1.Establishment of graded management standards for off-label use of Shenqi fuzheng injection
Min WU ; Mei YU ; Shengnan YIN ; Dongmei LIU
China Pharmacy 2026;37(5):650-654
OBJECTIVE To establish the graded management standards for off-label use of Shenqi fuzheng injection. METHODS Systematic searches were conducted in databases including CNKI, PubMed and the Cochrane Library to retrieve guidelines/consensuses, systematic reviews/meta-analyses, and randomized controlled trials (RCTs) of Shenqi fuzheng injection. The quality of evidence was evaluated using AGREE Ⅱ, AMSTAR Ⅱ, and the Risk of Bias 1.0 tool recommended by Cochrane Collaboration, and the graded management standard for off-label use of Shenqi fuzheng injection was developed by using the Thomson grading system. RESULTS A total of 534 articles were involved, including 11 guidelines, 22 systematic reviews/meta-analysis, and 501 RCTs. They covered 79 off-label indications for Shenqi fuzheng injection: cancer-related fatigue, colorectal cancer and breast cancer, all with high-quality evidence were classified under grade A management (grade Ⅰ commendation), allowing all physicians across the hospital to prescribe relevant treatments; five diseases, such as ovarian cancer, liver cancer, leukemia, heart failure and cerebral infarction, were classified under grade B management (grade Ⅱa commendation), with prescription restricted to physicians with intermediate or higher professional titles in specific departments; eleven diseases, including sepsis, cervical cancer, esophageal cancer, etc., were classified under grade C management (grade Ⅱb commendation), requiring strict evaluation by senior physicians before prescription; the use of Shenqi fuzheng injection for other conditions was explicitly prohibited due to a lack of sufficient evidence. CONCLUSIONS Off-label use of Shenqi fuzheng injection is prevalent. The graded management standard established by evidence-based medical approach provides a scientific basis for standardizing the clinical application of traditional Chinese medicine injections and offers an operable paradigm for implementing differentiated drug use supervision in medical institutions.
2.Mechanism of Shenqi Dihuangtang in Blocking Renal Fibrosis Injury in Diabetic Kidney Disease Mediated by Epithelial-mesenchymal Transition Through Inhibiting TGF-β1/Smad Signaling Axis
Liangjing LIU ; Haolan LIU ; Xiaoling MAO ; Min YU ; Weitong YAN ; Chao LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(7):32-45
ObjectiveThis paper aims to study the potential active compound components and action mechanism of Shenqi Dihuangtang in the treatment of diabetic kidney disease (DKD) through network pharmacology and in vivo experimental verification. MethodsUltra-high-performance liquid chromatography-Q-exactive orbitrap mass spectrometry (UPLC-Q-Exactive Orbitrap MS) technology was used to clarify the main active chemical components of Shenqi Dihuangtang, and it was combined with network pharmacology methods such as gene ontology (GO) functional annotations and Kyoto encyclopedia of genes and genome (KEGG) to predict the potential action mechanism of Shenqi Dihuangtang in treating DKD. Subsequently, the DKD model of db/db male mice was established, and the mice were randomly divided into model group, low-dose Shenqi Dihuangtang group (6.10 g·kg-1), medium-dose Shenqi Dihuangtang group (12.19 g·kg-1), high-dose Shenqi Dihuangtang group (24.38 g·kg-1), and daplizin group (1.25 mg·kg-1). During the same period, C57BL/6J male mice were selected into normal group and received drug intervention for 8 weeks, respectively. During this period, the body weight and fasting blood glucose (FBG) of the mice were dynamically monitored, and oral glucose tolerance test (OGTT) and insulin tolerance test (ITT) were performed at the end of dosing. The levels of serum creatinine (SCr), blood urea nitrogen (BUN), uric acid (UA), albumin (ALB), and total protein (TP) were measured by an automatic biochemical analyzer, and 24-hour urine protein was measured by a urine protein quantitative