糖克软胶囊治疗2型糖尿病气阴两虚证的临床研究

目的:观察糖克软胶囊治疗2型糖尿病气阴两虚证的临床疗效。方法:采取随机、双盲、安慰剂设计,试验组给予糖克软胶囊(0.2g/粒),1粒/次,1日2次(早晚各一次);对照组给予安慰剂软胶囊(0.2g/粒),1粒/次,1日2次(早晚各一次),均于餐前口服。疗程为84天,观察糖化血红蛋白、血糖、中医证候、胰岛素敏感性指标及血脂变化情况。结果:糖克软胶囊具有降低糖化血红蛋白的作用,与对照组比较差异有统计学意义;同时对血糖(FPG、2hPG)和糖负荷后曲线下面积(AUCG)、中医证候、胰岛素敏感性指标(ISI)、血脂(TG、TC、HDL-C、LDL-C)具有一定作用,但与对照组比较,差异均无统计学意义。结论:糖克软胶囊具有降低2型糖尿病-气阴两虚证患者糖化血红蛋白的作用,值得进一步研究。     

克糖胶囊治疗2型糖尿病临床研究

克糖胶囊由糖消口服液浓缩精制而成.为著名老中医王鸣周五代家传治疗消喝病尿甜的验方.分型特点:①强劳伤肾、肺肾津液通调失和,内热聚毒消瘦型.②脾胃湿热内蕴,生化失职,湿热积聚肌腠,脂肪代谢失和,堆积肥胖型.施治特点:1、滋肺肾之阴,抑内热安五脏使毒化无源.2、醒脾利湿泄胃热、强运化、降脂而控制多食、多饮、多尿尿甜、口干、眩晕.增强胰脏(三焦)泌清浊的自体调控机能.激发胰岛β细胞分泌胰岛素,而治疗2型糖尿病的初、早、中期反复发病.该研究被审定为2002年河南省科技攻关计划.     

克糖症治疗2型糖尿病的临床观察

目的 :观察克糖症治疗 2型糖尿病的临床疗效。方法 :治疗组予克糖症水煎液 5 0 m L/次 ,分别于早、晚饭前半小时服用 ,治疗 3个月 ;对照组予一般口服降糖药物治疗。结果 :克糖症能有效改善疲软乏力等临床症状 ,降低餐后 2小时血糖水平 ,抗血管内皮氧化损伤 ,调节血管舒缩功能。结论 :克糖症具有较好的防治糖尿病及其血管并发症的作用。     

溶栓克糖胶囊治疗2型糖尿病43例观察

自1999年以来，我院糖尿病科采用溶栓克糖胶囊治疗2型糖尿病效果满意，总结如下。 1 一般资料 共73例，随机分为溶栓克糖胶囊组(治疗组)和……     

消糖散治疗2型糖尿病临床研究

1998年 1 0月～ 2 0 0 0年 1 0月 ,笔者用消糖散治疗 2型糖尿病 84例 ,疗效满意 ,报告如下。1　临床资料1 48例患者皆符合 1 980年以来 WHO关于 2型糖尿病的诊断标准。男 75例 ,女 73例 ;年龄 35～ 65岁 ,平均 5 0岁 ;发病时间 :3个月者 35例 ,4～ 1 2个月69例 ,1～ 2年 32例 ,2年以上 1 1例 ,平均 1 9.5个月 ;发病原因 :过于劳累 30例 ,过食肥甘 9例 ,情志所伤43例 ,原因不明 66例 ;临床表现口渴多饮者 1 2 8例 ,多食易饥者 98例 ,小便频数量多者 1 1 6例 ,体痛乏力者 64例 ,形体消瘦者 64例 ,下肢浮肿者 34例 ;合并高血压 1 4例 ,视网膜…     

糖克软胶囊Ⅰ期临床人体耐受性研究

目的观察健康受试者单次和连续口服糖克软胶囊的耐受性和安全性,为Ⅱ期临床试验提供安全的剂量范围。方法42名受试者分为单次给药组和连续给药组。单次给药组分别口服糖克软胶囊1、2、4、6、9、12粒;连续给药组根据单次给药“最大耐受量”,下降1个剂量进行累积性试验,连续给药7d。给药前后检查心电图、血常规、尿常规、便常规、肝肾功能等,观察可能出现的不良反应。结果单次给药组服药9粒（0．9g）,3例出现自觉发热、脸麻、心慌、汗出或头晕等轻度不良反应,连续给药组未发现不良反应。结论人体一次性给予糖克软胶囊不超过0．6g或连续服药不超过0．6g／d,是安全的。     

