Mailed treatment to augment primary care for alcohol disorders: A randomised controlled trial

Introduction and Aims. Remote delivery of interventions is needed to address large numbers of people with alcohol use disorders who are spread over large areas. Previous correspondence trials typically examined its effects as stand‐alone treatment. This study aimed to test whether adding postal treatment to general practitioner (GP) support would lower alcohol use more than GP intervention alone. Design and Methods. A single‐blind, randomised controlled trial with a crossover design was conducted over 12 months on 204 people with alcohol use disorders. Participants in an immediate correspondence condition received treatment over the first 3 months; those receiving delayed treatment received it in months 3–6. Results. Few participants were referred from GPs, and little intervention was offered by them. At 3 months, 78% of participants remained in the study. Those in immediate treatment showed greater reductions in alcohol per week, drinking days, anxiety, depression and distress than those in the delayed condition. However, post‐treatment and follow‐up outcomes still showed elevated alcohol use, depression, anxiety and distress. Greater baseline anxiety predicted better alcohol outcomes, although more mental distress at baseline predicted dropout. Discussion and Conclusions. The study gave consistent results with those from previous research on correspondence treatments, and showed that high levels of participant engagement over 3 months can be obtained. Substantial reductions in alcohol use are seen, with indications that they are well maintained. However, many participants continue to show high‐risk alcohol use and psychological distress.[Kavanagh D, Connolly JM. Mailed treatment to augment primary care for alcohol disorders: A randomised controlled trial. Drug Alcohol Rev 2009;28:73–80]     

Pilot randomized controlled trial of a brief alcohol intervention group for adolescents

The aim of this study was to identify whether a brief motivational interviewing and cognitive - behavioural-based alcohol intervention group (AIG) programme is feasible with young people at risk of developing a problem with alcohol, and to assess the short-term effectiveness of the intervention. Participants were assigned randomly to receive a group intervention of four sessions duration (n = 17; AIG) or no treatment (n = 17, control group). Participants were volunteers recruited from a youth centre on the Central Coast of New South Wales, Australia, comprising youths aged 12 - 19 years who were interested in participating in the study. The Readiness to Change Questionnaire, items from the AUDIT, the DAP Quick Screen and a knowledge questionnaire were administered at pretreatment, post-treatment and at 1- and 2-month follow-ups. Participants in the AIG programme showed an increase in readiness to reduce their alcohol consumption. They also reduced their frequency of drinking at post-treatment and the first follow-up assessment, while the control group reported increases at the second follow-up assessment. The control group also increased their hazardous drinking and frequency of binge drinking compared to the AIG. The intervention appeared to improve the AIG participants' knowledge about alcohol and its effects. The results provide preliminary evidence for the effectiveness of the AIG programme in training young people to set limits on alcohol consumption, increase awareness of safe drinking levels and the effects of alcohol abuse. This pilot study also showed that young people who are identified as being 'at risk' of developing alcohol abuse, and who are also ambivalent about changing drinking behaviours, can be recruited and retained in a treatment programme. [Bailey KA, Baker AL, Webster RA, Lewin TJ. Pilot randomized controlled trial of a brief alcohol intervention group for adolescents. Drug Alcohol Rev 2004;23:157 - 166]     

Bacillus clausii therapy to reduce side-effects of anti-Helicobacter pylori treatment: randomized, double-blind, placebo controlled trial

BACKGROUND: Helicobacter pylori eradication fails in about 10% of patients, particularly because of the occurrence of resistance to antibiotics and side-effects. During anti-H. pylori therapy, probiotics have been successfully used to reduce the incidence of side-effects. AIM: To evaluate the effect of Bacillus clausii, a probiotic, on incidence (primary variable) and severity of antibiotic-associated side-effects during anti-H. pylori therapy. METHODS: One hundred and twenty H. pylori-positive patients were randomly screened to receive: (i) a standard 7 days triple therapy with rabeprazole 20 mg b.d., clarithromycin 500 mg b.d. and amoxicillin 1 g b.d. and B. clausii t.d.s. (each preparation containing 2 x 10(9) spores) for 14 days starting from the first day of treatment. (ii) The same 7 days triple therapy and placebo t.d.s. for 14 days starting from the first day of treatment. Side-effects were assessed using a validated questionnaire and were recorded for 4 weeks from the start of therapy. RESULTS: The incidences of nausea, diarrhoea and epigastric pain in patients treated with B. clausii were significantly lower than in placebo group, in both PP and ITT analysis. Equally, intensity of nausea and diarrhoea in patients treated with B. clausii was significantly lower than in placebo group. There were no differences in adherence to treatment and H. pylori eradication rates between groups. Conclusion : In symptom-free, H. pylori-positive subjects B. clausii bacteriotherapy reduces the incidence of the most common side-effects related to anti-H. pylori antibiotic therapy compared with placebo.     

