1.Expert Consensus on Clinical Application of Qidong Yixin Oral Liquid
Changkuan FU ; Xiaochang MA ; Mingjun ZHU ; Yue DENG ; Hongxu LIU ; Mingxue ZHANG ; Ying CHEN ; Yan ZHOU ; Ling ZHANG ; Jianhua FU ; Wei YANG ; Yu'er HU ; Ming CHEN ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(4):147-158
The prescription of Qidong Yixin oral liquid is derived from the experience of national medical master Ren Jixue in treating viral myocarditis (VMC). It has the functions of tonifying Qi, nourishing the heart,calming the mind, and relieving palpitations. It is used to treat VMC and angina pectoris of coronary heart disease caused by deficiency of both Qi and Yin. However,the understanding of its efficacy evidence, advantageous aspects, dosage and administration, and medication safety remains insufficient in clinical practice. Therefore,the development of the Expert Consensus on the Clinical Application of Qidong Yixin Oral Liquid (hereinafter referred to as consensus) was initiated. Consensus strictly followed the process and methods of the expert consensus on the clinical application of Chinese patent medicines of the China Association of Chinese Medicine,successively completing multiple tasks such as the consensus project initiation,determination of clinical problems,evidence search and evaluation,formation of recommendation opinions and consensus suggestions,solicitation of opinions,peer review, submission for review and release, and so on. Consensus formed a total of 10 recommendation opinions and 12 consensus suggestions,clarifying the clinical positioning,efficacy advantages,syndrome differentiation,dosage and administration,combination therapy,timing of medication,adverse reactions,contraindications, and precautions of Qidong Yixin oral liquid,indicating that it has good clinical advantages and safety in the treatment of VMC and angina pectoris of coronary heart disease,providing norms and references for physicians to safely and rationally apply Qidong Yixin oral liquid. Consensus was reviewed and approved for release by the Standardization Office of the China Association of Chinese Medicine on December 23, 2024. Standard number:GSCACM-376-2024.
2.A Case of Multidisciplinary Treatment for a Patient with Gorham-Stout Disease
Jing HU ; Ying JIN ; Yan ZHANG ; Ji LI ; Wenhui WANG ; Yue CHI ; Chunxu LI ; Zhenjie ZHANG ; Yaping LIU ; Xiaotian CHU ; Jin XU ; Min SHEN
JOURNAL OF RARE DISEASES 2026;5(1):52-59
Gorham-Stout disease(GSD) is a rare osteolytic disorder characterized by spontaneous and progressive osteolysis, along with abnormal angiogenesis and lymphangiogenesis, with no new bone formation. We present a case of a 15-year-old female admitted due to " recurrent right leg pain for 5 years, 11 months after undergoing right femoral fracture surgery". Through comprehensive integration of the patient's clinical phenotype, laboratory tests, imaging findings, pathological examinations, and molecular biological test results, GSD was considered highly likely. A multidisciplinary treatment approach was conducted, including a combination of zoledronic acid and sirolimus to inhibit osteolysis, along with rehabilitation training and orthopedic intervention, providing a personalized and comprehensive treatment strategy.
