Incidence Of Endpoint Events Research Articles

Efficacy and safety of Yiqi Peiyuan granules for improving the short-term prognosis of patients with acute kidney injury: A multicenter, double-blind, placebo-controlled, randomized trial

BackgroundYiqi Peiyuan (YQPY) prescription, a composite prescription of traditional Chinese medicine, has been used to prevent or delay the continued deterioration of renal function after acute kidney injury (AKI) in some institutions and has shown considerable efficacy. ObjectiveThis is the first randomized controlled trial to assess efficacy and safety of YQPY for improving short-term prognosis in adult patients with AKI. Design, setting, participants and interventionsThis is a prospective, double-blind, multicenter, randomized, and placebo-controlled clinical trial. A total of 144 enrolled participants were randomly allocated to two groups according to a randomization schedule. Participants, caregivers and investigators assessing the outcomes were blinded to group assignment. Patients in the YQPY group received 36 g YQPY granules twice a day for 28 days. Patients in the placebo group received a placebo in the same dose as the YQPY granules. Main outcome measuresThe primary outcome was the change in the estimated glomerular filtration rate (eGFR) between baseline and after 4 and 24 weeks of treatment. The secondary outcomes were the change of serum creatinine (Scr) level between baseline and after treatment, and the incidence of endpoint events, defined as eGFR increasing by more than 25% above baseline, eGFR >75 mL/min per 1.73 m2 or the composite endpoint, which was defined as the sum of patients meeting either of the above criteria. ResultsData from a total of 114 patients (59 in the YQPY group and 55 in the control group) were analyzed. The mean changes in eGFR and Scr in weeks 4 and 24 had no difference between the two groups. In further subgroup analysis (22 in the YQPY group and 31 in the control group), the mean change in eGFR after treatment for 4 weeks was 27.39 mL/min per 1.73 m2 in the YQPY group and 5.78 mL/min per 1.73 m2 in the placebo group, and the mean difference between groups was 21.61 mL/min per 1.73 m2 (P < 0.001). Thirteen (59.1%) patients in the YQPY group and 5 (16.1%) in the placebo group reached the composite endpoints (P = 0.002). During the intervention, 2 and 4 severe adverse events were reported in the YQPY and placebo groups, respectively. ConclusionThe YQPY granules can effectively improve the renal function of patients 4 weeks after the onset of AKI, indicating that it has good efficacy for improving short-term renal outcomes in patients with AKI. The YQPY granules may be a promising therapy for adults with AKI. Trial RegistrationChinese Clinical Trial Registry ChiCTR2100051723.Please cite this article as: Wu JJ, Zhang TY, Qi YH, Zhu MY, Fang Y, Qi CJ, Cao LO, Lu JF, Lu BH, Tang LM, Shen JX, Mou S. Efficacy and safety of Yiqi Peiyuan granules for improving the short-term prognosis of patients with acute kidney injury: a multicenter, double-blind, placebo-controlled, randomized trial. J Integr Med. 2024; 22(3): 279–285.

Prognosis of IgA Nephropathy with Stages 3b-5 CKD

Introduction: There are conflicting opinions regarding the use of immunosuppressant treatment in IgA nephropathy (IgAN) patients with an estimated glomerular filtration rate (eGFR) of less than 45 mL/min/1.73 m2 and persistent proteinuria with a daily excretion of ≥1.0 g. Methods: This retrospective study involved 110 IgAN patients for whom clinical data were available; of these, 90 had complete follow-up data. Patients were grouped based on whether they received immunotherapy during follow-up, their renal function, proteinuria levels, and the percentage of crescentic glomeruli observed at the time of renal biopsy. Results: The mean eGFR for the participants was 32.0 ± 10.2 mL/min/1.73 m2. The average follow-up duration was 46.1 ± 37.9 months. The mean rate of decline in eGFR was 3.6 mL/min/1.73 m2 per year. There were 43 (47.8%) composite kidney endpoints occurred in these patients. In the group that received immunotherapy, the incidence of kidney endpoint events was lower than in the untreated group (45.1% vs. 57.9%), but the difference was not statistically significant (p = 0.320). Among patients with stage CKD 3b, the incidence of endpoint events was lower than in those with stages CKD 4 and 5 (36.8% vs. 66.7%, p = 0.006). Conversely, the high proteinuria group saw a higher incidence of endpoint events compared to the low proteinuria group (51.9% vs. 23.1%), although this difference was not statistically significant (p = 0.054). Meanwhile, there was no significant difference in the incidence of endpoint events between the two crescent glomerular ratio groups (48.7% vs. 41.7%, p = 0.649). Kaplan-Meier survival analysis indicated that renal function level (p < 0.001) and proteinuria (p = 0.023) were associated with renal survival in IgAN patients. In contrast, the administration of immunosuppressive therapy (p = 0.288) and the prevalence of C lesions (p = 0.982) did not show a significant association with renal survival. Further, Cox regression analysis identified systolic blood pressure, fibrinogen, and CKD stage as risk factors for eGFR decline in IgAN patients (all p < 0.05). Conclusion: IgAN patients with stages 3b-5 CKD exhibited a poor prognosis. It appears that in this specific cohort of IgAN patients, immunosuppressive therapy may not provide significant advantages over supportive care therapeutic regimens in terms of disease management.