kit. Hematoxylin-eosin (HE), periodic-acid Schiff (PAS), and Masson staining were employed to observe the renal histopathology. The expression of nephrotic protein Nephrin was observed by immunohistochemistry. Western blot was used to detect the expression of epithelial-mesenchymal transition (EMT)-related proteins such as TGF-β1, Smad2/3, α-smooth muscle actin (α-SMA), neural-cadherin (N-Cadherin), and snail protein. ResultsUPLC-Q-Exactive Orbitrap MS identified 384 active compounds in the aqueous extract of Shenqi Dihuangtang. According to oral bioavailability≥30% and the five drug-like principles, 44 key active ingredients were screened out, and 169 intersection targets highly correlated with DKD were matched. Among them, there was a significant interaction relationship between tumor necrosis factor(TNF), interleukin(IL)-6, protein kinase B(Akt)1, Caspase-3, Jun proto-oncogene (JUN), hypoxia inducible factor-1α(HIF-1α), B cell lymphoma-2(Bcl-2), matrix metallopeptidase-9(MMP-9), IL-1β, and TGF-β1. GO functional annotations were significantly enriched in cellular components such as membrane rafts, membrane microdomains, and collagen-containing extracellular matrix, molecular functions such as DNA-binding transcription factor binding, R-Smad binding, and Smad protein binding, as well as biological processes such as reactions to lipopolysaccharides(LPS), reactions to bacteria-derived molecules, and wound healing. The KEGG pathway was significantly enriched in lipids and atherosclerosis, TGF-β signaling pathway, phosphatidylinositol 3 kinase (PI3K)/Akt signaling pathway, etc. In vivo experimental results showed that the high-dose Shenqi Dihuangtang group could significantly reduce FBG levels in db/db mice (P<0.01), improve OGTT (P<0.01) and ITT (P<0.01) levels, reduce SCr (P<0.01), BUN (P<0.01), UA (P<0.01) and 24-hour BUN (P<0.01), and increase ALB (P<0.01) and TP (P<0.01) levels. Pathological staining confirmed that the high-dose Shenqi Dihuangtang group could significantly reduce the glomerular mesangial matrix area and collagen deposition (P<0.01) and upregulate the positive expression rate of Nephrin (P<0.01). Western blot results showed that the high-dose Shenqi Dihuangtang group significantly downregulated the expression of TGF-β1 (P<0.01) and Smad2/3 (P<0.01) signal molecules and inhibited the protein levels of α-SMA (P<0.01), N-Cadherin (P<0.01), and Snail (P<0.01). ConclusionShenqi Dihuangtang can inhibit the TGF-β1/Smad signaling axis and block the renal EMT process, thereby improving DKD renal fibrosis damage. Further analysis of its key active components and clinical transformation pathways is needed in the future.
3.Disease-syndrome Combination Animal Models in Andrology of Traditional Chinese Medicine: A Review and Prospects
Jigang CAO ; Jianxiong LIU ; Min XIAO ; Xiaocui JIANG ; Aidi LIANG ; Xingyu JIANG ; Yanyan ZHOU ; Xiaoming YU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(13):303-314
The disease-syndrome combination animal model in traditional Chinese medicine (TCM) andrology serves as an important bridge linking TCM theory with modern medical research, providing a key experimental platform for elucidating the 'syndrome-disease' correlation mechanism in male-specific diseases and for screening effective prescriptions. This article reviews recent progress in animal model research on common TCM andrological diseases, including prostatic diseases, sexual dysfunction, and male infertility, with a focus on analyzing the application, advantages, and disadvantages of various modeling strategies, such as immune induction, hormonal intervention, and multi-factor combination across different syndrome types. However, despite breakthroughs in model construction techniques, current research still faces several challenges, including insufficient standardization of syndrome differentiation and difficulties in quantifying TCM-specific indicators. Future studies need to optimize model evaluation systems by integrating modern technologies, in order to promote the standardization and internationalization of TCM andrology research.
