosed diabetes rose from 3.5% (95% CI: 3.2-4.0%) to 7.2% (95% CI: 6.6-7.9%) with an APC/AAPC of 4.1% (95% CI: 0.5-7.3%, P <0.05). However, diabetes awareness and treatment rates showed annual declines of 1.4% (95% CI: -3.0% to -0.2%, P <0.05) and 1.3% (95% CI: -2.6% to -0.2%, P <0.05), respectively. The diabetes control rate decreased from 21.5% to 19.1%, although not statistically significant (APC/AAPC = -1.5%, 95% CI: -5.6% to 1.9%). Overweight and obesity were identified as risk factors for diabetes, with ORs of 1.65 (95% CI: 1.38-1.98) and 2.48 (95% CI: 2.07-2.99), respectively. CONCLUSIONS The prevalence of diabetes in Beijing has significantly increased between 2005 and 2022, particularly among young adults and rural residents. Meanwhile, there has been a concerning decrease in diabetes awareness and treatment rates, while control rates have remained stagnant. Regular blood glucose testing, especially among adults aged 18-59 years, should be warranted. Furthermore, being male, elderly, overweight, or obese was associated with higher diabetes risk, suggesting the needs for targeted management strategies.
Humans ; Adult ; Middle Aged ; Male ; Female ; Aged ; Adolescent ; Young Adult ; Cross-Sectional Studies ; Diabetes Mellitus/epidemiology* ; Beijing/epidemiology* ; Prevalence ; China/epidemiology* ; Surveys and Questionnaires

This study primarily investigates the effect of Liuwei Dihuang Pills on the activation and proliferation of female germline stem cells(FGSCs) in the ovaries and cortex of mice with premature ovarian failure(POF), and how it improves ovarian function. ICR mice were randomly divided into the control group, model group, Liuwei Dihuang Pills group, Liuwei Dihuang Pills double-dose group, and estradiol valerate group. A mouse model of POF was established by intraperitoneal injection of cyclophosphamide. After successful modeling, the mice were treated with Liuwei Dihuang Pills or estradiol valerate for 28 days. Vaginal smears were prepared to observe the estrous cycle and body weight. After the last administration, mice were sacrificed and sampled. Serum levels of estradiol(E_2), follicle-stimulating hormone(FSH), luteinizing hormone(LH), and anti-Müllerian hormone(AMH) were measured by enzyme-linked immunosorbent assay(ELISA). Hematoxylin-eosin(HE) staining was used to observe ovarian morphology and to count follicles at all stages to evaluate ovarian function. Immunohistochemistry was used to detect the expression of mouse vasa homolog(MVH), a marker of ovarian FGSCs. Immunofluorescence staining, using co-labeling of MVH and proliferating cell nuclear antigen(PCNA), was used to detect the expression and localization of specific markers of FGSCs. Western blot was employed to assess the protein expression of MVH, octamer-binding transcription factor 4(Oct4), and PCNA in the ovaries. The results showed that compared with the control group, the model group exhibited disordered estrous cycles, decreased ovarian index, increased atretic follicles, and a reduced number of follicles at all stages. FSH and LH levels were significantly elevated, while AMH and E_2 levels were significantly reduced, indicating the success of the model. After treatment with Liuwei Dihuang Pills or estradiol valerate, hormone levels improved, the number of atretic follicles decreased, and the number of follicles at all stages increased. MVH marker protein and PCNA proliferative protein expression in ovarian tissue also increased. These results suggest that Liuwei Dihuang Pills regulate estrous cycles and hormone disorders in POF mice, promote the proliferation of FGSCs, improve follicular development in POF mice, and enhance ovarian function.
Animals ; Female ; Drugs, Chinese Herbal/administration & dosage* ; Mice ; Cell Proliferation/drug effects* ; Mice, Inbred ICR ; Ovary/cytology* ; Primary Ovarian Insufficiency/genetics* ; Follicle Stimulating Hormone/metabolism* ; Humans ; Anti-Mullerian Hormone/blood* ; Antineoplastic Agents/adverse effects* ; Luteinizing Hormone/metabolism* ; Cyclophosphamide/adverse effects*

