西尼地平治疗轻、中度原发性高血压病人的疗效和安全性

目的 :观察西尼地平治疗轻、中度原发性高血压病人的降压疗效和安全性。方法 :采用随机、双盲、平行对照试验设计。经过 2wk安慰剂洗脱后 ,筛选轻、中度高血压病病人 4 8例。分为A组 2 4例 ,给西尼地平 5mg加苯磺酸氨氯地平模拟片 ,po ,qd ;B组 2 4例 ,为苯磺酸氨氯地平 5mg加西尼地平模拟片 ,po ,qd。 4wk末如达目标血压 (坐位舒张压≤ 12kPa) ,继续服用至 8wk末 ,否则剂量加倍服用至 8wk末。结果 :2组总有效率分别为 75 %和 83% ,2组收缩压降低幅度分别为 (0 .2 6±s 0 .16 )kPa和 (0 .31± 0 .16 )kPa ,舒张压降低幅度分别为 (0 .2 1± 0 .11)kPa和 (0 .2 4± 0 .0 8)kPa(均P <0 .0 1)。不良反应 2组无显著差异。结论 :西尼地平治疗对轻、中度原发性高血压病人有效、安全     

吡格列酮治疗2型糖尿病的双盲、随机、平行对照多中心临床研究

目的 :观察吡格列酮对 2型糖尿病病人血糖控制的疗效和安全性。方法 :多中心、随机双盲、安慰剂平行对照的为期 12wk试验。吡格列酮组12 0例 ,安慰剂组 12 0例。结果 :吡格列酮组空腹和餐后 2h血糖治疗后较前皆明显下降 :(1.5±s1.8)mmol·L- 1和 (2 .2± 2 .8)mmol·L- 1(P <0 .0 1) ,糖化血红蛋白从 (7.5± 1.2 ) %下降至 (6 .7± 1.3) %。而安慰剂组则从 (7.3± 1.4 ) %上升至(7.6± 1.2 ) % ,2组间存在非常显著差异 (P <0 .0 1)。但 2组治疗前后的空腹及餐后 2h胰岛素变化无显著差异 (P >0 .0 5 )。吡格列酮组的HDL明显高于安慰剂组 (P <0 .0 5 ) ,而TG/HDL比值则无显著差异 (P >0 .0 5 )。吡格列酮组和安慰剂组的不良反应发生率分别为 6 .0 %和 4 .4 % ,2组间无显著差异 (P >0 .0 5 )。结论 :吡格列酮有良好的降糖作用 ,还可改善脂代谢 ,而且不良反应较低     

维胺酯2种给药方案治疗寻常痤疮44例

目的 :观察维胺酯不同剂量治疗痤疮的疗效和安全性 ,探索有效治疗方案。方法 :将 4 4例中、重度寻常痤疮病人分为 2组 ,A组 2 4例 ,总疗程 6mo ,分别在mo 1～ 2按 1mg·kg- 1·d- 1;在mo 3～ 4按 2 5mg ,qd ;在mo 5～ 6按 2 5mg ,qod的剂量口服。B组 2 0例 ,5 0mg ,tid ,总疗程 6wk。结果 :2组总累积量A组为 (6 14 3±s 5 71)mg ,B组为 6 30 0mg ;治疗后临床评分分别为 (7.7± 1.7)分vs(7.7±1.6 )分 ;基本痊愈率分别为 5 4%vs 5 0 % ,差异均无显著意义 (P >0 .0 5 )。日剂量分别为 (0 .5 3±0 .0 3)mg·kg- 1·d- 1vs (2 .4± 0 .3)mg·kg- 1·d- 1、不良反应率为 8%vs 4 0 % ;复发率 12 %vs4 5 % ,差异均有显著意义 (P <0 .0 5或P <0 .0 1)。结论 :应用维胺酯低剂量长疗程治疗寻常痤疮 ,疗效好 ,安全性高 ,复发率低。     