3.Pharmacoeconomic evaluation of zolbetuximab combined with chemotherapy as first-line treatment for CLDN18.2-positive and HER2-negative advanced gastric cancer
Ying HUANG ; Su LI ; Yan WANG ; Danxue HUANG
China Pharmacy 2026;37(7):920-926
OBJECTIVE To evaluate the cost-effectiveness of zolbetuximab combined with chemotherapy as first-line treatment for CLDN18.2-positive and HER2-negative advanced gastric cancer from the perspective of China’s healthcare system. METHODS Based on individual data from the GLOW clinical trial involving CLDN18.2-positive and HER2-negative patients with advanced gastric cancer, a comparison was made between the zolbetuximab combined with chemotherapy regimen and the chemotherapy alone regimen. A dynamic Markov model was employed for simulation, with a cycle length of 21 days and a time horizon of ten years. A cost-utility analysis was employed, with both costs and health outcomes discounted at an annual rate of 5%. The primary outcome measures included total cost, quality-adjusted life years (QALY) and incremental cost-effectiveness ratio (ICER), with the willingness-to-pay (WTP) threshold set at three times China’s per capita gross domestic product in 2024 (287 247 yuan/QALY). One-way analysis and probabilistic sensitivity analysis were performed to assess the robustness of the model. Furthermore, scenario analysis and threshold analysis were conducted to explore the impact of drug price adjustments on cost-effectiveness and the threshold price. RESULTS Compared with the chemotherapy alone regimen, the ICER of zolbetuximab combined with chemotherapy was 2 611 943.00 yuan/QALY. One-way sensitivity analysis indicated that the utility value of the progression free survival, the cost of zolbetuximab and body surface area were the three most influential parameters affecting the ICER. The results of the probabilistic sensitivity analysis showed that when the WTP threshold was set at 2 617 450 yuan/QALY, the probability that the combined regimen was cost-effective approached 50%. Scenario analysis revealed that only when the price of zolbetuximab was reduced to 10% of the baseline price did the ICER of the combined regimen fall below the aforementioned WTP threshold. Threshold analysis further indicated that when the unit price of zolbetuximab dropped to 3.81 yuan/mg, the probability of the combination regimen being cost-effective was approximately 50%. CONCLUSIONS From the perspective of China’s healthcare system, zolbetuximab combined with chemotherapy regimen as first-line treatment for CLDN18.2-positive and HER2-negative advanced gastric cancer is not cost-effective compared with chemotherapy alone regimen. When the unit price of zolbetuximab drops to 3.81 yuan/mg or below, the regimen becomes cost-effective.
4.Establishment and application of the method for plasma concentration determination of lamotrigine,levetiracetam and perampanel in children with epilepsy
Wenlin SONG ; Ying ZHOU ; Haoran CHEN ; Ziyue LIN ; Yan LI ; Jie LIU ; Taiwei JIN ; Xuqiang ZHOU
China Pharmacy 2026;37(10):1313-1317
OBJECTIVE To establish a method for simultaneous determination of plasma concentration of lamotrigine(LTG), levetiracetam(LEV) and perampanel(PER) in children with epilepsy and apply this method in clinical practice. METHODS Plasma proteins were precipitated with acetonitrile. Using PER-D 5 as internal standard, ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method was adopted. The determination was performed on ACQUITY UPLC HSS T3 C 18 column with mobile phase consisted of 0.1% formic acid with 5 mmol/L ammonium acetate-acetonitrile (gradient elution) at the flow rate of 0.3 mL/min. The column temperature was 40 ℃, and sample size was 5 μL. The analysis time was 5 min. The electrospray ionization source and multiple reaction monitoring mode were used for positive ion scanning. The ion pairs used for quantitative analysis of LTG, LEV, PER and internal standard were m / z 255.9→144.9, m / z 171.1→126.1, m / z 350.1→219.0 and m / z 354.9→220.2, respectively. The steady-state trough concentrations of the aforementioned drugs in the plasma of 14 pediatric epilepsy patients receiving combination therapy were determined using the same UPLC-MS/MS method as above. RESULTS The linear ranges of LTG, LEV and PER were 0.15-24 μg/mL ( R 2 >0.993), 0.312 5-50 μg/mL ( R 2 >0.997) and 6.25-1 000 ng/mL ( R 2 >0.997), respectively. The lower limits of quantification were 0.15 μg/mL, 0.312 5 μg/mL and 6.25 ng/mL, respectively. RSDs of intraday and interday precision tests of the three drugs were no more than 9.83%, and the accuracies (relative errors) were between -9.33% and 13.72%( n =6 or n =18); the average extraction recovery rates were 86.4%-97.9%, and the average matrix effects were 86.9%-110.0% ( n =6). The absolute values of the relative errors in the stability tests were all below 15%. The steady-state trough concentrations of LTG, LEV and PER were (5.64±4.03)μg/mL, (10.67±8.78)μg/mL and(450.20±251.27)ng/mL, respectively; the rates of achieving target trough concentrations were 71.4%, 37.5% and 84.6%, respectively. CONCLUSIONS The established UPLC-MS/MS method is specific, rapid and suitable for the plasma concentration monitoring in epileptic children receiving combination therapy.
