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 explore the association between lipid profiles and left ventricular hypertrophy in a Chinese general population. Methods We conducted a retrospective observational study to investigate the relationship between lipid markers [including triglycerides, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein (HDL) cholesterol, non-HDL-cholesterol, apolipoprotein A-I, apolipoprotein B, lipoprotein[a], and composite lipid profiles] and left ventricular hypertrophy. A total of 309,400 participants of two populations (one from Beijing and another from nationwide) who underwent physical examinations at different health management centers between 2009 and 2018 in China were included in the cross-sectional study. 7,475 participants who had multiple physical examinations and initially did not have left ventricular hypertrophy constituted a longitudinal cohort to analyze the association between lipid markers and the new-onset of left ventricular hypertrophy. Left ventricular hypertrophy was measured by echocardiography and defined as an end-diastolic thickness of the interventricular septum or left ventricle posterior wall > 11 mm. The Logistic regression model was used in the cross-sectional study. Cox model and Cox model with restricted cubic splines were used in the longitudinal cohort. Results In the cross-sectional study, for participants in the highest tertile of each lipid marker compared to the respective lowest, triglycerides [odds ratio (OR): 1.250, 95％CI: 1.060 to 1.474], HDL-cholesterol (OR: 0.780, 95％CI: 0.662 to 0.918), and lipoprotein(a) (OR: 1.311, 95％CI: 1.115 to 1.541) had an association with left ventricular hypertrophy. In the longitudinal cohort, for participants in the highest tertile of each lipid marker at the baseline compared to the respective lowest, triglycerides [hazard ratio (HR): 3.277, 95％CI: 1.720 to 6.244], HDL-cholesterol (HR: 0.516, 95％CI: 0.283 to 0.940), non-HDL-cholesterol (HR: 2.309, 95％CI: 1.296 to 4.112), apolipoprotein B (HR: 2.244, 95％CI: 1.251 to 4.032) showed an association with new-onset left ventricular hypertrophy. In the Cox model with forward stepwise selection, triglycerides were the only lipid markers entered into the final model. Conclusion Lipids levels, especially triglycerides, are associated with left ventricular hypertrophy. Controlling triglycerides level potentiate to be a strategy in harnessing cardiac remodeling but deserve to be further investigated.

Objective:To observe the clinical effect of Buyang huanwu decoction combined with hyperbaric oxygen therapy on acute cerebral infarction (ACI) of qi deficiency and blood stasis type.Methods:A total of 78 patients with acute cerebral infarction of qi deficiency and blood stasis type admitted to the 901 Hospital of CPLA from June 2016 to May 2019 were selected as study objects and randomly divided into 3 groups according to random number table method: Traditional Chinese medicine (TCM) group, HBO group, and combination group ( n=26). The TCM group was treated with traditional Chinese medicine decoction on the basis of the conventional treatment of ACI; the HBO group was treated with HBO on the basis of conventional treatment of ACI; the combination group was treated with traditional Chinese medicine decoction and HBO on the basis of the conventional treatment of ACI. After 20 days of treatment, the National Institute of Health stroke scale (NIHSS) scores and TCM syndrome scores of the 3 groups were statistically analyzed according to their basic clinical characteristics. Results:There were no significantly statistical differences in terms of NIHSS score or TCM syndrome score before treatment among the 3 groups ( H=0.304, P=0.859; H=0.379, P=0.827). After treatment, the NIHSS score of the combination group was lower than those of the TCM group and the HBO group ( P’=0.033, P’=0.011). The difference of NIHSS score after treatment in the combination group was higher than those in the TCM group and the HBO group ( P’=0.025, P’=0.003). After treatment, the TCM syndrome score of the combination group was lower than those of the TCM group and the HBO group ( P’=0.016, P’=0.046). After treatment, the difference of TCM syndrome score in the combination group was higher than those in the TCM group and the HBO group ( P’=0.005, P’=0.023). The overall clinical efficacy of the combination group was better than those of the TCM group and the HBO group ( P’=0.045, P’=0.010)). Conclusion:Buyang Huanwu decoction combined with hyperbaric oxygen therapy has a synergistic effect in the treatment of ACI, which is worthy of clinical application.

Objective:To observe the clinical effect of Buyang huanwu decoction combined with hyperbaric oxygen therapy on acute cerebral infarction (ACI) of qi deficiency and blood stasis type.Methods:A total of 78 patients with acute cerebral infarction of qi deficiency and blood stasis type admitted to the 901 Hospital of CPLA from June 2016 to May 2019 were selected as study objects and randomly divided into 3 groups according to random number table method: Traditional Chinese medicine (TCM) group, HBO group, and combination group ( n=26). The TCM group was treated with traditional Chinese medicine decoction on the basis of the conventional treatment of ACI; the HBO group was treated with HBO on the basis of conventional treatment of ACI; the combination group was treated with traditional Chinese medicine decoction and HBO on the basis of the conventional treatment of ACI. After 20 days of treatment, the National Institute of Health stroke scale (NIHSS) scores and TCM syndrome scores of the 3 groups were statistically analyzed according to their basic clinical characteristics. Results:There were no significantly statistical differences in terms of NIHSS score or TCM syndrome score before treatment among the 3 groups ( H=0.304, P=0.859; H=0.379, P=0.827). After treatment, the NIHSS score of the combination group was lower than those of the TCM group and the HBO group ( P’=0.033, P’=0.011). The difference of NIHSS score after treatment in the combination group was higher than those in the TCM group and the HBO group ( P’=0.025, P’=0.003). After treatment, the TCM syndrome score of the combination group was lower than those of the TCM group and the HBO group ( P’=0.016, P’=0.046). After treatment, the difference of TCM syndrome score in the combination group was higher than those in the TCM group and the HBO group ( P’=0.005, P’=0.023). The overall clinical efficacy of the combination group was better than those of the TCM group and the HBO group ( P’=0.045, P’=0.010)). Conclusion:Buyang Huanwu decoction combined with hyperbaric oxygen therapy has a synergistic effect in the treatment of ACI, which is worthy of clinical application.

