1.Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
ZHANG Jun ; NING Baoming ; WEI Shifeng ; SHEN Haoyu ; SHANG Yue ; ZHU Ran ; XU Xinyi ; CHEN Lei ; LIU Tingting ; MA Shuangcheng
Drug Standards of China 2025;26(1):034-044
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.
2.Effectiveness of the integrated schistosomiasis control programme in Sichuan Province from 2015 to 2023
Chen PU ; Yu ZHANG ; Jiajia WAN ; Nannan WANG ; Jingye SHANG ; Liang XU ; Ling CHEN ; Lin CHEN ; Zisong WU ; Bo ZHONG ; Yang LIU
Chinese Journal of Schistosomiasis Control 2025;37(3):284-288
Objective To investigate the effectiveness of the integrated schistosomiasis control programme in Sichuan Province during the stage moving from transmission interruption to elimination (2015—2023), so as to provide insights into formulation of the schistosomiasis control measures during the post-elimination stage. Methods Schistosomiasis control data were retrospectively collected from departments of health, agriculture and rural affairs, forestry and grassland, water resources, and natural resources in Sichuan Province from 2015 to 2023, and a database was created to document examinations and treatments of human and livestock schistosomiasis, and snail survey and control, conversion of paddy fields to dry fields, ditch hardening, rivers and lakes management and building of forests for snail control and schistosomiasis prevention. The completion of schistosomiasis control measures was investigated, and the effectiveness was evaluated. Results A total of 20 545 155 person-times received human schistosomiasis examinations in Sichuan Province during the period from 2015 to 2023, and 232 157 person-times were seropositive, with a reduction in the seroprevalence from 2.10% (44 299/2 107 003) in 2015 to 1.12% (9 361/837 896) in 2023 (χ2 = 7.68, P < 0.001). The seroprevalence of human schistosomiasis appeared a tendency towards a decline in Sichuan Province over years from 2015 to 2023 (b = −8.375, t = −10.052, P < 0.001); however, no egg positive individuals were identified during the period from 2018 to 2023, with the prevalence of human Schistosoma japonicum infections maintained at 0. Expanded chemotherapy was administered to 2 754 515 person-times, and medical assistance of advanced schistosomiasis was given to 6 436 persontimes, with the treatment coverage increasing from 46.80% (827/1 767) in 2015 to 64.87% (868/1 338) in 2023. Parasitological tests for livestock schistosomiasis were performed in 35 113 herd-times, and expanded chemotherapy was administered to 513 043 herd-times, while the number of fenced livestock decreased from 121 631 in 2015 to 103 489 in 2023, with a reduction of 14.92%. Snail survey covered 433 621.80 hm2 in Sichuan Province from 2015 to 2023, with 204 602.81 hm2 treated by chemical control and 4 637.74 hm2 by environmental modifications. The area of snail habitats decreased from the peak of 5 029.80 hm2 in 2016 to 3 709.72 hm2 in 2023, and the actual area of snail habitats decreased from the peak of 8 585.48 hm2 in 2016 to 473.09 hm2 in 2023. The mean density of living snails remained low across the study period except in 2017 (0.62 snails/0.1 m2). Schistosomiasis control efforts by departments of agriculture and rural affairs in Sichuan Province included conversion of paddy fields to dry fields covering 153 346.93 hm2, hardening of 6 110.31 km ditches, building of 70 356 biogas digesters, replacement of cattle with 227 161 sets of machines, and captive breeding of 21 161 070 livestock from 2015 to 2023, and the control efforts by departments of water resources included rivers and lakes management measuring 5 676.92 km and renovation of 2 331 irrigation areas, while the control efforts by departments of forestry and grassland included building of forests for snail control and schistosomiasis prevention covering 23 913.33 hm2, renovation of snail control forests covering 8 720 hm2 and newly building of shelterbelts covering 764 686.67 hm2. All 63 endemic counties (cities and districts) had achieved the criterion for schistosomiasis elimination criteria in Sichuan Province by the end of 2023. Conclusion Following the integrated control efforts from 2015 to 2023, remarkable achievements have been obtained in the schistosomiasis control programme in Sichuan Province, with all endemic counties successfully attaining the schistosomiasis elimination target at the county level.
