Narrowband ultraviolet B versus psoralen plus ultraviolet A therapy for severe plaque psoriasis: an Indian perspective

There is a dearth of studies comparing the efficacy of psoralen ultraviolet A (PUVA) and narrowband (NB)‐UVB in psoriasis in South Asian patients. Patients having plaque psoriasis with > 20% body surface area involvement were randomly assigned to one of two groups (group A: NB‐UVB, group B: PUVA). The response to treatment was assessed by the Psoriasis Area and Severity Index (PASI) at baseline and every 2 weeks thereafter. The maximum possible treatment duration was 16 weeks. In total, 43 patients (21 NB‐UVB, 22 PUVA) completed the study. Marked improvement was seen in 80.9% of the patients in group A and 81.8% in group B (NS: P > 0.05). The mean ± SD time taken to achieve marked improvement was 9.9 ± 3.3 and 9.9 ± 3.5 weeks, respectively. In total, 29 patients were available for the analysis of the remission data at 6 months after treatment completion; 26.7% of the patients in group A and 42.8% in group B were in remission (NS: P > 0.05). Both methods seem to be equally effective in achieving clearance and maintaining remission of severe chronic plaque psoriasis in patients with Fitzpatrick skin type 4 and 5.     

Stanozolol in chronic urticaria: a double blind, placebo controlled trial

H1-type antihistamine drugs are mainstays in the management of chronic urticaria. For patients with refractory, chronic, idiopathic urticaria who have failed to benefit from conventional therapy, other safe therapeutic modalities are required. To evaluate the role of stanozolol as an adjunctive therapeutic agent with H1-antihistamine in refractory chronic idiopathic urticaria, we conducted this study. Fifty-eight patients with chronic refractory urticaria were enrolled in this trial and were randomly assigned to two groups (A and B). Patients in group A received 2 mg stanozolol twice daily along with cetrizine 10 mg daily. Patients in group B received cetrizine 10 mg daily and placebo tablets twice daily. The improvement was monitored by estimation of severity score. Of the 58 patients, 26 in group A and 24 in group B could be evaluated. At the end of 12 weeks, 17 patients in group A showed marked to complete resolution as compared to 7 patients in group B (chi-square p<0.01). The intention to treat analysis p value was a found to be <0.007. There was a highly significant decrease in mean severity score at 12 weeks (p<0.001) in group A patients. The present study demonstrated that stanozolol is an effective and safe adjuvant therapy for treatment of chronic refractory urticaria.     

A comparative trial of single dose chemotherapy in paucibacillary leprosy patients with two to three skin lesions

A multicentric, double-blind, controlled, clinical trial was carried out to compare the efficacy of a combination of rifampicin 600 mg plus ofloxacin 400 mg plus minocycline 100 mg (ROM) administered as single dose with that of standard WHO/MDT/PB six months regimen. The study subjects were 236 previously untreated, smear-negative patients, without nerve trunk involvement and having only two or three skin lesions. Randomization was done on individual patient basis. Results were analyzed for mean clinical score for improvement, marked clinical improvement and complete clinical cure at the time of release from treatment and at 12 months and 18 months of follow-up. Clinical improvement was seen in most patients in both regimens. Marked improvement (i.e., more than 90% reduction in clinical score) at 18 months was seen in 46.2% and 53.4% of the patients treated with ROM and standard regimens, respectively. But, significant difference in favour of standard PB regimen was seen in patients with three skin lesions and in patients in whom more than one body part was affected. Reversal reaction and adverse drug reactions were minimal in both groups.     

