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.

⁶⁰Co-γ ray irradiation has the unique advantages of high efficiency， strong penetration， operation at room temperature and no residue， which has been widely used in the sterilization of Chinese medicinal materials， decoction pieces， Chinese patent medicine. However， the irradiation effect may cause changes in the content of chemical components in Chinese materia medica or the emergence of new radiolysis products， leading to reduced efficacy and uncontrollable safety risks. This paper reviewed the relevant literature at home and abroad， summarized the effect of irradiation sterilization on various types of chemical compositions of Chinese medicinal materials and their preparations， and analyzed and explored the rule of change. The results showed that the content changes of various chemical components in Chinese materia medica after ⁶⁰Co-γ ray irradiation sterilization varied. The contents of most flavonoids， terpenoids， phenylpropanoids and quinones decreased after irradiation， and the degree of decrease increased with the elevated irradiation dose. The contents of lignans， alkaloids， isoflavones and some terpenoids did not change significantly before and after irradiation， while the content changes of triterpenoid saponins， dihydroflavonols， chalcones， sugars and glycosides after irradiation were not yet uniform. Therefore， it is recommended to pay attention to the compositional changes of irradiated Chinese medicines， strengthen the research on the standards of irradiated Chinese medicines， and standardize the irradiation and sterilization of Chinese medicines in order to promote the healthy and rational application of irradiated Chinese medicines.

BACKGROUND: Severe stroke has high rates of mortality and morbidity. This study aimed to investigate the clinical course, causes of worsening, and outcomes of severe ischemic stroke. METHODS: This prospective, multicenter cohort study enrolled adult patients admitted ≤30 days after ischemic stroke from nine hospitals in China between September 2017 and December 2019. Severe stroke was defined as a score of ≥15 on the National Institutes of Health Stroke Scale (NIHSS). Clinical worsening was defined as an increase of 4 in the NIHSS score from baseline. Unfavorable functional outcome was defined as a modified Rankin scale score ≥3 at 3 months and 1 year after stroke onset, respectively. We performed Logistic regression to explore baseline features and reperfusion therapies associated with clinical worsening and functional outcomes. RESULTS: Among 4201 patients enrolled, 854 patients (20.33%) had severe stroke on admission. Of 3347 patients without severe stroke on admission, 142 (4.24%) patients developed severe stroke in hospital. Of 854 patients with severe stroke on admission, 33.95% (290/854) experienced clinical worsening (median time from stroke onset: 43 h, Q1-Q3: 20-88 h), with brain edema (54.83% [159/290]) as the leading cause; 24.59% (210/854) of these patients died by 30 days, and 81.47% (677/831) and 78.44% (633/807) had unfavorable functional outcomes at 3 months and 1 year respectively. Reperfusion reduced the risk of worsening (adjusted odds ratio [OR]: 0.24, 95% confidence interval [CI]: 0.12-0.49, P  <0.01), 30-day death (adjusted OR: 0.22, 95% CI: 0.11-0.41, P  <0.01), and unfavorable functional outcomes at 3 months (adjusted OR: 0.24, 95% CI: 0.08-0.68, P <0.01) and 1 year (adjusted OR: 0.17, 95% CI: 0.06-0.50, P  <0.01). CONCLUSIONS: Approximately one-fifth of patients with ischemic stroke had severe neurological deficits on admission. Clinical worsening mainly occurred in the first 3 to 4 days after stroke onset, with brain edema as the leading cause of worsening. Reperfusion reduced the risk of clinical worsening and improved functional outcomes. REGISTRATION ClinicalTrials.gov , NCT03222024.
Humans ; Male ; Female ; Prospective Studies ; Ischemic Stroke/mortality* ; Aged ; Middle Aged ; Aged, 80 and over ; Stroke ; Brain Ischemia

Critically ill patients are at high risk for hospital acquired infections, which can significantly increase the mortality rate and treatment costs for these patients. Therefore, in the process of treating the primary disease, strict prevention and control of new hospital infections is an essential component of the treatment for critically ill patients. The treatment of critically ill patients involves multiple steps and requires a concerted effort from various aspects such as theory, management, education, standards, and supervision to achieve effective prevention and control of hospital infections. However, there is currently a lack of unified understanding and standards for hospital infection prevention and control. To address this, in March 2024, a group of experts in critical care medicine, infectious diseases, and hospital infection from China discussed the current situation and issues of hospital infection control in the intensive care unit together. Based on a review of the latest evidence-based medical evidence from both domestic and international sources, 2024 Expert Consensus on Hospital Acquired Infection Control Principles in the Department of Critical Care Medicine was formed, aiming to provide a basis for the development of hospital infection prevention and control strategies in the field of critical care medicine.