Low expression of acyl-CoA thioesterase 13 is associated with poor prognosis in ovarian serous cystadenocarcinoma.

Objective: Acyl-CoA thioesterase 13 (ACOT13) encodes a member of the thioesterase superfamily. It has not been reported in ovarian cancer. This research aimed at evaluating the expression and prognostic value of ACOT13 in ovarian serous cystadenocarcinoma (OSC). Methods: We extracted and analyzed TCGA, GEPIA, THPA, GTEx, miRWalk, and GDSC databases to investigate the potential carcinogenic mechanism of ACOT13 in OSC, including the correlation of ACOT13 with prognosis, immune checkpoint, tumor mutational burden (TMB), and 50% inhibition concentration (IC50) score. The incidence of endpoint events was compared with Kaplan-Meier survival analysis. Independent prognostic factors for OSC were evaluated with univariate and multivariate Cox regression analyses, and a nomogram was established. Results: The expression of ACOT13 was increased in OSC and correlated with tumor stage, with higher expression in stages I and II than in stages III and IV. Besides, it was observed that low expression of ACOT13 is correlated with poor overall survival (OS), progression-free survival (PFS), and disease-specific survival (DSS) in patients with OSC. There was a positive correlation between ACOT13 expression and immune checkpoint sialic acid-binding Ig-like lectin (SIGLEC) 15 and TMB. Patients with low ACOT13 expression had higher cisplatin IC50 scores. Conclusion: ACOT13 is an independent prognostic factor and a promising clinical target for OSC. In the future, the carcinogenic mechanism and clinical application value of ACOT13 in ovarian cancer need to be further studied.

Outcome of surgical repair for aortic coarctation with coexisting descending aortic aneurysm in adult patients

Objective: To evaluate the efficacy of surgical treatment of aortic coarctation combined with descending aortic aneurysm in adult patients. Methods: This is a retrospective cohort study. Adult patients with aortic coarctation who were hospitalized in Beijing Anzhen Hospital from January 2015 to April 2019 were enrolled. The aortic coarctation was diagnosed by aortic CT angiography, and the included patients were divided into the combined descending aortic aneurysm group and the uncomplicated descending aortic aneurysm group based on descending aortic diameter. General clinical data and surgery-related data were collected from the included patients, and death and complications were recorded at 30 days after surgery, and upper limb systolic blood pressure was measured in all patients at discharge. Patients were followed up after discharge by outpatient visit or telephone call for their survival and the occurrence of repeat interventions and adverse events, which included death, cerebrovascular events, transient ischemic attack, myocardial infarction, hypertension, postoperative restenosis, and other cardiovascular-related interventions. Results: A total of 107 patients with aortic coarctation aged (34.1±15.2) years were included, and 68 (63.6%) were males. There were 16 cases in the combined descending aortic aneurysm group and 91 cases in the uncomplicated descending aortic aneurysm group. In the combined descending aortic aneurysm group, 6 cases (6/16) underwent artificial vessel bypass, 4 cases (4/16) underwent thoracic aortic artificial vessel replacement, 4 cases (4/16) underwent aortic arch replacement+elephant trunk procedure, and 2 cases (2/16) underwent thoracic endovascular aneurysm repair. There was no statistically significant difference between the two groups in the choice of surgical approach (all P>0.05). In the combined descending aortic aneurysm group at 30 days after surgery, one case underwent re-thoracotomy surgery, one case developed incomplete paraplegia of the lower extremity, and one case died; and the differences in the incidence of endpoint events at 30 days after surgery were similar between the two groups (P>0.05). Systolic blood pressure in the upper extremity at discharge was significantly lower in both groups compared with the preoperative period (in the combined descending aortic aneurysm group: (127.3±16.3) mmHg vs. (140.9±16.3) mmHg, P=0.030, 1 mmHg=0.133 kPa; in the uncomplicated descending aortic aneurysm group: (120.7±13.2) mmHg vs. (151.8±26.3) mmHg, P=0.001). The follow-up time was 3.5 (3.1, 4.4) years. There were no new deaths in the combined descending aortic aneurysm group, no transient ischemic attack, myocardial infarction or re-thoracotomy surgery, and one patient (1/15) suffered cerebral infarction and 10 patients (10/15) were diagnosed with hypertension. The differences in the occurrence of endpoint events during postoperative follow-up were similar between the two groups (P>0.05). Conclusion: In experienced centers, long-term prognosis of patients with aortic coarctation combined with descending aortic aneurysm is satisfactory post surgical intervention.