Paroxetine treatment of pathological gambling: a multi-centre randomized controlled trial

Previous studies have suggested the efficacy of serotonergic agents in the treatment of pathological gambling. The aim of the present study was to determine whether treatment with paroxetine in a large sample of subjects with pathological gambling would effectively diminish the severity of gambling symptoms. A 16-week, double-blind, placebo-controlled trial was conducted at five outpatient academic research centres in two countries (USA and Spain). Seventy-six outpatients (mean age 45.4+/-10.6 years; 30 women, 46 men) with pathological gambling were randomized to acute treatment with paroxetine in flexible daily dosages of 10-60 mg/day (n=36) or placebo (n=40). The primary outcome measure was the Clinical Global Impressions scale. Both the paroxetine- and the placebo-treated groups demonstrated comparable improvement at 16 weeks (59% response rate in the paroxetine group, 49% rate in the placebo group; chi squared=0.737; d.f.=1; P=0.390). Paroxetine consistently resulted in a greater percentage of responders at each study visit compared to placebo but failed to demonstrate statistical superiority to placebo on scores on the Clinical Global Impressions scale, the Yale-Brown Obsessive-Compulsive Scale Modified for Pathological Gambling, or the Gambling Symptom Assessment Scale. High rates of symptom improvement were observed in pathological gamblers receiving either paroxetine or placebo after 16 weeks. Paroxetine consistently demonstrated an advantage over placebo on the Clinical Global Impressions scale; however, a larger sample size may have registered significant differences.     

Cognitive behavioral smoking cessation during alcohol detoxification treatment: A randomized,controlled trial

Background

Among alcohol-dependent subjects tobacco smoking is very common and causes a variety of health risks. Therefore, it is necessary to reach this high-risk population early with appropriate smoking interventions.

Methods

Smokers in alcohol detoxification treatment were offered to participate in a smoking cessation study. A total of 103 patients was enrolled and randomly assigned to either the experimental group (EG) receiving a cognitive behavioral smoking cessation treatment (CBT) or the control group (CG) receiving autogenic training. Smoking outcomes were measured by self-report and carbon monoxide levels, directly after intervention and 6 months later, where additionally alcohol outcomes were recorded.

Results

There were no differences in smoking quit rates directly after intervention. However, patients in the EG were significantly more likely to reduce their daily cigarette use compared to CG (p = .046). Sub-group analyses revealed that heavy smokers (FTND score ≥ 7) seemed to profit most in the EG regarding cigarette reduction. After 6 months, these positive effects had leveled out. No evidence was found that smoking cessation might jeopardize alcohol outcomes.

Conclusions

Results suggest that alcohol-dependent smokers are interested in smoking interventions even during alcohol detoxification. CBT is promising in short-term smoking outcomes and in the approach of harm reduction, however, long-term effects are desirable. These findings underline the feasibility and the importance to provide smoking cessation interventions to patients in alcohol detoxification treatments.     

