1.Clinical efficacy of Huangkui capsules in the treatment of targeted drug-related proteinuria in patients with hepatocellular carcinoma
Miao LI ; Jia YUAN ; Chu LIU ; Maopei CHEN ; Xin XU ; Ningling GE ; Yi CHEN ; Lan ZHANG ; Rongxin CHEN ; Yan WANG
Chinese Journal of Clinical Medicine 2026;33(1):88-94
Objective To investigate the therapeutic effect of Huangkui capsules on targeted drug-related proteinuria in patients with hepatocellular carcinoma (HCC). Methods A retrospective analysis was conducted on clinical data of HCC patients with targeted drug-related proteinuria from June 2023 to December 2024 at Zhongshan Hospital, Fudan University. According to the treatment plan, patients were divided into the conventional treatment group and the Huangkui combination treatment group (Huangkui capsules combined with conventional treatment), and the clinical efficacy between the two groups was compared. The logistic regression analysis was used to identify the main factors affecting treatment efficacy. Results The Huangkui combination treatment group (n=29) showed a significantly higher overall effective rate (79.3% vs 42.3%, P=0.005), and an earlier proteinuria improvement (median time: 3 months vs 6 months, P=0.008) than the conventional treatment group (n=26) . The multivariate logistic regression analysis showed angiotensin-converting enzyme inhibitor (ACEI) or angiotensin Ⅱ receptor blocker (ARB) using (OR=0.190, 95%CI 0.045-0.808, P=0.025), targeted drug adjustment (OR=0.132, 95%CI 0.030-0.581, P=0.007), and Huangkui capsules using (OR=0.168, 95%CI 0.039-0.730, P=0.017) were protective factors for treatment efficacy of targeted drug-related proteinuria. Conclusions On the basis of conventional treatment, additive treatment with Huangkui capsules can alleviate targeted drug-related proteinuria faster and more effectively in HCC patients.
2.Guidelines for the management of therapeutic drug monitoring
Zhengxiang LI ; Liyan MIAO ; Rong DUAN ; Xiaocong ZUO ; Xianglin ZHANG ; Zhuo WANG ; Miao YAN ; Lingli ZHANG ; Rongsheng ZHAO ; Suodi ZHAI ; Guobiao GAO ; Jinhui TIAN
China Pharmacy 2026;37(11):1381-1392
OBJECTIVE To further standardize the technical operations and management processes throughout therapeutic drug monitoring (TDM), clarify the clinical value of TDM implementation, improve the scientific validity and reliability of monitoring results, and provide a solid reference basis for the formulation and optimization of clinical individualized precision dosing regimens. METHODS The Guidelines for the Management of Therapeutic Drug Monitoring were formulated in accordance with the latest definition of guidelines by the Institute of Medicine of the National Academies and the standard guideline development methodology of the World Health Organization, and in compliance with the requirements of the appraisal of guidelines for research and evaluation. A modified Delphi method was adopted to establish the research question system; evidence-based medicine research methods were applied to systematically search multiple databases to screen the latest and most comprehensive evidence. Evidence was graded and evaluated based on the evidence grading system of the Chinese Evidence-Based Medicine Center, and the grading criteria for recommendation strength from the Oxford Centre for Evidence-Based Medicine were used to determine the recommendation strength. The recommendation opinions were formed through multidisciplinary expert consensus. RESULTS The Guidelines for the Management of Therapeutic Drug Monitoring cover four core modules, including TDM application indications, technical procedures, result interpretation and clinical application, and quality control, involving 18 primary research questions, 34 secondary research questions, and yield 82 recommendations. CONCLUSIONS The guidelines systematically standardize the key technical links and management requirements of the whole TDM process, provide scientific and operable standardized tools, help improve the standardization level of TDM work, promote the translation of monitoring results into clinical decision-making, and provide strong support for precision personalized medicine and ensuring the safety and rationality of medication use.
