1.Cost-utility analysis of amivantamab combined with lazertinib in the first-line treatment of EGFR-mutated advanced NSCLC
Ran LIU ; Shengnan GAO ; Yuxi ZHANG ; Ranran ZHANG ; Congxin LI ; Guoqiang LIU
China Pharmacy 2026;37(5):633-638
OBJECTIVE To evaluate the cost-effectiveness of amivantamab combined with lazertinib (hereinafter referred to as “AL”) regimen as first-line treatment for EGFR -mutated advanced non-small cell lung cancer (NSCLC) from the perspective of China’s healthcare system. METHODS A partitioned survival model was established based on updated data from the MARIPOSA study, with a 10-year time horizon and 28-day cycles. The primary outcome index was quality adjusted life year (QALY), and the willingness-to-pay (WTP) threshold was set at three times China’s per capita GDP in 2024 (287 247 yuan/QALY). Cost-utility analysis was used to calculate the incremental cost-effectiveness ratio (ICER) of AL regimen versus osimertinib monotherapy regimen as first-line treatment for EGFR -mutated advanced NSCLC. One-way and probabilistic sensitivity analyses were performed to test model robustness. Scena rio analyses were conducted to explore the impact of utility values for different health states on the outcomes and determine the required price reductions of amivantamab and lazertinib to achieve cost-effectiveness. RESULTS Compared with the osimertinib monotherapy regimen, the ICER for the AL regimen as first-line treatment for advanced EGFR -mutated NSCLC was 2 062 096.15 yuan/QALY, significantly exceeding the WTP threshold established in this study. One-way sensitivity analysis revealed that the utility value of progression-free survival state and the price of amivantamab were the primary factors influencing the ICER. Probabilistic sensitivity analysis revealed that the AL regimen only became cost-effective when the WTP threshold was set at 2 050 000 yuan/QALY. Scenario analysis indicated that altering the utility value still rendered the AL regimen non-cost-effective. When amivantamab (350 mg) prices decreased by 80%, 85%, and 90% respectively, lazertinib (80 mg) prices would need to decrease by 95.97%, 40.63%, 5.29%, respectively. This would enable the AL regimen’s ICER to consistently fall within the WTP threshold established in this study. CONCLUSIONS At the WTP threshold established in this study, the AL regimen does not demonstrate cost-effectiveness for first-line treatment of advanced EGFR -mutated NSCLC compared to the osimertinib monotherapy regimen. Significant price reductions for both drugs would be required to alleviate the financial burden on patients.
2.Pharmacoeconomic evaluation of culmerciclib combined with fulvestrant in the second-line treatment of HR+/HER2− locally advanced or metastatic breast cancer
Ran LIU ; Shengnan GAO ; Congxin LI ; Yuxi ZHANG ; Ranran ZHANG ; Yue WANG ; Ziyi LIU ; Guoqiang LIU
China Pharmacy 2026;37(8):1033-1038
OBJECTIVE To evaluate the cost-effectiveness of culmerciclib combined with fulvestrant as second-line treatment for patients with hormone receptor-positive(HR+)/human epidermal growth factor receptor 2-negative (HER2–) locally advanced or metastatic breast cancer, within the context of the Chinese healthcare system. METHODS A partitioned survival model was established based on the CULMATE-1 study, with a simulation time horizon set at 15 years and a cycle length of 28 days. The incremental cost-effectiveness ratio (ICER) of culmerciclib combined with fulvestrant versus fulvestrant monotherapy as second-line treatment for HR+/HER2– breast cancer was calculated. One-way sensitivity analysis and probabilistic sensitivity analysis were performed to assess the robustness of the model. Meanwhile, scenario analysis of culmerciclib price reduction was conducted; the required price reduction and price to reach the willingness-to-pay (WTP) threshold in this study were calculated. RESULTS The results of the base-case analysis indicated that, compared with the fulvestrant monotherapy regimen, culmerciclib combined with fulvestrant yielded an additional 0.823 quality-adjusted life year (QALY), with a corresponding ICER of 371 696.26 yuan/QALY, which exceeded the WTP threshold (199 330 yuan/QALY). The results of the univariate sensitivity analysis indicated that