1.Incidence and prognosis of olfactory and gustatory dysfunctions related to infection of SARS-CoV-2 Omicron strain: a national multi-center survey of 35 566 population.
Meng Fan LIU ; Rui Xia MA ; Xian Bao CAO ; Hua ZHANG ; Shui Hong ZHOU ; Wei Hong JIANG ; Yan JIANG ; Jing Wu SUN ; Qin Tai YANG ; Xue Zhong LI ; Ya Nan SUN ; Li SHI ; Min WANG ; Xi Cheng SONG ; Fu Quan CHEN ; Xiao Shu ZHANG ; Hong Quan WEI ; Shao Qing YU ; Dong Dong ZHU ; Luo BA ; Zhi Wei CAO ; Xu Ping XIAO ; Xin WEI ; Zhi Hong LIN ; Feng Hong CHEN ; Chun Guang SHAN ; Guang Ke WANG ; Jing YE ; Shen Hong QU ; Chang Qing ZHAO ; Zhen Lin WANG ; Hua Bin LI ; Feng LIU ; Xiao Bo CUI ; Sheng Nan YE ; Zheng LIU ; Yu XU ; Xiao CAI ; Wei HANG ; Ru Xin ZHANG ; Yu Lin ZHAO ; Guo Dong YU ; Guang Gang SHI ; Mei Ping LU ; Yang SHEN ; Yu Tong ZHAO ; Jia Hong PEI ; Shao Bing XIE ; Long Gang YU ; Ye Hai LIU ; Shao wei GU ; Yu Cheng YANG ; Lei CHENG ; Jian Feng LIU
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2023;58(6):579-588
Objective: This cross-sectional investigation aimed to determine the incidence, clinical characteristics, prognosis, and related risk factors of olfactory and gustatory dysfunctions related to infection with the SARS-CoV-2 Omicron strain in mainland China. Methods: Data of patients with SARS-CoV-2 from December 28, 2022, to February 21, 2023, were collected through online and offline questionnaires from 45 tertiary hospitals and one center for disease control and prevention in mainland China. The questionnaire included demographic information, previous health history, smoking and alcohol drinking, SARS-CoV-2 vaccination, olfactory and gustatory function before and after infection, other symptoms after infection, as well as the duration and improvement of olfactory and gustatory dysfunction. The self-reported olfactory and gustatory functions of patients were evaluated using the Olfactory VAS scale and Gustatory VAS scale. Results: A total of 35 566 valid questionnaires were obtained, revealing a high incidence of olfactory and taste dysfunctions related to infection with the SARS-CoV-2 Omicron strain (67.75%). Females(χ2=367.013, P<0.001) and young people(χ2=120.210, P<0.001) were more likely to develop these dysfunctions. Gender(OR=1.564, 95%CI: 1.487-1.645), SARS-CoV-2 vaccination status (OR=1.334, 95%CI: 1.164-1.530), oral health status (OR=0.881, 95%CI: 0.839-0.926), smoking history (OR=1.152, 95%CI=1.080-1.229), and drinking history (OR=0.854, 95%CI: 0.785-0.928) were correlated with the occurrence of olfactory and taste dysfunctions related to SARS-CoV-2(above P<0.001). 44.62% (4 391/9 840) of the patients who had not recovered their sense of smell and taste also suffered from nasal congestion, runny nose, and 32.62% (3 210/9 840) suffered from dry mouth and sore throat. The improvement of olfactory and taste functions was correlated with the persistence of accompanying symptoms(χ2=10.873, P=0.001). The average score of olfactory and taste VAS scale was 8.41 and 8.51 respectively before SARS-CoV-2 infection, but decreased to3.69 and 4.29 respectively after SARS-CoV-2 infection, and recovered to 5.83and 6.55 respectively at the time of the survey. The median duration of olfactory and gustatory dysfunctions was 15 days and 12 days, respectively, with 0.5% (121/24 096) of patients experiencing these dysfunctions for more than 28 days. The overall self-reported improvement rate of smell and taste dysfunctions was 59.16% (14 256/24 096). Gender(OR=0.893, 95%CI: 0.839-0.951), SARS-CoV-2 vaccination status (OR=1.334, 95%CI: 1.164-1.530), history of head and facial trauma(OR=1.180, 95%CI: 1.036-1.344, P=0.013), nose (OR=1.104, 95%CI: 1.042-1.171, P=0.001) and oral (OR=1.162, 95%CI: 1.096-1.233) health status, smoking history(OR=0.765, 95%CI: 0.709-0.825), and the persistence of accompanying symptoms (OR=0.359, 95%CI: 0.332-0.388) were correlated with the recovery of olfactory and taste dysfunctions related to SARS-CoV-2 (above P<0.001 except for the indicated values). Conclusion: The incidence of olfactory and taste dysfunctions related to infection with the SARS-CoV-2 Omicron strain is high in mainland China, with females and young people more likely to develop these dysfunctions. Active and effective intervention measures may be required for cases that persist for a long time. The recovery of olfactory and taste functions is influenced by several factors, including gender, SARS-CoV-2 vaccination status, history of head and facial trauma, nasal and oral health status, smoking history, and persistence of accompanying symptoms.