3.Establishment and verification of a detection method for the cytotoxic activity of human cascade-primed immune cell injection against non-small cell lung cancer
ZHOU Qiao1 ; LI Meiling1 ; CHEN Zhigang2 ; WANG Zhuang1 ; SHANG Sunyulin1 ; XU Qiuling1 ; ZHU Yanping1 ; ZHANG Yili1
Chinese Journal of Cancer Biotherapy 2025;31(8):862-869
[摘 要] 目的:构建绿色荧光蛋白(GFP)/萤光素酶(Luc)双荧光标记的肿瘤细胞株,建立人链式激活免疫细胞制剂对非小细胞肺癌细胞杀伤活性的检测方法,并进行初步验证。方法: 通过HLA高分辨分型筛选出HLA-A、HLA-B、HLA-C基因型别为纯合子且相应等位基因的分布频率高于2.500%的非小细胞肺癌细胞系作为细胞模型,采用携带有GFP和Luc基因的重组慢病毒感染原始细胞株而获得GFP、Luc稳定表达的细胞系作为靶细胞。通过效应细胞与靶细胞共培养,并优化靶细胞前处理步骤、共培养时间、效靶比等参数,建立人链式激活免疫细胞制剂对非小细胞肺癌杀伤活性的检测方法,并进行专属性、精密度验证。结果:通过HLA高分辨分型,成功筛选出高频等位基因HLA‑A*11:01:01(20.893%)、HLA‑B*52:01:01(2.991%)、HLA‑C*12:02:02(3.139%)的非小细胞肺癌(HCC827)细胞株作为细胞模型。通过慢病毒载体成功构建GFP/Luc双荧光标记的HCC827细胞株,GFP阳性率达 96%。重组慢病毒滴度为1.83 × 10⁷ TU/mL。效靶比为5∶1、10∶1、15∶1、20∶1时,各组间杀伤活性差异显著(P < 0.05),且杀伤活性随培养时间延长显著升高(P <0.000 1)。经综合评估后确认最优参数效靶比为10∶1,共培养时间为72 h。方法学验证表明,建立的方法专属性强;重复性变异系数为0.80%~1.86%;精密度变异系数为1.00%~1.58%,方差分析显示差异无统计学意义(P > 0.05),说明方法重复性良好。结论: 成功建立了人链式激活免疫细胞制剂对非小细胞肺癌杀伤活性的检测方法并验证成功,该方法有助于人链式激活免疫细胞制剂在细胞免疫治疗有效性评价中发挥重要作用。
4.Clinical analysis of 6 cases of diffuse panbronchiolitis in children.
Li-Xin DENG ; De-Hui CHEN ; Yu-Neng LIN ; Shang-Zhi WU ; Jia-Xing XU ; Zhan-Hang HUANG ; Ying-Ying GU ; Jun-Xiang FENG
Chinese Journal of Contemporary Pediatrics 2025;27(3):334-339
OBJECTIVES:
To analyze the clinical characteristics of diffuse panbronchiolitis (DPB) in children and to enhance the clinical diagnosis and treatment of this disease.
METHODS:
A retrospective analysis was conducted on the clinical data of 6 children diagnosed with DPB who were hospitalized at The First Affiliated Hospital of Guangzhou Medical University from January 2011 to December 2019.
RESULTS:
Among the 6 patients, there were 2 males and 4 females; the age at diagnosis ranged from 7 to 12 years. All patients presented with cough, sputum production, and exertional dyspnea, and all had a history of sinusitis. Two cases showed positive serum cold agglutinin tests, and 5 cases exhibited pathological changes consistent with chronic bronchiolitis. High-resolution chest CT in all patients revealed centrilobular nodules diffusely distributed throughout both lungs with a tree-in-bud appearance. Five patients received low-dose azithromycin maintenance therapy, but 3 showed inadequate treatment response. After empirical anti-tuberculosis treatment, non-tuberculous Mycobacteria were found in the bronchoalveolar lavage fluid. Follow-up over 2 years showed 1 case cured, 3 cases significantly improved, and 2 cases partially improved.