the cost of culmerciclib, the discount rate, the utility values for progression disease and progression free survival status were significant factors influencing the ICER; both the univariate sensitivity analysis and the probabilistic sensitivity analysis validated the robustness of the model results. Scenario analysis indicated that when the price of culmerciclib was reduced by 30%, 55% and 85% respectively, the corresponding ICER values fell below 3, 2, and 1 times China’s per capita GDP in 2025, with the probability of cost-effectiveness being 3.00%, 94.90%, 100%. When the cost of culmerciclib (60 mg) was reduced by 52.6% to 50.96 yuan, the ICER value met the WTP threshold established in this study. CONCLUSIONS When the WTP threshold is set at twice China’s per capita GDP in 2025, second-line treatment with culmerciclib combined with fulvestrant for HR+/HER2– locally advanced or metastatic breast cancer does not exhibit cost-effectiveness advantage over fulvestrant monotherapy. Therefore, a reasonable price reduction is required to alleviate the financial burden on patients.
3.Shuhe Granules (舒和颗粒) in Treating Rheumatoid Arthritis Comorbid with Insomnia with Kidney-Heart Deficiency and Qi-Blood Disharmony Syndrome:An Exploratory Single-Arm Clinical Trial
Yonghao PAN ; Yuxi LI ; Yu GAO ; Xiangbin CHEN ; Kaixin GAO ; Runyue HUANG ; Fei TAN ; Jiamin YUAN ; Biyun XU ; Zhimin YANG
Journal of Traditional Chinese Medicine 2026;67(16):1743-1751
ObjectiveTo investigate the clinical effects and safety of Shuhe Granules (舒和颗粒) in patients with rheumatoid arthritis (RA) comorbid with insomnia. MethodsA single-arm prospective exploratory design was adopted. Thirty RA patients comorbid with insomnia and diagnosed with the traditional Chinese medicine (TCM) syndrome of kidney-heart deficiency and qi-blood disharmony were enrolled. On the basis of maintaining their original RA treatment regimens, all patients received oral Shuhe Granules, one dose per day, for 12 consecutive weeks. The outcomes were assessed before treatment and at weeks 4, 8, and 12 after treatment. Sleep and related psychosomatic function were evaluated using the insomnia severity index (ISI), Pittsburgh sleep quality index (PSQI), fatigue severity scale (FSS), patient health questionnaire-9 (PHQ-9), generalized anxiety disorder-7 (GAD-7), and Montreal cognitive assessment (MoCA) scores. RA-related assessments included the 28-joint disease activity score based on C-reactive protein (DAS28-CRP), pain visual analog scale (VAS), tender joint count (TJC28), swollen joint count (SJC28), morning stiffness duration, and health assessment questionnaire (HAQ) score. Laboratory parameters included erythrocyte sedimentation rate (ESR), serum C-reactive protein (CRP), anti-cyclic citrullinated peptide antibody (anti-CCP), and rheumatoid factor (RF) levels. A literature-based historical control group was established through literature retrieval and meta-analysis. The ISI, PSQI, DAS28-CRP, and pain VAS scores were compared between the treatment group in the present study and the historical control group. Safety assessments were also performed. ResultsCompared with baseline before treatment, ISI and PSQI scores decreased at weeks 4, 8, and 12, while MoCA scores increased at weeks 4, 8, and 12. FSS scores decreased at weeks 4 and 12. At weeks 8 and 12, GAD-7 scores, DAS28-CRP scores, duration of morning stiffness, TJC28, and SJC28 were reduced. At week 12, PHQ-9, pain VAS, and HAQ scores significantly decreased (P<0.05). FSS and DAS28-CRP scores at week 12 were lower than those at week 4, and CRP levels at week 8 were lower than those at week 4 (P<0.05). Compared with the historical control group, the treatment group showed superior improvement in ISI and PSQI scores (P<0.001); however, no statistically significant differences were observed between the two groups in DAS28-CRP or pain VAS scores (P>0.05). No serious adverse events occurred during the study, and the 4 reported mild adverse events were all considered unrelated to the study medication. ConclusionShuhe Granules significantly improve sleep quality, fatigue, emotional status, cognitive function, RA-related symptoms, and joint function in patients with RA comorbid insomnia, with good safety and tolerability.