4.Cage design-centric glider approach to full-endoscopic lumbar fusion: optimizing nerve root protection in facet-sparing and facet-resecting techniques
Yu-Chia HSU ; Hao-Chun CHUANG ; Yuan-Fu LIU ; Chao-Jui CHANG ; Yu-Meng HSIAO ; Yi-Hung HUANG ; Keng-Chang LIU ; Chien-Min CHEN ; Hyeun-Sung KIM ; Cheng-Li LIN
Asian Spine Journal 2026;20(2):343-353
Endoscopic transforaminal lumbar interbody fusion (TLIF) offers substantial advantages in the management of degenerative spinal diseases, including accelerated postoperative recovery. However, its technical complexity and steep learning curve pose risks for nerve root injury. Optimizing nerve root protection in full-endoscopic facet-sparing TLIF (FE fs-TLIF) and full-endoscopic facet-resecting TLIF (FE fr-TLIF) is essential for enhancing surgical safety. This study aimed to improve the nerve root protection in FE fs-TLIF and FE fr-TLIF by optimizing cage glider selection and insertion techniques based on the specific cage shape—banana-shaped or bullet-shaped. The goal was to ensure safe cage positioning and mitigate nerve root injury during discectomy, endplate preparation, and cage insertion. These strategies were validated through cadaveric simulations and clinical implementation. In FE fr-TLIF utilizing bullet-shaped (straight) cages, one-tip and two-tip cage gliders effectively protected the traversing nerve root by facilitating medial cage entry, thereby minimizing irritation of the exiting nerve root. Conversely, in FE fr-TLIF with banana-shaped cages, the lateral tilt of the cage holder during implantation required the use of a two-tip cage glider to protect the traversing and exiting nerve roots, thereby mitigating the potential risk of nerve irritation. In FE fs-TLIF, a one-tip cage glider is preferred for safeguarding the exiting nerve root, while the traversing root is inherently protected by the medial wall of the facet joint. The use of a two-tip cage glider in FE fs-TLIF can cause injury to the nerve root during glider insertion. In addition to the selection of cage gliders, improper cage insertion steps can also contribute to postoperative neurapraxia. The appropriate selection of cage gliders with corresponding insertion techniques is critical for nerve root protection in endoscopic TLIF. Tailoring these choices to the specific approach (FE fs-TLIF or FE fr-TLIF) and cage type (banana or bullet) enhances surgical safety and clinical outcomes.
5.Analysis on the Theory and Application of"Shuanggu Yitong"Acupuncture in the Treatment of Urinary Incontinence After Radical Prostate Cancer Surgery
Yu ZHANG ; Qianni LIU ; Wei LU ; Song WU ; Fengxia LIANG ; Yunsong YANG ; Min ZHAO
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(9):2738-2744
Urinary incontinence is the most common complication after radical prostatectomy.Traditional Chinese medicine treatments for this disease,such as acupuncture,are diverse and have definite therapeutic effects.The disease is located in the bladder,and its etiology and pathogenesis are mostly related to the dysfunction of the kidney,spleen,triple energizer and other viscera.In view of the insufficiency of kidney essence,decline of the gate of vitality fire(mingmen fire),Qi deficiency leading to impaired bladder containment,compounded by obstruction of meridians from pathogenic factors including blood stasis,damp-heat,and phlegm turbidity.The"Shuanggu Yitong"acupuncture achieves"Dual fortification"through tonifying the kidney and primordial qi consolidation,combined with spleen strengthening and qi supplementation.Additionally,"purging"targets the elimination of blood stasis,phlegm turbidity,damp-heat and other solid evils.This integrated approach combines acupuncture and moxibustion modalities with reinforcing-reducing needle manipulation techniques,simultaneously addressing both the symptoms and root causes of the problem.By coordinating pathogen elimination with constitutional regulation,this method demonstrates favorable therapeutic outcomes in clinical practice and is worthy of further clinical promotion.
6.Danlou tablet ameliorates lipid deposition in HepG2 cells by regulating oxidative stress
Zhiqi SONG ; Nan SONG ; Yu LIU ; Jingnan LIU ; Qun WANG ; Lianqun JIA ; Dongyu MIN
Journal of China Medical University 2025;54(10):865-868,882
Objective To investigate whether Danlou tablet-containing serum ameliorates lipid deposition in HepG2 cells by regulating oxidative stress.Methods Optimal treatment conditions,including concentration and exposure time of Danlou tablet and concentration of oleic acid,were determined,and their effects on cell viability were assessed using the CCK-8 assay.An in vitro model of lipid depo-sition was established by inducing HepG2 cells with oleic acid.HepG2 cells were divided into control,model(treated with oleic acid),and Danlou tablet groups(treated with oleic acid and Danlou tablet).Intracellular lipid droplets were visualized using oil red O staining.Lipid content including non-esterified fatty acid(NEFA)and triglyceride(TG),as well as oxidative stress markers in the cell supernatant,were quantified by enzyme-linked immunosorbent assay.Ultimately,reactive oxygen species(ROS)levels were measured using a fluores-cent probe.Results The optimal conditions were 10%Danlou tablet,24-hour treatment,and 800 μmol/L oleic acid.Compared with the control group,the model group exhibited significantly increased lipid droplet number and size,elevated supernatant levels of NEFA,TG,malondialdehyde,cyclooxygenase-2,and ROS(P<0.01),and decreased levels of catalase and superoxide dismutase(P<0.01).Compared with the model group,the Danlou tablet group showed reduced lipid deposition and oxidative stress markers,and increased antioxidant enzyme activity.Conclusion Danlou tablet may ameliorate oleic acid-induced lipid deposition in HepG2 cells by regulating oxidative stress response.
