REXEEDTM系列高通量透析器疗效和安全性的临床随机对照试验

目的 评价REXEEDTM系列高通量透析器的疗效和安全性。 方法 研究对象为上海两家医院规律性血液透析（血透）患者72例。采用随机化交叉设计,采用REXEEDTM不同膜面积（1.5 m2和2.1 m2）15AC、15UC、21AC、21UC透析器（试验组）以及APS-15U、BIO-HX100透析器（对照组）,分别按2个3×3拉丁方进行透析治疗。检测透析器尿素、肌酐、磷、β2微球蛋白清除率,尿素、肌酐下降比率及治疗前后安全性指标。观察及记录不良反应。 结果 试验组15AC、15UC透析器的尿素、肌酐清除率均显著大于对照组APS-15U[分别为（222.07±18.74） ml/min、（220.23±26.26） ml/min比（199.56±14.21） ml/min;（176.73±16.41） ml/min、（175.22±25.94） ml/min比 （165.42±14.68） ml/min,均P < 0.05]。两组间磷和β2微球蛋白清除率差异均无统计学意义。21AC、21UC透析器尿素、肌酐、β2微球蛋白清除率均显著大于对照组BIO-HX100[分别为（230.59±15.24） ml/min、（233.96±7.06） ml/min比（203.43±36.66） ml/min;（183.50±25.90） ml/min、（181.05±23.94） ml/min比（166.25±29.82） ml/min;（111.77±53.42） ml/min、（125.54±51.99） ml/min比（42.39±4.81） ml/min,均P < 0.05]。两组间磷清除率差异无统计学意义。试验组4种透析器尿素下降比率均大于89%,治疗前后安全性监测指标均无明显变化。不良反应和不良事件少而程度轻,无严重不良反应。 结论 REXEEDTM-AC、UC系列高通量透析器临床使用安全有效。     

高通量血液透析对血液透析患者瘙痒疗效的观察

尿毒症皮肤瘙痒是慢性肾衰竭血液透析患者常见的症状之一,约占血液透析患者80%左右,常在透析期间或透析结束后较为明显[1],目前公认为这些临床问题存在是尿毒症另一种主要致病物质所致。其原因还可能与皮肤干燥,汗腺皮脂腺萎缩,分泌低下,皮肤的钙、磷、镁沉积增加,继发性甲状旁腺亢     

阿法迪三冲击和每日治疗对血液透析患者继发性甲旁亢疗效的随机多中心对照临床研究

目的评价阿法迪三(R)[lα-(OH)-D3]每日或冲击治疗血液透析患者继发性甲状旁腺功能亢进(甲旁亢)的有效性和安全性.方法选择158例维持性血透患者,血全段甲状旁腺激素(iPTH)水平＞200 pg/ml,随机分为冲击组和每日组,分别采用阿法迪三(R)2μgbiw～tiw口服和0.5μgqd口服治疗,总观察期为20周,终点指标为iPTH水平＜200ph/ml.分别检测治疗前后血iPTH及钙磷代谢相关指标,并对不良反应进行监测.结果(1)两组患者年龄、透析龄、基础肾病分布、曾接受活性Vit D3治疗比例、平均血iPTH水平[冲击组(570.47±295.86)pg/ml,每日组(498.33±207.84)pg/ml]及血钙血磷等生化指标均无显著性差异.(2)冲击组治疗4周达标率明显高于每日组(35.2%比19.4%,P＜0.05).治疗至终点时两组总达标率相比无明显差异.iPTH%/周水平在iPTH 200～500pg/ml亚组冲击法高于每日法[(10.68±7.32)%比(7.42±7.89)%,P＜0.05].治疗终点时两组患者碱性磷酸酶(AKP)水平均较治疗前明显下降.(3)治疗终点和治疗前相比,每日组血磷、钙磷乘积均上升,而冲击组治疗前后无明显差异.(4)两组患者不良反应轻微.结论 (1)阿法迪三(R)(1α-(OH)-D3)口服和冲击治疗均能有效控制血透患者继发性甲旁亢,安全性良好.(2)早期冲击疗法对于血透患者中度继发性甲旁亢患者疗效更显著,起效更快.     