4.Protective effect of paravertebral nerve block combined with general anesthesia on postoperative liver injury in patients undergoing laparoscopic hepatectomy
Yuxi SONG ; Xiao XU ; Xian GAO ; Jiaxiang DUAN ; Jing WEN ; Jiaolin NING
Journal of Army Medical University 2025;47(7):720-727
Objective To investigate the protective effect of paravertebral nerve block combined with general anesthesia on liver injury after laparoscopic hepatectomy(LH).Methods A randomized controlled trial was conducted on 51 patients undergoing LH in our hospital between April and August 2024.They were randomly divided into control group(n=25,general anesthesia)and paravertebral block group(n=26,paravertebral nerve block before general anesthesia induction).Beside anesthesia,they received same other medical treatment.The following indicators were compared between the 2 groups,that is,serum levels of alanine aminotransferase(ALT),aspartate aminotransferase(AST),total bilirubin(TBIL)and albumin(ALB),and systemic-immune inflammation(SII)index within 7 d before and on the 1st and 2nd days after surgery;heart rate and mean arterial pressure(MAP)before anesthesia induction(T1),before pneumoperitoneum establishment(T2),pneumoperitoneum establishment(T3),and at the first hilar occlusion(T4);usages of intraoperative norepinephrine,sevoflurane,and analgesic drugs 24 h postoperatively;as well as operation time,extubation time,and lengths of postanesthesia care unit(PACU)stay and hospital stay.Results The paravertebral block group had significantly lower ALT on the 1st day after surgery[178.40(126.55,325.86)vs 292.20(197.20,468.95)U/L],SII on the 2nd day after surgery[704.13(486.61,1 078.59)vs 1 075.09(753.80,1 614.38)],and amount of analgesic drugs in 24 h after surgery[29.70(27.37,32.07)vs 31.99(28.92,40.81)mg],and decreased MAP level at T3 and T4,early extubation,and shorter lengths of PACU stay and hospital stay when compared with the control group(all P<0.05).Conclusion Paravertebral nerve block combined with general anesthesia can reduce inflammatory responses,relieve postoperative pain,stabilize hemodynamics for patients undergoing LH,and thereby alleviate postoperative liver injury in them.
5.Cost-utility analysis of benmelstobart plus anlotinib and chemotherapy as first-line treatment for extensive-stage small cell lung cancer
Bing FENG ; Ning GAO ; Shengnan GAO ; Yuxi ZHANG ; Ranran ZHANG ; Guoqiang LIU
China Pharmacy 2025;36(5):579-583
OBJECTIVE To evaluate the cost-utility of benmelstobart combined with anlotinib and chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) from the perspective of China’s healthcare system. METHODS Based on the data from the ETER 701 study, a partitioned survival model was constructed with a cycle of 3 weeks to simulate the total cost, quality-adjusted life years (QALY), and incremental cost-effectiveness ratio (ICER) over 10 years for patients with ES- SCLC treated with benmelstobart plus anlotinib and chemotherapy, or chemotherapy alone. One-way sensitivity analysis and probability sensitivity analysis were performed to verify the robustness of the simulation results. The willingness-to-pay (WTP) threshold was set at 3 times the per capita gross domestic product (GDP) of China in 2023, which amounted to 268 074 yuan/QALY. RESULTS Compared with chemotherapy alone, benmelstobart combined with anlotinib and chemotherapy gained 0.438 QALY more at the cost of 403 505.55 yuan more, with an ICER of 922 031.37 yuan/QALY, which was higher than the WTP threshold set in this study. One-way sensitivity analysis showed that benmelstobart’s cost and utility value of the progression-free survival state had a greater impact on the ICER value; probabilistic sensitivity analysis confirmed the robustness of the model; only when the price of benmelstobart was reduced by 75.4%, the combined regimen would be cost-effective. CONCLUSIONS The first-line treatment of ES-SCLC with benmelstobart combined with anlotinib and chemotherapy is not cost-effective from the perspective of China’s healthcare system at present.
