1.Current Status of Traditional Chinese Medicine Diagnosis and Treatment of Inflammatory Bowel Disease and the Research on Mechanism
Junxiang LI ; Hong SHEN ; Tangyou MAO ; Lei ZHU ; Jiaqi ZHANG ; Zhibin WANG ; Xudong TANG
Journal of Traditional Chinese Medicine 2026;67(1):103-110
In recent years, traditional Chinese medicine (TCM) has achieved significant progress in the treatment of inflammatory bowel disease (IBD). A comprehensive literature search was conducted covering the period from January 1, 2010, to December 30, 2024, across Chinese databases including China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP China Science and Technology Journal Database, and the Chinese Biomedical Literature Service System, as well as international databases such as PubMed, Web of Science, and Embase. The clinical applications and mechanistic studies of TCM in IBD were systematically reviewed. The current status of TCM research on the etiology and pathogenesis of IBD, innovative clinical practices, and multimodal therapeutic approaches, including Chinese herbal formulas, single herbs or active compounds, acupuncture, herbal retention enema, and acupoint application, were summarized, together with their synergistic effects when combined with western medical treatments. The development and application of Chinese patent medicines for IBD are undergoing a profound transition from efficacy validation to mechanistic exploration. Mechanistic studies on the effects of TCM in IBD mainly focus on regulating gut microbiota homeostasis, repairing the intestinal mucosal barrier, and modulating intestinal immune balance. Furthermore, future research directions for TCM-based IBD management are proposed, including the establishment of TCM diagnostic and treatment models, expanding integrated applications of external and internal TCM therapies, innovating personalized treatment strategies, and advancing drug development. These efforts aim to provide insights for the standardized and precision-oriented development of TCM in the diagnosis and treatment of IBD.
2.Cost-utility analysis of rezivertinib versus gefitinib as first-line treatment for EGFR mutation-positive advanced non-small cell lung cancer
Xiaowei ZHU ; Tongming ZHU ; Jia YI ; Wenqiang LI ; Piaopiao LU ; Aizong SHEN
China Pharmacy 2026;37(1):55-60
OBJECTIVE To evaluate the cost-effectiveness of rezivertinib versus gefitinib as first-line treatment for epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC) from the perspective of the Chinese healthcare system. METHODS A Markov model was constructed based on the REZOR trial data, with a cycle length of 3 weeks and a study duration of 5 years. Both costs and health outcomes were discounted at an annual rate of 5%. A cost-utility analysis was conducted using 3 times China’s 2024 per capita gross domestic product as the willingness-to-pay (WTP) threshold. The economic differences between the rezivertinib regimen versus the gefitinib regimen were evaluated using the incremental cost- effectiveness ratio (ICER) and incremental net monetary benefit (INMB). Sensitivity and scenario analyses were performed to verify the robustness of the model. RESULTS Compared to the gefitinib regimen, the rezivertinib regimen saved 225 310.47 yuan and gained an additional 0.57 quality- adjusted life years (QALYs), resulting in an ICER of -395 562.80 yuan/QALY, which was much lower than the WTP threshold of this study, indicating that rezivertinib had an absolute economic advantage. The INMB analysis (389 041.26 yuan) further validated this conclusion. One-way and probabilistic sensitivity analyses confirmed the robustness of the model. Scenario analysis, incorporating a 15% reduction in drug prices and adjustments to the utility values for progression free survival and progression disease, yielded consistent results with the base case analysis. CONCLUSIONS Compared to gefitinib, rezivertinib as a first-line treatment for EGFR mutation-positive advanced NSCLC has an absolute economic advantage.
