1.Clinical study of Shenbao tablet in the treatment of kidney-yang deficiency syndrome
Xiu-Dian LI ; Ping CHENG ; Zhe CAO ; Qiong HUA ; Xiang-Xin MENG ; Qing-Gang ZHOU
The Chinese Journal of Clinical Pharmacology 2024;40(4):524-528
Objective To evaluate the efficacy and safety of Shenbao tablet in the treatment of kidney-yang deficiency syndrome.Methods Patients with kidney-yang deficiency syndrome,will were treated with Shenbao Tablets orally,3 tablets once,3 times a day,and the course of treatment was 56 days or 84 days,depending on the condition.By comparing the clinical efficacy,the changes of symptom scores and syndrome scores before and after treatment,and symptoms remission time,the effectiveness of Shenbao tablet in the treatment of kidney-yang deficiency syndrome was evaluated.The safety was evaluated by adverse reactions.Results There were 339 patients in the 56-day group and 345 patients in the 84-day group.After treatment,the clinical effective rates of the 56-day group and the 84-day group were 91.74%and 97.97%,respectively,and the difference was statistically significant(P<0.05).In the 56-day group and the 84-day group,the excellent rate were 58.41%and 59.13%,clinical control rates were 18.58%and 27.54%,and the progress rates were 14.75%and 11.30%,respectively.After treatment,the symptom scores of kidney-yang deficiency syndrome were significantly reduced respectively within both groups(P<0.05).In the 56-day group and the 84-day group,the nocturia scores of were 0.89±1.27 and 0.60±1.03,the soreness of waist scores were 1.31±1.19 and 0.72±1.00,the morning diarrhea scores were 0.28±0.74 and 0.19±0.61,the anaphrodisia scores were 0.65±1.13 and 0.53±0.98,the low spirits scores were 0.29±0.81 and 0.08±0.40,the cold limbs score were 1.09±1.20 and 0.55±0.93,the edema scores were 0.14±0.55 and 0.05±0.30,the bright pale complexion scores were 0.20±0.59 and 0.24±0.65,respectively.There were significant differences in the reduction of each symptom score between the two groups(P<0.05);the 56-day group had a more significant decrease in the score of cold limbs than the 84-day group.The remaining symptom scores decreased more significantly in the 84-day group.After treatment,the syndrome scores of kidney-yang deficiency syndrome in the two groups were significantly lower than those before treatment(all P<0.05);the change rates of score in the 56-day group and the 84-day group were(-72.33±24.57)%and(-78.77±19.53)%,respectively,and the difference was statistically significant(P<0.05).The self-reported time to first symptom relief was(14.85±7.18)days in the 56-day group and(14.10±7.78)days in the 84-day group,with no significant difference(P>0.05).The incidence of adverse reactions of Shenbao tablets was 5.37%,mainly reflected in hepatobiliary system diseases,gastrointestinal system diseases and various examination abnormalities.Conclusions After taking Shenbao tablets for 2 to 3 months,the clinical symptoms of kidney-yang deficiency were better improved,and the improvement was more significant after 3 months of treatment.The security of Shenbao Tablets was good.
2.A new elemane-type sesquiterpenoid glycoside from Curcuma phaeocaulis
Cheng-zhe LI ; Cheng PENG ; Xiao-cui LI ; Juan LIU ; Qin-mei ZHOU ; Chun-wang MENG ; Fei LIU ; Liang XIONG
Acta Pharmaceutica Sinica 2023;58(3):736-739
To study the chemical constituents and their biological activities in the rhizomes of
3.A retrospective comparative study of haplotype hematopoietic stem cell transplantation and human leukocyte antigen-matched sibling donor hematopoietic stem cell transplantation in the treatment of acute B-lymphocyte leukemia.