Objective To investigate the clinical effects and complications of endoscopic tandem ligation and hemorrhoids ligation.Methods Clinical data of 120 patients with grade Ⅰ～Ⅲ internal hemorrhoids who were hospitalized due to hematochezia from November 2021 to March 2023 were retrospectively analyzed.According to the different surgical methods,60 patients who received endoscopic hemorrhoid ligation were divided into control group;60 patients who underwent endoscopic tandem ligation were divided into treatment group.The effective rate of hemorrhoidal hemorrhage,the effect of internal hemorrhoidal prolapse and the incidence of postoperative complications were compared between two groups within 6 months after operation.Results The effective rate of internal hemorrhoidal bleeding was 100.00％in both groups,and the efficacy of the treatment group in the treatment of degree Ⅱ internal hemorrhoidal prolapse was similar to that in the control group(P＞0.05),but the treatment group was significantly better than the control group in the treatment of degree Ⅲ internal hemorrhoidal prolapse(P＜0.01),the postoperative anal pain in the treatment group was significantly more than the control group(P＜0.05);There were no significant differences in postoperative perianal pain,urinary retention,and abnormal defecation between the two groups(P＞0.05).No thrombotic external hemorrhoids occured in two groups.Conclusion The short-term efficacy of endoscopic tandem ligation and hemorrhoidal ligation in the treatment of internal hemorrhoidal bleeding is similar and both achieved satisfactory results,the short-term efficacy of the two in the treatment of degree Ⅱ internal hemorrhoidal prolapse is similar,the short-term efficacy of the former in the treatment of degree Ⅲ internal hemorrhoidal prolapse is significantly better,the feeling of anal heaviness in the treatment group is more than that in the control group,and there is no striking difference in the other complications.

Objective To investigate the relationship between the levels of soluble growth stimulation expressed gene 2 protein (sST2), myoglobin (Myo), interleukin-6 (IL-6) in peripheral blood and cardiac function in elderly patients with diastolic heart failure (DHF) complicated with sarcopenia. Methods A total of 122 patients with DHF were divided into DHF complicated with sarcopenia group (60 cases) and DHF group (62 cases) according to the presence or absence of sarcopenia. In addition, 58 healthy healthy population with physical examination and 60 patients with sarcopenia alone were included in the control group and sarcopenia alone group, respectively. The levels of sST2, Myo, IL-6 and cardiac function indexes[left ventricular ejection fraction (LVEF), cardiac output (CO), heart rate (HR), stroke volume (SV), and cardiac index (CI)]were measured in each group. Pearson correlation analysis was used to analyze the correlations between sST2, Myo, IL-6 and each cardiac function index. Receiver operating characteristic (ROC) curves were drawn to analyze the diagnostic efficacy of sST2, Myo, IL-6 alone and their combination in diagnosing DHF complicated with sarcopenia. Results Compared with the control groupand the sarcopenia alone group, the levels of sST2, Myo, IL-6 and HR were increased, while LVEF, CO, SV, and CI were decreased in the DHF group and the DHF complicated with sarcopenia group (P < 0.05). Compared with the DHF group, the levels of sST2, Myo, IL-6 and HR were increased, while LVEF, CO, SV, and CI were decreased in the DHF complicated with sarcopenia group (P < 0.05). The sST2, Myo, and IL-6 were negatively correlated with LVEF, CO, SV, and CI (P < 0.001), and positively correlated with HR (P < 0.001). The sST2, Myo, IL-6, LVEF, and SV were independent influencing factors for DHF complicated with sarcopenia (P < 0.05). The area under the curve of combined detection of sST2, Myo, and IL-6 for diagnosing DHF complicated with sarcopenia was 0.936, indicating a better diagnostic efficacy than individual tests. Conclusion The levels of sST2, Myo, and IL-6 in peripheral blood are significantly increased in elderly patients with DHF complicated with sarcopenia, and these markers are significantly correlated with cardiac function indexes. Combined detection of these three markers has a higher diagnostic efficacy for DHF complicated with sarcopenia.

