Efficacy of a heat inactivated hepatitis B vaccine in male homosexuals: outcome of a placebo controlled double blind trial

The efficacy of a heat inactivated hepatitis B virus vaccine, containing 3 micrograms hepatitis B surface antigen (HBsAg), was studied in a high risk group of 800 susceptible homosexual men by a randomised placebo controlled double blind trial. At the trial end point (21.5 months), 17 hepatitis B virus infections had occurred in vaccinated subjects (attack rate 4.8%) and 56 in subjects receiving a placebo (attack rate 23.8%). This reduction in the incidence of hepatitis B virus infections in vaccinated subjects was highly significant (p less than 0.0001). Two months after the first injection 72.3% of the vaccinated subjects had formed antibodies against hepatitis B surface antigen, and this percentage increased to 89% at four months. Maximum anti-HBs titres were reached five months after the first vaccination, the geometric mean titre being 107.6 mIU. Even vaccinated subjects with a low antibody response (greater than or equal to 1 and less than 10 mIU) were found to be protected from HBsAg-positive infections. The vaccine had no serious side effects.     

Sulphasalazine in ankylosing spondylitis: a double blind controlled study in 60 patients

Sulphasalazine has been reported to be effective in ankylosing spondylitis with peripheral arthritis, but its efficacy in spondylitis is unknown. Thus 60 patients with active ankylosing spondylitis without peripheral arthritis or gastrointestinal symptoms were randomly allocated to one of two therapeutic groups. One group received 2 g sulphasalazine daily for six months and the other a placebo. Thirteen patients (six given placebo and seven given sulphasalazine) dropped out of the trial and were considered to be treatment failures. After six months' follow up efficacy was rated as good or very good by 15 of the 30 patients given sulphasalazine and by only six of the 30 given placebo (p less than 0.02). Furthermore, in the patients given sulphasalazine the daily consumption of non-steroidal anti-inflammatory drugs, functional index, and plasma IgG concentrations had fallen significantly. These data suggest that sulphasalazine may be a safe and effective treatment for spondylitis in ankylosing spondylitis.     

Prevention of recurrent acute cystitis by methenamine hippurate: double blind controlled crossover long term study

In a randomised, double blind, long term, crossover study 1 g twice daily of methenamine hippurate was compared with placebo for its preventive effect on recurrent attacks of acute cystitis. Methenamine hippurate and placebo were interchanged every six months for two years. During one of the years patients took 250 ml extra fluid every morning and evening. Out of 21 enrolled patients, 14 completed the first year and 13 both years of treatment, which permitted the evaluation of 27 patient years. There were 52 episodes of acute cystitis caused by reinfection: 41 occurred during placebo treatment and only 11 during the methenamine hippurate regimen (p less than 0.01). Extra fluid intake did not reduce the incidence of acute cystitis, nor did it reduce the effect of methenamine hippurate. Methenamine hippurate is an effective prophylactic agent against recurrent acute cystitis and has the advantage of not inducing cross resistance to conventional antibiotics.     

补充抗氧化剂对预防马拉维儿童恶性营养不良的作用：随机、双盲、安慰剂对照试验

目的：在马拉维儿童恶性营养不良发生的高危人群中评价抗氧化剂的补充对预防恶性营养不良的效果。     

Sulphasalazine in rheumatoid arthritis: a double blind comparison of sulphasalazine with placebo and sodium aurothiomalate

Uncontrolled studies have suggested that sulphasalazine may be an effective second line agent in rheumatoid arthritis. Sulphasalazine was therefore compared with placebo and intramuscular sodium aurothiomalate in 90 patients with active rheumatoid arthritis. After six months' treatment both sulphasalazine and sodium aurothiomalate had produced significant clinical and laboratory benefit, whereas placebo had produced no significant change in any variable. Thirteen patients stopped taking the placebo because of lack of effect whereas only two patients stopped taking sulphasalazine and one sodium aurothiomalate for this reason. The major toxicity encountered in the group treated with sulphasalazine was nausea or vomiting, or both; this may be related to slow acetylator phenotype. Sulphasalazine appears to be an effective second line agent, and further pharmacokinetic studies might prove useful in diminishing gastrointestinal side effects.     

