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.

Objective To compare the effects of different doses of budesonide and formoterol fumarate powder for inhalation combined with montelukast sodium tablet in the treatment of cough variant asthma(CVA)and the improvement of airway function and inflammatory factors.Methods Elderly patients with cough variant asthma were randomly divided into group A and group B.Both groups of patients received budesonide and formoterol fumarate powder for inhalation combined with montelukast sodium tablet.Group A was given budesonide and formoterol fumarate powder for inhalation(Ⅱ),2 inhalation per time,twice a day;Group B was given budesonide and formoterol fumarate powder for inhalation,4 inhalation per time,twice a day;budesonide fumatrol inhalation powder mist for continuous treatment for 6 months,and montelukast sodium tablet 10 mg once a day for at least 3 months.The nighttime cough scores of the two groups were compared before treatment and after treatment.The percentage of forced expiratory volume in one second(FEV1)in the predicted value,the maximum mid expiratory flow(MMEF),the fractional exhaled nitric oxide(FeNO),interleukin-5(IL-5)and eosinophils were compared between the two groups.The incidence of adverse drug reactions and the recurrence rate within 1 year were compared between the two groups.Results A total of 45 cases were enrolled in both the group A and the group B.At 9 months after treatment,the nocturnal cough scores of the group A and the group B were(0.93±0.42)and(0.65±0.29)points,respectively;the percentage of FEV1 in the predicted value were(97.75±9.67)％and(100.93±11.06)％,respectively;the MMEF values were(2.81±1.04)and(3.08±1.09)L·s-1,respectively;the FeNO values were(18.94±9.75)and(15.94±7.96)ppb,respectively;the IL-5 levels were(10.88±7.06)and(8.11±5.56)pg·mL-1,respectively.The above indicators in group B showed statistically significant differences compared to group A(all P＜0.05).The total incidence of adverse drug reactions in group A and group B were 8.89％(5 cases/45 cases)and 13.33％(6 cases/45 cases),respectively.The recurrence rates was 15.56％(7 cases/45 cases)and 13.33％(6 cases/45 cases),respectively.There was no statistically significant difference in the above indicators between group B and group A(all P＞0.05).Conclusion For elderly patients with CVA,higher dose of budesonide and formoterol fumarate powder for inhalation combined with montelukast sodium tablet can better improve cough symptoms,reduce the level of airway hyperresponsiveness and inflammatory factors,reduce the recurrence rate,and the patients are well tolerated.

Objective To compare the effects of different doses of budesonide and formoterol fumarate powder for inhalation combined with montelukast sodium tablet in the treatment of cough variant asthma(CVA)and the improvement of airway function and inflammatory factors.Methods Elderly patients with cough variant asthma were randomly divided into group A and group B.Both groups of patients received budesonide and formoterol fumarate powder for inhalation combined with montelukast sodium tablet.Group A was given budesonide and formoterol fumarate powder for inhalation(Ⅱ),2 inhalation per time,twice a day;Group B was given budesonide and formoterol fumarate powder for inhalation,4 inhalation per time,twice a day;budesonide fumatrol inhalation powder mist for continuous treatment for 6 months,and montelukast sodium tablet 10 mg once a day for at least 3 months.The nighttime cough scores of the two groups were compared before treatment and after treatment.The percentage of forced expiratory volume in one second(FEV1)in the predicted value,the maximum mid expiratory flow(MMEF),the fractional exhaled nitric oxide(FeNO),interleukin-5(IL-5)and eosinophils were compared between the two groups.The incidence of adverse drug reactions and the recurrence rate within 1 year were compared between the two groups.Results A total of 45 cases were enrolled in both the group A and the group B.At 9 months after treatment,the nocturnal cough scores of the group A and the group B were(0.93±0.42)and(0.65±0.29)points,respectively;the percentage of FEV1 in the predicted value were(97.75±9.67)％and(100.93±11.06)％,respectively;the MMEF values were(2.81±1.04)and(3.08±1.09)L·s-1,respectively;the FeNO values were(18.94±9.75)and(15.94±7.96)ppb,respectively;the IL-5 levels were(10.88±7.06)and(8.11±5.56)pg·mL-1,respectively.The above indicators in group B showed statistically significant differences compared to group A(all P＜0.05).The total incidence of adverse drug reactions in group A and group B were 8.89％(5 cases/45 cases)and 13.33％(6 cases/45 cases),respectively.The recurrence rates was 15.56％(7 cases/45 cases)and 13.33％(6 cases/45 cases),respectively.There was no statistically significant difference in the above indicators between group B and group A(all P＞0.05).Conclusion For elderly patients with CVA,higher dose of budesonide and formoterol fumarate powder for inhalation combined with montelukast sodium tablet can better improve cough symptoms,reduce the level of airway hyperresponsiveness and inflammatory factors,reduce the recurrence rate,and the patients are well tolerated.

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.

