克林霉素磷酸酯外用溶液剂联合重组人表皮生长因子凝胶外用治疗轻中度痤疮疗效观察

目的：探讨克林霉素磷酸酯外用溶液剂联合重组人表皮生长因子凝胶外用治疗轻中度痤疮疗效.方法：将80例患者随机分为两组,治疗组40例采用克林霉素磷酸酯外用溶液剂涂擦皮损处,早晚各1次,重组人表皮生长因子凝胶外用皮损处,每日中午1次;对照组40例采用克林霉素磷酸酯外用溶液剂外涂皮损处,早晚各1次.8周后进行疗效判断.结果：治疗组和对照组总有效率分别为92.5％和82.5％,痊愈率分别为45％和30％,差异均有统计学意义（P＜0.05）.结论：克林霉素磷酸酯外用溶液剂联合重组人表皮生长因子凝胶治疗轻中度痤疮疗效优于单用克林霉素磷酸酯外用溶液剂.     

The safety and efficacy of clindamycin phosphate foam 1% versus clindamycin phosphate topical gel 1% for the treatment of acne vulgaris

Clindamycin phosphate is the most widely used topical antibacterial agent for acne treatment. Treatment of patients with mild to moderate acne vulgaris with a new foam formulation (clindamycin foam, CF) for 12 weeks was at least as effective as clindamycin gel (CG) based on the Investigator's Static Global Assessment (ISGA) score. CF was superior to CG based on the reduction from baseline in total (P = .0014), inflammatory (P = .0478), and noninflammatory (P = .0037) acne lesion counts. Additionally, CF achieved efficacy that was superior to that of vehicle foam based on ISGA score (P = .0025) and all 3 lesion counts (all P < .05). Adverse experiences in the active treatment groups were mild or moderate and transient in nature. Thus the foam formulation of clindamycin is a safe and effective acne treatment; the unique foam delivery vehicle may offer cosmetic benefits to the patient and thus increase compliance.     

Combination of azelaic acid 5% and clindamycin 2% for the treatment of acne vulgaris

Context and objective: Acne vulgaris, an inflammatory skin disease with different clinical appearances, is a common problem in most adolescents. It seems that using combinations of topical agents can decrease resistance to the treatment and improve the efficacy. Therefore, we evaluated the effects of azelaic acid (AA) 5% and clindamycin (Clin) 2% combination (AA-Clin) on mild-to-moderate acne vulgaris.

Materials and methods: The efficacy and safety of 12-week treatment with AA-Clin in patients with mild-to-moderate facial acne vulgaris were evaluated by a multicenter, randomized, and double-blind study. A total of 88 male and 62 female patients were randomly assigned to one of these treatments: AA 5%, Clin 2%, and combination of them. Every 4 weeks, total inflammatory and noninflammatory lesions were counted, acne severity index (ASI) was calculated, and patient satisfaction was recorded.

Results: Treatment for 12 weeks with combination gel significantly reduced the total lesion number compared with baseline (p?<?0.01), as well as Clin 2% or AA 5% treatment groups (p?<?0.05 or p?<?0.01). The percentage of reduction in ASI in combination treated group (64.16?±?6.01) was significantly more than those in the Clin 2% (47.73?±?6.62, p?<?0.05) and 5% AA (32.46?±?5.27, p?<?0.01) groups after 12 weeks. Among the patients in the AA-Clin group, 75.86% of males were satisfied or very satisfied and 85.71% of females were satisfied or very satisfied. This trend was significant in comparison to the number of patients who were satisfied with AA 5% or Clin 2% treatment (p?<?0.01). Seven patients in AA-Clin group (incidence?=?22%) showed adverse effects that were not statistically significant compared to treatment with individual active ingredients.

Discussion and conclusion: The profound reduction in lesion count and ASI by combination therapy with AA-Clin gel in comparison to individual treatment with 5% AA or Clin 2% suggested the combination formula as an effective alternative in treatment of acne vulgaris.     

