Efficacy and safety of a novel multi-electrode radiofrequency ablation catheter for renal sympathetic denervation in pigs

Objective To investigate the safety and efficacy of a self-developed novel multi-electrode radiofrequency ablation catheter (Spark) for catheter-based renal denervation (RDN). Methods A total of 14 experimental miniature pigs were randomly divided into four groups (55°& 5-watt, 55°& 8-watt, 65°& 5-watt, and 65° & 8-watt groups). Spark was used for left and right renal artery radiofrequency ablation. Blood samples collected from renal arteries and veins as well as renal arteriography were performed on all animals before, immediately after, and three months after procedure to evaluate the effects of Spark on the levels of plasma renin, aldosterone, angiotensin I, and angiotensin II as well as the pathological changes of renal arteries. Results One pig died of an anesthetic accident, 13 pigs successfully underwent the bilateral renal artery ablation. Compared with basic measurements, pigs in all the four groups had significantly decreased mean arterial pressure after procedure. Histopathological analysis showed that this procedure could result in intimal hyperplasia, significant peripheral sympathetic nerve damage in the renal arteries such as inflammatory cell infiltration and fibrosis in perineurium, uneven distribution of nerve fibers, tissue necrosis, severe vacuolization, fragmented and unclear nucleoli myelin degeneration, sparse axons, and interruption of continuity. In addition, the renal artery radiofrequency ablation could significantly reduce the levels of plasma renin, aldosterone, angiotensin I, and angiotensin II in pigs. Conclusions The results suggest that this type of multi-electrode catheter-based radiofrequency ablation could effectively remove peripheral renal sympathetic nerves and reduce the activity of systemic renin-angiotensin system in pigs, thus facilitating the control of systemic blood pressure in pigs.     

Efficacy and safety of renal denervation in elderly patients with resistant hypertension

Background : Catheter‐based renal sympathetic denervation (RD) causes significant blood pressure (BP) reductions in patients with resistant hypertension (rHTN). However, hypertensive elderly patients reportedly have a lower sympathetic tone than younger patients and a BP lowering effect of RD in this population has not yet been demonstrated. The purpose of this study was to assess the efficacy and safety of RD in elderly patients. Methods : We reviewed all consecutive patients aged ≥ 75 years (mean: 78 years) with rHTN treated with RD. Twenty‐four patients were included in this prospective study. Office and ambulatory BPs were assessed at baseline and 6‐months follow‐up. Primary endpoint was the change in office systolic BP at 6 months. Results : Baseline mean office BP was 173/86 ± 21/13 mm Hg. Baseline 24‐hr mean ambulatory BP, available in 22 patients, was 158/80 ± 20/13 mm Hg. Baseline creatinine was 1.0 ± 0.18 mg/dl and mean number of antihypertensive agents at baseline 4.3 ± 1.4. No device‐ or procedure‐related adverse events occurred. At 6‐months follow‐up, the mean office BP decreased by 19/11 ± 29/16 mm Hg (P < 0.01 compared to baseline). Mean systolic 24 hr ambulatory BP, available in 17 patients, decreased by 9/5 ± 13/13 mm Hg. Antihypertensive medications could be reduced in nine patients. Furthermore, renal function was not impaired. Conclusion : According to our findings, a similar magnitude of BP reduction as reported in previous trials can be expected in elderly patients. Elderly patients with rHTN should not be excluded from renal denervation. © 2015 Wiley Periodicals, Inc.     

Catheter-based renal denervation in Chinese patients with chronic kidney disease and uncontrolled hypertension

Sympathetic activation contributes to the progression of hypertension and chronic kidney disease (CKD). Ablation of renal sympathetic nerves lowers blood pressure (BP) and preserves renal function in patients with CKD and uncontrolled hypertension by reducing sympathetic nerve activity. But whether this approach is safe and effective in Chinese patients with CKD is unknown. We performed an observational study of eight patients with CKD stages from 1 to 5, office BP ≥150/90 mmHg, while on at least three antihypertensive drug classes including a diuretic, and diagnosis confirmed by 24 h ambulatory systolic BP measurement ≥135 mmHg. All patients underwent catheter-based renal denervation (RDN) using a newly designed RDN System (Golden Leaf Medtech, Shanghai, China). For up to 6 months after RDN, BP was monitored and renal function was assessed. Mean baseline office BP was 165.0 ± 13.9/97.8 ± 5.5 mmHg, despite treatment with three antihypertensive drugs. Six months after RDN, office BP was reduced by 22.1 ± 12.0 (P = .002)/11.0 ± 8.8 mmHg (P = .012) and average 24 h ambulatory BP by 18 ± 13.7 (P = .01)/9.3 ± 7.7 mmHg (P = .016). After RDN, heart rate and estimated glomerular filtration rate (GFR) had no significant change compared with before RDN. In Chinese patients with CKD, our observational pilot study found that treating hypertension with RDN lowers BP while not affecting renal function. Brief Abstract: We performed RDN in eight Chinese patients with hypertension and CKD. The results showed that RDN lowered blood pressure of these patients significantly and eGFR was stable. No obvious adverse event was observed.     