Zhi Dong WANG ; Yu Qian SUN ; Chen Hua YAN ; Feng Rong WANG ; Xiao Dong MO ; Meng LYU ; Xiao Su ZHAO ; Wei HAN ; Huan CHEN ; Yu Hong CHEN ; Yu WANG ; Lan Ping XU ; Ya Zhe WANG ; Yan Rong LIU ; Yi Fei CHENG ; Xiao Hui ZHANG ; Kai Yan LIU ; Xiao Jun HUANG ; Ying Jun CHANG
Chinese Journal of Hematology 2022;43(3):221-228
Objective: To investigate whether haplotype hematopoietic stem cell transplantation (haplo-HSCT) is effective in the treatment of pre transplant minimal residual disease (Pre-MRD) positive acute B lymphoblastic leukemia (B-ALL) compared with HLA- matched sibling donor transplantation (MSDT) . Methods: A total of 998 patients with B-ALL in complete remission pre-HSCT who either received haplo-HSCT (n=788) or underwent MSDT (n=210) were retrospectively analyzed. The pre-transplantation leukemia burden was evaluated according to Pre-MRD determinedusing multiparameter flow cytometry (MFC) . Results: Of these patients, 997 (99.9% ) achieved sustained, full donor chimerism. The 100-day cumulative incidences of neutrophil engraftment, platelet engraftment, and grades Ⅱ-Ⅳ acute graft-versus-host disease (GVHD) were 99.9% (997/998) , 95.3% (951/998) , and 26.6% (95% CI 23.8% -29.4% ) , respectively. The 3-year cumulative incidence of total chronic GVHD was 49.1% (95% CI 45.7% -52.4% ) . The 3-year cumulative incidence of relapse (CIR) and non-relapse mortality (NRM) of the 998 cases were 17.3% (95% CI 15.0% -19.7% ) and 13.8% (95% CI 11.6% -16.0% ) , respectively. The 3-year probabilities of leukemia-free survival (LFS) and overall survival (OS) were 69.1% (95% CI 66.1% -72.1% ) and 73.0% (95% CI 70.2% -75.8% ) , respectively. In the total patient group, cases with positive Pre-MRD (n=282) experienced significantly higher CIR than that of subjects with negative Pre-MRD [n=716, 31.6% (95% CI 25.8% -37.5% ) vs 14.3% (95% CI 11.4% -17.2% ) , P<0.001]. For patients in the positive Pre-MRD subgroup, cases treated with haplo-HSCT (n=219) had a lower 3-year CIR than that of cases who underwent MSDT [n=63, 27.2% (95% CI 21.0% -33.4% ) vs 47.0% (95% CI 33.8% -60.2% ) , P=0.002]. The total 998 cases were classified as five subgroups, including cases with negative Pre-MRD group (n=716) , cases with Pre-MRD<0.01% group (n=46) , cases with Pre-MRD 0.01% -<0.1% group (n=117) , cases with Pre-MRD 0.1% -<1% group (n=87) , and cases with Pre-MRD≥1% group (n=32) . For subjects in the Pre-MRD<0.01% group, haplo-HSCT (n=40) had a lower CIR than that of MSDT [n=6, 10.0% (95% CI 0.4% -19.6% ) vs 32.3% (95% CI 0% -69.9% ) , P=0.017]. For patients in the Pre-MRD 0.01% -<0.1% group, haplo-HSCT (n=81) also had a lower 3-year CIR than that of MSDT [n=36, 20.4% (95% CI 10.4% -30.4% ) vs 47.0% (95% CI 29.2% -64.8% ) , P=0.004]. In the other three subgroups, the 3-year CIR was comparable between patients who underwent haplo-HSCT and those received MSDT. A subgroup analysis of patients with Pre-MRD<0.1% (n=163) was performed, the results showed that cases received haplo-HSCT (n=121) experienced lower 3-year CIR [16.0% (95% CI 9.4% -22.7% ) vs 40.5% (95% CI 25.2% -55.8% ) , P<0.001], better 3-year LFS [78.2% (95% CI 70.6% -85.8% ) vs 47.6% (95% CI 32.2% -63.0% ) , P<0.001] and OS [80.5% (95% CI 73.1% -87.9% ) vs 54.6% (95% CI 39.2% -70.0% ) , P<0.001] than those of MSDT (n=42) , but comparable in 3-year NRM [5.8% (95% CI 1.6% -10.0% ) vs 11.9% (95% CI 2.0% -21.8% ) , P=0.188]. Multivariate analysis showed that haplo-HSCT was associated with lower CIR (HR=0.248, 95% CI 0.131-0.472, P<0.001) , and superior LFS (HR=0.275, 95% CI 0.157-0.483, P<0.001) and OS (HR=0.286, 95% CI 0.159-0.513, P<0.001) . Conclusion: Haplo HSCT has a survival advantage over MSDT in the treatment of B-ALL patients with pre MRD<0.1% .