异维A酸红霉素凝胶联合强脉冲光治疗轻中度痤疮的临床研究

目的探讨轻中度痤疮患者采用异维A酸红霉素凝胶联合强脉冲光治疗的临床效果。方法将94例轻中度痤疮患者随机分为对照组与观察组,每组47例,两组患者均采用异维A酸红霉素凝胶,观察组患者在此基础上联合给予强脉冲光治疗,比较两组患者的临床治疗效果。结果观察组患者治疗后皮损数量、皮疹形态、皮疹类型及皮脂分泌率均明显好于对照组(P<0.05),且治疗4、8、12周后的总有效率高于对照组(P<0.05)。两组患者不良反应发生率比较差异无统计学意义(P>0.05)。结论异维A酸红霉素凝胶联合强脉冲光治疗轻中度痤疮的临床效果较好,且具有良好的安全性。     

西尼地平胶囊治疗轻中度原发性高血压的多中心临床研究

目的:评价西尼地平胶囊治疗轻中度原发性高血压的临床疗效和安全性。方法:采用随机、双盲、平行对照的多中心研究。227例轻中度原发性高血压患者经2周安慰剂洗脱后,随机分入试验组(n=114)或对照组(n=113),分别服用西尼地平胶囊或西尼地平片5mg·d~(-1),治疗2周末坐位舒张压≥90 mmHg者剂量加倍至10 mg·d~(-1)治疗至8周末。于安慰剂洗脱末及治疗2,4,6,8周末测量诊室血压、心率、体征及记录不良反应,试验开始前及结束时进行实验室及心电图检查。结果:203例完成试验,其中西尼地平胶囊组101例,西尼地平片组102例。服药8周后试验组和对照组总有效率分别为78．22%和80．39%,组间比较无统计学差异(P＞0．05)。两组服药后2,4,6,8周坐位收缩压和舒张压与服药前比较均有统计学意义的明显降低(P＜0．05);服药后血压下降幅度组间比较无统计学差异(P＞0．05)。两组血压达标率及剂量加倍情况无统计学差异。两组不良反应轻微,组间比较无显著差异。结论:西尼地平胶囊5～10mg每日一次治疗轻、中度原发性高血压安全有效。     

Study results of benzoyl peroxide 5%/clindamycin 1% topical gel, adapalene 0.1% gel, and use in combination for acne vulgaris

Combination therapy is the standard of care in the management of acne vulgaris. It is essential to treat as many aspects of acne pathogenesis as possible. Due to increasing insensitivity of Propionibacterium acnes to antibiotics, the concomitant use of other topical agents that exhibit other modes of antibacterial and anti-inflammatory activity is integral to the successful treatment of acne. The combination of topical benzoyl peroxide and clindamycin gel has been shown to be more effective than either agent alone. The addition of a topical retinoid may further enhance therapeutic results. This 12-week study evaluated the safety and efficacy of initial topical benzoyl peroxide 5%/clindamycin 1% gel as monotherapy and in combination with adapalene gel versus adapalene gel monotherapy in the management of acne.     

A multicenter efficacy and tolerability evaluation of benzoyl peroxide in a 10% urea vehicle for the treatment of acne vulgaris

