Budesonide enema active haemorrhagic proctitis—a controlled trial against hydrocortisone foam enema

Background: The aim was to compare budesonide enema, 2 mg/100 mL (Entocort) and hydrocortisone acetate foam enema, 125 mg (Colifoam) in patients with active haemorrhagic proctitis. Methods: The trial was a controlled, randomized, investigator-blind study with two parallel groups. Endoscopy, histology and diary cards were used to assessed the response to therapy. Safety was assessed by laboratory tests and adverse event recording. Results: Seventy-two patients were included. Investigations were made before treatment and after 2 and 4 weeks. Both treatment groups showed statistically significant improvement in endoscopic scores but significant differences between the groups were not found. In the hydrocortisone group, plasma cortisol was significantly lowered after 4 weeks compared with budesonide. Bowel habits and quality of life variables did not differ between the treatments. The recorded adverse events were mild or moderate and may have been due to the proctitis. Conclusions: These results suggest that budesonide enema is as effective as hydrocortisone foam enema, but without the potential for side-effects associated with suppression of plasma cortisol.     

那格列奈片治疗2型糖尿病的多中心随机双盲平行对照临床试验

目的　以瑞格列奈为对照,评价那格列奈治疗2型糖尿病的疗效和安全性。方法　用多中心随机双盲双模拟平行对照的试验设计,观察了228例2型糖尿病病人,其中那格列奈组111例,瑞格列奈组117例。结果　与基础值比较,治疗12周后那格列奈组空腹血糖(FBG)、餐后2h血糖(PBG)及糖化血红蛋白(HbA1c)分别下降(1.25±1.79) mmol.L-1,(4.03±2.82) mmol.L-1和(0.56±1.07)%;瑞格列奈组病人FBG、PBG及HbA1c分别下降(1.54±1.49)mmol.L-1,(3.79±3.44) mmol.L-1和(0.53±0.97)%;2组下降各指标比较均有显著性差异,而2组间比较无显著性差异。2组药物不良反应发生率比较无统计学差异。结论　那格列奈是治疗2型糖尿病有效和安全的药物。     

西尼地平胶囊治疗原发性高血压双盲双模拟随机对照多中心研究

目的:评价国产西尼地平胶囊治疗轻度至中度高血压的临床疗效及安全性。方法:以国产西尼地平片为对照药,在252例轻度至中度高血压病人中进行多中心、随机、双盲、平行、活性药物对照的临床试验。结果:治疗8wk后,西尼地平胶囊组平均坐位收缩压和舒张压分别下降(18±s 11)mmHg (11．9％)和(12±8)mmHg(12．6％),西尼地平片组平均坐位收缩压和舒张压分别下降(19±13)mmHg (12．5％)和(12±8)mmHg(12．9％),2药的总有效率分别为80．3％和82．9％。西尼地平胶囊和西尼地平片对心率无明显影响,与药物有关的不良反应分别为6例和4例,主要表现为轻到中度的头晕、头痛、面红、心悸等。2药的疗效和不良反应比较无统计学差异(P＞0．05)。结论:国产西尼地平胶囊与国产西尼地平片相似,治疗轻中度原发性高血压具有明确的降压疗效与良好的安全性。     

吡格列酮二甲双胍片治疗2型糖尿病的多中心随机双盲平行对照临床试验

目的 以盐酸二甲双胍和盐酸吡格列酮(均降糖药)为对照,评价吡格列酮二甲双胍片治疗2型糖尿病的疗效和安全性.方法 用多中心随机双盲双模拟阳性平行对照的试验设计,观察240例2型糖尿病病人,分为吡格列酮二甲双胍片组(试验组)和盐酸二甲双胍、盐酸吡格列酮组(对照组).结果 用药16周后,与基础值相比,试验组空腹血糖(FBG)、餐后2 h血糖(P2hBG)、糖化血红蛋白(HbAlC)分别下降(1.92±1.77)mmol·L~(-1),(2.49±3.13)mmol·L~(-1),(1.27±1.45)%;对照组,FBG、PBG、HbA1c分别下降(2.24±2.11)mmol·L~(-1),(2.89±3.71)mmol·L~(-1),(1.49±1.52)%,2组下降各指标治疗前后比较均有显著性差异;但2组间比较无显著性差异.2组不良反应发生率比较无统计学差异(10% vs 12%).结论 吡格列酮二甲双胍片是治疗2型糖尿病有效和安全的药物.     

