1.Comparison of Long-term Outcomes in Patients with Premature Triple-vessel Coronary Disease Undergoing Three Different Treatment Strategies: A Prospective Cohort Study.
Jing-Jing XU ; Yin ZHANG ; Lin JIANG ; Jian TIAN ; Lei SONG ; Zhan GAO ; Xin-Xing FENG ; Xue-Yan ZHAO ; Yan-Yan ZHAO ; Dong WANG ; Kai SUN ; Lian-Jun XU ; Ru LIU ; Run-Lin GAO ; Bo XU ; Lei SONG ; Jin-Qing YUAN
Chinese Medical Journal 2018;131(1):1-9
BACKGROUNDPatients with premature triple-vessel disease (PTVD) have a higher risk of recurrent coronary events and repeat revascularization; however, the long-term outcome of coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), and medical therapy (MT) alone for PTVD patients is controversial. The aim of this study is to evaluate the long-term outcome of PTVD patients among these three treatment strategies, to find out the most appropriate treatment methods for these patients.
METHODSOne thousand seven hundred and ninety-two patients with PTVD (age: men ≤50 years and women ≤60 years) were enrolled between 2004 and 2011. The primary end point was all-cause death. The secondary end points were cardiac death, myocardial infarction, stroke, or repeat revascularization.
RESULTSPCI, CABG, and MT alone were performed in 933 (52.1%), 459 (25.6%), and 400 (22.3%) patients. Both PCI and CABG were associated with lower all-cause death (4.6% vs. 4.1% vs. 15.5%, respectively, P < 0.01) and cardiac death (2.8% vs. 2.0% vs. 9.8%, respectively, P < 0.01) versus MT alone. The rate of repeat revascularization in the CABG group was significantly lower than those in the PCI and MT groups. After adjusting for baseline factors, PCI and CABG were still associated with similar lower risk of all-cause death and cardiac death versus MT alone (all-cause death: hazard ratio [HR]: 0.35, 95% confidence interval [CI]: 0.23-0.53, P < 0.01 and HR: 0.35, 95% CI: 0.18-0.70, P = 0.003, respectively, and cardiac death: HR: 0.32, 95% CI: 0.19-0.54, P < 0.01 and HR: 0.36, 95% CI: 0.14-0.93, P = 0.03, respectively).
CONCLUSIONSPCI and CABG provided equal long-term benefits for all-cause death and cardiac death for PTVD patients. Patients undergoing MT alone had the worst long-term clinical outcomes.
TRIAL REGISTRATIONClinicalTrials.gov; Identifier: NCT02634086. https://www.clinicaltrials.gov/ct2/show/record/NCT02634086?term=NCT02634086&rank=1.
2.A clinical analysis of 15 children with systemic lupus erythematosus accompanied by pulmonary hypertension.
Ji LI ; Jing-Ran MA ; Zhi-Xing SUN ; Jing-Jing JIANG ; Yan-Qing DONG ; Qian WANG ; Hong-Mei SONG
Chinese Journal of Contemporary Pediatrics 2017;19(6):658-662
OBJECTIVETo evaluate the clinical features, laboratory findings, diagnosis and treatment, and prognosis of children with systemic lupus erythematosus (SLE) accompanied by pulmonary hypertension (PH).
METHODSThe clinical symptoms, laboratory findings, echocardiographic features, SLE disease activity index, and treatment outcome of 15 hospitalized children with SLE accompanied by PH were retrospectively analyzed.
RESULTSAmong the 15 patients, the median interval from diagnosis of SLE to diagnosis of PH was 0.1 year (range: 0-6.5 years). Aside from PH-related symptoms, Raynaud's phenomenon was observed in 6 (40%) of the 15 patients. There was no significant difference in SLE disease activity (evaluated by complements 3 and 4 levels, erythrocyte sedimentation rate, and positive rate of anti-double-stranded DNA) between patients with mild-to-moderate PH and those with severe PH (P<0.05). As for treatment, 13 patients received immunosuppressive therapy with glucocorticoids, and among them 2 patients received PH-targeted therapy. During a median follow-up of 8.0 years (range: 0.5-18.1 years) since the diagnosis of PH, 2 deaths were noted with class III or IV cardiac function (World Health Organization), while the other patients were in a stable condition.
