Metformin in the treatment of HIV lipodystrophy syndrome: A randomized controlled trial

CONTEXT: A syndrome of lipodystrophy, characterized by fat redistribution and insulin resistance, has been estimated to affect the majority of human immunodeficiency virus (HIV)-infected individuals who are treated with combination antiretroviral therapy. There are no proven therapies for the metabolic disturbances associated with HIV lipodystrophy syndrome. OBJECTIVE: To determine the safety and efficacy of metformin therapy in HIV-infected patients with fat redistribution and abnormal glucose homeostasis. DESIGN AND SETTING: Randomized, double-blind, placebo-controlled pilot study conducted in a university hospital between December 1998 and January 2000. PATIENTS: Twenty-six HIV-infected, nondiabetic patients with fat redistribution and abnormal oral glucose tolerance test (OGTT) results, hyperinsulinemia, or both. INTERVENTIONS: Patients were randomly assigned to receive metformin, 500 mg twice daily (n = 14), or identical placebo (n = 12), for 3 months. MAIN OUTCOME MEASURES: Insulin area under the curve (AUC), calculated 120 minutes following a 75-g OGTT at baseline vs at 3-month follow-up and compared between treatment groups. RESULTS: Patients treated with metformin demonstrated significant reductions in mean (SEM) insulin AUC 120 minutes after OGTT (-2930 [912] vs -414 [432] microIU/mL [-20349 6334 vs -2875 3000 pmol/L]; P =.01), weight (-1.3 [0.6] vs 1.1 [0.4] kg; P =.005), and diastolic blood pressure (-5 [4] vs 5 [2] mm Hg; P =.009) vs controls, respectively. Metformin therapy was associated with a decrease in visceral abdominal fat (VAT; -1115 [819] vs 1191 [699] mm(2); P =.08) and a proportional reduction in subcutaneous abdominal fat (SAT); the VAT-SAT ratio was unchanged in metformin-treated vs placebo-treated patients. No increase in lactate or liver transaminase levels was observed with metformin treatment. Mild diarrhea was the most common adverse effect of metformin. No patient discontinued therapy because of adverse effects. CONCLUSIONS: This study suggests that a relatively low dosage of metformin reduces insulin resistance and related cardiovascular risk parameters in HIV-infected patients with lipodystrophy. JAMA. 2000;284:472-477     

从拖线术治疗肛瘘方案设计探讨外科手术临床试验特点：前瞻性多中心随机对照临床试验

背景：外科手术类干预措施在进行临床试验时,虽然方案设计的基本原则与药物临床试验类似,但在具体操作环节上,有许多自身特点需要引起关注和讨论。目的：通过隧道式拖线术治疗单纯性肛瘘临床试验实例,探讨手术疗法临床试验方案设计的特点。设计、场所、对象和干预措施：该临床方案为前瞻性、多中心、随机、开放、对照的试验设计。病例来源于上海中医药大学附属龙华医院和岳阳中西医结合医院肛以及江西中医学院附属医院。按高位和低位单纯性肛瘘的疾病亚型分层随机。采用全分析集进行病例分布和基线资料等的比较,采用符合方案集进行疗效和安全性评价。治疗方法为隧道式拖线术,以传统切挂法为对照。主要结局指标：以治愈时间、治愈率、生活质量等为疗效指标,并作安全性分析。结果：按优效性检验方法估算样本。共入组单纯性肛瘘244例,最终有效病例236例。治疗组和对照组两类（低位和高位）单纯性肛瘘患者治愈率比较,差异均无统计学意义。低位单纯性肛瘘治疗组治愈时间为（22．26±8．67）d,对照组为（31．41±11．39）d;高位单纯性肛瘘治疗组治愈时间为（24．73±8．15）d,对照组为（32．20±12．60）d。两组比较,差异均有统计学意义（P〈0．01）。经过治疗后,低位单纯性肛瘘患者各项生活质量积分在两组间的差异无统计学意义;高位单纯性肛瘘治疗组肛门括约功能积分和对治疗信心积分均明显优于对照组（P〈0．05）;两组其余各项积分比较,差异无统计学意义。安全性分析示两组均无不良事件发生,隧道式拖线组治疗前后肛管最大收缩压无明显变化。结论：隧道式拖线术治疗单纯性肛瘘可以明显缩短病程,提高患者生活质量,是一种安全的手术方法。临床治疗方案的培训是手术类临床试验质量保证的重要环节。盲法的实施几乎是不可能的,只能采用开放的方法,一般不能用安慰剂对照,多采用阳性对照。     