AIM To establish an HPLC-MS/MS method for the simultaneous content determination of berberine,coptisine,gallic acid,corilagin,geniposide,toosendanin,rutinum,chlorogenic acid,luteolin,asiatica,emodin and astilbin in Tufuling Qiwei Powder.METHODS The analysis was performed on a 35℃ thermostatic Shim-pack GIST-HP C18 column (2.1 mm × 100 mm,3 μm),with the mobile phase comprising of methanol-water (containing 0.1％ formic acid) flowing at 0.25 mL/min in a gradient elution manner,and electron spray ionization source was adopted in negative and positive ion detection with multiple reaction monitoring mode.RESULTS Twelve constituents showed good linear relationships within their own ranges (r≥0.9990),whose average recoveries were 94.83％-104.42％ with the RSDs of 1.30％-4.88％.CONCLUSION This simple,rapid and accurate method can be used for the quality control of Tufuling Qiwei Powder.

Metabolic dysfunction-associated fatty liver disease (MAFLD) is an increasingly common liver disease worldwide. MAFLD is diagnosed based on the presence of steatosis on images, histological findings, or serum marker levels as well as the presence of at least one of the three metabolic features: overweight/obesity, type 2 diabetes mellitus, and metabolic risk factors. MAFLD is not only a liver disease but also a factor contributing to or related to cardiovascular diseases (CVD), which is the major etiology responsible for morbidity and mortality in patients with MAFLD. Hence, understanding the association between MAFLD and CVD, surveillance and risk stratification of MAFLD in patients with CVD, and assessment of the current status of MAFLD management are urgent requirements for both hepatologists and cardiologists. This Taiwan position statement reviews the literature and provides suggestions regarding the epidemiology, etiology, risk factors, risk stratification, nonpharmacological interventions, and potential drug treatments of MAFLD, focusing on its association with CVD.

Objectives: This study aimed to present the Asia-Pacific consensus on long-term and sequential therapy for osteoporosis, offering evidence-based recommendations for the effective management of this chronic condition.The primary focus is on achieving optimal fracture prevention through a comprehensive, individualized approach. Methods: A panel of experts convened to develop consensus statements by synthesizing the current literature and leveraging clinical expertise. The review encompassed long-term anti-osteoporosis medication goals, first-line treatments for individuals at very high fracture risk, and the strategic integration of anabolic and anti resorptive agents in sequential therapy approaches. Results: The panelists reached a consensus on 12 statements. Key recommendations included advocating for anabolic agents as the first-line treatment for individuals at very high fracture risk and transitioning to anti resorptive agents following the completion of anabolic therapy. Anabolic therapy remains an option for in dividuals experiencing new fractures or persistent high fracture risk despite antiresorptive treatment. In cases of inadequate response, the consensus recommended considering a switch to more potent medications. The consensus also addressed the management of medication-related complications, proposing alternatives instead of discontinuation of treatment. Conclusions This consensus provides a comprehensive, cost-effective strategy for fracture prevention with an emphasis on shared decision-making and the incorporation of country-specific case management systems, such as fracture liaison services. It serves as a valuable guide for healthcare professionals in the Asia-Pacific region, contributing to the ongoing evolution of osteoporosis management.

Objective To observe the effects of budesonide,glycopyrronium bromide and formoterol fumarate inhalation aerosol on lung function,inflammatory markers,and exercise tolerance in stable chronic obstructive pulmonary disease(COPD)patients.Methods Stable COPD patients were randomly divided into control group and treatment group.The treatment group inhaled budesonide,glycopyrronium bromide and formoterol fumarate inhalation aerosol,1 shovel per time,twice a day,once in the morning and once in the evening;respiratory function exercise for 15 minutes each time,bid.The control group was given budesonide and formoterol fumarate powder for inhalation(Ⅱ),1 shovel each time,bid.The respiratory function exercise method was the same as that of the treatment group.Both groups of patients were treated continuously for 3 months.Compare the clinical efficacy of two groups of patients after treatment,and compare the lung function[forced expiratory volume in one second(FEV1),percentage of FEV1 to expected value(FEV,％),FEV1/forced vital capacity(FVC)],inflammatory indicators[interleukin-6(IL-6),IL-10],immune function indicators[T lymphocyte subsets(CD3+CD4+,CD8+),CD4+/CD8+],exercise tolerance[6-minute walking distance(6MWD),peak oxygen uptake(VO2 peak),maximum metabolic equivalents(METs)],and safety evaluation.Results Fifty cases were enrolled in the treatment group,2 cases were dropped out,and ultimately 48 cases were included in the statistical analysis;50 cases were enrolled in the control group,2 cases were dropped out,and ultimately 48 cases were included in the statistical analysis.The total effective rates of the treatment group and the control group were 91.67％(44 cases/48 cases)and 75.00％(36 cases/48 cases),with significant difference(P＜0.05).After treatment,the FEV1 of the treatment group and the control group were(1.99±0.19)and(1.79±0.21)L,the FEV1％were(64.18±5.85)％and(59.81±5.02)％,the FEV1/FVC were 61.82±5.37 and 53.45±6.11,the IL-6 levels were(19.53±4.08)and(27.82±4.57)ng·L-1,the IL-10 levels were(22.49±3.71)and(17.69±3.05)ng·L-1,the CD3+levels were(67.11±5.09)％and(64.20±4.26)％,the CD4+levels were(38.76±2.89)％and(36.15±3.04)％,the CD8+levels were(27.28±2.35)％and(28.76±2.59)％,the CD4+/CD8+were 1.49±0.28and 1.30±0.22,the 6MWD were(421.07±31.46)and(391.89±30.44)m,the VO2peak were(20.22±1.47)and(17.66±1.41)mL·min-1·kg-1,the METs were 5.61±1.02 and 4.86±1.04,respectively,the differences were statistically significant(all P＜0.05).The adverse drug reactions in the treatment group included palpitations and headache;the adverse drug reactions in the control group included palpitations,headache and hoarseness.The total incidences of adverse drug reactions in the treatment group and the control group were 6.25％(3 cases/48 cases)and 6.25％(3 cases/48 cases),without statistically significant difference(P＞0.05).Conclusion Budesonide,glycopyrronium bromide and formoterol fumarate inhalation aerosol combined with respiratory function exercise has significant therapeutic effects and good safety in stable COPD patients.