3.Efficacy and safety of sequential or combined therapy with tenofovir alafenamide fumarate in entecavir-treated patients with low-level viremia
Yijing ZHANG ; Lingying HUANG ; Bowu CHEN ; Wanchun ZHU ; Man LI ; Jie SHEN ; Yueqiu GAO
Journal of Clinical Hepatology 2026;42(1):66-73
ObjectiveTo investigate the efficacy of sequential tenofovir alafenamide fumarate (TAF) therapy versus the regimen of entecavir (ETV) combined with TAF in chronic hepatitis B (CHB) patients experiencing low-level viremia (LLV) after ETV therapy, as well as their impact on virologic response, liver and renal function, and blood lipid levels. MethodsA total of 217 CHB patients with LLV after ETV treatment who were admitted to Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from May 2020 to December 2023 were enrolled, and according to the treatment regimen, they were divided into TAF group (180 patients receiving sequential TAF therapy) and combined group (37 patients receiving ETV+TAF therapy). The propensity score matching (PSM) method was used to match the patients at a ratio of 1∶1, and finally 37 patients were included in each group to balance the baseline confounding factors. The two groups were compared in terms of hepatitis B virus DNA (HBV DNA) clearance rate, hepatitis B envelope antigen (HBeAg) clearance rate, liver and renal function parameters (liver stiffness measurement [LSM], platelet count [PLT], aspartate aminotransferase [AST], alanine aminotransferase [ALT], and creatinine [Cr]), blood lipid levels (total cholesterol [TC], triglyceride [TG], high-density lipoprotein cholesterol [HDL-C], and low-density lipoprotein cholesterol [LDL-C]), and the incidence rate of adverse reactions. The independent samples t-test was used for comparison of normally distributed continuous data between two groups, and the paired t-test was used for comparison within each group; the chi-square test was used for comparison of categorical data between groups. ResultsAfter 48 weeks of treatment, compared with the TAF group, the combined group had significantly higher HBV DNA clearance rate (86.49% vs 59.46%, χ²=6.852, P=0.009) and HBeAg clearance rate (59.46% vs 35.14%, χ²=4.391, P=0.036). After treatment, compared with the TAF group, the combined group had significantly lower levels of LSM (7.01±1.50 kPa vs 7.90±1.68 kPa, t=2.404, P=0.019), AST (18.02±2.28 U/L vs 21.12±2.85 U/L, t=5.166, P<0.001), and ALT (19.85±3.86 U/L vs 22.00±3.90 U/L, t=2.383, P=0.020) and significantly higher levels of PLT [(218.35±42.60)×109/L vs (192.82±44.13)×109/L, t=2.532, P=0.014] and Cr (70.92±6.54 μmoL/L vs 67.60±6.13 μmoL/L, t=2.253, P=0.027). After treatment, there was a slight increase in the level of TC in both the TAF group (5.60±0.89 mmol/L vs 5.18±0.85 mmol/L, t=2.076, P=0.041) and the combined group (5.45±0.80 mmol/L vs 5.02±0.83 mmol/L, t=2.269, P=0.026). There was no significant difference in the incidence rate of adverse reactions between the TAF group and the combined group (21.62% vs 18.92%, χ²=0.084, P=0.772). ConclusionFor ETV-treated CHB patients experiencing LLV, compared with sequential TAF therapy, the ETV+TAF combined therapy can effectively increase virologic response rate, alleviate liver fibrosis, and improve liver function, whereas sequential TAF therapy has less impact on renal function. Sequential or combined therapy with TAF may induce a slight increase in the level of TC, which should be taken seriously in clinical practice.