雌-孕激素治疗绝经后妇女高胆固醇血症的临床研究

目的 探讨绝经后高胆固醇血症妇女用雌-孕激素治疗后血中脂蛋白及性激素水平的变化.方法 选取符合条件的绝经后高胆固醇血症妇女52例,给予妊马雌酮0.625 mg/d,安宫黄体酮（MPA）4 mg/d治疗.于治疗前及治疗后3个月、6个月测定空腹血脂、性激素及身高体重,计算体重指数（BMI）.结果 49例患者按计划完成疗程,治疗后3个月、6个月与治疗前比较,血中高密度脂蛋白（HDL-C）显著升高（P〈0.05）,低密度脂蛋白（LDL-C）显著下降（P〈0.05）,总胆固醇（TC）有所下降,但差异无显著性（P〉0.05）,三酰甘油（TG）有所升高,但在正常范围,差异无显著性（P〉0.05）.结论 雌-孕激素对绝经后高胆固醇血症妇女脂代谢产生有益的影响.     

双球囊与单球囊椎体后凸成形术治疗骨质疏松性脊柱压缩骨折的临床对照研究

目的 评价双球囊与单球囊椎体后凸成形术治疗骨质疏松性脊柱压缩骨折的临床价值.方法 51例疼痛性骨质疏松脊柱压缩骨折患者,累及椎体69个.在X线监测下,经双侧椎弓根穿刺伤椎,完成球囊扩张,骨水泥填充.双球囊组患者29例(38个椎体),应用双球囊在椎体内双侧同时协调扩张;单球囊组患者22例(31个椎体),应用单球囊双侧入路在椎体内先后交替扩张.比较术前与术后椎体高度与Cobb角的差异,并分别计算两组的术后椎体高度平均恢复率和与Cobb角平均矫正度,比较两组之间差异,并随访6-12个月.结果 51例患者手术顺利,术后第96小时内疼痛均明显缓解,无临床并发症.患者10分制视觉模拟疼痛评分法评分由术前平均7.7分降至术后2.6分(P＜0.01);Oswestry功能障碍指数评分由术前平均73%降至术后26%(P＜0.01).双球囊组伤椎椎体前缘和中部平均丢失高度由术前14.7 mm和10.5 mm改善至术后10.1 mm和5.5 mm,Cobb角由术前平均22.4°,矫正至术后12.3°,手术前后差异具有显著性意义(P＜0.01);单球囊组伤椎椎体前缘和中部平均丢失高度由术前14.7 mm和10.6 mm,改善至术后10.4 mm和6.5 mm,Cobb角由术前平均21.2°,矫正至术后11.6°,手术前后差异具有显著性意义(P＜0.01).双球囊组与单球囊组术后椎体平均高度恢复率分别为72.8%、70.1%,Cobb角平均矫正度分别为10.1°和9.5°,两组相比差异无统计学意义(P＞0.05).随访期间,无疼痛加重病例出现.结论 双球囊与单球囊椎体后凸成形术治疗老年骨质疏松脊柱压缩骨折均可获得满意疗效.     

咬合板治疗肌筋膜痛效果评估－随机双盲对照实验

Background Occlusal splints have been the preferred modalities in the management of myofascial temporomandibular disorders (TMDs),but now controversy exists in reporting whether they are successful for...     

Treatment of the restless legs syndrome with carbamazepine: a double blind study

One hundred and seventy four patients suffering from the restless legs syndrome were examined in a double blind, between patient, placebo controlled study in general practice for five weeks to investigate the effects of carbamazepine and placebo on the syndrome. The syndrome was more common among middle aged women with relatively low systolic blood pressure. The median haemoglobin concentration was about average for the population, but the severity of the symptoms seemed to increase with decreasing concentrations of haemoglobin. Both placebo and carbamazepine showed a significant therapeutic effect (p less than 0.01). Carbamazepine was significantly more effective than placebo (p less than or equal to 0.03). The significant therapeutic effect of placebo in restless legs showed that only double blind controlled trials can confirm the efficacy of suggested treatments.     

雌孕激素联合疗法对绝经后妇女骨密度和血脂的影响

目的:研究雌孕激素联合方案(雌二醇2 mg/醋酸炔诺酮1 mg)对绝经后妇女心血管危险因素(血脂、血压和体重),骨密度,绝经症状和阴道出血情况的影响.方法 :采用双盲、随机、安慰剂对照的平行临床研究,安慰剂及激素组各60例均治疗12个月.结果: (1)用药后激素组TC、TG、LDL-C分别下降13.3%(P<0.05)、8.2%、21.4%(P<0.001),HDL-C上升2.0%;安慰剂组用药后TC、LDL-C分别下降1.6%、13.2%,TG及HDL-C分别上升17.4%及17.8%,P>0.05.用药后两组间在调整基线后比较,激素组TC、TG明显低于安慰剂组(P<0.05),而HDL-C及LDL-C的变化无差异.两组患者用药前后血压及体重无明显变化.(2) 用药后激素组腰椎及髋关节骨密度(BMD)分别增加6%及3%(P<0.001),安慰剂组BMD分别增加1%及2%(P<0.05),用药后激素组与安慰剂组BMD相比差异均有显著性.(3)激素组对更年期症状评分的降低程度大于安慰剂组,但两组评分用药前后差异无显著性.(4)激素组突破出血在前3个月及后3个月的发生率分别为61.6%及22.8%,子宫内膜厚度>5 mm的患者内膜活检无增生.结论:雌孕激素联合使用能提高骨密度、预防骨质疏松,改善血脂,缓解更年期症状,防止子宫内膜增生.虽然用药的前3个月阴道出血率较高,但激素组无患者因阴道出血中断治疗.     

