1.Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients (version 2024)
Yao LU ; Yang LI ; Leiying ZHANG ; Hao TANG ; Huidan JING ; Yaoli WANG ; Xiangzhi JIA ; Li BA ; Maohong BIAN ; Dan CAI ; Hui CAI ; Xiaohong CAI ; Zhanshan ZHA ; Bingyu CHEN ; Daqing CHEN ; Feng CHEN ; Guoan CHEN ; Haiming CHEN ; Jing CHEN ; Min CHEN ; Qing CHEN ; Shu CHEN ; Xi CHEN ; Jinfeng CHENG ; Xiaoling CHU ; Hongwang CUI ; Xin CUI ; Zhen DA ; Ying DAI ; Surong DENG ; Weiqun DONG ; Weimin FAN ; Ke FENG ; Danhui FU ; Yongshui FU ; Qi FU ; Xuemei FU ; Jia GAN ; Xinyu GAN ; Wei GAO ; Huaizheng GONG ; Rong GUI ; Geng GUO ; Ning HAN ; Yiwen HAO ; Wubing HE ; Qiang HONG ; Ruiqin HOU ; Wei HOU ; Jie HU ; Peiyang HU ; Xi HU ; Xiaoyu HU ; Guangbin HUANG ; Jie HUANG ; Xiangyan HUANG ; Yuanshuai HUANG ; Shouyong HUN ; Xuebing JIANG ; Ping JIN ; Dong LAI ; Aiping LE ; Hongmei LI ; Bijuan LI ; Cuiying LI ; Daihong LI ; Haihong LI ; He LI ; Hui LI ; Jianping LI ; Ning LI ; Xiying LI ; Xiangmin LI ; Xiaofei LI ; Xiaojuan LI ; Zhiqiang LI ; Zhongjun LI ; Zunyan LI ; Huaqin LIANG ; Xiaohua LIANG ; Dongfa LIAO ; Qun LIAO ; Yan LIAO ; Jiajin LIN ; Chunxia LIU ; Fenghua LIU ; Peixian LIU ; Tiemei LIU ; Xiaoxin LIU ; Zhiwei LIU ; Zhongdi LIU ; Hua LU ; Jianfeng LUAN ; Jianjun LUO ; Qun LUO ; Dingfeng LYU ; Qi LYU ; Xianping LYU ; Aijun MA ; Liqiang MA ; Shuxuan MA ; Xainjun MA ; Xiaogang MA ; Xiaoli MA ; Guoqing MAO ; Shijie MU ; Shaolin NIE ; Shujuan OUYANG ; Xilin OUYANG ; Chunqiu PAN ; Jian PAN ; Xiaohua PAN ; Lei PENG ; Tao PENG ; Baohua QIAN ; Shu QIAO ; Li QIN ; Ying REN ; Zhaoqi REN ; Ruiming RONG ; Changshan SU ; Mingwei SUN ; Wenwu SUN ; Zhenwei SUN ; Haiping TANG ; Xiaofeng TANG ; Changjiu TANG ; Cuihua TAO ; Zhibin TIAN ; Juan WANG ; Baoyan WANG ; Chunyan WANG ; Gefei WANG ; Haiyan WANG ; Hongjie WANG ; Peng WANG ; Pengli WANG ; Qiushi WANG ; Xiaoning WANG ; Xinhua WANG ; Xuefeng WANG ; Yong WANG ; Yongjun WANG ; Yuanjie WANG ; Zhihua WANG ; Shaojun WEI ; Yaming WEI ; Jianbo WEN ; Jun WEN ; Jiang WU ; Jufeng WU ; Aijun XIA ; Fei XIA ; Rong XIA ; Jue XIE ; Yanchao XING ; Yan XIONG ; Feng XU ; Yongzhu XU ; Yongan XU ; Yonghe YAN ; Beizhan YAN ; Jiang YANG ; Jiangcun YANG ; Jun YANG ; Xinwen YANG ; Yongyi YANG ; Chunyan YAO ; Mingliang YE ; Changlin YIN ; Ming YIN ; Wen YIN ; Lianling YU ; Shuhong YU ; Zebo YU ; Yigang YU ; Anyong YU ; Hong YUAN ; Yi YUAN ; Chan ZHANG ; Jinjun ZHANG ; Jun ZHANG ; Kai ZHANG ; Leibing ZHANG ; Quan ZHANG ; Rongjiang ZHANG ; Sanming ZHANG ; Shengji ZHANG ; Shuo ZHANG ; Wei ZHANG ; Weidong ZHANG ; Xi ZHANG ; Xingwen ZHANG ; Guixi ZHANG ; Xiaojun ZHANG ; Guoqing ZHAO ; Jianpeng ZHAO ; Shuming ZHAO ; Beibei ZHENG ; Shangen ZHENG ; Huayou ZHOU ; Jicheng ZHOU ; Lihong ZHOU ; Mou ZHOU ; Xiaoyu ZHOU ; Xuelian ZHOU ; Yuan ZHOU ; Zheng ZHOU ; Zuhuang ZHOU ; Haiyan ZHU ; Peiyuan ZHU ; Changju ZHU ; Lili ZHU ; Zhengguo WANG ; Jianxin JIANG ; Deqing WANG ; Jiongcai LAN ; Quanli WANG ; Yang YU ; Lianyang ZHANG ; Aiqing WEN
Chinese Journal of Trauma 2024;40(10):865-881
Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.
2. The therapeutic effect of Balanophora polysaccharide on acetic acid gastric ulcer in rats and its mechanism
De-Yao XIA ; Fang-Yu ZHAO ; Xian-Bing CHEN ; De-Yao XIA ; Sheng-Zhe HUANG ; Yi-Ru ZHAO ; Jiang-Hua WANG ; Jun-Yan MOU ; Feng-Jie WANG ; Xian-Bing CHEN
Chinese Pharmacological Bulletin 2023;39(1):193-199
Aim To study the therapeutic effect of Balanophora polysaccharide(BPS)on gastric ulcer(GU)induced by acetic acid in rats and to investigateits mechanisms. Methods Sixty male SD rats were randomly divided into sham-operated group, GU model group, omeprazole positive group(3.6 mg·kg-1), and low, medium and high dose of BPS treatment groups(100, 200 and 400 mg·kg-1). The GU model group was prepared by acetic acid cautery method, and the morphology and pathological changes of ulcers were observed by visual observation combined with HE staining, and the ulcer area and inhibition rate were measured and calculated; superoxide dismutase(SOD)activity, malondialdehyde(MDA)content and glutathione peroxidase(GSH-PX)activity were measured by enzymatic assay; tumor necrosis factor-α(TNF-α)and interleukin-6(IL-6)content were detected by ELISA. The expression levels of epidermal growth factor(EGF)and epidermal growth factor receptor(EGFR)were measured by immunohistochemistry staining and Western blot. Results Compared with the sham-operated group, obvious ulcer damage was seen in the model group. Compared with the model group, the BPS-treated group showed a significant reduction in ulcer area, an increase in SOD and GSH-PX activity and EGF and EGFR expression levels, and a significant decrease in MDA, TNF-α and IL-6 content. Conclusions BPS has a therapeutic effect on GU in rats, and its mechanism may be related to the inhibition of oxidative stress, suppression of inflammatory stimuli and promotion of regenerative repair of gastric mucosa.
3.Analysis of Chinese Medical Syndrome Features of Ischemic Stroke Based on Similarity of Symptoms Subgroup.