4.Evaluation of the anticoagulant effect of nafamostat mesylate in continuous veno-venous hemofiltration with different dilution methods for uremic patients
Li SHEN ; Yao ZHANG ; Jun WANG ; Hong ZHU ; Yong QIN ; Yuewu TANG ; Ni DU
China Pharmacy 2026;37(3):350-355
OBJECTIVE To evaluate the anticoagulant efficacy and safety of nafamostat mesylate (NM) in the treatment of uremic patients at high risk of bleeding undergoing continuous veno-venous hemofiltration (CVVH) with different methods (pre- dilution and post-dilution). METHODS A total of 130 uremic patients at high risk of bleeding who underwent CVVH treatment in the nephrology department of Chongqing University Three Gorges Hospital from July 2023 to September 2024 were selected. They were divided into pre-dilution group and post-dilution group according to the random number table method, with 65 cases in each group. Both groups of patients received CVVH treatment under NM anticoagulation. The pre-dilution group adopted the pre-dilution replacement method, while the post-dilution group adopted the post-dilution replacement method. The coagulation, pressure, and usage duration of the filter and dialysis circuit venous reservoirs were compared between the two groups. The changes in prothrombin time (PT), prothrombin time-international normalized ratio (PT-INR), activated partial thromboplastin time (APTT), and fibrinogen (FIB) in the peripheral venous blood before the heparin pump and after the filter at 1, 4 and 7 h of CVVH treatment, as well as 20 min after the end of treatment, were compared between the two groups. The single-compartment urea clearance rate (spKt/V), β2-microglobulin (β2-MG) clearance rate and the incidence of adverse reactions were duni2007@foxmail.com compared between the two groups. RESULTS Both the pre-dilution and post-dilution groups had 60 patients who completed the study. The incidence of grade Ⅱ-Ⅲ coagulation of the filter and venous reservoirs, as well as the number of patients with transmembrane and venous pressure alarm intervention in the post- dilution group were significantly higher or more than those in the pre-dilution group (P<0.05), while usage time of the filter and the pipeline in the post-dilution group was significantly shorter than that in the pre-dilution group (P<0.05). The APTT values before the heparin pump as well as PT and APTT values after the filter at 1 h, 4 h, and 7 h of CVVH treatment in the post-dilution group were significantly higher than those in the pre-dilution group (P<0.001). There were no significant differences in PT, PT- INR, APTT and FIB between the two groups of patients 20 min after the end of treatment (P>0.05). The spKt/v and β2-MG clearance rates in the post-dilution group were significantly higher than those in the pre-dilution group (P<0.001). There was no significant difference in the incidence of adverse reactions between the two groups (P>0.05). CONCLUSIONS When NM is used as an anticoagulant in the CVVH treatment of uremic patients at high risk of bleeding, compared with the pre-dilution treatment method, the post-dilution treatment method has a higher incidence of filter and dialysis tubing venous reservoir, a shorter usage time of the filter and pipeline, and a greater impact on extracorporeal coagulation, but has a higher solute clearance rate. Clinically, different dilution methods can be selected according to the different treatment needs of patients.
5.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.
6.Effects of oral non-peptidic thrombopoietin receptor agonists on hepatic enzyme in adult patients with immune thrombocytopenia:a meta-analysis
Tiantian LU ; Nan SHEN ; Suyue ZHU ; Jingjing YAN
China Pharmacy 2026;37(4):510-515
OBJECTIVE To systematically evaluate the effects of oral non-peptidic thrombopoietin receptor agonists (TPO-RAs) on hepatic enzyme in adult patients with immune thrombocytopenia. METHODS A comprehensive literature search was conducted in PubMed, Web of Science, CNKI, Wanfang database and the Chinese Medical Association Journal Full-Text Database to collect randomized controlled trials (RCTs) comparing oral non-peptidic TPO-RAs (intervention group) with placebo or conventional therapy (control group). All databases were searched from their inception to June 2025. After literature screening, data extraction and quality assessment of the included studies, meta-analysis was conducted using RevMan 5.4.1 software. RESULTS Twelve RCTs comprising 1 388 patients were included, with 971 in the intervention group and 417 in the control group. Meta-analysis results showed that there were no significant differences between the two groups in terms of the incidence of hepatic enzyme elevation[OR=1.24, 95%CI (0.77, 1.99), P =0.37 ] , the incidence of hepatic enzyme elevation in patients treated for ≥6 weeks[OR=1.21, 95%CI (0.73, 1.99), P =0.46 ] , and the incidence of severe hepatic enzyme elevation[OR=1.39, 95%CI(0.46, 4.20), P =0.55 ] . Subgroup analysis showed that there were no significant differences in the incidence of hepatic enzyme elevation between the intervention group and control group among patients using eltrombopag[OR=1.57,95%CI(0.85,2.87), P =0.15 ] , avatrombopag[OR=0.88,95%CI (0.09,8.46), P =0.91 ] , and hetrombopag[OR=1.04,95%CI(0.30,3.65), P =0.95 ] , respectively. CONCLUSIONS Oral non-peptidic TPO-RAs do not significantly increase the risk of hepatic enzyme elevation in adult patients with immune thrombocytopenia, and show an overall favorable hepatic safety profile.