Surgery vs orthosis vs watchful waiting for hallux valgus: a randomized controlled trial

CONTEXT: Hallux valgus is a common foot deformation in adults, but evidence for effectiveness of surgical and conservative treatments for this condition is limited. OBJECTIVE: To compare the effectiveness of surgical and orthotic treatment with no treatment in patients with hallux valgus. DESIGN AND SETTING: Randomized controlled trial conducted in 4 general community hospitals in Finland in 1997-1998, with a follow-up period of 12 months. PARTICIPANTS: Two hundred nine consecutive patients (mean age, 48 years; 93% women) with a painful bunion and a hallux valgus angle 35 degrees or less. INTERVENTIONS: Patients were randomly assigned to surgery (distal chevron osteotomy; n = 71), orthosis (n = 69), or a 1-year waiting list (control group, n = 69). MAIN OUTCOME MEASURES: Pain intensity during walking on a visual analog scale (0-100), patient assessment of global improvement, number of painful days, cosmetic disturbance, footwear problems, functional status, and treatment satisfaction, compared among treatment groups. RESULTS: Follow-up rates at 6 and 12 months were 99% and 98%, respectively. At 6 months, pain intensity decreased more in the surgical group than in the control group (adjusted mean differences, -20 [95% confidence interval (CI), -28 to -12]) and more in orthosis than in the control groups (adjusted mean difference, -14 [95% CI, -22 to -6. At 1 year, pain intensity decreased more in the surgical than in the control groups (adjusted mean difference, -19 [95% CI, -28 to -10]) and more than in the surgical and orthosis groups (adjusted mean difference, -14 [95% CI, -22 to -5]). At 1 year, 83%, 46%, and 24% in the surgery, orthosis, and control groups, respectively, thought they had improved compared with baseline (number needed to treat), 1.7 between surgical and control groups). Number of painful days, cosmetic disturbance, and footwear problems were least and functional status and satisfaction with treatment were best in the surgical group. CONCLUSIONS: Surgical osteotomy is an effective treatment for painful hallux valgus. Orthoses provide short-term symptomatic relief.     

Intravenous nesiritide vs nitroglycerin for treatment of decompensated congestive heart failure: a randomized controlled trial

Context  Decompensated congestive heart failure (CHF) is the leading hospital discharge diagnosis in patients older than 65 years. Objective  To compare the efficacy and safety of intravenous nesiritide, intravenous nitroglycerin, and placebo. Design, Setting, and Patients  Randomized, double-blind trial of 489 inpatients with dyspnea at rest from decompensated CHF, including 246 who received pulmonary artery catheterization, that was conducted at 55 community and academic hospitals between October 1999 and July 2000. Interventions  Intravenous nesiritide (n = 204), intravenous nitroglycerin (n = 143), or placebo (n = 142) added to standard medications for 3 hours, followed by nesiritide (n = 278) or nitroglycerin (n = 216) added to standard medication for 24 hours. Main Outcome Measures  Change in pulmonary capillary wedge pressure (PCWP) among catheterized patients and patient self-evaluation of dyspnea at 3 hours after initiation of study drug among all patients. Secondary outcomes included comparisons of hemodynamic and clinical effects between nesiritide and nitroglycerin at 24 hours. Results  At 3 hours, the mean (SD) decrease in PCWP from baseline was –5.8 (6.5) mm Hg for nesiritide (vs placebo, P<.001; vs nitroglycerin, P = .03), –3.8 (5.3) mm Hg for nitroglycerin (vs placebo, P = .09), and –2 (4.2) mm Hg for placebo. At 3 hours, nesiritide resulted in improvement in dyspnea compared with placebo (P = .03), but there was no significant difference in dyspnea or global clinical status with nesiritide compared with nitroglycerin. At 24 hours, the reduction in PCWP was greater in the nesiritide group (-8.2 mm Hg) than the nitroglycerin group (-6.3 mm Hg), but patients reported no significant differences in dyspnea and only modest improvement in global clinical status. Conclusion  When added to standard care in patients hospitalized with acutely decompensated CHF, nesiritide improves hemodynamic function and some self-reported symptoms more effectively than intravenous nitroglycerin or placebo.      