Campylobacter pyloridis and associated gastritis: investigator blind, placebo controlled trial of bismuth salicylate and erythromycin ethylsuccinate

An investigator blind trial was performed comparing bismuth salicylate, erythromycin ethylsuccinate, and placebo in the treatment of Campylobacter pyloridis associated gastritis in patients without peptic ulceration. Fifty patients fulfilled the study criteria. There was a strong correlation between the presence of C pyloridis and histologically confirmed gastritis. Clearance of organisms led to improvement of the gastritis. C pyloridis was cleared from 15 patients; of these, 13 had gastritis initially, which resolved in 12. Conversely, gastritis resolved in only four of 32 patients not cleared of organisms (p less than 0.0001). There was significantly greater improvement in endoscopic appearances in the patients cleared of C pyloridis compared with those whose infection persisted (p less than 0.001). In the three treatment groups organisms were cleared from 14 of 18 patients receiving the locally active bismuth salicylate, only one of 15 patients receiving erythromycin ethylsuccinate, and none of 17 patients taking placebo. These findings suggest that the ideal antimicrobial for the successful eradication of C pyloridis associated gastritis should be locally active, stable at low pH, and should penetrate gastric mucus. The resolution of gastritis and improvement in endoscopic appearances associated with clearance of C pyloridis support the view that these organisms may play a part in this condition.     

降纤酶治疗急性脑梗死的随机双盲对照研究

目的　为了评价国产降纤酶治疗急性脑梗死 (ACI)的临床疗效及其安全性。方法　采用随机、双盲、安慰剂对照的前瞻性研究方法 ,用国产降纤酶治疗 90例ACI患者 ,分两种给药方案 ,方案一 ,降纤酶首剂量为 10U ,第三、第五天各 5U ;方案二 ,首剂量为 15U ,以后根据用药 2 4小时血浆纤维蛋白原 (fibrinogen ,FIB)水平隔日或隔两日 (FIB<0 .5 /L时 )一次 ,每次 5U ,共 5次。对照组按同样方法给药。用药前后分别对患者进行临床神经功能缺损评分和 3个月时Barthel指数评定 ,另外还检测用药前后血浆FIB、凝血酶元时间 (PT)、凝血酶元活动度 (PA)、肝、肾功能等。结果　方案一 ,与对照组相比降纤酶组治疗后血浆FIB水平明显下降 (P <0 .0 5 ) ,但 14d时临床神经功能缺损评分和 3个月时Barthel指数与对照组相比差异无显著性 ;方案二 ,与对照组相比降纤酶组治疗后血浆FIB水平明显下降 (P <0 .0 0 1) ,且 14d时临床神经功能缺损评分和 3个月时Barthel指数与治疗组相比差异有显著性 (P <0 .0 1～ 0 .0 0 1)。两种治疗方案均未增加出血事件及其他副作用的发生率。结论　降纤酶能够显著降低血浆FIB水平 ,掌握好用药的时间窗、用药剂量和方法 ,降纤酶能够改善ACI患者的近期和 3个月的预后     

腰椎骨髓脂肪与腹部脂肪相关性的前瞻性研究

目的探讨腰椎骨髓脂肪与腹部脂肪的相关性。方法共68人（男32人,女36人,年龄21~74岁,中位年龄49.5岁）纳入前
瞻性研究。1.5T MR采用单体素点分辨波谱法（PRESS）对L3椎体进行波谱采集,计算脂肪比（FF%）;同时行腰椎64排CT检
查,用定量CT（QCT）分析软件测量L3相应层面腹部皮下脂肪（SAT）与内脏脂肪（VAT）。男、女按年龄各分为两组（≥50岁和<
50 岁）,用SPSS 19.0 软件进行统计学分析。结果男性BMI、FF%、VAT及SAT≥50 岁组和<50 岁组比较均无显著性差异（P>
0.05）,FF%与BMI、VAT及SAT均无明显相关性（r分别为-0.109、0.034、-0.066,P>0.05）。女性BMI、FF%、VAT及SAT≥50岁组
和<50岁组比较均有显著性差异（P<0.05）;女性≥50岁组,FF%与VAT呈明显正相关（r为0.499,P<0.05）,FF%与SAT无明显相
关性（r为0.221,P>0.05）;女性<50岁组,FF%与VAT或SAT均无明显相关性（r分别为-0.076、-0.067,P>0.05）。结论中老年女
性（≥50岁）腰椎骨髓脂肪含量与VAT关系密切,男性与年轻女性（<50岁女性）腰椎骨髓脂肪含量与腹部脂肪无关。
     