7.Risk identification and intervention efficacy evaluation of hospital-acquired infections in neurosurgery department based on failure mode and effect analysis
Puyu YANG ; Ye QIU ; Ya YANG ; Zhimin WEI ; Jingru ZHAO ; Weiping ZHU ; Yifeng SHEN ; Yuanping WANG
Shanghai Journal of Preventive Medicine 2026;38(2):159-164
ObjectiveTo establish a regional risk assessment system for hospital-acquired infections in neurosurgery department of general hospital, and to evaluate its prevention and control effectiveness. MethodsFailure mode and effect analysis (FMEA) was used to identify the core risk factors for infections in neurosurgery department. The risk priority number (RPN) of each risk factor was calculated to determine the priority intervention targets. Targeted interventions were developed and continuously refined through the plan-do-check-act (PDCA) cycles. Data from January to June 2023 (control group) and July to December 2023 (intervention group) were collected to compare the differences in environmental hygiene monitoring qualification rate, incidence rate of hospital-acquired infections among inpatients, and detection rate of bacterial antimicrobial resistance. ResultsHigh-risk factors for hospital-acquired infections in neurosurgery department included patient-related risk factors, inadequate implementation of isolation measures for special infections, and poor compliance with surgical site infection (SSI) prevention protocols. After intervention, the environmental hygiene qualification rate significantly increased from 81.55% to 100.00% (χ²=120.49, P<0.001). The overall hospital-acquired infection rate among inpatients decreased from 2.62% to 2.45%, the infection rate of per case declined from 3.12% to 2.84%, and the detection rate of multidrug-resistant organism infections reduced from 43.72% to 36.79%. Additionally, antimicrobial utilization rate decreased from 48.75% to 42.53% (χ²=34.09, P<0.001). ConclusionThe FMEA-based risk assessment system can effectively identify critical infection risks in neurosurgery department, and targeted interventions can significantly improve infection prevention and control performance.
8.A Case of Multidisciplinary Treatment for Inflammatory Myofibroblastic Tumor Complicated by ANCA-Associated Vasculitis
Shaoying WANG ; Linyi PENG ; Ke ZHENG ; Zhiwei WANG ; Dachun ZHAO ; Xia ZHANG ; Lin ZHAO ; Wenhui WANG ; Weiqing WANG ; Zhenzhen ZHU ; Jin XU ; Min SHEN
JOURNAL OF RARE DISEASES 2026;5(1):43-51
A 51-year-old male presented with nasal obstruction, followed by progressive hearing loss and blurred vision. Imaging identified space-occupying lesions in the paranasal sinuses, orbits, and paraspinal regions, while laboratory tests confirmed positive anti-proteinase 3 anti-neutrophil cytoplasmic antibody(PR3- ANCA) immunoglobulin G (IgG)and markedly elevated serum IgG4. Despite treatment with corticosteroids, immunosuppressants, and radiotherapy, the patient exhibited steroid dependency with relentless disease progression. Following multidisciplinary consultation, a diagnosis of inflammatory myofibroblastic tumor (IMT) coexisting with ANCA- associated vasculitis (AAV) was favored, though IgG4-related disease remained a critical differential. Ultimately, profound immunosuppression precipitated a severe herpesvirus infection, leading to disseminated intravascular coagulation and multiple organ dysfunction syndrome. This case underscores the rarity and diagnostic complexity of concurrent IMT and AAV, highlights the therapeutic dilemma of balancing primary disease control against fatal opportunistic infections, and emphasizes the critical role of multidisciplinary collaboration in the diagnosis and treatment of complex diseases.
9.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.