Xiao-Qing LIU ; Run-Shun ZHANG ; Xue-Zhong ZHOU ; Hong ZHOU ; Yu-Yao HE ; Shu HAN ; Jing ZHANG ; Zi-Xin SHU ; Xue-Bin ZHANG ; Jing-Hui JI ; Quan ZHONG ; Li-Li ZHANG ; Zi-Jun MOU ; Li-Yun HE ; Lun-Zhong ZHANG ; Jie YANG ; Yan-Jie HU ; Zheng-Guang CHEN ; Xiao-Zhen LI ; Yan TAN ; Zhan-Feng YAN ; Ke-Gang CAO ; Wei MENG ; He ZHAO ; Wei ZHANG ; Li-Qun ZHONG
Chinese journal of integrative medicine 2023;29(5):441-447
OBJECTIVE:
To derive the Chinese medicine (CM) syndrome classification and subgroup syndrome characteristics of ischemic stroke patients.
METHODS:
By extracting the CM clinical electronic medical records (EMRs) of 7,170 hospitalized patients with ischemic stroke from 2016 to 2018 at Weifang Hospital of Traditional Chinese Medicine, Shandong Province, China, a patient similarity network (PSN) was constructed based on the symptomatic phenotype of the patients. Thereafter the efficient community detection method BGLL was used to identify subgroups of patients. Finally, subgroups with a large number of cases were selected to analyze the specific manifestations of clinical symptoms and CM syndromes in each subgroup.
RESULTS:
Seven main subgroups of patients with specific symptom characteristics were identified, including M3, M2, M1, M5, M0, M29 and M4. M3 and M0 subgroups had prominent posterior circulatory symptoms, while M3 was associated with autonomic disorders, and M4 manifested as anxiety; M2 and M4 had motor and motor coordination disorders; M1 had sensory disorders; M5 had more obvious lung infections; M29 had a disorder of consciousness. The specificity of CM syndromes of each subgroup was as follows. M3, M2, M1, M0, M29 and M4 all had the same syndrome as wind phlegm pattern; M3 and M0 both showed hyperactivity of Gan (Liver) yang pattern; M2 and M29 had similar syndromes, which corresponded to intertwined phlegm and blood stasis pattern and phlegm-stasis obstructing meridians pattern, respectively. The manifestations of CM syndromes often appeared in a combination of 2 or more syndrome elements. The most common combination of these 7 subgroups was wind-phlegm. The 7 subgroups of CM syndrome elements were specifically manifested as pathogenic wind, pathogenic phlegm, and deficiency pathogens.
CONCLUSIONS
There were 7 main symptom similarity-based subgroups in ischemic stroke patients, and their specific characteristics were obvious. The main syndromes were wind phlegm pattern and hyperactivity of Gan yang pattern.
Humans
;
Syndrome
;
Ischemic Stroke
;
Medicine, Chinese Traditional
;
Liver
;
Phenotype
4.Clinical trial of two different antiplatelet regimens in patients with acute myocardial infarction
Yan-Jie LIU ; Zhan-Hu LI ; Li-Na MOU ; Xue-Lian LIU
The Chinese Journal of Clinical Pharmacology 2023;39(24):3561-3565
Objective To study the efficacy and safety of different dual antiplatelet therapy(DAPT)in patients with acute myocardial infarction(AMI)undergoing percutaneous coronary intervention(PCI)treatment.Methods AMI patients receiving PCI treatment were randomly divided into treatment group and control group.The treatment group was given clopidogrel(50 mg,bid)combined with ticagrelor(90 mg,bid)after PCI,while the control group was given aspirin(100 mg,qd)combined with clopidogrel(75 mg,qd)after PCI.The treatment course for both groups was 6 months.Platelet activation and endothelial function-related indicators were compared between the two groups,and major adverse cardiovascular events(MACE)and adverse drug reactions were followed up during the treatment period.Results During the trial,5 cases dropped out,and finally,98 cases and 97 cases were included in the treatment group and control group,respectively.After