0.75%甲硝唑凝胶和安慰剂治疗酒渣鼻临床疗效及安全性评估

目的观察0.75%甲硝唑凝胶治疗酒渣鼻临床疗效和安全性.方法采用随机双盲、安慰剂对照、平行分组、多中心临床试验,每天外用2次,疗程12周.在治疗前,治疗第4,8和12周进行观察.结果共156例患者入选,甲硝唑组和安慰剂组各78例.在治疗的第4,8,12周,甲硝唑组对炎性损害(丘疹和脓疱的总和)计数减少均明显优于安慰剂组(P＜0.001).对炎性损害较治疗前减少百分数,在治疗的第4周甲硝唑组为40.9%,安慰剂组为10.7%;在第8周分别为61.0%和32.7%;在第12周分别为65.4%和40.5%.在治疗的第4,8,12周,对红斑严重性程度改善甲硝唑组与安慰剂组比较统计学上均无显著性差异(P＞0.05).在治疗的第12周,总体疗效评估甲硝唑组有效率为56.1%,优于安慰剂组37.9%(P＜0.05).甲硝唑组不良反应发生率为17.9%,安慰剂组为19.2%,均表现为皮肤局部刺激性皮炎,以轻中度为主.结论0.75%甲硝唑凝胶治疗酒渣鼻疗效肯定,安全性高,是治疗酒渣鼻的良好选择.     

兰索拉唑与奥美拉唑治疗消化性溃疡的比较

目的 :观察兰索拉唑对消化性溃疡的疗效并与奥美拉唑进行比较。方法 :64例经内镜确诊的消化性溃疡病人分为 2组。兰索拉唑组 36例 (男性2 8例 ,女性 8例 ,年龄 4 1±s 8a)用兰索拉唑 30mg ,po ,qm× 4wk ;奥美拉唑组 2 8例 (男性 2 2例 ,女性 6例 ,年龄 4 2± 10a)以奥美拉唑 2 0mg ,po ,qm× 4wk。结果 :2组在溃疡愈合率 ( 89%vs90 % )、总有效率 ( 94 %vs 93% )和d 7腹痛缓解率( 97%vs 96% )均无显著差异 (P均 >0 .0 5)。但d 3腹痛缓解率兰索拉唑组显著高于奥美拉唑组 ( 83%vs 71% ,P <0 .0 5)。 2组不良反应均轻微。结论 :兰索拉唑对消化性溃疡有良好疗效     

左旋氨氯地平和氨氯地平对高血压病人内皮功能及血清胆固醇影响

目的 :比较左旋氨氯地平及氨氯地平对原发性高血压 (EH)病人血管内皮功能及血清胆固醇的影响。方法 :将 6 0例EH病人随机分为 2组A组 ,用左旋氨氯地平 2 .5mg ,po ,qd ;B组用氨氯地平 5mg ,po ,qd。并设健康对照组 ,不用任何药物。6wk后测量结果 ,将 2药交叉继续用药 6wk复测各数值。对内皮功能与高血压危险分层进行相关分析。结果 :应用 2药 6wk ,2组肱动脉反应性充血时内径变化率 (FMD)较治疗前有明显改善 ,分别为(4±s 4 ) %vs (6± 7) % (P <0 .0 1) ,(3± 4 ) %vs(6± 8) % (P <0 .0 1) ,2组间比较无显著差异 (P >0 .0 5 ) ,2药交叉治疗后结果不变。 2组治疗后 12wk血清胆固醇水平下降。FMD(% )与病人高血压危险分层间呈负相关。结论 :左旋氨氯地平与氨氯地平均可改善高血压病人内皮功能 ,效果相似。 2药可轻度降低血清胆固醇。内皮功能随高血压危险分层增高而降低     

