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 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 establish an analytical method for HPLC fingerprint chromatography of Simiao Junyi ointment to provide basis for the quality control standard. Methods:The separation conditions were established to obtain the HPLC fingerprint chromatog-raphy of the main ingredients in Simiao Junyi ointment. The conditions were as follows:the chromatographic column was Ultimate C18-ODS(250 mm ×4.6 mm,5 μm), the mobile phase was acetonitrile-0.1% phosphate solution, the flow rate was 1.0 ml·min-1, the detection wavelength was 280 nm, and the column temperature was 35℃. The common peaks in the chromatography were analyzed for their belongings. Results:Gradient elution was performed under the above optimal separation conditions, the constituents in Simiao Ju-nyi ointment were separated from each other perfectly, and the optimal fingerprint chromatography was obtained. Though the methodolo-gy examination, the indicators such as precision, stability and repeatability of the method were all promising, and the fingerprint chro-matography could be seen clearly and was easy to be analyzed. The relationships between Simiao Junyi ointment and the common peaks of four medicinal materials in the fingerprint chromatography were preliminary determined, which provided important basis for the quali-ty control of Simiao Junyi ointment. Conclusion:The HPLC fingerprint chromatography of Simiao Junyi ointment can be used as an a-nalysis method for the quality control of Simiao Junyi ointment, which provides reference for the quality control standard for the finished product.

Objective To explore the effect of comprehensive intervention on social function and quality of life of patients with bipolar disorder (BD) in maintenance treatment period.Methods A total of 83 patients with BD were assigned into intervention group (n=41) and control group (n=42).Based on the original drug treatment,the intervention group was given comprehensive intervention,including BD health education,drug self-management,serf-monitoring of symptoms,interpersonal skills,coping and relaxation skills,learning to seek help from medical staff and others.The control group was treated with simple drug therapy.Before grouping,at the end of the third month and twelfth month,Young Mania Rating Scale (YMRS),Hamilton Depression Scale 17 items (HAMD17),Social Disability Screening Schedule (SDSS),Short Form 36 items Health survey Questionnaire (SF-36) were assessed.Results There were no differences in YMRS,HAMD,SDSS total score between the two groups before grouping(P＞0.05).The score of YMRS in the intervention group ((0.59±1.45) was lower than that in the control group(2.07±3.87) at the end of the 12th month,the difference was statistically significant (P=0.024).The score of SDSS in the intervention group (1.63± 1.77,0.78± 1.78) were statistically lower than that in control group (3.57± 1.78,2.74± 1.27) at the end of the 3th and 12th month(P＜0.01).There were statistically differences between the two groups in rolephysical(RP) (t=2.858,P =0.005),role-emotional (RE) (t =2.956,P =0.005),social function (SF) (t =4.163,P＜0.01),vitality (VT) (t =5.150,P＜ 0.01),mental health (MH) (t =2.830,P=0.007),general health (GH) (t=4.055,P＜0.01),difference in reported health transition (HT) (t=-2.092,P=0.042)at the end of 3th month.The differences were statistically significant in RE (t =3.290,P =0.001),SF (t =2.876,P =0.006),VT(t=5.831,P＜0.01),MH(t=4.839,P＜0.01),GH(t=3.752,P＜0.01) at the end of 12th month between the two groups.Conclusion On the base of medicine treatment,comprehensive intervention can effectively improve the social function and life quality of patients with BD in maintenance treatment period.