艾司西酞普兰与西酞普兰治疗抑郁症的随机、双盲对照研究

目的观察艾司西酞普兰治疗抑郁症的疗效及安全性。方法将符合CCMD-3诊断标准的48例抑郁症患者随机分为2组,试验组用艾司西酞普兰治疗,对照组用西酞普兰治疗,疗程6周。在治疗前及治疗1、2、4、6周末用汉密尔顿抑郁量表（HAMD）各评定1次。结果6周末试验组和对照组的HAMD总分分别从（21．36±2．69）、（20．78±2．43）减到（6．76±3．10）、（6．91±4．70）,有效率分别为84．0％、82．6％,痊愈率为52．0％、47．8％,2组间总体疗效相当（P〉0．05）。但在1周末时试验组比对照组的HAMD减分及减分率明显增加,2组间差异有显著性（P〈0．05）。2组间不良反应较轻,无显著性差异（P〉0．05）。结论国产艾司西酞普兰是一种安全有效的抗抑郁药。     

Randomized, controlled, double-blind trial of taranabant for smoking cessation

Rationale  

It has been proposed that cannabinoid-1 receptor inverse agonists might be effective for smoking cessation. We evaluated this hypothesis with the cannabinoid-1 receptor inverse agonist taranabant.     

复方法莫替丁咀嚼片缓解胃酸相关性症状随机双盲双模拟多中心研究

目的:评价复方法莫替丁咀嚼片缓解烧心、反酸等胃酸相关性症状的有效性和安全性。方法:采用多中心、随机、双盲、双模拟、法莫替丁阳性药平行对照研究。共入组215例,复方法莫替丁咀嚼片组(试验组)106例,法莫替丁组(对照组)109例。结果:治疗2 wk后,试验组烧心、反酸等症状发作频率、症状积分、症状总积分下降值与治疗前比较差异均有统计学意义(P＜0．05)。试验组和对照组首次服药后烧心症状缓解时间分别为(87±s 125)min和(120±131)min(P＜0．05)。2组不良反应发生率为8．6％和6．6％(P＞0．05)。结论:复方法莫替丁咀嚼片能迅速改善烧心、反酸等胃酸相关性症状,且使用方便、安全、有效。     

A double-blind,double-dummy,randomized, placebo-controlled trial to evaluate the effect of statin therapy on triglyceride levels in Mexican hypertriglyceridemic patients

Abstract

Objective:

The most prevalent dyslipidemias in Mexico are low high-density lipoprotein (HDL) and high triglyceride (TG) levels. Hypertriglyceridemia (HTG) has been considered an independent risk factor for cardiovascular disease (CVD). The aim of this study was to evaluate the efficacy of rosuvastatin (RSV) in reducing TG levels in Mexican patients.     

氯硝西泮治疗强迫症的双盲对照试验

目的：观察氯硝西洋对强迫症的疗效。方法：氯硝西泮与安慰剂（维生素Ｂ６）双盲自身对照治疗强迫症１４例（男性８例，女性６例；年龄２９±ｓ１１ａ），氯硝西泮剂量为６～１２ｍｇ／ｄ，疗程６ｗｋ以Ｍａｒｋｓ的恐怖强迫量表为评定工具，按双向序贯ｔ检验逐个观察。结果：经序贯ｔ检验评价：氯硝西泮的疗效显著优于安慰剂，且未发现明显的不良反应。结论：氯硝西泮治疗强迫症安全、有效。     

马来酸多潘立酮治疗功能性消化不良63例的Ⅱ期临床试验

目的:观察马来酸多潘立酮片治疗功能性消化不良(FD)的疗效和安全性。方法:采用随机、双盲、双模拟、阳性药对照、多中心设计。研究对象为141例FD病人,年龄18~65a,治疗组(63例)口服马来酸多潘立酮片,12.72mg,tid;对照组(69例)口服多潘立酮,10mg,tid,疗程均为4wk。评价指标有症状评分、胃排空功能、临床症状总积分以及不良反应等。结果:用药2,4wk后,2组病人主要症状积分均有显著下降(P<0.05或P<0.01)。治疗组用药后早饱、腹胀、恶心、呕吐、上腹部疼痛、食欲不振、烧心和嗳气等8项主要症状的有效率分别为85%,89%,90%,90%,86%,81%,81%和86%;对照组分别为87%,93%,91%,82%,66%,81%,92%和94%,2组比较均无显著差异(P>0.05),2组病人均无严重不良反应。结论:马来酸多潘立酮片治疗FD安全、有效。     