3.Application research of linear calibration using two reference substances in the establishment of qualitative standards for multi-component analysis of Saposhnikovia divaricata
YAN Jingyi ; ZHOU Hongxu ; TAO Muke ; XIE LinJuan ; JU Miao ; ZHANG Yi
Drug Standards of China 2026;27(1):0092-0099
Objective: Establishment of a HPLC method for six chemical components in Saposhnikovia divaricata (prim-O-glucosylcimifugin, cimifugin, 5-O-methylvisamminoside, sec-O-glucosylhamaudol, psoralen, and imperatorin), comparison of the advantages and disadvantages of the dual-standard linear calibration method and the relative retention time method, and investigation of the feasibility of the linear calibration using two reference substances for qualitative analysis of multiple components in Saposhnikovia divaricata.
Methods: A HPLC method was employed, using 21 different brands and models of C18 columns. The mobile phase consisted of acetonitrile (A) and 0.02% phosphoric acid aqueous solution (B), with gradient elution (0-20 min, 18%A; 20-45 min, 18%A-50%A; 45-60 min, 50%A). The column temperature was set at 30 ℃, the flow rate was 1 mL·min-1, and the detection wavelength was 254 nm.
Results: The results predicted by the linear calibration using two reference substances were accurate and superior to those of the relative retention time method, and the six components exhibited good linear relationships within their respective ranges.
Conclusion: The established linear calibration using two reference substances accurately predicts the retention times of the target components. This method is stable and reliable, providing a reference for the establishment of digital standards in traditional Chinese medicine.
4.Horticultural Therapy Combined with Intradermal Needling for Patients with Generalized Anxiety Disorder of Liver Depression Transforming into Fire Syndrome Under Transcranial Magnetic Stimulation and Psychological Therapy:Clinical Observation of 60 Cases
Wanyun ZHANG ; Jiayi YAN ; Qingyi QIU ; Yumei PENG ; Xiaoling ZHONG ; Jinwen ZHANG ; Rundong TANG ; Miao WU ; Dan HU ; Guang SU
Journal of Traditional Chinese Medicine 2025;66(1):50-58
ObjectiveTo observe the clinical effectiveness of horticultural therapy involving the planting of Chinese medicinal herbs (mint and lily potted plants) combined with intradermal needling therapy for generalized anxiety disorder (GAD) of liver depression transforming into fire syndrome under transcranial magnetic stimulation and basic psychological therapy, and to explore the possible mechanisms of action. MethodsA total of 180 patients with GAD of liver depression transforming into fire syndrome were randomly divided into three groups, horticultural therapy group, intradermal needling group, and horticultural therapy+intradermal needling group, with 60 patients in each. All groups received basic treatment including basic psychological therapy and transcranial magnetic stimulation. The horticultural therapy group received horticultural therapy in addition to the basic treatment; the intradermal needling group received intradermal needling therapy once a week for 8 weeks in addition to the basic treatment; the horticultural therapy+intradermal needling group received both horticultural therapy and intradermal needling therapy, following the same procedures and duration. Hamilton Anxiety Rating Scale (HAMA), Self-Rating Anxiety Scale (SAS), and Pittsburgh Sleep Quality Index (PSQI) scores were assessed at baseline and after 2, 4, 6, and 8 weeks of treatment. Serum levels of adrenocorticotropic hormone (ACTH) and corticosterone (CORT) were measured before treatment and after 8 weeks of treatment. Motor-evoked potential (MEP) baseline levels were recorded before treatment, and MEP amplitude ratios were compared after 1 week and 8 weeks of treatment. Clinical effectiveness and safety were evaluated after 8 weeks of treatment. Pearson correlation analysis was used to examine the relationships between serum ACTH and CORT levels, MEP amplitude, and anxiety. ResultsIn the horticultural therapy group and intradermal needling group, HAMA, SAS and PSQI scores after 4, 6, and 8 weeks treatment were lower than baseline scores (P<0.05). In the horticultural therapy+intradermal needling group, these scores showed a significant decline starting after 2 weeks treatment and continuing through 8 weeks after treatment (P<0.05). The HAMA, SAS, and PSQI scores in the horticultural