BACKGROUND: Acne vulgaris is a common skin disease that affects 70 to 96% of individuals. Topical benzoyl peroxide has been used successfully for acne treatment; however, it may be accompanied by drying and or flaking skin. The addition of a 10% urea to the product excipient is theorized to moisturize the skin due to its humectant properties, aid in the efficacy of benzoyl peroxide due to its keratolytic properties, and effectively combat Propionibacterium acnes due to its antibacterial properties. OBJECTIVE: To assess the efficacy and tolerability of the treatment of acne vulgaris with multiple strengths of benzoyl peroxide in a 10% urea vehicle gel or cream and cleanser. Methods: A multicenter, non-randomized, open-label study in which 1,089 patients with acne vulgaris were enrolled at 133 participating physician office sites. Qualifying and consenting patients were prescribed either 4.5% or 8.5% benzoyl peroxide in a 10% urea vehicle cream or gel and cleanser. Additional medications were permitted during the study with the exception of those containing benzoyl peroxide. The physician assessed lesion counts, both inflammatory and non-inflammatory, at baseline and Week 4. Dryness and erythema were rated by the physician on a scale from 0 (none) to 8 (severe or deep) at baseline and Week 4. RESULTS: Nine hundred sixty-three patients completed the study. The following significant treatment arms were analyzed: patients treated with 4.5%/8.5% benzoyl peroxide in a 10% urea vehicle product only, patients treated with 4.5%/8.5% benzoyl peroxide in a 10% urea vehicle products along with oral doxycycline, and patients treated with 4.5%/8.5% benzoyl peroxide in a 10% urea vehicle products along with oral minocycline. A 44% (n=567) mean reduction in total lesion count was observed after 4 weeks of treatment with 4.5%/8.5% benzoyl peroxide in a 10% urea vehicle products only. Dual therapy using oral doxycycline (n=17) proved to be even more effective with a significant mean reduction in lesion count of 52% after only 4 weeks of treatment. Dual therapy using oral minocycline (n=21) yielded a significant mean reduction in lesion count of 34% after 14 weeks of treatment. The overall tolerability of the treatment illustrated the utility of urea as a moisturizing agent. CONCLUSION: Benzoyl peroxide in a 10% urea vehicle gel or cream and cleanser, used once daily for 4 weeks was found to be both effective and well tolerated for the treatment of symptoms related to acne vulgaris.     

An evaluation of dapsone gel 5% in the treatment of acne vulgaris

Background: Oral dapsone has been available for over 60 years. Its first clinical use was discovered in 1945, when it was found to be efficacious in inhibiting the progression of leprosy. The combined antibacterial and anti-inflammatory pharmacologic activities of dapsone have made it a widely investigated drug, particularly for use in refractory and unusual dermatologic conditions. However, the possibility of significant hematological side effects, even at low doses, has limited its use. Currently, oral dapsone has FDA approval for the treatment of leprosy and dermatitis herpetiformis. The potential of oral dapsone to treat acne vulgaris is well established, but the risks of serious side effects have made it an undesirable drug for use in the relatively healthy acne population. Recently, a topical formulation of dapsone (Aczone^?, Allergan, Inc., Irvine, CA, USA) has been approved by the FDA for the treatment of acne vulgaris. Objective/methods: The aims of this study were to review the published literature on dapsone pharmacology and pharmacokinetics, and to evaluate the gel's efficacy and safety in treating acne vulgaris, and finally to provide personal insight into its future as a topical agent for acne vulgaris. Results/conclusions: Clinical studies indicate dapsone gel 5% is effective in treating mild to moderately severe acne. It is well tolerated, with pharmacokinetic evidence indicating topical dosing in comparison to oral administration significantly reduces systemic concentrations of the drug, and therefore risk of serious side effects. Data suggests that dapsone gel 5% has the potential to become an established topical drug for the treatment of acne vulgaris. However, studies comparing the clinical effectiveness of the dapsone gel 5% to other available topical antiacne drugs are needed as are studies accessing its usefulness and safety when combined with other acne pharmaceuticals.     

