河车大造胶囊联合克龄蒙治疗卵巢早衰临床观察

目的 观察河车大造胶囊联合克龄蒙治疗卵巢早衰的临床疗效.方法 将41例卵巢早衰患者随机分为治疗组(n=21)和对照组(n=20),对照组患者口服克龄蒙,治疗组患者加服河车大造胶囊.每个疗程21 d,共3个疗程.治疗前后分别观察两组临床疗效,检测血清卵泡刺激素(follicle stimulating hormone,FSH)、黄体生成素(luteinizing hormone,LH)和雌二醇(estradiol,E2)水平.结果 治疗组总有效率显著高于对照组(85.70％ vs 55.00％,P＜0.05).与治疗前比较,两组治疗后血清FSH水平均显著降低(P＜0.05),E2水平均显著升高(P＜0.05),LH水平无明显变化(P＞0.05);两组治疗前后血清FSH降低值和E2升高值比较,差异均无统计学意义(P＞0.05).结论 河车大造胶囊联合克龄蒙治疗卵巢早衰,可提高临床疗效,调节血清性激素水平,但尚需大样本量数据的验证.     

芪白平肺胶囊对慢性阻塞性肺疾病痰瘀阻肺证大鼠血清CAM-2和VEGF的影响

目的 观察芪白平肺胶囊对慢性阻塞性肺疾病(chronic obstructive pulmonary disease,COPD)痰瘀阻肺证大鼠血清钙调节蛋白-2(calmodulin-2,CAM-2)和血管内皮生长因子(vascular endothelial growth factor,VEGF)的影响,探究其作用机制.方法 将280只SD大鼠随机分为正常组(60只)、模型组(60只)、芪白平肺胶囊预防组(芪预组,40只)、芪白平肺胶囊治疗组(芪治组,40只)、尼可地尔预防组(尼预组,40只)、尼可地尔治疗组(尼治组,40只).采用连续4周的强迫游泳、烟熏和低氧应激的复合方法复制COPD痰瘀阻肺证大鼠模型.正常组和模型组分别在实验第4周、第8周、第12周各处死20只大鼠,检测血清CAM-2和VEGF水平;芪预组和尼预组均在模型复制同时预防性给药4周,分别在实验第4周、第8周各处死20只大鼠,检测血清CAM-2和VEGF水平;芪治组和尼治组均在模型复制结束后连续给药4周,分别在实验第8周、第12周各处死20只大鼠,检测血清CAM-2和VEGF水平.结果 两因素方差分析结果显示,模型因素和时间因素对大鼠血清CAM-2和VEGF水平的主效应及其交互作用均具有统计学意义(P＜0.05).在实验第4周、第8周、第12周,模型组大鼠血清CAM-2水平均显著低于正常组(P＜0.05),血清VEGF水平均显著高于正常组(P＜0.05).与同时间模型组比较,尼预组和芪预组大鼠血清CAM-2水平显著升高(P＜0.05),而血清VEGF水平显著降低(P＜0.05).与同时间尼预组比较,芪预组CAM-2水平显著升高(P＜0.05),VEGF水平显著降低(P＜0.05).与同一时间模型组比较,芪治组和尼治组大鼠血清CAM-2水平显著升高(P＜0.05),VEGF水平显著降低(P＜0.05);在实验第12周,芪治组大鼠血清VEGF水平显著低于尼治组(P＜0.05).结论 芪白平肺胶囊和尼可地尔预防性给药和治疗性给药均可调节COPD痰瘀阻肺证大鼠血清CAM-2和VEGF的异常,芪白平肺胶囊的远期效应优于尼可地尔.     

OMOM胶囊内镜对小肠疾病的诊断价值

目的:探讨国产OMOM胶囊内镜对消化道疾病,特别是小肠疾病的诊断价值。方法:总结分析我院2011年5月至2014年5月来自门诊和住院的不明原因消化道出血及腹痛腹胀腹泻等患者共56例。所有患者进行OMOM胶囊内镜检查前均行胃镜、肠镜及消化道钡餐检查,未发现可解释疾病的病因。结果:所有患者均完成检查,56例检出小肠疾病40例(71.4%),不明原因消化道出血组26例检出小肠疾病23例88.4%(23/26),腹痛腹胀腹泻等组30例检出小肠疾病17例56.6%(17/30)。结论:国产OMOM胶囊内镜对小肠疾病诊断率高,操作简单、安全,且价格低、无创伤。可作为小肠疾病的常规筛查手段。     