Catheter‐based renal denervation in Chinese patients with chronic kidney disease and uncontrolled hypertension

Sympathetic activation contributes to the progression of hypertension and chronic kidney disease (CKD). Ablation of renal sympathetic nerves lowers blood pressure (BP) and preserves renal function in patients with CKD and uncontrolled hypertension by reducing sympathetic nerve activity. But whether this approach is safe and effective in Chinese patients with CKD is unknown. We performed an observational study of eight patients with CKD stages from 1 to 5, office BP ≥150/90 mmHg, while on at least three antihypertensive drug classes including a diuretic, and diagnosis confirmed by 24 h ambulatory systolic BP measurement ≥135 mmHg. All patients underwent catheter‐based renal denervation (RDN) using a newly designed RDN System (Golden Leaf Medtech, Shanghai, China). For up to 6 months after RDN, BP was monitored and renal function was assessed. Mean baseline office BP was 165.0 ± 13.9/97.8 ± 5.5 mmHg, despite treatment with three antihypertensive drugs. Six months after RDN, office BP was reduced by 22.1 ± 12.0 (P = .002)/11.0 ± 8.8 mmHg (P = .012) and average 24 h ambulatory BP by 18 ± 13.7 (P = .01)/9.3 ± 7.7 mmHg (P = .016). After RDN, heart rate and estimated glomerular filtration rate (GFR) had no significant change compared with before RDN. In Chinese patients with CKD, our observational pilot study found that treating hypertension with RDN lowers BP while not affecting renal function.Brief Abstract: We performed RDN in eight Chinese patients with hypertension and CKD. The results showed that RDN lowered blood pressure of these patients significantly and eGFR was stable. No obvious adverse event was observed.     

Olmesartan combined with renal denervation reduces blood pressure in association with sympatho-inhibitory and aldosterone-reducing effects in hypertensive mice with chronic kidney disease

Background: Augmented sympathetic nerve activity (SNA) and renin-angiotensin-aldosterone system (RAAS) activity are involved in the pathogenesis of hypertension (HT) accompanied by chronic kidney disease (CKD). Oxidative stress in the hypothalamus increases SNA in HT. Administration of an angiotensin ΙΙ receptor blocker (olmesartan; OLM) or renal denervation (RDN) exerts an antihypertensive effect in HT with CKD; however, the precise mechanisms of the combination therapy are not fully elucidated. In the present study, we examined whether combination therapy with OLM and RDN reduces both SNA by decreasing oxidative stress in the hypothalamus and RAAS activity in hypertensive mice with CKD.

Methods and Results: In 5/6-nephrectomized ICR-mice (Nx-mice) at 4-weeks after nephrectomy, systolic blood pressure (SBP) was significantly increased, accompanied by increased SNA and albuminuria compared with control-mice. Nx-mice were orally administered OLM, vehicle, or underwent RDN during OLM administration, and divided into Nx-OLM, Nx-VEH, and Nx-OLM/RDN groups, respectively. In Nx-OLM and Nx-OLM/RDN compared with Nx-VEH at 8-weeks after treatment, SBP was significantly decreased and both SNA and oxidative stress levels in the hypothalamus were significantly suppressed, without worsened creatinine clearance. In Nx-OLM and Nx-OLM/RDN compared with Nx-VEH, albuminuria was also suppressed, and the heart per body weight was decreased. In Nx-OLM/RDN, but not in Nx-OLM, the plasma aldosterone concentration was significantly decreased compared with Nx-VEH.

Conclusion: These findings suggest that combination therapy with OLM/RDN has antihypertensive effects in association with suppressing SNA by reducing oxidative stress in the hypothalamus and the plasma aldosterone concentration in hypertensive mice with CKD.     

