中药治疗糖尿病肾脏疾病随机对照试验结局指标的现状分析

目的 分析中药治疗糖尿病肾脏疾病（DKD）随机对照试验中结局指标的使用情况和其他试验设计要素,为中药治疗DKD临床试验的设计及核心指标集的构建提供依据。方法 计算机检索知网、万方、维普、中国生物医学等7个医学数据库及2个临床试验注册中心（clinicaltrials.gov、chinadrugtrials.org.cn）近5年收录的中药治疗DKD随机对照试验,运用Cochrance手册对纳入的文献进行偏倚风险评估,对结局指标及其他试验设计要素进行统计与分析。结果 共纳入97项随机对照试验（RCTs）,包含5项试验注册方案,研究发现,97项研究总体偏倚风险较高;DKD Ⅲ期（36项,41.38%）和气阴两虚兼血瘀证（16次,26.23%）为应用最多的DKD分期及中医证型;92项RCTs的疗程最多96周,最少2周,其中52项（56.52%）研究疗程为12周;92项RCTs及5项注册试验共采用152种结局指标,使用1 040次,共分为8大类,实验室检查（血液）、实验室检查（尿液）、临床疗效、中医证候积分、生活质量量表、生命体征、其他指标及其他事件,应用频率较高的依次是血肌酐（68次,70.10%）、临床有效率（55次,56.70%）、空腹血糖（51次,52.58%）、尿素氮（48次,49.48%）、总胆固醇（47次,48.45%）、24 h尿蛋白定量（43次,44.33%）等;56项RCTs及2项注册试验共采用安全性指标53种,频数227次,使用频率较高的依次是,不良反应（49次,84.48%）、肝功能（28次,48.28%）、血常规（24次,41.38%）、心电图（17次,29.31%）、尿常规（14次,24.14%）;10项RCTs及5项注册试验报告了主要结局指标;54项RCTs报告了临床有效率指标。结论 目前中药治疗DKD的RCTs结局指标设计尚不规范,未来应积极构建突显出中医药特色的核心结局指标集,提升临床研究的质量,提高试验结果的应用价值。     

Vitamin B12 Supplementation in Diabetic Neuropathy: A 1-Year,Randomized, Double-Blind,Placebo-Controlled Trial

Aim: To investigate the effect of normalizing vitamin B12 (B12) levels with oral B12 (methylcobalamin) 1000 μg/day for one year in patients with diabetic neuropathy (DN). Patients and methods: In this prospective, double-blind, placebo-controlled trial, 90 patients with type 2 diabetes on metformin for at least four years and both peripheral and autonomic DN were randomized to an active treatment group (n = 44) receiving B12 and a control group (n = 46) receiving a placebo. All patients had B12 levels less than 400 pmol/L. Subjects underwent measurements of sural nerve conduction velocity (SNCV), sural nerve action potential (amplitude) (SNAP), and vibration perception threshold (VPT), and they performed cardiovascular autonomic reflex tests (CARTs: mean circular resultant (MCR), Valsalva test, postural index, and orthostatic hypotension). Sudomotor function was assessed with the SUDOSCAN that measures electrochemical skin conductance in hands and feet (ESCH and ESCF, respectively). We also used the Michigan Neuropathy Screening Instrument Questionnaire and Examination (MNSIQ and MNSIE, respectively) and questionnaires to evaluate quality of life (QoL) and level of pain (pain score). Results: B12 levels increased from 232.0 ± 71.8 at baseline to 776.7 ± 242.3 pmol/L at follow-up, p < 0.0001, in the active group but not in the control group. VPT, MNSIQ, QoL, pain score, SNCV, SNAP, and ESCF significantly improved in the active group (p < 0.001, p = 0.002, p < 0.0001, p < 0.000, p < 0.0001, p < 0.0001, and p = 0.014, respectively), whereas CARTS and MNSIE improved but not significantly. MCR, MNSIQ, SNCV, SNAP, and pain score significantly deteriorated in the control group (p = 0.025, p = 0.017, p = 0.045, p < 0.0001, and p < 0.0001, respectively). Conclusions: The treatment of patients with DN with 1 mg of oral methylcobalamin for twelve months increased plasma B12 levels and improved all neurophysiological parameters, sudomotor function, pain score, and QoL, but it did not improve CARTS and MNSIE.     