糖克丸治疗非胰岛素依赖型糖尿病的临床研究

为了探究糖克丸在非胰岛依赖型糖尿病(NIDDM)治疗中的作用,我们于1997-03～1998-09进行了糖克丸治疗(NIDDM)的临床研究,现将结果报告如下。1 材料和方法1.1 一般资料 全部病例均为浙江省中西医结合医院中医内科门诊病人和临安市人民医院内科住院病人,其中治疗组(糖克丸组)46例,男22例,女24例;年龄30～60岁;病程<1年14例,<3年22例,>3年10例。对照组(二甲双胍片组)30例,男14例,女16例;年龄30～60岁;病程<1年11例,<3年12例,>3年7例。     

西格列汀联合阿卡波糖治疗初发2型糖尿病临床研究

目的探讨西格列汀联用阿卡波糖对初诊2型糖尿病患者血糖的影响。方法选择2型糖尿病患者116例,按照随机原则分成观察组和对照组,每组58例。对照组应用阿卡波糖治疗,观察组应用西格列汀联合阿卡波糖治疗,观察2组临床治疗效果,血糖变化、肝肾功能及体质量指数变化等情况,同时观察低血糖以及药物不良反应发生情况。结果治疗后观察组总有效率为95%,对照组83%,2组比较具有显著性差异(P0.05);治疗后2组空腹血糖均明显下降(P0.05),但组间比较无显著性差异。治疗后2组患者餐后2 h血糖均明显降低(P0.05),且观察组血糖水平显著低于对照组(P0.05);2组糖化血红蛋白(HbA1c)治疗后均有显著下降,且观察组下降水平更明显(P0.05);治疗后2组患者肝肾功能比较无显著性差异,观察组体质量指数比对照组稍降低,但二者比较无显著性差异;2组均无低血糖发生。结论西格列汀联合阿卡波糖口服治疗初诊2型糖尿病能更有效控制血糖,有利于血糖的长期控制。     

芪参糖宁胶囊治疗2型糖尿病临床研究

目的:观察芪参糖宁胶囊治疗2型糖尿病的临床疗效。方法:将患者随机分为两组,治疗组口服芪参糖宁胶囊,对照组口服消渴丸,均治疗4周为1疗程,分别观察3疗程的综合疗效、中医证候疗效。结果:两组治疗后综合疗效、中医证候疗效比较有显著性差异(P<0.05)。结论:芪参糖宁胶囊治疗2型糖尿病疗效显著。     

肠舒止泻胶囊治疗脾虚湿热型慢性泄泻的多中心随机双盲对照临床试验

目的 评价肠舒止泻胶囊(鸡矢藤、砂仁、人参、山药、苍术、黄柏、黄连等)治疗脾虚湿热型慢性泄泻的有效性与安全性.方法 将440患者按3∶1随机分为试验组和对照组,分别给予肠舒止泻胶囊和参苓白术胶囊,疗程10 d,根据大便次数、止泻时间、证候积分和综合疗效进行疗效评价.结果 全分析集(FAS)结果表明,试验组综合疗效的显效率、总有效率高于对照组(P＜0.01);治疗后试验组证候积分低于对照组,治疗前后积分差和变化率高于对照组(P＜0.01);试验组的中位止泻时间6.00d,对照组中位止泻时间7.00d,差异有显著性意义(P＜0.01).试验组大便泄泻、腹痛腹胀、肠鸣和口渴治疗前后的积分差大于对照组(P＜0.05).在试验过程中,试验组有1例病例出现烧心恶心欲呕,对照组未出现不良事件.结论 肠舒止泻胶囊治疗脾虚湿热型慢性泄泻疗效显著,安全性好.     