6.Compound Xishu Granules Inhibit Proliferation of Hepatocellular Carcinoma Cells by Regulating Ferroptosis
Yuan TIAN ; Yuxi WANG ; Zhen LIU ; Yuncheng MA ; Hongyu ZHU ; Xiaozhu WANG ; Qian LI ; Jian GAO ; Weiling WANG ; Wenhui XU ; Ting WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):37-45
ObjectiveTo study the mechanism of compound Xishu granules (CXG) in inhibiting the proliferation of hepatocellular carcinoma cells by regulating ferroptosis. MethodsThe transplanted tumor model of human Huh7 was established with nude mice and the successfully modeled mice were randomized into model, Fufang Banmao (0.21 g·kg-1), low-dose (1.87 g·kg-1) CXG, medium-dose (3.74 g·kg-1) CXG, and high-dose (7.49 g·kg-1) CXG groups. Mice were administrated with drinking water or CXG for 28 days, and the body weight and tumor volume were measured every 4 days. Hematoxylin-eosin staining was employed to observe the histopathological changes of tumors. The cell-counting kit-8 (CCK-8) was used to examine the survival rate of Huh7 cells treated with different concentrations (0, 31.25, 62.5, 125, 250, 500, 1 000 mg·L-1) of CXG for 24 h and 48 h. CA-AM, DCFH-DA, and C11-BODIPY581/591 fluorescent probes were used to determine the intracellular levels of ferrous ion (Fe2+), reactive oxygen species (ROS), and lipid peroxide (LPO), respectively. The colorimetric method was employed to measure the levels of glutathione (GSH) and superoxide dismutase (SOD). Western blot was employed to determine the protein levels of glutathione peroxidase 4 (GPX4), transferrin receptor 1 (TFR1), and ferritin heavy chain 1 (FTH1), respectively. ResultsIn the animal experiment, compared with the model group, the drug treatment groups showed reductions in the tumor volume from day 12 (P<0.01). After treatment, the Fufang Banmao and low-, medium-, and high-dose CXG groups had lower tumor volume, relative tumor volume, and tumor weight than the model group (P<0.05), with tumor inhibition rates of 48.99%, 79.93%, 91.38%, and 97.36%, respectively. Moreover, the CXG groups had lower tumor volume and relative tumor volume (P<0.05 in all the three dose groups) and lower tumor weight (P<0.05 in medium-dose and high-dose groups) than the Fufang Banmao group. Compared with the model group, the drug treatment groups showed reduced number of tumor cells, necrotic foci with karyopyknosis, nuclear fragmentation, and nucleolysis, and the high-dose CXG group showed an increase in the proportion of interstitial fibroblasts. In the cell experiment, compared with the blank group, CXG reduced the survival rate of Huh7 cells in a dose-dependent manner after incubation for 24 h and 48 h (P<0.05). Compared with the blank group, the RSL3 group and the low-, medium-, and high-dose CXG groups showed a decrease in the relative fluorescence intensity of CA-AM and increases in the fluorescence intensity of DCFH-DA and fluorescence ratio of C11-BODIPY581/591, which indicated elevations in the levels of Fe2+ (P<0.01), ROS (P<0.05), and LPO (P<0.01), respectively. Compared with the blank group, the RSL3 and low-, medium-, and high-dose CXG groups showed lowered levels of GSH and SOD (P<0.05). In addition, the RSL3 group and the medium- and high-dose CXG groups showed down-regulated expression of GPX4 and FTH1 (P<0.05), and the low- and high-dose CXG groups presented up-regulated expression of TFR1 (P<0.05). ConclusionCXG suppresses the proliferation of hepatocellular carcinoma cells by inducing ferroptosis via downregulating the GSH-GPX4 signaling axis and increasing intracellular Fe2+and LPO levels.
