1.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
To standardize the clinical application of oral Chinese patent medicines (CPMs), and address the safety issues arising from their dosage form characteristics, irrational clinical use, and the lack of targeted pharmacovigilance systems, the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines, aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China (2019 revision), the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, led a drafting group comprising 18 institutions. After multiple rounds of expert interviews, literature retrieval, evidence screening, and extensive solicitation of opinions, the Guidelines were registered internationally. Systematic standardization focused on safety monitoring, risk identification, assessment, control, and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring, known risks, and potential risks, compared to non-oral CPMs. Then, risk control measures were proposed, including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs, the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine (TCM), which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions, pharmaceutical manufacturers, and regulatory authorities.
2.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
To standardize the clinical application of oral Chinese patent medicines (CPMs), and address the safety issues arising from their dosage form characteristics, irrational clinical use, and the lack of targeted pharmacovigilance systems, the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines, aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China (2019 revision), the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, led a drafting group comprising 18 institutions. After multiple rounds of expert interviews, literature retrieval, evidence screening, and extensive solicitation of opinions, the Guidelines were registered internationally. Systematic standardization focused on safety monitoring, risk identification, assessment, control, and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring, known risks, and potential risks, compared to non-oral CPMs. Then, risk control measures were proposed, including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs, the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine (TCM), which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions, pharmaceutical manufacturers, and regulatory authorities.
3.Approach to the patient with myxedema coma
Jianxia SHI ; Qiuyu FANG ; Wenqian REN ; Yunqin MA ; Qin ZHEN ; Li ZHAO ; Yufan WANG ; Yongde PENG ; Fang LIU
Chinese Journal of Endocrinology and Metabolism 2025;41(3):233-236
Myxedema coma is a rare condition, typically arising from long-standing, untreated hypothyroidism and triggered by factors such as infection, hypothermia, or severe illness. This report details a successfully treated case of myxedema coma with cardiac attest, accompanied by a literature review, to enhance clinical awareness and improve the diagnosis and management of this critical condition.
4.Approach to the patient with myxedema coma
Jianxia SHI ; Qiuyu FANG ; Wenqian REN ; Yunqin MA ; Qin ZHEN ; Li ZHAO ; Yufan WANG ; Yongde PENG ; Fang LIU
Chinese Journal of Endocrinology and Metabolism 2025;41(3):233-236
Myxedema coma is a rare condition, typically arising from long-standing, untreated hypothyroidism and triggered by factors such as infection, hypothermia, or severe illness. This report details a successfully treated case of myxedema coma with cardiac attest, accompanied by a literature review, to enhance clinical awareness and improve the diagnosis and management of this critical condition.
5.Analysis of the clinical effects of a three dimensional-printed intracranial pressure balancing device in preventing complications after suboccipital craniectomy
Peng GUO ; Tao LI ; Yutao PENG ; Wenqian WU ; Haoyu ZHANG ; Ziwen YANG ; Yinglun SONG ; Jinping LI
Chinese Journal of Surgery 2024;62(12):1120-1127
Objective:To explore the clinical effects of a 3D-printed intracranial pressure balancing device in preventing complications after suboccipital craniectomy (DC).Methods:This study is a retrospective cohort analysis. The clinical data of 35 patients who underwent DC at Department of Neurosurgery, Beijing Chaoyang Hospital, Capital Medical University, from September 2020 to September 2023 were reviewed. The cohort included 24 males and 11 females, with an age of (48.7±14.9) years (range:17 to 74 years). Nineteen patients (experimental group) received the intracranial pressure balancing device fixed to the bone defect site post-DC. This device was made using medical-grade dicyanamide resin and was three dimensional printed based on postoperative CT scans of the patients. The remaining 16 patients (control group) did not receive the intracranial pressure balancing device, while other treatments and procedures were consistent with the experimental group. Data were compared using the χ2 test or Fisher′s exact probability method. Results:Out of the 35 patients, 30 cases (85.7%) experienced complications following DC. Specific complications included cerebral infarction in 3 cases (8.6%), intracerebral hemorrhage in 1 case (2.9%), subdural effusion in 27 cases (77.1%) with a median onset of (8.8±6.5) days (range: 1 to 23 days), brain tissue protrusion in 15 cases (42.9%) with a median onset of ( M(IQR)) 7.0 (21.0) days (range:2 to 106 days), and hydrocephalus in 6 cases (17.14%) with a median onset of 34.5 (111.0) days (range: 22 to 136 days). There were no significant differences in the occurrence of complications(all P>0.05). However, there was a significant reduction in the incidence of subdural effusion in the experimental group prior to cranioplasty ( P=0.013). No significant differences were noted in mRS scores between the two groups after cranioplasty ( P>0.05). Conclusions:The intracranial pressure balancing device has the effect of prevention and treatment of subdural effusion. However, it did not significantly improve patient prognosis post-DC, warranting further investigation.