回肠袢式造口术和结肠造口术对老年左侧结直肠癌患者的临床疗效比较

目的观察回肠袢式造口术以及结肠造口术对老年左侧结肠癌患者的临床疗效对比。方法临床纳入老年结肠癌患者90例,根据随机数字表法分为回肠袢式造口术组与结肠造口术组,回肠袢式造口术组进行回肠袢式造口术,结肠造口术组进行结肠造口术。采用SPSS 16.0统计学软件进行数据处理,两组手术情况比较、血清胃泌素、肝细胞生长因子(HGF)水平采用t检验;两组患者术后并发症情况比较用(%)表示,χ~2检验,以P0.05为差异说明存在统计学意义。结果回肠袢式造口术组住院时间、首次排气时间、手术时间明显短于结肠造口术组(P0.05);血清胃泌素(59.3±24.2)pg/ml、HGF水平(853.6±94.9)pg/ml,均明显低于结肠造口术组(69.9±25.9)pg/ml、(1 009.6±100.3)pg/ml(t=2.01、7.59,P0.05);回肠袢式造口术组并发症感染率仅为2.2%(1/45),明显低于结肠造口术组的26.7%(12/45),(χ~2=10.88,P0.05);差异均有统计学意义。结论老年结肠癌患者采用回肠袢式造口术,患者术后恢复迅速,术后并发症低,临床效果确诊,值得临床推广。     

Magnesium carbonate for phosphate control in patients on hemodialysis. A randomized controlled trial

Background Magnesium salts bind dietary phosphorus, but their use in renal patients is limited due to their potential for causing side effects. The aim of this study was to evaluate the efficacy and safety of magnesium carbonate (MgCO₃) as a phosphate-binder in hemodialysis patients. Methods Forty-six stable hemodialysis patients were randomly allocated to receive either MgCO₃ (n = 25) or calcium carbonate (CaCO₃), (n = 21) for 6 months. The concentration of Mg in the dialysate bath was 0.30 mmol/l in the MgCO₃ group and 0.48 mmol/l in the CaCO₃ group. Results Only two of 25 patients (8%) discontinued ingestion of MgCO₃ due to complications: one (4%) because of persistent diarrhea, and the other (4%) because of recurrent hypermagnesemia. In the MgCO₃ and CaCO₃ groups, respectively, time-averaged (months 1–6) serum concentrations were: phosphate (P), 5.47 vs. 5.29 mg/dl, P = ns; Ca, 9.13 vs. 9.60 mg/dl, P < 0.001; Ca × P product, 50.35 vs. 50.70 (mg/dl)², P = ns; Mg, 2.57 vs. 2.41 mg/dl, P = ns; intact parathyroid hormone (iPTH), 285 vs. 235 pg/ml, P < 0.01. At month 6, iPTH levels did not differ between groups: 251 vs. 212 pg/ml, P = ns. At month 6 the percentages of patients with serum levels of phosphate, Ca × P product and iPTH that fell within the Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines were similar in both groups, whereas more patients in the MgCO₃ group (17/23; 73.91%) than in the CaCO₃ group (5/20, 25%) had serum Ca levels that fell within these guidelines, with the difference being significant at P < 0.01. Conclusion Our study shows that MgCO₃ administered for a period of 6 months is an effective and inexpensive agent to control serum phosphate levels in hemodialysis patients. The administration of MgCO₃ in combination with a low dialysate Mg concentration avoids the risk of severe hypermagnesemia.     