Effect of out-hospital blood pressure management on prognosis of patients with acute aortic syndrome complicated with hypertension after TEVAR

Objective: To investigate the influence of blood pressure control after discharge on prognosis of patients with acute aortic syndrome (AAS) complicated with hypertension who underwent thoracic endovascular aortic repair (TEVAR). Methods: This is a retrospective case analysis. Patients diagnosed with AAS complicated with hypertension and undergoing TEVAR in Northern Theater Command General Hospital from June 2002 to December 2021 were consecutively enrolled. Average systolic blood pressure (SBP) and the occurrence of endpoint events were recorded at one month, one year and every 2 years after TEVAR. According to the patients' average SBP, patients with average SBP<140 mmHg (1 mmHg=0.133 kPa) or<150 mmHg were divided into the target blood pressure achievement group, and the others were divided into target blood pressure non-achievement group. Endpoint events included all-cause death, aortic death, stroke, renal insufficiency, aortic related adverse events and a composite of these events (overall clinical adverse events), and re-accepting TEVAR. The incidence of endpoint events was compared between the two groups at each follow-up period. Results: A total of 987 patients were included, aged (55.7±11.7) years, including 779 male (78.9%). When the cutoff value was 140 mmHg, the rate of average target SBP achievement was 71.2% (703/987) at one month, 66.7% (618/927) during 1st to 12th month and 65.1% (542/832) from the first year to the third year after TEVAR. The proportion of patients taking≥2 antihypertensive agents was higher in the group of target blood pressure non-achievement group than the target blood pressure achievement group after TEVAR at 1 month (74.3% (211/284) vs.65.9% (463/703), P=0.010) and during 1st to 12th month (71.5% (221/309) vs. 63.6% (393/618), P=0.016). There were no statistical differences in the all-cause deaths, stroke, aortic related adverse events, and repeat TEVAR between the two groups (All P>0.05) during above follow-up periods. When the cutoff value was 150 mmHg, the rate of target SBP achievement was 89.3% (881/987) at one month, 85.2% (790/927) during 1st to 12th month and 85.6%(712/832) from the first year to the third year after TEVAR. The incidence of clinical total adverse events (8.8% (12/137) vs. 4.2% (33/790), P=0.021) and repeat TEVAR (4.4% (6/137) vs. 1.0% (8/790), P=0.003) in target blood pressure non-achievement group were significantly higher than the target blood pressure achievement group during 1st to 12th month after TEVAR. The incidence of all-cause deaths (5.8% (7/120) vs. 2.4% (17/712), P=0.037) in the target blood pressure non-achievement group was significantly higher than the target blood pressure achievement group from the first year to the third year follow-up period, but there were no statistical differences in the incidence of clinical total adverse events between the two group (P>0.05). Conclusion: Among TEVAR treated AAS patients complicated with hypertension, the average SBP more than 150 mmHg post discharge is associated with increased risk of adverse events. Ideal blood pressure control should be encouraged to improve the outcome of these patients.