treatment,the incidence of stent restenosis in the treatment group and control group were 2.04%(2 cases/98 cases)and 9.27%(9 cases/97 cases),respectively;the incidence of MACE were 4.08%(4 cases/98 cases)and 13.40%(13 cases/97 cases),respectively,with significant differences between the two groups(P<0.05).After treatment,the inhibition of platelet aggregation(IPA)in the treatment group and control group were(54.97±6.43)%and(52.38±6.12)%,respectively;the serum nitric oxide(NO)levels were(64.29±8.12)and(59.61±8.45)μmol·L-1,respectively;the prostacyclin(PGI2)levels were(42.15±3.94)and(38.46±3.71)ng·L-1,respectively;the maximum platelet aggregation rate(MPAR)were(31.65±3.86)%and(32.97±4.25)%,respectively;the platelet count(PC)were(169.84±36.71)× 109·L-1 and(172.63±38.94)× 109·L-1,respectively;the positive rates of P-selectin(CD62P)were(24.58±5.34)%and(27.13±5.82)%;the positive rates of platelet activated complex-1(PAC-1)were(7.63±2.15)%and(8.45±2.69)%;serum endothelin-1(ET-1)levels were(61.03±5.97)and(65.39±7.14)ng·L-1,which were significantly reduced compared with those before treatment(all P<0.05).The adverse drug reactions in treatment group were mainly headache,dyspnea and bleeding events,and the adverse drug reactions in control group were mainly dyspnea and bleeding events.The total incidence rates of adverse drug reactions in treatment group and control group were 11.22%(11 cases/98 cases)and 9.28%(9 cases/97 cases),respectively(P>0.05).Conclusion Cilostazol combined with ticagrelor in patients with AMI after PCI is beneficial to inhibiting the platelet aggregation and activation,relieving the vascular endothelial function injury and reducing the risk of in-stent restenosis and MACE,and it has obvious advantages over aspirin combined with clopidogrel.
5.Rule of point selection in treatment of cerebral palsy in children with acupuncture based on data mining of 1584 electronic medical records.
Zi-Jun MOU ; Li-Yun HE ; Hu-Jie SONG ; Qiu CHENG ; Bao-Yan LIU
Chinese Acupuncture & Moxibustion 2021;41(3):355-358
OBJECTIVE:
To explore the rule of point selection in treatment of cerebral palsy with acupuncture in preschool children.
METHODS:
Based on the electronic medical records of Xi'an Encephalopathy Hospital of TCM, through structuring medical record text, acupuncture prescriptions were extracted. Using the data mining tools of the ancient and modern medical record cloud platform V2.2.3 and the clinical effective prescription and molecular mechanism analysis system of traditional Chinese medicine V2.0, the cluster analysis and complex network analysis were conducted on acupuncture prescriptions.
RESULTS:
Of 1584 acupuncture prescriptions for cerebral palsy in children, there were 84 acupoints and stimulating areas of scalp acupuncture, of which, foot-motor-sensory area, balance area and Sanyinjiao (SP 6) were the top 3 acupoints with the highest use rate. With cluster analysis, 5 groups of common supplementary acupoints and stimulating areas were found, named, Weizhong (BL 40) and Waiguan (TE 5), Shousanli (LI 10), Xingjian (LR 2), Xuanzhong (GB 39) and Chengfu (BL 36), foot-motor-sensory area, balance area and Sanyinjiao (SP 6), Xuehai (SP 10) and Fenglong (ST 40), Pishu (BL 20), motor area and Yanglingquan (GB 34). With complex network analysis on core prescriptions, 13 core acupoints and stimulating areas of scalp acupuncture were obtained, including 3 core main points, i.e. Sanyinjiao (SP 6), balance area and foot-motor-sensory area and 10 sub-core points, i.e. Taichong (LR 3), motor area, Xuehai (SP 10), Ganshu (BL 18), Pishu (BL 20), Yanglingquan (GB 34), Sishencong (EX-HN 1), Baihui (GV 20), Fengchi (GB 20) and Shenshu (BL 23).