5.A Nomogram for Predicting Metachronous Gastric Cancer After Endoscopic Submucosal Dissection of Early Gastric Cancer Following Successful Helicobacter pylori Eradication
Shangtao MAO ; Miao LIU ; Tao ZHAO ; Qiong YAN ; Ying XIANG ; Hai WU ; Wenjun LI ; Hongji TAO ; Duanming ZHUANG ; Lei WANG ; Guifang XU
Journal of Gastric Cancer 2026;26(2):279-294
Purpose:
Due to the preservation of the entire stomach after endoscopic resection, the occurrence of metachronous gastric cancer (MGC) remains a possibility. In this study, we investigated the incidence and risk factors for MGC in patients with early gastric cancer who underwent endoscopic submucosal dissection (ESD) and successfully eradicatedHelicobacter pylori.
Materials and Methods:
A retrospective analysis was conducted of 1,191 patients who underwent ESD and successfully eradicated H. pylori at the Affiliated Drum Tower Hospital of Nanjing University. Endoscopic surveillance was performed at 3, 6, and 12 months post-resection, and annually thereafter. MGC was defined as the development of a new cancer at a site other than the primary gastric cancer site, at least 1 year after the initial endoscopic resection.
Results:
A total of 77 patients were diagnosed with MGC during a median follow-up of 41.5 months. Kaplan-Meier analysis showed a 5-year cumulative incidence of MGC of 9.4% after successful H. pylori eradication. Multivariate analysis of the training set using Cox proportional hazards models identified male sex, severe atrophic gastritis, multiple gastric cancers before H. pylori eradication, and smoking history as independent risk factors for MGC.The nomogram exhibited favorable discrimination, with area under the curves of 0.767 and 0.822 in the training set and 0.724 and 0.745 in the testing set at 3 and 5 years, respectively.
Conclusions
Patients with gastric cancer who undergo endoscopic resection, even after successful H. pylori eradication, should undergo annual and continuous endoscopic surveillance for MGC.
6.Identification and infection rate of densovirus in Culex pipiens pallens in Beijing in 2023
Xiu-yan XU ; Ting YAN ; Si-jie ZHU ; Jing LI ; Mei-de LIU ; Hong-jiang ZHANG ; Ting LIU ; Qiu-hong LI ; Xiao-jie ZHOU ; Ying TONG ; Yong ZHANG
Acta Parasitologica et Medica Entomologica Sinica 2026;33(1):25-30
Objective This study conducted molecular biological identification of the viruses carried by Culex pipiens pallens specimens collected in Shunyi District, Beijing in 2023, and observed the changes in the infection rate of the viruses carried by Cx. pipiens pallens at different collection times. Methods Cx. pipiens pallens were collected using carbon dioxide mosquito traps. The mosquito samples were ground in batches and analyzed by molecular biology technologies. The virus infection rate at different collection times was analyzed statistically. Results 17 strains of Culex pipiens pallens densovirus(CppDNV)were identified from Cx. pipiens pallens samples collected in Shunyi District, Beijing, in 2023. The nucleotide sequence analysis of the virus genome coding region showed that CppDNV was a single-stranded DNA virus with a total length of 3 335 nt, encoding 2 non-structural proteins(NS1, NS2)and 1 capsid protein(VP). The nucleotide(amino acid)sequence lengths of the three proteins were 2 376 nt(791 aa),1 092 nt(363 aa)and 1 071 nt(356 aa), respectively. Phylogenetic analysis showed that CppDNV was located in genus Brevihamaparvovirus. Statistical analysis showed no significant difference in infection rates across collection times(χ2=4.429, P=0.194). Conclusions CppDNV was identified in Cx. pipiens pallens in Beijing, and it was stably maintained in this natural population.
7.Investigation of mosquito species and breeding sources of larvae in the rice planting area of Beijing
Ting YAN ; Xiu-yan XU ; Jing LI ; Xiao-jie ZHOU ; Yong ZHANG ; Ying TONG
Acta Parasitologica et Medica Entomologica Sinica 2026;33(1):49-52
Objective To investigate the species composition of mosquitoes and breeding conditions of larvae in the rice planting areas of Beijing, and to provide a scientific basis for mosquito control in rice fields. Methods Adult mosquitoes were collected using CO2-baited light traps, and mosquito larvae(including pupae)were sampled via the dipping method. Results A total of 4 genera and 6 species of adult mosquitoes were captured in the study area. The dominant species were Culex pipiens pallens, Cx. tritaeniorhynchus, and Anopheles sinensis. The average adult mosquito density was 5.11 specimens per trap-hour, with slightly lower density in July compared to August. For larvae and pupae,3 genera and 4 species were identified, dominated by Cx. tritaeniorhynchus, An. sinensis, and Aedes vexans. Conclusions The mosquito species composition in Beijing′s rice planting areas is diverse. Mosquito control strategies should prioritize the management of adult mosquitoes, while density control of mosquito larvae in paddy fields can be achieved through intermittent irrigation techniques.