Objective:To evaluate the clinical value of 5.0 T ultra-high filed MRI system in assessing intracranial arteries segments and vessel branchers.Methods:This study was a prospective study. Totally 40 consecutive healthy volunteers were recruited from Zhongshan Hospital, Fudan University from September 1, 2021 to November 30, and all participants who underwent either 3.0 T or 5.0 T time-of-flight MR angiography (TOF-MRA) in random order were divided into 3.0 T MR group and 5.0 T MR group with 20 volunteers for each group. Image quality was assessed by Likert 5 scoring systems and signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR),and score in visualization of intracranial arteries [middle cerebral artery (MCA) and its segments, anterior cerebral artery (ACA) and its segments, posterior cerebral artery (PCA) and its segments, lenticulostriate arteries (LA) and pontine artery (PA)] were assessed from 0 to 3 (≥2: good depiction of vessel segment). Quantitative indicators were compared between 2 groups using independent t test or Mann-Whitney U test. Results:Among the 40 subjects, there were 29 males and 11 females, aged 20-69 (50±12) years. SNR and CNR were both significantly higher in 5.0 T MR group than those in 3.0 T MR group (SNR: 187±9 vs 91±4, t=31.59, P<0.001; CNR: 156±7 vs 70±4, t=31.45, P<0.001), but there was no significant difference in subjective scores of image quality between the 5.0 T MR and 3.0 T MR groups [5.0 (4.0, 5.0), 5.0 (5.0, 5.0) points, respectively, Z=-1.23, P=0.218]. In the evaluation of cerebral arteries, the visualizations of the proximal and middle segments of MCA, ACA and PCA was better than those in the 3.0 T MR group, and there was no significant difference in the scores ( P>0.05), while the visualizations of proximal arteries in the 5.0 T MR group were significantly better than those in the 3.0 T MR group ( P<0.05). Furthermore, small vessel branches such as LA and PA in 5.0 T MR group were visualized better than those in 3.0 T MR group ( P<0.001). Conclusion:TOF-MRA by ultra-high filed 5.0-T provides an optimal choice in visualization of distal large arteries and small vessel branches, which could be useful for the diagnosis on cerebral vascular disease.

Objective:To explore the effects of interpregnancy interval (IPI) on pregnancy outcomes of subsequent pregnancy.Methods:A multicenter retrospective study was conducted in 21 hospitals in China. Information of age, height, pre-pregnancy weight, IPI, history of diseases, complications of pregnancy, gestational age of delivery, delivery mode, and pregnancy outcomes of the participants were collected by consulting medical records of pregnant women who had two consecutive deliveries in the same hospital during 2011 to 2018. The participants were divided into 4 groups according to IPI:<18 months, 18-23 months, 24-59 months and ≥60 months. According to the WHO′s recommendation, with the IPI of 24-59 months group as a reference, to the effects of IPI on pregnancy outcomes of subsequent pregnancy were analyzed. Stratified analysis was further carried out based on age, history of gestational diabetes mellitus (GDM), macrosomia, and premature delivery, to explore the differences in the effects of IPI on pregnancy outcomes among women with different characteristics.Results:A total of 8 026 women were included in this study. There were 423, 623, 5 512 and 1 468 participants in <18 months group, 18-23 months group, 24-59 months group and ≥60 months group, respectively. (1) The age, pre-pregnancy body mass index (BMI), history of cesarean section, GDM, gestational hypertension and cesarean section delivery rate of <18 months group, 18-23 months group, 24-59 months group and ≥60 months group were gradually increased, and the differences were statistically significant ( P<0.05). (2) After adjusting for potential confounding factors, compared with women in the IPI of 24-59 months group, the risk of premature delivery, premature rupture of membranes, and oligohydramnios were increased by 42% ( OR=1.42, 95% CI: 1.07-1.88, P=0.015), 46% ( OR=1.46, 95% CI: 1.13-1.88, P=0.004), and 64% ( OR=1.64, 95% CI: 1.13-2.38, P=0.009) respectively for women in the IPI≥60 months group. No effects of IPI on other pregnancy outcomes were found in this study ( P>0.05). (3) After stratified by age and adjusted for confounding factors, compared with women in the IPI of 24-59 months group, IPI≥60 months would significantly increase the risk of oligohydramnios for women with advanced age ( OR=2.87, 95% CI: 1.41-5.83, P=0.004); and <18 months could increase the risk of premature rupture of membranes for women under the age of 35 ( OR=1.59, 95% CI: 1.04-2.43, P=0.032). Both the risk of premature rupture of membranes ( OR=1.58, 95% CI: 1.18-2.13, P=0.002) and premature delivery ( OR=1.52, 95% CI: 1.07-2.17, P=0.020) were significantly increased in the IPI≥60 months group. After stratified by history of GDM and adjusted for confounding factors, compared with women in the IPI of 24-59 months group, IPI≥60 months would lead to an increased risk of postpartum hemorrhage for women with a history of GDM ( OR=5.34, 95% CI: 1.45-19.70, P=0.012) and an increased risk of premature rupture of membranes for women without a history of GDM ( OR=1.44, 95% CI: 1.10-1.90, P=0.009). After stratified by history of macrosomia and adjusted for confounding factors, compared with women in the IPI of 24-59 months group, IPI≥60 months could increase the proportion of cesarean section for women with a history of macrosomia ( OR=4.11, 95% CI: 1.18-14.27, P=0.026) and the risk of premature rupture of membranes for women without a history of macrosomia ( OR=1.46, 95% CI: 1.12-1.89, P=0.005). After stratified by history of premature delivery and adjusted for confounding factors, compared with women in the IPI of 24-59 months group, IPI≥60 months would significantly increase the risk of premature rupture of membranes for women without a history of premature delivery ( OR=1.47, 95% CI: 1.13-1.92, P=0.004). Conclusions:Both IPI≥60 months and <18 months would increase the risk of adverse pregnancy outcomes in the subsequent pregnancy. Healthcare education and consultation should be conducted for women of reproductive age to maintain an appropriate IPI when they plan to pregnant again, to reduce the risk of adverse pregnancy outcomes in the subsequent pregnancy.