Effects of vitamin E-coated dialyzer on oxidative stress and inflammation status in hemodialysis patients: a systematic review and meta-analysis

Background: Vitamin E-coated dialyzer may have an effect on oxidative stress and inflammation status in hemodialysis (HD) patients. Therefore, we performed a systematic review to assess the anti-oxidation and anti-inflammatory effects of vitamin E-coated dialyzer in HD patients. Methods: The randomized controlled trials (RCTs) and quasi-RCTs of vitamin E-coated dialyzer versus conventional dialyzer for HD patients were searched from multiple databases. We screened relevant studies according to predefined inclusion criteria and performed meta-analyses using RevMan 5.1 software. Results: Meta-analysis showed vitamin E-coated dialyzer therapy could significantly decrease the serum thiobarbituric acid reacting substances (TBARS) (SMD, ?0.95; 95% CI, ?1.28 to ?0.61; p?p?=?0.005), interleukin-6 (IL-6) (SMD, ?0.65; 95% CI, ?0.97 to ?0.32; p?p?=?0.03) compared with that of the control group. However, vitamin E-coated dialyzer did not result in increasing the total antioxidant status (TAS) (SMD, 0.23; 95% CI, ?0.16 to 0.61; p?=?0.25) and the fractional clearance of urea index (Kt/v) levels (MD, ?0.07; 95% CI, ?0.14 to 0.00; p?=?0.06), in addition, there was no significant difference in plasma superoxide dismutase (SOD) level compared with that of the conventional dialyzer &; oral vitamin E group (SMD, 0.28; 95% CI, ?0.20 to 0.75; p?=?0.26). Conclusions: Vitamin E-coated dialyzer can reduce the oxidative stress and inflammation status reflected by the decreasing of serum TBARS, oxLDL, CRP, and IL-6 levels, and this new dialyzer does not affect the dialysis adequacy.     

他克莫司胶囊和缓释胶囊预防肝移植急性排斥反应的效果和安全性

目的 研究稳定期的肝移植受者分别服用他克莫司缓释胶囊和他克莫司胶囊在预防急性排斥反应的效果和安全性方面的差异.方法 采用多中心、随机、开放、对照的研究方法.试验组和对照组入组的稳定期肝移植受者各86例.试验组受试者的年龄为(46±10)岁;对照组受试者的年龄为(49±9)岁.试验组口服他克莫司缓释胶囊,每天1次,根据血药浓度谷值调整药量,维持血药浓度谷值为2～10 μg/L;对照组口服他克莫司胶囊,每天2次,维持血药浓度谷值为2～10 μg/L.结果 试验组和对照组分别有1.20%和1.18%的受试者发生急性排斥反应,两组的95%可信区间分别为-3.25%～3.31%和-3.26%～3.34%,可信区间上限均低于10%的非劣效标准.试验组和对照组急性排斥反应的发生率分别为1.20%和1.18%,两组患者发生急性排斥反应的次数均为1次,患者及移植物的存活率均为100%,以上指标两组间的差异均无统计学意义(P＞0.05).试验组有15例(占17.65%)共发生16次与试验药物相关的不良反应,对照组有10例(11.63%)共发生10次与试验药物相关的不良反应;试验药物有关严重不良反应中,试验组有4例(占4.71%)共发生4次,对照组有2例(占2.33%)共发生2次.两组不良反应发生率的差异均无统计学意义.结论 稳定期肝移植受者服用他克莫司缓释胶囊和他克莫司胶囊在预防急性排斥反应的疗效和安全性方面无明显差异.