银屑病甲损害与超声下远端指间关节改变的相关性分析

目的:分析银屑病患者甲损害与超声下远端指间关节改变的相关性。方法:纳入中重度寻常型银屑病(PsO)患者和关节病型银屑病(PsA)患者,记录患者的基本临床资料、甲损害特点以及超声下甲单元及远端指间关节情况。结果:研究共纳入中重度PsO患者38例,PsA患者35例。PsA组甲损害发生率高于中重度PsO组(85.7%vs 63.2%,P=0.028),前者mNAPSI评分(P=0.042)及甲板厚度(P<0.001)也高于后者。与中重度PsO组相比,PsA组附着点炎及骨赘形成的检出率高(77.1%vs 28.9%,P<0.001;74.3%vs 31.6%,P<0.001)。在中重度PsO患者的手指中,甲损害组指伸肌腱附着点炎及关节积液的发生率高于无甲损害组(11.4%vs 2.6%,P<0.001;35.6%vs 12.6%,P<0.001),在PsA患者的手指中,甲损害组指伸肌腱附着点炎、关节积液、滑膜炎、骨侵蚀、骨赘形成的发生率均高于无甲损害组(均P<0.05);所有患者同一手指水平mNAPSI评分、甲剥离、甲凹点均与指伸肌腱附着点炎相关,相关性最显...     

The efficacy of methotrexate plus pioglitazone vs. methotrexate alone in the management of patients with plaque‐type psoriasis: a single‐blinded randomized controlled trial

Recently, thiazolidinediones have shown to be efficacious with a favorable safety profile when used in the treatment of chronic plaque‐type psoriasis. The aim of this study was to evaluate and compare the efficacy and safety of a combination of methotrexate plus pioglitazone and methotrexate alone in plaque‐type psoriasis. A total of 44 adult patients with plaque‐type psoriasis were included in the study. Patients were randomized to treatment with methotrexate alone (group A) or methotrexate plus pioglitazone (group B) for 16 weeks. The primary efficacy outcome measure was psoriasis area and severity index (PASI) score change between the study groups at week 16 relative to baseline. The secondary efficacy outcome measure was dermatology life quality index (DLQI) score change between the two groups at week 16 relative to baseline. The PASI 75 score was also measured. After 16 weeks of therapy, the percentage of reduction in the mean PASI score was 70.3% in group B and 60.2% in group A. PASI 75 was achieved in 14 patients (63.6%) in group B compared with two patients (9.1%) in group A within 16 weeks, which was significant (P < 0.001). At 16 weeks from the baseline, a 63.6% decrease in the mean DLQI score of group B was seen, while the decrease for group A was 56.9%. Pioglitazone enhances the therapeutic effect of methotrexate in plaque‐type psoriasis, as demonstrated by a reduction in the mean PASI scores. In terms of DLQI, there was no extra benefit by the addition of pioglitazone to methotrexate therapy.     

Combined trichloroacetic acid peel and topical ascorbic acid versus trichloroacetic acid peel alone in the treatment of melasma: a comparative study

Background Melasma is a common acquired hypermelanosis that is difficult to treat. Several chemical peeling agents were used in treatment of melasma. Topical vitamin C was also used with minimal side effects. Aim To compare the effect of 20% trichloroacetic acid (TCA) peel alone vs. 20% TCA peel combined with topical 5% ascorbic acid in cases of epidermal melasma. Patients and methods Thirty women with bilateral epidermal melasma (Fitzpatrick skin types III and IV) were divided into two groups (A and B, 15 patients each). Before therapy, digital photography and a melasma area and severity index (MASI) score were done for each patient. Groups A and B were primed for 2 weeks before TCA peel. Group B also applied 5% ascorbic acid topically once daily; 20% TCA peel was done for all patients weekly until clearance of melasma or for a maximum of six peels. Group B continued to use 5% ascorbic acid topically in between peels and during the 16‐week follow‐up period. Patients were assessed at the end of peeling sessions and at the end of follow‐up by photography, MASI score, and a global evaluation by the patient. Results Group B compared with group A showed a significant decrease in MASI score at the end of TCA peels (P < 0.001) and at the end of the 16‐week follow‐up period (P < 0.003). Global evaluation showed that 13 patients (87%) in group B improved or maintained their improvement compared with only 10 patients (67%) in group A. Conclusion Topical ascorbic acid combined with 20% TCA peel in melasma improves the results and helps in maintaining the response to therapy.     