Objective To investigate the association between serum ferritin(SF) level at early and mid trimester of pregnancy and gestational diabetes mellitus (GDM) and insulin resistance (IR).Methods A total of 192 cases of women who were accepted antenatal examination from the first trimester of pregnancy at Yueqing People Hospital from July,2012 to October,2013 was prospectively analyzed and followed up.All cases were divided into two groups:96 cases of GDM pregnant women who were diagnosed as GDM at mid trimester of pregnancy as GDM group,and 96 cases of pregnant women with normal glucose tolerance at the same time as the control,normal glucose tolerance (NGT group).The differences in clinical data were compared between two groups.The relationship between SF level and fasting plasma glucose (FPG),fasting insulin (FINS),homeostasis model assessment insulin resistance (HOMA-IR),and C-peptide was investigated with Spearman rank correlation analysis.The predictive values of SF and relative variables to GDM were calculated by receiver operating characteristic curve (ROC) or Logistic regression analysis.Results (1) There was statistically significant difference in body weight and body mass index (BMI) at prepregnancy and mid trimester of pregnancy,Hb,FPG,FINS,SF,and C-peptide at the first trimester of pregnancy,SF level and FPG and HOMA-IR and C-peptide at mid trimester of pregnancy between two groups (P ＜ 0.01 or P ＜ 0.05).(2) As showed by Spearman rank correlation analysis,there was statistical correlation between SF at mid trimester of pregnancy,and FPG,FINS,HOMA-IR and C-peptide (P ＜0.01 or P ＜ 0.05);while no statistical correlation was found between SF at the first trimester of pregnancy and the same factors above (P ＞ 0.05).(3) The area under the ROC curve of SF at mid trimester of pregnancy for GDM was 0.653.The sensitivity and specificity were 68.8％ and 59.4％ in predicting GDM at the cut-off value of 16.61 ng/ml.As showed by Logistic regression analysis,high level of SF at mid trimester of pregnancy was a independent risk factor for GDM.Odds ratio (OR) was 1.032 (95％ CI:1.008 ～ 1.058,P ＜ 0.01).Conclusions The relationship between SF at different trimester of pregnancy and GDM is variant.There is relationship between high level SF of mid trimester of pregnancy in GDM pregnant women and IR.The level of SF might predict the occurrence of GDM.

Objective To evaluate the cosmetic outcomes of nasal aesthetic sub-unit principle. Methods From May 2007 to March 2015,19 patients with traumatic soft tissue defects of nose had a Single-stage reconstruction with suitable reconstructive method. Full-thick-ness skin transplantation was performed in 1 case,forehead nasal flap in 1 case,bilobed flaps in 2 cases,nasolabial flaps in 9 cases,a folded nasolabial flap in 2 cases,free auricular composite flap in 1 case,the temporal flap pedicled with the orbicular oculi muscle in 3 cases. All pa-tients were followed up for 5~27 months,evaluation items were recorded and analyzed. Results Skin transplantation and local flap were all survived. But 1 case with nasolabial flap infected was healing by second intention,the rest were primary healing,free auricular composite flap was gloomy,and it became normal 5 months after operation. The radian and the curve of the folded nasolabial flap to repair the nasal alar area were slightly poor. Condusion Good aesthetic effets come from nasal aesthetic sub-unit principle in Single-stage soft tissue reconstruction of a traumatic nasal defects.

Objective To investigate the treatment of inverted nipple by continual extension with S tractors made of Kirschner wires on the base of preliminary clinical obervation.Methods Under local anesthesia,with the inverted nipples being dragged out by a presutured thread or a pair of towel clips,a Kirschner wire of 10 cm long and 0.5-1.0 mm in diameter was transversly penetrated through the base of inverted nipple.Then the Kirschner wire was bended at both points of 1.5 cm distantly from the nipple center in clockwise cemicircularly.Two cemicircular Kirschner wires were folded downward hingelikely and the center axis was supported by two cemicircles.This folded S tractor pushed and supported the inverted nipple forwardly and constantly.The hinge angle was adjusted during the treatment according to the traction requirment.It was nessessary for wearing these S tractors for at least 6 months before the Kirschner wires were being taken out.During referrals,the hinge angle was revised for mentaining the extension efforts.Results We treated 32 cases of inverted nipple,total 58 moderate and severe lesions,with this method effectively.No infection was observed during the treatment.The nipple form was naturally and stably outstanding after Kirschner wires taken out.No relapses were observed during a mean 6 monthe following up.Conclusions This procedure is simple and convenient without the need of complicated surgical procedures or perplexed equipments.The nipple shaps are observed natural and stable after Kirschner wire is removed.No recurrences are observed.There are no damages to breastfeeding function.The obvious drawback of this method is its reqairing of long continuously wearing and its inconvenience.