Efficacy of terbinafine for toenail onychomycosis. A multicenter trial of various treatment durations

The efficacy of terbinafine (250 mg/day) in the treatment of toenail onychomycosis was evaluated in a large open-label, multicenter trial of 12, 18, and 24 weeks of therapy. All 1,534 patients had onychomycosis, confirmed by either positive potassium hydroxide (KOH) wet mount, positive fungal culture, or both, and all received at least 12 weeks of treatment. Treatment was continued for an additional 6 or 12 weeks, depending on the extent of the disease at follow-up. Mycologic cure rates (negative culture plus negative KOH) at week 72 were 72.1% in the 12-week treatment group, 72.5% in the 18-week group, and 77.0% in the 24-week group. In all groups, clinical cure rates were higher at week 72 than at week 48: 49.5% of the 12-week group, 49.2% of the 18-week group, and 44.6% of the 24-week group experienced clinical cure by the end of the study. Both mycologic and clinical recurrence rates were low in all treatment groups at the 72-week assessment. The results of this study confirm the efficacy of terbinafine in the treatment of toenail onychomycosis as demonstrated in previous registration and large-scale clinical trials.     

A randomized, double-blind, multicenter, controlled clinical trial of cyclosporine plus chloroquine vs. cyclosporine plus placebo in early-onset rheumatoid arthritis

BACKGROUND: Our objective was to assess the efficacy and safety of cyclosporine-A (CsA) plus chloroquine (Clq) in early-onset rheumatoid arthritis (RA) compared to CsA plus placebo. METHODS: We conducted a prospective, 12-month follow-up, multicenter, double-blind, placebo-controlled study of CsA (2.5-5 mg/kg/day[d]) plus Clq (150 mg/d) vs. CsA plus placebo in active RA of <2 years of evolution. RESULTS: A total of 149 patients were included; 111 patients (74.4%) completed the 12-month follow-up period. Evaluation at 6 and 12 months showed improvement for all clinical disease parameters. In both groups there was a decrease in tender joint count, swollen joint count, pain, assessment of efficacy by both investigator and patient, functional assessment, and morning stiffness, all differences statistically significant. With an intention-to-treat analysis, there was 64% in the CsA plus Clq group (CsA/Clq) and 63% in the CsA plus placebo group (CsA/Plac) at 12 months in the American College of Rheumatology (ACR)-20 criteria of improvement. Response rate for ACR-50 was 48 and 47%, and for ACR-70 it was 29% in both groups; the difference was not statistically significant between study groups. Gastrointestinal complaints were common in both groups. Four patients in CsA/Clq group and five patients in CsA/placebo group increased creatinine levels; two patients in each group discontinued treatment due to this reason. CONCLUSIONS: There was no advantage to adding chloroquine to cyclosporine in patients with RA.     

Western medication plus Traditional Chinese Medicine preparations in patients with chronic heart failure: a prospective,single-blind,randomized, controlled,and multicenter clinical trial

Objective

To assess the efficacy and safety in patients with chronic heart failure (CHF) of Western medication plus Traditional Chinese Medicine (TCM) preparations.

Effectiveness of team-managed home-based primary care: a randomized multicenter trial