彩色多普勒超声定位体外超声聚焦刀去肾交感神经的有效性与安全性研究

目的研究经彩色多普勒超声定位体外超声聚焦刀在去肾交感神经术中的安全性和有效性。方法 8个月大健康雄性广西巴马小香猪18只,随机分为三组,消融组1、消融组2及对照组,每组6只。消融组1行超声聚焦刀双侧肾动脉交感神经消融术,每一点单次消融强度为280 W×2 s;消融组2每点消融强度为320 W×2 s;对照组于麻醉后仅以CDFI行肾动脉超声检查。所有动物于术前、术后即刻、术后7 d和28 d测血压、采集血样,并评估血液指标(包括去甲肾上腺素、肾功能等),术后28 d处死并观察组织形态与病理变化。结果与手术前比较,消融组2手术后第7 d收缩压下降[(132.67±6.86)mm Hg vs.(122.33±6.15)mm Hg],差异具有统计学意义(P0.05),第28 d收缩压下降[(132.67±6.86)mm Hg vs.(117.83±6.49)mm Hg],差异具有显著统计学意义(P0.01)。与对照组比较,消融组2在术后第7、28 d收缩压下降,差异具有统计学意义(P均0.05)。与手术前比较,消融组1、消融组2术后7d、术后28 d测得血浆NE浓度降低,差异具有显著统计学意义(P均0.01)。与对照组和消融组1比较,消融组2术后7 d与术后28 d NE浓度降低,差异具有显著统计学意义(P均0.01)。三组术前与术后、三组之间血肌酐、尿素氮、尿酸比较,差异无统计学意义(P均0.05)。光镜下可见对照组肾动脉血管壁的内膜、中膜与外膜结构组织完整,未见血管壁损伤、变性或坏死。消融组可见伴行于血管外膜的神经细胞水肿、变性,并有轻度脱髓鞘改变。结论彩色多普勒定位体外超声聚焦刀去肾交感神经术具有可操作性,可在无创条件下去肾交感神经、抑制去甲肾上腺素释放、降低血压。     

Efficacy and safety of amlodipine in hypertensive patients with renal dysfunction

Amlodipine, a dihydropyridine calcium antagonist, was administered at 2.5-5.0 mg/day for 8 weeks to 35 hypertensive patients with renal dysfunction, and its efficacy and safety were evaluated. The target reduction in blood pressure was achieved in 28 of the 35 patients (80%), while blood pressure was decreased in 4 patients (11.4%) and unchanged in 3 patients (8.6%). A side effect of mild headache was reported by one patient (2.9%). In addition, abnormal changes in laboratory values were observed in five patients, but all of the changes were mild. Blood urea nitrogen and serum creatinine levels both increased in two of these five patients, and serum creatinine levels increased in another two patients. Serum amlodipine concentration was 4.86 ± 2.57 ng/ml (n = 8) and 3.01 ± 1.02 ng/ml (n = 8) in patients receiving a daily dose of 2.5 mg for 2-5 weeks and 8-10 weeks, respectively. Serum concentration in patients receiving 5 mg from Weeks 2-6 was 9.72 ± 6.89 ng/ml (n = 6) after 7-9 weeks, suggesting no tendency for the accumulation of this drug. The drug was rated as of clinical benefit in 27 of the 35 patients (77.1%), and as slightly beneficial in another 5 patients (14.3%). Thus, amlodipine significantly decreased the blood pressure while causing little or no aggravation of renal dysfunction in hypertensive patients with renal impairment.     

慢性肾脏病患者交感神经系统及肾素-血管紧张素-醛固酮系统与肾脏疾病进展之间的关系

随着人们生活水平的提高和生活方式的改变,慢性肾脏病(CKD)甚至终末期肾病的发病率日趋增加。导致CKD患者肾功能恶化的原因是多方面的。越来越多的证据表明,交感神经系统(SNS)和肾素-血管紧张素-醛固酮系统(RAAS)激活与CKD的进展密切关联。本文简要总结了CKD患者SNS和RAAS激活与肾脏病进展之间的联系,并针对当前现状简单介绍了一些相关治疗研究。     

Review of the state of renal nerve ablation for patients with severe and resistant hypertension

Through modulation of renin secretion, glomerular filtration rate, and renal absorption of sodium, the sympathetic innervation of the kidneys plays an important role in the pathogenesis of hypertension. Renal nerve ablation technology is being developed for treatment of drug-treatment-resistant hypertension worldwide. Preliminary research with the use of radiofrequency-based renal denervation systems have demonstrated encouraging results with significant reduction of blood pressure in patients inadequately controlled despite nearly maximal drug therapy regimens. From work done thus far, the renal denervation procedure has not been associated with serious adverse effects. Long-term efficacy and safety still needs to be established for renal nerve ablation. This review focuses on the impact of the renal sympathetic system on blood pressure regulation, the clinical rationale for renal nerve ablation in severe and drug-treatment-resistant hypertension, and current evidence from the more advanced renal denervation devices.     

