[Objective] To establish a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection. [Methods] By adding the sample and factor Ⅶ deficient plasma to the sample cup and activating the reaction with prothrombin time assay reagent (PT reagent), the coagulation time of the sample was determined by the change in magnetic bead swing amplitude in the sample cup. The logarithm of coagulation time was inversely proportional to the logarithm of human factor Ⅶa potency. [Results] Under the experimental conditions, the specificity of the methodology was evaluated through spiked recovery, and the recovery rates ranged from 90.0% to 110.0%. Within the range from 0.125 to 1.000 IU/mL, there was a good linear response between the potency and coagulation time of the standard and sample, with correlation coefficients r>0.99. As for the accuracy and repeatability, the recovery rates of various concentrations detected in the stock solution were 101.0%, 100.0% and 112.0%, respectively, with RSD values of 2.6%, 4.0% and 0.0%, respectively. The recovery rates of various concentrations in finished product testing were 104.0%, 94.7% and 112.0%, respectively, with RSD values of 1.9%, 2.4% and 0.0%, respectively. As for the intermediate precision, the RSD were 4.5% and 3.7%, respectively. After treated with sample diluent, the sample was tested at room temperature for 6 hours and still exhibited relatively stable biological activity. [Conclusion] This detection method is accurate, stable, easy to operate and highly automated, and is suitable for detecting the potency of recombinant human coagulation factor Ⅶa for Injection.

OBJECTIVE: To evaluate the dynamic changes of glucocorticoid (GC) dose and the feasibility of GC discontinuation in rheumatoid arthritis (RA) patients under the background of Chinese medicine (CM). METHODS: This multicenter retrospective cohort study included 1,196 RA patients enrolled in the China Rheumatoid Arthritis Registry of Patients with Chinese Medicine (CERTAIN) from September 1, 2019 to December 4, 2023, who initiated GC therapy. Participants were divided into the Western medicine (WM) and integrative medicine (IM, combination of CM and WM) groups based on medication regimen. Follow-up was performed at least every 3 months to assess dynamic changes in GC dose. Changes in GC dose were analyzed by generalized estimator equation, the probability of GC discontinuation was assessed using Kaplan-Meier curve, and predictors of GC discontinuation were analyzed by Cox regression. Patients with <12 months of follow-up were excluded for the sensitivity analysis. RESULTS: Among 1,196 patients (85.4% female; median age 56.4 years), 880 (73.6%) received IM. Over a median 12-month follow-up, 34.3% (410 cases) discontinued GC, with significantly higher rates in the IM group (40.8% vs. 16.1% in WM; P<0.05). GC dose declined progressively, with IM patients demonstrating faster reductions (median 3.75 mg vs. 5.00 mg in WM at 12 months; P<0.05). Multivariate Cox analysis identified age <60 years [P<0.001, hazard ratios (HR)=2.142, 95% confidence interval (CI): 1.523-3.012], IM therapy (P=0.001, HR=2.175, 95% CI: 1.369-3.456), baseline GC dose ⩽7.5 mg (P=0.003, HR=1.637, 95% CI: 1.177-2.275), and absence of non-steroidal anti-inflammatory drugs use (P=0.001, HR=2.546, 95% CI: 1.432-4.527) as significant predictors of GC discontinuation. Sensitivity analysis (545 cases) confirmed these findings. CONCLUSIONS RA patients receiving CM face difficulties in following guideline-recommended GC discontinuation protocols. IM can promote GC discontinuation and is a promising strategy to reduce GC dependency in RA management. (Trial registration: ClinicalTrials.gov, No. NCT05219214).
Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; Arthritis, Rheumatoid/drug therapy* ; Glucocorticoids/therapeutic use* ; Medicine, Chinese Traditional ; Retrospective Studies