来氟米特治疗类风湿关节炎的随机双盲对照多中心临床研究

目的评价2种来氟米特治疗类风湿关节炎(RA)的有效性和安全性。方法采用多中心、随机、双盲、阳性药物平行对照试验设计,患者分试验组和对照组,均口服来氟米特20mg,qd,疗程24wk。对照组118例,试验组119例,观察指标包括休息痛、晨僵、28个关节肿胀关节数及指数、28个关节压痛关节数及指数、健康状况问卷、患者及医师对疾病总体状况的评价。以美国风湿病学会类风湿关节炎20%改善标准(ACR20)作为主要有效性评价标准,观察2组疗效和不良反应。结果试验组和对照组的ACR20分别为68.9%和69.5%,2组无显著差异(P>0.05)。2组ACR20差值的95%可信区间为-12.95%～19.88%,其下限高于-15%。不良反应发生率分别为:试验组51.3%,对照组44.9%,2组无显著差异(P>0.05)。结论2种来氟米特均是治疗类风湿关节炎的有效药物,疗效和安全性相当。     

洛美利嗪治疗偏头痛随机双盲多中心对照研究

目的:评价国产洛美利嗪胶囊治疗偏头痛的疗效及安全性。方法:采用多中心、随机、双盲、氟桂利嗪阳性药平行对照研究,为期56 d,洛美利嗪组(试验组)服用洛美利嗪(5 mg,bid),共105例,氟桂利嗪组 (对照组)服用氟桂利嗪(5 mg,qn),共99例。结果:治疗28,56 d,试验组病人在头痛综合评分、病人自觉头痛评分,综合临床疗效自身前后比较差异均有统计学意义(P<0．01),治疗28 d时试验组有效率(79．1％)略高于对照组(74％),试验组在短时间内疗效更明显;不良反应轻微,试验组发生率(5．6％)略低于对照组(8．8％), 均不影响继续用药。结论:洛美利嗪是一种不良反应较少、安全有效治疗偏头痛发作的药物。     

阿法骨化醇治疗老年骨质疏松症的双盲对照试验

目的：观察阿法骨化醇治疗骨质疏松的疗效及安全性。方法：Ａ组２８例（男性１例，女性２７例，年龄６３±ｓ７ａ），服淀粉加葡萄糖酸钙（３ｇ／ｄ）；Ｂ组２８例（男性４例，女性２４例，年龄６５±８ａ），服阿法骨化醇（０．５μｇ，ｑｄ）加葡萄糖酸钙（３ｇ／ｄ），２组疗程均为３ｍｏ。结果：Ｂ组疼痛症状改善率为７１％，显著高于Ａ组２１％（Ｐ＜０．０１）。Ｂ组跟骨骨密度、血清碱性磷酸酶显著高于Ａ组。Ｂ组治疗后尿羟脯氨酸及吡啶并酚显著减低，无明显不良反应。结论：阿法骨化醇对老年性及绝经后骨质疏松的疼痛症状有较好疗效，并能增加骨密度。     

Somatostatin in peptic ulcer bleeding--results of a double-blind controlled trial

The aim of this work was to assess the usefulness of somatostatin in acute peptic ulcer bleeding. Sixty-four patients with endoscopic evidence of duodenal ulcer bleeding completed a double-blind trial to compare the effectiveness of somatostain (6 mg i.v. per day) with that of placebo; incidence of treatment failure (i.e., rebleeding or persistent haemorrhage) was not different in the somatostatin and in the placebo groups (respectively 24% and 23%). Because the efficacy of cimetidine had previously been demonstrated in gastric ulcer bleeding, somatostatin was tested against cimetidine (1.6 g per day) in 50 patients with gastric ulcer haemorrhage. The treatment failed to control bleeding in 15% of somatostatin and in 17% of cimetidine treated subjects (n.s.). Both treatments were well tolerated and blood requirements were not different in the trial groups. These results show that the efficacy of somatostain in peptic ulcer bleeding is not different from placebo in duodenal ulcers and not different from cimetidine in gastric ulcers.     