8.Effect of Anzi Tiaochong Decoction Combined with Aspirin on Peripheral Blood CD19+CD24hiCD27+ Regulatory B Cells in Patients with Obstetric Antiphospholipid Syndrome (Pattern of Kidney Deficiency and Blood Stasis)
Yan CHEN ; Jia LI ; Suning HUANG ; Ying ZHAO ; Yan NING
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(18):189-196
ObjectiveTo observe the clinical efficacy of Anzi Tiaochong decoction combined with aspirin and the effects of this therapy on the peripheral blood phospholipid antibody titers, coagulation function, and CD19+CD24hiCD27+regulatory B (Breg) cells in patients with obstetric antiphospholipid syndrome (OAPS) (pattern of kidney deficiency and blood stasis). MethodsPatients who meet the inclusion criteria were randomly allocated into an observation group (50 patients, with 4 patients dropped out and 46 patients completed) and a control group (50 patients, with 2 patients dropped out, 1 patient excluded, and 47 patients completed) through a random number table method. The control group was treated with aspirin enteric-coated tablets, 75 mg/time, once a day, and the observation group with Anzi Tiaochong decoction, 1 bag/day on the basis of the therapy in the control group. The treatment course for both groups was 8 weeks, and the patients were followed up for 4 weeks. The traditional Chinese medicine (TCM) symptom scores, titers of peripheral blood phospholipid antibodies [anti-cardiolipin antibody IgM (ACA IgM), anti-cardiolipin antibody IgG (ACA IgG), anti-β2-glycoprotein 1 antibody IgM (β2GP1-IgM), and anti-β2-glycoprotein 1 antibody IgG (β2GP1-IgG)], D-dimer (D-D), thromboelastography parameters [clotting factor activity (R), platelet function maximum amplitude (MA), coagulation composite index (CI), and clot strength (G)], CD19+CD24hiCD27+ Breg expression rate, and adverse drug reactions were recorded for the two groups before and after treatment. ResultsAfter treatment, both groups showed decreased ACA IgM, ACA IgG, β2GP1-IgM, β2GP1-IgG, D-D, MA, and G (P<0.05) and increased R (P<0.05). There was no statistically significant difference in CI. Compared with the control group, the observation group showed more significant decreases in TCM symptom scores and phospholipid antibody titers (P<0.05). After treatment, the expression rate of Breg in the observation group was higher than that before treatment (P<0.05).There was no significant difference in Breg expression rate before and after treatment in the control group. Neither group experienced significant adverse reactions. ConclusionAnzi Tiaochong decoction combined with aspirin can alleviate the symptoms, reduce the phospholipid antibody titers, and restore the coagulation status of patients with obstetric antiphospholipid syndrome (pattern kidney deficiency and blood stasis). It may exert the therapeutic effects by regulating Breg to maintain the patient's immune balance.