CONCLUSIONS
The clinical presentation of DPB is non-specific and can easily lead to misdiagnosis. In cases where DPB is clinically diagnosed but does not show improvement with low-dose azithromycin treatment, special infections should be considered.
Humans
;
Male
;
Female
;
Bronchiolitis/drug therapy*
;
Retrospective Studies
;
Child
;
Haemophilus Infections/diagnosis*
5.Clinical features and immunotherapy for children with loss-of-function/gain-of-function mutations in the STAT gene: an analysis of 10 cases.
Hong-Wei LI ; Yan-Hong WANG ; Shang-Zhi WU ; Bi-Yun ZHANG ; Shi-Hui XU ; Jia-Xing XU ; Zhan-Hang HUANG ; Cheng-Yu LU ; De-Hui CHEN
Chinese Journal of Contemporary Pediatrics 2025;27(8):951-958
OBJECTIVES:
To investigate the clinical features of children with STAT gene mutations, and to explore corresponding immunotherapy strategies.
METHODS:
A retrospective analysis was performed for the clinical data of 10 children with STAT gene mutations who were admitted to the Department of Pediatrics of the First Affiliated Hospital of Guangzhou Medical University, from October 2015 to October 2024. Exploratory immunotherapy was implemented in some refractory cases, and the changes in symptoms, imaging manifestations, and cytokine levels were assessed after treatment.
RESULTS:
For the 10 children, the main clinical manifestations were recurrent rash since birth (7/10), cough (8/10), wheezing (5/10), expectoration (4/10), and purulent nasal discharge (4/10). Genotyping results showed that there was one child with heterozygous loss-of-function (LOF) mutation in the STAT1 gene, four children with heterozygous LOF mutation in the STAT3 gene, and five children with heterozygous gain-of-function (GOF) mutation in the STAT3 gene. Two children with LOF mutation in the STAT3 gene showed decreased interleukin-6 levels and improved clinical symptoms and imaging findings after omalizumab treatment. Three children with GOF mutation in the STAT3 gene achieved effective disease control after treatment with methylprednisolone (0.5 mg/kg per day). Two children with GOF mutation in the STAT3 gene received treatment with JAK inhibitor and then showed some improvement in symptoms.
CONCLUSIONS
STAT gene mutation screening should be considered for children with recurrent rash and purulent respiratory tract infections. Targeted immunotherapy may improve prognosis in patients with no response to conventional treatment.
Humans
;
Male
;
Immunotherapy
;
Female
;
Child, Preschool
;
Child
;
Gain of Function Mutation
;
Retrospective Studies
;
Infant
;
Loss of Function Mutation
;
STAT Transcription Factors/genetics*
6.Chinese Medicine for Treatment of COVID-19: A Review of Potential Pharmacological Components and Mechanisms.
Qian-Qian XU ; Dong-Dong YU ; Xiao-Dan FAN ; He-Rong CUI ; Qian-Qian DAI ; Xiao-Ying ZHONG ; Xin-Yi ZHANG ; Chen ZHAO ; Liang-Zhen YOU ; Hong-Cai SHANG
Chinese journal of integrative medicine 2025;31(1):83-95
Coronavirus disease 2019 (COVID-19) is an acute infectious respiratory disease that has been prevalent since December 2019. Chinese medicine (CM) has demonstrated its unique advantages in the fight against COVID-19 in the areas of disease prevention, improvement of clinical symptoms, and control of disease progression. This review summarized the relevant material components of CM in the treatment of COVID-19 by searching the relevant literature and reports on CM in the treatment of COVID-19 and combining with the physiological and pathological characteristics of the novel coronavirus. On the basis of sorting out experimental methods in vivo and in vitro, the mechanism of herb action was further clarified in terms of inhibiting virus invasion and replication and improving related complications. The aim of the article is to explore the strengths and characteristics of CM in the treatment of COVID-19, and to provide a basis for the research and scientific, standardized treatment of COVID-19 with CM.