Objective To observe the clinical efficacy of acupuncture at Neiyingxiang(EX-HN09)points combined with western medicine in the treatment of allergic rhinitis of deficiency-cold of lung qi type.Methods Sixty patients with deficiency-cold of lung qi type of allergic rhinitis were randomly divided into observation group and control group,with 30 patients in each group.The control group was treated with Desloratadine Tablets combined with Mometasone Furoate Aqueous Nasal Spray,and the observation group was treated with acupuncture at Neiyingxiang points combined with the self-made rhinitis recipe on the basis of the control group,and the clinical efficacy of the two groups was evaluated after 14 days.The changes of nasal symptom scores,Visual Analogue Scale(VAS)and rhinoconjunctivitis quality of life scores of the patients of the two groups were observed before and after the treatment.After 14 days of treatment,the clinical efficacy of the two groups was evaluated.The changes in nasal symptom scores,as well as VAS and rhinoconjunctivitis quality of life questionnaire(RQLQ)scores were observed before and after treatment.The changes in traditional Chinese medicine(TCM)sydnrome scores and serum immunoglobulin E(IgE)were compared before and after treatment in the two groups,and the safety of the two groups was evaluated.Results(1)The total effective rate of the observation group was 93.33%(28/30),and the control group was 73.33%(22/30).The efficacy of the observation group was superior to that of the control group,and the difference was statistically significant(P＜0.05).(2)After treatment,the symptoms of nasal congestion,sneezing,runny nose and nasal itching were significantly improved in the two groups(P＜0.01),and the observation group was significantly superior to the control group in improving nasal symptoms,and the differences were statistically significant(P＜0.05).(3)After treatment,the VAS scores of patients in the two groups were significantly improved(P＜0.01),and the observation group was superior to the control group in improving VAS scores,with statistically significant differences(P＜0.05).(4)After treatment,the PQLQ scores of patients in the two groups improved significantly(P＜0.01),and the observation group was significantly superior to the control group in improving the PQLQ scores,and the difference was statistically significant(P＜0.05).(5)After treatment,the TCM syndrome scores of the patients in the two groups were significantly improved(P＜0.01),and the observation group was significantly superior to the control group in improving TCM syndrome scores,with statistically significant differences(P＜0.05).(6)After treatment,the serum IgE levels of patients in the two groups were significantly improved(P＜0.01),and the observation group was significantly superior to the control group in improving serum IgE levels(P＜0.05),with a statistically significant difference.(7)There was no significant difference in the incidence of adverse reactions between the observation group and the control group(P＞0.05).Conclusion Acupuncture at Neiyingxiang points plus self-made rhinitis recipe combined with western medicine in the treatment of deficiency-cold of lung qi type of allergic rhinitis can significantly improve the clinical symptoms of the patients,thus improving the quality of life of the patients,and the therapeutic efficacy is remarkable.

In order to standardize the clinical diagnosis and treatment of upper airway cough syndrome (UACS) for children in China, Dongzhimen Hospital of Beijing University of Chinese Medicine and Affiliated Hospital of Liaoning University of Traditional Chinese Medicine initiated the development of this Traditional Chinese Medicine Diagnosis and Treatment Guidelines for Children with Upper Airway cough Syndrome based on evidence-based medical evidence. This guideline will process registration, write a plan, and develop relevant processes and writing norms, develop and publish official documents. This plan mainly introduces the scope of the guidelines, the purpose and significance, the composition of the guidelines working group, the management of conflicts of interest, the collection, selection and determination of clinical problems, the retrieval, screening and rating of evidence, and the consensus of recommendations. Registration information: This study has been registered in the international practice guidelines registry platform with the registration code of PREPARE-2023CN087.