Chinese herbal medicine for chronic heart failure: a multicenter,randomized, double-blind,placebo-controlled trial

ObjectiveThe purpose of this study was to assess the efficacy and safety of Chinese herbal medicine (CHM) in the treatment of chronic heart failure (CHF) patients according to syndrome differentiation.MethodsIn this multicenter, randomized, double-blind, placebo-controlled clinical trial, a total of 220 CHF patients were assigned to receive CHM or placebo granules without decoction according to syndrome differentiation in addition to their standard western treatment for 4 weeks. The change in the left ventricular ejection fraction (LVEF) was the primary outcome, and the changes in the TCM syndrome scores (TCM-SS) and New York Heart Association functional classification (NYHA-FC) were the secondary outcomes.ResultsAfter 4 weeks of treatment, the mean changes in the LVEF (13.1 ± 9.78 vs. 7.34 ± 7.40, P < 0.001) and the TCM syndrome scores (−34.2 ± 24.6 vs. −23.5 ± 25.2, P = 0.002) were better in the CHM group than in the placebo group. After two weeks of treatment, the mean changes in the LVEF (9.26 ± 7.83 vs. 4.72 ± 5.60, P < 0.001) and the TCM syndrome scores (−23.5 ± 18.6 vs. −14.0 ± 15.9, P < 0.001) were better in the CHM group than in the placebo group. In addition, repeated-measures analysis of variance (ANOVA) indicated significant time course effects of CHM versus placebo in the LVEF and TCM syndrome cores (P < 0.001 for all). The distention of the jugular vein (P = 0.021), expectoration (P = 0.044), abdominal distention (P = 0.004), and rib pain (P = 0.005) were significantly less in the CHM group than in the placebo group after two weeks of treatment. Fatigue (P = 0.001), less gas and lazy words (P = 0.001), dizziness (P = 0.003), gasping for breath (P = 0.027), abdominal distention (P = 0.011), nausea (P = 0.001) and emesis (P = 0.012) were significantly less in the CHM group than in the placebo group after treatment for four weeks. After four weeks of treatment, the change in the NYHA functional classification in the CHM group was better than that in the placebo group (P < 0.001). There was one death in the placebo group, and one patient in the CHM group experienced atrial fibrillation.ConclusionCHM treatment according to syndrome differentiation effectively improved the LVEF, TCM-SS, and NYHA-FC in patients with CHF and also appeared to be safe. Thus, CHM treatment could be used as an adjuvant therapy in the treatment of CHF (Clinical trial registration: NCT01939236).     

穴位贴敷治疗支气管哮喘：多中心随机对照研究

目的:观察穴位敷贴对支气管哮喘患者临床症状、生活质量的影响.方法:采用多中心、随机、双盲试验方法,将188例患者分为药物贴敷组(125例)及安慰组(63例).两组均取大椎、肺俞、天突等穴,药物贴敷组贴敷胡椒、白芥子、细辛等中药研磨混合姜油及姜汁制成的药饼;安慰组贴敷红米、黑米、玉米混合少量姜汁制成的圆饼.观察两组患者在生活质量评分(AQLQ),日间、夜间症状评分及自我疗效评分、肺功能值方面的变化.结果:药物贴敷组在AQLQ量表中日常行为、环境因素、AQLQ总计分值及日间症状、自我疗效评分方面较安慰组明显改善(均P<0.05).两组患者肺功能1秒钟用力呼气容积(FEV_1)及1秒钟用力呼气容积占预计值百分比(FEV_1/FVC)无明显差异(均P>0.05).结论:穴位敷贴对支气管哮喘患者临床症状改善显著,并能提高患者的生活质量.     

宁泌泰胶囊治疗III型前列腺炎随机双盲安慰剂对照临床研究

目的 评价宁泌泰胶囊治疗Ⅲ型前列腺炎的有效性和安全性。方法 采用随机、双盲以及安慰剂作为对照进行临床试验设计。试验共50例Ⅲ型前列腺炎患者入选,治疗组25例患者口服宁泌泰胶囊,每次4粒,每日3次,4周为1个疗程。对照组25例患者口服安慰剂胶囊,用法用量与治疗组完全一致。治疗有效性以美国国立卫生院前列腺炎症状评分（NIH-CPSI）为主要疗效评价指标;以治疗前后患者尿常规及肝肾功能指标评估其安全性;并记录不良事件。结果 治疗组NIH-CPSI总分治疗前为23.96±1.30,经4周治疗后下降为16.04±1.66（P<0.001）。安慰剂组与其不同,同治疗前相比,所有评分在4周治疗后无统计学差异（P＞0.05）。治疗组疼痛评分、排尿评分、生活质量评分均显著性降低（P<0.05）。参与本研究完成治疗的全部患者未见明显不良反应发生。结论 宁泌泰胶囊治疗Ⅲ型前列腺炎安全有效。     