CONCLUSION
In treatment of acupuncture for cerebral palsy in preschool children, the core prescriptions reveal the simultaneous treatment of exterior and interior, the mutual regulation of
Acupuncture Points
;
Acupuncture Therapy
;
Cerebral Palsy/therapy*
;
Child, Preschool
;
Data Mining
;
Electronic Health Records
;
Humans
6.Effect of Kidney-nourishing,Blood-activating,Phlegm-resolving and Resuscitation-inducing Decoction on Expression of NMDA Receptor Subtypes in Cochlear Spiral Ganglion Neurons of Tinnitus Rats
Guo Qin SUN ; Meng LUO ; Bo JIANG ; Mei Xian ZHANG ; Jie Hong XU ; Jie Yan MOU ; Kun LYU ; Qian YANG
Journal of Guangzhou University of Traditional Chinese Medicine 2018;35(1):129-134
Objective To observe the effect of Kidney-nourishing, Blood-activating, Phlegm-resolving and Resuscitation-inducing Decoction(KBPRD)on the expression of N-methyl-D-aspartate(NMDA)receptor subtype 1,2A,2B(NR1,NR2A,NR2B)in the cochlear spiral ganglion neurons(SGN)of tinnitus rats and to explore its mechanism, thus to provide experimental evidence for the treatment of tinnitus with KBPRD. Methods Sixty rats were randomly divided into normal group,model group,western medicine group,and low-,middle-,and high-dose Chinese medicine groups, 10 rats in each group. Rats were given intraperitoneal injection of sodium salicylate combined with water deprivation to induce tinnitus model. After successful establishment of the model, the rats in low-,middle-,and high-dose Chinese medicine groups were given gastric administration of KBPRD in the dosage of 5.5, 11, 22 g·kg-1·d-1 respectively, the rats in western medicine group were given gastric administration of 5 mg·kg-1·d-1 of carbamazepine,and rats in the model group and normal group were given gastric administration of 2 mL of normal saline,once every day,treatment time covering 8 weeks. The expression levels of NR1,NR2A,and NR2B in the cochlear SGN was detected by immunoblotting and real-time quantitative reverse transcription-polymerase chain reaction(qRT-PCR)after 8 weeks of treatment. Results Compared with the normal group,the expression levels of NR1, NR2A and NR2B in the model group were increased, the difference being significant (P < 0.05). Compared with the model group,the expression of NR1,NR2A and NR2B in low-,middle-,and high-dose Chinese medicine groups were significantly decreased(P<0.05).Conclusion KBPRD is effective on relieving tinnitus of rats, and its mechanism is correlated with lowering the increased expression of NR1,NR2A and NR2B in SGN of tinnitus rats.
7.Knockout of BMAL1 Gene Induces Apoptosis of HL-60 Cells and Inhibits its Proliferation.
Jiao MOU ; Jin-Qian DAI ; Ming-Li LIU ; Qing-Ren NI ; Yun-Jie ZHANG ; Jing WEN ; Yan-Ping SONG
Journal of Experimental Hematology 2018;26(4):1027-1032
OBJECTIVETo explore the biological function of BMAL1 in human acute myeloid leukemia by means of the HL-60 cell line in whica circadian gene BMAL1 was konocked-out by the CRISPR/Cas9 technology.
METHODSTwo sgRNAs for BMAL1 were designed and the PX459 knockout vectors containing the sgRNA were constructed. The activity of 2 sgRNAs was detected by T7 endonuclease I. the BMAL1 knocked out HL-60 cells were prepared by transient transfection of the target vectors into the cells. Western blot was used to detect the expression of BMAL1 protein. The apoptosis of the targeted cells was detected by flow cytometry. The proliferation status of the cells was assessed by the CCK-8 assay.
RESULTSThe PX459-sgRNA vectors were successfully constructed and screened to assure the activity of the targeting vector. It was found that the expression of BMAL1 protein was not detected in BMAL1-knocked out HL- 60 cells. Further, it was shown that BMAL1 knockdout could promote the apoptosis of HL-60 cells and inhibit the cell proliferation ability.
CONCLUSIONBMAL1 knocked out HL-60 cells have bean successfully established using the CRISPR/Cas9 gene editing technique, and BMAL1 knockout can promote the HL-60 cell apoptosis and inhibit its proliferation.These result reveal the biological role of the BMAL1 circadian gene in acute myeloid leukemia.