阿立哌唑治疗精神分裂症的多中心随机双盲对照试验

目的:评价阿立哌唑治疗精神分裂症的疗效及安全性。方法:采用多中心随机双盲双模拟、阳性药平行对照的方法。以利司哌酮(昔名利培酮)为对照,受试者分别口服阿立哌唑10~30 mg.d-1与利司哌酮2~6 mg.d-1,疗程42 d。结果:共收集精神分裂症病人222例,其中阿立哌唑组111例与利司哌酮组111例。治疗结束时,2组PANSS总分与BPRS总分较治疗前均显著降低(P<0.01);PANSS总分减分率阿立哌唑组(65±s28)%,利司哌酮组为(67±26)%,差异无显著意义(P>0.05)。临床总有效率:阿立哌唑组为77.0%,利司哌酮组为79.2%,2组比较差异无显著意义(P>0.05)。阿立哌唑组常见的不良反应为:静坐不能、震颤、失眠、心动过速,不良反应较利司哌酮组少。结论:阿立哌唑治疗精神分裂症的疗效与利司哌酮相似,不良反应较利司哌酮为少,是一种安全而有效的抗精神病药。     

比阿培南治疗急性细菌性感染的多中心随机对照临床试验

目的评价比阿培南(β内酰胺类抗生素)治疗急性细菌感染的有效性和安全性。方法用多中心随机开放平行对照研究方法,共入选有效病例272例,其中试验组(比阿培南)135例,给药剂量:比阿培南每次300mg,每日2次静脉滴注;对照组(亚胺培南/西司他丁钠)137例,每次亚胺培南500mg,每日3次静脉滴注。一般疗程均为7～14天,最短不少于5天。结果试验组与对照组临床痊愈率分别为62.79%和55.64%;总有效率分别为93.8%和88.72%;细菌清除率分别为90.41%和88.33%;药物不良反应发生率分别为10.37%和11.03%。结论比阿培南治疗临床常见急性细菌性感染安全、有效。     

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。     

艾灸治疗PICC置管后机械性静脉炎临床效果观察

目的:观察艾灸治疗PICC置管后机械性静脉炎的临床效果。方法:选择2013年3月—2015年3月于北京中医药大学东方医院住院治疗接受PICC置管发生机械性静脉炎的患者,将患者随机分成研究组和对照组,研究组在常规治疗的基础上采用艾灸治疗,在患者穿刺点上方4~5cm处沿穿刺静脉走行与皮肤相距2~3cm进行温和灸,以患者感觉温热舒适为宜,同时加灸足三里穴,每次灸10~15min,以局部皮肤起红晕为度。每日2次,连续7d观察两组临床治疗效果。结果:治疗前两组患者的各级静脉炎例数比较差异无统计学意义(P>0.05);经过艾灸联合治疗后研究组静脉炎Ⅰ级3例,Ⅱ级2例,无Ⅲ、Ⅳ级患者;对照组患者Ⅰ级9例,Ⅱ级6例,Ⅲ级5例、Ⅳ级2例,两组差异具有统计学意义(P<0.05);治疗后对照组患者临床痊愈43例,无效11例,总有效率79.63%;研究组患者临床痊愈49例,无效5例,总有效率90.74%,两组比较差异有统计学意义(P<0.05)。结论:艾灸联合西药能有效治疗PICC置管后机械性静脉炎,且具有操作简单、经济、患者易接受等优点,值得临床推广。     

Tobacco dependence treatment for hospitalized smokers: a randomized, controlled, pilot trial using varenicline

Objective

The hospital can be an important opportunity for smoking cessation interventions. This is the first randomized, double-blinded, placebo-controlled pilot trial utilizing varenicline and post-discharge, in-person behavioral treatment for hospitalized smokers.

Method

Seventy-nine smokers admitted to a university-based hospital with various diagnoses were enrolled from 2007 to 2009. The primary outcome was biochemically confirmed abstinence at 24 weeks following discharge. Secondary outcomes included withdrawal symptoms, motivation, utilization of treatment, and medical events.

Results

Overall abstinence at 24 weeks was 27% with no difference between varenicline and placebo treatment groups (23% vs. 31%). There were no significant differences in motivation to stop smoking or withdrawal symptoms. Over 40% of all subjects utilized post-discharge behavioral treatment with significantly higher abstinence rates compared with those who did not (53.1% vs. 8.5%, p < 0.01). Overall adverse events were similar in both treatment groups with the only significant difference being more nausea in the varenicline group (25% vs. 5%; p < 0.01). Twenty-three subjects were re-hospitalized with no significant differences between treatment groups (13 varenicline vs. 10 placebo).

