1.A randomized,double-blind,placebo-controlled,multicenter clinical study of Shengxuebao Mixture in treating cancer-related anemia
Zhu LIU ; Xiangrong LI ; Xiaojun DAI ; Yanjun WANG ; Xiao LI ; Keqiong WANG ; Tao WU ; Miaowen ZHONG ; Hongjiang YU ; Ji FENG ; Zuowei HU ; Kainan LI ; Shaowei CHEN ; Chunhua LI ; Zhengchuan FU ; Rui ZHANG ; Yongfa CHEN ; Hongyu XU ; Tao REN ; Yibo YAO ; Jianxu JIN ; Pengyin WANG ; Zhijiang HE ; Jian SHEN ; Lei WANG ; Min LI ; Wenming CHANG ; Xinyi CHEN ; Li HOU
Journal of Beijing University of Traditional Chinese Medicine 2025;48(10):1447-1459
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.
2.A randomized,double-blind,placebo-controlled,multicenter clinical study of Shengxuebao Mixture in treating cancer-related anemia
Zhu LIU ; Xiangrong LI ; Xiaojun DAI ; Yanjun WANG ; Xiao LI ; Keqiong WANG ; Tao WU ; Miaowen ZHONG ; Hongjiang YU ; Ji FENG ; Zuowei HU ; Kainan LI ; Shaowei CHEN ; Chunhua LI ; Zhengchuan FU ; Rui ZHANG ; Yongfa CHEN ; Hongyu XU ; Tao REN ; Yibo YAO ; Jianxu JIN ; Pengyin WANG ; Zhijiang HE ; Jian SHEN ; Lei WANG ; Min LI ; Wenming CHANG ; Xinyi CHEN ; Li HOU
Journal of Beijing University of Traditional Chinese Medicine 2025;48(10):1447-1459
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.
3.Association Between Lipid Profiles and Left Ventricular Hypertrophy: New Evidence from a Retrospective Study
Huang XUEWEI ; Deng KEQIONG ; Qin JUANJUAN ; Lei FANG ; Zhang XINGYUAN ; Wang WENXIN ; Lin LIJIN ; Zheng YUMING ; Yao DONGAI ; Lu HUIMING ; Liu FENG ; Chen LIDONG ; Zhang GUILAN ; Liu YUEPING ; Yang QIONGYU ; Cai JINGJING ; She ZHIGANG ; Li HONGLIANG
Chinese Medical Sciences Journal 2022;37(2):103-117
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.
4.Therapeutic effect of Buyang Huanwu Decoction combined with hyperbaric oxygen therapy on acute cerebral infarction of Qi deficiency and blood stasis type
Kewan LIU ; Xiaowei LIU ; Liangliang MIAO ; Chengcheng CHEN ; Keqiong WANG ; Yuxing LIU ; Houdong MEI ; Yulei LIANG
Chinese journal of nautical medicine and hyperbaric medicine 2020;27(6):691-695
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.
5.Therapeutic effect of Buyang Huanwu Decoction combined with hyperbaric oxygen therapy on acute cerebral infarction of Qi deficiency and blood stasis type
Kewan LIU ; Xiaowei LIU ; Liangliang MIAO ; Chengcheng CHEN ; Keqiong WANG ; Yuxing LIU ; Houdong MEI ; Yulei LIANG
Chinese journal of nautical medicine and hyperbaric medicine 2020;27(6):691-695
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.
6.Associated factors related to first spermatorrhea and menarche among high and primary school students, in Chongqing
Keqiong LI ; Hong WANG ; Jing GUO ; Baocheng YUAN ; Peiyu GUAN
Chinese Journal of Epidemiology 2016;37(2):169-173
Objective To understand the status and correlative factors on menarche and first spermatorrhea among children and adolescents,in Chongqing,in order to provide theoretical basis for carrying out sex and health education in this population.Methods By random stratified and cluster sampling,10 498 students (5 372 boys and 5 126 girls),5 to 18 years old and living in Chongqing urban districts,were enrolled.General situation and physical features of the population were studied.Statistics analysis system included logistic regression methods,t-test and chi-square test.Results For urban kids,first experience of spermatorrhea was 0.218 years later than those living in the rural areas (Z=-73.287,P<0.001),but median age for girls in urban areas was 0.073 years earlier than in rural areas (Z=-71.589,P<0.001).Except for factor as mother' s education level in the family (x2=21.564,P<0.001),other family or environment related factors did not show significant difference between the two groups of boys (P>0.05).However,significant difference appeared in average family income (x2=6.175,P=0.046) between two groups of girls.Data from the logistic analysis showed that BMI,hip circumference,height,weight,number of children in the family,time of sleep and the diet structure were associated with menarche.Correlative factors of boys' first spermatorrhea would include:high-energy snacks,hip circumference,weight,height,school type and mother's education level (P< 0.05).Conclusion First spermatorrhea and menstruation of boys and girls were closely related to environment of the family,diet and the time of sleep.