Context  Although home-based health care has grown over the past decade, its effectiveness remains controversial. A prior trial of Veterans Affairs (VA) Team-Managed Home-Based Primary Care (TM/HBPC) found favorable outcomes, but the replicability of the model and generalizability of the findings are unknown. Objectives  To assess the impact of TM/HBPC on functional status, health-related quality of life (HR-QoL), satisfaction with care, and cost of care. Design and Setting  Multisite randomized controlled trial conducted from October 1994 to September 1998 in 16 VA medical centers with HBPC programs. Participants  A total of 1966 patients with a mean age of 70 years who had 2 or more activities of daily living impairments or a terminal illness, congestive heart failure (CHF), or chronic obstructive pulmonary disease (COPD). Intervention  Home-based primary care (n = 981), including a primary care manager, 24-hour contact for patients, prior approval of hospital readmissions, and HBPC team participation in discharge planning, vs customary VA and private sector care (n = 985). Main Outcome Measures  Patient functional status, patient and caregiver HR-QoL and satisfaction, caregiver burden, hospital readmissions, and costs over 12 months. Results  Functional status as assessed by the Barthel Index did not differ for terminal (P = .40) or nonterminal (those with severe disability or who had CHF or COPD) (P = .17) patients by treatment group. Significant improvements were seen in terminal TM/HBPC patients in HR-QoL scales of emotional role function, social function, bodily pain, mental health, vitality, and general health. Team-Managed HBPC nonterminal patients had significant increases of 5 to 10 points in 5 of 6 satisfaction with care scales. The caregivers of terminal patients in the TM/HBPC group improved significantly in HR-QoL measures except for vitality and general health. Caregivers of nonterminal patients improved significantly in QoL measures and reported reduced caregiver burden (P = .008). Team-Managed HBPC patients with severe disability experienced a 22% relative decrease (0.7 readmissions/patient for TM/HBPC group vs 0.9 readmissions/patient for control group) in hospital readmissions (P = .03) at 6 months that was not sustained at 12 months. Total mean per person costs were 6.8% higher in the TM/HBPC group at 6 months ($19,190 vs $17,971) and 12.1% higher at 12 months ($31,401 vs $28,008). Conclusions  The TM/HBPC intervention improved most HR-QoL measures among terminally ill patients and satisfaction among non–terminally ill patients. It improved caregiver HR-QoL, satisfaction with care, and caregiver burden and reduced hospital readmissions at 6 months, but it did not substitute for other forms of care. The higher costs of TM/HBPC should be weighed against these benefits.      

依那西普治疗强直性脊柱炎的随机、双盲、平行对照临床研究

目的：评价依那西普治疗活动性强直性脊柱炎（AS）的临床疗效和安全性。方法：前6周为随机、双盲、安慰剂对照临床试验,后6周为开放研究。52位活动性AS患者随机接受6周的每周2次依那西普（25mg）或安慰剂皮下注射,主要疗效指标为达到ASAS20的患者比例,次要疗效指标达到ASASS0、ASAS70受试者比例,BAS—DAI改善达到50％的受试者比例。结果：6周时80％患者达到治疗反应,而安慰剂组仅31％（P〈0．001）;其他各项疗效指标治疗组也有明显的改善。常见不良反应为注射部位皮肤反应。结论：依那西普的安全性和耐受性好,能迅速减轻AS的症状和体征,控制AS患者的病情活动。     

运肠胶囊治疗功能性便秘的多中心随机、双盲、阳性药对照Ⅱ期临床研究

背景：尽管目前已有较多治疗便秘的中药,但尚缺乏多中心随机对照试验来论证其功效。目的：观察运肠胶囊对功能性便秘（气阴两虚兼毒邪内蕴证）的疗效,对其安全性作出评价,并探索运肠胶囊治疗功能性便秘的临床用药剂量。设计、场所、对象和干预措施：采用随机双盲、阳性药物平行对照、多中心临床试验方法,共纳入病例240例,源于四川大学华西医院、成都中医药大学附属医院、江西中医学院附属医院、天津中医学院第一附属医院以及福建省中医药研究院。将240例患者随机分为低剂量组80例、高剂量组80例和对照组80例。低剂量组口服运肠胶囊2粒／次（0．35g／粒）和运肠胶囊模拟剂1粒／次,3次／d;高剂量组口服运肠胶囊3粒／次（0．35g／粒）,3次／d;对照组口服便通胶囊3粒／次（0．35g／粒）,3次／d。疗程均为14d。主要结局指标：观察治疗前后症状、体征变化和不良反应,并进行血、尿、粪常规,肝肾功能及心电图检查。结果：纳入患者240例,脱落病例11例,剔除病例2例,最终进入意向性治疗分析234例。在改善功能性便秘症状方面,全分析集（full analysis set,FAS）示低剂量组愈显率为86．25％（69／80）,高剂量组为82．90％（63／76）,对照组为70．52％（55／78）;符合方案集（per—protocol population set,PPS）示低剂量组愈显率为85．71％（66／77）,高剂量组为83．56％（61／73）,对照组为70．13％（54／77）;3组疗效比较差异无统计学意义（P〉0．05）。在改善中医证候方面,FAS示低剂量组的愈显率为78．75％（63／80）,高剂量组为69．74％（53／76）,对照组为67．95％（53／78）;PPS示低剂量组的愈显率为77．929／6（60／77）,高剂量组为69．87％（51／73）,对照组为67．53％（52／77）;3组疗效比较差异无统计学意义（P〉0．05）。未见明显毒副作用和不良反应。结论：运肠胶囊适用于治疗功能性便秘气阴两虚兼毒邪内蕴证,高、低剂量的疗效相当。临床试验中未发现试验药物所致的明显毒副作用和不良反应。     

