1.Efficacy and safety of omadacycline in the treatment of macrolide-unresponsive Mycoplasma pneumoniae pneu-monia in children
Qingmei ZHU ; Jing WANG ; Lili SHI ; Dongliang YANG ; Jiawei HE ; Jing SHEN ; Jianhua YANG
China Pharmacy 2026;37(4):480-485
OBJECTIVE To investigate the efficacy and safety of omadacycline in the treatment of macrolide-unresponsive Mycoplasma pneumoniae pneumonia (MUMPP) in children. METHODS A retrospective study was conducted on children aged 1-18 years old with MUMPP who were hospitalized in the Department of Pediatrics, the First Affiliated Hospital of Xinjiang Medical University from January 2022 to June 2025. According to the selection of secondary antibiotics after 72 h of initial treatment with macrolides, they were divided into the omadacycline group and the doxycycline group. Based on conventional treatment, children in the omadacycline group were given intravenous infusion of 2.4 mg/kg (once daily) of omadacycline tosylate, while children in the doxycycline group were given oral doxycycline hydrochloride tablets at 2 mg/kg (twice daily). The efficacy and safety were compared between the two groups of pediatric patients. Univariate analysis and multivariate Logistic regression analysis were performed on clinical efficacy, and subgroup analysis along with multiple sensitivity analyses were conducted to verify the robustness of the conclusions. RESULTS A total of 284 children with MUMPP were included in this study, with 142 in the omadacycline group and 142 in the doxycycline group. In terms of efficacy, although the hospitalization time of children in the omadacycline group was longer than that in the doxycycline group ( P <0.05), the lung lesion absorption rate and clinical efficacy were significantly higher or better than those in the doxycycline group ( P <0.05). The results of multivariate Logistic regression analysis showed that medication (OR=5.300, 95%CI: 2.526-11.123), length of hospital stay (OR=1.348, 95%CI: 1.167-1.556), and medication duration (OR=1.422, 95%CI: 1.169-1.729) were influencing factors of clinical efficacy ( P <0.05). The subgroup analysis results showed that the clinical efficacy of omadacycline was significantly better than that of doxycycline in all subgroups ( P <0.05). The results of multiple sensitivity analysis showed that the regression coefficients B of the four models (gradually adjust variables) before and after inverse probability of treatment weighting were significantly greater than 1 ( P <0.05). In terms of safety, there was no statistically significant difference in the inci dence of adverse drug reactions between the two groups of patients ( χ 2 =0.447, P =0.504). CONCLUSIONS In the case of hospitalization and prolonged medication, the efficacy of omadacycline in treating childhood MUMPP is superior to that of doxycycline, and its safety is good.
2.Volatile Component Differences in Xihuangwan Prepared with Natural and Artificial Musk Based on Non-targeted and Targeted Metabolomics
Jing WANG ; Fangzhu XU ; Li MENG ; Qizhen ZHU ; Huanjun ZHAO ; Caina YU ; Xuelian CHEN ; Hui GAO ; Zimin YUAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):194-201
ObjectiveHeadspace solid-phase microextraction-gas chromatography-mass spectrometry(HS-SPME-GC-MS) and GC-triple quadrupole MS(GC-QqQ-MS) in combination with non-targeted and targeted metabolomics were employed to systematically analyze the chemical composition differences of Xihuangwan prepared with natural musk and artificial musk, and establish an identification system for them. MethodsThe volatile components of 9 batches of Xihuangwan samples from 8 manufacturers were analyzed by HS-SPME-GC-MS non-targeted metabolomics, and identified by comparing their MS data with the National Institute of Standards and Technology(NIST) spectral library. Orthogonal partial least squares-discriminant analysis(OPLS-DA) was used to identify differential volatile components of Xihuangwan prepared with natural musk and artificial musk. Additionally, GC-QqQ-MS targeted metabolomics was applied to quantify the levels of α-pinene, β-elemene, muscone, dehydroepiandrosterone, bornyl acetate, and octyl acetate in 27 batches of samples from 9 manufacturers. Cluster analysis, principal component analysis(PCA), and partial least squares-discriminant analysis(PLS-DA) were conducted to further explore the differences in volatile components between Xihuangwan samples prepared with natural musk and artificial musk. ResultsNon-targeted metabolomics identified 291 volatile compounds in Xihuangwan, including