CONCLUSIONSRaynaud's phenomenon is a common clinical manifestation in children with SLE accompanied by pulmonary hypertension (PH). PH severity is not significantly associated with SLE disease activity, and thus greater focus should be placed upon early screening of pulmonary arterial pressure in SLE patients. Early diagnosis and early treatment can improve the prognosis of children with SLE.
Adolescent ; Child ; Child, Preschool ; Female ; Humans ; Hypertension, Pulmonary ; complications ; drug therapy ; Infant ; Lupus Erythematosus, Systemic ; complications ; drug therapy ; Male
3.Continual improvement of quantitative analytical method development of Panax notogineng saponins based on quality by design.
Sheng-Yun DAI ; Bing XU ; Xin-Yuan SHI ; Xiang XU ; Ying-Qiang SUN ; Yan-Jiang QIAO
China Journal of Chinese Materia Medica 2017;42(6):1095-1103
This study is aimed to propose a continual improvement strategy based on quality by design (QbD). An ultra high performance liquid chromatography (UPLC) method was developed to accomplish the method transformation from HPLC to UPLC of Panax notogineng saponins (PNS) and achieve the continual improvement of PNS based on QbD, for example. Plackett-Burman screening design and Box-Behnken optimization design were employed to further understand the relationship between the critical method parameters (CMPs) and critical method attributes (CMAs). And then the Bayesian design space was built. The separation degree of the critical peaks (ginsenoside Rg₁ and ginsenoside Re) was over 2.0 and the analysis time was less than 17 min by a method chosen from the design space with 20% of the initial concentration of the acetonitrile, 10 min of the isocratic time and 6%•min⁻¹ of the gradient slope. At last, the optimum method was validated by accuracy profile. Based on the same analytical target profile (ATP), the comparison of HPLC and UPLC including chromatograph method, CMA identification, CMP-CMA model and system suitability test (SST) indicated that the UPLC method could shorten the analysis time, improve the critical separation and satisfy the requirement of the SST. In all, HPLC method could be replaced by UPLC for the quantity analysis of PNS.
4.Application of quality by design in granulation process for Ginkgo leaf tablet (Ⅲ): process control strategy based on design space.
Xiang-Long CUI ; Bing XU ; Fei SUN ; Sheng-Yun DAI ; Xin-Yuan SHI ; Yan-Jiang QIAO
China Journal of Chinese Materia Medica 2017;42(6):1048-1054
In this paper, under the guidance of quality by design (QbD) concept, the control strategy of the high shear wet granulation process of the ginkgo leaf tablet based on the design space was established to improve the process controllability and product quality consistency. The median granule size (D50) and bulk density (Da) of granules were identified as critical quality attributes (CQAs) and potential critical process parameters (pCPPs) were determined by the failure modes and effect analysis (FMEA). The Plackeet-Burmann experimental design was used to screen pCPPs and the results demonstrated that the binder amount, the wet massing time and the wet mixing impeller speed were critical process parameters (CPPs). The design space of the high shear wet granulation process was developed within pCPPs range based on the Box-Behnken design and quadratic polynomial regression models. ANOVA analysis showed that the P-values of model were less than 0.05 and the values of lack of fit test were more than 0.1, indicating that the relationship between CQAs and CPPs could be well described by the mathematical models. D₅₀ could be controlled within 170 to 500 μm, and the bulk density could be controlled within 0.30 to 0.44 g•cm⁻³ by using any CPPs combination within the scope of design space. Besides, granules produced by process parameters within the design space region could also meet the requirement of tensile strength of the ginkgo leaf tablet..
5.Ecological suitability assessment for Notopterygium plants transplanting along altitudinal gradients.
Shun-Yuan JIANG ; Yan ZHOU ; Hui SUN ; Yi ZHOU ; Ling-Yun WAN ; Yan-Xia ZHANG ; Jian WANG
China Journal of Chinese Materia Medica 2017;42(14):2649-2654
A comprehensive field research had been focused on growing status, underground biomass and active constituents of Notopterygium incisum and N. franchetii to evaluate the ecological suitability and appropriate cultivation zones by growing the two species seedlings along different elevation gradient. The results showed that compared to the survival rate and underground biomass, the beneficial altitude region to N. incisum was ranged from 2 600 m to 4 100 m, while N. franchetii required a lower altitude which ranges from 1 700 m to 3 600 m. For the active constituent contents, the values were higher in the range of 2 600 to 3 600 m for N. incisum, but for N. franchetii, the range was form 1 700 to 3 600 m. This result provides instructional guidance and scientific basis for artificial cultivation of N. incisum and N. franchetii.
