Abstract:
Background:Automated peritoneal dialysis (APD) can cater to individual needs, provide treatment while asleep, take into account the adequacy of dialysis, and improve the quality of life. Currently, independent research and development of APD machines made in China are more conducive to patients. A randomized, multicenter, crossover study was conducted by comparing an APD machine made in China with an imported machine. The safety, effectiveness, and manipulability of the two machines were compared. Methods:Two hundred and sixty patients who underwent peritoneal dialysis (PD) on a regular basis in 18 centers between August 2015 and February 2016 were included. The inclusion criteria include age ≥18 years and PD ≥30 days. The exclusion criteria were as follows: hemodialysis; exit site or tunnel infection; and peritonitis ≤30 days. The patients were randomly divided into Group A, who were first treated with a FM machine made in China, then changed to an imported machine; and Group B, who were treated using the reverse sequence. APD treatment was performed with 10 L/10 h and 5 cycles of exchange. After 72 h, the daily peritoneal Kt/V, the accuracy of the injection rate, accuracy of the injection temperature, safety, and manipulability of the machine were assessed. Noninferiority test was conducted between the two groups. Results:The daily peritoneal Kt/V in the APD machine made in China and the imported APD machine were 0.17 (0.14, 0.25) and 0.16 (0.13, 0.23), respectively. There was no significant difference between the groups (Z = 0.15, P = 0.703). The lower limit of the daily Kt/V difference between the two groups was 0.0069, which was greater than the noninferiority value of -0.07 in this study. The accuracy of the injection rate and injection temperature was 89.7% and 91.5%, respectively, in the domestic APD machine, which were both slightly better than the accuracy rates of 84.0% and 86.8% in the imported APD machine (89.7% vs. 84.0%, P = 0.2466; 91.5% vs. 86.8%, P = 0.0954). Therefore, the APD machine made in China was not inferior to the imported APD machine. The fuselage of the imported APD machine was space-saving, while the APD machine made in China was superior with respect to body mobility, man-machine dialog operation, alarm control, and patient information recognition. Conclusions:The FM machine made in China was not inferior to the imported APD machine. In addition, the FM machine made in China had better operability. Trial Registration:Clinicaltrials.gov, NCT02525497; https://clinicaltrials.gov/ct2/results?cond=&term=NCT02525497&cntry=& state=&city=&dist=. :迈达FM自动化腹膜透析机随机、多中心、交叉对照研究摘要背景: 通过随机、多中心交叉对照研究,评价迈达FM腹膜透析机用于维持性腹膜透析患者治疗的安全性、有效性和可操作性。 方法: 研究对象来自全国18家医院接受腹膜透析(PD)治疗的患者(年龄≥18岁,PD≥30天;排除联合血液透析、出口或隧道感染、腹膜炎后30天内的患者)。试验组选用迈达FM腹膜透析机治疗,对照组选用Homechoice腹膜透析机治疗。采用随机、多中心交叉对照设计,各进行1个周期的治疗。主要评价指标为每日腹膜Kt/V,次要评价指标为注入准确率、注入温度准确率以及毒素电解质变化情况。采用问卷评分法比较两组的安全性和可操作性。将两组研究结果进行非劣效检验。 结果: (1)共260例维持性腹膜透析患者参加本研究,男性158例,女性102例;平均年龄(49.33±15.26)岁;(2)主要有效性评价指标:试验组和对照组的每日腹膜Kt/V分别为0.17(0.14,0.25)和0.16(0.13,0.23)。P值为0.7029,大于0.05,差异无统计学意义;且试验组与对照组每日Kt/V差值的95%CI下限为0.0069,大于本研究的非劣效界值-0.07。;(3)次要有效性评价指标:试验组和对照组注入准确率(89.7%和84.0%)和注入温度准确率(91.5%和86.8%)无显著差异;(4)安全性及可操作性:两组治疗过程中患者生命体征平稳,耐受性良好;对照组机身较节省空间,试验组的机身移动性、人机对话操作、报警控制和患者信息识别较好。 结论: 通过多中心随机交叉对照研究,迈达FM腹膜透析机可操作性良好,有效性、安全性达标,不劣于Homechoice腹膜透析机。.
