1.Expert consensus on the design and implementation of clinical safety centralized monitoring study of Chinese medical injection.
Jun-Hua ZHANG ; Jing-Tian REN ; Jing-Qing HU ; Yan-Ming XIE ; Hai-Bo SONG ; Ming-Jun ZHU ; Rui GAO ; Zhong WANG ; Wen-Ke ZHENG ; Xue-Lin LI ; Meng JIANG ; Yu-Hong HUANG ; Fang LU ; Li-Yun HE ; Wei-Xiong LIAN ; Zhong-Qi YANG ; Wei-An YUAN ; Si-Yuan HU ; Bao-He WANG ; Wei-Liang WANG ; De-Quan REN ; Bo-Li ZHANG ; null ; null
China Journal of Chinese Materia Medica 2017;42(1):6-9
Along with the increase of clinical application, the safety of traditional Chinese medicine gained more and more attentions. In particular, the safety evaluation of Chinese medical injections has become a mandatory task should be completed by pharmaceutical companies under the supervision of China Food and Drug Administration(CFDA). Due to the weak foundation of previous studies, the safety issues of Chinese medical injections have not been fully understood, and lack of scientific and rational risk management programs. Clinical safety centralized monitoring(CSCM) is an important method for post-market safety evaluation of Chinese medicine. Due to the lack of appropriate norms and procedures, the quality of similar research is uneven, and the results vary. Combined with practical experience with experts' suggestions, we developed this expert consensus on the design and implementation of CSCM from three stages (design, implementation and report) with 20 technical points, which will provide technical support for future CSCM studies.
2.Adverse effects of high-dose methotrexate therapy.
Qing SUN ; Yao XIE ; Wei-Hong ZHAO ; Ying HUA ; Peng-Hui WU ; Shuo LI ; Xin-Tian LU
Chinese Journal of Contemporary Pediatrics 2017;19(7):781-785
OBJECTIVETo investigate the adverse effects of high-dose methotrexate (HDMTX) therapy, and to provide a theoretical basis for optimizing clinical treatment.
METHODSA retrospective analysis was performed for the clinical data of 120 children with acute lymphoblastic leukemia or non-Hodgkin lymphoma who underwent 601 times of HDMTX therapy. The adverse effects of various systems were analyzed according to the WHO criteria for the classification of adverse effects of anticancer drugs.
RESULTSAlmost all the children experienced bone marrow suppression, and 93.3% had granulocytopenia. The most common adverse effects in the digestive system and urinary system were elevated glutamic-pyruvic transaminase (60.4%) and proteinuria (9.2%) respectively. For skin symptoms, skin erythema had the highest incidence rate (7.2%). The adverse effects in the nervous system (hyperpathia, numbness of extremities, or headache) were only observed in 7 cases. Serious adverse effects were only seen in the blood system and digestive system. Compared with the 3 g/mmethotrexate (MTX) group, the 5 g/mHDMTX group had a significantly higher 24-hour plasma MTX concentration, significant reductions in hemoglobin and platelet count, and significantly higher incidence rates of oral mucositis, proteinuria, and skin symptoms (P<0.05).
CONCLUSIONSSerious adverse effects of HDMTX therapy mainly involve the blood system and digestive system, and the adverse effects such as bone marrow suppression, oral mucositis, proteinuria, and skin symptoms occur in a dose-dependent manner.
Antimetabolites, Antineoplastic ; adverse effects ; Child ; Child, Preschool ; Dose-Response Relationship, Drug ; Female ; Humans ; Lymphoma, Non-Hodgkin ; drug therapy ; Male ; Methotrexate ; adverse effects ; Precursor Cell Lymphoblastic Leukemia-Lymphoma ; drug therapy ; Retrospective Studies
3.Comparative identification studies on wild and cultivated Glycyrrhiza uralensis produced Ningxia based on index components and near-infrared spectroscopy.
Tian-Yun DI ; Xiao-Juan GAO ; Xia ZHANG ; Jian-Jun ZHAO ; Jing-Jiao YONG ; Ling MA ; Ying-Hua WANG ; Han-Qing WANG
China Journal of Chinese Materia Medica 2017;42(3):536-541
This study is to construct a rapid and effective method for identification of wild and cultivated Glycyrrhiza uralensis (hereinafter referred to as Glycyrrhizae Radix et Rhizoma) from Ningxia by comparison of the difference in chromatography identification based on index components and near-infrared spectroscopy identification. HPLC and UV methods were used to determine the content of liquiritin, glycyrrhizate and total flavonoids for 9 wild Glycyrrhizae Radix et Rhizoma and 14 cultivated Glycyrrhizae Radix et Rhizoma samples,and the near-infrared spectroscopy was also,collected. The results illustrated that the chromatography identification based on index components could not identify wild and cultivated Glycyrrhizae Radix et Rhizoma from Ningxia, while near-infrared spectroscopy could quickly and effectively achieve it. It provides an effective method for the growth pattern identification and application of Glycyrrhizae Radix et Rhizoma.