7.Efficacy and Mechanism of Shuanghua Drink in Treating Primary Dysmenorrhea Based on COX-2/NF-κB Signaling Pathway
Yuncheng MA ; Yuanyuan SHI ; Zhen LIU ; Yuxi WANG ; Yuan TIAN ; Qian LI ; Xiaozhu WANG ; Cheng HE ; Wenhui XU ; Weiling WANG ; Jian GAO ; Ting WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):72-80
ObjectiveTo evaluate the efficacy of Shuanghua drink in treating primary dysmenorrhea in the rat model and explore its mechanism of action. MethodsAn oxytocin-induced writhing mouse model was established to evaluate the analgesic effect of Shuanghua drink. Forty-eight non-pregnant female institute of cancer research (ICR) mice were randomly divided into six groups, including a blank group, a model group, an ibuprofen group (85.00 mg·kg-1), a low-dose group of Shuanghua drink (7.14 mL·kg-1), a medium-dose group of Shuanghua drink (14.28 mL·kg-1), and a high-dose group of Shuanghua drink (28.57 mL·kg-1). Each group consisted of eight mice. All treatment groups received daily intragastric administration at corresponding doses for 10 consecutive days. One hour after the final administration, 2 U of oxytocin was intraperitoneally injected per mouse. The writhing latency and number of writhing within 20 minutes were recorded. A primary dysmenorrhea rat model was established by using estradiol benzoate and oxytocin to evaluate the inhibitory effect of Shuanghua drink on the contraction of uterine smooth muscle. Forty-eight non-pregnant female Sprague-Dawley (SD) rats were divided into six groups, including a blank group, a model group, an ibuprofen group (51.00 mg·kg-1), a low-dose group of Shuanghua drink (4.28 mL·kg-1), a medium-dose group of Shuanghua drink (8.57 mL·kg-1), and a high-dose group of Shuanghua drink (17.10 mL·kg-1). Each group consisted of eight rats. Rats received subcutaneous injections of estradiol benzoate for 10 consecutive days to enhance uterine sensitivity. On the eleventh day, oxytocin (2 U/rat) was intraperitoneally administered to induce abnormal uterine contractions for establishing the primary dysmenorrhea model. All treatment groups received daily intragastric administration from the second day of modeling for 10 days. The effects of Shuanghua drink were evaluated by using parameters including uterine motility and the variation rate of uterine motility. The mechanism of action was investigated in rats with primary dysmenorrhea. The content of prostaglandin F2α (PGF2α), prostaglandin E2 (PGE2), thromboxane B2 (TXB2), prostacyclin metabolite (6-keto-PGF1α), and β-endorphin (β-EP) in uterine tissue of rats was detected by using enzyme-linked immunosorbent assay (ELISA). The changes in the content of nitric oxide (NO) and inducible nitric oxide synthase (iNOS) were analyzed via colorimetric assay. Western blot was performed to determine the content of phosphorylated inhibitor of kappa B kinase beta (p-IKKβ)/IKKβ, phosphorylated inhibitor of kappa B alpha (p-IκBα), IκBα, phosphorylated p65 (p-p65), p65, and cyclooxygenase-2 (COX-2) proteins in uterine tissue of rats. ResultsIn the oxytocin-induced writhing mouse model, the model group exhibited significantly shortened writhing latency and increased writhing frequency compared to the control group (P<0.01). Both the ibuprofen group and the high-dose group of Shuanghua drink displayed prolonged writhing latency (P<0.05), while the ibuprofen group and the low-dose, medium-dose, and high-dose groups of Shuanghua drink exhibited reduced writhing frequency (P<0.01). In the primary dysmenorrhea rat