缬沙坦对高血压病的疗效及其对肱动脉内皮功能的影响

目的 :观察缬沙坦对原发性高血压病人的降压疗效及其对肱动脉内皮功能的影响。方法 :35例高血压病病人 (治疗组 )应用缬沙坦 80mg ,po ,qd× 30wk。 2 2例健康志愿者为对照组。采用多普勒超声血管显象法测定 2组肱动脉血流调节的扩血管反应 (FMD)和硝酸甘油诱发的扩血管反应 (NMD)。结果 :治疗组应用缬沙坦后 2wk显著降压 (P <0 .0 1) ,4～ 6wk进一步降压 ,至 30wk持续平稳降压 (P <0 .0 1) ,降压总有效率 2wk为 5 1% ,30wk达 80 % ;治疗组FMD和NMD显著低于对照组[(6±s 5 ) %vs(18± 7) % ,(17± 9) %vs (2 8±11) % ,P <0 .0 1],治疗组应用缬沙坦后FMD与用药前比较显著提高 (P <0 .0 1) ,但仍低于对照组(P <0 .0 1)。结论 :缬沙坦具有降压和改善FMD ,恢复动脉内皮功能 ,预防动脉粥样硬化的作用     

伊贝沙坦与苯那普利治疗原发性高血压的疗效比较

目的 :用 2 4h动态血压监测 (ABPM)的方法 ,比较伊贝沙坦 (Irb)与苯那普利 (Ben)治疗原发性高血压的疗效。方法 :70例 2 4h平均舒张压 (DBP)≥ 85 m m Hg的原发性高血压患者。经 1wk药物洗脱期、2 wk安慰剂期后 ,随机服用 Irb15 0 mg/d,qd或 Ben10 m g/ d,qd。 4wk末坐位 DBP≥ 90 m m Hg者剂量分别加量至 Irb30 0 mg/ d,qd或 Ben2 0 mg/ d,qd,继续服用4wk。分别观察安慰剂期末和 8wk末的 2 4h ABPM值和实验室检查值的变化。结果 :8wk末 Irb组 2 3例中需服 30 0 mg者占 75 % ,Ben组 2 5例中需服 2 0 mg占 85 %。 2组用药后各时点血压均较治疗前降低 ,且可保持血压的昼夜节律。 SBP/ DBP下降值在 2 4h、日间 (6 :0 0～ 2 2 :0 0 )、夜间 (2 2 :0 0～ 6 :0 0 ) Irb组分别为 (16 .2± 11.8) / (10 .0± 7.9)、(18.2± 6 .2 ) / (11.6± 4.5 )、(11.8± 4.0 ) / (7.0± 2 .7) mm Hg;Ben组分别为 (9.9± 10 .4) / (5 .1± 5 .7)、(11.1± 3.4) / (6 .3± 2 .9)、(4 .6± 4.9) / (2 .8±4.1) mm Hg。DBP下降值组间比较 P<0 .0 5 ;SBP下降值组间比较 P>0 .0 5。 2组降压 T/ P均大于 5 0 %。Ben组咳嗽发生率9% ,而 Irb组无。结论 :Irb降压幅度好于 Ben。两药降压的同时均不影响血压昼夜节律 ,降压 T/ P满意     

西布曲明胶囊治疗单纯性肥胖

目的 :观察西布曲明胶囊治疗单纯性肥胖症的疗效及安全性。方法 :1 3 9例单纯性肥胖病人随机分为 2组。西布曲明组 69例 ,口服西布曲明胶囊 1 0～ 2 0mg ,qd× 2 4wk。安慰剂组 70例 ,口服模拟胶囊 ,用法同西布曲明组。西布曲明组和安慰剂组完成试验者分别为 61例、5 9例。结果 :治疗 2 4wk后 ,西布曲明组体重减轻 (4±s 4)kg ,体重指数(BMI)下降 (1 .8± 1 .8)kg·m-2 ,安慰剂组体重、BMI分别增加 (0 .6± 3 )kg和 (0 .2± 1 .2 )kg·m-2 ,2组比较差异有非常显著意义 (P <0 .0 1 )。西布曲明组不良反应主要为口干、厌食等 ,发生率为 3 4% ,高于安慰剂组 (1 0 % ) ,P <0 .0 1 ,但无严重不良反应发生。结论 :西布曲明胶囊能有效降低单纯性肥胖病人的体重 ,安全性较好     