Objective: To investigate the current status of milk tea consumption and its association with psychological distress among college students, so as to provide theoretial support for promoting the mental health of college students. Methods: From September to November 2023, a convenience sampling method was used to select 15 440 college students aged 17-24 from seven universities in Shanghai, Jiangxi, Hubei, and Shanxi. A self designed questionnaire and the Kessler Psychological Distress Scale were used to assess milk tea consumption and psychological distress, respectively. The Mantel-Haenszel test was employed to analyze the trend of psychological distress at different levels of milk tea consumption. Binary Logistic regression analysis was used to determine the association between milk tea consumption and psychological distress, and the restricted cubic spline method was applied to explore the nonlinear relationship between milk tea consumption and symptoms of psychological distress. Results: The detection rate of psychological distress among college students was 59.6%. Univariate analysis indicated a significant trend association between milk tea consumption frequency ( χ 2 trend =42.33) and milk tea intake level ( χ 2 trend = 5.17 ) with psychological distress ( P <0.05). Binary Logistic regression models showed a positive association between different levels of milk tea consumption frequency and psychological distress [1-3 times (mild to moderate distress, OR =1.20,1.41), 4-5 times (mild to severe distress, OR =2.80,5.44,4.12), and ≥6 times (severe distress, OR =8.04); and milk tea intake level: 1-1 500 mL (severe distress, OR =1.35), >1 500- <3 000 mL (mild to moderate distress, OR =1.21, 1.35), ≥3 000 mL (mild to severe distress, OR =1.33,1.71,1.29)] ( P <0.05 ). The restricted cubic spline model showed a nonlinear association between milk tea intake and the risk of psychological distress ( F = 107.34 , P non linear <0.01, P overall <0.01). Conclusions High frequency and high volume milk tea consumption are associated with an increased risk of psychological distress among college students. Reducing the consumption behavior of college students milk tea is helpful to improve mental health.

Objective:To investigate the association of exposure to PM 2.5 and its constituents during pregnancy and fetal growth and to further identify critical windows of exposure for fetal growth. Methods:We included 4 089 mother-child pairs from the Jiangsu Birth Cohort Study between January 2016 and October 2019. Data of general characteristics, clinical information, daily average PM 2.5 exposure, and its constituents during pregnancy were collected. Fetal growth parameters, including head circumference (HC), abdominal circumference (AC), and femur length (FL), were measured by ultrasound after 20 weeks of gestation, and then estimated fetal weight (EFW) was calculated. Generalized linear mixed models were adopted to examine the associations of prenatal exposure to PM 2.5 and its constituents with fetal growth. Distributed lag nonlinear models were used to identify critical exposure windows for each outcome. Results:A 10 μg/m 3 increase in PM 2.5 exposure during pregnancy was associated with a decrease of 0.025 ( β=-0.025, 95% CI: -0.048- -0.001) in HC Z-score, 0.026 ( β=-0.026, 95% CI: -0.049- -0.003) in AC Z-score, and 0.028 ( β=-0.028, 95% CI:-0.052--0.004) in EFW Z-score, along with an increased risk of 8.5% ( RR=1.085, 95% CI: 1.010-1.165) and 13.5% ( RR=1.135, 95% CI: 1.016-1.268) for undergrowth of HC and EFW, respectively. Regarding PM 2.5 constituents, prenatal exposure to black carbon, organic matter, nitrate, sulfate (SO 42-) and ammonium consistently correlated with decreased HC Z-score. SO 42- exposure was also associated with decreased FL Z-scores. In addition, we found that gestational weeks 2-5 were critical windows for HC, weeks 4-13 and 19-40 for AC, weeks 4-13 and 23-37 for FL, and weeks 4-12 and 20-40 for EFW. Conclusions:Our findings demonstrated that exposure to PM 2.5 and its constituents during pregnancy could adversely affect fetal growth and the critical windows for different fetal growth parameters are not completely consistent.

Objective:To explore the clinical features and prognosis of simultaneous double primary and single primary colorectal cancer patients.Methods:A retrospective case series study was conducted. The clinical data of 45 patients with simultaneous double primary colorectal cancer, 53 patients with single primary colon cancer and 59 patients with single primary rectal cancer in Shanxi Province Cancer Hospital from January 2015 to January 2018 were retrospectively analyzed, including gender, age, drinking history, smoking history, body mass index (BMI), carcinoembryonic antigen (CEA), carbohydrate antigen 199 (CA199), hemoglobin, albumin, TNM stage. The clinicopathological characteristics of the three groups were compared. Survival analysis was performed using the Kaplan-Meier method to compare the overall survival of the three groups.Results:The age of simultaneous double primary colorectal cancer patients was (63±11) years old, including 28 males and 17 females; the age of single primary colon cancer patients was (61±12) years old, including 30 males and 23 females; the age of single primary rectal cancer patients was (60±11) years old, including 30 males and 29 females. There was a significant difference in BMI between patients with double primary cancer and single primary colon cancer ( P = 0.041), but there were no significant differences in gender, age, drinking history, smoking history, CEA, CA199, hemoglobin, albumin and TNM stage (all P > 0.05). There were significant differences in BMI, CEA and CA199 between patients with double primary cancer and single primary rectal cancer (all P < 0.05), but there were no significant differences in gender, age, drinking history, smoking history, hemoglobin, albumin and TNM stage (all P > 0.05). The 1-, 3- and 5-year overall survival rates of the double primary cancer patients were 95.56%, 77.78% and 62.22%, the single primary colon cancer patients were 94.34%, 81.13% and 69.81%, and the single primary rectal cancer patients were 100.00%, 88.14% and 72.88%, respectively. There was no significant difference in OS among patients with double primary cancer, single primary rectal cancer and single primary rectal cancer (both P > 0.05). Conclusions:Abnormally elevated BMI may be associated with the risk of developing simultaneous double primary colorectal cancer. Detection of CEA and CA199 is helpful in monitoring rectal cancer patients for the combination of other primary tumors. The prognosis of patients with single primary colon or rectal cancer is comparable to that of patients with simultaneous double primary colorectal cancer.