model, the uterine motility and its variation rate in the model group were significantly higher than those in the blank group (P<0.01). These parameters were markedly suppressed by ibuprofen and Shuanghua drink at all tested doses (P<0.01). For the mechanism of action, the model group showed significantly increased PGF2α/PGE2, TXB2/6-keto-PGF1α, NO, and iNOS in uterine tissue (P<0.05, P<0.01) and significantly decreased β-EP (P<0.01). These parameters were significantly attenuated in the ibuprofen group and the low-dose, medium-dose, and high-dose groups of Shuanghua drink. The PGF2α/PGE2 (P<0.01), TXB2/6-keto-PGF1α (P<0.01), NO (medium-dose group P<0.05), and iNOS (P<0.01) were reduced, and the β-EP (medium-dose group P<0.05) was up-regulated. Compared to the model group, the ibuprofen group and medium-dose group of Shuanghua drink showed significantly increased content of β-EP in the serum of rats (P<0.05). Compared to the blank group, the model group showed significantly elevated expressions of COX-2, p-IKKβ/IKKβ, p-IκBα/IκBα, and p-p65/p65 proteins (P<0.01) and significantly reduced anti-inflammatory protein IκBα (P<0.05). Compared to the model group, the ibuprofen group and the low-dose, medium-dose, and high-dose groups of Shuanghua drink showed significantly reduced expressions of COX-2 (P<0.01), p-IKKβ/IKKβ (P<0.01), p-IκBα/IκBα (P<0.05, P<0.01), and p-p65/p65(P<0.01) and up-regulated expression of IκBα protein (P<0.05, P<0.01). ConclusionShuanghua drink effectively alleviates primary dysmenorrhea through analgesia and suppression of abnormal contractions of uterine smooth muscle. Its mechanism may be mediated by reduced levels of PGF2α/PGE2, TXB2/6-keto-PGF1α, iNOS, and NO, elevated β-EP level, and inhibited COX-2/NF-κB signaling pathway.
8.Efficacy and Mechanism of Shuanghua Drink in Treating Primary Dysmenorrhea Based on COX-2/NF-κB Signaling Pathway
Yuncheng MA ; Yuanyuan SHI ; Zhen LIU ; Yuxi WANG ; Yuan TIAN ; Qian LI ; Xiaozhu WANG ; Cheng HE ; Wenhui XU ; Weiling WANG ; Jian GAO ; Ting WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):72-80
ObjectiveTo evaluate the efficacy of Shuanghua drink in treating primary dysmenorrhea in the rat model and explore its mechanism of action. MethodsAn oxytocin-induced writhing mouse model was established to evaluate the analgesic effect of Shuanghua drink. Forty-eight non-pregnant female institute of cancer research (ICR) mice were randomly divided into six groups, including a blank group, a model group, an ibuprofen group (85.00 mg·kg-1), a low-dose group of Shuanghua drink (7.14 mL·kg-1), a medium-dose group of Shuanghua drink (14.28 mL·kg-1), and a high-dose group of Shuanghua drink (28.57 mL·kg-1). Each group consisted of eight mice. All treatment groups received daily intragastric administration at corresponding doses for 10 consecutive days. One hour after the final administration, 2 U of oxytocin was intraperitoneally injected per mouse. The writhing latency and number of writhing within 20 minutes were recorded. A primary dysmenorrhea rat model was established by using estradiol benzoate and oxytocin to evaluate the inhibitory effect of Shuanghua drink on the contraction of uterine smooth muscle. Forty-eight non-pregnant female Sprague-Dawley (SD) rats were divided into six groups, including a blank group, a model group, an ibuprofen group (51.00 mg·kg-1), a low-dose group of Shuanghua drink (4.28 mL·kg-1), a medium-dose group of Shuanghua drink (8.57 mL·kg-1), and a high-dose group of Shuanghua drink (17.10 mL·kg-1). Each