Exercise plus behavioral management in patients with Alzheimer disease: a randomized controlled trial

Context  Exercise training for patients with Alzheimer disease combined with teaching caregivers how to manage behavioral problems may help decrease the frailty and behavioral impairment that are often prevalent in patients with Alzheimer disease. Objective  To determine whether a home-based exercise program combined with caregiver training in behavioral management techniques would reduce functional dependence and delay institutionalization among patients with Alzheimer disease. Design, Setting, and Patients  Randomized controlled trial of 153 community-dwelling patients meeting National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer Disease and Related Disorders Association criteria for Alzheimer disease, conducted between June 1994 and April 1999. Interventions  Patient-caregiver dyads were randomly assigned to the combined exercise and caregiver training progam, Reducing Disability in Alzheimer Disease (RDAD), or to routine medical care (RMC). The RDAD program was conducted in the patients' home over 3 months. Main Outcome Measures  Physical health and function (36-item Short-Form Health Survey's [SF-36] physical functioning and physical role functioning subscales and Sickness Impact Profile's Mobility subscale), and affective status (Hamilton Depression Rating Scale and Cornell Depression Scale for Depression in Dementia). Results  At 3 months, in comparison with the routine care patients, more patients in the RDAD group exercised at least 60 min/wk (odds ratio [OR], 2.82; 95% confidence interval [CI], 1.25-6.39; P = .01) and had fewer days of restricted activity (OR, 3.10; 95% CI, 1.08-8.95; P<.001). Patients in the RDAD group also had improved scores for physical role functioning compared with worse scores for patients in the RMC group (mean difference, 19.29; 95% CI, 8.75-29.83; P<.001). Patients in the RDAD group had improved Cornell Depression Scale for Depression in Dementia scores while the patients in the RMC group had worse scores (mean difference, -1.03; 95% CI, -0.17 to -1.91; P = .02). At 2 years, the RDAD patients continued to have better physical role functioning scores than the RMC patients (mean difference, 10.89; 95% CI, 3.62-18.16; P = .003) and showed a trend (19% vs 50%) for less institutionalization due to behavioral disturbance. For patients with higher depression scores at baseline, those in the RDAD group improved significantly more at 3 months on the Hamilton Depression Rating Scale (mean difference, 2.21; 95% CI, 0.22-4.20; P = .04) and maintained that improvement at 24 months (mean difference, 2.14; 95% CI, 0.14-4.17; P = .04). Conclusion  Exercise training combined with teaching caregivers behavioral management techniques improved physical health and depression in patients with Alzheimer disease.      