Objective:To establish a multilocus sequence typing (MLST) assay for Corynebacterium ( C.) striatum, explore the population structure and evolution relationship of clinical isolates of C. striatum. Methods:Seven housekeeping genes ( gyrA, gyrB, hsp65, sodA, secA1, rpoB, 16S rRNA) were amplified with PCR by using self-designed specific primers and sequenced. Then, the sequences were assembled with software SeqMan. The gene diversity and gene recombination characteristics were evaluated by using software DnaSP 5.10.01 and Splits tree 4.14.2. The phylogenetic tree and the minimum spanning tree were constructed based on the sequence types (ST) characteristics by using software MEGA 7.0.14 and BioNumerics, respectively. In addition, the genetic evolutionary relationship among STs were analyzed by using software eBURST 3.0. Results:The expected amplification products of seven sites selected in all the test strains were obtained. Splits tree showed that the clustering of all C. striatum strains was consistent, suggesting that gene recombination is the potential driving force for the evolution of C. striatum. All of the 344 C.striatum strains were divided into 72 STs by MLST and 85.7% of the strains formed clonal complexes. CC19 was the predominant clonal complex, whereas ST16 in the clonal complex was detected in the most strains. ST had a certain geographic clustering and a certain correlation with the isolation time. Conclusions:C. striatum showed high genetic diversity in China and CC19 was the predominant clonal complex. The MLST assay established in this study can be used for the typing of C. striatum, but further improvement is needed.

Objective To study the influence of exchange transfusion therapy on the complications and prognosis in newborns with bilirubin encephalopathy.Methods From June 2013 to June 2016,76 children with bilirubin encephalopathy in Feicheng People's Hospital were selected and divided into study group(n =41) and control group(n =35) according to whether or not accepted the exchange transfusion treatment.The levels of total bilirubin (TBIL),indirect bilirubin(IBIL),direct bilirubin(DBIL) and the ratio of total bilirubin to plasma albumin(B/A)were detected and compared between the two groups.The complications and prognosis of the two groups were recorded.Results After exchange transfusion,the TBIL,IBIL,DBIL and B/A values in the study group were (209.49 ± 48.82) μmol/L,(201.81 ± 39.62) μmoL/L,(21.92 ± 19.47) μmoL/L and (5.15 ± 1.89),respectively,which were significantly lower than those before exchange transfusion [(492.35 ± 42.41) μmol/L,(439.44 ± 52.56) μmol/L,(69.38 ± 21.56) μmol/L and (13.28 ± 0.40)] (t =28.007,23.117,10.461,26.947,all P ＜ 0.05).The incidence rates of anemia,sinus bradycardia and electrolyte disturbances in the study group were 48.78％,48.78,60.98％,respectively,which were significantly higher than those in the control group(17.14％,14.29％,14.29％) (x2 =8.397,10.178,17.228,all P ＜ 0.05).The incidence rates of death,hearing impairment and brain damage in the study group were 7.32％,70.73％ and 12.20％,respectively,which in the control group were 11.43％,71.43％ and 14.29％,respectively,there were no statistically significant differences between the two groups (x2 =0.382,0.004,0.072,all P ＞ 0.05).Conclusion Exchange transfusion can significantly reduce the levels of bilirubin and B/A in the treatment of newborns with bilirubin encephalopathy,but it can increase the incidence rate of anemia,sinus bradycardia and electrolyte disturbances,which has no significant influence on the prognosis of patients.