外用1%双氯芬酸钾凝胶治疗骨关节炎的临床疗效

目的 :探讨 1%的双氯芬酸钾凝胶 (DPG )局部外用治疗骨关节炎 (OA)的疗效和安全性。方法 :用随机、双盲、多中心平行性临床研究方法 ,将12 0例膝关节OA病人随机分为 2组 ,分别局部外用 1%DPG和 1%的双氯芬酸钠凝胶 (DSG) ,疗程2wk ,观察疗效和不良反应。结果 :1%DPG和1%DSG均能明显改善OA的多种临床指标 ,经治疗 1wk时DPG组和DSG组的总有效率分别为6 8%和 6 0 % (P >0 .0 5 ) ,2wk时分别为 77%和72 % (P >0 .0 5 ) ;镇痛起效时间DPG组和DSG组分别为 (12 6± 30 )min和 (146± 33)min (P <0 .0 5 )。不良反应发生率DPG和DSG组分别为 5 %和 3% (P >0 .0 5 )。结论 :外用 1%DPG治疗OA安全有效 ,且耐受性好 ,其起效时间较外用 1%DSG短     

Combined effect of anti-inflammatory dose doxycycline (40-mg doxycycline, usp monohydrate controlled-release capsules) and metronidazole topical gel 1% in the treatment of rosacea

Research into the pathophysiology of rosacea suggests a central role for inflammatory mediators such as nitric oxide (NO), reactive oxygen species (ROS), and matrix metalloproteinases (MMPs). Effective treatments for rosacea, including topical metronidazole and systemic antibiotics, have anti-inflammatory activity, which may be more important than their antimicrobial activity in this setting. Phase III studies have substantiated the efficacy of anti-inflammatory dose doxycycline (40-mg doxycycline monohydrate controlled-release capsules) administered once daily for the treatment of inflammatory lesions of rosacea. Results of a 16-week, randomized, double-blind, placebo-controlled study of anti-inflammatory dose doxycycline plus topical metronidazole gel 1% for mild to moderate rosacea are presented here. At week 12, metronidazole was discontinued and patients continued on either placebo or doxycycline. Combination therapy significantly reduced inflammatory lesion counts as early as week 4 and through week 12 compared to topical metronidazole 1% gel monotherapy. The combined therapy appeared effective and well-tolerated.     

Evaluation of topical metronidazole gel in acne rosacea

Topical metronidazole gel (0.75%) was compared to placebo gel in a randomized, double-blind, placebo-controlled, split-face clinical trial for the treatment of 59 patients with acne rosacea. Statistically significant differences in inflammatory lesions, erythema, and global assessments were seen at three, six, and nine weeks post-baseline in favor of the active treatment side. It did not, however, alter the telangiectatic component of the disease. No known drug-related side effects were detected, and the low topical dose along with low serum levels of metronidazole indicate a high safety profile for this therapeutic agent. This work suggests that metronidazole gel, as specifically formulated, is safe and effective in reducing the symptomatology of acne rosacea.     

Managing rosacea: a review of the use of metronidazole alone and in combination with oral antibiotics

BACKGROUND: Rosacea is an extremely common chronic dermatosis affecting an estimated 14 million Americans. Rosacea is most commonly managed with topical metronidazole, sometimes in combination with oral antibiotics. PURPOSE: To review published studies about topical metronidazole therapy for rosacea, both as a monotherapy and in conjunction with oral antibiotics. METHODS: Medline searches were conducted for clinical trials using metronidazole, tetracycline, and doxycycline for rosacea. RESULTS: Topical metronidazole has been well studied as a rosacea therapy. Twice-daily dosing of metronidazole 1.0% cream is as effective as 250 mg tetracycline twice daily. Metronidazole 1.0% gel used once daily is as effective as azelaic acid 15% gel dosed twice daily. When dosed at subantimicrobial levels, doxycycline 20 mg taken twice daily is effective in decreasing inflammatory lesions and erythema associated with rosacea. Metronidazole 0.75% lotion is more effective when used in combination with doxycycline 20 mg dosed twice daily. DISCUSSION: Metronidazole in 0.75% strength lotion, cream, and gel and 1.0% metronidazole cream and gel are all efficacious in treating rosacea. Combination treatment with oral antibiotics at both antimicrobial and subantimicrobial doses is an efficacious means of treating rosacea. Maintenance treatment with topical metronidazole decreases relapses and allows for longer intervals between flares.     