group consisted of eight rats. Rats received subcutaneous injections of estradiol benzoate for 10 consecutive days to enhance uterine sensitivity. On the eleventh day, oxytocin (2 U/rat) was intraperitoneally administered to induce abnormal uterine contractions for establishing the primary dysmenorrhea model. All treatment groups received daily intragastric administration from the second day of modeling for 10 days. The effects of Shuanghua drink were evaluated by using parameters including uterine motility and the variation rate of uterine motility. The mechanism of action was investigated in rats with primary dysmenorrhea. The content of prostaglandin F2α (PGF2α), prostaglandin E2 (PGE2), thromboxane B2 (TXB2), prostacyclin metabolite (6-keto-PGF1α), and β-endorphin (β-EP) in uterine tissue of rats was detected by using enzyme-linked immunosorbent assay (ELISA). The changes in the content of nitric oxide (NO) and inducible nitric oxide synthase (iNOS) were analyzed via colorimetric assay. Western blot was performed to determine the content of phosphorylated inhibitor of kappa B kinase beta (p-IKKβ)/IKKβ, phosphorylated inhibitor of kappa B alpha (p-IκBα), IκBα, phosphorylated p65 (p-p65), p65, and cyclooxygenase-2 (COX-2) proteins in uterine tissue of rats. ResultsIn the oxytocin-induced writhing mouse model, the model group exhibited significantly shortened writhing latency and increased writhing frequency compared to the control group (P<0.01). Both the ibuprofen group and the high-dose group of Shuanghua drink displayed prolonged writhing latency (P<0.05), while the ibuprofen group and the low-dose, medium-dose, and high-dose groups of Shuanghua drink exhibited reduced writhing frequency (P<0.01). In the primary dysmenorrhea rat model, the uterine motility and its variation rate in the model group were significantly higher than those in the blank group (P<0.01). These parameters were markedly suppressed by ibuprofen and Shuanghua drink at all tested doses (P<0.01). For the mechanism of action, the model group showed significantly increased PGF2α/PGE2, TXB2/6-keto-PGF1α, NO, and iNOS in uterine tissue (P<0.05, P<0.01) and significantly decreased β-EP (P<0.01). These parameters were significantly attenuated in the ibuprofen group and the low-dose, medium-dose, and high-dose groups of Shuanghua drink. The PGF2α/PGE2 (P<0.01), TXB2/6-keto-PGF1α (P<0.01), NO (medium-dose group P<0.05), and iNOS (P<0.01) were reduced, and the β-EP (medium-dose group P<0.05) was up-regulated. Compared to the model group, the ibuprofen group and medium-dose group of Shuanghua drink showed significantly increased content of β-EP in the serum of rats (P<0.05). Compared to the blank group, the model group showed significantly elevated expressions of COX-2, p-IKKβ/IKKβ, p-IκBα/IκBα, and p-p65/p65 proteins (P<0.01) and significantly reduced anti-inflammatory protein IκBα (P<0.05). Compared to the model group, the ibuprofen group and the low-dose, medium-dose, and high-dose groups of Shuanghua drink showed significantly reduced expressions of COX-2 (P<0.01), p-IKKβ/IKKβ (P<0.01), p-IκBα/IκBα (P<0.05, P<0.01), and p-p65/p65(P<0.01) and up-regulated expression of IκBα protein (P<0.05, P<0.01). ConclusionShuanghua drink effectively alleviates primary dysmenorrhea through analgesia and suppression of abnormal contractions of uterine smooth muscle. Its mechanism may be mediated by reduced levels of PGF2α/PGE2, TXB2/6-keto-PGF1α, iNOS, and NO, elevated β-EP level, and inhibited COX-2/NF-κB signaling pathway.