Female
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Humans
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Adolescent
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SARS-CoV-2
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Smell
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COVID-19/complications*
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Cross-Sectional Studies
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COVID-19 Vaccines
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Incidence
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Olfaction Disorders/etiology*
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Taste Disorders/etiology*
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Prognosis
2.MaxEnt model-ArcGIS-based evaluation of habitat suitability of Hedysari Radix
Xin LIN ; Cheng-Yi LI ; Xiao-Cheng WEI ; Rui-Juan ZHOU ; Guang-Mao ZHANG ; Yao-Hui XIE ; Xue-Yan TAN ; Shan-Ru LIU
Chinese Traditional Patent Medicine 2023;45(12):4005-4010
AIM To evaluate the habitat suitability of Hedysari Radix based on MaxEnt model and ArcGIS.METHODS Using the MaxEnt model to screen the ecological factors affecting the distribution of Hedysari Radix,an evaluation model was thus established.ArcGIS software was used to evaluate the ecological suitability of Hedysari Radix to obtain the data about the highly suitable area,the moderate suitable area,the low suitable area and non-suitable area for its growth in China.RESULTS Hedysari Radix found its 1.29×106 km2 suitable area in China,among which the highly suitable area was 5×104 km2,mainly in Gansu Province,the moderately suitable area was 3.38×105 km2,and the low-suitable area was 9×105 km2,occupying 4.03%,26.20%and 69.77%of all,respectively.The main ecological factors affecting the distribution of Hedysari Radix were determined to be altitude,precipitation in the hottest quarter,solar radiation in September and December,seasonal temperature variation deviation and basic saturation of upper soil(0-30 cm).CONCLUSION With its result complying well with the literature records,this study provides theoretical basis for the introduction and cultivation of Hedysari Radix,and sustainable utilization of resources as well.
3.Panax Notoginseng Saponins Inhibits Ventricular Remodeling after Myocardial Infarction in Rats Through Regulating ATF3/MAP2K3/p38 MAPK and NF κ B Pathway.
Ru-Feng MA ; Guang CHEN ; Hong-Zheng LI ; Yun ZHANG ; Yong-Mei LIU ; Hao-Qiang HE ; Chen-Yue LIU ; Zi-Cong XIE ; Zhen-Peng ZHANG ; Jie WANG
Chinese journal of integrative medicine 2020;26(12):897-904
OBJECTIVE:
To explore whether Panax notoginseng saponins (PNS) exhibits heart protective effect in myocardial infarction (MI) rats and to identify the potential signaling pathways involved.