10.The Effect of Zhiqiao Gancao Decoction (枳壳甘草汤) on Intervertebral Disc Nucleus Pulposus Cell Apoptosis and the Hippo-YAP/TAZ Signaling Pathway in Tail Intervertebral Disc Degeneration Model Rats
Zaishi ZHU ; Zeling HUANG ; Junming CHEN ; Bo XU ; Binjie LU ; Hua CHEN ; Xingxing DUAN ; Yuwei LI ; Xiaofeng SHEN
Journal of Traditional Chinese Medicine 2025;66(5):509-517
ObjectiveTo investigate the possible mechanism by which Zhiqiao Gancao Decoction (枳壳甘草汤, ZGD) delays intervertebral disc degeneration (IDD) based on the Hippo-yes-associated protein (YAP)/transcriptional co-activator with PDZ-binding motif (TAZ) signaling pathway. MethodsA total of 50 SD rats were randomly divided into sham surgery group, model group, low-dose ZGD group, high-dose ZGD group, and high-dose ZGD + inhibitor group, with 10 rats in each group. In the sham surgery group, the rats were pierced in the skin and muscle at the Co6/7/8 segments of the tail with a 21G needle (depth approximately 2 mm) without damaging the intervertebral disc. In the other groups, rats were injected with a 21G needle at the Co6/7/8 segments of the tail to establish an IDD model by piercing the tail intervertebral disc 5 mm. One week after modeling, rats in the low-dose and high-dose ZGD groups were given 6.24 and 12.24 g/(kg·d) of the decoction via gastric gavage, respectively. The high-dose ZGD + inhibitor group was given 12.24 g/(kg·d) of the decoction and an intraperitoneal injection of YAP/TAZ inhibitor Verteporfin 10 mg/kg. The sham surgery and model groups were given 5 ml/(kg·d) of normal saline via gavage. The gavage was given once a day, and the intraperitoneal injection was given every other day. After 4 weeks of continuous intervention, the pathological changes of the tail intervertebral discs were observed using HE staining, Oil Red O-Green staining, and Toluidine Blue staining. Immunohistochemistry was used to detect the expression of aggrecan and MMP3 in the nucleus pulposus. TUNEL fluorescence staining was performed to detect apoptosis in the nucleus pulposus, and the apoptosis rate was calculated. Western blot was used to detect the Hippo-YAP/TAZ signaling pathway, including YAP, phosphorylated YAP (p-YAP), phosphorylated MST1/2 (p-MST1/2), phosphorylated TAZ (p-TAZ) and apoptosis-related proteins, such as Cleaved Caspase 3, P53, Bcl-2 and Bax. ResultsCompared with sham surgery group, the rats in the model group showed significant degenerative changes in the intervertebral disc. The levels of aggrecan, Bcl-2, and YAP proteins in the nucleus pulposus decreased, while the levels of p-MST1/2, p-YAP, p-TAZ, P53, Bax, Cleaved Caspase 3, MMP3 proteins, and the apoptosis rate increased (P < 0.01). Compared with the model group, the drug intervention groups showed partial recovery in intervertebral disc degeneration. The levels of aggrecan, Bcl-2, and YAP proteins increased, while the levels of p-MST1/2, p-YAP, p-TAZ, P53, Bax, Cleaved Caspase 3, MMP3 proteins, and the apoptosis rate decreased (P<0.05 or P<0.01). The high-dose ZGD group showed more significant recovery in intervertebral disc degeneration compared to the low-dose ZGD group, with a decrease in the levels of p-MST1/2, p-YAP, p-TAZ, P53, Bax, Cleaved Caspase 3, MMP3 proteins, and apoptosis rate, and an increase in the levels of aggrecan, Bcl-2, and YAP proteins (P<0.05 or P<0.01). Compared with the high-dose ZGD group, the high-dose ZGD + inhibitor group showed a reduced recovery in intervertebral disc degeneration, with an increase in the levels of p-MST1/2, p-YAP, p-TAZ, P53, Bax, Cleaved Caspase 3, MMP3 proteins, and apoptosis rate, and a decrease in the levels of aggrecan, Bcl-2, and YAP proteins (P<0.05 or P<0.01). ConclusionZGD may delay intervertebral disc degeneration by inhibiting the phosphorylation of YAP in the nucleus pulposus, maintaining the function of the Hippo-YAP/TAZ signaling pathway, and reducing apoptosis of nucleus pulposus cells.

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