Abstract：

Objective To evaluate the efficacy and safety of tacrolimus exposure in stable liver transplant recipients converted from FK506 twice a day to Advagraf (tacrolimus extended-release capsules) once daily. Methods This was an open-label, random, control and multi-center study.Eligible patients were 19 to 70 years of age, 6 months post-transplant with stable renal and hepatic function and receiving stable doses of tacrolimus twice a day for 2 weeks prior to enrollment. There were 86 patients in the experimental group and the control group, separately. The average age of experimental group and control group was 46 ± 10 and 49 ± 9, respectively. Patients in experimental group received Advagraf, once daily, and the dose was adjusted according to the drug concentration,and the drug concentration was between 2 to 10 μg/L. The control group given tacrolimus, twice daily, and the drug concentration was between 2 to 10 μg/L. Results The incidence of acute rejection reaction was 1.20 % and 1.18 % respectively in experimental group and control group, and the 95 %confidence interval was -3.25% ～3.31 % and -3.26% ～ 3.34 %, individually. There was 1 case of acute rejection reaction in experimental group and control group, respectively. The patient and organ survival rate was 100%. Sixteen adverse events occurred in 15 patients (17.65 %) of the experimental group, and 10 adverse events occurred in 10 patients (11.63 %) of control group. Severe adverse events relating to the test drug in experimental group occurred in 4 patients (4. 71 %). and 2 patients (2. 33) in control group.Conclision Clinical trials indicated that Advagraf has efficacy and safety profiles similar to those of tacrolimus. The drug is safe and may improve patient compliance.     

蔗糖铁注射液治疗维持性血液透析患者肾性贫血的前瞻性、随机对照多中心研究

目的比较蔗糖铁(森铁能)与右旋糖酐铁(科莫非)静脉注射液治疗维持性血液透析(MHD)患者缺铁性贫血的疗效与安全性。方法采用前瞻性、随机对照的多中心研究。 80例MHD患者分为试验组(蔗糖铁组)与对照组(右旋糖酐铁组),每组各40例。治疗前,两组患者男女性别比例、年龄、维持透析时间、血红蛋白(Hb)、红细胞比容(Hct)、铁蛋白(SP)和转铁蛋白饱和度(TSAT)等均无显著性差异。将100 mg蔗糖铁和100 mg右旋糖酐铁分别稀释于 100 ml生理盐水,于每次血透时使用。每周治疗2次,治疗时间为5周,观察时间共8周。两组患者的总补铁量均为1000 mg。全部病例都合并使用红细胞生成素(FPO)治疗,剂量为120～150 U·kg-1·周-1,皮下或静脉应用。观察并比较两组患者治疗贫血的效果、铁代谢指标变化及不良反应发生情况。结果经治疗后,试验组与对照组的Hb均较治疗前显著升高,分别为[(98．85± 17．45)g／L比 (75．20±9．66)g／L,P<0．01]和[(94．93±14．03)g／L比(75．53±10．61)g／L,P< 0．01];Hct也较治疗前明显升高(P<0．01),而试验组的上升幅度大于对照组,但差异无统计学意义。治疗后两组铁蛋白和转铁蛋白饱和度均明显高于治疗前,试验组铁蛋白为[(399．92± 200．90)μg／L比(106．61±78．24)μg／L,P<0．01];转铁蛋白饱和度为[(27．28±11．87)μg／L比 (17．95±9．17)μg/L,P<0．01]。试验组的上升幅度大于对照组,但两组相比差异无统计学意义。两组患者血清BUN、Scr、ALT和AST等均无明显变化。两组患者均无严重不良反应发生,对照组有1例发生下肢肌肉酸痛。结论蔗糖铁是治疗伴有缺铁的血液透析患者肾性贫血的一种安全而有效的药物。     