Objective To investigate the effects of Huoxue Yiqi Decoction(composed of Carthami Flos,Crataegi Fructus,Salviae Miltiorrhizae Radix et Rhizoma,and Astragali Radix)combined with Pinggan Qianyang Muzu Powder(composed of Uncariae Ramulus cum Uncis,Prunellae Spica,Chrysanthemi Flos,Lonicerae Japonicae Flos and Cassiae Semen)on blood lipid metabolism and cardiac function in female patients with essential hypertension.Methods A total of 220 female patients with essential hypertension of qi deficiency and blood stasis type were randomly divided into observation group and control group,with 110 cases in each group.The control group was treated with conventional western medicine,and the observation group was treated with Huoxue Yiqi Decoction orally combined with Pinggan Qianyang Muzu Powder for foot bath on the basis of treatment for the control group.The course of treatment for the two groups covered one month.Before and after treatment,the two groups were observed in the changes of blood pressure,blood lipid,traditional Chinese medicine(TCM)syndrome scores and cardiac function indicators of left ventricular ejection fraction(LVEF)and stroke volume(SV).After treatment,the clinical efficacy of the two groups was evaluated.Results(1)After one month of treatment,the total effective rate of the observation group was 95.45%(105/110),and that of the control group was 84.55%(93/110).The intergroup comparison(tested by chi-square test)showed that the efficacy of the observation group was superior to that of the control group(P＜0.01).(2)After treatment,the TCM syndrome scores of primary symptoms and secondary symptoms in the two groups were decreased when compared with those before treatment(P＜0.05),and the decrease in the observation group was superior to that in the control group(P＜0.01).(3)After treatment,the levels of systolic blood pressure(SBP)and diastolic blood pressure(DBP)in the two groups were lower than those before treatment(P＜0.05),and the decrease of SBP and DBP levels in the observation group was significantly superior to that in the control group(P＜0.01).(4)After treatment,the levels of blood lipid indicators of total cholesterol(TC),triglyceride(TG)and low density lipoprotein cholesterol(LDL-C)in the two groups were lower than those before treatment(P＜0.05),and the levels of high density lipoprotein cholesterol(HDL-C)were higher than those before treatment(P＜0.05).The decrease of TC,TG and LDL-C levels and the increase of HDL-C level in the observation group were significantly superior to those in the control group(P＜0.01).(5)After treatment,the levels of cardiac function indicators of LVEF and SV in the two groups were higher than those before treatment(P＜0.05),and the increase of LVEF and SV levels in the observation group was significantly superior to that in the control group(P＜0.01).Conclusion The combination of Huoxue Yiqi Decoction and Pinggan Qianyang Muzu Powder exerts certain effect in the treatment of female patients with essential hypertension of qi deficiency and blood stasis type.The combined therapy is effective on controlling blood pressure,improving blood lipid metabolism and cardiac function indicators.

Objective To observe the clinical efficacy of ZHU's scalp acupuncture combined with Danzhi Xiaoyao San in the treatment of tinnitus of liver constraint transforming into fire type.Methods A total of 70 patients with tinnitus of liver constraint transforming into fire type were randomly divided into treatment group and control group,35 cases in each group.The treatment group was treated with ZHU's scalp acupuncture combined with Danzhi Xiaoyao San,and the control group was treated with Yinxingye Tablets and Mecobalamin Tablets.The course of treatment was three weeks.After three weeks of treatment,the clinical efficacy of the two groups was evaluated,and telephone follow-up was conducted at three and six months after the end of treatment to evaluate the clinical efficacy.The changes of Tinnitus Evaluation Scale(TEQ)Score and Self-Rating Anxiety Scale(SAS)score were observed before and after treatment in the two groups.The changes of Tinnitus Handicap Inventory(THI)scores were compared before and after treatment between the two groups.The safety and adverse reactions of the two groups were evaluated.Results(1)After treatment,the total effective rate of the treatment group was 88.57%(31/35),and that of the control group was 62.86%(22/35),and the therapeutic efficacy of the treatment group was superior to that of the control group,and the difference was statistically significant(P＜0.05).(2)After treatment,the TEQ,SAS,and THI scores of the two groups were significantly improved(P＜0.01),and the treatment group was significantly superior to the control group in improving TEQ,SAS,and THI scores,and the differences were statistically significant(P＜0.05).(3)At the 3-month follow-up after the end of treatment,the overall effective rate was 85.71%(30/35)in the treatment group and 60.00%(21/35)in the control group.At the 6-month follow-up after the end of treatment,the overall effective rate was 82.86%(29/35)in the treatment group and 54.29%(19/35)in the control group.At the 3-and 6-month follow-up after the end of treatment,the efficacy of the treatment group was superior to that of the control group,and the differences were statistically significant(P＜0.05).(4)No obvious adverse reactions were seen in the two groups of patients,and the difference in the incidence of adverse reactions between the two groups was not statistically significant(P＞0.05).Conclusion ZHU's scalp needling combined with Danzhi Xiaoyao San for the treatment of tinnitus of liver constraint transforming into fire type can significantly improve the tinnitus symptoms of patients,with high safety,no adverse reactions,and remarkable efficacy.