Prospective double-blind study of CEE3 in peri- and postmenopausal women: effects on bone loss and lipoprotein lipids.

A prospective double-blind study was carried out in 136 women 0.5 to 21 years since menopause (YSM) in order to demonstrate the effects of a long-acting estriol derivative-Nylestriol (CEE3) on bone loss and lipoprotein lipids. They were orally administered at 2 mg of CEE3 or placebo every 2 weeks. Among 90 subjects who finished 1 year of medication, 49 received CEE3 and 41 placebo. The results were: 1. Serum ALP, Ca/Cr and Hop/Cr in fasting urine decreased in 3 months (P < 0.05); 2. Menopause-related reduction of forearm bone density was restrained; 3. LDL-C decreased in 3 months and HDL-C increased in 6 months (P < 0.05), with no significant changes in TC and TG; 4. Side effects were mild. 1/3 of those with intact uterus had spotting and another 1/3 had moderate withdrawal bleeding after the addition of medroxyprogesterone acetate at the end of 12 months of CEE3 therapy. This study demonstrates that CEE3 is effective and acceptable for preventing osteoporosis and lipoprotein lipids disorder in postmenopausal women. Long-term application awaits further studies.

     

骨代谢生化指标与绝经后骨质疏松性腰椎骨折相关性分析

目的：探讨骨代谢生化指标与绝经后骨质疏松性腰椎骨折相关性,进而预测绝经后骨质疏松性合并腰椎骨折风险。方法回顾性分析100例绝经后骨质疏松症患者的临床资料,包括绝经后骨质疏松症腰椎无骨折患者50例和绝经后骨质疏松症合并腰椎骨折患者50例,记录并观察髋部、腰椎骨密度、骨代谢生化标志物Ⅰ型前胶原氨基端前肽（P1NP）、Ⅰ型胶原羧基端肽β特殊序列（β-CTX）、骨钙素 N 端中分子（N-MID）、25-羟基维生素 D[25-（OH）VitD]和血清 Ca2＋。结果 P1NP、β-CTX 和25-（OH）VitD 的差异具有统计学意义（P ＜0．05）,绝经后骨质疏松性腰椎骨折与血清 P1NP 呈正相关（P ＜0．05）,25-（OH）VitD 呈负相关（P ＜0．05）,β-CTX 无相关性（P ＞0．05）。结论骨代谢标志物 P1NP、25-（OH）VitD 能够很好地预测绝经后骨质疏松腰椎骨折风险,骨密度预测骨质疏松症骨折风险具有一定局限性。     

Lack of effect of oral magnesium on high blood pressure: a double blind study

Seventeen unselected patients with mild to moderate essential hypertension and whose average supine blood pressure after two months' observation with no treatment was 154/100 mm Hg were entered into a double blind randomised crossover study of one month's treatment with magnesium aspartate (15 mmol magnesium/day) and treatment with placebo for a further month. This preparation of magnesium was well tolerated and did not cause diarrhoea. Despite a significant increase in plasma magnesium concentration and a significant increase in urinary excretion of magnesium while taking magnesium aspartate there was no fall in blood pressure compared with either treatment with placebo or values before treatment. The results provide no evidence for a role of dietary magnesium in the regulation of high blood pressure and are contrary to recent speculations.     

Dose dependent response of symptoms, pituitary, and bone to transdermal oestrogen in postmenopausal women

The effect of the plasma oestradiol concentration on climacteric symptoms, gonadotrophin release, and bone resorption was studied in three groups of postmenopausal women given 0.025 mg, 0.05 mg, or 0.1 mg transdermal oestradiol daily. There was a dose related reduction in symptoms, plasma follicle stimulating hormone concentration, and urinary calcium and hydroxyproline excretion. The relation of the response to plasma oestradiol values was similar for each variable with an initial large reduction and little change in response to increases in the plasma oestradiol concentration above 150 pmol/l (41 pg/ml). Hormone replacement therapy producing an effect equivalent to higher oestradiol concentrations is likely to increase the risk of side effects without conferring any additional benefit.