METHODS:
MI rats induced by ligating the left anterior descending (LAD) coronary artery were assigned to sham coronary artery ligation or coronary artery ligation. Totally 36 Sprague-Dawley rats were randomly divided into sham group (distilled water, n=9), MI group (distilled water, n=9), PNS group (PNS, 40 mg/kg daily, n=9) and fosinopril group (FIP, 1.2 mg/kg daily, n=9) according to a random number table. The left ventricular morphology and function were conducted by echocardiography. Histological alterations were evaluated by the stainings of HE and Masson. The serum levels of C reactive protein (CRP), tumor necrosis factor α (TNF-α), growth differentiation factor-15 (GDF-15) and the ratio of metalloproteinase-9 (MMP-9) and tissue inhibitor of MMP-9 (TIMP-1) were determined by ELISA. The levels of activating transcription factor 3 (ATF3), mitogen-activated protein kinase kinase 3 (MAP2K3), p38 mitogen-activated protein kinase (p38 MAPK), phosphorylation of p38 MAPK (p-p38 MAPK), transforming growth factor-β (TGF-β1), collagen I, nuclear factor kappa B p65 (NFκB p65), phosphorylation of NFκB p65 (p-NFκB p65), and phosphorylation of inhibitory kappa Bα (p-Iκ Bα) in hearts were measured by Western blot and immunohistochemical staining, respectively.
RESULTS:
PNS improved cardiac function and fibrosis in MI rats (P<0.05). The serum levels of CRP, TNF-α, GDF-15 and the ratio of MMP9/TIMP1 were reversed by PNS in MI rats. The expressions of TGF-β1, collagen I, MAP2K3, p38 MAPK, p-p38 MAPK, NFκB p65, p-NFκB p65, and p-IκBα were down-regulated, while ATF3 increased with the treatment of PNS (P<0.05).
CONCLUSIONS
PNS may improve cardiac function and fibrosis in MI rats via regulating ATF3/MAP2K3/p38 MAPK and NFκB signaling pathways. These results suggest the potential of PNS in preventing the development of ventricular remodeling in MI rats.
4.Comprehensive treatment with Chinese medicine in patients with advanced non-small cell lung cancer: A multicenter, prospective, cohort study.
Jie LIU ; Hong-Sheng LIN ; Wei HOU ; Bao-Jin HUA ; Pei-Tong ZHANG ; Jie LI ; Shen-Yu WANG ; Ying XIE ; Yue ZHANG ; Guang-Ru XIE ; Mei-Ying ZHANG ; Wen-Guang SHI ; Nian-Bo GUAN ; Tian-Yu GUAN ; Cong-Huang LI ; Li-Yuan LU ; Ying ZHANG ; Dao-Rui LI ; Hao LIU
Chinese journal of integrative medicine 2017;23(10):733-739
OBJECTIVETo determine whether additional Chinese medicine (CM) could prolong survival and improve the quality of life (QOL) in patients with advanced non-small cell lung cancer (NSCLC) compared with Western medicine (WM) alone.
METHODSThis was a multicenter, prospective cohort study. A total of 474 hospitalized patients with stage III-IV NSCLC were recruited and divided into 2 groups. Patients in the WM group received radiotherapy, chemotherapy, and optimal supportive therapy according to the National Comprehensive Cancer Network (NCCN) guidelines. In the integrative medicine (IM) group, individualized CM (Chinese patent medicines and injections) and WM were administered. The primary end point was overall survival, and the secondary end points were time to disease progression, adverse events, and QOL. Follow-up clinical examinations and chest radiography were performed every 2 months.
RESULTSThe median survival was 16.60 months in the IM group and 13.13 months in the WM group (P<0.01). The incidences of loss of appetite, nausea, and vomiting in the IM group were significantly lower than those in the WM group (P<0.05). The QOL based on Functional Assessment of Cancer Therapy-Lung in the IM group was markedly higher than that in the WM group at the fourth course (P<0.05).
CONCLUSIONSAdditional CM may prolong survival and improve the QOL patients with NSCLC. The adverse effects of radio- and chemotherapy may be attenuated as CM is used in combination with conventional treatments.
5.A Retrospective Study of Chinese Herbal Medicine Combined with Systemic Chemotherapy and/or Regional Arterial Perfusion for Pancreatic Cancer with Liver Metastases.