依普罗沙坦与氯沙坦在轻中度原发性高血压病人中的降压疗效比较

目的:以氯沙坦为对照,观察依普罗沙坦治疗轻、中度原发性高血压(EH)病人的疗效与安全性。方法:采用前瞻性、随机、双盲、阳性药对照研究。符合方案的50例轻、中度EH病人经筛选期(2 wk)、安慰剂导入期(2 wk)后,随机分为依普罗沙坦组(n=24)与氯沙坦组(n=26)。在治疗期,2组病人分别每日1次口服依普罗沙坦600 mg或氯沙坦50 mg。若4 wk血压不达标,即坐位舒张压(DBP)≥90 mmHg (1 mmHg=0．133 3 kPa),加氢氯噻嗪12．5 mg,每日1次口服至8 wk。观察治疗前、治疗后4 wk与8 wk血压、心率以及治疗前后血、尿常规,血生化及心电图改变。结果:在治疗后8 wk,依普罗沙坦组的收缩压(SBP)与DBP分别下降了(12±s 10)mmHg与(12±5)mmHg,氯沙坦组的降压幅度分别为(14±9)mmHg与(10±6)mmHg,治疗前后比较有非常显著差异(P<0．01);但2组间血压下降的幅度无显著差异(P>0．05)。依普罗沙坦组与氯沙坦组的降压总有效率分别为100％和8l％,2组疗效无显著差异(P>0．05)。依普罗沙坦组加用氢氯噻嗪病例为9例(38％),而氯沙坦组为6例(23％),p> 0．05。2组心率及血液生化检查结果,治疗前后变化均无显著意义(P>0．05),均无严重不良反应发生。结论:依普罗沙坦与氯沙坦均能有效降低轻、中度EH病人的血压,疗效相似,都具有良好的安全性。     

Topical metronidazole combination therapy in the clinical management of rosacea

Metronidazole was the first topical agent approved by the U.S. Food and Drug Administration for the treatment of rosacea. Several controlled studies have confirmed the efficacy and safety of topical metronidazole 0.75% gel, lotion and cream and 1% cream for rosacea. At present, little data exists regarding the use of combination topical therapy in rosacea management, although anecdotal evidence and preliminary studies suggest at least some additive benefit when topical metronidazole is used in combination with sulfacetamide 10% /sulfur 5%. In this paper, the results of observational experience evaluating topical metronidazole 0.75% gel used in combination with other topical rosacea therapies and/or subantimicrobial dose doxycycline are reported.     

Topical metronidazole: a new therapy for rosacea

The chemistry, mechanism of action, pharmacokinetics, and adverse effects of topically applied metronidazole are reviewed, and the drug's use and efficacy in the treatment of rosacea and other conditions are discussed. Metronidazole is a synthetic, nitroimidazole-derivative antibacterial and antiprotozoal agent. For topical use, metronidazole is available in the United States as an aqueous gel. Polar reduction products of the drug appear to be responsible for its antimicrobial effects, which include disruption of DNA. The mechanism by which metronidazole ameliorates the lesions and erythema of rosacea may be related to anti-inflammatory or immunosuppressive actions of the drug rather than to suppression of skin bacteria. Metronidazole does not seem to be appreciably absorbed after topical application to the skin. Little is known about the distribution and elimination of topically applied metronidazole. Topical metronidazole has been designated an orphan drug by the FDA for the treatment of rosacea. In clinical studies metronidazole 0.75% topical gel or 1% cream resulted in improvement in inflammatory lesions in 68-96% of patients. Like other currently available therapies, metronidazole is only palliative; when the drug is withdrawn, symptoms commonly recur. Topical metronidazole has been used with some success in the treatment of decubitus and other ulcers and in certain dental conditions. The drug seems to have low toxicity and generally is well tolerated when applied topically. The principal adverse effects are local reactions, such as burning and stinging. Topical metronidazole provides another option for the treatment of rosacea.     

Efficacy of 1% terbinafine cream in comparison with 0.75% metronidazole gel for the treatment of papulopustular rosacea

Background: Topical antifungals comprising imidazole derivatives have been used for the treatment of rosacea previously, owing to their anti-inflammatory activities. Terbinafine, an antifungal agent belongs to allylamine group, has also anti-inflammatory effects. Currently, there are only a few unpublished studies, in which terbinafine has been used systemically for rosacea treatment.