7.Research progress on mechanism of action of selective phosphodiesterase inhibitors in prevention and treatment of inflammatory bowel disease
Na GAO ; Yu WANG ; Zhen-hua LIU ; Wei-min YANG ; Chuang XIAO
Chinese Pharmacological Bulletin 2025;41(10):1813-1817
Inflammatory bowel disease(IBD)is a common di-gestive system disease with an increasing morbidity year by year.Its pathological mechanisms have not been fully clarified,and there are currently no ideal or effective curative methods.Phos-phodiesterase(PDE)can regulate intracellular cAMP/cGMP levels to mediate downstream signaling pathways,participating in various pathophysiological processes.In recent years,the po-tential efficacy of PDE inhibitors in the treatment of IBD has gradually attracted attention.This article reviews the pharmaco-logical effects and mechanisms of selective PDE subtype inhibi-tors in the prevention and treatment of IBD,providing references for further research of IBD therapeutic drugs.
8.A randomized,double-blind,placebo-controlled,multicenter clinical study of Shengxuebao Mixture in treating cancer-related anemia
Zhu LIU ; Xiangrong LI ; Xiaojun DAI ; Yanjun WANG ; Xiao LI ; Keqiong WANG ; Tao WU ; Miaowen ZHONG ; Hongjiang YU ; Ji FENG ; Zuowei HU ; Kainan LI ; Shaowei CHEN ; Chunhua LI ; Zhengchuan FU ; Rui ZHANG ; Yongfa CHEN ; Hongyu XU ; Tao REN ; Yibo YAO ; Jianxu JIN ; Pengyin WANG ; Zhijiang HE ; Jian SHEN ; Lei WANG ; Min LI ; Wenming CHANG ; Xinyi CHEN ; Li HOU
Journal of Beijing University of Traditional Chinese Medicine 2025;48(10):1447-1459
Objective We aimed to evaluate the efficacy and safety of Shengxuebao Mixture in the treatment of cancer-related anemia(CRA)presenting with syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood.Methods A randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted.Eligible patients with malignant tumors meeting the inclusion and exclusion criteria were enrolled from 26 hospitals,including Dongzhimen Hospital,Beijing University of Chinese Medicine,Xiaogan Central Hospital,and Yangzhou Hospital of Traditional Chinese Medicine,from June 1,2022,to September 30,2024.Patients were allocated 1:1 to either the experimental group receiving Shengxuebao Mixture or the control group receiving its simulator(placebo)using a block randomization method under double-blind conditions.Both groups received 15 mL orally three times daily for 28 consecutive days.The primary efficacy indicators included the hemoglobin(Hb)improvement rate(RHb)and the traditional Chinese medicine(TCM)syndrome improvement rate(RTCM)at week 4 of treatment.The secondary efficacy indicators encompassed Hb and red blood cell(RBC)count,Karnofsky Performance Status(KPS)score,TCM syndrome score,individual TCM symptom scores,and changes in each of these indicators compared to the baseline period at weeks 2,4,and 6 of treatment.Safety evaluations were conducted at week 4 of treatment.Results A total of 239 patients were enrolled,with 225 cases included in the Full Analysis Set(FAS)(109 in the experimental group vs.116 control group),163 in the Per Protocol Set(PPS)(77 vs.86),and 225 in the Safety Set(SS)(109 vs.116).Baseline characteristics between groups showed no significant differences.Significant differences were observed between the experimental and control groups in RHb at week 4(FAS:49.51%vs.35.24%,P<0.05;PPS:53.25%vs.36.05%,P<0.05)and RTCM at week 4(FAS:61.54%vs.39.62%,P<0.01;PPS:64.94%vs.40.70%,P<0.01).At weeks 2,4,and 6,the experimental group showed greater improvements in Hb and RBC counts than the control group.Additionally,the TCM syndrome scores were lower in the experimental group than in the control group at these time points.Except for week 2 in PPS,the KPS improvement was better in the experimental group than in the control group(P<0.05).The experimental group also demonstrated a greater reduction in scores for individual TCM symptoms such as spiritlessness and weakness,poor appetite and reduced food intake at weeks 4 and 6 compared to the control group(P<0.05,P<0.01).Furthermore,the reduction in vertigo score was more pronounced in the experimental group at week 6(P<0.01).For the score of pale and lusterless complexion,only in the PPS was the reduction from baseline more significant in the experimental group than in the control group at weeks 4 and 6(P<0.05).No significant differences were observed between the experimental and control groups in the incidence of all adverse events or drug-related adverse reactions.Conclusion Shengxuebao Mixture demonstrates significant efficacy in patients with CRA presenting syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood,effectively increasing Hb levels,ameliorating TCM syndromes,alleviating clinical symptoms,and enhancing functional status,with no significant difference in adverse drug reactions compared to the placebo.