Treatment of complicated grief: a randomized controlled trial

Context  Complicated grief is a debilitating disorder associated with important negative health consequences, but the results of existing treatments for it have been disappointing. Objective  To compare the efficacy of a novel approach, complicated grief treatment, with a standard psychotherapy (interpersonal psychotherapy). Design  Two-cell, prospective, randomized controlled clinical trial, stratified by manner of death of loved one and treatment site. Setting  A university-based psychiatric research clinic as well as a satellite clinic in a low-income African American community between April 2001 and April 2004. Participants  A total of 83 women and 12 men aged 18 to 85 years recruited through professional referral, self-referral, and media announcements who met criteria for complicated grief. Interventions  Participants were randomly assigned to receive interpersonal psychotherapy (n = 46) or complicated grief treatment (n = 49); both were administered in 16 sessions during an average interval of 19 weeks per participant. Main Outcome Measure  Treatment response, defined either as independent evaluator-rated Clinical Global Improvement score of 1 or 2 or as time to a 20-point or better improvement in the self-reported Inventory of Complicated Grief. Results  Both treatments produced improvement in complicated grief symptoms. The response rate was greater for complicated grief treatment (51%) than for interpersonal psychotherapy (28%; P = .02) and time to response was faster for complicated grief treatment (P = .02). The number needed to treat was 4.3. Conclusion  Complicated grief treatment is an improved treatment over interpersonal psychotherapy, showing higher response rates and faster time to response.      

Infliximab monotherapy for Chinese patients with moderate to severe plaque psoriasis: a randomized, double-blind, placebo-controlled multicenter trial

Background  Tumor necrosis factor-α is a key mediator in the pathogenesis of psoriasis. Infliximab is a monoclonal antibody that specifically binds to tumor necrosis factor-α. The purpose of this study was to validate the efficacy and safety of 5 mg/kg infliximab therapy in Chinese patients with moderate to severe plaque psoriasis.

Methods  In this multicenter, double-blind, placebo-controlled trial, 129 patients with moderate-to-severe psoriasis were randomized to the induction therapy (weeks 0, 2 and 6) with infliximab 5 mg/kg (n=84) or placebo (n=45), followed with infliximab 5 mg/kg scheduled at week 14 and week 22 in the infliximab group, and infliximab 5 mg/kg scheduled at weeks 10, 12 and 16 in the placebo group. The primary end point was the proportion of patients who achieved at least 75% improvement in Psoriasis Area and Severity Index (PASI 75 response rate) from baseline at week 10.

Results  At week 10, 81.0% of patients treated with infliximab (5 mg/kg) achieved a 75% or greater improvement compared with 2.2% of patients treated with placebo (P <0.001). A significant improvement in PASI, Physician’s Global Assessment (PGA) and Dermatology Life Quality Index (DLQI), was seen from week 6 through week 14 in the infliximab group compared with the placebo group. Through week 22, PASI, PGA, DLQI were well maintained. The incidence of adverse events for the infliximab treatment group was slightly higher in comparison to the placebo treatment group during the first 10 weeks without statistical significance. However, there were 3 cases of tuberculosis that developed during the 26 weeks treatment with infliximal.

Conclusions  Infliximab treatment was effective as induction and maintenance treatments for Chinese patients with moderate to severe plaque psoriasis. Most drug-induced adverse events were mild to moderate, and well tolerated. Screening for tuberculosis is essential and prophylactic treatment should be given if necessary.

     

Treatment of antidepressant-associated sexual dysfunction with sildenafil: a randomized controlled trial