therapy+intradermal needling group were significantly lower than those in the other two groups after 2, 4, 6, and 8 weeks treatment (P<0.05). After 8 weeks of treatment, serum CORT and ACTH levels in the horticultural therapy+intradermal needling group were significantly lower than baseline levels (P<0.05) and were also lower than those in the horticultural therapy group and intradermal needling group at the same time point (P<0.01). When comparing the level after 8 weeks treatment to that after 1 week treatment, under PAS10 stimulation, the MEP amplitude ratio in the intradermal needling group decreased at 30 minutes, while in the horticultural therapy+intradermal needling group, the MEP amplitude ratio decreased at all time points (P<0.05 or P<0.001); under PAS25 stimulation, the MEP amplitude ratio in the horticultural therapy group increased at 20 minutes, and in the intradermal needle group at 10 minutes (P<0.05). In the horticultural therapy+intradermal needling group, the MEP amplitude ratio increased significantly at all time points after treatment (P<0.001). The cure rate in the horticultural therapy+intradermal needling group (74.14%, 43/58) was significantly higher than that in the horticultural therapy group (30.00%, 18/60) and the intradermal needling group (48.28%, 28/58, P<0.05). Correlation analysis revealed that serum ACTH and CORT levels were positively correlated with HAMA scores (r = 0.488, P<0.01; r = 0.428, P<0.01). Following PAS10 intervention, the MEP amplitude ratio was positively correlated with HAMA scores (r = 0.458, P<0.01), whereas after PAS25 intervention, the MEP amplitude ratio was negatively correlated with HAMA scores (r = -0.562, P<0.01). ConclusionHorticultural therapy combined with intradermal needling treatment, under transcranial magnetic stimulation and basic psychological therapy, demonstrates significant clinical effectiveness in patients with GAD of liver depression transforming into fire syndrome. Its mechanism of action may be related to the regulation of hyperactivation of the hypothalamic-pituitary-adrenal (HPA) axis and the reduction of cortical excitability.
5.Progress in pharmaceutical crystallographic study of mannitol
Huina LIU ; Ke ZHANG ; Yan MIAO ; Yuanfeng WEI ; Yuan GAO
Journal of China Pharmaceutical University 2025;56(2):264-270
As a pharmaceutical excipient with low caloric value, low hygroscopicity, and high stability, mannitol is widely used in various dosage forms, such as solid, lyophilized and inhalation preparations, etc. It has different crystal structures (α, β and δ) and cocrystal, and the changes in the crystal structure will affect formulation properties of pharmaceutical formulations. This paper reviews structural features, physicochemical properties, and preparation methods of mannitol polymorphs and cocrystal formation, with emphasis on polymorphic transformation pathways, monitoring methods and the effect of polymorphic transformation on properties and application in pharmaceutical formulations, including tabletability, disintegration and dissolution properties. By systematically summarizing the crystallographic study of mannitol, this study attempts to provide new ideas for the development of novel pharmaceutical excipients and applications in pharmaceutical formulations.
6.Progress in pharmaceutical crystallographic study of mannitol
Huina LIU ; Ke ZHANG ; Yan MIAO ; Yuanfeng WEI ; Yuan GAO
Journal of China Pharmaceutical University 2025;56(2):264-270
As a pharmaceutical excipient with low caloric value, low hygroscopicity, and high stability, mannitol is widely used in various dosage forms, such as solid, lyophilized and inhalation preparations, etc. It has different crystal structures (α, β and δ) and cocrystal, and the changes in the crystal structure will affect formulation properties of pharmaceutical formulations. This paper reviews structural features, physicochemical properties, and preparation methods of mannitol polymorphs and cocrystal formation, with emphasis on polymorphic transformation pathways, monitoring methods and the effect of polymorphic transformation on properties and application in pharmaceutical formulations, including tabletability, disintegration and dissolution properties. By systematically summarizing the crystallographic study of mannitol, this study attempts to provide new ideas for the development of novel pharmaceutical excipients and applications in pharmaceutical formulations.