生血胶囊的毒理学研究

目的本研究观察小鼠和大鼠口服生血胶囊的急性毒性和长期毒性反应,为临床用药提供参考。方法取健康小鼠和大鼠各30只,灌胃给药,2次/d,每次剂量分别为24和16 g/kg,给药后观察14 d,记录动物死亡及不良反应症状,取健康SD大鼠160只,随机分为低、中、高(0.5、2.5、5.0 g/kg)3个剂量组和一个对照组。灌胃,2次/d,每次10 ml/kg,连续26周。用药13周、26周和停药4周后分别取样进行血液学、血液生化学、脏器重量及重量指数,病理组织学检查。结果生血胶囊对小鼠和大鼠的口服最大给药量分别大于24和16 g/kg,该剂量是临床成人拟推荐用药剂量(0.08 g/kg)的240和160倍;长期毒性实验中各组大鼠的一般状况、体质量、血液学指标、血液生化学指标及主要脏器系数与对照组比较未见显著差异和异常改变;肉眼观察服药组心、肝、脾、肺、肾等脏器外观形态、颜色均无异常改变,光镜检查也未见各脏器组织结构和细胞形态异常。结论在推荐临床剂量下服用生血胶囊是安全可靠的。     

中国汉族成人内囊体积与年龄相关性研究

目的探讨中国汉族正常成人内囊体积与年龄的相关性,为内囊病变的临床诊断提供直接依据。资料与方法选择汉族健康成人1000名,按年龄分为A(18～30岁)、B(31～40岁)、C(41～50岁)、D(51～60岁)、E(61～80岁)5组,每组200名,男、女各100名。对每名志愿者用1.5 T MR扫描仪进行研究,应用3D体积分析软件手动逐层勾画出内囊边界,软件自动测算出体积。结果测量得A、B、C、D、E 5组左、右侧内囊(总的、前肢、膝部、后肢)体积,将A、B、C、D、E 5组左侧内囊(总的、前肢、膝部、后肢)体积分别与右侧内囊比较,经统计学检验左右侧间均有显著性差异(P<0.05)。将左、右侧内囊的体积进行标准化处理后,左、右侧内囊体积与年龄之间均呈负相关(r值分别为-0.718、-0.637,P值均<0.05)。结论内囊体积与年龄呈负相关,即随着年龄的增大内囊体积逐渐缩小。     

A Multicenter,Randomized,Double-blind Clinical Study on Wufuxinnaoqing Soft Capsule(五福心脑清胶囊) in Treatment of Chronic Stable Angina Patients with Blood Stasis Syndrome

Objective:To confirm the efficacy and safety of Wufuxinnaoqing Soft Capsule(五福心脑清胶囊,WSC)in the treatment of chronic stable angina(blood stasis syndrome).Methods:A multicenter,randomized,double-blind,placebo-controlled trial with superiority test was designed.A total of 240 patients with chronic stable angina(blood stasis syndrome)from multiple centers were randomly and equally assigned to the treatment group and the control group.Based on standard treatment of Westem medicine,the treatment group was given WSC,while the control group was given WSC mimetic,both for 12 weeks.Observed indicators included the efficacy in angina,the efficacy in Chinese medicine syndrome,the withdrawal or reduce rate of nitroglycerin and routine safety indices.Results:After 12-week treatment,the significant effective rate and total effective rate of the treatment group were significantly better than those of the control group(23.5%vs.9.2%,64.7%vs.30.8%),respectively,with statistically significant difference(P0.01).After 12-week treatment,the decreased points and the decreased rate of angina symptom score in the treatment group were better than in the control group(5.1±4.2 points vs.2.8±3.5 points,44.9%±37.2%vs.25.4%±30.7%)respectively,with significant difference(P0.01).After 12-week treatment,the significant effective rate and total effective rate of the treatment group were better than the control group(respectively,30.3%vs.15.0%,67.2%vs.45.0%,P0.01).After 8-or 12-week treatment,the decreased points and the decreased rate of Chinese medicine syndrome score in the treatment group were better than the control group(P0.05 or P0.01).After 12-week treatment,nitroglycerin withdrawal rate and the withdrawal or reduce rate in treatment group were better than the control group(P0.01).On safety evaluation,the incidence of adverse events(7.563%vs.7.500%)and the incidence of cardiovascular events(0.840%vs.0.000%)in the treatment group were similar with the control group,and the difference was not statistically significant(P0.05).Conclusion:In treatment of chronic stable angina(blood stasis syndrome),WSC can reduce angina attacks and consumption of nitroglycerin,decrease angina severity degree,effectively relieve the blood stasis syndromes,such as chest pain,chest tightness,palpitations,dark purple tongue and other symptoms.Besides,adverse events and cardiovascular adverse events in the treatment group and the control group showed no difference.All shows that the drug is safe and effective.[This study was registered in Chinese Clinical Trial Registry(ChiCTR),with registration number:ChiCTR-TRC-14005158.]     

Efficacy and Safety Investigation of Kuntai Capsule for the Add-back Therapy of Gonadotropin Releasing Hormone Agonist Administration to Endometriosis Patients: A Randomized,Double-blind,Blank- and Tibolone-controlled Study

Background:

As a Chinese Traditional Medicine product, Kuntai capsule could improve the peri-menopausal symptoms in postmenopausal women. But it is still not clear whether Kuntai capsule has a good effect on alleviating peri-menopausal symptoms induced by gonadotropin releasing hormone agonist (GnRH-a) treatment. The purpose of this study was to investigate the clinical effectiveness and safety of Kuntai capsule, on peri-menopausal symptoms in endometriosis (EMS) patients, with postoperative GnRH-a treatment.