6.Clinical Efficacy of Low-dose Decitabine Combined with CAG Regimen in Patients with Myelodysplastic Syndrome-refractory Anemia with Excess Blasts(MDS-RAEB).
Meng WANG ; Hao-Hao HAN ; Rong GUO ; Yan-Fang LIU ; Zhong-Xing JIANG ; Hui SUN
Journal of Experimental Hematology 2017;25(5):1482-1486
OBJECTIVETo investigate the clinical efficacy of low-dose decitabine combined with CAG regimen in patients with myelodysplastic syndrome-refractory anemia with excess blasts (MDS-RAEB) through retrospective analysis.
METHODSThirty-six patients with MDS-RAEB who ever received low-dose decitabine combined with CAG regimen were enrolled into decitabine + CAG group and 40 patients with MDS-RAEB treated by decitabine alone in our center were enolled into the control group. The clinical characteristics, efficacy and adverse reactions (AE) were compared between the 2 groups.
RESULTSCompared with the control group, the overall response rate (ORR) [complete remission (CR)+partial remission (PR) + hematologic improvement (HI) rate] of the decitabine+CAG group was higher (83.3% vs 62.5%)(P=0.043), and the AEs were not significantly increased. Cytopenia grade ≥3 and infection after treatment were the most prevalent AEs, which occurred in the early stage (within the first 2 cycles) and gradually decreased later. Other non-hematologic AEs were infrequent.
CONCLUSIONLow-dose decitabine combined with CAG regimen has better clinical efficacy for patients with MDS-RAEB than that of decitabine alone. It is worthy to be applied in clinic, especially for these patients who are not ineligible for hematopoietic stem cell transplantation.
7.Characteristics of Long-term Nonprogressors and Viremia Controllers Infected with HIV-1 via Contaminated Blood Donations or Transfusions Conducted 20 Years Earlier.
Jia LIU ; Pan Ying FAN ; Xiu Juan XUE ; Jiang Zhou YAN ; Guo Qing SUN ; Chun Hua LIU ; Sui An TIAN ; Ning LI ; Ding Yong SUN ; Qian ZHU ; Zhe WANG
Biomedical and Environmental Sciences 2017;30(12):907-912
To characterize long-term nonprogressors (LTNPs) and viremia controllers (VCs), infected with HIV-1 through contaminated blood donation or transfusion between 1992 and 1996 in Henan, China. LTNPs and VCs were defined by CD4+T lymphocyte (CD4) count and viral load (VL). Of 29,294 patients infected with HIV-1 via contaminated blood donation or transfusion that had conducted for more than 20 years, 92 were LTNPs/VCs. There were 70 LTNPs (0.24%), 43 VCs (0.15%), and 48 LTNPs+VCs- (0.16%). VCs had a significantly lower CD4 nadir, compared to LTNPs and LTNPs+VCs-, and no significant differences for the highest VL and HIV-1 DNA. Cases P4 and P5 were LTNPs, while their VL reached approximately 4.3 log copies/mL. P6 was a VC, but with CD4 < 500 cells/μL constantly. Data from the LTNPs/VCs cohort provided valuable information, future research is needed.
8.Clinical Analysis for 42 Imatinib-resistant Patients with Chronic Myelogenous Leukemia.
Xi LIU ; Si-Lin GAN ; Jie MA ; Yan-Fang LIU ; Xin-Sheng XIE ; Zhong-Xing JIANG ; Yuan-Dong CHENG ; Hui SUN
Journal of Experimental Hematology 2017;25(2):377-381
OBJECTIVETo analyze the kinase mutation ratio, related factors, effectiveness and safety of the second generation drugs for imatinib-resistant patients with chronic myeloid leukemia(CML).