Hua-qiang OUYANG ; Zhan-yu PAN ; Fang LIU ; Guang-ru XIE ; Zhu-chen YAN
Chinese Journal of Integrated Traditional and Western Medicine 2015;35(6):654-658
OBJECTIVETo evaluate the efficacy and safety of Chinese herbal medicine combined with systemic chemotherapy and/or regional arterial perfusion for pancreatic cancer with liver metastases (PCLM).
METHODSWe retrospectively selected 292 patients with PCLM who were treated by Chinese herbal medicine combined with systemic chemotherapy and/or regional arterial perfusion at Tianjin Medical University Cancer Hospital from January 2001 to December 2010. All patients were assigned to the Western medicine treatment group (157 cases) and the integrative medicine treatment group (135 cases). Patients in the Western medicine treatment group were treated with gemcitabine (GEM)-based chemotherapy, and partial of them received regional arterial perfusion. Those in the integrative medicine treatment group additionally took Chinese herbs of clearing heat and eliminating mass for at least 4 weeks. The median survival time (MST) , adverse reactions and the incidence of complications were observed.
RESULTSThere was no statistical significance in general data between the two groups (P > 0.05). There was statistical difference in MST between the two groups (4.8 months vs 5.5 months, P < 0.05). No death occurred during chemotherapy or regional arterial perfusion. All toxic or adverse reactions were tolerable.
CONCLUSIONChinese herbal medicine combined with systemic chemotherapy and/or regional arterial perfusion was effective and safe, and it could be optimally selected as palliative therapy for PCLM.
Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Complementary Therapies ; methods ; Deoxycytidine ; analogs & derivatives ; Drugs, Chinese Herbal ; therapeutic use ; Humans ; Liver Neoplasms ; drug therapy ; secondary ; Pancreatic Neoplasms ; drug therapy ; pathology ; Retrospective Studies
6.Randomized and double -blind controlled clinical trial of dezocine injection for analgesia
Li SUN ; Guo-Zhu XU ; Li-Yang SHEN ; Yan-Ping DENG ; Tian-Yue ZHU ; Qi-Wei XIE ; Jie-Jun WANG ; Guang-Ru XIE ; Jie SHI
The Chinese Journal of Clinical Pharmacology 2014;(4):312-314
Objective To evaluate the efficacy and safety of dezocine injection for analgesia.Methods A multicenter , randomized , double blind, parallel group controlled study was performed with dezocine as the test drug , and pethidine injection and morphine injection as positive con-trol for the single treatment and 7 days treatment of moderate and severe pain , respectively.The test drug was dezocine injection.One hundred of forty patients with postoperative moderate and severe pain received single treatment with dezocine ( single injection of dezocine , n=70 ) or pethi-dine ( single injection of pethidine and placebo , n =70 ).Fifty -six cancer pain patients received 7 days treatment with dezocine or morphine as follows:the test group was intramuscularly injected two dezocines each time ( n=31 ) , and the control group was injected morphine and moe-phine simulation respectively ( n=25 , four times a day ) .Pain intensity difference ( PID) was evaluated as the primary analgesic effect criteria.Results There was no significant difference in PID between the test group and the control one both in the controlled trail of postoperative pain and that of chronic cancer pain.The most common adverse reactions of dezocine were nausea , vomiting and dizziness , et al.Conclusion The analgesic effect and adverse effects of dezocine were similar to those of morphine , which indicats dezocine is an effective and safe analgesic for postoperative pain and chronic cancer pain that are moderate and severe.
7.An open-labeled, randomized, multicenter phase IIa study of gambogic acid injection for advanced malignant tumors.
Yihebali CHI ; Xiao-kai ZHAN ; Hao YU ; Guang-ru XIE ; Zhen-zhong WANG ; Wei XIAO ; Yong-gang WANG ; Fu-xing XIONG ; Jun-feng HU ; Lin YANG ; Cheng-xu CUI ; Jin-wan WANG
Chinese Medical Journal 2013;126(9):1642-1646
BACKGROUNDGambogic acid is a pure active compound isolated from the traditional Chinese medicinal plant gamboge (Garcinia morella Desv.). Based on the preliminary results of a phase I study, this phase IIa study compared the efficacy and safety of different dosage schedules of gambogic acid in patients with advanced malignant tumors.