journal_name
Chin Med J (Engl)journal_title
Chinese medical journalauthors
Cao XY,He YN,Zhou JH,Sun SR,Miao LN,Chen W,Fang JA,Wang M,Wang NS,Lin HL,Liu J,Ni ZH,Liu WH,Na Y,Zhao JY,Guo ZY,Zheng HG,Shi W,Jiang GR,Cai GY,Chen XMdoi
10.4103/0366-6999.246079subject
Has Abstractpub_date
2018-12-05 00:00:00pages
2785-2791issue
23eissn
0366-6999issn
2542-5641pii
ChinMedJ_2018_131_23_2785_246079journal_volume
131pub_type
杂志文章,多中心研究,随机对照试验abstract:BACKGROUND:Peripheral nerve injury causes a high rate of disability and a huge economic burden, and is currently one of the serious health problems in the world. The use of nerve grafts plays a vital role in repairing nerve defects. Acellular nerve grafts have been widely used in many experimental models as a periphera...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:2011-12-01 00:00:00
abstract:BACKGROUND:Dynesys dynamic stabilization system was first implanted in patients in 1994, and introduced to China in 2007. Therefore, it was a new technique for Chinese orthopedics and hence necessary to collect clinical data about Dynesys in China. The objective of this study was to report the preliminary results of Dy...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:2013-11-01 00:00:00
abstract:OBJECTIVE:To identify novel tumor suppressor genes at chromosome 3p24-26 in human nasopharyngeal carcinoma (NPC). METHODS:Twenty epithelial-derived expressed sequence tags (EST) were selected from chromosome 3p24-26. RT-PCR and Northern blot were used to detect the expression of the ESTs in NPC cell line, HNE-1, and p...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:2001-05-01 00:00:00
abstract:Background:Macrophage polarization is involved in the development of many diseases such as obesity, diabetes, and cancer. This study aimed to understand the trends and hotspots of macrophage polarization research. Methods:We searched through the Web of Science Core Collection database to obtain original articles in th...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:10.4103/0366-6999.247215
更新日期:2018-12-20 00:00:00
abstract:BACKGROUND:Benign prostate hyperplasia is one of the most common diseases affecting the health of the aging males. Watchful waiting is an acceptable management strategy for benign prostate hyperplasia in which the patient is monitored by the physician but receives no active intervention. The epidemiological data on thi...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:2006-12-20 00:00:00
abstract:OBJECTIVE:To investigate whether the decrease in expression of interleukin-2 (IL-2) after trauma is associated with changes in DNA binding activity of nuclear factor of activated T cells (NFAT) and activator protein-1 (AP-1). METHODS:Mice with closed impact injury with fracture in both hind limbs were adopted as the t...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:2002-09-01 00:00:00
abstract:BACKGROUND:Hepatocellular carcinoma (HCC) is a common primary cancer frequently associated with hepatitis B virus (HBV) infection. However, whether these identified genes are particularly associated with HBV-related HCC remains unknown. The aim of this study was to investigate the differential gene expression between H...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:2011-07-05 00:00:00
abstract:OBJECTIVE:To describe the methods which were used to develop collagen-based materials for wound dressing. METHODS:Fresh frozen bovine tendon was treated with 0.05 mol/L acetic acid at pH 3.2 for 48-72 hours, homogenized, filtered, mixed with 8% chondroitin sulphate, for creating a deaerated 1.5%-2.5% collagen solution...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:2003-03-01 00:00:00
abstract:BACKGROUND:Recently, conservative surgery is acceptable in young patients with borderline ovarian tumor and ovarian cancer. The preservation of these patients' future fertility has been the focus of recent interest. This study aimed to observe the effect of gonadotropin-releasing hormone agonists (GnRHa) cotreatment du...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:2013-02-01 00:00:00
abstract:OBJECTIVE:To evaluate the feasibility, safety and diagnostic accuracy of pharmacologic stress of (99m)Technetium-MIBI single-photon emission computed tomography (SPECT) with intravenous adenosine triphosphate (ATP) in patients with suspected coronary artery disease. METHODS:The study group included 263 patients who we...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:2002-11-01 00:00:00
abstract:BACKGROUND:There are few reports of microsurgical treatment of dorsum sellae meningiomas-which, because of location, size, and differences in growth direction, clinical presentations, degree of surgical difficulty, have varied posttreatment sequelae. In pursuit of an optimal microsurgical treatment option for dorsum se...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:2009-08-20 00:00:00
abstract:BACKGROUND:In the past 5 years, new treatment materials and techniques offering a different concept in endovascular treatment have been described for cerebral arteriovenous malformations (CAVMs). The aim of this study was to assess the endovascular treatment of CAVMs by using a liquid embolic material, Onyx (Micro Ther...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:2005-12-20 00:00:00
abstract:OBJECTIVE:Familial hypertrophic cardiomyopathy (FHCM) is a primary myocardial disease characterized by unexplained ventricular hypertrophy. The application of the techniques of reverse genetics has identified at least five chromosomal loci as the major causes for FHCM in diverse ethnic populations, suggesting substanti...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:1998-05-01 00:00:00
abstract:BACKGROUND:Genetic factors contribute to the development of coronary artery disease (CAD). Recently, a missense mutation in the low density lipoprotein receptor related protein 6 (LRP6) gene, encoding low density lipoprotein receptor related protein 6, has been implicated in an autosomal dominant form of early-onset CA...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:2012-02-01 00:00:00
abstract:BACKGROUND:Cardiovascular complications of Kawasaki disease (KD) are a common cause of heart disease in pediatric populations. Previous studies have suggested a role for endothelial progenitor cells (EPCs) in coronary artery lesions associated with KD. However, long-term observations of EPCs during the natural progress...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:2012-02-01 00:00:00