Methods:

Ninety EMS ovarian cyst women with postoperative GnRH-a administration were enrolled in the study, and were randomly divided into Kuntai group, Tibolone group, or blank Control group. The therapeutic strategy in Kuntai group was 4 Kuntai capsules tid,po for 12 weeks after the first GnRH-a injection, while Tibolone 2.5 mg qd, po for 12 weeks in Tibolone group. There was no drug addition in Control group. Climacteric complaints were evaluated by Kupperman menopausal index (KMI) and hot flash/sweating score. Liver and renal functions, lipid profile, serum sex hormone levels and endometrial thickness were measured, and the frequency of adverse events in Kuntai and Tibolone groups was recorded.

Results:

(1) Before GnRH-a therapy, the baseline parameter results were comparable in the three groups (P > 0.05). (2) After GnRH-a therapy, KMI and hot flash/sweating scores in all the three groups increased significantly (P < 0.05). At the 4^th week after GnRH-a therapy, KMI and hot flash/sweating score results were as follows: Control group > Kuntai group > Tibolone group (P < 0.05); at the 8^th and 12^th week after GnRH-a therapy, KMI and hot flash/sweating score in Control group were significantly higher than the other two groups (P < 0.05), and no significant difference was identified between Kuntai and Tibolone group (P > 0.05). (3) No statistical change took place in the liver and renal functions and lipid profile in all the three groups after the treatment (P > 0.05). (4) The posttherapeutic serum follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol (E2) level and endometrial thickness decreased significantly in all the three groups (P < 0.05). After therapy, serum E2 level in Tibolone group was obviously higher than the other two groups (P < 0.05), while FSH and LH levels were obviously lower (P < 0.05). (5) The incidence of vaginal bleeding, breast distending pain in Tibolne group was obviously higher than Kuntai group (P < 0. 05).

Conclusions:

Kuntai capsule is effective on the peri-menopausal symptoms induced by postoperative GnRH-a administration to EMS patients, although its clinical effect might be a few weeks later than Tibolone. Kuntai capsule might be a little safer than Tibolone tablet.     

HPLC法测定元胡止痛胶囊中延胡索乙素及其不确定度评定

目的 建立元胡止痛胶囊中延胡索乙素的定量测定方法,并对所建立方法进行不确定度评定。方法 采用HPLC法测定元胡止痛胶囊中延胡索乙素,再根据方法学验证数据,对测定过程中引入的不确定度进行评估,由此计算合成不确定度,最终给出测量结果在95%置信区间下的扩展不确定度。结果 采用本方法定量测定元胡止痛胶囊中延胡索乙素的扩展不确定度为4.10%。结论 建立的延胡索乙素定量测定方法,结果准确且重现性好,可用于元胡止痛胶囊的质量控制;建立的不确定度评定法适用于HPLC法测定中药有效成分的不确定度分析。     

前列欣胶囊治疗慢性前列腺炎180例疗效观察

慢性前列腺炎(chronic prostatitis,CP)是指前列腺在病原体或／和某些非感染因素作用下,患者出现以骨盆区域疼痛或不适、排尿异常等症状为特征的1组疾病.根据1995年美国国立卫生研究院(National Institutes of Health,NIH)新的分类方法,其中Ⅲ型：慢性前列腺炎／慢性骨盆疼痛综合征(chronic prostatitis/chronic pelvic pain syndromes,CP/CPPS),是前列腺炎中最常见的类型,约占慢性前列腺炎的90%以上.主要表现为长期、反复的骨盆区域疼痛或不适,持续时间超过3个月,可伴有不同程度的排尿症状和性功能障碍,严重影响患者的生活质量[1].有资料显示约有50%的男性在一生中的某个时期会受到该疾病的影响.各个年龄段的成年男性都可以受到前列腺炎的影响,其中以50岁以下的成年男性患病率较高.     

黄葵胶囊联合氯沙坦治疗肾移植术后蛋白尿的临床观察

目的探讨黄葵胶囊联合氯沙坦治疗肾移植术后蛋白尿的临床疗效。方法接受尸体肾移植、术后时间达半年以上、24 h尿蛋白定量≥300 mg的患者80例,将其随机分成治疗组（40例）和对照组（40例）。治疗组给予黄葵胶囊5粒,每日3次,口服;同时服用氯沙坦80 mg,每日1次,口服。对照组给予氯沙坦80 mg,每日1次,口服。连续用药8周,在用药前及用药8周后分别测定24 h尿蛋白定量、血白蛋白、肾功能,并比较组间差异和组内差异,同时评价临床疗效。结果治疗组总有效率明显优于对照组,差异有统计学意义（P〈0.05）;连续用药8周后,治疗组尿白蛋白、血清白蛋白测定结果与对照组比较,差异有统计学意义（P〈0.05）;治疗组组内不同时间所有测定结果比较差异有统计学意义（均P〈0.05）。结论黄葵胶囊联合氯沙坦治疗肾移植术后蛋白尿安全有效,值得临床推广使用。