7.Guideline for Adult Weight Management in China
Weiqing WANG ; Qin WAN ; Jianhua MA ; Guang WANG ; Yufan WANG ; Guixia WANG ; Yongquan SHI ; Tingjun YE ; Xiaoguang SHI ; Jian KUANG ; Bo FENG ; Xiuyan FENG ; Guang NING ; Yiming MU ; Hongyu KUANG ; Xiaoping XING ; Chunli PIAO ; Xingbo CHENG ; Zhifeng CHENG ; Yufang BI ; Yan BI ; Wenshan LYU ; Dalong ZHU ; Cuiyan ZHU ; Wei ZHU ; Fei HUA ; Fei XIANG ; Shuang YAN ; Zilin SUN ; Yadong SUN ; Liqin SUN ; Luying SUN ; Li YAN ; Yanbing LI ; Hong LI ; Shu LI ; Ling LI ; Yiming LI ; Chenzhong LI ; Hua YANG ; Jinkui YANG ; Ling YANG ; Ying YANG ; Tao YANG ; Xiao YANG ; Xinhua XIAO ; Dan WU ; Jinsong KUANG ; Lanjie HE ; Wei GU ; Jie SHEN ; Yongfeng SONG ; Qiao ZHANG ; Hong ZHANG ; Yuwei ZHANG ; Junqing ZHANG ; Xianfeng ZHANG ; Miao ZHANG ; Yifei ZHANG ; Yingli LU ; Hong CHEN ; Li CHEN ; Bing CHEN ; Shihong CHEN ; Guiyan CHEN ; Haibing CHEN ; Lei CHEN ; Yanyan CHEN ; Genben CHEN ; Yikun ZHOU ; Xianghai ZHOU ; Qiang ZHOU ; Jiaqiang ZHOU ; Hongting ZHENG ; Zhongyan SHAN ; Jiajun ZHAO ; Dong ZHAO ; Ji HU ; Jiang HU ; Xinguo HOU ; Bimin SHI ; Tianpei HONG ; Mingxia YUAN ; Weibo XIA ; Xuejiang GU ; Yong XU ; Shuguang PANG ; Tianshu GAO ; Zuhua GAO ; Xiaohui GUO ; Hongyi CAO ; Mingfeng CAO ; Xiaopei CAO ; Jing MA ; Bin LU ; Zhen LIANG ; Jun LIANG ; Min LONG ; Yongde PENG ; Jin LU ; Hongyun LU ; Yan LU ; Chunping ZENG ; Binhong WEN ; Xueyong LOU ; Qingbo GUAN ; Lin LIAO ; Xin LIAO ; Ping XIONG ; Yaoming XUE
Chinese Journal of Endocrinology and Metabolism 2025;41(11):891-907
Body weight abnormalities, including overweight, obesity, and underweight, have become a dual public health challenge in Chinese adults: overweight and obesity lead to a variety of chronic complications, while underweight increases the risks of malnutrition, sarcopenia, and organ dysfunction. To systematically address these issues, multidisciplinary experts in endocrinology, sports science, nutrition, and psychiatry from various regions have held multiple weight management seminars. Based on the latest epidemiological data and clinical evidence, they expanded the guideline to include assessment and intervention strategies for underweight, in addition to the core content of obesity management. This guideline outlines the etiological mechanisms, evaluation methods, and multidimensional management strategies for overweight and obesity, covering key areas such as diagnosis and assessment, medical nutrition therapy, exercise prescription, pharmacological intervention, and psychological support. It is intended to provide a scientific and standardized approach to weight management across the adult population, aiming to curb the rising prevalence of obesity, mitigate complications associated with abnormal body weight, and improve nutritional status and overall quality of life.