Ipriflavone in the treatment of postmenopausal osteoporosis: a randomized controlled trial

CONTEXT: Data on the efficacy and safety of ipriflavone for prevention of postmenopausal bone loss are conflicting. OBJECTIVES: To investigate the effect of oral ipriflavone on prevention of postmenopausal bone loss and to assess the safety profile of long-term treatment with ipriflavone in postmenopausal osteoporotic women. DESIGN AND SETTING: Prospective, randomized, double-blind, placebo-controlled, 4-year study conducted in 4 centers in Belgium, Denmark, and Italy from August 1994 to July 1998. PARTICIPANTS: Four hundred seventy-four postmenopausal white women, aged 45 to 75 years, with bone mineral densities (BMDs) of less than 0.86 g/cm(2). INTERVENTIONS: Patients were randomly assigned to receive ipriflavone, 200 mg 3 times per day (n = 234), or placebo (n = 240); all received 500 mg/d of calcium. MAIN OUTCOME MEASURES: Efficacy measures included spine, hip, and forearm BMD and biochemical markers of bone resorption (urinary hydroxyproline corrected for creatinine and urinary CrossLaps [Osteometer Biotech, Herlev, Denmark] corrected for creatinine), assessed every 6 months. Laboratory safety measures and adverse events were recorded every 3 months. RESULTS: Based on intent-to-treat analysis, after 36 months of treatment, the annual percentage change from baseline in BMD of the lumbar spine for ipriflavone vs placebo (0.1% [95% confidence interval (CI), -7.9% to 8.1%] vs 0.8% [95% CI, -9.1% to 10.7%]; P =.14), or in any of the other sites measured, did not differ significantly between groups. The response in biochemical markers was also similar between groups (eg, for hydroxyproline corrected for creatinine, 20.13 mg/g [95% CI, 18.85-21.41 mg/g] vs 20.67 mg/g [95% CI, 19.41-21.92 mg/g]; P =.96); urinary CrossLaps corrected for creatinine, 268 mg/mol (95% CI, 249-288 mg/mol) vs 268 mg/mol (95% CI, 254-282 mg/mol); P =.81. The number of women with new vertebral fracture was identical or nearly so in the 2 groups at all time points. Lymphocyte concentrations decreased significantly (500/microL (0.5 x 10(9)/L]) in women treated with ipriflavone. Thirty-one women (13.2%) in the ipriflavone group developed subclinical lymphocytopenia, of whom 29 developed it during ipriflavone treatment. Of these, 15 (52%) of 29 had recovered spontaneously by 1 year and 22 (81%) of 29 by 2 years. CONCLUSIONS: Our data indicate that ipriflavone does not prevent bone loss or affect biochemical markers of bone metabolism. Additionally, ipriflavone induces lymphocytopenia in a significant number of women.     

Three- vs four-drug antiretroviral regimens for the initial treatment of HIV-1 infection: a randomized controlled trial