利扎曲普坦治疗偏头痛随机双盲多中心对照研究

目的:评价利扎曲普坦片对偏头痛急性发作的有效性和安全性。方法:共入组偏头痛病例115例。其中先给利扎曲普坦后给安慰剂 57例,先给安慰剂后给利扎曲普坦 58例。治疗前 2组的一般资料、临床评价和实验室指标无显著差异。结果:利扎曲普坦组和安慰剂组的 2h内头痛消失率分别为(57±s5)%和 (37±4)% (P<0. 01)。利扎曲普坦组 2h内头痛缓解率为 (67±4)%,安慰剂组 2h内头痛缓解率为(50±5)% (P<0. 01)。治疗中,仅1例出现一过性的血小板减少,无肝、肾功能等影响。结论:利扎曲普坦治疗偏头痛安全性好,可作为治疗偏头痛急性发作的有效药物。     

国产西尼地平治疗原发性高血压的多中心随机双盲双模拟临床研究

目的 对西尼地平治疗原发性高血压患者的疗效与安全性进行临床评价。方法 用多中心双盲双摸拟随机平行对照的试验方法,研究国产西尼地平与对照药苯磺酸氨氯地平对233例轻中度原发性高血压患者的降压疗效及药物不良反应。结果 治疗8周后,西尼地平组平均坐位收缩压(SBP)及舒张压(DBP)下降幅度分别为16.2,1 2.7 mmHg,苯磺酸氨氯地平组分别下降23.1,15.1 mmHg;两药总有效率分别为76.6％和87.7％,与治疗前比较有显著性差异(P<0.01);两药对心率无明显影响;两组药物不良反应的发生率分别为16.7％和12.9％。长期服用西尼地平疗效能持续,并有良好的耐受性。结论 西尼地平治疗轻中度原发性高血压具有明确的降压疗效与良好的安全性。     

美金刚治疗阿尔茨海默病的随机双盲对照试验

目的评估盐酸美金刚治疗阿尔茨海默病(AD)的疗效与安全性。方法采用随机、双盲双模拟、阳性药对照、剂量可调整的研究方法,58例AD患者随机分为2组,试验组予盐酸美金刚5~20 mg,po,qd,对照组予盐酸多奈哌齐片5~10 mg,po,qd,共16 wk。采用简易智能状态检查量表(MMSE)、日常生活能力量表(ADL)、临床疗效总评量表(CGI)总体疗效指标评估临床疗效,以不良反应量表(TESS)评估不良反应情况,每4 wk随访一次。结果2组MMSE总评分均有一定程度提高,在12、16 wk后与基线相比差异均有高度统计学意义(P<0.01),2组MMSE加分比较,差异无统计学意义(P>0.05)。2组CGI总体疗效差异无统计学意义(P>0.05)。2组ADL总评分治疗前后自身比较,差异无统计学意义(P>0.05)。试验组1例(3.4%)出现头晕,对照组6例(20.7%)出现不良反应,主要表现是胃肠道反应与兴奋。试验组的不良反应发生率低于对照组(P<0.05)。结论美金刚能一定程度改善或稳定AD患者的认知功能,疗效与多奈哌齐相当,不良反应发生率低,安全性较好。     

A double-blind controlled trial of metronidazole suppositories in children undergoing appendicectomy

A total of 133 children, aged 16 months to 15 years (mean 6.7 years), with presumptive acute appendicitis, was included in a double-blind, placebo-controlled trial of the short-term (72 hour) use of metronidazole suppositories as prophylaxis against post-operative infection. There was no significant difference in the incidence or severity of wound infection or post-operative intra-abdominal sepsis between the metronidazole-treated and placebo groups. It is suggested that intra-rectal metronidazole, when used exclusively, is not sufficient for effective prophylaxis for appendicitis in childhood.     

A double-blind controlled trial of metronidazole suppositories in children undergoing appendicectomy

Summary

A total of 133 children, aged 16 months to 15 years (mean 6.7 years), with presumptive acute appendicitis, was included in a double-blind, placebo-controlled trial of the short-term (72 hour) use of metronidazole suppositories as prophylaxis against post-operative infection. There was no significant difference in the incidence or severity of wound infection or post-operative intra-abdominal sepsis between the metronidazole-treated and placebo groups. It is suggested that intra-rectal metronidazole, when used exclusively, is not sufficient for effective prophylaxis for appendicitis in childhood.