Humans
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Drugs, Chinese Herbal/pharmacology*
;
COVID-19 Drug Treatment
;
SARS-CoV-2/drug effects*
;
COVID-19/therapy*
;
Medicine, Chinese Traditional/methods*
;
Antiviral Agents/pharmacology*
;
Animals
7.Effect of Kuanxiong Aerosol on Perioperative Coronary Microcirculation in Patients with Unstable Angina Undergoing Elective PCI: A Pilot Randomized Controlled Trial.
Zi-Hao LIU ; Wen-Long XING ; Hong-Xu LIU ; Ju-Ju SHANG ; Ai-Yong LI ; Qi ZHOU ; Zhen-Min ZHANG ; Zhi-Bao LI ; Ke-Ji CHEN
Chinese journal of integrative medicine 2025;31(3):206-214
OBJECTIVE:
To evaluate the immediate effect of Kuanxiong Aerosol (KXA) on perioperative coronary microcirculation in patients with unstable angina (UA) suffering from elective percutaneous coronary intervention (PCI).
METHODS:
From February 2021 to July 2023, UA inpatients who underwent PCI alone in the left anterior descending (LAD) branch were included. Random numbers were generated to divide patients into the trial group and the control group at a ratio of 1:1. The index of coronary microcirculation resistance (IMR) was measured before PCI, and the trial group was given two sprays of KXA, while the control group was not given. IMR was measured again after PCI, cardiac troponin I (cTnI) and creatine kinase isoenzyme-MB (CK-MB) were detected before and 24 h after surgery, and major cardiovascular adverse events (MACEs) were recorded for 30 days. The data statistics and analysis personnel were blinded.
RESULTS:
Totally 859 patients were screened, and 62 of them were involved into this study. Finally, 1 patient in the trial group failed to complete the post-PCI IMR and was excluded, 30 patients were included for data analysis, while 31 patients in the control group were enrolled in data analysis. There was no significant difference in baseline data (age, gender, risk factors, previous history, biochemical index, and drug therapy, etc.) between the two groups. In addition, differences in IMR, cTnI and CK-MB were not statistically significant between the two groups before surgery. After PCI, the IMR level of the trial group was significantly lower than that of the control group (19.56 ± 14.37 vs. 27.15 ± 15.03, P=0.048). Besides, the incidence of perioperative myocardial injury (PMI) was lower in the trial group, but the difference was not statistically significant (6.67% vs. 16.13%, P=0.425). No MACEs were reported in either group.
CONCLUSIONS
KXA has the potential of improving coronary microvascular dysfunction. This study provides reference for the application of KXA in UA patients undergoing elective PCI. (Registration No. ChiCTR2300069831).
Humans
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Percutaneous Coronary Intervention
;
Male
;
Microcirculation/drug effects*
;
Female
;
Angina, Unstable/physiopathology*
;
Pilot Projects
;
Middle Aged
;
Aged
;
Drugs, Chinese Herbal/pharmacology*
;
Aerosols
;
Troponin I/blood*
;
Coronary Circulation/drug effects*
;
Elective Surgical Procedures
8.Marine-derived new peptaibols with antibacterial activities by targeting bacterial membrane phospholipids.