9.Cost-effectiveness analysis of sacituzumab tirumotecan versus single-agent chemotherapy in second-line and later-line treatment for metastatic triple-negative breast cancer
Ranran ZHANG ; Yuxi ZHANG ; Shengnan GAO ; Bing FENG ; Ning GAO ; Guoqiang LIU
China Pharmacy 2025;36(16):2024-2029
OBJECTIVE To evaluate the cost-effectiveness of sacituzumab tirumotecan (ST) versus chemotherapy treatment physician’s choice (TPC) as second-line and later-line treatment for metastatic triple-negative breast cancer (mTNBC) from the perspective of China’s healthcare system. METHODS A partitioned survival model was constructed based on the OptiTROP-Breast 01 trial, with a cycle length of 4 weeks and a time horizon of 10 years, applying a 5% discount rate. Quality adjusted life year (QALY) and costs were used as outcome measures, and the incremental cost-effectiveness ratio (ICER) of ST versus TPC for second-line and later-line treatment of mTNBC was calculated. Sensitivity analyses were conducted to validate the robustness of the base-case results. RESULTS At a willingness-to-pay threshold (WTP) of 3 times China’s 2024 per capita gross domestic product (GDP) (287 247 yuan/QALY), patients receiving ST gained incremental utility (0.42 QALY) at a higher cost, yielding an ICER of 205 562.07 yuan/QALY, which was lower than WTP, indicating that ST was more cost-effective compared to TPC. One-way sensitivity analysis revealed that key factors influencing the ICER included the utility value of progression-free survival and the price of ST. Probabilistic sensitivity analysis and scenario analysis showed that the base-case results were robust. CONCLUSIONS From the perspective of China’s healthcare system, at a WTP of 3 times China’s per capita GDP, ST is more cost-effective than TPC as second-line and later-line treatment for mTNBC.
10.Ginkgo biloba extract EGb761 mitigates ischemic stroke via metabolic pathway modulation
Xiaoyao Liu ; Yuan Tian ; Wenhui Xu ; Yuxi Wang ; Zhen Liu ; Yuncheng Ma ; Weiling Wang ; Jian Gao ; Ting Wang
Journal of Traditional Chinese Medical Sciences 2025;2025(1):13-23
Objective:
To confirm the therapeutic efficacy of the ginkgo biloba extract EGb761 on ischemic stroke and elucidate its underlying mechanism.
Methods:
Male Sprague-Dawley rats were divided into three groups: sham, model, and EGb761 (ginkgo biloba extract). Ischemic stroke was then simulated in rats via embolic middle cerebral artery occlusion surgery, with the extract administered half an hour before surgery. Neurological deficit scores, infarct volume, cerebral edema rate, and inflammatory factors served as the primary metrics for drug efficacy. Serum metabolites were analyzed using 1H-nuclear magnetic resonance to elucidate the operative mechanism.
Results:
Treatment with the ginkgo biloba extract EGb761 significantly ameliorated the neurological deficit scores (P = .0343), diminished the cerebral infarct volume (P = .0001) and cerebral edema rate (P = .0030), and alleviated neuroinflammation (all P < .05) in middle cerebral artery occlusion rats. In addition, it significantly altered the contents of various metabolites, such as 2-hydroxybutyrate, isoleucine, isopropanol, isobutyric acid, N6-acetyllysine, glutamate, glutamine, methionine, and N,N-dimethylglycine (all P < .05). Enrichment analysis of the differential metabolites indicated that EGb761 may be involved in the regulation of amino acid metabolism, betaine metabolism, glucose-alanine cycle, Warburg effect, and urea cycle.
Conclusion
The ginkgo biloba extract EGb761 demonstrates anti-ischemic stroke effect on ischemic stroke model rats by regulating amino acids and amino acid derivatives, such as isoleucine, N6-acetyllysine, glutamate, methionine, and N,N-dimethylglycine.


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