4.Knockout of LSD1 Gene by CRISPR/Cas9 System Significantly Inhibited Proliferation and Expression of CD235a in K562 Cells.
Jie GAO ; Si-Rui REN ; Bing-Rui WANG ; Qing GUO ; Tian-Tian FENG ; Ding WANG ; Jin-Hua LIU ; Jing-Yuan TONG ; Li-Hong SHI
Journal of Experimental Hematology 2017;25(5):1327-1333
OBJECTIVETo study the effect of LSD1 knock-out on human chronic myeloid leukemia cells(K562 cells).
METHODSThe LSD1 gene in K562 cells was knocked-out specifically by using CRISPR/Cas9 system, the single cells were gained by flow cytometric sorting technique, the LSD1and LSD1cell lines were gained after amplificantion and culture, identification of Western blot and sequencing. The MTS assay was used to detect the effect of LSD1 knockout on the proliferation of K562 cells, the flow cytometry was used to examine the expression of K562 cell surface marker after LSD1 knockout.
RESULTSThe LSD1 stable knockout cell line of K562 (LSD1and LSD1)were successfully costructed. It was found that knockout of LSD1 significantly inhibited the proliferation of K562 and the expression of CD235a.
CONCLUSIONLSD1 plays a key role in the regulation of K562 cell proliferation and CD235a expression.
5.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.
6.Consensus by Chinese Expert Panel on-Resistant and-Persistent Infection.
Man-Li QI ; Yuan-Li GUO ; Qian-Qiu WANG ; Xiang-Sheng CHEN ; Jian-De HAN ; Xiao-Hong SU ; Wen-Hui LUN ; Hao CHENG ; Jin-Hua XU ; Hong-Qing TIAN ; Li CHEN ; Zhi-Yuan YAO ; Wen-Li FENG ; Juan JIANG ; Ping-Yu ZHOU ; Xian-Biao ZOU ; Hong-Hui XU ; Wei-Min SHI ; Jun LIU ; Lin ZHU ; Quan-Zhong LIU
Chinese Medical Journal 2017;130(23):2852-2856
7.Application of Keyhole Microneurosurgery in China.
Li-Gang CHEN ; Shu-Da CHEN ; Guang-Fu HUANG ; Ying HUANG ; De-Zhi KANG ; Qing LAN ; Gang LI ; Xin-Gang LI ; Zhi-Xiong LIU ; Song-Tao QI ; Xin-Hua TIAN ; Guo-Liang WANG ; Shuo WANG ; Xiang-Yu WANG ; Yong-Fei WANG ; Yun-Jie WANG ; Chao YOU ; Yan-Bing YU ; Shu-Yuan YUE ; Dong ZHANG ; Jian-Min ZHANG ; Jian-Ning ZHANG ; Jun-Ting ZHANG ; Shi-Zhong ZHANG ; Xian ZHANG ; Ya-Zhuo ZHANG ; Ji-Zong ZHAO ; Wei-Guo ZHAO ; Yuan-Li ZHAO ; Ding-Biao ZHOU ; Liang-Fu ZHOU ; null
Chinese Medical Journal 2017;130(16):1987-1994
8.Anesthesia management in robotic-assisted esophagectomy with triple incisions: analysis of 53 cases.
Xiao-Qing LIU ; Tian-Hua ZHANG ; Jing CHENG ; Hui-Ting LI ; Long-Hui CAO ; Zi-Hui TAN ; Wen-Qian LIN
Journal of Southern Medical University 2017;37(5):712-714
Between March, 2016 and January, 2017, 53 patients underwent robotic-assisted esophagectomy with triple incisions. All the patients were intubated with Double lumen endotracheal tub with one-lung ventilation and COpneumoperitoneum, and COpneumothorax was used in 7 cases. Most of the patients could tolerate OLV and COpneumoperitoneum, and 4 patients with COpneumothorax had hypoxemia and required double-lung ventilation or high frequency ventilation; 15 patients developed postoperative pulmonary complications and were transferred to ICU. These results suggest that COpneumothorax during robotic-assisted esophagectomy with triple incision seriously disturbs pulmonary function, and careful anesthesia management is essential for preventing complications.