7.Analysis of microcephaly and related factors among 31 902 infants of Chongqing, China
Keqiong LI ; Jing LI ; Hong WANG ; Zhiyang JIANG
Chinese Journal of Preventive Medicine 2016;50(7):625-628
Objective To analyze the status of head circumference development and related factors of microcephaly among infants in Chongqing, China. Methods We included infants aged 7-24 months who had received child health care services at a Chongqing hospital from 1 February 2010 to 1 November 2014. We collected data of sex, age, head circumference, childbirth conditions, mother's pregnancy history, infant feeding patterns, and parents' educational level. Ultimately, 31 902 infants (17 511 males and 14 391 females) were analyzed. The t-test was used to compare head circumference by sex, and logistic regression models used to analyze the related factors of microcephaly. Odds ratios (OR) and 95%confidence intervals (CI) were calculated. Results Among the different age groups (7-8, 9-10, 11-12, 13-18, and 19-24 months), head circumferences for males were (44.3±1.3), (45.2±1.4), (46.1±1.5), (46.8±1.4), and (47.8±1.4) cm, respectively;for females, head circumferences were (43.1±1.3), (44.1±1.3), (44.8±1.4), (45.7±1.4), and (46.7±1.3)cm, respectively. Head circumference for males were all greater than those for girls (t-values were 32.09, 27.73, 32.21, 41.66, and 32.03, respectively; P<0.001). The rate of microcephaly was 3.2%(1 025/31 902) among infants. Birth weights and fetal times were related to microcephaly in infants, with OR (95%CI) values 0.15(0.13-0.18) and 1.31(1.11-1.54), respectively. Factors including urban location, delayed birth, cesarean section, formula feeding, and mixed feeding patterns might reduce the risks of microcephaly compared with suburban location, term birth, eutocia, and breastfeeding; OR (95% CI) values were 0.60 (0.52-0.68), 0.55 (0.44-0.70), 0.76 (0.67-0.87), 0.46 (0.32-0.67), and 0.51 (0.34-0.75), respectively. Conclusion Head circumference development among infants in Chongqing was satisfactory. Family environmental factors, birth conditions, and feeding patterns were found to be important factors related to microcephaly.
8.Analysis of microcephaly and related factors among 31 902 infants of Chongqing, China
Keqiong LI ; Jing LI ; Hong WANG ; Zhiyang JIANG
Chinese Journal of Preventive Medicine 2016;50(7):625-628
Objective To analyze the status of head circumference development and related factors of microcephaly among infants in Chongqing, China. Methods We included infants aged 7-24 months who had received child health care services at a Chongqing hospital from 1 February 2010 to 1 November 2014. We collected data of sex, age, head circumference, childbirth conditions, mother's pregnancy history, infant feeding patterns, and parents' educational level. Ultimately, 31 902 infants (17 511 males and 14 391 females) were analyzed. The t-test was used to compare head circumference by sex, and logistic regression models used to analyze the related factors of microcephaly. Odds ratios (OR) and 95%confidence intervals (CI) were calculated. Results Among the different age groups (7-8, 9-10, 11-12, 13-18, and 19-24 months), head circumferences for males were (44.3±1.3), (45.2±1.4), (46.1±1.5), (46.8±1.4), and (47.8±1.4) cm, respectively;for females, head circumferences were (43.1±1.3), (44.1±1.3), (44.8±1.4), (45.7±1.4), and (46.7±1.3)cm, respectively. Head circumference for males were all greater than those for girls (t-values were 32.09, 27.73, 32.21, 41.66, and 32.03, respectively; P<0.001). The rate of microcephaly was 3.2%(1 025/31 902) among infants. Birth weights and fetal times were related to microcephaly in infants, with OR (95%CI) values 0.15(0.13-0.18) and 1.31(1.11-1.54), respectively. Factors including urban location, delayed birth, cesarean section, formula feeding, and mixed feeding patterns might reduce the risks of microcephaly compared with suburban location, term birth, eutocia, and breastfeeding; OR (95% CI) values were 0.60 (0.52-0.68), 0.55 (0.44-0.70), 0.76 (0.67-0.87), 0.46 (0.32-0.67), and 0.51 (0.34-0.75), respectively. Conclusion Head circumference development among infants in Chongqing was satisfactory. Family environmental factors, birth conditions, and feeding patterns were found to be important factors related to microcephaly.

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