Background::Gastric cancer (GC), a malignant tumor with poor prognosis, is one of the leading causes of cancer-related deaths worldwide; consequently, identifying novel therapeutic targets is crucial for its corresponding treatment. NUF2, a component of the NDC80 kinetochore complex, promotes cancer progression in multiple malignancies. Therefore, this study aimed to explore the potential of NUF2 as a therapeutic target to inhibit GC progression. Methods::Clinical samples were obtained from patients who underwent radical resection of GC at Lanzhou University Second Hospital from 2016 to 2021. Cell count assays, colony formation assays, and cell-derived xenotransplantation (CDX) models were used to determine the effects of NUF2 on GC progression. Flow cytometry was used to detect the effect of NUF2 or quercetin on cell cycle progression and apoptosis. A live-cell time-lapse imaging assay was performed to determine the effect of NUF2 on the regulation of mitotic progression. Transcriptomics was used to investigate the NUF2-associated molecular mechanisms. Virtual docking and microscale thermophoresis were used to identify NUF2 inhibitors. Finally, CDX, organoid, and patient-derived xenograft (PDX) models were used to examine the efficacy of the NUF2 inhibitor in GC. Results::NUF2 expression was significantly increased in GC and was negatively correlated with prognosis. The deletion of NUF2 suppressed GC progression both in vivo and in vitro. NUF2 significantly regulated the mitogen-activated protein kinase (MAPK) pathway, promoted G2/M phase transition, and inhibited apoptosis in GC cells. Additionally, quercetin was identified as a selective NUF2 inhibitor with low toxicity that significantly suppressed tumor growth in GC cells, organoids, CDX, and PDX models. Conclusions::Collectively, NUF2-mediated G2/M phase transition and apoptosis inhibition promoted GC progression; additionally, NUF2 inhibitors exhibited potent anti-GC activity. This study provides a new strategy for targeting NUF2 to suppress GC progression in clinical settings.

Objective:To summarize the experience of designing transplanted hair based on the orbital morphology and tissue characteristics for the treatment of eyebrow defects after burns.Methods:A retrospective analysis was conducted on clinical data of the patients with eyebrow defects after burns who treated at Hair Transplantation Center, Plastic Surgery Hospital, Chinese Academy of Medical Sciences between January 2011 and September 2023. The location and appearance of eyebrow were designed according to the orbital morphology and tissue characteristics. The follicles were extracted by incision of scalps strips and follicle unit excision (FUE) on the donor area of the occipital region near the posterior hairline or the posterior ear hairline. Scalps with scars that needed to be removed or had "dog ear" deformities following scalp expansion surgery that needed to be repaired were also be used as donor sites. The follicles were divided as follicle units (FUs) including single hair. The recipient area was punched with syringe needle of 22 or 22 G to subcutaneous superficial layer. Then the hair shaft was clamped with microforceps and the hairs were transplanted to the defective area to restore the appearance of eyebrow. The density, morphology, direction and scars of the donor sites were observed by following-ups.Results:A total of 197 patients with 282 eyebrows were recruited. There were 133 males and 64 females. The average age was 33.7 (9 to 62) years. There were 17 patients with skin graft transplantation in the eyebrow arch, 33 with flap and expanded flap repair, 36 with eyelid skin grafting, 111 with burn scar healing. A total of 51 patients had complete eyebrow defects on both sides, and 34 had partial defects. Sixty-five patients had complete eyebrow defects on single side, and 47 had partial defects. The amount of hair transplantation was from 53 to 600 FUs on 282 eyebrows. Seventy-five patients extracted follicles with incision of scalps strips and 122 with FUE. The patients were followed up for 9 months to 10 years. Folliculitis were found in 17 patients and completely cured by 75% alcohol disinfection. Nine patients with insufficient density underwent hair transplantation for a second time to increase the density of hairs one year later. And the implanted hairs grew well, which were similar to the shape and direction of normal eyebrows. Transplanted hairs of the rest patients grew well. The direction and appearance were satisfied. The scar in the donor site was not obvious.Conclusion:The transplanted hair should be designed primarily based on the orbital morphology and tissue characteristics for the treatment of eyebrow defects after burns. Then the position of the eyebrow and the bilateral symmetry should be considered. The ideal effect of eyebrow reconstruction would depend on the full consideration of the receipt site.