Efficacy and safety of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation and hypertrophic cardiomyopathy

Objective: To evaluate the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOAC) in patients with atrial fibrillation (AF) and hypertrophic cardiomyopathy (HCM). Methods: This study was a prospective cohort study. The data of this study were based on the Chinese Atrial Fibrillation Registry (CAFR) Study, which was a prospective, multicenter registry study. The CAFR Study enrolled inpatients and outpatients with AF from 31 hospitals. Patients with AF and HCM were selected from August 2011 to December 2018. The patients were divided into NOAC-treated group and warfarin-treated group. General clinical data, echocardiographic results and treatment options were collected and compared between the two groups. Patients were followed up every 6 months; outcome events included effective endpoint events(thromboembolism)and safety endpoint events(major bleeding). The incidence of endpoint events in both groups was calculated and compared. Cox proportional hazards regression models and Kaplan-Meier survival analysis were performed to determine the association between NOAC use and endpoint events. Results: A total of 393 patients were included (average age: (60.5±11.8) years, 252 men (64.1%)). There were 133 (34.0%) patients in the NOAC-treated group and 260 (66.0%) patients in the warfarin-treated group. Compared with the warfarin-treated group, the patients in the NOAC-treated group had a higher proportion of paroxysmal AF, catheter ablation of AF, a lower proportion of hypertension, ischemic stroke/transient ischemic attack (TIA), lower heart rate, lower usage rate of angiotensin-converting enzyme inhibitors(ACEI)/angiotensin receptor blockers(ARB), β-blockers, non-dihydropyridine calcium channel blockers(NDH-CCB)(P<0.05). There were no significant differences on the echocardiographic results, including interventricular septal thickness, left ventricular posterior wall thickness, left ventricular end-diastolic diameter, left atrial diameter, left ventricular ejection fraction(P>0.05). After a follow-up of 42 (24, 60)months, the incidence rates of thromboembolism were 1.63 and 2.10 events per 100 person-years for NOAC-and warfarin-treated group, and those of major bleeding were 0.66 and 1.03 events per 100 person-years. Kaplan-Meier survival analysis showed survival rates free from endpoint events were similar between NOAC-treated group and warfarin-treated group(thromboembolism-free survival comparison, P=0.476; major bleeding-free survival comparison, P=0.855). Cox multivariate regression analysis revealed that there was no significant difference on risk of thromboembolism(HR=1.21, 95%CI: 0.42-3.50, P=0.720) and major bleeding(HR=1.50, 95%CI: 0.27-8.41, P=0.642) between NOAC-treated and warfarin-treated group. Conclusion: Patients with AF and HCM can be safely and effectively treated with NOAC.

Impact of comprehensive management on clinical outcomes in hypertensive patients with coronary artery disease: HIJ-CREATE sub-study

Abstract Background There are limited data on the effects of blood pressure (BP) control and lipid lowering in secondary prevention of coronary artery disease (CAD) patients. We report a secondary analysis of the effects of BP control and lipid management in participants of the HIJ-CREATE, a prospective randomized trial. Methods HIJ-CREATE was a multicenter, prospective, randomized, controlled trial that compared the effects of candesartan-based therapy with those of non-ARB-based standard therapy on major adverse cardiac events (MACE; a composite of cardiovascular death, non-fatal myocardial infarction, unstable angina, heart failure, stroke, and other cardiovascular events requiring hospitalization) in 2,049 hypertensive patients with angiographically documented CAD. In both groups, titration of antihypertensive agents was performed to reach the target BP of &amp;lt;130/85 mmHg. The primary endpoint was the time to first MACE. Incidence of endpoint events in addition to biochemistry tests and office BP was determined during the scheduled 6, 12, 24, 36, 48, and 60-month visits. Achieved systolic BP and LDL-Cholesterol (LDL-C) level were defined as the mean values of these measurements in patients who did not develop MACEs and as the mean values of them prior to MACEs in those who developed MACEs during follow-up. Results During a median follow-up of 4.2 years (follow-up rate of 99.6%), the primary outcome occurred in 304 patients (30.3%). Among HIJ-CREATE participants, 905 (44.2%) were prescribed statins on enrollment. Kaplan–Meier curves for the primary outcome revealed that there was no relationship between statin therapy and MACEs in hypertensive patients with CAD. The original HIJ-CREATE population was divided into 9 groups based on equal tertiles based on mean achieved BP and LDL-C during follow-up. For the analysis of subgroups, estimates of relative risk and the associated 95% CIs were generated with a Cox proportional-hazards model (Figure 1). The relation between LDL cholesterol level and hazard ratios for MACEs was nonlinear, with a significant increase of MACEs only in the patients with inadequate controlled LDL-C level even in the patients with tightly controlled BP. Conclusions The results of the post-hoc analysis of the HIJ-CREATE suggest that clinicians should pay careful attention to conduct comprehensive management of lipid lowering even in the contemporary BP lowering for the secondary prevention in hypertensive patients with CAD. Figure 1 Funding Acknowledgement Type of funding source: None