红蓝光联合异维A酸治疗中重度痤疮30例临床观察

目的:探讨红蓝光照射联合异维A酸治疗中、重度痤疮的临床疗效和安全性。方法:将入选的60例中、重度痤疮患者随机分为两组,治疗组(30例)予红蓝光联合口服异维A酸治疗,对照组(30例)仅口服异维A酸治疗,比较两组的治疗效果。结果:有效率治疗组为86.7%,对照组为70.0%,差异有统计学意义(P<0.05)。两组均未出现导致治疗终止的严重不良反应。结论:红蓝光联合异维A酸治疗中、重度痤疮疗效好,安全性高。     

Combination of a new radiofrequency device and blue light for the treatment of acne vulgaris

Acne vulgaris is the most common skin disease treated by physicians. Current topical and oral treatments may have short- and long-term negative consequences. Since radiofrequency (RF) energy has been shown to reduce sebum production and 410-nm blue light has been shown to kill Propionibacterium acnes (P. acnes) cells, these modalities in combination should be a highly effective treatment of acne vulgaris with little or no downtime or risk. This case report describes the efficacy and safety of RF energy (Accent, Alma Lasers Inc, Buffalo Grove, IL) and blue light (BLU-U, Dusa Pharmaceuticals, Inc, Wilmington, MA) used in combination to treat grade 4 cystic acne and acne scars in an Asian woman of skin type IV. The results were considered excellent by both investigators and the patient, with improvement in the skin tone as an added cosmetic benefit.     

国产果酸联合清痘术和莫匹罗星软膏治疗轻中度寻常痤疮的临床疗效及安全性

目的探讨国产果酸联合清痘术和莫匹罗星软膏治疗轻中度寻常痤疮的临床疗效及安全性。方法回顾性分析2016年1月～2018年7月于我院就诊的中轻度寻常痤疮患者病例60例,根据治疗方法所有患者分为果酸组(n=26)及联合组(n=34)。所有患者常规行果酸治疗,频率为每四周一次,其中果酸组运用国产果酸溶液进行治疗,果酸治疗后3d行清痘术;联合组则在果酸治疗及清痘术后联合莫匹罗星软膏进行治疗,于清痘术后涂抹莫匹罗星软膏,平时于洁面后涂抹,每日2次。以2～4次果酸及清痘术为一个疗程,于开始治疗后4、8周评定两组患者治疗效果然后进行比较,并记录两组患者治疗过程中出现的不良反应情况进行比较。治疗后随访1月,观察两组患者复发情况并进行对比。结果治疗后4周及8周时,联合组治疗总有效率显著高于果酸组(χ~2=4.517,4.412,P 0.05);两组患者治疗期间不良反应发生情况差异无统计学意义(P 0.05);联合组复发率明显低于果酸组(P 0.05)。结论国产果酸联合清痘术及莫匹罗星软膏能有效治疗轻中度寻常痤疮,起效相对作用快,同时安全性也较好。     

A comparison of intense pulsed light, combination radiofrequency and intense pulsed light, and blue light in photodynamic therapy for acne vulgaris

BACKGROUND: Photodynamic therapy (PDT) with 5-aminolevulinic acid (ALA) is an emerging modality for the treatment of acne vulgaris. However, optimal therapeutic protocols have not been established. OBJECTIVES: To compare the efficacies of 3 different light sources for activating ALA-induced protoporphyrin IX for the treatment of acne vulgaris. METHODS: Twenty-two patients with moderate to severe acne vulgaris were randomly assigned to receive ALA-PDT with photoactivation by intense pulsed light (IPL, 600-850 nm), a combination of IPL (580-980 nm) and bipolar radiofrequency (RF) energies, or blue light (417 nm). Each patient received 3 ALA-PDT sessions at 2-week intervals. Follow-up evaluations were conducted 1 and 3 months after the final treatment. RESULTS: At 1 month and 3 months, median lesion count reduction percentages were highest with IPL activation and lowest with blue light activation, although the differences did not reach statistical significance. At 1 month and 3 months, median investigator-assessed improvements were highest with IPL activation and lowest with blue light activation. The variability of responses was significantly smaller with IPL activation than with either RF-IPL or blue light activation. CONCLUSION: ALA-PDT with activation by IPL appears to provide greater, longer-lasting, and more consistent improvement than either RF-IPL or blue light activation in the treatment of moderate to severe acne vulgaris.     