alkanes, esters, alkanes, alcohols, ketones, naphthalenes and others. OPLS-DA analysis revealed distinct separation between Xihuangwan samples containing artificial musk(A1, C1, D1, E1, F1, G1, I1) and those containing natural musk(H1, H3). A total of 30 differential metabolites were identified. The relative contents of these 30 differential metabolites were visualized using a radar chart, revealing significant differences in the levels of octanol, borneol acetate and muscone. Cluster analysis and PCA results from targeted metabolomics indicated that Xihuangwan could be classified into two distinct groups:one composed of natural musk(H1, H3) and the other of artificial musk, sample H2. PLS-DA identified muscone, octyl acetate, and dehydroepiandrosterone as key differential volatile components. Although no significant difference was observed in the content of octyl acetate between the two groups, statistically significant differences were found for muscone and dehydroepiandrosterone(P<0.05). ConclusionMuscone and dehydroepiandrosterone can be used for the differentiation of Xihuangwan samples containing natural musk from those containing artificial musk. This study systematically and comprehensively analyzed the differences in the types and contents of major volatile components in Xihuangwan prepared with natural musk and artificial musk, providing a scientific basis for quality evaluation and control of Xihuangwan.
3.Volatile Component Differences in Xihuangwan Prepared with Natural and Artificial Musk Based on Non-targeted and Targeted Metabolomics
Jing WANG ; Fangzhu XU ; Li MENG ; Qizhen ZHU ; Huanjun ZHAO ; Caina YU ; Xuelian CHEN ; Hui GAO ; Zimin YUAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):194-201
ObjectiveHeadspace solid-phase microextraction-gas chromatography-mass spectrometry(HS-SPME-GC-MS) and GC-triple quadrupole MS(GC-QqQ-MS) in combination with non-targeted and targeted metabolomics were employed to systematically analyze the chemical composition differences of Xihuangwan prepared with natural musk and artificial musk, and establish an identification system for them. MethodsThe volatile components of 9 batches of Xihuangwan samples from 8 manufacturers were analyzed by HS-SPME-GC-MS non-targeted metabolomics, and identified by comparing their MS data with the National Institute of Standards and Technology(NIST) spectral library. Orthogonal partial least squares-discriminant analysis(OPLS-DA) was used to identify differential volatile components of Xihuangwan prepared with natural musk and artificial musk. Additionally, GC-QqQ-MS targeted metabolomics was applied to quantify the levels of α-pinene, β-elemene, muscone, dehydroepiandrosterone, bornyl acetate, and octyl acetate in 27 batches of samples from 9 manufacturers. Cluster analysis, principal component analysis(PCA), and partial least squares-discriminant analysis(PLS-DA) were conducted to further explore the differences in volatile components between Xihuangwan samples prepared with natural musk and artificial musk. ResultsNon-targeted metabolomics identified 291 volatile compounds in Xihuangwan, including alkanes, esters, alkanes, alcohols, ketones, naphthalenes and others. OPLS-DA analysis revealed distinct separation between Xihuangwan samples containing artificial musk(A1, C1, D1, E1, F1, G1, I1) and those containing natural musk(H1, H3). A total of 30 differential metabolites were identified. The relative contents of these 30 differential metabolites were visualized using a radar chart, revealing significant differences in the levels of octanol, borneol acetate and muscone. Cluster analysis and PCA results from targeted metabolomics indicated that Xihuangwan could be classified into two distinct groups:one composed of natural musk(H1, H3) and the other of artificial musk, sample H2. PLS-DA identified muscone, octyl acetate, and dehydroepiandrosterone as key differential volatile components. Although no significant difference was observed in the content of octyl acetate between the two groups, statistically significant differences were found for muscone and dehydroepiandrosterone(P<0.05). ConclusionMuscone and dehydroepiandrosterone can be used for the differentiation of Xihuangwan samples containing natural musk from those containing artificial musk. This study systematically and comprehensively analyzed the differences in the types and contents of major volatile components in Xihuangwan prepared with natural musk and artificial musk, providing a scientific basis for quality evaluation and control of Xihuangwan.