Context  Three-drug antiretroviral regimens are standard of care for initial treatment of human immunodeficiency virus 1 (HIV-1) infection, but a 4-drug regimen could improve antiretroviral activity and be more effective than a 3-drug regimen. Objective  To compare the safety/efficacy of 3-drug vs 4-drug regimens for initial treatment of HIV-1 infection. Design  The AIDS Clinical Trials Group (ACTG) A5095 study, a randomized, double-blind, placebo-controlled study with enrollment and follow-up conducted from March 22, 2001, to March 1, 2005, and enrolling treatment-naive, HIV-1–infected patients with HIV-1 RNA levels of 400 copies/mL or greater from US clinical trials units of the ACTG. Interventions  Zidovudine/lamivudine plus efavirenz (3-drug regimen) vs zidovudine/lamivudine/abacavir plus efavirenz (4-drug regimen). Main Outcome Measures  Time to virologic failure (defined as time to first of 2 successive HIV-1 RNA levels 200 copies/mL at or after week 16), CD4 cell count changes, and grade 3 or 4 adverse events. HIV-1 RNA data were intent-to-treat, regardless of treatment changes. Results  Seven hundred sixty-five patients with a baseline mean HIV-1 RNA level of 4.86 log₁₀ (72 444) copies/mL and CD4 cell count of 240 cells/mm³ were randomized. After a median 3-year follow-up, 99 (26%) of 382 and 94 (25%) of 383 patients receiving the 3-drug and 4-drug regimens, respectively, reached protocol-defined virologic failure; time to virologic failure was not significantly different (hazard ratio, 0.95; 97.5% confidence interval, 0.69-1.33; P = .73). In planned subgroup analyses, increased risk for virologic failure was seen in non-Hispanic black patients (adjusted hazard ratio, 1.66; 95% confidence interval, 1.18-2.34; P = .003). At 3 years, the HIV-1 RNA level was less than 200 copies/mL in 152 (90%) of 169 and 143 (92%) of 156 patients receiving the 3-drug and 4-drug regimens, respectively (P = .59), and less than 50 copies/mL in 144 (85%) of 169 and 137 (88%) of 156 patients (P = .39). CD4 cell count increases and grade 3 or 4 adverse events were not significantly different. Conclusions  In treatment-naive patients, there were no significant differences between the 3-drug and 4-drug antiretroviral regimens; overall, at least approximately 80% of patients had HIV-1 RNA levels less than 50 copies/mL through 3 years. These results support current guidelines recommending 2 nucleosides plus efavirenz for initial treatment of HIV-1 infection; adding abacavir as a fourth drug provided no additional benefit. Clinical Trials Registration  clinicaltrials.gov Identifier: NCT00013520      

Guggulipid for the treatment of hypercholesterolemia: a randomized controlled trial

Context  Herbal extracts from Commiphora mukul (guggul) have been widely used in Asia as cholesterol-lowering agents, and their popularity is increasing in the United States. Recently, guggulsterones, the purported bioactive compounds of guggul, have been shown to be potent antagonists of 2 nuclear hormone receptors involved in cholesterol metabolism, establishing a plausible mechanism of action for the hypolipidemic effects of these extracts. However, there are currently no published safety or efficacy data on the use of guggul extracts in Western populations. Objective  To study the short-term safety and efficacy of 2 doses of a standardized guggul extract (guggulipid, containing 2.5% guggulsterones) in healthy adults with hyperlipidemia eating a typical Western diet. Design  Double-blind, randomized, placebo-controlled trial using a parallel design, conducted March 2000-August 2001. Participants and Setting  A total of 103 ambulatory, community-dwelling, healthy adults with hypercholesterolemia in the Philadelphia, Pa, metropolitan area. Intervention  Oral, 3 times daily doses of standard-dose guggulipid (1000 mg), high-dose guggulipid (2000 mg), or matching placebo. Main Outcome Measures  Percentage change in levels of directly measured low-density lipoprotein cholesterol (LDL-C) after 8 weeks of therapy. Secondary outcome measures included levels of total cholesterol, high-density lipoprotein cholesterol (HDL-C), triglycerides, and directly measured very low-density lipoprotein cholesterol (VLDL-C), as well as adverse events reports and laboratory safety measures including electrolyte levels and hepatic and renal function. Results  Compared with participants randomized to placebo (n = 36), in whom levels of LDL-C decreased by 5%, both standard-dose guggulipid (n = 33) and high-dose guggulipid (n = 34) raised levels of LDL-C by 4% (P = .01 vs placebo) and 5% (P = .006 vs placebo), respectively, at 8 weeks, for a net positive change of 9% to 10%. There were no significant changes in levels of total cholesterol, HDL-C, triglycerides, or VLDL-C in response to treatment with guggulipid in the intention-to-treat analysis. While guggulipid was generally well tolerated, 6 participants treated with guggulipid developed a hypersensitivity rash compared with none in the placebo group. Conclusions  Despite plausible mechanisms of action, guggulipid did not appear to improve levels of serum cholesterol over the short term in this population of adults with hypercholesterolemia, and might in fact raise levels of LDL-C. Guggulipid also appeared to cause a dermatologic hypersensitivity reaction in some patients.      