Objective:To summarize the experience of designing transplanted hair based on the orbital morphology and tissue characteristics for the treatment of eyebrow defects after burns.Methods:A retrospective analysis was conducted on clinical data of the patients with eyebrow defects after burns who treated at Hair Transplantation Center, Plastic Surgery Hospital, Chinese Academy of Medical Sciences between January 2011 and September 2023. The location and appearance of eyebrow were designed according to the orbital morphology and tissue characteristics. The follicles were extracted by incision of scalps strips and follicle unit excision (FUE) on the donor area of the occipital region near the posterior hairline or the posterior ear hairline. Scalps with scars that needed to be removed or had "dog ear" deformities following scalp expansion surgery that needed to be repaired were also be used as donor sites. The follicles were divided as follicle units (FUs) including single hair. The recipient area was punched with syringe needle of 22 or 22 G to subcutaneous superficial layer. Then the hair shaft was clamped with microforceps and the hairs were transplanted to the defective area to restore the appearance of eyebrow. The density, morphology, direction and scars of the donor sites were observed by following-ups.Results:A total of 197 patients with 282 eyebrows were recruited. There were 133 males and 64 females. The average age was 33.7 (9 to 62) years. There were 17 patients with skin graft transplantation in the eyebrow arch, 33 with flap and expanded flap repair, 36 with eyelid skin grafting, 111 with burn scar healing. A total of 51 patients had complete eyebrow defects on both sides, and 34 had partial defects. Sixty-five patients had complete eyebrow defects on single side, and 47 had partial defects. The amount of hair transplantation was from 53 to 600 FUs on 282 eyebrows. Seventy-five patients extracted follicles with incision of scalps strips and 122 with FUE. The patients were followed up for 9 months to 10 years. Folliculitis were found in 17 patients and completely cured by 75% alcohol disinfection. Nine patients with insufficient density underwent hair transplantation for a second time to increase the density of hairs one year later. And the implanted hairs grew well, which were similar to the shape and direction of normal eyebrows. Transplanted hairs of the rest patients grew well. The direction and appearance were satisfied. The scar in the donor site was not obvious.Conclusion:The transplanted hair should be designed primarily based on the orbital morphology and tissue characteristics for the treatment of eyebrow defects after burns. Then the position of the eyebrow and the bilateral symmetry should be considered. The ideal effect of eyebrow reconstruction would depend on the full consideration of the receipt site.

Objective:To compare the clinical efficacy of laparoscopic right colon cancer radical resection(CME+D3,60 cases) based on membrane anatomy and traditional laparoscopic right colon cancer radical resection(CME/D3, 120 cases).Methods:A retrospective cohort study was used to collect the consecutively admitted cases undergoing laparoscopic radical right colon cancer resection at the Department of Colorectal Surgery, Shanxi Hospital from Jan 2018 to Jun 2020.The postoperative data , postoperative complications, follow-up outcomes were compared between the two groups.Results:Compared with the CME/D3 group, that the based on membrane anatomy(CME+D3) group had a decreased intraoperative blood loss [(79.3±16.7) ml vs. (103.6±20.8) ml, t=-3.894, P<0.001],and more lymph node harvest [(27.0±5.1) vs. (25.1±6.2), t=2.138, P=0.034]; The sectional grading of surgical specimens was also better than that in the traditional operation group(χ 2=4.146, P=0.042); while the operation time was slightly longer than that of the traditional operation group [(161.1±18.4) minutes vs.(142.6±19.5) minutes, t=-6.166, P<0.001]. There was no significant difference in the length of specimen resection, postoperative exhaust time, hospital stay, incidence of postoperative complications, proportion of unplanned reoperation within 30 days, re-admission within 30 days, and mortality within 30 days ( all P>0.05). The median follow-up time was 36.7 (5.3-48.7) months, and there was no significant difference in overall survival rates between the two groups ( P>0.05); The difference in disease-free survival rates between the two groups is significant(χ 2=4.246, P=0.039). Conclusions:Compared with the traditional laparoscopic right colon cancer radical surgery (CME/D3),laparoscopic radical resection of right colon cancer (CME+D3) based on membrane anatomy reduces intraoperative bleeding, improves the number of lymph node dissection and specimen quality, and has higher 1-year and 3-year disease-free survival rate .