8.Feasibility analysis of laparoscopic total hysterectomy in patients with obliterated rectouterine pouch
Erniao LIU ; Fei MIAO ; Yingfang ZHOU ; Yan HUANG ; Lei ZHANG ; Chao PENG
Chinese Journal of Obstetrics and Gynecology 2025;60(5):355-362
Objective:To analysis the safety and feasibility of laparoscopic total hysterectomy in patients with obliterated rectouterine pouch.Methods:A retrospective analysis was conducted on 197 patients who underwent laparoscopic total hysterectomy at Peking University First Hospital, from July 2022 to July 2024. According to intraoperative observations, 197 patients were categorized into two groups: 58 cases with completely obliterated rectouterine pouch (obliterated group) and 139 cases with non-obliterated pouch (control group). General clinical characteristics, perioperative outcomes and 3-month follow-up after surgery were compared between two groups.Results:(1) Baseline characteristics: the age of the obliterated group was (45.7±3.7) years, and the control group was (48.0±3.8) years ( P<0.001). Primary complaint: dysmenorrhea prevalence was 53.4% (31/58) in the obliterated group, and was 35.3% (49/139; P<0.05) in the control group. Surgical indications: the proportion of adenomyosis and ovarian endometrioma was 77.6% (45/58) in the obliterated group, and was 51.1% (71/139; P<0.001) in the control group. No significant differences in body mass index, pelvic surgical history, or preoperative medication between the two groups (all P>0.05). (2) Intraoperative outcomes: the obliterated group demonstrated significantly higher rates of surgical interventions compared to the control group. Superficial endometriosis resection was performed in 91.4% (53/58) of the obliterated group versus 33.8% (47/139) in the control group ( P<0.001). Deep infiltrating endometriosis excision was required in 82.8% (48/58) of the obliterated group, contrasting sharply with 10.1% (14/139) in the control group ( P<0.001). Ureterolysis procedures were similarly elevated in the obliterated group (77.6%, 45/58) compared to the control group (7.9%, 11/139; P<0.001). Operative metrics revealed substantial intergroup disparities: the obliterated group exhibited a median surgical duration of 149.0 minutes (interquartile range: 114.0, 180.0 minutes), significantly prolonged relative to the control group′s 91.0 minutes (77.0, 107.0 minutes; P<0.001). Estimated blood loss followed a parallel pattern, with median volumes of 50.0 ml (20.0, 100.0 ml) in the obliterated group versus 20.0 ml (10.0, 20.0 ml) in the control group ( P<0.001). (3) Postoperative outcomes: the uterine weight of the obliterated group was 200.0 g (132.5, 260.0 g), and the control group was 240.0 g (180.0, 336.0 g; P<0.05). Hospital stay was prolonged in the obliterated group compared with the control group [7.0 days (6.0, 8.3 days) vs 6.0 days (5.0, 7.0 days); P<0.001]. The incidences of postoperative fever in the obliterated group and the control group were 20.7% (12/58) vs 12.2% (17/139; P>0.05). The incidences of minor complications in the obliterated group and the control group were 3.4% (2/58) vs 0 (0/139; P>0.05). No major complications (intraoperative hemorrhage, transfusion, visceral injury, conversion to laparotomy, or thromboembolism) occurred. (4) Follow up at 3 months after surgery: three months postoperatively, all patients underwent outpatient follow-up visits, during which symptoms such as pain were alleviated. Gynecological ultrasound and pelvic examinations were performed, and the vaginal stump exhibited good healing. Conclusion:Laparoscopic total hysterectomy performed by experienced minimally invasive gynecological specialists is safe and feasible for patients with obliterated rectouterine pouch.
9.Investigation of the prevalence of progestogen drug contraindications in patients with endometriosis and adenomyosis
Fei MIAO ; Erniao LIU ; Yingfang ZHOU ; Yan HUANG ; Lei ZHANG ; Chao PENG
Chinese Journal of Obstetrics and Gynecology 2025;60(7):534-540
Objective:To discuss the prevalence of contraindications to progestogens in patients with endometriosis and adenomyosis.Methods:Women of childbearing age aged 15-49 years, except for menopausal and malignant tumors, were enrolled in Peking University First Hospital from April to August 2024 for laparoscopic or open surgery, regardless of whether they had used or would be using progestogen drugs. The patients were divided into two groups: the case group was patients with pathologically confirmed endometriosis and adenomyosis, and the control group was patients with other benign gynecological diseases. The patient′s medical history and clinical data were collected.Results:A total of 745 patients were enrolled, including 362 cases (48.6%, 362/745) in the case group, 383 cases (51.4%, 383/745) in the control group; 61 patients with contraindications to progestogens, including 32 cases (8.8%, 32/362) in the case group, and 29 cases (7.6%, 29/383) in the control group ( χ2=0.398, P>0.05). Among them, there were 33 cases of liver disease, all of which were liver tumor (hepatic hemangioma only), including 18 cases (5.0%, 18/362) in the case group and 15 cases (3.9%, 15/383) in the control group. There were 11 cases of sex hormone-dependent or related tumors (breast cancer only), including 4 cases (1.1%, 4/362) in the case group and 7 cases (1.8%, 7/383) in the control group. There were 10 cases of vascular disease, including 4 cases of diabetic vascular disease, including 2 cases (0.6%, 2/362) in the case group and 2 cases (0.5%, 2/383) in the control group. There were 3 cases of venous thrombosis, including 2 cases (0.6%, 2/362) in the case group and 1 case (0.3%, 1/383) in the control group. There were 3 cases of cardiovascular and cerebrovascular diseases, including 1 case in the case group (0.3%, 1/362) and 2 cases (0.5%, 2/383) in the control group. There were 7 cases of renal insufficiency, including 3 cases of chronic nephritis complicated with renal insufficiency [including 2 cases (0.6%, 2/362) in the case group and 1 case (0.3%, 1/383) in the control group]; two cases of membranous nephropathy complicated with renal insufficiency were in the case group (0.6%, 2/362); one case of diabetic nephropathy complicated with renal insufficiency was in the control group (0.3%, 1/383); one case of uremia was in the case group (0.3%, 1/362). There were no statistically significant differences between the two groups (all P>0.05). Conclusions:There is no difference in the contraindications of progestogens in patients with endometriosis and adenomyosis compared with patients with other gynecological benign diseases. Liver tumors are more common in both two groups.