Effects of clopidogrel resistence and CYP2C19 genotype on the clinical prognosis of patients with acute coronary syndrome undergoing percutaneous coronary intervention

Objective: To investigate the effects of clopidogrel resistence and CYP2C19 genotype on the clinical prognosis of acute coronary syndrome(ACS) patients undergoing percutaneous coronary intervention(PCI). Methods: This study was a retrospective cohort study. ACS patients who underwent PCI in Beijing Anzhen Hospital from October 2015 to January 2017 were recruited. The inhibition rate of adenosine diphosphate(ADP) was monitored by thromboelastography. All of these patients were divided into clopidogrel resistance and non-resistance group according to the monitoring results. CYP2C19 genotype was detected by TaqMan probe-based real-time quantitative PCR. Patients were divided into slow, medium and fast metabolic group, according to the CYP2C19 genotype. After 12 months of follow-up, the end points included all-cause death, cardiac death, angina, myocardial infarction, stent thrombosis, ischemic stroke and hemorrhage were collected. Combined thrombotic events were defined as a composite of angina, myocardial infarction, stent thrombosis and ischemic stroke. The differences of the incidence of clinical events between groups were compared. Cox regression was used to analyze the effects of clopidogrel resistance and CYP2C19 genotype on the combined thrombotic events, cardiac death and hemorrhage. Results: A total of 1 696 patients were included, and the age was (59.4±9.6) years, with 1 280(75.5%) males. There were 471 cases(27.8%) in clopidogrel resistance group, and 1 225 cases(72.2%) in clopidogrel non-resistance group. There were 218 patients(12.9%) were in slow metabolic group, 668(39.4%) in medium metabolic group, and 810 (47.8%) in fast metabolic group. The median follow-up time was 13.3 months, and 131 cases were lost to follow-up, with a loss follow-up rate of 7.7%. Compared with the clopidogrel non-resistance group, the clopidogrel resistance group had a higher incidence of myocardial infarction(7.6%(36/471) vs. 5.1%(62/1 225), P=0.041), a lower incidence of hemorrhage (13.2%(62/471) vs. 17.9%(219/1 225), P=0.020) and minor hemorrhage(11.5%(54/471) vs. 15.8% (194/1 225), P=0.022). There were no statistically significant difference in all-cause death, cardiac death, angina, stent thrombosis, ischemic stroke and severe bleeding between clopidogrel resistance and non-resistance group(all P>0.05). There was no statistically significant difference in the incidence of endpoint events among different CYP2C19 genotypes (all P>0.05). Cox regression analysis showed that clopidogrel resistance was an independent factor of combined thrombotic events (OR=2.334, 95%CI 1.215-4.443, P=0.016) and bleeding events (OR=0.481, 95%CI 0.174-0.901, P=0.023). While CYP2C19 genotype was not independent factor for combined thrombotic events, cardiac death and hemorrhage (all P>0.05). Conclusion: For ACS patients after PCI, clopidogrel resistance can increase the risk of combined thrombotic events, but also reduce the risk of bleeding; while CYP2C19 genotype is not an independent factor for clinical prognosis.

Efficacy and safety of Abelmoschus manihot for IgA nephropathy: A multicenter randomized clinical trial

Rationale and ObjectiveIgA nephropathy (IgAN) is an important cause for end-stage renal disease worldwide. The treatment for IgAN remains challenging, and few randomized and controlled clinical trials have been conducted to evaluate new therapies. The present study assesses the efficacy and safety of Abelmoschus manihot (AM) in IgAN patients. Study DesignRandomized, non-inferiority, double-blind, double-dummy multicenter trial. Setting and ParticipantsThis trial was designed to recruit 1,600 biopsy-proven IgAN patients (proteinuria between 0.5-3.0 g/d and estimated glomerular filtration rate [eGFR] of ≥ 45 ml/min/1.73 m2) across China. InterventionsThe participants were randomized at 1:1 to AM (2.5 g for three times per day) or losartan potassium (100 mg per day) for 48 weeks. OutcomesThe primary outcome was the change in 24-hour proteinuria from baseline to week 48. The secondary outcomes were the change in eGFR from baseline to week 48, and the incidents of endpoint events (proteinuria ≥ 3.5 g/24 h, doubling of serum creatinine, or receiving renal replacement treatment). ResultsAmong 1,470 randomized patients (mean age, 37.4 [SD, 10.6] years old; 777 [52.9%] were female; mean eGFR, 95.0 [SD, 24.3] mL/min/1.73 m2; mean 24-hour proteinuria, 1.2 [SD, 0.7] g/d), the mean decline in 24-h proteinuria at week 48 was 230 mg and 253 mg in the AM and losartan potassium groups, respectively (P = 0.676). The mean difference in the change in 24-h proteinuria between these two groups was -23.32 mg (95% confident interval: -123.2 to 76.6, p = 0.647). The mean decline in eGFR was 0.41 ml/min/1.73 m2 and 0.76 ml/min/1.73 m2 in the AM and losartan potassium groups, respectively (p = 0.661). The mean difference in the change in eGFR between these two groups was -0.43 ml/min/1.73 m2 (95% confident interval: -1.99 to 1.13, p = 0.589). The incidence of endpoint events was 8.6% in the AM group and 8.2% in the losartan group (p = 0.851). LimitationsThe results of the trial may not be generalized to IgAN patients with a proteinuria of > 3.0 g/d and an eGFR of < 45 ml/min/1.73 m2. The long-term benefits of AM in reducing the risk of progressive renal dysfunction remains unclear, based on this 48-week observation. ConclusionAM can be recommended as a promising treatment for IgAN patients.