6.Comparison of the microbiota diversity between autogenous and anautogenous Culex pipiens pallens
Jingjing LEI ; Wenxiang LÜ ; Wenqian WANG ; Haifang WANG ; Xiuxia GUO ; Peng CHENG ; Maoqing GONG ; Lijuan LIU
Chinese Journal of Schistosomiasis Control 2024;36(1):52-58
Objective To investigate the microbiota composition and diversity between autogenous and anautogenous Culex pipiens pallens, so as to provide insights into unraveling the pathogenesis of autogeny in Cx. pipiens pallens. Methods Autogenous and anautogenous adult Cx. pipiens pallens samples were collected at 25 ℃, and the hypervariable regions of the microbial 16S ribosomal RNA (16S rRNA) gene was sequenced on the Illumina NovaSeq 6000 sequencing platform. The microbiota abundance and diversity were evaluated using the alpha diversity index, and the difference in the microbiota structure was examined using the beta diversity index. The microbiota with significant differences in the abundance between autogenous and anautogenous adult Cx. pipiens pallens samples was identified using the linear discriminant analysis effect size (LEfSe). Results The microbiota in autogenous and anautogenous Cx. pipiens pallens samples belonged to 18 phyla, 28 classes, 70 orders, 113 families, and 170 genera, and the dominant phyla included Proteobacteria, Bacteroidetes, and so on. At the genus level, Wolbachia was a common dominant genus, and the relative abundance was (77.6 ± 11.3)% in autogenous Cx. pipiens pallens samples and (47.5 ± 8.5)% in anautogenous mosquito samples, while Faecalibaculum (0.4% ± 0.1%), Dubosiella (0.5% ± 0.0%) and Massilia (0.5% ± 0.1%) were specific species in autogenous Cx. pipiens pallens samples. Alpha diversity analysis showed that higher Chao1 index and ACE index in autogenous Cx. pipiens pallens samples than in anautogenous samples (both P values > 0.05), and lower Shannon index (P > 0.05) and Simpson index (P < 0.05) in autogenous Cx. pipiens pallens samples than in anautogenous samples. LEfSe analysis showed a total of 48 significantly different taxa between autogenous and anautogenous Cx. pipiens pallens samples (all P values < 0.05). Conclusion There is a significant difference in the microbiota diversity between autogenous and anautogenous Cx. pipiens pallens.
7.Correlation between serum calcium level and prognosis of acute kidney injury patients with hypercalcemia
Dan PENG ; Wenqian WEI ; Dongfang ZHAO ; Zhouxia XIANG ; Kasimumali AYIJIAKEN ; Meng HE ; Shu RONG
Clinical Medicine of China 2024;40(2):81-87
Objective:To analyze the correlation between serum calcium levels and the prognosis of survival and renal recovery in patients with acute kidney injury (AKI) accompanied by hypercalcemia.Methods:This retrospective study analyzed the clinical data of patients with AKI accompanied by hypercalcemia admitted to Shanghai General Hospital from December 2015 to August 2022. There were 157 patients included in the study. The observation endpoint was set at discharge, focusing on the patients' survival and renal recovery during this period. Based on their status at discharge, patients were divided into a survival group (116 cases) and a death group (41 cases); and among the survivors, into a renal recovery group (63 cases) and a non-recovery group (53 cases). Continuous variables conforming to normal distribution were expressed as xˉ± s, and the mean comparison between the two groups was performed using an independent sample t-test. Continuous variables not conforming to normal distribution were represented by median (interquartile range) and compared between groups using the Mann-Whitney U test. Categorical variables were expressed as frequency (percentage), and comparisons were made using the chi-squared (χ 2) test or Fisher's exact test, as applicable. The correlation between serum calcium levels and patient outcomes was analyzed using univariate and multivariate Logistic regression. Results:The average age of the study subjects was (68.37±16.28) years, with 97 males (61.78%). The ages in the survival and death groups were (65.39±16.13) years and (76.80±13.67) years, respectively, with 66 males in the survival group and 31 in the death group. The history of malignancy (excluding multiple myeloma) was 37 cases and 23 cases, respectively, and serum albumin levels were (35.41±6.84) g/L and (30.82±5.75) g/L, respectively. Significant Statistical differences were observed in age, gender, history of malignancy (excluding multiple myeloma), and serum albumin were found between the survival and death groups (statistical values: t=4.04, χ 2=4.49, χ 