10.Heat shock protein family A member 5 regulation of ferroptosis alleviates acute-phase mucosal injury in ulcerative colitis
Jingxian YAN ; Xinyu BAI ; Hao LIANG ; Fengrui ZHANG ; Yinglei MIAO ; Junkun NIU
Chinese Journal of Internal Medicine 2025;64(7):643-651
Objective:This study aimed to investigate the role of heat shock protein family A member 5 (HSPA5) in ferroptosis at its regulatory mechanisms in ulcerative colitis (UC), using both a dextran sulfate sodium (DSS)-induced mouse model of acute colitis and in vitro cell experiments.Methods:Differentially expressed genes in UC were identified using the GSE87466 dataset from the Gene Expression Omnibus, cross-referenced with the ferroptosis-related gene database FerrDB (version 2). A protein-protein interaction (PPI) network was constructed, identifying HSPA5 as a core hub gene. To validate its role in vivo, acute colitis was induced in C57BL/6 mice using DSS, followed by treatment with the ferroptosis inhibitor Ferrostatin-1 (Fer-1). Lipid peroxidation and ferroptosis levels were assessed by measuring malondialdehyde (MDA) and iron content in colon tissues. The expression of ferroptosis-related proteins, including prostaglandin-endoperoxide synthase 2 (PTGS2), glutathione peroxidase 4 (GPX4), ferritin light chain (FTL), activating transcription factor 4 (ATF4), and HSPA5, in addition to tight junction proteins ZO-1 and Occludin, were evaluated using immunohistochemistry and Western blotting. In vitro, an inflammatory model was established using lipopolysaccharide (LPS)-stimulated Caco-2 cells. Lentiviral knockdown of HSPA5 was performed to assess its regulatory effects on ferroptosis by assessing MDA levels, GPX4 activity, and the expression of related proteins. Statistical analyses were conducted with SPSS (version 29.1), with t-tests or one-way ANOVA for normally distributed data and the Mann-Whitney U test for ordinal data. Statistical significance was set at P<0.05. Results:Based on the PPI analysis and previous research, HSPA5 emerged as a key gene linking UC and ferroptosis. In DSS-treated mice, colonic injury was accompanied by elevated MDA levels ( t=5.72, P<0.001) and iron accumulation ( t=6.32, P<0.001). DSS also increased the expression of PTGS2 and proteins in the ATF4-HSPA5 pathway, while reducing the levels of GPX4, FTL, ZO-1, and Occludin. These findings could be partially reversed by Fer-1 (MDA: t=2.92, P<0.05; iron: t=5.84, P<0.001). In Caco-2 cells, LPS treatment elevated the expression of PTGS2, ATF4, and HSPA5, and elevated the MDA content ( t=9.63, P<0.001), while reducing the expression of FTL, GPX4, ZO-1, and Occludin, as well as GPX4 enzyme activity ( t=-11.20, P<0.001). Knockdown of HSPA5 further exacerbated these changes, significantly increasing MDA levels ( t=4.15, P<0.01), decreasing GPX4 activity ( t=-9.81, P<0.001), and altering ferroptosis-related protein expression. Conclusion:HSPA5 appears to protect against intestinal damage in UC by enhancing GPX4 expression and activity, thereby reducing ferroptosis and preserving epithelial barrier integrity through the maintenance of tight junction proteins.

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