Apoptosis ; Cell Proliferation ; HL-60 Cells ; Humans ; Leukemia, Myeloid, Acute ; Transfection
8.The diagnostic value of fractional exhaled nitric oxide in allergic asthma
Su-Lan WEI ; Jian WANG ; Yan MOU ; Yan-Jie YANG ; Mei-Ling JIN ; Lei ZHU ; Ling YE
Chinese Journal of Clinical Medicine 2017;24(5):710-714
Objective:To evaluate the diagnostic value of fractional exhaled nitric oxide (FeNO) in allergic asthma.Methods:A total of 147 cases of asthma patients who were newly diagnosed or non-standardly treated in the Respiratory Department of Zhongshan Hospital Affiliated to Fudan University from August 2015 to September 2016 were enrolled.The patients were divided into allergic asthma group (n =107) and non-allergic asthma group (n =40).Before standardized treatment,FeNO,lung function,and serum total IgE tests were performed.The receiver operating characteristic curve (ROC) was made to evaluate the diagnostic value of FeNO in allergic asthma.Results:The values of FeNO and total serum IgE were significantly higher in allergic asthma group than those in non-allergic asthma group (P<0.05),but there was no statistical difference between these two groups in FEV1 % pred,FEV1/FVC,or FVC% pred.In allergic asthma group,the FeNO level was positively correlated with serum total IgE (r=0.298,P<0.001),but had no correlation with FEV1 %pred,FEV1/FVC,or FVC%pred.There was no correlation between FeNO and serum total IgE,FEV1 %,FEV1/FVC,or FVC% in non-allergic asthma group.In allergic asthma group,there was no statistical difference in FeNO levels between positive and negative patients in the bronchial dilation test.The cut-off value of FeNO to differentiate allergic asthma was 40.05 ppb (1 ppb =1 μL/m3) according to the ROC curve (AUC 0.971,sensitivity 96.3%,specificity 85.0%).Conclusions:FeNO is significantly increased in newly diagnosed or non-standard treatment of allergic asthma and has positive correlation with serum total IgE.When the FeNO value is above 40.05 ppb,the diagnosis of allergic asthma is highly likely.
9.The clinical comparison of totally laparoscopic versus open total gastrectomy for gastric cancer.
Ke CHEN ; Yi-Ping MOU ; Xiao-Wu XU ; Jie WANG ; Jia-Fei YAN ; Ren-Chao ZHANG ; Yu-Cheng ZHOU
Chinese Journal of Surgery 2013;51(1):22-25
OBJECTIVETo investigate the feasibility, safety and oncological effect of totally laparoscopic total gastrectomy (TLTG).
METHODSThe clinical data of TLTG cases and open total gastrectomy (OTG) patients between November 2007 and October 2011 were analyzed. Also compared the feasibility, safety and short-term outcomes of TLTG with OTG.
RESULTSNinty cases were analyzed. There were 18 cases in the TLTG group and 72 cases in the OTG group. Operation time was significantly longer in the TLTG group ((310 ± 86) minutes) than in the OTG group ((256 ± 57) min, t = 4.963, P = 0.002), However, the blood loss were significantly lower in the TLTG group ((136 ± 84) ml vs. (359 ± 141) ml, t = -11.734, P = 0.000). The post operative morbidity was similar between the TLTG and OTG group. First flatus time (t = -7.020), first diet time (t = -6.166 and -5.698), and post operative hospital stay (t = -4.610) were significantly shorter in the TLTG group than in the OTG group (P < 0.05).
CONCLUSIONSLTG is a safe and feasible procedure with quick post-operation recovery. The laparoscopic side-to-side esophagojejunal anastomosis is a safe and feasible method of alimentary reconstruction after laparoscopic total gastrectomy.