Paroxetine controlled release in the treatment of menopausal hot flashes: a randomized controlled trial

Context  Standard therapy for hot flashes has been hormone replacement with estradiol or progestational agents, but recent data suggest that antidepressants inhibiting serotonin reuptake may also be effective. Objective  To evaluate a selective serotonin reuptake inhibitor (paroxetine controlled release [CR]) in treating the vasomotor symptoms displayed by a general cross-section of menopausal women. Design and Setting  Randomized, double-blind, placebo-controlled, parallel group study conducted across 17 US sites, including urban, suburban, and rural clinics. Patients  A total of 165 menopausal women aged 18 years or older experiencing at least 2 to 3 daily hot flashes and must have discontinued any hormone replacement therapy for at least 6 weeks. Women were excluded if they had any signs of active cancer or were undergoing chemotherapy or radiation therapy. Intervention  After a 1-week placebo run-in phase, study participants were randomized to receive placebo or receive 12.5 mg/d or 25.0 mg/d of paroxetine CR (in a 1:1:1 ratio) for 6 weeks. Main Outcome Measures  Mean change from baseline to week 6 in the daily hot flash composite score (frequency x severity). Results  Fifty-six participants were randomly assigned to receive placebo and 51 to receive 12.5 mg/d and 58 to receive 25.0 mg/d of paroxetine CR. The mean reductions in the hot flash frequency composite score from baseline to week 6 were statistically significantly greater for those receiving paroxetine CR than for those receiving placebo. By week 6, the mean daily hot flash frequency went from 7.1 to 3.8 (mean reduction, 3.3) for those in the 12.5-mg/d and from 6.4 to 3.2 (mean reduction, 3.2) for those in the 25-mg/d paroxetine CR groups and from 6.6 to 4.8 (mean reduction, 1.8) for those in the placebo group. Mean placebo-adjusted reduction in hot flash composite scores were -4.7 (95% confidence interval, - 8.1 to -1.3; P = .007) comparing 12.5-mg/d paroxetine CR with placebo; and -3.6 (95% confidence interval, -6.8 to -0.4; P = .03) comparing 25.0-mg/d paroxetine CR with placebo. This corresponded to median reductions of 62.2% for those in the 12.5-mg/d and 64.6% for those in the 25.0-mg/d paroxetine CR groups compared with 37.8% for those in the placebo group. Conclusion  Paroxetine CR may be an effective and acceptable alternative to hormone replacement and other therapies in treating menopausal hot flash symptoms.      

超声对腕管综合征患者治疗方式的指导应用

目的探讨超声对腕管综合征患者辅助诊断,与指导选择最佳治疗方案的临床应用。方法对2009年1月-2010年10月我院就诊的26例35侧腕管综合征患者,经临床症状及电生理检测确诊,治疗前通过超声了解正中神经位置、形态、走向、回声的改变及周边情况,测量钩骨钩处腕横韧带厚度及神经外膜厚度,选择实施最适合患者的治疗方案。结果 8例10侧CTS患者钩骨钩水平腕横韧带≤0.40cm、神经外膜厚度≤0.060cm,经保守治疗2个月,6例8侧症状明显缓解,半年内未复发。12例18侧CTS患者钩骨钩水平腕横韧带厚度〉0.40cm,神经外膜厚度≤0.06cm,行开放式腕横韧带彻底松懈术,11例16侧症状明显缓解,半年内未复发。6例7侧CTS患者神经外膜厚度〉0.060cm,采取显微镜下神经外膜松懈术,5例6侧症状明显缓解,半年内未复发。结论超声通过测量钩骨钩处腕横韧带厚度及神经外膜厚度,可为临床治疗腕管综合征提供参考,从而选择合适治疗方案,减轻患者痛苦。     

Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial

Context  Compared with bare metal stents, sirolimus-eluting and paclitaxel-eluting stents have been shown to markedly improve angiographic and clinical outcomes after percutaneous coronary revascularization, but their performance in the treatment of de novo coronary lesions has not been compared in a prospective multicenter study. Objective  To compare the safety and efficacy of sirolimus-eluting vs paclitaxel-eluting coronary stents. Design  Prospective, randomized comparative trial (the REALITY trial) conducted between August 2003 and February 2004, with angiographic follow-up at 8 months and clinical follow-up at 12 months. Setting  Ninety hospitals in Europe, Latin America, and Asia. Patients  A total of 1386 patients (mean age, 62.6 years; 73.1% men; 28.0% with diabetes) with angina pectoris and 1 or 2 de novo lesions (2.25-3.00 mm in diameter) in native coronary arteries. Intervention  Patients were randomly assigned in a 1:1 ratio to receive a sirolimus-eluting stent (n = 701) or a paclitaxel-eluting stent (n = 685). Main Outcome Measures  The primary end point was in-lesion binary restenosis (presence of a more than 50% luminal-diameter stenosis) at 8 months. Secondary end points included 1-year rates of target lesion and vessel revascularization and a composite end point of cardiac death, Q-wave or non–Q-wave myocardial infarction, coronary artery bypass graft surgery, or repeat target lesion revascularization. Results  In-lesion binary restenosis at 8 months occurred in 86 patients (9.6%) with a sirolimus-eluting stent vs 95 (11.1%) with a paclitaxel-eluting stent (relative risk [RR], 0.84; 95% confidence interval [CI], 0.61-1.17; P = .31). For sirolimus- vs paclitaxel-eluting stents, respectively, the mean (SD) in-stent late loss was 0.09 (0.43) mm vs 0.31 (0.44) mm (difference, –0.22 mm; 95% CI, –0.26 to –0.18 mm; P<.001), mean (SD) in-stent diameter stenosis was 23.1% (16.6%) vs 26.7% (15.8%) (difference, –3.60%; 95% CI, –5.12% to –2.08%; P<.001), and the number of major adverse cardiac events at 1 year was 73 (10.7%) vs 76 (11.4%) (RR, 0.94; 95% CI, 0.69-1.27; P = .73). Conclusion  In this trial comparing sirolimus- and paclitaxel-eluting coronary stents, there were no differences in the rates of binary restenosis or major adverse cardiac events. Clinical Trial Registration  ClinicalTrials.gov Identifier: NCT00235092      

小切口治疗腕管综合征74例临床分析

目的:对小切口治疗腕管综合征的临床分析。方法:对本院2011-06~2013-06期间收治的74例腕管综合征患者展开研究,行传统开放式手术和小切口法治疗,分析比较两组患者的治疗效果。结果:两组患者在手术情况、术后两点分辨觉以及并发症的比较,差异具有统计学意义(P<0.05)。结论:小切口对腕管综合征的治疗取得了显著的疗效,其具有手术时间短、出血量少、并发症少等特点,值得在临床上推广使用。     

15例急性腕管综合征非手术治疗效果观察

目的总结急性腕管综合征的非手术治疗方法、临床疗效及可行性。方法分析2007年1月至2009年7月收治的15例腕管综合征急性发作而不愿手术的患者的临床资料,采取外敷2号活血散,配合手法松解等非手术保守治疗。结果腕管综合征的急性正中神经压迫症状得以消退或减缓,总有效率为93％,随访半年,疗效良好。结论对于腕管综合征的急性发作而不愿手术的患者,采用非手术保守治疗,局部外敷2号活血散,配合手法松解,临床神经压迫症状可以消退或减缓,具有一定可行性。     

Cognitive behavioral therapy vs zopiclone for treatment of chronic primary insomnia in older adults: a randomized controlled trial