abstract::Using ambulatory electrocardiography (AE), the spontaneous variability in 40 cases of chronic stable premature ventricular complexes (PVCs) was studied. The mean hourly PVC frequencies over 24 hours ranged 2-1 682. When analysing pooled data, there was significant variance between different monitoring periods and betw...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:1989-04-01 00:00:00
abstract:BACKGROUND:Jaw osteonecrosis possibly associated with the administration of bisphosphonates is expected to be treated with a non-pharmacologic approach. This study aimed to determine whether noninvasive, mechanically mediated vibration would inhibit the decline in bone mineral density (BMD) that follows menopause, enha...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:2008-07-05 00:00:00
abstract:BACKGROUND:Endothelial dysfunction is thought to be critical events in the pathogenesis of Alzheimer's disease (AD). Endothelial progenitor cells (EPCs) have provided insight into maintaining and repairing endothelial function. To study the relation between EPCs and AD, we explored the number of circulating EPCs in pat...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:2011-03-01 00:00:00
abstract:OBJECTIVE:To investigate the effectiveness of using continuous veno venous hemofiltration (CVVH) in the treatment of acute necrotizing pancreatitis (ANP). METHODS:Thirteen ANP patients were involved in this study, including 4 females and 9 males, averaging 50.6 +/- 10.8 years old. CT scans upon admission revealed 33% ...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:2003-04-01 00:00:00
abstract::The radiographic measurement of the prevertebral soft tissue of cervical vertebrae was performed in 87 normal adults. According to the results of the measurement, 10 mm and 20 mm were used as the upper limit normal values of the retropharyngeal and retrotracheal space respectively. We conclude that although the widene...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:1994-06-01 00:00:00
abstract:BACKGROUND:The duration of viral shedding and the transmission of 2009 H1N1 influenza among individuals, especially among the younger population with mild illness, are not well understood now. The aim of this study was to determine the viral shedding of the young adult patients with mild 2009 H1N1 influenza in China. ...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:2011-05-01 00:00:00
abstract::The unclear DNA content was measured with flow cytometry (FCM) in 167 specimens of normal nasopharyngeal epithelium (NE), adjacent tissue to carcinoma (ATC) and nasopharyngeal carcinoma (NPC). All 20 patients with NE showed diploid, whereas 38 (38%) of 101 patients with NPC, 7 (58%) of 12 patients with recurrent NPC, ...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:1994-05-01 00:00:00
abstract::Enhanced recovery after cesarean (ERAC) delivery is an evidence-based, multi-disciplinary approach throughout pre-, intra-, post-operative period. The ultimate goal of ERAC is to enhance recovery and improve the maternal and neonatal outcomes. This review highlights the role of anesthesiologist in ERAC protocols. This...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:10.1097/CM9.0000000000000644
更新日期:2020-03-05 00:00:00
abstract::The model was established in male rabbits with experimental atherosclerosis, which was induced by diet cholesterol (0.5 g per day for 8 weeks), by means of intravenous injection of one unit of pituitrin (P.P.). To evaluate the effects of aspirin, heparin and viper venom (VV) on this model, 26 male rabbits were divided...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:1995-05-01 00:00:00
abstract:BACKGROUND:Interferon (IFN) can inhibit human immunodeficiency virus type 1 (HIV-1) replication in vitro and in clinic. However, IFN therapy for HIV infection was limited by its moderate antiviral efficacy and its frequent adverse effects. In the present study we evaluated the anti-HIV efficacy of a novel synthesized s...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:2011-02-01 00:00:00
abstract::Two thousand patients aged 15 years and below, who underwent surgical treatment for intracranial tumors in Beijing Tiantan Hospital from 1955 to 1989, were studied. All of the tumors in this series have been verified by operative findings and histological studies. This series accounts for 15.1% of all cases of intracr...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:1992-06-01 00:00:00
abstract:BACKGROUND:Transcatheter bronchial artery embolization (BAE) is widely used for the treatment of hemoptysis and the immediate success rate is high, but there are still some hemorrhage recurrences. One of the common reasons for failure of BAE is collateral branches as blood supply. The inferior phrenic artery (IPA) is o...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:2009-03-05 00:00:00
abstract:BACKGROUND:Human epididymis secretory protein 4 (HE4) is a new ovarian cancer biomarker. The factors influencing HE4 levels are not clear, and the reference data in China are limited. Here, we aim to evaluate the effects of menopause and age on HE4 levels and to provide a possible reference value for HE4 in healthy Chi...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:10.1097/CM9.0000000000000785
更新日期:2020-06-05 00:00:00
abstract:OBJECTIVE:To explore the mechanism of cisplatin resistance and its reversion in human ovarian cancer. MATERIALS AND METHODS:A cisplatin resistant cell subline of SKOV3, SKOV3/cp, was established, and a xenograft mice model of human ovarian cancer was established by microencapsulation technology. Various biochemical ch...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:1996-05-01 00:00:00
abstract:BACKGROUND:Despite the presigmoid transpetrosal approach has been used by different researchers in various ways, the surgical injury rate remains high. Applying a minimally invasive keyhole idea, we devised a presigmoid transpetrosal keyhole approach (PTKA), classified and quantitatively assessed their approach to the ...
journal_title:Chinese medical journal
pub_type: 杂志文章
doi:
更新日期:2008-04-20 00:00:00