Efficacy and safety of sotagliflozin in patients with type 2 diabetes and stage 3 chronic kidney disease

Aim

To assess the efficacy and safety of sotagliflozin, a dual inhibitor of sodium-glucose co-transporters 1 and 2, in adults with type 2 diabetes (T2D) and stage 3 chronic kidney disease (CKD3).

Materials and Methods

This phase 3, randomized, placebo-controlled trial evaluated sotagliflozin 200 and 400 mg in 787 patients with T2D and an estimated glomerular filtration rate of 30-59 ml/min/1.73m². The primary objective was superiority of week 26 HbA1c reductions with sotagliflozin versus placebo. Secondary endpoints included changes in other glycaemic and renal endpoints overall and in CKD3 subgroups.

Results

At 26 weeks, the placebo-adjusted mean change in HbA1c (from a baseline of 8.3% ± 1.0%) was –0.1% (95% CI: –0.2% to 0.05%; P = .2095) and –0.2% (–0.4% to –0.09%; P = .0021) in the sotagliflozin 200 and 400 mg groups, respectively. Significant reductions in fasting plasma glucose and body weight, but not systolic blood pressure, were observed. Among patients with at least A2 albuminuria at week 26, the urine albumin-creatinine ratio (UACR) was reduced with both sotagliflozin doses relative to placebo. At week 52, UACR was reduced with sotagliflozin 200 mg in the CKD3B group. Adverse events (AEs), including serious AEs, were similar between the treatment groups.

Conclusions

After 26 weeks, HbA1c was significantly reduced with sotagliflozin 400 but not 200 mg compared with placebo in this CKD3 cohort. UACR in patients with at least A2 albuminuria was reduced with each of the two doses at 26 weeks, but changes were not sustained at week 52. The safety findings were consistent with previous reports (NCT03242252).     

Objective performance goals of safety and blood pressure efficacy for clinical trials of renal artery bare metal stents in hypertensive patients with atherosclerotic renal artery stenosis

Objective : To provide safety and performance goals for prospective single‐arm trials of bare metal renal artery stenting in patients with resistant hypertension associated with high grade atherosclerotic renal artery stenosis. Background : To date, there have been no US Pre‐Market Approval (PMA) bare metal renal stent device trials which have focused on improvement of blood pressure control as a primary effectiveness endpoint. Methods : Analysis of subject‐level data from three large industry sponsored pre‐market approval (PMA) trials was performed. Hypertensive patients (≥155 mmHg) with a ≥50% atherosclerotic renal artery stenosis were included. Thirty day and 9‐month systolic and diastolic blood pressure measurements, renal function and 9‐month duplex ultrasound assessment of renal artery patency were analyzed. Results : Initial data analysis of 600 patients from the 3 PMA trials identified 286 patients who met inclusion criteria. The mean baseline systolic blood pressure was 177.8 ± 19.3 mmHg with a mean 68.1% diameter renal artery stenosis. Nine months after successful stenting, the mean SBP was 156.7 ± 24.1 mmHg; the 9 month restenosis rate was 14.4%. Conclusion : Based on the statistical modeling of these data and a priori established performance criteria, the co‐primary endpoints of 9 month reduction in blood pressure and in‐stent restenosis are proposed. The reduction in blood pressure will be analyzed as a continuous variable and will be compared to this performance goal. © 2011 Wiley‐Liss, Inc.     

Efficacy and safety of renal denervation for the management of arterial hypertension: A systematic review and meta‐analysis of randomized,sham‐controlled,catheter‐based trials