4.Impact of childhood maltreatment and sleep quality on depressive symptoms among middle school students
Chinese Journal of School Health 2025;46(1):73-77
Objective:
To explore the impact of sleep quality, experience of childhood maltreatment, and their interaction on depressive symptoms among middle school students, so as to provide the reference for early intervention of depressive symptoms among middle school students.
Methods:
From September to December 2023, a questionnaire survey was conducted among 1 231 students from two secondary schools in Harbin, Heilongjiang Province by a convenient sampling method. The survey included general demographic information, Childhood Trauma Questionnaire Short Form, Pittsburgh Sleep Quality Index and Short Version of Center for Epidemiological Studies Depression Scale. The Chi square test was used to analyze the differences in depressive symptom, sleep quality and childhood maltreatment among students with different demographic characteristics. Correlation analysis was conducted using Logistic regression, and interaction analysis was performed by both additive and multiplicative interaction models.
Results:
The detection rate of depressive symptoms among middle school students was 22.7%, and the rate for high school students (35.2%) was significantly higher than that for middle school students (17.0%) ( χ 2=50.35, P <0.01). The detection rates of depressive symptoms among middle school students with a history of childhood maltreatment and poor sleep quality were 45.8% and 44.0%, respectively. Multivariate Logistic regression analysis showed that compared to students without a history of childhood maltreatment, students with a history of childhood maltreatment had a higher risk of depressive symptoms ( OR =4.49,95% CI =3.31~ 6.09 , P <0.01);students with poor sleep quality had a higher risk of depressive symptoms than students with good sleep quality ( OR = 5.99,95% CI =4.37~8.22, P <0.01).The interaction results showed that the presence of childhood maltreatment and poor sleep quality had an additive interaction on the occurrence of depression in middle school students. Compared with students without childhood maltreatment and having good sleep quality, students with childhood maltreatment and poor sleep quality had a 22.49 times higher risk of developing depression ( OR =22.49,95% CI =14.22~35.59, P <0.01).
Conclusion
Depressive symptoms among middle school students are associated with childhood maltreatment and poor sleep quality, and there is an additive interaction between childhood maltreatment and poor sleep quality on the impact of depressive symptoms.
5.Research progress of nano drug delivery system based on metal-polyphenol network for the diagnosis and treatment of inflammatory diseases
Meng-jie ZHAO ; Xia-li ZHU ; Yi-jing LI ; Zi-ang WANG ; Yun-long ZHAO ; Gao-jian WEI ; Yu CHEN ; Sheng-nan HUANG
Acta Pharmaceutica Sinica 2025;60(2):323-336
Inflammatory diseases (IDs) are a general term of diseases characterized by chronic inflammation as the primary pathogenetic mechanism, which seriously affect the quality of patient′s life and cause significant social and medical burden. Current drugs for IDs include nonsteroidal anti-inflammatory drugs, corticosteroids, immunomodulators, biologics, and antioxidants, but these drugs may cause gastrointestinal side effects, induce or worsen infections, and cause non-response or intolerance. Given the outstanding performance of metal polyphenol network (MPN) in the fields of drug delivery, biomedical imaging, and catalytic therapy, its application in the diagnosis and treatment of IDs has attracted much attention and significant progress has been made. In this paper, we first provide an overview of the types of IDs and their generating mechanisms, then sort out and summarize the different forms of MPN in recent years, and finally discuss in detail the characteristics of MPN and their latest research progress in the diagnosis and treatment of IDs. This research may provide useful references for scientific research and clinical practice in the related fields.