B-Lymphocytes
;
Graft vs Host Disease
;
HLA Antigens/genetics*
;
Haplotypes
;
Hematopoietic Stem Cell Transplantation/adverse effects*
;
Humans
;
Leukemia, B-Cell/complications*
;
Leukemia, Lymphocytic, Chronic, B-Cell/complications*
;
Neoplasm, Residual
;
Precursor Cell Lymphoblastic Leukemia-Lymphoma/therapy*
;
Recurrence
;
Retrospective Studies
;
Siblings
4.Performance test and evaluation on Halcyon medical linear accelerator
PENG Jun zhe ZHAI He zheng CHEN Dong hui ZHAI Zi po LONG Hui jia CHENG Yan meng
China Occupational Medicine 2022;52(04):458-
Abstract: Objective
To evaluate the key quality control and protective performance test of Halcyon medical linear accelerator.
Methods WS 674-2020Specification for Testing of Quality Control in Medical Linear Accelerator(
According to the hereinafter
WS 674-2020) ,
referred to and the manufacturer´s manual the performance of the first Halcyon medical linear accelerator in
Results , ,
Hunan Province was tested. The results showed that all ten indicators of the accelerator including dose deviation
, , ( , , , -
repeatability linearity daily stability and symmetry the results were 0.10% 0.03% 0.04% 0.50% and 100.50% 100.80%
), - -
respectively met the requirements of WS 674 2020. The results of manufacturer quality control indicators such as dose rate
, ,
stability in beam gantry rotation isocenter and mechanical position accuracy megavolt image parameters and cone beam
computer tomography image parameters met the requirements of the manufacturer´s regulations. Due to the special structure and
, - :
function of the accelerator it is difficult to detect the parameter required by WS 674 2020 as below the radiation leakage
- , , , ,
outside the M zone the uniformity the indicators related to the light field the offset of the radiation beam axis the zero scale
Conclusion -
position of the rotating motion scale and others. It is difficult to carry out complete testing according to WS 6742020
for Halcyon medical linear accelerator and it is urgent for the state to issue relevant testing standards to standardize and
strengthen the quality control testing of various accelerators.
5.Exploration of objective quality evaluation parameter of Alismatis Rhizoma decoction pieces.
De-Wen LIU ; Zhe DENG ; Jia SHI ; Meng-Jiao JIAO ; Yan TONG ; Jin-Yu WANG ; Jin-Tang CHENG ; Sha CHEN ; Chang CHEN ; Jun ZHANG ; Li SHEN ; Huan YU ; Zheng-Hong PAN ; Qian-Feng GONG ; An LIU
China Journal of Chinese Materia Medica 2019;44(9):1729-1733
To establish a quality constant evaluation system of Alismatis Rhizoma decoction pieces,in order to provide reference for regulating the market circulation of this decoction pieces. A total of 18 batches of Alismatis Rhizoma decoction pieces were collected from different pharmaceutical factories,and the morphological parameters of each sample were tested. The content of alisol B 23-acetate in Alismatis Rhizoma decoction pieces was determined by HPLC in the 2015 edition of Chinese Pharmacopoeia,and the parameters such as quality constant and relative quality constant were calculated. The quality constant range of 18 batches of Alismatis Rhizoma decoction pieces was 0. 390-2. 076. If 18 batches of Alismatis Rhizoma decoction pieces were divided into 3 grades,taking 80% of the maximum quality constant as first grade,50% to 80% as second grade,and the rest as third grade,then the quality constant of firstgrade samples was ≥1. 66,the quality constant of second-grade samples was ≥1. 04 and <1. 66,and the quality constant of third-grade samples was <1. 04. The established quality constant evaluation method is objective and feasible,which can be used to classify the grade of Alismatis Rhizoma decoction pieces and provide a reference method to control the quality of this decoction pieces.