Shang CHEN ; Dong LIU ; Liyang WANG ; Aili FAN ; Mengyue WU ; Ning XU ; Kui ZHU ; Wenhan LIN
Acta Pharmaceutica Sinica B 2025;15(5):2764-2777
Antibiotic resistance is spreading at a faster rate than new antibiotic agents applied for clinical remedies. It is an urgent need to discover potential compounds to combat multidrug-resistant (MDR) bacteria. Marine fungi offer a promising avenue for mining antibiotic-like molecules with chemical diversity. To discover structurally novel and antibiotic metabolites, we screened the in-house marine fungus genome library and found a fungus Stephanonectria keithii LZD-10-1 containing a non-ribosomal peptide synthetase (NRPS) cluster with 18 modules to synthesize a new subfamily of peptaibols with effective eradication against MDR pathogens. Targeting isolation of the cultured fungus afforded six new peptaibols, which exhibit the ability to kill MDR bacteria by targeting bacterial membrane phospholipids, especially phosphatidylglycerol (PG), leading to the dysfunction of bacterial membranes. Furthermore, their efficacies against methicillin-resistant Staphylococcus aureus (MRSA) in both Galleria mellonella and mouse wound infection models were observed. This study underscores the significance of employing genome-guided approaches to identify untapped marine fungi as potential sources for novel antibiotic candidates with unique scaffolds.
9.Expert consensus on local anesthesia application in pediatric dental therapies.
Yan WANG ; Jing ZOU ; Yang JI ; Jun WANG ; Bin XIA ; Wei ZHAO ; Li'an WU ; Guangtai SONG ; Yuan LIU ; Xu CHEN ; Jiajian SHANG ; Qin DU ; Qingyu GUO ; Beizhan JIANG ; Hongmei ZHANG ; Xianghui XING ; Yanhong LI
West China Journal of Stomatology 2025;43(4):455-461
Dental treatments for children and adolescents have unique clinical characteristics that differ from dental care for adults in terms of children's physiology, psychology, and behavior. These differences impose specific requirements on the application of local anesthesia in pediatric dental procedures. This article presents expert consensus on the principles of local anesthesia techniques in pediatric dental therapies, including the use of common anesthetic drugs and dosage control, safety and efficacy evaluation, and prevention and management of complications. The aim is to improve the safety and quality of pediatric dental treatments and offer guidance for clinical application by dentists.
Humans
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Child
;
Anesthesia, Local/methods*
;
Consensus
;
Anesthesia, Dental/methods*
;
Adolescent
;
Anesthetics, Local/administration & dosage*
;
Dental Care for Children
10.Expert consensus on the evaluation and rehabilitation management of shoulder syndrome after neek dissection for oral and maxillofacial malignancies
Jiacun LI ; Moyi SUN ; Jiaojie REN ; Wei GUO ; Longjiang LI ; Zhangui TANG ; Guoxin REN ; Zhijun SUN ; Jian MENG ; Wei SHANG ; Shaoyan LIU ; Jie ZHANG ; Jicheng LI ; Yue HE ; Chunjie LI ; Kai YANG ; Zhongcheng GONG ; Qing XI ; Bing HAN ; Huaming MAI ; Yanping CHEN ; Jie ZHANG ; Yadong WU ; Chao LI ; Changming AN ; Chuanzheng SUN ; Hua YUAN ; Fan YANG ; Haiguang YUAN ; Dandong WU ; Shuai FAN ; Fei LI ; Chao XU ; Wei WEI
Journal of Practical Stomatology 2024;40(5):597-607
Neck dissection(ND)is one of the main treatment methods for oral and maxillofacial malignancies.Although ND type is in con-stant improvement,but intraoperative peal-pull-push injury of the accessory nerve,muscle,muscle membrane,fascia and ligament induced shoulder syndrome(SS)is still a common postoperative complication,combined with the influence of radiochemotherapy,not only can cause pain,stiffness,numbness,limited dysfunction of shoulder neck and arm,but also may have serious impact on patient's life quality and phys-ical and mental health.At present,there is still a lack of a systematic evaluation and rehabilitation management program for postoperative SS of oral and maxillofacial malignant tumors.Based on the previous clinical practice and the current available evidence,refer to the relevant lit-erature at home and abroad,the experts in the field of maxillofacial tumor surgery and rehabilitation were invited to discuss,modify and reach a consenusus on the etiology,assessment diagnosis,differential diagnosis,rehabilitation strategy and prevention of SS,in order to provide clinical reference.

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