Aims: In this single-blind, 8-week study, we investigated the potential efficacy and safety of terbinafine 1% cream for the treatment of mild and moderate papulopustular rosacea, and compared the results with those of 0.75% metronidazole gel.

Patients/methods: Forty patients, 30 females and 10 males, with papulopustular rosacea were enrolled into the study between 2006 and 2007 years. Twenty of the patients were instructed to apply 1% terbinafine cream, whereas others patients of the study population were instructed to use 0.75% metronidazole gel. A total of 32 patients completed the study. Pre-treatment and post-treatment total severity score (TSS) of the disease were determined by assessing the severity of erythema/telangiectasia, and the number of papules/pustules of the whole face. The overall response rates, differences of pre-/post-treatment scores of each criterium and the percentages of the decrease in TSS of the study groups were compared statistically.

Results: There was no statistically significant difference between the groups in terms of age, sex, and disease duration (P = 0.937, 1.000, and 0.055, respectively). No significant difference was found between the mean post-treatment TSSs of the two groups (P = 0.605). The percentage of clearance assessed by the differences between pre-treatment and post-treatment TSSs was 55% in terbinafine group, although the percentage was 45% in metronidazole group, with no statistically significant difference between the groups (P = 0.496). Local side effects including erythema, pruritus, and burning were mild and transient in both groups, with similar frequencies (P = 0.101).

Conclusion: This preliminary study suggests that 1% terbinafine cream is an effective and safe treatment for papulopustular rosacea, and can be an option for patients who cannot tolerate other modalities.     

氯氟乙酯(25例)和地西泮(23例)治疗焦虑障碍的疗效和安全性比较

目的 :评价氯氟乙酯治疗焦虑障碍的疗效和安全性。方法 :采用双盲、双模拟、随机、平行对照研究。完成 4wk治疗的病人共 4 8例。其中试验组 (氯氟乙酯组 ) 2 5例 ,对照组 (地西泮组 ) 2 3例。试验组早、午餐后服氯氟乙酯安慰剂及地西泮安慰剂各 1片 ,晚餐后服氯氟乙酯 2mg及地西泮安慰剂各 1片 ;对照组早、午、晚餐后服氯氟乙酯安慰剂及地西泮 2 .5mg各 1片 ,疗程为 4wk。结果 :治疗 4wk后 ,试验组的HAMA总分显著降低 ,HAMA减分率达 (5 9± 2 5 ) % ,临床总有效率达72 % ,与对照组相比无显著意义 (P >0 .0 5 )。试验组的不良反应的发生率为 8% ,与对照组相比无显著意义 (P >0 .0 5 )。结论 :氯氟乙酯治疗焦虑障碍的疗效 ,与地西泮相似 ,无明显不良反应。     

氯氟乙酯(21例)和地西泮(22例)治疗焦虑障碍的疗效和安全性比较

目的 :评价氯氟乙酯与地西泮治疗焦虑障碍的疗效和安全性。方法 :采用双盲、双模拟、随机、平行对照研究。完成 4wk治疗的病人共 4 3例。其中试验组 (氯氟乙酯组 ) 2 1例于早、午餐后服氯氟乙酯安慰剂及地西泮安慰剂各 1片 ,晚餐后服氯氟乙酯 2mg及地西泮安慰剂各 1片 ,对照组(地西泮组 ) 2 2例于早、午、晚餐后服氯氟乙酯安慰剂及地西泮 2 .5mg各 1片 ,疗程均为 4wk。结果 :治疗 4wk后 ,试验组的HAMA总分显著降低 ,HAMA减分率达 (6 6± 10 ) % ,临床总有效率达95 % ,与对照组相比无显著意义 (P >0 .0 5 )。试验组的不良反应的发生率为 14 % ,与对照组相比无显著意义 (P >0 .0 5 )。结论 :氯氟乙酯治疗焦虑障碍有明显疗效 ,无明显不良反应。