9.Wheat-grain moxibustion at the Guanyuan point to regulate low testosterone and hypothalamic-pituitary-gonadal axis in naturally aged mice
Meng-fan CUI ; Bing-zhe MA ; Zhi-yang YIN ; Yu-tong QIAN ; Dan-li JIAO ; Shi-min LIU
National Journal of Andrology 2025;31(2):157-164
Objective:To investigate the effects of wheat-grain moxibustion at the Guanyuan point on testosterone(T)synthe-sis and the hypothalamic-pituitary-gonadal(HPG)axis in naturally aged mice.Methods:We fed 40 twelve-month-old SPF male C57BL/6J mice with a normal diet for 3 months,randomized them into a moxibustion and an aged group of an equal number,and se-lected 7 four-month-old ones as young controls.We treated the animals of the moxibustion group by wheat-grain moxibustion at the Guanyuan point,once 5 moxibustion sticks,qd,5 times a week,and fed those of the aged group normally,all for 12 weeks.After treatment,we obtained the testicular index of the mice,observed the histomorphology of the testis tissue by HE staining,measured the contents of T in the testis,gonadotropin-releasing hormone(GnRH)in the hypothalamus and total T(tT),free T(fT),luteinizing hormone(LH)and follicle-stimulating hormone(FSH)in the serum by ELISA,and determined the expressions of silence information regulator-1(SIRT1),P53,glutathione peroxidase(GPX4)and cholesterol side-chain?cleavage enzym e(CYP11A1)in the testis by Western blot.Results:Compared with the young controls,the mice in the aged group showed obviously losing and dull hair,energy declination,loose structure of the spermatogenic tubule with different degrees of cell loss and rupture,reduced testicular index,and ev-ident aging phenotype.In comparison with the aged mice,the animals of the moxibustion group were fairly energetic and exhibited dis-tinct structure of the spermatogenic tubules,orderly arranged and highly differentiated cells at all levels,significantly increased T lev-el,up-regulated expressions of SIRT1,GPX4 and CYP11 A1,and down-regulated expression of P53 in testis tissue,and elevated levels of GnRH,FSH,LH,tT and fT in the HPG axis.Conclusion:Wheat-grain moxibustion at the Guanyuan point protects testosterone synthesis in the testis tissue of naturally aged mice,promotes negative feedback regulation of the HPG axis,and improves low testoster-one.
10.Research advance in the mechanisms of myopia control with orthokeratology in adolescent
Renxiang TANG ; Yu CHENG ; Xiaolu ZHENG ; Wei YANG ; Min FU ; Bingqin LI ; Bo LIU
Recent Advances in Ophthalmology 2025;45(5):415-420
In recent years,the global prevalence of myopia has remained high,seriously endangering the eye health of adolescents.A large number of studies have confirmed that orthokeratology lens can control or delay the progression of my-opia and reduce the incidence of fundus lesions in high myopia.Although the efficacy of myopia control with orthokeratolo-gy has been widely recognized,its exact mechanism of action is still unclear,and there are many hypotheses.This paper re-views the role of factors such as accommodation,defocus,choroidal thickness,high-order aberrations and biomechanics in myopia control with orthokeratology,and explores how these factors jointly affect the development of myopia.

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