Conclusion

This pilot trial of varenicline in hospitalized smokers demonstrated feasibility of implementation, produced some hypothesis-generating findings, and suggested the potential benefit of face-to-face treatment following discharge.     

乙氧苯柳胺软膏治疗慢性湿疹的随机对照临床试验

目的：研究乙氧苯柳胺软膏治疗慢性湿疹的疗效和安全性。方法：６０ 例慢性湿疹病人,３０ 例（ 男性２３ 例,女性７ 例;年龄５０ ａ ±ｓ １５ ａ） 用乙氧苯柳胺软膏均匀涂布患处,ｔｉｄ , ４ ｗｋ 为一个疗程;另３０例（ 男性２４ 例,女性６ 例,年龄４４ ａ ±１４ ａ） 采用乙氧苯柳胺软膏基质（ 基质） 均匀涂敷患处,ｔｉｄ ,４ ｗｋ 为一个疗程。结果：乙氧苯柳胺胺膏２ ｗ ｋ 和４ ｗｋ 时的总有效率分别为２０ ％ 和６３ ％ ,基质的总有效率分别为１０ ％ 和１４ ％ 。乙氧苯柳胺软膏的不良反应发生率为７ ％ ,基质为３ ％ 。结论：乙氧苯柳胺软膏治疗慢性湿疹有效,不良反应发生率与基质无明显差异。     

度洛西汀肠溶胶囊治疗抑郁症的多中心随机双盲对照临床研究

目的评价度洛西汀肠溶胶囊治疗抑郁症的疗效和安全性。方法采用随机、双盲、双模拟、氟西汀平行对照、剂量固定的多中心研究。受试者分别口服度洛西汀肠溶胶囊60 mg·d~(-1)或氟西汀胶囊20 mg·d~(-1),共观察6 wk。结果意向性分析集(ITT)抑郁症病人238例,其中度洛西汀组(试验组)117例和氟西汀组(对照组)121例。符合方案集(PP)病人228例,其中试验组111例,对照组117例。根据PP样本,治疗6 wk后,试验组和对照组汉密尔顿焦虑量表(HAMD)17项总分减分值分别为(15±s 5)分及(16±6)分,与基线相比均存在非常显著差异(P<0.01),但组间无显著差异(P>0.05);试验组和对照组的有效率分别为89.2%和88.0%,2组相比差异无显著意义(P>0.05)。试验组总不良反应发生率为35.0%,对照组为24.8%,2组相比差异无显著意义(P>0.05)。结论度洛西汀肠溶胶囊治疗抑郁症的疗效、安全性以及治疗抑郁症伴焦虑的疗效均与氟西汀相似,是一种安全有效的抗抑郁药。     

扎来普隆与唑吡坦治疗失眠症的多中心随机双盲对照比较

目的 :评价国产Ⅱ类新药扎来普隆治疗失眠症的有效性和安全性。方法 :采用多中心随机双盲双模拟、阳性药平行对照研究。唑吡坦组 12 0例 ,扎来普隆组 118例分别口服扎来普隆片 10mg·d- 1或唑吡坦片 10mg·d- 1。 14d为一个疗程。结果 :意向性 (ITT)分析样本病人有 2 38例。疗效评价的睡眠障碍量表 (SDRS)评分在治疗结束时较基线显著减少 (F检验 ,P <0 .0 1)。唑吡坦组的有效率77.5 % ,扎来普隆组的有效率 73.7% ,差异无显著意义 (P >0 .0 5 )。不良反应分析显示 2组较常见的不良反应为思睡、口干、便秘、头晕和头痛。结论 :国产扎来普隆与唑吡坦具有类似的疗效 ,不良反应相当。为治疗睡眠障碍的安全而有效的新药。     