Analyzing polysorbate 20(PS20)composition and the impact of each component on stability and safety is crucial due to formulation variations and individual tolerance.The similar structures and polarities of PS20 components make accurate separation,identification,and quantification challenging.In this work,a high-resolution quantitative method was developed using single-dimensional high-performance liquid chromatography(HPLC)with charged aerosol detection(CAD)to separate 18 key components with multiple esters.The separated components were characterized by ultra-high-performance liquid chro-matography-quadrupole time-of-flight mass spectrometry(UHPLC-Q-TOF-MS)with an identical gradient as the HPLC-CAD analysis.The polysorbate compound database and library were expanded over 7-time compared to the commercial database.The method investigated differences in PS20 samples from various origins and grades for different dosage forms to evaluate the composition-process relationship.UHPLC-Q-TOF-MS identified 1329 to 1511 compounds in 4 batches of PS20 from different sources.The method observed the impact of 4 degradation conditions on peak components,identifying stable components and their tendencies to change.HPLC-CAD and UHPLC-Q-TOF-MS results provided insights into fingerprint differences,distinguishing quasi products.

Objective To explore the protective effect of Lycium barbanun glycopeptide(LbGP)against osteogenic inhibition induced by exosomes derived from human gingival fibroblasts(HGFs)exposed to radiation.Methods Cultured HGFs with or without LbGP pretreatment were exposed to 8 Gy X-ray radiation,and the changes in cell apoptosis,senescence and α-SMA level were detected using RT-qPCR,Western blotting and β-galactosidase staining.The exosomes secreted by the treated cells were extracted,and after identification by electron microscopy,particle size analysis and Western blotting,the exosomes were added into primary cultured bone mesenchymal stem cells(BMSCs),and osteoclast activity and osteogenesis in the cell cultures were detected by Trap staining,Alizarin red staining,ALP staining,RT-qPCR and Western blotting.Results In cultured HGFs,X-ray radiation significantly increased the percentage of senescent cells,which was obviously lowered by LbGP treatment.X-ray radiation significantly reduced Bcl-2/Bax ratio and increased α-SMA expression in HGFs,and these changes were significantly suppressed by LbGP pretreatment.In rat BMSCs,incubation with the exosomes derived from HGFs with radiation exposure caused a significant increase of osteoclasts,reduced calcium nodules and lowered alkaline phosphatase expression in the cells;The opposite changes were observed in the cells treated with exosomes from LbGP-pretreated HGFs,which also significantly increased the cellular expressions of the osteogenic genes(BMP2,ALP,and RUNX2)and proteins(ALP and RUNX2)as compared with the exosomes from irradiated HGFs.Conclusion LbGP can effectively inhibit osteoclast activity and promote osteogenesis by acting on exosomes secreted by irradiated HGFs,suggesting its potential value for treatment of osteoradionecrosis of the jaw.