Adult ; Aged ; Female ; Gastrectomy ; methods ; Humans ; Laparoscopy ; Laparotomy ; Length of Stay ; Lymph Node Excision ; Male ; Middle Aged ; Stomach Neoplasms ; surgery ; Treatment Outcome
10.Efficacy and safety of Changfu peritoneal dialysis solution: a multi-center prospective randomized controlled trial.
Jian-Hui ZHOU ; Zhao-Hui NI ; Chang-Lin MEI ; Xue-Qing YU ; Fu-You LIU ; Li-Ning MIAO ; Zhi-Hong LIU ; Wei-Jie YUAN ; Ai-Ping ZHANG ; Hong-Li LIN ; Meng-Hua CHEN ; Jiang-Hua CHEN ; Jin-Yuan ZHANG ; Ya-Ni HE ; Jian CHEN ; Jiu-Yang ZHAO ; Xiao-Qiang DING ; Ying LI ; Rong-Shan LI ; Ru-Juan XIE ; Wen-Hu LIU ; Chang-Ying XING ; Rong WANG ; Yue-Yi DENG ; Xue-Ying CAO ; Guang-Yan CAI ; Shan MOU ; Zhi-Guo MAO ; Xiao YANG ; Hong LIU ; Jing SUN ; Yu-Sheng YU ; Jun LIU ; Shu-Mei SHI ; Long-Kai LI ; Na TIAN ; Xiao-Hui ZHANG ; Wei ZHOU ; Jie YANG ; Yong ZHANG ; Jing-di SUN ; Jun JI ; Tao ZHANG ; Yan YAN ; Xiao-Gang LIU ; Gang WANG ; Li ZHANG ; Hong ZHANG ; Jian-Hua LUO ; Xiang-Mei CHEN
Chinese Medical Journal 2013;126(22):4204-4209
BACKGROUNDA multi-center large scale study is needed to confirm the efficacy and safety of domestic peritoneal dialysis (PD) solutions. Some researchers believe that 6 L/d is enough for adequate dialysis, but there is no multi-center prospective study on Chinese population to confirm this. In this study, we evaluated the efficacy and safety of domestic PD solution (Changfu) and its difference between 6 L and 8 L dosage.
METHODSAdult PD patients who had taken PD therapy for at least one month were selected and divided into four groups according to two dialysis solution brands and two dialysis dosages, i.e., 6 L dose with Changfu dialysis solution, 6 L dose with Baxter dialysis solution, 8 L dose with Changfu dialysis solution, and 8 L dose with Baxter dialysis solution. After 48 weeks, the changes of primary and secondary efficacy indices were compared between different types and different dosages. We also analyzed the changes of safety indices.
RESULTSChanges of Kt/V from baseline to 48 weeks between Changfu and Baxter showed no statistical differences; so did those of creatinine clearance rate (Ccr). Normalized protein catabolic rate (nPCR) from baseline to 48 weeks between Changfu and Baxter showed no statistical differences; so did those of net ultrafiltration volume (nUF) and estimated glomerular filtration rate (eGFR). Changes of nPCR from baseline to 48 weeks between 6 L and 8 L showed no statistical differences; so did those of nUF and eGFR. The decline of Kt/V from baseline to 48 weeks in 6 L group was more than that in 8 L group. Change of Ccr was similar. During the 48-week period, the mean Kt/V was above 1.7/w, and mean Ccr was above 50 L×1.73 m(-2)×w(-1). More adverse events were found in Changfu group before Changfu Corporation commenced technology optimization, and the statistical differences disappeared after that.
CONCLUSIONSThe domestic PD solution (Changfu) was proven to be as effective as Baxter dialysis solution. During 48-week period, a dosage of 6 L/d was enough for these patients to reach adequate PD. Clinical study promotes technological optimization, further helps to improve the safety indices of the medical products.
Adolescent ; Adult ; Aged ; Dialysis Solutions ; therapeutic use ; Female ; Humans ; Male ; Middle Aged ; Peritoneal Dialysis ; methods ; Young Adult

Result Analysis
Print
Save
E-mail