2=7.51, t=3.85; all P<0.05). AIK 1 stage were 33.33%(21/63) and 64.15%(34/53), 2 stage were 36.51%(23/63) and 24.53%(13/34), 3 stage were 30.16%(23/63) and 11.32%(6/34) in the renal recovery and non-recovery groupsrespectively. Serum calcium at discharge in the renal recovery and non-recovery groups were (2.50±0.38) mmol/L and (2.70±0.58) mmol/L, respectively, with mean serum calcium levels of (2.60±0.29) mmol/L and (2.78±0.39) mmol/L, and lowest serum calcium levels of (2.28±0.36) mmol/L and (2.50±0.51) mmol/L, respectively. BNP levels were 118 (64, 283) ng/L and 248 (69, 1 383) ng/L, respectively. Significant differences in AKI stage, serum calcium at discharge, mean serum calcium, lowest serum calcium, and BNP were observed between the two groups (statistical values: χ 2=11.84, t=2.26, t=2.75, t=2.73, U=2.62, all P<0.05). Multivariate logistic regression analysis showed that age ( OR=1.062, 95% CI 1.027-1.098, P<0.001), history of malignancy (excluding multiple myeloma) ( OR=3.811, 95% CI 1.623-8.951, P=0.002), and serum albumin ( OR=0.889, 95% CI 0.829-0.953, P=0.001) were independent risk factors for in-hospital mortality of patients; severity of AKI(AKI2 OR=2.984, 95% CI 1.281-6.954, P=0.011, AKI3 OR=5.280, 95% CI 1.863-14.963, P=0.002) and serum calcium level at discharge ( OR=0.813, 95% CI 0.666-0.992, P=0.041) were independent risk factors affecting early renal recovery of patients. Conclusion:Serum calcium level is not associated with the risk of in-hospital mortality in patients with AKI accompanied by hypercalcemia but is related to the prognosis of early renal recovery. Proactively managing serum calcium, along with treatment of the primary malignancy and correction of hypoalbuminemia can help improve the prognosis of these patients.
8.Study on Mechanism of Sanhuang Decoction in Alleviating Ulcerative Colitis in Mice under Candida albicans Colonization Based on Dectin-1-Syk-CARD9 Signaling Pathway
Jing PENG ; Yiyuan PAN ; Xin BAO ; Feng CHEN ; Wenqian LI ; Kelong MA
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(4):86-93
Objective To study the mechanism of Sanhuang Decotion in the treatment of ulcerative colitis(UC)under Candida albicans colonization in mice based on Dectin-1-Syk-CARD9 signaling pathway.Methods Mice model of UC with fungal colonization were established with dextran sodium sulfate free drinking and C.albicans intragastric administration.Mice were divided into normal control group,model group,sulfasalazine group,fluconazole group,and Sanhuang Decotion low-and high-dosage groups,and receive corresponding drug interventions.General state of mice were observed,and the disease activity index(DAI)score of mice were calculated.The load of C.albicans in intestine was detected,the length of the colon was measured,and pathological scoring of the colon tissue was performed.The ultrastructural changes of colon epithelium were observed under transmission electron microscopy.The contents of TNF-α,IL-6 and IL-12 in serum and colon tissues were detected by ELISA.The mRNA and protein expression of Dectin-1,Syk,CARD9,NF-κBp65 and inflammation factors in intestinal epithelial cells and colon tissues were detected by qPCR,Western blot and immunohistochemistry.Results Compared with the normal control group,the model group mice showed reduced activity,decreased food intake,accompanied by loose stools,significantly increased DAI score,increased load of C.albicans in the intestine,shortened colon length,and increased histopathological score,with widening of gap between colon epithelial cells,cytoplasmic dissolution,mitochondrial swelling;TNF-α,IL-6 and IL-12 in serum and colon tissue increased,the expressions of Dectin-1 and CARD9 mRNA and protein in colon epithelial cells increased,p-Syk,p-NF-κBp65,CARD9,TNF-α,IL-1β,IL-6 protein expression in colon tissue increased(P<0.01,P<0.05).Compared with the model group,the Sanhuang Decotion high-dosage group mice showed a significant decrease in DAI score,decreased intestinal C.albicans load,increased colon length,decreased histopathological score,more complete and orderly arrangement of microvilli in colon epithelial cells,mild mitochondrial swelling,TNF-α,IL-6 and IL-12 in serum and colon tissue decreased,and the mRNA and protein expression of Dectin-1 and CARD9 in colon tissue increased,the expression of p-Syk,p-NF-κBp65,CARD9,TNF-α,IL-1β,IL-6 protein in colon tissue decreased(P<0.01,P<0.05).Conclusion Sanhuang Decotion may exert an anti C.albicans colonization UC effect by inhibiting the Dectin-1-Syk-CARD9 signaling pathway and reducing the release of inflammatory factors.