苓芍枣仁配方颗粒治疗女性膀胱过度活动症临床研究

目的 评价苓芍枣仁配方颗粒治疗女性膀胱过度活动症(overactive bladder,OAB)的疗效.方法 将符合入选标准的女性OAB患者60例,采用随机、对照、双盲的原则分为2组,每组30例.对照组采用酒石酸托特罗定缓释片联合苓芍枣仁配方颗粒安慰剂治疗,治疗组采用酒石酸托特罗定缓释片联合苓芍枣仁配方颗粒治疗,2组均治疗4周.采用膀胱过度活动症症状量表(Overactive Bladder Symptom Scale,OABSS)判定OAB严重程度.结果 治疗后14、28d,OABSS量表评分治疗组[(5.3±2.3)分、(1.4±1.2)分比(8.4±2.4)分,F=137.209]、对照组[(7.8±1.9)分、(6.8±1.4)分比(8.6±2.6)分,F=8.927]均低于同组治疗前(P<0.01),治疗组治疗后14、28d的OABSS量表评分低于对照组(t值分别为4.668、15.678,P值均<0.01);治疗组疼痛症状评分[(5.9±1.9)分、(2.7±1.1)分比(9.5±2.3)分,F=108.819]低于同组治疗前(P<0.01),治疗组治疗后14、28d疼痛症状评分低于对照组(t值分别为6.342、14.812,P值均<0.01);小腹不适评分治疗组[(1.9±1.4)分、(1.1±1.0)分比(3.3±1.1)分,F=28.762]、对照组[(2.7±1.0)、(2.4±0.8)分比(3.4±1.2)分,F=12.103]均低于同组治疗前(P<0.01),治疗组治疗后14、28d小腹不适评分低于对照组(t值分别为2.521、5.041,P<0.05或P<0.01).结论 苓芍枣仁配方颗粒可明显降低女性OAB患者OABSS评分、疼痛症状评分、小腹不适症状评分,改善临床症状.     

葛根芩连汤加味方干预肠道湿热型急性感染性腹泻的多中心、随机双盲、安慰剂对照临床研究

目的观察葛根芩连汤加味方联合基础治疗对肠道湿热型急性感染性腹泻的临床疗效及安全性。方法采用多中心、随机双盲、安慰剂设计,将144例肠道湿热证急性感染性腹泻患者,随机分为治疗组和对照组,每组72例。两组均予西医基础治疗,治疗组加用葛根芩连汤加味方,对照组加用中药安慰剂。两组疗程均为3天,观察临床疗效,比较中医证候积分、止泻时间及粪便镜检白细胞的变化情况。结果 (1)试验期间,脱落和剔除病例共9例,最终完成试验者135例。调整意向分析集与安全性分析集均为139例,其中治疗组69例,对照组70例。符合方案分析集为135例,治疗组68例,对照组67例。(2)治疗组、对照组临床总有效率分别为94.20%、85.71%;组间临床疗效比较,治疗组明显优于对照组(P0.05)。(3)两组平均止泻时间比较,差异有统计学意义,治疗组平均止泻时间明显短于对照组(P0.05)。(4)治疗前后组内比较,两组粪便镜检白细胞正常率均差异有统计学意义(P0.05);组间治疗后比较,粪便镜检白细胞正常率差异无统计学意义(P0.05)。(5)治疗组不良反应发生情况为0/69,对照组不良反应发生情况为0/70,组间不良反应发生率比较,差异无统计学意义(P0.05)。结论葛根芩连汤加味方结合西医基础治疗对肠道湿热型急性感染性腹泻患者的临床症状改善显著,可有效缩短腹泻病程。     