Background::Although overnight fasting is recommended prior to endoscopic retrograde cholangiopancreatography (ERCP), the benefits and safety of high-carbohydrate fluid diet (CFD) intake 2 h before ERCP remain unclear. This study aimed to analyze whether high-CFD intake 2 h before ERCP can be safe and accelerate patients’ recovery.Methods::This prospective, multicenter, randomized controlled trial involved 15 tertiary ERCP centers. A total of 1330 patients were randomized into CFD group ( n = 665) and fasting group ( n = 665). The CFD group received 400 mL of maltodextrin orally 2 h before ERCP, while the control group abstained from food/water overnight (>6 h) before ERCP. All ERCP procedures were performed using deep sedation with intravenous propofol. The investigators were blinded but not the patients. The primary outcomes included postoperative fatigue and abdominal pain score, and the secondary outcomes included complications and changes in metabolic indicators. The outcomes were analyzed according to a modified intention-to-treat principle. Results::The post-ERCP fatigue scores were significantly lower at 4 h (4.1 ± 2.6 vs. 4.8 ± 2.8, t = 4.23, P <0.001) and 20 h (2.4 ± 2.1 vs. 3.4 ± 2.4, t= 7.94, P <0.001) in the CFD group, with least-squares mean differences of 0.48 (95% confidence interval [CI]: 0.26–0.71, P <0.001) and 0.76 (95% CI: 0.57–0.95, P <0.001), respectively. The 4-h pain scores (2.1 ± 1.7 vs. 2.2 ± 1.7, t = 2.60, P = 0.009, with a least-squares mean difference of 0.21 [95% CI: 0.05–0.37]) and positive urine ketone levels (7.7% [39/509] vs. 15.4% [82/533], χ2 = 15.13, P <0.001) were lower in the CFD group. The CFD group had significantly less cholangitis (2.1% [13/634] vs. 4.0% [26/658], χ2 = 3.99, P = 0.046) but not pancreatitis (5.5% [35/634] vs. 6.5% [43/658], χ2 = 0.59, P = 0.444). Subgroup analysis revealed that CFD reduced the incidence of complications in patients with native papilla (odds ratio [OR]: 0.61, 95% CI: 0.39–0.95, P = 0.028) in the multivariable models. Conclusion::Ingesting 400 mL of CFD 2 h before ERCP is safe, with a reduction in post-ERCP fatigue, abdominal pain, and cholangitis during recovery.Trail Registration::ClinicalTrials.gov, No. NCT03075280.

Objective To explore the protective effect of Lycium barbanun glycopeptide(LbGP)against osteogenic inhibition induced by exosomes derived from human gingival fibroblasts(HGFs)exposed to radiation.Methods Cultured HGFs with or without LbGP pretreatment were exposed to 8 Gy X-ray radiation,and the changes in cell apoptosis,senescence and α-SMA level were detected using RT-qPCR,Western blotting and β-galactosidase staining.The exosomes secreted by the treated cells were extracted,and after identification by electron microscopy,particle size analysis and Western blotting,the exosomes were added into primary cultured bone mesenchymal stem cells(BMSCs),and osteoclast activity and osteogenesis in the cell cultures were detected by Trap staining,Alizarin red staining,ALP staining,RT-qPCR and Western blotting.Results In cultured HGFs,X-ray radiation significantly increased the percentage of senescent cells,which was obviously lowered by LbGP treatment.X-ray radiation significantly reduced Bcl-2/Bax ratio and increased α-SMA expression in HGFs,and these changes were significantly suppressed by LbGP pretreatment.In rat BMSCs,incubation with the exosomes derived from HGFs with radiation exposure caused a significant increase of osteoclasts,reduced calcium nodules and lowered alkaline phosphatase expression in the cells;The opposite changes were observed in the cells treated with exosomes from LbGP-pretreated HGFs,which also significantly increased the cellular expressions of the osteogenic genes(BMP2,ALP,and RUNX2)and proteins(ALP and RUNX2)as compared with the exosomes from irradiated HGFs.Conclusion LbGP can effectively inhibit osteoclast activity and promote osteogenesis by acting on exosomes secreted by irradiated HGFs,suggesting its potential value for treatment of osteoradionecrosis of the jaw.