Clinical value of a new mode of early cardiac rehabilitation after percutaneous coronary intervention in patients with acute myocardial infarction

Objective To investigate the effects of a new mode of early cardiac rehabilitation after percutaneous coronary intervention(PCI)on the cardiac function recovery, quality of life and incidence of endpoint events in patients with acute myocardial infarction(AMI). Methods A total of 110 AMI patients undergoing PCI at our hospital from August 2016 to July 2017 were selected.The patients were randomly divided into the conventional group(n=55)receiving the conventional cardiac rehabilitation, and the rehabilitation group(n=55)undergoing a new mode of early cardiac rehabilitation after PCI.The cardiac function, health-related quality-of-life score(by SF-36 quality-of-life evaluation scale), and incidence of endpoint events were compared between the two groups before and after cardiac rehabilitation. Results After rehabilitation, the left ventricular ejection fraction(LVEF)and left ventricular end-diastolic volume(LVEDV)were significantly lower in the rehabilitation group than in the conventional group(P<0.01). The health-related quality-of-life scores including societal function, physiological function, physical pain and overall health were significantly higher in the rehabilitation group than in the conventional group(P<0.05). The incidence of endpoint events was lower in the rehabilitation group than in the conventional group(14.5% vs.32.7%, χ2=5.037, P=0.025). Conclusions The new model of early cardiac rehabilitation after PCI has a good early nursing effects on AMI patients after PCI, which can not only improve the cardiac function of patients and benefit the prognosis and quality of life, but also reduce the incidence of endpoint events. Key words: Myocardial infarction; Angioplasty, transluminal, percutaneous coronary; Rehabilitation

Abelmoschus manihot \u2013 a traditional Chinese medicine versus losartan potassium for treating IgA nephropathy: study protocol for a randomized controlled trial

BackgroundIgA nephropathy (IgAN) is one of the most common primary glomerular diseases worldwide, but effective therapy remains limited and many patients progress to end-stage renal disease (ESRD). Only angiotensin-converting enzyme inhibitors (ACE-I)/angiotensin-receptor blockers (ARB) show a high level of evidence (1B level) of being of value in the treatment for IgAN according to the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. However, traditional Chinese medicine has raised attention in kidney disease research. Abelmoschus manihot, a single medicament of traditional Chinese medicine has shown therapeutic effects in primary glomerular disease according to the randomized controlled clinical trial that we have completed. Here, we conduct a new study to assess the efficacy and safety of Abelmoschus manihot in IgAN. Also, this study is currently the largest double-blind, randomized controlled registered clinical research for the treatment of IgAN.MethodsWe will conduct a multicenter, prospective, double-blind, double-dummy randomized controlled study. The study is designed as a noninferiority clinical trial. Approximately 1600 biopsy-proven IgAN patients will be enrolled at 100 centers in China and followed up for as long as 48 weeks. IgAN patients will be randomized assigned to the Abelmoschus manihot group (in the form of a huangkui capsule, 2.5 g, three times per day) and the losartan potassium group (losartan potassium, 100 mg/d). The primary outcome is the change in 24-h proteinuria from baseline after 48 weeks of treatment. Change in estimated glomerular filtration rate (eGFR) from baseline after 48 weeks of treatment, the incidence of endpoint events (proteinuria ≥3.5 g/24 h, the doubling of serum creatinine, or receiving blood purification treatment) are the secondary outcomes. Twenty-four-hour proteinuria and eGFR are measured at 0, 4, 12, 24, 36 and 48 weeks.DiscussionThis study will be of sufficient size and scope to evaluate the efficacy and safety of Abelmoschus manihot compared to losartan potassium in treating patients with IgAN. The results of this study may provide a new, effective and safe treatment strategy for IgAN.Trial registrationClinicalTrials.gov, identifier: NCT02231125. Registered on 30 August 2014.