A new approach to comparing efficacy results from clinical trials of topical acne vulgaris treatments

Clinicians must evaluate a voluminous amount of information from clinical trials when choosing among the growing number of topical acne treatments. This article describes a simple way to evaluate and broadly compare the efficacy results of well-controlled phase III clinical trials of topical acne treatments by taking into account the placebo effect (or active control effect). Key efficacy results are drawn from the package inserts of 7 primary topical acne treatments. To account for placebo effect, the mean percent reduction with placebo was subtracted from that of the active treatment for each type of lesion and also calculated as an average of these differences for all lesions. Based upon the principles of research, this method accounts for within study variances and offers a quick assessment of product efficacy. Clinicians should be cautioned that this method only allows for broad comparisons and does not establish definitive differences between treatments.     

Clinical safety and efficacy studies of a novel formulation combining 1.2% clindamycin phosphate and 0.025% tretinoin for the treatment of acne vulgaris

Clindamycin phosphate 1.2% and tretinoin 0.025% gel (CLIN/RA gel [ZIANA Gel]) is a novel topical combination agent approved by the FDA for the treatment of acne vulgaris in patients 12 years of age or older. A solution of clindamycin phosphate 1.2% combined with partially solubilized and crystalline tretinoin 0.025% suspended in an aqueous-based, alcohol-free gel formulation, CLIN/RA gel was studied in 2 randomized, vehicle-controlled trials involving more than 4,500 patients. Efficacy results from these studies showed that treatment with the combination significantly reduced lesion counts and improved patients' overall appearance to a greater extent than the individual components. Individual ingredients and the combination were well-tolerated. Among those treated with the combination formulation, discontinuation rates due to adverse events were 1% or less.     

异维A酸凝胶治疗寻常痤疮多中心随机双盲安慰剂对照临床研究

目的 评价0.05%异维A酸凝胶（抗面部痤疮药）治疗寻常痤疮的疗效及安全性.方法 用多中心随机双盲安慰剂对照试验设计,以凝胶基质为对照,2药分别外用患处,每日2次,疗程12周.结果 0.05%异维A酸凝胶与凝胶基质比较,治疗寻常痤疮的有效率分别为78.5%和23.3%;2药的药物不良反应发生率分别为23.2%和15.6%（P＞0.05）.结论 0.05%异维A酸凝胶治疗寻常痤疮是安全有效的外用药物.     

乌灵胶囊治疗伴轻中度抑郁焦虑症状的老年功能性消化不良的多中心随机对照临床试验

目的观察乌灵胶囊对伴轻、中度抑郁焦虑症状的功能性消化不良老年患者的疗效,并评估其临床应用的安全性。方法采用多中心、随机、阳性药物平行对照试验方法,以氟哌噻吨-美利曲辛为对照药物。266例功能性消化不良患者被随机分成试验组(145例)和对照组(121例)。试验组给予乌灵胶囊口服,3粒,每日3次;对照组给予氟哌噻吨-美利曲辛口服,1片,每日1次,疗程均为6wk。同时2组受试者均根据功能性消化不良分型及症状酌情给予抑酸、促动力、助消化药物。观察2组临床疗效、汉密尔顿抑郁量表(HAMD)评分、汉密尔顿焦虑量表(HAMA)评分及匹兹堡睡眠质量指数(PSQI)评分;根据副反应量表观察不良反应。结果试验组在治疗2、4及6 wk末的临床疗效与对照组相比均无显著差异(P>0.05);2组治疗6wk后与治疗前比较均有显著改善(P<0.01)。4、6wk末试验组的HAMD评分和HAMA评分的减分率均高于对照组。2组治疗6wk末PSQI评分与治疗前相比,均有显著改善(P<0.05),2组间PSQI评分的减分率无显著差异(P>0.05)。2组均无中、重度不良反应发生。结论乌灵胶囊治疗伴轻、中度抑郁焦虑症状的老年功能性消化不良患者的疗效较好,不良反应小,安全性好。