Context  Sexual dysfunction is a common adverse effect of antidepressants that frequently results in treatment noncompliance. Objective  To assess the efficacy of sildenafil citrate in men with sexual dysfunction associated with the use of selective and nonselective serotonin reuptake inhibitor (SRI) antidepressants. Design, Setting, and Patients  Prospective, parallel-group, randomized, double-blind, placebo-controlled trial conducted between November 1, 2000, and January 1, 2001, at 3 US university medical centers among 90 male outpatients (mean [SD] age, 45 [8] years) with major depression in remission and sexual dysfunction associated with SRI antidepressant treatment. Intervention  Patients were randomly assigned to take sildenafil (n = 45) or placebo (n = 45) at a flexible dose starting at 50 mg and adjustable to 100 mg before sexual activity for 6 weeks. Main Outcome Measures  The primary outcome measure was score on the Clinical Global Impression-Sexual Function (CGI-SF); secondary measures were scores on the International Index of Erectile Function, Arizona Sexual Experience Scale, Massachusetts General Hospital-Sexual Functioning Questionnaire, and Hamilton Rating Scale for Depression (HAM-D). Results  Among the 90 randomized patients, 93% (83/89) of patients treated per protocol took at least 1 dose of study drug and 85% (76/89) completed week 6 end-point assessments with last observation carried forward analyses. At a CGI-SF score of 2 or lower, 54.5% (24/44) of sildenafil compared with 4.4% (2/45) of placebo patients were much or very much improved (P<.001). Erectile function, arousal, ejaculation, orgasm, and overall satisfaction domain measures improved significantly in sildenafil compared with placebo patients. Mean depression scores remained consistent with remission (HAM-D score 10) in both groups for the study duration. Conclusion  In our study, sildenafil effectively improved erectile function and other aspects of sexual function in men with sexual dysfunction associated with the use of SRI antidepressants. These improvements may allow patients to maintain adherence with effective antidepressant treatment.      

参松养心胶囊治疗室性早搏的多中心随机对照研究

目的观察参松养心胶囊治疗不同病因室性早搏(VPB)的疗效与安全性。方法选择心功能NYHAI~III级的VPB患者164例,采用多中心随机对照,按2∶1分为治疗组(108例)和对照组(56例),治疗组口服参松养心胶囊4粒,每日3次;对照组口服慢心律150mg,每日3次,疗程4周。观察2组患者室性早搏的总有效率、症状改善率及安全性。并分析比较有器质性病因VPB亚组和无器质性病因VPB亚组的治疗效果。结果治疗组总有效率为88.9%,症状改善率为93.5%;对照组总有效率为71.4%,症状改善率55.3%,2组比较差异有显著意义(P<0.01)。对无器质性病因的VPB,治疗组对症状改善和早搏次数的控制均优于对照组(分别为91.2%对47.6%,P<0.05;85.3%对57.1%,P<0.05);对有器质性病因的VPB,治疗组对症状的改善优于对照组(94.6%对60.0%,P<0.05)。结论参松养心胶囊对不同病因的室性早搏有明显疗效,且无严重不良反应。     

中医及中西医结合治疗老年单纯收缩期高血压的多中心随机双盲对照临床试验

背景：单纯收缩期高血压（isolated systolic hypertension,ISH）是老年人的常见病,严重危害老年人的健康。中医及中西医结合治疗模式在改善老年ISH患者生活质量以及保护靶器官等方面具有一定优势,但需要进一步的循证医学研究。目的：观察中医（降压胶囊）及中西医结合（降压胶囊联合尼莫地平）治疗模式对老年ISH患者血压、血管活性物质的影响及其安全性。设计、场所、受试者和干预措施：采用多中心、随机双盲、阳性对照的试验设计。按标准入选中国中医科学院西苑医院、北京延庆县中医院及延庆社区卫生服务中心的老年ISH患者270例,采用随机区组法分为中医组（降压胶囊联合尼莫地平模拟药）、中西医结合组（降压胶囊联合尼莫地平）和西医组（尼莫地平联合降压胶囊模拟药）,每组各90例。疗程为4周。主要结局指标：观察各组治疗后诊室血压和动态血压水平,血管活性物质如内皮素-1（endothelin-1,ET-1）、一氧化氮（nitric oxide,NO）、血栓素B_2（thromboxane B_2,TXB_2）和6-酮-前列腺素1α（6-ketoprostaglandin1α,6-keto-PGF1α）水平的变化,并评价其安全性。结果：治疗结束后,中医组脱落10例（80例完成试验）,中西医结合组脱落14例（76例完成试验）,西医组脱落5例（85例完成试验）。治疗后各组收缩期血压值低于治疗前,差异均有统计学意义（P〈0.05）,中西医结合组收缩期血压明显低于中医组或西医组（P〈0.05）。治疗后各组24 h平均收缩压及昼间平均收缩压明显降低,中西医结合组夜间平均收缩压亦明显降低,与治疗前比较,差异有统计学意义（P〈0.05）;中西医结合组24 h平均收缩压和昼间平均收缩压低于中医组和西医组（P〈0.05）。治疗后各组患者血清NO、血浆6-keto-PGF1α水平均升高,而血浆ET-1和TXB_2水平降低（P〈0.05）,且中西医结合疗法对降低血浆TXB_2含量的作用明显优于中医或西医疗法（P〈0.05）。结论：中医及中西医结合治疗模式应用于老年ISH患者的疗效肯定,安全性高,且中西医结合治疗模式在降压及相关指标改善等方面具有明显协同增效的优势,值得进一步研究。     