METHODSPatients with advanced or metastases cancer who had not received any effective routine conventional treatment or who had failed to respond to the existing conventional treatment were randomly assigned to receive either 45 mg/m(2) gambogic acid intravenously from Days 1 to 5 of a 2-week cycle (Group A), or 45 mg/m(2) every other day for a total of five times during a 2-week cycle (Group B). The primary endpoint was objective response rate (ORR).
RESULTSTwenty-one patients assigned to Group A and 26 to Group B were included in the final analysis. The ORRs were 14.3% in Group A and 0% in Group B. It was not possible to analyze the significant difference because one of the values was zero. The disease control rates (DCRs) were 76.2% in Group A and 61.5% in Group B (P = 0.0456). The observed adverse reactions were mostly Grades I and II, and occurred in most patients after administration of the trial drug. There was no significant difference in the incidence of adverse reactions between the two arms.
CONCLUSIONSThe preliminary results of this phase IIa exploratory study suggest that gambogic acid has a favorable safety profile when administered at 45 mg/m(2). The DCR was greater in patients receiving gambogic acid on Days 1 - 5 of a 2-week cycle, but the incidence of adverse reactions was similar irrespective of the administration schedule.
Adult ; Aged ; Antineoplastic Agents, Phytogenic ; administration & dosage ; Female ; Humans ; Injections ; Male ; Middle Aged ; Neoplasms ; drug therapy ; Xanthones ; administration & dosage ; adverse effects
8.Protective effect of Pinus massoniana bark extracts against cisplatin-induced nephrotoxicity in human embryonic kidney cells.
Dong-Ru FENG ; Qing-Chen DAI ; Heng XIE ; Ruo-Da LI ; Guang-Yao ZHENG ; Jin-Fa WANG ; Hong-Bin WANG
China Journal of Chinese Materia Medica 2013;38(17):2868-2873
OBJECTIVETo investigate the in vitro protective effect of Pinus massoniana bark extracts (PMBE) against cisplatin-induced nephrotoxicity in human embryonic kidney cells (HEK293), and preliminarily study its mechanism.
METHODHuman embryonic kidney cells (HEK293) were cultured in vitro. The MTT assay was adopted to test the effect of PMBE and cisplatin on growth of HEK293 cells, and the protective effect of PMBE on cisplatin-induced nephrotoxicity of HEK293, and then detect the intracellular reactive oxygen species (ROS), malondialdehyde (MDA), glutathione (GSH) content, catalase (CAT), superoxide dismutase (SOD) and activity of thioredoxin reductase (TrxR).
RESULTPMBE could promote growth of HEK293 cells at low concentrations, but generate slight nephrotoxicity at high concentration. Cisplatin could inhibit growth of HEK293 cells, increase ROS and MDA content, while reducing SOD, CAT and TrxR. The pre-protective PMBE was added to reduce cisplatin's injury to HEK293 cells, ROS, MDA and GSH content, SOD, CAT and TrxR within certain range.
CONCLUSIONPMBE at specific concentration has the protective effect in cisplatin-induced nephrotoxicity in HEK293 cells. Its mechanism may be related to PMBE's antioxidant activity.
Animals ; Antioxidants ; metabolism ; Cisplatin ; toxicity ; Epithelial Cells ; drug effects ; enzymology ; metabolism ; Glutathione ; metabolism ; Glutathione Peroxidase ; metabolism ; HEK293 Cells ; Humans ; Kidney ; drug effects ; enzymology ; metabolism ; Malondialdehyde ; metabolism ; Mice ; Pinus ; chemistry ; Plant Bark ; chemistry ; Plant Extracts ; pharmacology ; Protective Agents ; pharmacology ; Reactive Oxygen Species ; metabolism ; Superoxide Dismutase ; metabolism ; Thioredoxin-Disulfide Reductase ; metabolism
9.Prevalence, awareness, treatment, and control of hypertension in the non-dialysis chronic kidney disease patients.