6.Analysis of the association between the use of oral progesterone drugs in early pregnancy and gestational diabetes mellitus
Yan QIN ; Jinhua GU ; Jing ZHU ; Lin LUO ; Peng PING ; Lingqi GU
China Pharmacy 2025;36(6):721-726
OBJECTIVE To explore the association between the use of oral progesterone drugs in early pregnancy and gestational diabetes mellitus (GDM). METHODS Through real-world retrospective cohort research method, pregnant women who underwent the oral glucose tolerance test (OGTT) at the Affiliated Maternal and Child Health Hospital of Nantong University between January 2022 and January 2023 were enrolled. Based on whether oral progesterone drugs were used in early pregnancy, they were divided into treatment group and control group; propensity score matching (PSM) with a 1∶1 ratio was employed to control for confounding factors; Logistic regression and linear regression were employed to analyze the association between drug factors (whether use of oral progesterone drug, duration of medication, dosage, and drug type) and outcome indicators (occurrence of GDM, fasting blood glucose levels, and OGTT 1 and 2 h blood glucose levels in late pregnancy). RESULTS A total of 709 pregnant women were enrolled in the two groups before PSM; after PSM, 256 cases were included in both the treatment group and the control group. The results of association analysis indicated that there was no significant association between the use of oral progesterone drugs and GDM (P>0.05); but a significant correlation was found with OGTT 1 h blood glucose levels [β=0.965, 95%CI (0.007,1.922), P<0.05], specifically with Dydrogesterone tablets [β=0.977, 95%CI (0.009, 1.944), P<0.05] and Progesterone soft capsules [β =1.089, 95%CI (0.077, 2.102), P<0.05]. There was no significant correlation between other drug factors and outcome indicators (P>0.05). CONCLUSIONS The use of oral progestogen drugs in early pregnancy is not significantly associated with GDM. The blood glucose levels in late pregnancy, especially OGTT 1 h blood glucose levels, have a certain correlation with Progesterone soft capsules and Dydrogesterone tablets.
7.Establishment of a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection
Rong WU ; Liping WANG ; Jinye LANG ; Yue ZHU ; Jing ZHOU ; Xun LIU ; Jing NI ; Shunbo ZHOU ; Yaling DING
Chinese Journal of Blood Transfusion 2025;38(3):415-420
[Objective] To establish a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection. [Methods] By adding the sample and factor Ⅶ deficient plasma to the sample cup and activating the reaction with prothrombin time assay reagent (PT reagent), the coagulation time of the sample was determined by the change in magnetic bead swing amplitude in the sample cup. The logarithm of coagulation time was inversely proportional to the logarithm of human factor Ⅶa potency. [Results] Under the experimental conditions, the specificity of the methodology was evaluated through spiked recovery, and the recovery rates ranged from 90.0% to 110.0%. Within the range from 0.125 to 1.000 IU/mL, there was a good linear response between the potency and coagulation time of the standard and sample, with correlation coefficients r>0.99. As for the accuracy and repeatability, the recovery rates of various concentrations detected in the stock solution were 101.0%, 100.0% and 112.0%, respectively, with RSD values of 2.6%, 4.0% and 0.0%, respectively. The recovery rates of various concentrations in finished product testing were 104.0%, 94.7% and 112.0%, respectively, with RSD values of 1.9%, 2.4% and 0.0%, respectively. As for the intermediate precision, the RSD were 4.5% and 3.7%, respectively. After treated with sample diluent, the sample was tested at room temperature for 6 hours and still exhibited relatively stable biological activity. [Conclusion] This detection method is accurate, stable, easy to operate and highly automated, and is suitable for detecting the potency of recombinant human coagulation factor Ⅶa for Injection.