阿莫罗芬甲搽剂联合口服伊曲康唑与联合口服特比萘芬治疗甲真菌病的疗效观察

目的:探讨甲真菌病采用阿莫罗芬甲搽剂与伊曲康唑口服联合治疗和与特比萘芬口服联合治疗效果展开对比。方法:选取甲真菌病100例,随机分组,分别为阿莫罗芬甲搽剂与伊曲康唑联用组(A组,n=50)和特比萘芬口服联用组(B组,n=50),研究两组效果对比。结果:A组近期痊愈率为26%,远期痊愈率为86%;B组近期痊愈率为24%,远期痊愈率为60%,远期痊愈率比较,差异有统计学意义(P<0.05);A组真菌清除率为86%,B组为70%。两组均无严重不良事件发生。结论:甲真菌病采用阿莫罗芬甲搽剂与伊曲康唑口服联用,可获得理想的临床效果,真菌清除率较高,具有非常重要的应用价值,可显著改善患者生存质量。     

Treatment of acne vulgaris with a pulsed dye laser: a randomized controlled trial

Context  The high prevalence of acne vulgaris and its significant morbidity underscore the need for convenient, low-risk, and efficacious therapy. Treatment with various lasers has been reported to improve acne. Objective  To evaluate the clinical efficacy of pulsed dye laser therapy in the treatment of acne. Design, Setting, and Patients  Randomized, single-blind, controlled, split-face clinical trial of a volunteer sample of 40 patients aged 13 years or older with facial acne conducted at an academic referral center from August 2002 to September 2003. Intervention  One or 2 nonpurpuric pulsed dye laser treatments to half of the face (fluence of 3 J/cm²), serial blinded clinical assessments (lesion counts), and grading of acne severity using standardized bilateral serial photographs. Main Outcome Measures  Comparison of the changes in lesion counts from baseline to 12 weeks between treated and untreated sides of the face and changes in photographic evidence of acne severity as graded by a panel of dermatologists blinded to treatment assignment. Results  After 12 weeks, using intent-to-treat analysis with last observation carried forward, there were no significant differences between laser-treated and untreated skin for changes in mean papule counts (–4.2 vs –2.2; P = .08), mean pustule counts (0 vs –1.0; P = .12), or mean comedone counts (2.9 vs 1.6; P = .63). Grading of serial photographs confirmed the clinical assessments, showing no significant mean (SE) differences in Leeds scores (range, 1-12) for treated skin (3.98 [0.32] at baseline and 3.94 [0.27] at week 12) compared with untreated skin (3.83 [0.32] at baseline and 3.79 [0.28] at week 12) (P>.99). Conclusions  In this study, the nonpurpuric pulsed dye laser therapy did not result in significant improvement of facial acne. More research is needed before this laser therapy may be recommended as an acne treatment.      