Despite the availability of a numerous antihypertensive agents, hypertension treatment and control rates remain low in many countries. The role of the sympathetic nervous system has long been recognized, but recent sham control renal denervation studies demonstrated conflicting results. In this reviewe paper, the authors performed a systematic review and meta‐analysis to examine outcomes of sham‐controlled studies utilizing new technologies and procedures. Six published randomized, sham‐controlled studies were included in this meta‐analysis. Of those, three trials used the first‐generation radiofrequency renal denervation device and technique and the other three used second‐generation devices and techniques. In total, 981 patients with hypertension were randomized in all 6 trials to undergo renal denervation (n = 585) or sham procedure (n = 396). Overall, renal denervation resulted in a decrease of 24‐hours systolic ambulatory blood pressure (ABP) by 3.62 mm Hg (95% CI: −5.28‐−1.96; I² = 0%), compared to sham procedure (GRADE: low). Renal denervation also reduced daytime systolic ABP by 5.51 mm Hg (95% CI: −7.79‐−3.23; I² = 0%), compared to sham procedure but not nighttime systolic ABP. Office systolic blood pressure was reduced by 5.47 mm Hg (95% CI −8.10‐−2.84; I² = 0%), compared to sham control. Further analysis demonstrated that second‐generation devices were effective in reducing blood pressure, whereas the first‐generation devices were not. These results indicate that effective renal denervation can result in significant and clinically meaningful blood pressure reduction. The second‐generation devices provide better renal nerve ablation.     

The benefit of renal artery stenting in patients with atheromatous renovascular disease and advanced chronic kidney disease

Background : Around 16% of all patients who present with atheromatous renovascular disease (ARVD) in the United States undergo revascularization. Historically, patients with advanced chronic kidney disease (CKD) have been considered least likely to show improvement in renal functional terms, or survival. We aimed to investigate whether differences in outcomes after revascularization compared to medical management might be observed in ARVD patients if stratified by their CKD classes. Methods : Two prospective cohorts, a UK center with a traditionally conservative approach, and a German center who undertook a proactive revascularization approach, were compared. An improvement in renal function was defined as > 20% renal improvement at one year's follow‐up. To improve validity and comparability, revascularized patients in the UK center were also used within analyses, Results : 347 (UK conservative group), 89 (UK revascularized group), and 472 (German center) patients were included in the analysis. When subdivided by CKD stage, patient ages between the two centers were comparable. Improvements in renal function were observed in twice as many patients who underwent revascularization as compared to medical treatment, particularly in the latter CKD stages, 15.2 (German revascularization) vs. 0% in CKD 1–2, 12.2 (UK), and 32.8 (German) revascularization vs. 14.1% in CKD3, and 53.1 and 53.8 vs. 28.3 in patients with CKD 4–5. The improvements in eGFR were 10.2 (16) and 8.1 (12.5) ml/min/year in the German and UK revascularized groups, respectively, vs. ?0.05 (6.8) ml/min/year in the medical cohort in CKD 4–5. Improvements in blood pressure control were noted at 1 year overall and within each CKD category. Multivariate analysis revealed that revascularization independently reduced the risk of death by 45% in all patients combined (RR 0.55, P = 0.013). Conclusions : Although this study has significant methodological limitations, it does shows that percutaneous renal revascularization can improve renal function in advanced CKD (stages 4–5), and that this can provide a survival advantage in prospective analysis. © 2009 Wiley‐Liss, Inc.     

1 alpha(OH)D3 (ETALPHA) treatment and receptor studies in 16 patients with chronic and myeloproliferative disorders

10 patients with CLL and 2 with CML were treated with gradually increasing doses of 1 alpha(OH)D3, up to 4 micrograms daily during 6 wk. 3 patients with preleukemia and 1 with myelofibrosis were treated with 2 micrograms daily of 1 alpha(OH)D3 for a prolonged period up to 17 wk. The treatment with 1 alpha (OH)D3 did not result in changes of disease parameters in any of the patients under study. Receptor studies for 1,25(OH)2D3 were performed in 8 CLL patients and revealed only 1 patient with increased specific receptor binding capacity. The maximum tolerable dose of 1 alpha(OH)D3 varied individually, but was in the range of 2-4 micrograms daily.     

The role of decoy receptor 3 in inflammation and atherosclerosis in patients with chronic kidney disease and renal transplant patients