Alisma
;
chemistry
;
Chromatography, High Pressure Liquid
;
Drugs, Chinese Herbal
;
standards
;
Quality Control
;
Rhizome
;
chemistry
6.Efficacy and safety of domestic dasatinib as second-line treatment for chronic myeloid leukemia patients in the chronic phase.
Yi Lin CHEN ; Long WANG ; Guo Lin YAN ; Zhuang Zhi YANG ; Zhi Ping HUANG ; You Shan ZHANG ; Zhe ZHAO ; Chu Cheng WAN ; Ying BAO ; Hang XIANG ; Hua YIN ; Li Feng CHEN ; Ying Yuan XIONG ; Li MENG ; Wei Ming LI
Chinese Journal of Hematology 2019;40(2):98-104
Objective: To investigate the efficiency and safety of domestic tyrosine kinase inhibitor (TKI) dasatinib (Yinishu) as second-line treatment for patients with chronic myeloid leukemia in chronic phase (CML-CP). Methods: A retrospective analysis of clinical data of CML-CP patients who received domestic dasatinib as second-line treatment in the CML collaborative group hospitals of Hubei province from March 2016 to July 2018 was performed. The optimal response rate, the cumulative complete cytogenetic response (CCyR), the cumulative major molecular responses (MMR), progression free survival (PFS), event free survival (EFS) and adverse effects (AEs) of the patients were assessed at 3, 6 and 12 months of treatment. Results: A total of 83 CML-CP patients were enrolled in this study. The median follow-up time was 23 months. The optimal response rates at 3, 6 and 12 months in 83 CML-CP patients treated with dasatinib were 77.5% (54/71), 72.6% (61/75) and 60.7% (51/69), respectively. By the end of follow-up, the cumulative CCyR and MMR rates were 65.5% (55/80) and 57.1% (48/73), respectively. The median time to achieving CCyR and MMR was 3 months. During follow-up time, the PFS rate was 94.0% (79/83) and the EFS rate was 77.4% (65/83). The most common non-hematological AEs of dasatinib were edema (32.5%), rash itching (18.1%) and fatigue (13.3%). The common hematological AEs of dasatinib were thrombocytopenia (31.3%), leukopenia (19.3%) and anemia (6.0%). Conclusion: Domestic dasatinib was effective and safe as the second-line treatment of CML-CP patients and it can be used as an option for CML-CP patients.
Antineoplastic Agents
;
Dasatinib/therapeutic use*
;
Humans
;
Imatinib Mesylate
;
Leukemia, Myelogenous, Chronic, BCR-ABL Positive/drug therapy*
;
Protein Kinase Inhibitors
;
Retrospective Studies
;
Treatment Outcome
7.Prognostic significance of early molecular response after second-line treatment with dasatinib of chronic myeloid leukemia patients.
Yi Lin CHEN ; Li MENG ; Guo Lin YUAN ; Zhuang Zhi YANG ; Zhi Ping HUANG ; You Shan ZHANG ; Zhe ZHAO ; Chu Cheng WANG ; Ying BAO ; Hang XIANG ; Hua YIN ; Li Feng CHEN ; Ying Yuan XIONG ; Long WANG ; Wei Ming LI
Chinese Journal of Hematology 2019;40(7):608-611
8.Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Medication Adherence (MISSION-2).
Chong-Yang LIU ; Jun-Zhe DU ; Chen-Fei RAO ; Heng ZHANG ; Han-Ning LIU ; Yan ZHAO ; Li-Meng YANG ; Xi LI ; Jing LI ; Jue WANG ; Hui-Shan WANG ; Zhi-Gang LIU ; Zhao-Yun CHENG ; Zhe ZHENG
Chinese Medical Journal 2018;131(12):1480-1489
Background:
Secondary preventive therapies play a key role in the prevention of adverse outcomes after coronary artery bypass grafting (CABG). However, medication adherence after CABG is often poor, and conventional interventions for improving adherence have limited success. With increasing penetration of smartphones, health-related smartphone applications might provide an opportunity to improve adherence. Carefully designed trials are needed to provide reliable evidence for the use of these applications in patients after CABG.