METHODSCOX proportional hazard regression model was used for unvariate and multvariate analysis of various factors affecting the kinase mutation and for evaluating the effectiveness and safety of second generation tyrosine kinase inhibitor(TKI).
RESULTS13 kinds of mutation were detected in 19 out of 42 cases for 22 times, including 4 times of F359V, 3 times of E255K, 2 time for F359C, F317L, T315I, Y253H, 1 time for D256R, C250R, D276G, F486S, M244V, Y256H and G250E, 3 cases with mixed mutations. The main adverse effects of patients receiving nilotinib were skin rash and fluid retention, while that for patients receiving dasatinib were eyelid edema and elevated bilirubin.
CONCLUSIONThe WBC count, spleen enlargement degree, chromosome karyotypes, disease staging, drug used before treatment and time of acheiving CCyR are the related factors of the kinase mutations, but the patients receiving the second generation TKI can survive well.
9.Clinical Values of Combined Diffused Optical Tomography and PET-CT in the Diagnosis of Breast Cancer.
Hong-Yan WANG ; Xiao-Na JIN ; Yu-Xin JIANG ; Zhao-Hui ZHU ; Ying XU ; Qing-Li ZHU ; Qing DAI ; Jian-Chu LI ; Fang LI ; Qiang SUN
Acta Academiae Medicinae Sinicae 2017;39(5):682-687
Objective To investigate the clinical values of combined diffused optical tomography (DOT) combined positron emission tomography-computed tomography (PET-CT) in the diagnosis of breast cancer. Methods We performed DOT and PET-CT examinations in 38 patients with 40 lesions and compared these images with the pathological results to analyze the sensitivity,specificity,accuracy,positive predictive value,and negative predictive value of these two techniques and their combination.Results The sensitivity,specificity,accuracy,positive predictive value,and negative predictive value in diagnosing breast cancer were 78.26%,76.47%,77.50%,72.22%,and 81.81% for DOT,86.96%,82.35%,85.00%,86.96%,and 82.35% for PET-CT,and 86.96%,94.12%,90.00%,95.23%,and 84.21% for the combination of PET-CT and DOT.Conclusions DOT and PET-CT are both effective diagnostic methods for breast cancer.Combined DOT and PET-CT can improve the diagnostic efficacy in terms of specificity,positive predictive value,and accuracy.
10.Individualized scalp acupuncture for motor dysfunction in stroke: a randomized controlled trial.
Jun WANG ; Jian PEI ; Xiao CUI ; Kexing SUN ; Qinhui FU ; Chunyan XING ; Chao JIANG ; Cuixia ZHOU ; Yujie CHEN ; Minghang YAN
Chinese Acupuncture & Moxibustion 2017;37(9):918-924
OBJECTIVETo evaluate the effect of individualized scalp acupuncture base on location of brain function for motor dysfunction in stroke patients.
METHODSA total of 180 patients were randomly assigned into an individualized scalp acupuncture (ISA) group, a conventional scalp acupuncture (CSA) group and a rehabilitation group, 60 cases in each one. In the ISA group, we stimulated Sishencong (EX-HN 1), motor area and balance area, matched with pre-motor area for higher muscle tension, application area and's three-needle for involuntary motion, application area for poor motor coordination, forehead five-needle for cognitive disorder, sensory area for sensory disturbance. In the CSA group, the affected Dingnieqianxiexian (MS 6), Dingniehouxiexian (MS 7) and Zhenxiapangxian (MS 14) were selected. Rehabilitation was used during needle retained in the two groups. Simple rehabilitation was used in the rehabilitation group. All the treatment was given from Monday to Friday for 4 weeks, once a day for 20 times. Eight-week follow-up was applied. The Fugl-Meyer assessment (FMA) for motor function, modified Barthel Index (MBI) were used to evaluate clinical effect.
RESULTSAfter treatment and at follow-up, FMA and MBI scores increased compared with those before treatment in the three groups(all<0.01), with significant differences among the three groups (all<0.000 1) and better results in the ISA group compared with those in the other two groups (<0.05,<0.01) at the two time points. The FMA and MBI scores in the CSA group were higher than those in the rehabilitation group after treatment and at follow-up (all<0.05).
CONCLUSIONThe individualized scalp acupuncture can improve motor dysfunction and self-care ability of daily life for stroke patients.

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