Simultaneous Bilateral Carotid Stenting for Symptomatic Bilateral High-Grade Carotid Stenosis: A Retrospective Clinical Investigation.

BackgroundThis retrospective clinical investigation aimed to evaluate the short-term effectiveness and safety of SBCAS for symptomatic bilateral high-grade CS.Material/MethodsFrom 2009 to 2014, 145 patients were recruited. Among them, 70 underwent SBCAS, and other 75 patients underwent SAMM and served as controls. The immediate postprocedural complications and postprocedural neurological evaluation, as well as restenosis at 6-month and 1-year follow-ups in the SBCAS group are reported. Additionally, baseline risk factors for ischemic stroke, adverse effects of drugs, and outcomes at 30-day, 6-month, and 1-year follow-ups were compared between the 2 groups.ResultsOur data did not reveal significant differences between the 2 groups in baseline risk factors for ischemic stroke. In the SBCAS group, both HPS (5.7%) and HD (40%) occurred, but they were not very severe, and no patients had postprocedural neurological deficit. Moreover, restenosis only occurred in 3 patients at 3 stent placement sites (4.3%) at 1-year follow-up. Adverse effects of drugs did not occur in SBCAS group, but adverse effects of Bayer aspirin and Lipitor occurred in 4 patients (5.4%) and 18 patients (24.3%), respectively, at 6-month follow-up in the control group. Furthermore, there were significant differences in outcomes between the 2 groups at 30-day, 6-month, and 1-year follow-ups, in that NIHSS, CS ratio, and incidence of endpoint events, as well as 1-year cumulative probability of endpoint events, were all lower in the SBCAS group than in the control group (p<0.05).ConclusionsCompared to SAMM, we found that SBCAS was more effective and safer for symptomatic bilateral high-grade CS.

Outcomes of IgA Nephropathy with Segmental Glomerular Necrosis But without Crescent Formation

Background: The significance of segmental glomerular necrosis (SGN) was not evident in immunoglobulin A nephropathy (IgAN) patients. Especially, there were a number of patients who presented with slight histopathological damage except SGN. We, therefore, conducted a study to highlight the occurrence of these cases and to define their clinical characteristics and outcomes at our centre. Methods: The clinical, laboratory and pathological manifestations and outcomes of these IgAN patients were collected and compared with IgAN patients with simily histopathological background but without SGN. Survival curves were constructed according to the Kaplan-Meier method. Multivariate Cox regression analysis was used to identify independent factors for the development of endpoint. Results: Eighty-two patients with SGN but without crescents were found in Haas grades I-III. Macroscopic hematuria and prodromal infection were more popular and the mean daily proteinuria was significantly higher in patients with SGN. More patients had high serum IgA in the ecrotizing IgAN group. At last follow-up, there were no differences in hypertension, proteinuria, serum creatinine, estimated GFR and the incidence of end-point events between 2 groups. SGN was not an independent predictor for the prognosis of IgAN. Corticosteroid treatment could decrease proteinuria significantly. The outcomes of the 2 populations of necrotizing IgAN patients with or without corticosteroid treatment were not different. Conclusions: SGN can be found in mild pathological damage patients and is not always associated with crescent formation. Heavier proteinuria was found in these IgAN patients. SGN was not an independent predictor for the prognosis of IgAN.

Prospective study of the short-term effect of 1.75 mmol/L calcium concentration dialysate on hemodialysis patients