8.Research status of quality assessment of hospice care for children with cancer abroad
Jing WU ; Xianhong ZHANG ; Lu WEI ; Xiaochuan ZHU
Chinese Medical Ethics 2025;38(3):275-280
The effectiveness and professionalism of hospice care services for children with cancer are of great significance for improving their quality of life and reducing the mental and economic burden on their families. Currently, a relatively complete quality evaluation system for hospice care for children with cancer has been established abroad, while research in this field in China is still in its infancy. By elaborating on the concept and connotation of quality assessment of hospice care for children with cancer in detail, systematically reviewing the research status of quality assessment of hospice care for children with cancer abroad, and addressing the problems and challenges faced by quality assessment of hospice care for children with cancer in China, corresponding inspirations and improvement strategies were proposed, aiming to provide a reference for improving the quality of hospice care for children with cancer in China.
9.Clinical Safety Monitoring of 3 035 Cases of Juvenile Feilike Mixture After Marketing in Hospital
Jian ZHU ; Zhong WANG ; Jing LIU ; Jun LIU ; Wei YANG ; Yanan YU ; Hongli WU ; Sha ZHOU ; Zhiyu PAN ; Guang WU ; Mengmeng WU ; Zhiwei JING
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(10):194-200
ObjectiveTo explore the clinical safety of Feilike Mixture (FLK) in the real world. MethodsThe safety of all children who received FLK from 29 institutions in 12 provinces between January 21,2021 and December 25,2021 was evaluated through prospective centralized surveillance and a nested case control study. ResultsA total of 3 035 juveniles were included. There were 29 research centers involved,which are distributed across 12 provinces,including one traditional Chinese medicine (TCM) hospital and 28 general hospitals. The average age among the juveniles was (4.77±3.56) years old,and the average weight was (21.81±12.97) kg. Among them,119 cases (3.92%) of juveniles had a history of allergies. Acute bronchitis was the main diagnosis for juveniles,with 1 656 cases (54.46%). FLK was first used in 2 016 cases (66.43%),and 142 juvenile patients had special dosages,accounting for 4.68%. Among them,92 adverse drug reactions (ADRs) occurred,including 73 cases of gastrointestinal system disorders,10 cases of metabolic and nutritional disorders,eight cases of skin and subcutaneous tissue diseases,two cases of vascular and lymphatic disorders,and one case of systemic diseases and various reactions at the administration site. The manifestations of ADRs were mainly diarrhea,stool discoloration,and vomiting,and no serious ADRs occurred. The results of multi-factor analysis indicated that special dosages (the use of FLK)[odds ratio (OR) of 2.642, 95% confidence interval (CI) of 1.105-6.323],combined administration: spleen aminopeptide (OR of 4.978, 95%CI of 1.200-20.655),and reason for combined administration: anti-infection (OR of 1.814, 95%CI of 1.071-3.075) were the risk factors for ADRs caused by FLK. Conclusion92 ADRs occurred among 3 035 juveniles using FLK. The incidence of ADRs caused by FLK was 3.03%,and the severity was mainly mild or moderate. Generally,the prognosis was favorable after symptomatic treatment such as drug withdrawal or dosage reduction,suggesting that FLK has good clinical safety.
10.Changes and Trends in the microbiological-related standards in the Chinese Pharmacopoeia 2025 Edition
FAN Yiling ; ZHU Ran ; YANG Yan ; JIANG Bo ; SONG Minghui ; WANG Jing ; LI Qiongqiong ; LI Gaomin ; WANG Shujuan ; SHAO Hong ; MA Shihong ; CAO Xiaoyun ; HU Changqin ; MA Shuangcheng, ; YANG Meicheng
Drug Standards of China 2025;26(1):093-098
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.


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