Ying ZHENG ; Guang-Yan CAI ; Xiang-Mei CHEN ; Ping FU ; Jiang-Hua CHEN ; Xiao-Qiang DING ; Xue-Qing YU ; Hong-Li LIN ; Jian LIU ; Ru-Juan XIE ; Li-Ning WANG ; Zhao-Hui NI ; Fu-You LIU ; Ai-Ping YIN ; Chang-Ying XING ; Li WANG ; Wei SHI ; Jian-She LIU ; Ya-Ni HE ; Guo-Hua DING ; Wen-Ge LI ; Guang-Li WU ; Li-Ning MIAO ; Nan CHEN ; Zhen SU ; Chang-Lin MEI ; Jiu-Yang ZHAO ; Yong GU ; Yun-Kai BAI ; Hui-Min LUO ; Shan LIN ; Meng-Hua CHEN ; Li GONG ; Yi-Bin YANG ; Xiao-Ping YANG ; Ying LI ; Jian-Xin WAN ; Nian-Song WANG ; Hai-Ying LI ; Chun-Sheng XI ; Li HAO ; Yan XU ; Jing-Ai FANG ; Bi-Cheng LIU ; Rong-Shan LI ; Rong WANG ; Jing-Hong ZHANG ; Jian-Qin WANG ; Tan-Qi LOU ; Feng-Min SHAO ; Feng MEI ; Zhi-Hong LIU ; Wei-Jie YUAN ; Shi-Ren SUN ; Ling ZHANG ; Chun-Hua ZHOU ; Qin-Kai CHEN ; Shun-Lian JIA ; Zhi-Feng GONG ; Guang-Ju GUAN ; Tian XIA ; Liang-Bao ZHONG ; null
Chinese Medical Journal 2013;126(12):2276-2280
BACKGROUNDData on the epidemiology of hypertension in Chinese non-dialysis chronic kidney disease (CKD) patients are limited. The aim of the present study was to investigate the prevalence, awareness, treatment, and control of hypertension in the non-dialysis CKD patients through a nationwide, multicenter study in China.
METHODSThe survey was performed in 61 tertiary hospitals in 31 provinces, municipalities, and autonomous regions in China (except Hong Kong, Macao, and Taiwan). Trained physicians collected demographic and clinical data and measured blood pressure (BP) using a standardized protocol. Hypertension was defined as systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg, and/or use of antihypertensive medications. BP < 140/90 mmHg and < 130/80 mmHg were used as the 2 thresholds of hypertension control. In multivariate logistic regression with adjustment for sex and age, we analyzed the association between CKD stages and uncontrolled hypertension in non-dialysis CKD patients.
RESULTSThe analysis included 8927 non-dialysis CKD patients. The prevalence, awareness, and treatment of hypertension in non-dialysis CKD patients were 67.3%, 85.8%, and 81.0%, respectively. Of hypertensive CKD patients, 33.1% and 14.1% had controlled BP to < 140/90 mmHg and < 130/80 mmHg, respectively. With successive CKD stages, the prevalence of hypertension in non-dialysis CKD patients increased, but the control of hypertension decreased (P < 0.001). When the threshold of BP < 130/80 mmHg was considered, the risk of uncontrolled hypertension in CKD 2, 3a, 3b, 4, and 5 stages increased 1.3, 1.4, 1.4, 2.5, and 4.0 times compared with CKD 1 stage, respectively (P < 0.05). Using the threshold of < 140/90 mmHg, the risk of uncontrolled hypertension increased in advanced stages (P < 0.05).
CONCLUSIONSThe prevalence of hypertension Chinese non-dialysis CKD patients was high, and the hypertension control was suboptimal. With successive CKD stages, the risk of uncontrolled hypertension increased.
Adult ; Aged ; Awareness ; Female ; Humans ; Hypertension ; complications ; epidemiology ; therapy ; Male ; Middle Aged ; Prevalence ; Renal Insufficiency, Chronic ; complications
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

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