蔗糖铁注射液治疗血液透析患者肾性贫血的多中心研究

目的比较静脉用铁剂蔗糖铁(维乐福)、口服铁剂琥珀酸亚铁(速力菲)分别与基因重组人红细胞生成素(EPO)联合应用,治疗伴有缺铁的维持性血液透析患者肾性贫血的有效性和安全性。方法采用前瞻性、随机、对照的多中心研究。120例血透患者分为静脉组和口服组,每组各60例。静脉组:200mg蔗糖铁稀释于100ml生理盐水,每次透析时使用,直至完成总预计补铁量。总预计补铁量=体重(kg)×(150-Hb实际值)(g/L)×0.24 500(mg)。口服组:琥珀酸亚铁200mg每日3次,共8周。两组患者均使用EPO治疗,剂量为120～150U·kg-1·周-1,皮下或静脉应用。观察并比较两组患者贫血治疗的效果、铁代谢指标的变化及不良反应发生情况。结果治疗前静脉组与口服组间在男女性别比例、年龄、体重和接受治疗前维持透析时间及血红蛋白(Hb)、铁蛋白和转铁蛋白饱和度等方面均无显著差异。治疗后静脉组Hb犤(90.9±15.8)比(74.6±8.3)g/L,P<0.001犦和口服组Hb犤(84.5±11.9)比(76.6±7.8)g/L,P<0.001犦均较治疗前明显升高。而静脉组Hb上升幅度明显高于口服组犤(17.9±10.1)比(7.9±11.0)g/L,P<0.001犦;其治疗时间明显短于口服组犤(5.2±0.4)比8.0周,P<0.001犦;静脉组Hb上升速度明显快于口服组犤(3.5±2.0)比(1.0±1.4)g·L-1·周-1,P=0.003犦。两组平均EP     

A prospective randomized controlled trial of simple Bascom's technique versus Bascom's cleft closure for the treatment of chronic pilonidal disease

Background

The aim of this study was to determine which of Bascom's simple techniques, Bascom's simple surgery or Bascom's cleft closure, is preferred in the management of moderate-severity pilonidal disease.

Methods

Fifty-five patients with chronic pilonidal disease were randomized to receive Bascom's simple surgery (n = 29) or cleft closure (n = 26) under local anesthetic. The primary end point was time to healing. Patients were followed up for a median of 3 years (range, .7-4 y).

Results

After Bascom's simple surgery, 5 of 29 patients did not heal and proceeded to cleft closure. The remaining patients healed at a median of 4 weeks (range, 3-35 wk). After cleft closure, 21 of 26 wounds healed primarily on removal of sutures at 10 to 13 days. The remaining 5 wounds healed at a median of 4.5 weeks (range, 2-5 wk). Fifty of 55 (91%) patients were contacted for follow-up evaluation, disease recurrence occurred in 2 of 24 after Bascom's simple surgery and in 0 of 26 after cleft closure.

Conclusions

Cleft closure offers more predictable healing than Bascom's simple surgery, with less need for re-operation. Disease recurrence is more prevalent after Bascom's simple surgery.     

Comparison of puncture methods in patients with hemodialysis: A randomized controlled trial

Introduction: Arteriovenous fistula or arteriovenous graft is essential to long-term survival and quality of life in patients receiving hemodialysis. To date, no research has examined the clinical impacts of different puncture methods. This study compared the rope ladder and area puncture techniques in terms of vascular patency, pain, and quality of life among patients receiving hemodialysis. Methods: A prospective longitudinal study was performed with 6-month follow-up. A total of 98 participants recruited from a hemodialysis center in Taiwan were randomly assigned to receive the rope ladder technique (experimental group) or the area puncture technique (control group). Vascular patency was assessed by examining access flow and percutaneous transluminal angioplasty rate. Pain and quality of life were measured using the Numerical Pain Rating Scale (NPRS) and Kidney Disease Quality of Life Instrument (KDQOL-36™), respectively. All outcome variables were measured repeatedly and analyzed using a generalized estimating equation. Results: Overall, quality of life was significantly better for the experimental group than for the control group (β = 47.23, p < 0.001). The percutaneous transluminal angioplasty rate was lower for the experimental group than for the control group (12.0% vs. 18.8%). However, no significant differences were found in access flow and pain level between the two groups over time. Conclusion: Hemodialysis patients who received the rope ladder puncture technique had a lower percutaneous angioplasty rate and better quality of life than patients who received the area puncture technique, suggesting that the rope ladder technique could be implemented as a routine cannulation method in hemodialysis clinics.