显微外科技术治疗周围神经嵌压症

目的 :为探讨显微外科技术治疗周围神经嵌压症的疗效。方法 :采用显微外科技术对各部位周围神经嵌压症 2 5例进行神经内外松解术。结果 :2 5例周围神经嵌压症患者术后症状、体征及肌电图检查均较术前明显改善 ,疗效满意。结论 :显微外科技术是治疗周围神经嵌压症的一种有效方法。     

川芎嗪、山莨菪碱、蝮蛇抗栓酶及卡托普利对糖尿病大鼠肾脏的保护作用

目的　探讨川芎嗪、山莨菪碱、蝮蛇抗栓酶及卡托普利对实验大鼠糖尿病肾病 (DN)的预防作用。方法　SD大鼠 6 0只 ,分为正常对照组、糖尿病组及各糖尿病治疗组。以四氧嘧啶腹腔内注射制成糖尿病模型。各治疗组分别给予上述药物治疗 ,每周 5次 ,共 14周。取肾脏行光镜和电镜检查 ,并进行图像分析 ,同时测定蛋白糖基化产物 (GP)。结果　与糖尿病组比较 ,各治疗组肾组织中水平明显降低 (P <0 .0 1) ;除蝮蛇抗栓酶组外 ,其他治疗组大鼠肾小球截面积亦明显缩小 (P <0 .0 5 ) ;糖尿病组大鼠肾小球基底膜显著不均匀增厚 ,而各治疗组病变较轻 ,尤以卡托普利组疗效最为明显。结论　改善微循环、血液流变学及血流动力学治疗可减慢实验大鼠DN的进展。     

银杏黄酮甙和甲基B_(12)联合治疗糖尿病周围神经病变的疗效观察

目的　探讨银杏黄酮甙和甲基B12 对糖尿病周围病变的治疗效果。方法　将 14 9例糖尿病周围神经病变患者随机分为 4组 ,分别为常规治疗组 (对照组 )、银杏黄酮甙组 (第 1组 )、甲基B12 组 (第 2组 )、银杏黄酮甙与甲基B12 联合组(第 3组 )。疗程为 8周。观察治疗前后自觉症状、腱反射和神经传导速度。结果　第 3组总有效率为 95 % ,显著高于对照组 (17% ) (P <0 .0 0 5 )。第 1组和第 2组 ,总有效率分别为 6 9%和 72 % ,与对照组比较均有显著差异 (P <0 .0 1)。第 3组神经传导速度治疗后较冶疗前显著改善 (P <0 .0 1) ,而且显著优于对照组 (P <0 .0 1)、第 1组 (P <0 .0 5 )和第 2组 (P <0 .0 5 )。结论　银杏黄酮甙和甲基B12 联合治疗糖尿病周围神经病变较单独应用更为有效。     

生长激素对糖尿病及其微血管病变的影响

目的 :探讨生长激素对糖尿病及其微血管病变的影响。方法 :采用放射免疫法测定 6 7例Ⅱ型糖尿病患者及 18例正常人的血清生长激素 (GH)及胰岛素 (INS)水平。结果 :糖尿病合并微血管病变组 ,空腹生长激素 (FGH)明显高于正常对照组 (P <0 .0 1)及糖尿病无微血管病变组 (P <0 .0 1)。糖尿病无微血管病变组的FGH与正常对照组的FGH相比未见明显差异 (P >0 .0 5 )。餐后 2h的生长激素 (PGH)在 3组之间均无显著差异 (P >0 .0 5 )。FGH与HbA1c、空腹血糖 (FBS)呈正相关 (r=0 .5 46 ,P <0 .0 1;r=0 .437,P <0 .0 1) ,与UAER呈正相关 (r=0 .486 ,P <0 .0 1) ;FGH与病程无相关 (r=0 .2 2 ,P >0 .0 5 ) ,与FINS无相关 (r =- 0 .0 2 9,P >0 .0 5 )。结论 :GH水平的增高 ,与糖代谢紊乱有关 ,参与了糖尿病微血管病变的发生。     

老年糖尿病肾病中药治疗前后血脂、过氧化物歧化酶的变化

目的研究益肾活血中药对老年临床糖尿病肾病（ＤＮ）的疗效和机制。方法６８例老年临床糖尿病肾病患者随 机分为治疗组（３４例,服降糖药加益肾活血中药）与对照组（３４例,仅服降糖药）。测定治疗前后患者血脂、过氧化物 歧化酶（ＳＯＤ）及血清过氧化脂质（ＬＰＯ）含量及 ２４ ｈ尿蛋白定量的变化,并分别与 ３０名健康人组作比较。结果老 年临床糖尿病患者 ＳＯＤ明显低于健康人组（Ｐ＜０．０５）,而血脂、ＬＰＯ及 ２４ ｈ尿蛋白定量均明显高于健康人组（Ｐ＜０．０１）。 治疗 ４周后治疗组 ＳＯＤ水平明显升高（Ｐ＜０．０５）,血脂、ＬＰＯ及 ２４ ｈ尿蛋白定量明显下降,与对照组相比有显著性差 异（Ｐ＜０．０５）。结论益肾活血中药对抗过氧化损伤、防治老年ＤＮ有临床意义。     