Context  Insomnia is a common condition in older adults and is associated with a number of adverse medical, social, and psychological consequences. Previous research has suggested beneficial outcomes of both psychological and pharmacological treatments, but blinded placebo-controlled trials comparing the effects of these treatments are lacking. Objective  To examine short- and long-term clinical efficacy of cognitive behavioral therapy (CBT) and pharmacological treatment in older adults experiencing chronic primary insomnia. Design, Setting, and Participants  A randomized, double-blinded, placebo-controlled trial of 46 adults (mean age, 60.8 y; 22 women) with chronic primary insomnia conducted between January 2004 and December 2005 in a single Norwegian university-based outpatient clinic for adults and elderly patients. Intervention  CBT (sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relaxation; n = 18), sleep medication (7.5-mg zopiclone each night; n = 16), or placebo medication (n = 12). All treatment duration was 6 weeks, and the 2 active treatments were followed up at 6 months. Main Outcome Measures  Ambulant clinical polysomnographic data and sleep diaries were used to determine total wake time, total sleep time, sleep efficiency, and slow-wave sleep (only assessed using polysomnography) on all 3 assessment points. Results  CBT resulted in improved short- and long-term outcomes compared with zopiclone on 3 out of 4 outcome measures. For most outcomes, zopiclone did not differ from placebo. Participants receiving CBT improved their sleep efficiency from 81.4% at pretreatment to 90.1% at 6-month follow-up compared with a decrease from 82.3% to 81.9% in the zopiclone group. Participants in the CBT group spent much more time in slow-wave sleep (stages 3 and 4) compared with those in other groups, and spent less time awake during the night. Total sleep time was similar in all 3 groups; at 6 months, patients receiving CBT had better sleep efficiency using polysomnography than those taking zopiclone. Conclusion  These results suggest that interventions based on CBT are superior to zopiclone treatment both in short- and long-term management of insomnia in older adults. Trial Registration  clinicaltrials.gov Identifier: NCT00295386      

调和肝脾核心汤治疗腹泻型肠易激综合征的随机对照临床试验

背景：肠易激综合征（irritable bowel syndrome, IBS）对患者生活质量影响较大且需花费高额医疗费用,其病因及发病机制迄今尚未完全明了,对本病的防治至今还缺乏足够有效的方法。 目的：观察在肝脾相关理论指导下自拟调和肝脾核心汤治疗腹泻型IBS的疗效。 设计、场所、对象和干预措施：纳入2007年9月至2009年3月在暨南大学第一附属医院、广州红十字会医院和广州中医药大学第一附属医院就诊的40例腹泻型IBS患者。将40例患者随机平均分为两组,治疗组给予调和肝脾核心汤,对照组给予匹维溴铵,疗程均为4周。 主要结局指标：评价治疗组和对照组治疗前后中医证候积分、临床总显效率、症状消失率和症状积分的变化。 结果：治疗后,治疗组和对照组中医证候积分均低于治疗前（P＜0.01）,且治疗组中医证候积分亦低于对照组（P＜0.01）;治疗组和对照组临床总显效率分别为85%（17/20）和45%（9/20）,两组比较,差异有统计学意义（P＜0.01）;治疗组腹痛、腹胀、排便不尽感、大便次数、大便性状和黏液便各症状消失率均高于对照组（P＜0.05）;治疗组腹痛、腹胀、排便不尽感、大便次数、大便性状和黏液便各症状积分均低于对照组（P〈0.05）。 结论：运用肝脾相关理论自拟调和肝脾核心汤治疗腹泻型IBS能明显改善患者的临床症状。     