Objective To observe the effects of budesonide,glycopyrronium bromide and formoterol fumarate inhalation aerosol on lung function,inflammatory markers,and exercise tolerance in stable chronic obstructive pulmonary disease(COPD)patients.Methods Stable COPD patients were randomly divided into control group and treatment group.The treatment group inhaled budesonide,glycopyrronium bromide and formoterol fumarate inhalation aerosol,1 shovel per time,twice a day,once in the morning and once in the evening;respiratory function exercise for 15 minutes each time,bid.The control group was given budesonide and formoterol fumarate powder for inhalation(Ⅱ),1 shovel each time,bid.The respiratory function exercise method was the same as that of the treatment group.Both groups of patients were treated continuously for 3 months.Compare the clinical efficacy of two groups of patients after treatment,and compare the lung function[forced expiratory volume in one second(FEV1),percentage of FEV1 to expected value(FEV,％),FEV1/forced vital capacity(FVC)],inflammatory indicators[interleukin-6(IL-6),IL-10],immune function indicators[T lymphocyte subsets(CD3+CD4+,CD8+),CD4+/CD8+],exercise tolerance[6-minute walking distance(6MWD),peak oxygen uptake(VO2 peak),maximum metabolic equivalents(METs)],and safety evaluation.Results Fifty cases were enrolled in the treatment group,2 cases were dropped out,and ultimately 48 cases were included in the statistical analysis;50 cases were enrolled in the control group,2 cases were dropped out,and ultimately 48 cases were included in the statistical analysis.The total effective rates of the treatment group and the control group were 91.67％(44 cases/48 cases)and 75.00％(36 cases/48 cases),with significant difference(P＜0.05).After treatment,the FEV1 of the treatment group and the control group were(1.99±0.19)and(1.79±0.21)L,the FEV1％were(64.18±5.85)％and(59.81±5.02)％,the FEV1/FVC were 61.82±5.37 and 53.45±6.11,the IL-6 levels were(19.53±4.08)and(27.82±4.57)ng·L-1,the IL-10 levels were(22.49±3.71)and(17.69±3.05)ng·L-1,the CD3+levels were(67.11±5.09)％and(64.20±4.26)％,the CD4+levels were(38.76±2.89)％and(36.15±3.04)％,the CD8+levels were(27.28±2.35)％and(28.76±2.59)％,the CD4+/CD8+were 1.49±0.28and 1.30±0.22,the 6MWD were(421.07±31.46)and(391.89±30.44)m,the VO2peak were(20.22±1.47)and(17.66±1.41)mL·min-1·kg-1,the METs were 5.61±1.02 and 4.86±1.04,respectively,the differences were statistically significant(all P＜0.05).The adverse drug reactions in the treatment group included palpitations and headache;the adverse drug reactions in the control group included palpitations,headache and hoarseness.The total incidences of adverse drug reactions in the treatment group and the control group were 6.25％(3 cases/48 cases)and 6.25％(3 cases/48 cases),without statistically significant difference(P＞0.05).Conclusion Budesonide,glycopyrronium bromide and formoterol fumarate inhalation aerosol combined with respiratory function exercise has significant therapeutic effects and good safety in stable COPD patients.

AIM To establish an HPLC-MS/MS method for the simultaneous content determination of berberine,coptisine,gallic acid,corilagin,geniposide,toosendanin,rutinum,chlorogenic acid,luteolin,asiatica,emodin and astilbin in Tufuling Qiwei Powder.METHODS The analysis was performed on a 35℃ thermostatic Shim-pack GIST-HP C18 column (2.1 mm × 100 mm,3 μm),with the mobile phase comprising of methanol-water (containing 0.1％ formic acid) flowing at 0.25 mL/min in a gradient elution manner,and electron spray ionization source was adopted in negative and positive ion detection with multiple reaction monitoring mode.RESULTS Twelve constituents showed good linear relationships within their own ranges (r≥0.9990),whose average recoveries were 94.83％-104.42％ with the RSDs of 1.30％-4.88％.CONCLUSION This simple,rapid and accurate method can be used for the quality control of Tufuling Qiwei Powder.