IntroductionThe cardiovascular risk has been increased in chronic kidney disease associated with chronic inflammation and atherosclerosis. Decoy receptor 3, is a member of the TNF receptor superfamily and associated with inflammation and atherosclerosis. The aim of our study is to determine the relationship, between serum DcR3 levels and inflammatory markers in patients with renal transplantation, those receiving dialysis treatment and cases with chronic renal failure that did not receive replacement therapy, and to evaluate their correlation with USG findings.Material and methodsA total of 150 patients aged between 22–86 years, consisting of 4 groups, namely renal transplantation, dialysis, predialysis chronic kidney disease and control groups, were included in the study. Serum decoy receptor 3, VCAM-1, ICAM-1 and IL-8 measured with ELISA method. Carotid intima-media thickness and presence of carotis arter plaque performed by ultrasound probe, non-invasively.ResultsAll serum markers were higher in dialysis and pre-dialysis chronic kidney disease groups compared to renal transplant and control groups (p < 0.05). Serum decoy receptor 3 level (median(min–max)) of renal transplant group (0.49 ng/mL (0.19–1.65)) was higher than control group (0.35 ng/mL (0.19–2.22)). There was no difference between patients receiving dialysis (0.89 ng/mL (0.41–4.98)) and patients with pre-dialysis chronic kidney disease (0.71 ng/mL (0.29–1.68)). There was no difference between patient groups in terms of the presence of plaque.ConclusionAlthough renal transplantation provides a significant improvement in the inflammatory process, not return completely. Inflammatory process associated with uremic milieu may predispose to atherosclerosis in patients with pre-dialysis chronic kidney disease and hemodialysis patients.     

The effect of trajectory of serum uric acid on survival and renal outcomes in patients with stage 3 chronic kidney disease

Uric acid (UA) is associated with renal disease and patient survival, but the causal associations remain unclear. Also, the longitudinal UA control (trajectory) is not well understood.We enrolled 808 subjects diagnosed with stage 3 chronic kidney disease from 2007 to 2017. We plotted the mean UA over a period of 6 months with a minimum requirement of 3 samples of UA. From the sampled points, we generated an interpolated line for each patient by joining mean values of UA levels over time. Using lines from all patients, we classified them into 3 groups of trajectories (low, medium, and high) through group-based trajectory modeling, and then we further separated them into either treatment or nontreatment subgroups. Due to multiple comparisons, we performed post hoc analysis by Bonferroni adjustment. Using univariate competing-risks regression, we calculated the competing risk analysis with subdistribution hazard ratio of possible confounders.All of the 6 trajectories appeared showed a gradual decline in function over time without any of the curves crossing over one another. For all-cause mortality risk, none of the variables (including age, gender, coronary arterial disease, cerebrovascular disease, diabetes mellitus, renin–angiotensin–aldosterone system inhibitors, trajectories of UA, and treatment of UA) were statistically significant. All 6 trajectories appeared as steady curves without crossovers among them over the entire period of follow-up. Patients with diabetes mellitus were statistically more likely to undergo dialysis. The only trend was seen in the on-treatment trajectories, which showed lower risks for dialysis compared to their nontreatment trajectories. There was no effect of UA control on survival.Initial treatment of UA is crucially important for UA control. However, the long-term effects on patients and renal survival appeared to be minor and without statistical significance.     

Levels of 1,25(OH)2D3 for patients with pulmonary tuberculosis and correlations of 1,25(OH)2D3 with the clinical features of TB

Background

To determine the 1,25-dihydroxyvitamin D3 [1,25(OH)2D3] concentrations to patients with tuberculosis (TB) and whether it influenced the patient’s clinical features.

Methods

For the first part, a total of 153 healthy adults and 74 patients with pulmonary TB (PTB) were enrolled. Serum concentrations of 1,25(OH)2D3 were determined by liquid chromatography-tandem mass spectroscopy to examine the 1,25(OH)2D3 concentrations of the two groups from the peripheral blood. If there are differences between the two groups, what follow will increase the experimental group numbers to examine the relationship among the 1,25(OH)2D3 concentrations with the numbers of the lesion area, the tubercule bacilli in sputum and the CD4/CD8 ratio of T lymphocytes in the peripheral blood.

Results

In the first part, the 1,25(OH)2D3 concentrations was lower in patients with TB than in those healthy adults [365.9 (SD 235.7) vs. 464.3 (SD 335.6), P<0.05]. In the second part, we increased the sample size to 134 (male 91 cases, female 43 cases). we found that the plasma levels of 1,25(OH)2D3 are not correlated with the numbers of the lesion area and the tubercule bacilli in sputum, but the 1,25(OH)2D3 levels can interact the ratio of CD4/CD8 T lymphocytes, it shows a positive correlation with the ratio of CD4/CD8 T lymphocytes.

Conclusions

The 1,25(OH)2D3 concentrations in TB patients lower than the healthy adults, it might exist as a risk factor during the development of TB or TB might affect the levels of 1,25(OH)2D3. But the different status vitamin D concentration might not affect the numbers of the lesion area, the tubercule bacilli in sputum. It shows a positive correlation with the ratio of CD4/CD8 T lymphocytes. The study will have a significance value to clinical medicine, but further study will need to study the levels of 1,25(OH)2D3 with the TB.