<h3>Objective</h3> The purpose of the current study was to determine the influence of a 1.75 mmol/L calcium (Ca) concentration dialysate (DCa 1.75) during maintenance hemodialysis (MHD) therapy for patients with chronic kidney disease, mineral, and bone disorders (CKD-MBD) on biochemical indices and clinical prognosis. <h3>Methods</h3> Four hundred eighty-three MHD patients from three hemodialysis centers were enrolled. During 24 months of follow-up (January 2011 to December 2012), 289 patients from Center 1 who used 1.50 mmol/L Ca concentration dialysate (Dca 1.50) between January and December 2011 and DCa 1.75 between January and December 2012 were included in the high Ca group. The remaining 194 patients from the other centers who used DCa 1.50 for hemodialysis between January 2011 and December 2012 were included in the ordinary Ca group. The following CKD-MBD biochemical indices were monitored: blood Ca; blood phosphorus (P); intact parathyroid hormone (iPTH); and bone-specific alkaline phosphatase (BAP). The metastatic calcification index included calcification of aortic arch scoring (AoACS), abdominal aorta calcification (AAC), and cardiac valve calcification (CVC). The study end points included all-cause mortality (ACM), cardiovascular and cerebrovascular diseases (CCVDs), fractures, and new metastatic calcifications. The changes between the two groups in the observed indices were compared. <h3>Results</h3> Two hundred eighty-four patients in the high Ca group (98.3%) and 194 patients in the ordinary Ca group (100.0%) completed an average follow-up of 21.3±5.6 months. After DCa 1.75 was used, the blood Ca in the high Ca group increased [(2.39±0.22) mmol/L vs. (2.34±0.21) mmol/L, t=−2.910, <i>P</i>=0.004] compared to the previous year, and increased [(2.39±0.22) mmol/L vs. (2.30±0.16) mmol/L, t=5.187, <i>P</i>&lt;0.001] compared to the ordinary Ca group in the same year. The blood P and iPTH decreased [(1.78±0.39) mmol/L vs. (1.89±0.42) mmol/L, t=2.909, <i>P</i>=0.004 and (306.5±298.6) pg/ml vs. (425.7±365.1) pg/ml, t=8.377, <i>P</i>&lt;0.001, respectively] compared with the previous year, and decreased [(1.78±0.39) mmol/L vs (1.86±0.39) mmol/L, t=−2.016, <i>P</i>=0.044 and (306.5±298.6) pg/ml vs. (366.6±341.0) pg/ml, t=−2.113, <i>P</i>=0.035, respectively] compared with the ordinary Ca group in the same year. There was no difference in AoACS between the two groups before and after the change in DCa in the high Ca group (<i>P</i>&gt;0.05). In 2011, there was 13 CCVDs, 2 fractures, and 13 new metastatic calcifications in the ordinary Ca group compared to 8 CCVDs, 3 fractures, and 16 new metastatic calcifications in the high Ca group; there were no statistically significant differences in the incidence of end point events between the two groups (χ^<i>2</i>=2.747, <i>P</i>=0.098). In 2012, the values for the ordinary Ca group were 13, 2, and 15, respectively, while the values for the high Ca group were 8, 1, and 19, respectively, which indicated a statistically significant difference in the incidence of end point events between the two groups (χ^<i>2</i>=4.391, <i>P</i>=0.036). <h3>Conclusion</h3> Short-term use of DCa 1.75 significantly reduced the blood P and iPTH levels in MHD patients, significantly increased the blood Ca level, did not increase the proportion of new cardiovascular calcifications, and decreased the overall incidence of end point events.

Long-term effects of quinapril with high affinity for tissue angiotensin-converting enzyme after coronary intervention in Japanese

Background Angiotensin-converting enzyme inhibitors have been shown experimentally to prevent restenosis after balloon injury. We previously reported that quinapril reduced the 6-month restenosis (percent diameter stenosis ≥50%) rate after percutaneous coronary intervention (PCI). However, it was not established whether this favorable outcome was maintained for longer periods. Methods This study was a prospective, randomized, open, and non–placebo controlled trial. Patients with coronary artery disease were enrolled after successful coronary balloon angioplasty or stenting. Two hundred and fifty-three patients were randomly assigned to the quinapril (10–20 mg per day) or control groups. The major clinical end points included death, myocardial infarction, cerebrovascular accident, or revascularization (either coronary artery bypass grafting or repeat PCI). These were tabulated according to the intention-to-treat principle. Results Long-term follow-up was available with a median of 4.8 (interquartile range 4.2–5.1) years after the procedure. The incidence of combined end points of mortality and morbidity (myocardial infarction and cerebrovascular accident) in the quinapril group was lower than that in the control group (6.1% vs 14.8%; relative risk [RR] 0.42, 95% CI 0.18–0.96, P = .033). The overall incidence of end-point events in patients with quinapril also occurred less frequently (29.8% vs 46.7%; RR 0.58, 95% CI 0.38–0.86, P = .007). Conclusions These clinical outcomes show that the benefit of quinapril in patients following PCI is maintained for 4 years.