国产降纤酶治疗脑梗塞的前瞻性随机双盲对照临床研究

本文采用全国脑防办双盲编号的国产降纤酶静滴治疗发病24h以内的急性脑梗塞病人34例,降纤酶治疗组21例,对照组13例,在应用降纤酶治疗前进行神经功能缺损评分,在出院时和第12周进行两次病人日常生活功能的评估（Barthel氏指数）,并同时于治疗前,后检测血浆中纤维蛋白原含量,肝功,肾功,研究结果显示,近期疗效降纤酶治疗组优于对照组,神经功能缺损评分进步亦优于对照组,但不具备统计学显著性差异（P＞0．05）,病人第12周日常生活能力评估（Barthel氏指数）较出院时有显著（P＜0．001）,研究显示国产降纤酶确为有效降低血浆纤维蛋白原的药物,对急性脑梗塞治疗有一定的疗效。     

进口阿莫西林-舒巴坦治疗社区获得性肺炎的多中心随机对照研究

目的 评价进口阿莫西林-舒巴坦(特福猛)治疗轻、中度社区获得性肺炎(CAP)的有效性和安全性.方法 采用随机多中心研究设计.受试组接受特福猛治疗,轻度患者剂量为1.5 g/12 h;中度患者剂量为3.0 g/12 h;对照组接受注射用头孢呋辛钠(西力欣)治疗,轻度患者剂量为1.5 g/12 h;中度患者剂量为1.5g/8 h.各组均为静脉滴注,疗程7～14 d.结果 共327例患者入选,可进行疗效分析的病例共316例.受试组痊愈率和有效率分别为32.9%和88.2%,相应的对照组分别为33.5%和89.0%,两组相比差异无统计学意义(P>0.05).受试组和对照组细菌清除率分别为85.2%和85.5%,两组相比差异无统计学意义(P>0.05).两组药物相关不良反应发生率分别为6.06%和4.93%,组间差异无统计学意义(P>0.05).结论 进口阿莫西林-舒巴坦对轻、中度CAP临床疗效较好,使用安全,有较高的临床应用价值.     

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。     

双环醇治疗慢性乙型肝炎双盲、随机、对照的临床研究

目的 :评估双环醇治疗慢性乙型肝炎的疗效和安全性。方法 :慢性乙型肝炎病人随机分成双环醇组 (2 69例 )和联苯双酯组 (1 3 8例) ,分别服用双环醇或联苯双酯 2 5mg,tid,共 2 4wk。结果 :经双环醇治疗后 ,临床症状有较大程度的改善。ALT和AST的复常率分别为 5 3 .5 %和 48.7% ,停药 1 2wk后分别为 40 .2 %和 48.7%。与联苯双酯组(61 .6%和 44.2 % ;45 .7%和 5 0 .0 % )比较 ,P >0 .0 5。治疗结束和停药 1 2wk后 ,双环醇组血清HBeAg阴转率分别为 2 0 .8%和 2 9.0 % ,HBeAg/抗HBe血清转换率分别为 1 5 .6%和 2 0 .8% ,HBV DNA阴转率分别为 3 9.0 %和 45 .7% ,上述指标均高于联苯双酯组。双环醇组治疗前ALT水平≥ 2 0 0U·L-1者 ,在停药 1 2wk时HBeAg阴转率和血清转换率分别为 48%和 3 8% ,显著高于联苯双酯组 (2 2 %和 1 2 % ) ,(P <0 .0 5 )。病人在治疗期间未出现明显不良反应。结论 :双环醇对改善乙肝病人临床症状和降低转氨酶有很好的疗效 ,不良反应少 ,病人耐受性好     

扎来普隆胶囊治疗失眠症的多中心随机双盲对照临床试验

目的 评价国产扎来普隆胶囊治疗失眠的有效性和安全性。方法用多中心随机双盲双摸拟、阳性药平行对照的方法。受试者分别口服扎来普隆胶囊10mg或酒石酸唑吡坦片10 mg。疗程14天。结果 意向性(ITT)分析226例,其中扎来普隆胶囊组113例,酒石酸唑吡坦片组113例。治疗后7,14天与治疗前比较,两种药物都能缩短入睡时间,延长睡眠时间(P<0. 001),但两者之间比较差异无显著性(P>0. 05)。两组常见药物不良反应为头晕、头痛、困倦、乏力、腹泻、记忆减退。但扎来普隆组的头晕、头痛、困倦、乏力相对较酒石酸唑吡坦片组要少。结论 扎来普隆为治疗失眠症的安全有效的药物。