Methods:
The Measurement and Improvement Studies of Surgical Coronary Revascularization: Medication Adherence (MISSION-2) study is a multicenter randomized controlled trial, aiming to randomize 1000 CABG patients to the intervention or control groups in a 1:1 ratio. We developed the multifaceted, patient-centered, smartphone-based Heart Health Application to encourage medication adherence in the intervention group through a health self-management program initiated during hospital admission for CABG. The application integrated daily scheduled reminders to take the discharge medications, cardiac educational materials, a dynamic dashboard to review cardiovascular risk factors and secondary prevention targets, and weekly questionnaires with interactive feedback. The primary outcome was secondary preventive medication adherence measured by the Chinese version of the 8-item Morisky Medication Adherence Scale at 6 months after randomization. Secondary outcomes included all-cause death, cardiovascular rehospitalization, and a composite of death, myocardial infarction, stroke, and repeat revascularization.
Discussion:
Findings will not only provide evidence regarding the feasibility and effectiveness of the described intervention for improving adherence to CABG secondary preventive therapies but also explore a model for outpatient health self-management that could be translated to various chronic diseases and widely disseminated across resource-limited settings.
Trial Registration
https://clinicaltrials.gov (NCT02432469).
Coronary Artery Bypass
;
methods
;
Humans
;
Medication Adherence
;
Myocardial Infarction
;
prevention & control
;
Secondary Prevention
;
methods
;
Smartphone
;
Stroke
;
prevention & control
9.A new aurone with anti-inflammatory activity from Cleistocalyx operculatus flower buds.
Wen-Jun LIU ; Zhao-Liang LI ; Ning-Bo CHENG ; Yu-Mei HU ; Zhao-Qing MENG ; Zhen-Zhen SU ; Biao YANG ; Wen-Zhe HUANG ; Zhen-Zhong WANG ; Wei XIAO
China Journal of Chinese Materia Medica 2018;43(7):1467-1470
A new compound(Z)-6-hydroxy-4-methoxy-5,7-dimethylaurone was isolated from Cleistocalyx operculatus flower buds. Its structure was identified by spectroscopic data including MS, ¹H-NMR, ¹³C-NMR HSQC and HMBC. A known compound, 2',4'-dihydroxy-6'-methoxy-3'5'-dimethylchalcone (DMC), was also isolated and identified,and used as material to synthesize (Z)-6-hydroxy-4-methoxy-5,7-dimethylaurone.Anti-inflammatory activities of the two compounds were tested . The results showed that (Z)-6-hydroxy-4-methoxy-5,7-dimethylaurone possesses much stronger PGE₂ inhibitory activity (IC₅₀ 6.12 nmol·L⁻¹) than the positive control ibuprofen (68.66 nmol·L⁻¹).
10.Research on standard decoction of processed Curcumae Longae Rhizoma containing volatile oil.
Zhe DENG ; Fan ZHANG ; Meng-Jiao JIAO ; Jun ZHANG ; Jia SHI ; Jin-Tang CHENG ; An LIU
China Journal of Chinese Materia Medica 2018;43(5):879-884
To prepare processed Curcumae Longae Rhizoma standard decoction, establish its quality standard, provides quality reference for formulated Jianghuang granules and lay a foundation for standard decoction research for the pieces containing volatile oil. Thirteen batches of processed Curcumae Longae Rhizoma standard decoctions were prepared according to the preparation requirements for standard decoction of Chinese herbal medicine containing volatile oil. With curcumin as the detection index, the transfer rate and extraction ratio were calculated; the pH value was determined and HPLC fingerprint analysis method was established. The results showed that the transfer rate ranged from 0.67% to 2.24%; the extraction rate was at a range of 9.95% to 18.36% and pH value was 3.86 to 6.05. Then the Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine (2012A) was used to analyze and compare the fingerprint. Sixteen common peaks were determined and three were identified including bisdemethoxycurcumin (peak 7), demethoxycurcumin (peak 8) and curcumin (peak 9). Moreover, the similarity was over 0.78 in the similarity evaluation of 13 batches of samples. HPLC fingerprint analysis method of processed Curcumae Longae Rhizoma standard decoction was established, showing good precision, stability and repeatability with certain identification effect, suitable for the quality control of formulated Jianghuang granules.

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