The efficacy of Silybum marianum (L.) Gaertn. (silymarin) in the treatment of type II diabetes: a randomized, double-blind, placebo-controlled, clinical trial

Oxidative stresses are increasingly implicated in the pathogenesis of diabetic complications which may either cause direct pancreatic beta-cell damage or lead to metabolic abnormalities that can induce or aggravate diabetes. The valuable effect of antioxidant nutrients on the glycemic control of diabetic patients has been reported in experimental and clinical studies. The present study was designed to investigate the effects of the herbal medicine, Silybum marianum seed extract (silymarin), which is known to have antioxidant properties on the glycemic profile in diabetic patients. A 4-month randomized double-blind clinical trial was conducted in 51 type II diabetic patients in two well-matched groups. The first group (n = 25) received a silymarin (200 mg) tablet 3 times a day plus conventional therapy. The second group (n = 26) received the same therapy but a placebo tablet instead of silymarin. The patients were visited monthly and glycosylated hemoglobin (HbA(1)c), fasting blood glucose (FBS), insulin, total cholesterol, LDL and HDL, triglyceride, SGOT and SGPT levels were determined at the beginning and the end of the study. The results showed a significant decrease in HbA(1)c, FBS, total cholesterol, LDL, triglyceride SGOT and SGPT levels in silymarin treated patients compared with placebo as well as with values at the beginning of the study in each group. In conclusion, silymarin treatment in type II diabetic patients for 4 months has a beneficial effect on improving the glycemic profile.     

Jiawei Xiaoyao capsule treatment for mild to moderate major depression with anxiety symptoms: a randomized,double-blind,double-dummy,controlled, multicenter,parallel-treatment trial

OBJECTIVE:To assess the efficacy and safety of Jiawei Xiaoyao(JWXY)capsules on mild to moderate depression with anxiety symptoms,a randomized,double-blind,double-dummy controlled,multicenter,parallel-treatment trial was carried out among 210 outpatients with mild to moderate depression and anxiety symptoms from three hospitals in Beijing China.METHODS:Participants were randomized into the JWXY group or the sertraline group.Each group received JWXY treatment and sertraline placebo,or sertraline and JWXY placebo for 8 weeks.Main outcomes were measured using the Hamilton Depression Rating Scale(HAMD),Hamilton Anxiety Rating Scale(HAMA)and the Clinical Global Impression Scale.RESULTS:JWXY and sertraline had the equivalent effect on HAMD at every interview point.JWXY was more effective at reducing the HAMA scores at the 2 nd and 12 th week,HAMD sleep disturbance subscale scores at the 8 th and 12 th week,and HAMA somatic anxiety subscale scores at the 12 th week.The rate of adverse events in the two groups was the same.CONCLUSION:For mild to moderate depression with anxiety symptoms,JWXY could be as effective as sertraline in alleviating depressive symptoms.For anxiety symptoms,JWXY may be effective more quickly and with longer lasting effects than sertraline.In particular,it may also improve quality of sleep and somatic anxiety symptoms.JWXY is safe and cheaper than conventional antidepressants,and may be the first alternative choice for depression with anxiety symptoms.     

美洛昔康与萘丁美酮双盲随机对照治疗类风湿关节炎

目的 评价美洛昔康／萘丁美酮治疗类风湿关系炎的疗效和安全性。方法 随机对照、双盲的比较研究。共完成病例120例（美洛昔康59例，萘丁美酮61例）。po美洛昔康15mg每天一次或萘丁美酮1000mg第天一次，疗程4周，其中41例患者连用8周。结果 4，8周时美洛昔康总有效率为69．5％，95．0％；萘丁美酮为67．2％，90．5％，两药均能显著改善患者的症状和体征，降低血沉。8周时美洛昔康改善患者的休息痛和关节压痛指数两项优于萘丁美酮（P＜0．05）。安全性评价：美洛昔良不良反应发生率：10．2％；萘丁美酮18．0％，统计分析两药的耐受性无明显差异。不良反应以消化疲道症状为主，无因不良反应药病例。结果 美洛昔康和萘丁美酮治疗类风湿关节炎的疗效和安全性相似。