9.Effect of Femoral Resection on Coronal Overall Alignment after Conventional Total Knee Arthroplasty.
Min-Wei ZHAO ; Lu WANG ; Lin ZENG ; Yu-Qing HU ; Jin-Xin HU ; Hua TIAN
Chinese Medical Journal 2016;129(21):2535-2539
BACKGROUNDA good postoperative alignment in total knee arthroplasty (TKA) is the key to achieving satisfactory results. We assessed the effect of femoral and tibial resection on the overall alignment after conventional TKA.
METHODSWe conducted a retrospective analysis of 212 primary TKAs in 188 patients. Intramedullary (IM)-guided resection was applied on the femoral side while extramedullary (EM)-guided resection was used on the tibial side. Using full-length X-ray, the preoperative femoral valgus angle and lower extremity alignment, as well as 2-week postoperative femoral and tibial prosthetic coronal alignment and overall lower extremity alignment, were measured.
RESULTSPostoperatively, good prosthetic alignment was achieved in 191 cases (90.1%) on the tibial side and in 144 cases (67.9%) on the femoral side (χ2 = 5.441, P = 0.02). Multiple linear regression analysis was used to assess the effect of different alignment sides on the overall alignment in the coronal plane. Data were divided into five subgroups based on the valgus or varus status of the prostheses. The standardized regression coefficients of the femoral and tibial prosthetic alignment on the overall alignment were 0.666 and 0.414, respectively; in varus on both sides were 0.658 and 0.377, respectively; in valgus, 0.555 and 0.030; femoral side varus and tibial side valgus, 0.702 and 0.211; femoral side valgus and tibial side varus, -0.416 and 0.287. The study showed that the overall low extremity alignment was statistically influenced by the prosthetic alignment, except for the tibial prosthetic alignment when femoral prosthesis was in valgus (P = 0.153).
CONCLUSIONSIn conventional TKA, tibial side EM-guided resection may offer satisfactory postoperative alignment, and femoral resection relying on IM guide may lead to more undesirable results. Postoperative coronal alignment is mainly affected by the femoral resection. Therefore, femoral side operation should receive adequate attention from the surgeons.
Arthroplasty, Replacement, Knee ; methods ; Asian Continental Ancestry Group ; Bone Malalignment ; prevention & control ; Femur ; surgery ; Humans ; Postoperative Period ; Retrospective Studies ; Tibia ; surgery
10.Knockdown of ezrin suppresses the migration and angiogenesis of human umbilical vein endothelial cells in vitro.
Liang-ping ZHAO ; Lei HUANG ; Xun TIAN ; Feng-qi LIANG ; Jun-cheng WEI ; Xian ZHANG ; Sha LI ; Qing-hua ZHANG
Journal of Huazhong University of Science and Technology (Medical Sciences) 2016;36(2):243-248
Progressive tumor growth is dependent on angiogenesis. The mechanisms by which endothelial cells (ECs) are incorporated to develop new blood vessels are not well understood. Recent studies reveal that the ezrin radixin moesin (ERM) family members are key regulators of cellular activities such as adhesion, morphogenetic change, and migration. We hypothesized that ezrin, one of the ERM family members, may play important roles in ECs organization during angiogenesis, and new vessels formation in preexisting tissues. To test this hypothesis, in this study, we investigated the effects of ezrin gene silencing on the migration and angiogenesis of human umbilical vein endothelial cells (HUVECs) in vitro. HUVECs were transfected with plasmids with ezrin-targeting short hairpin RNA by using the lipofectamine-2000 system. Wound assay in vitro and three-dimensional culture were used to detect the migration and angiogenesis capacity of HUVECs. The morphological changes of transfected cells were observed by confocal and phase contrast microscopy. Our results demonstrated that the decreased expression of ezrin in HUVECs significantly induced the morphogenetic changes and cytoskeletal reorganization of the transfected cells, and also reduced cell migration and angiogenesis capacity in vitro, suggesting that ezrin play an important role in the process of HUVECs migration and angiogenesis.
Cell Movement
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genetics
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Cytoskeletal Proteins
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genetics
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metabolism
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Cytoskeleton
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metabolism
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Human Umbilical Vein Endothelial Cells
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cytology
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metabolism
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physiology
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Humans
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Neovascularization, Physiologic
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genetics

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