9.Construction and application of a comprehensive evaluation system for oral Chinese patent medicines in children
Sichao YAN ; Jingtai CHEN ; Weixin ZENG ; Tao YANG ; Jianliang LI ; Ying CHEN ; Guofeng PAN
China Pharmacy 2026;37(18):2357-2362
OBJECTIVE To construct a comprehensive evaluation system for oral Chinese patent medicines in children that is compatible with pediatric physiological characteristics and the features of traditional Chinese medicine (TCM), and provide a basis for the selection, pharmaceutical management, and medical insurance procurement of oral Chinese patent medicines in children.METHODS According to the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs ( 2021 Trial Edition ) and related policy documents and literatures, six first-level indicators were determined: safety, efficacy, suitability, economy, accessibility, and innovation. An initial indicator pool was constructed through literature retrieval, policy text analysis, and semi-structured expert interviews. A preliminary survey using a 5-point Likert scale was conducted to determine the primary indicator list. Two rounds of Delphi expert consultation were carried out. The analytic hierarchy process (AHP) was used to determine the weights and scores of indicators at all levels, and the methodological quality of the questionnaire and reliability were evaluated. Five oral Chinese patent medicines for pediatric respiratory diseases were selected for empirical evaluation. Two independent blinded reviewers scored the medicines, and the Kappa value was calculated to evaluate inter-rater consistency.RESULTS Both rounds of Delphi consulting had 21 experts, with a positive coefficient of 100% and an authoritative coefficient of 0.89. The Kendall’s W coefficients of concordance for the first and second rounds of Delphi expert consultation were 0.812 and 0.856, respectively ( P <0.01). The consistency ratios of all AHP judgment matrices ranged from 0.032 to 0.087 (all <0.10). The Cronbach’s α coefficient was 0.847. A comprehensive evaluation system for oral Chinese patent medicines in children was established, comprising 6 first-level indicators, 25 second-level indicators, and 78 third-level indicators. The weights of the first-level indicators were 0.32, 0.24, 0.16, 0.13, 0.10 and 0.05, respectively, for safety, effectiveness, suitability, economy, accessibility and innovation. The empirical evaluation showed that Xiao’er chiqiao qingre granules obtained the highest comprehensive score (90.8 points), followed by Xiao’er feire kechuan oral liquid (86.3 points), Ertong qingfei oral liquid (82.8 points), Xiao’er xiaoji zhike oral liquid (82.0 points), and Jinzhen oral liquid (81.5 points). The inter-rater consistency Kappa value was 0.91.CONCLUSIONS The comprehensive evaluation system for oral Chinese patent medicines in children constructed in this study, includes 12 pediatric-specific third-level indicators and integrates key evaluation points of both traditional Chinese and Western medicine. It demonstrates good consistency and reliability, with good operability and reproducibility.
10.Analysis of Volatile Component Variations in Coptidis Rhizoma Processed with Euodiae Fructus Juice by HS-SPME-GC-MS Combined with Chemometrics and ROAV
Lin YAN ; Yun WANG ; Puling LI ; Lingbang MENG ; Zhe JIA ; Ying LI ; Ying LIU ; Min JIN ; Cun ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(21):218-225
ObjectiveTo analyze the volatile components in raw Coptidis Rhizoma, Euodiae Fructus juice-processed Coptidis Rhizoma (Yuhuanglian), and the processing adjuvant Euodiae Fructus juice, identify marker volatile components in the processed product, and elucidate the material basis changes during the processing with Euodiae Fructus juice. MethodsHeadspace solid-phase microextraction coupled with gas chromatography-quadrupole-time-of-flight mass spectrometry (HS-SPME-GC-Q-TOF-MS) was employed to analyze the volatile components in raw Coptidis Rhizoma, Yuhuanglian, and Euodiae Fructus juice. Chemometric analysis was performed to compare volatile components among samples and screen the marker components. Finally, the relative odor activity value (ROAV) was calculated to investigate odor characteristics. ResultsA total of 127 components were detected, with 27, 75, 84 volatile components identified in Euodiae Fructus juice, raw Coptidis Rhizoma, and Yuhuanglian, respectively. Processing with Euodiae Fructus juice significantly increased the number and content of volatile components. Chemometric analysis revealed significant changes in volatile components among the three sample types, allowing clear discrimination. After processing, 39 components such as methyl octanoate and allyl propionate were introduced, while 34 components including furfural and hexanoic acid increased in content, and 11 components including butyric acid and octanal decreased. Additionally, eight components, including zingiberene, 6-methyl-6-hepten-2-one, and 5-methyl-2-hexanone, were screened as marker components of Yuhuanglian. Moreover, processing enhanced the ROAV values of 2,5-dimethylpyrazine (roasted, nutty, coffee-like aroma), 3-ethylphenol, and guaiacol (smoky, woody aroma). Additionally, it incorporated 1-hepten-3-one from Euodiae Fructus juice and the newly generated 1-hexen-3-one, contributing mushroom and cucumber-like odors. The sensory profile of Yuhuanglian integrated nutty, roasted, smoky, and woody notes with the citrus and fruity aroma originally contributed by octanal. ConclusionThe processing with Euodiae Fructus juice introduced components from adjuvant, significantly altering the volatile component profile and enhancing the sensory odor characteristics of Yuhuanglian. This study provides a valuable reference for exploring the material basis of volatile components and establishing processing specifications for Yuhuanglian.


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