9.Analysis of the clinical effects of a three dimensional-printed intracranial pressure balancing device in preventing complications after suboccipital craniectomy
Peng GUO ; Tao LI ; Yutao PENG ; Wenqian WU ; Haoyu ZHANG ; Ziwen YANG ; Yinglun SONG ; Jinping LI
Chinese Journal of Surgery 2024;62(12):1120-1127
Objective:To explore the clinical effects of a 3D-printed intracranial pressure balancing device in preventing complications after suboccipital craniectomy (DC).Methods:This study is a retrospective cohort analysis. The clinical data of 35 patients who underwent DC at Department of Neurosurgery, Beijing Chaoyang Hospital, Capital Medical University, from September 2020 to September 2023 were reviewed. The cohort included 24 males and 11 females, with an age of (48.7±14.9) years (range:17 to 74 years). Nineteen patients (experimental group) received the intracranial pressure balancing device fixed to the bone defect site post-DC. This device was made using medical-grade dicyanamide resin and was three dimensional printed based on postoperative CT scans of the patients. The remaining 16 patients (control group) did not receive the intracranial pressure balancing device, while other treatments and procedures were consistent with the experimental group. Data were compared using the χ2 test or Fisher′s exact probability method. Results:Out of the 35 patients, 30 cases (85.7%) experienced complications following DC. Specific complications included cerebral infarction in 3 cases (8.6%), intracerebral hemorrhage in 1 case (2.9%), subdural effusion in 27 cases (77.1%) with a median onset of (8.8±6.5) days (range: 1 to 23 days), brain tissue protrusion in 15 cases (42.9%) with a median onset of ( M(IQR)) 7.0 (21.0) days (range:2 to 106 days), and hydrocephalus in 6 cases (17.14%) with a median onset of 34.5 (111.0) days (range: 22 to 136 days). There were no significant differences in the occurrence of complications(all P>0.05). However, there was a significant reduction in the incidence of subdural effusion in the experimental group prior to cranioplasty ( P=0.013). No significant differences were noted in mRS scores between the two groups after cranioplasty ( P>0.05). Conclusions:The intracranial pressure balancing device has the effect of prevention and treatment of subdural effusion. However, it did not significantly improve patient prognosis post-DC, warranting further investigation.
10.Research progress of pachychoroid spectrum disorders
Xianhui ZHOU ; Jiaxin PENG ; Wenqian DENG ; Juan YU
Chinese Journal of Ocular Fundus Diseases 2024;40(10):803-807
The pachychoroid spectrum disorders (PSD) refers to a group of clinical disorders characterized by common features of pathological choroidal thickening and potential pathogenic mechanisms. The pathological mechanism of PSD is very complex, and the theory of venous overload provides valuable research directions. The multimodal imaging technology represented by optical coherence tomography angiography has continuously evolved to provide clear and three-dimensional images of the fundus, making it easier to diagnose and monitor PSD at an early stage. There is no unified consensus on how to develop a treatment plan for PSD, and current research has shown that feasible treatments include drug therapy, laser photocoagulation therapy, and photodynamic therapy. However, the evidence of effectiveness and safety provided by these studies is still not sufficient. Surgery and integrative Chinese and Western medicine may provide new prospects for the treatment of PSD. In the future, it is necessary to further develop reasonable research programs, expand the sample size, strengthen follow-up observation, and provide more safe and effective treatment programs for patients.

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