小剂量他克莫司联合雷公藤多苷治疗激素抵抗性肾病综合征随机对照研究

目的观察小剂量他克莫司(TAC)联合雷公藤多苷(TW)治疗激素抵抗性肾病综合征(SRNS)的临床疗效和安全性。方法经肾活检并结合临床诊断为系膜增生性肾炎(MesPGN)和局灶节段性肾小球硬化(FSGS)、经泼尼松[1 mg/(kg.d),最大60 mg/d]治疗3个月无效的患者,随机分为2组。小剂量TAC+TW组:TAC首次使用0.05 mg/(kg.d),分2次、间隔12 h于餐后2 h服用,服药3 d后检测TAC浓度,维持血药浓度1.5～4 ng/ml;同时加用TW治疗剂量60 mg/d,分3次餐前口服。TW组:单用TW,治疗剂量60 mg/d,分3次餐前口服。观察各组的疗效、不良反应以及TAC的浓度变化。结果(1)符合入组条件的SRNS患者共20例,小剂量TAC+TW组11例,TW组9例。入组基线年龄、性别分布、发病时间、血压、24h尿蛋白定量、血清白蛋白、肌酐、胆固醇、三酰甘油、空腹血糖、肾脏病理类型及服用泼尼松时间等无明显统计学差异。(2)小剂量TAC+TW组治疗1个月后尿蛋白开始下降,随访至12个月时有8例完全缓解(72.7%),2例部分缓解(18.2%),1例无效(9.1%),总有效率(90.9%)。而TW组同样治疗1个月后尿蛋白开始减少,但随访至12个月时仅有2例完全缓解(22.2%),部分缓解4例(44.5%),无效3例(33.3%),总有效率(66.7%)。随访至终点小剂量TAC+TW组完全缓解率高于TW组。(3)小剂量TAC+TW组治疗后患者血浆蛋白明显升高,治疗至6个月时血浆蛋白基本恢复至正常水平;而TW组血浆蛋白升高却不明显。两组患者血肌酐水平治疗前后无明显改变。(4)不良反应的发生率两组之间无明显差异。结论小剂量TAC+TW能有效减少SRNS患者蛋白尿,临床缓解率较高;并且患者耐受性好,是治疗SRNS的有效方法。     

Methadone maintenance vs 180-day psychosocially enriched detoxification for treatment of opioid dependence: a randomized controlled trial

Context  Despite evidence that methadone maintenance treatment (MMT) is effective for opioid dependence, it remains a controversial therapy because of its indefinite provision of a dependence-producing medication. Objective  To compare outcomes of patients with opioid dependence treated with MMT vs an alternative treatment, psychosocially enriched 180-day methadone-assisted detoxification. Design  Randomized controlled trial conducted from May 1995 to April 1999. Setting  Research clinic in an established drug treatment service. Patients  Of 858 volunteers screened, 179 adults with diagnosed opioid dependence were randomized into the study; 154 completed 12 weeks of follow-up. Interventions  Patients were randomized to MMT (n = 91), which required 2 hours of psychosocial therapy per week during the first 6 months; or detoxification (n = 88), which required 3 hours of psychosocial therapy per week, 14 education sessions, and 1 hour of cocaine group therapy, if appropriate, for 6 months, and 6 months of (nonmethadone) aftercare services. Main Outcome Measures  Treatment retention, heroin and cocaine abstinence (by self-report and monthly urinalysis), human immunodeficiency virus (HIV) risk behaviors (Risk of AIDS Behavior scale score), and function in 5 problem areas: employment, family, psychiatric, legal, and alcohol use (Addiction Severity Index), compared by intervention group. Results  Methadone maintenance therapy resulted in greater treatment retention (median, 438.5 vs 174.0 days) and lower heroin use rates than did detoxification. Cocaine use was more closely related to study dropout in detoxification than in MMT. Methadone maintenance therapy resulted in a lower rate of drug-related (mean [SD] at 12 months, 2.17 [3.88] vs 3.73 [6.86]) but not sex-related HIV risk behaviors and in a lower severity score for legal status (mean [SD] at 12 months, 0.05 [0.13] vs 0.13 [0.19]). There were no differences between groups in employment or family functioning or alcohol use. In both groups, monthly heroin use rates were 50% or greater, but days of use per month dropped markedly from baseline. Conclusions  Our results confirm the usefulness of MMT in reducing heroin use and HIV risk behaviors. Illicit opioid use continued in both groups, but frequency was reduced. Results do not provide support for diverting resources from MMT into long-term detoxification.