补肾益髓法治疗β地中海贫血的平行对照临床研究

目的:研究补肾益髓代表方益髓生血颗粒治疗β地中海贫血的临床效果及安全性。方法:采用随机、单盲和安慰剂平行对照进行60例患者临床观察,疗程3个月,观察治疗前后症状、血红蛋白、红细胞、胎儿血红蛋白、网织红细胞水平变化和肝、脾B超。结果:治疗组患者自疗程第1个月起至第3个月结束,各项血液学参数(血红蛋白、红细胞、胎儿血红蛋白、网织红细胞)均有提高,与治疗前相比,差异有统计学意义(P<0.01);肝脾肿大缓解(P<0.05);中医临床症状改善及动态观察与血液参数提高一致(P<0.01);未见副作用。安慰剂组患者各项血液指标及中医证候治疗前后无明显改善,肝脾肿大未见缓解(P>0.05)。结论:益髓生血颗粒治疗β地中海贫血疗效显著,未见毒副作用。     

肛裂切除黏膜下移术治疗陈旧性肛裂的前瞻性多中心随机对照试验

背景：肛裂是常见肛肠科疾病之一,约10%陈旧性肛裂患者最终需要手术治疗。如何通过技术改良减轻手术痛苦和预防功能损伤是肛肠外科医师关注的热点。目的：评价肛裂切除黏膜下移术治疗陈旧性肛裂的疗效和安全性。设计、场所、对象和干预措施：采用前瞻性、多中心、随机、对照临床试验设计方案,纳入2009年1月～2010年4月来自上海中医药大学附属岳阳中西医结合医院和上海市中医医院、上海交通大学医学院附属第九人民医院肛肠科住院的陈旧性肛裂患者120例,采用各分中心随机分层,随机分为试验组（肛裂切除黏膜下移术）和对照组（肛裂切除术）各60例。两组均采取手术治疗,术后观察期为2周,短期随访6周。主要结局指标：以治愈率、创面愈合时间和临床症状为主要观察指标,观察术后并发症以及手术前后肛管张力变化进行安全性评价。结果：3例患者（试验组1例,对照组2例）因术后1周内提早出院而退出试验。术后第6周,试验组疗效优于对照组（P〈0.05）。试验组创面愈合时间为（17.22±4.41）d,对照组为（21.24±7.44）d,两组比较差异有统计学意义（P〈0.05）。术后第3天、第14天和第6周时试验组肛门疼痛程度轻于对照组（P〈0.05）;术后第3天和第14天,试验组肛门出血情况优于对照组（P〈0.05）,术后6周试验组与对照组出血情况比较,差异无统计学意义（P=0.051）。术后两组肛管张力比较,差异无统计学意义（P〉0.05）。术后2周内两组患者并发症（排尿障碍、创缘水肿、术后发热、术后感染、肛门失禁、肛门变形）比较,差异无统计学意义（P〉0.05）。两组均随访6周,所有随访患者未见术后并发症,未见复发。结论：陈旧性肛裂患者采用肛裂切除黏膜下移术能提高手术疗效,缩短疗程,改善患者术后痛苦,同时具有较好的安全性。     

盐酸非索非那定胶囊治疗季节性变应性鼻炎多中心双盲对照临床试验

目的：评价盐酸非索非那定胶囊治疗季节性变应性鼻炎的有效性和安全性。方法：采用多中心、随机、双盲、双模拟、阳性药物平行对照临床试验方法，随机分为试验组和对照组。试验组口服盐酸非索非那定胶囊(60?mg/粒)，对照组口服二盐酸西替利嗪(10?mg/粒)，每天早、晚各1次，连续服用2周。用药后第1周、第2周随访，2周末评价疗效与不良反应。结果：入组140例，试验组71例，对照组69例。完成137例，脱落3例，其中试验组2例，对照组1例；可评价疗效与安全性例数分别为137例和140例。试验组和对照组的总有效率分别为66.20%和68.12%，不良反应的发生率组间比较差异无统计学意义（P＞0.05）。结论：盐酸非索非那定胶囊治疗季节性变应性鼻炎疗效可靠，使用安全，与二盐酸西替利嗪相当。