Pain during sexual activity and ejaculation following hernia repair: A retrospective comparison of transabdominal preperitoneal versus Lichtenstein repair

Pain during sexual activity and ejaculation are the unspoken long-term complications of groin hernia repair. Laparoscopic surgical techniques are associated with decreased post-operative pain and earlier return to daily activities, but its effect on these complications is unclear. This study aims to investigate the effect of transabdominal preperitoneal repair (TAPP) on de-novo pain during sexual intercourse and ejaculation and to compare with open repair. For this reason, two groups were determined according to the surgical technique: the Lichtenstein repair and the TAPP groups and a questionnaire was sent to the patients a minimum of 6 months following the surgery. A total of 317 patients included, as 115 in TAPP and 202 in Lichtenstein repair group. No significant difference was observed concerning pre-operative pain during sexual activity and ejaculation in both groups (p = .75, p = .56). Following the surgery, the number of patients experiencing painful sexual activity was significantly higher in the Lichtenstein repair group compared to the TAPP group (19.3% vs. 11.3%, respectively, p = .03). The post-operative painful ejaculation rate was also significantly lower for the TAPP group (p = .04). The lower rates of post-operative dysejaculation and pain during sexual activity can be achieved with the advantage of laparoscopic surgery.     

Association between atherosclerotic cardiovascular diseases risk and renal outcome in patients with type 2 diabetes mellitus

AimsChronic kidney disease (CKD) and diabetes mellitus increase atherosclerotic cardiovascular diseases (ASCVD) risk. However, the association between renal outcome of diabetic kidney disease (DKD) and ASCVD risk is unclear.MethodsThis retrospective study enrolled 218 type 2 diabetic patients with biopsy-proven DKD, and without known cardiovascular diseases. Baseline characteristics were obtained and the 10-year ASCVD risk score was calculated using the Pooled Cohort Equation (PCE). Renal outcome was defined as progression to end-stage renal disease (ESRD). The association between ASCVD risk and renal function and outcome was analyzed with logistic regression and Cox analysis.ResultsAmong all patients, the median 10-year ASCVD risk score was 14.1%. The median of ASCVD risk score in CKD stage 1, 2, 3, and 4 was 10.9%, 12.3%, 16.5%, and 14.8%, respectively (p = 0.268). Compared with patients with lower ASCVD risk (＜14.1%), those with higher ASCVD risk had lower eGFR, higher systolic blood pressure, and more severe renal interstitial inflammation. High ASCVD risk (>14.1%) was an independent indicator of renal dysfunction in multivariable-adjusted logistic analysis (OR, 3.997; 95%CI, 1.385–11.530; p = 0.010), though failed to be an independent risk factor for ESRD in patients with DKD in univariate and multivariate Cox analysis.ConclusionsDKD patients even in CKD stage 1 had comparable ASCVD risk score to patients in CKD stage 2, 3, and 4. Higher ASCVD risk indicated severe renal insufficiency, while no prognostic value of ASVCD risk for renal outcome was observed, which implied macroangiopathy and microangiopathy in patients with DKD were related, but relatively independent.     

基于TLR4/MyD88/NF-κB通路探究桃红四物汤对糖尿病周围神经病变大鼠炎症反应的影响

目的:探究桃红四物汤对糖尿病周围神经病变(DPN)大鼠炎症反应及对Toll样受体4(TLR4)/髓样分化因子88(MyD88)/核转录因子kappan B(NF-κB)通路的影响。方法:从45只SD大鼠中随机选取10只为对照组,其余35只大鼠建立DPN模型,3只大鼠建模失败,其余随机分为模型组,桃红四物汤低、高剂量组及α-硫辛酸组,每组各8只。桃红四物汤低、高剂量组分别给予4.5、18 g/(kg·d)的桃红四物汤,α-硫辛酸组给予α-硫辛酸20 mg/(kg·d),对照组及模型组给予等量的0.9%氯化钠溶液,均灌胃给药。连续给药8周后,检测大鼠血清炎症因子、血糖及血脂指标及神经传导情况,观察坐骨神经病理学变化,检测TLR4相关通路蛋白表达情况。结果:与对照组比较,模型组血清肿瘤坏死因子-α(TNF-α)、白细胞介素-1β(IL-1β)及白细胞介素-6(IL-6)水平升高,血糖、糖化血红蛋白(HbA1c)、甘油三酯(TG)及血清总胆固醇(TC)水平升高,感觉神经传导速度(SNCV)及运动神经传导速度(MNCV)水平降低,TLR4、MyD88、NF-κB蛋白表达上调(P<0.05)...