Different therapeutic modalities for treatment of melasma

Background Chemical peels and topical depigmenting agents have become a popular modality in the treatment of melasma. Aims To compare the clinical efficacy of trichloroacetic acid peel 20%vs. Jessner’s solution peel vs. the topical mixture of hydroquinone 2% and kojic acid. Patients and methods Forty five patients with melasma were randomly assigned into three groups of fifteen patients each. Group A received Jessner’s solution peel, group B received trichloroacetic acid peel 20%, and group C received topical hydroquinone 2% and kojic acid. All patients were seen in follow‐up period after 16 weeks; clinical evaluation using Melasma Area and Severity Index (MASI) score and photography were recorded before and after treatment and after 16 weeks. Results There was a decrease in MASI score in all three groups after treatment and after follow‐up period but after treatment MASI score was statistically significantly lower in group A than group C (P = 0.01), and it was also statistically significantly lower in group B than group C (P < 0.001) but there was no statistically significant difference between groups A and B. After the follow‐up period, MASI score was statistically significantly lower in group A than group C (P < 0.001), statistically significantly lower in group B than group C (P < 0.001), and statistically significantly lower in group B than group A (P = 0.035). The statistical analysis was done through one‐way anova followed by least significant difference (LSD). Conclusion Trichloroacetic acid 20% showed better results than Jessner’s solution as peeling agent and hydroquinone 2% with kojic acid as a topical agent in the treatment of melasma.     

Treatment of psoriatic nails with topical cyclosporin: a prospective,randomized placebo-controlled study

BACKGROUND: Nail involvement is a frequent event in the course of psoriasis causing severe distress. While systemic cyclosporin (CsA) represents a well-established therapy of psoriasis, its topical use is limited by the difficult penetration of the molecule through the skin and the nail because of its highly lipophilic nature. OBJECTIVES: We carried out a prospective randomized placebo-controlled study in order to analyze the effectiveness and tolerability of topical oil-dissolved 70% CsA solution in nail psoriasis. METHODS: Sixteen adult patients with nail psoriasis, divided randomly into two groups of 8 patients (group A and group B), were treated respectively with a 70% maize-oil-dissolved oral CsA solution and maize oil alone. To compare the therapeutic effectiveness, all patients were evaluated, before starting the treatment and after 12 weeks of therapy, by the same dermatologists. The patients were also asked to assess the severity of their nail involvement at baseline and at the end of the treatment. RESULTS: In group A, 3 patients came to a complete resolution of nail lesions and 5 showed a substantial improvement of the overall severity score. In group B, a slight improvement was noted in only 1 patient. All the patients of group A judged positively the results of the therapy, while in group B only 1 patient reported a moderate improvement. CONCLUSION: Our results show that topical therapy with oral CsA solution is a safe, effective and cosmetically highly acceptable treatment modality for nail psoriasis. The ability of CsA to influence keratinocyte proliferation and T-cell lymphokine release, reducing the cornification of the upper layers of the epidermis, may prevent the typical alterations observed in nail psoriasis.     

The treatment of acute nerve function impairment in leprosy: results from a prospective cohort study in Bangladesh

In this paper, the outcome of 132 patients having acute nerve function impairment (NFI) is reported at 4 and 12 months after the start of prednisolone treatment. In all, 68% of sensory nerves and 67% of motor nerves showed improvement at 12 months, with no statistical difference in responsiveness of various nerves to prednisolone. Duration and severity of impairment were not found significant predictors of treatment outcome. A core of 32% of impaired nerves did not respond to prednisolone, and 12% of impaired nerves had functional deterioration despite treatment. The mean eye-hand-foot (EHF) score improved from 2.02 to 1.33 in the treatment group (median score improved from 2 to 1). Approximately one-third of all patients requiring prednisolone treatment did not receive it, an important reason being that some patients developed new NFI against a background of chronic impairment, and were thus overlooked. The 'unjustly untreated' group of patients had a spontaneous sensory nerve function improvement rate of 62% and a motor nerve function improvement rate of 33% at 12 months from onset of NFI. The EHF score showed no statistically significant improvement.     

Methotrexate/narrowband UVB phototherapy combination vs. narrowband UVB phototherapy in the treatment of chronic plaque‐type psoriasis – a randomized single‐blinded placebo‐controlled study

Background Psoriasis is a chronic, recurring inflammatory disease affecting the skin, joints and nails that has a significant negative impact on the quality of life. Efficacy of combination of methotrexate/narrowband ultraviolet B (NBUVB) phototherapy in the treatment of psoriasis has been rarely assessed. Objectives To compare the efficacy of methotrexate/NBUVB phototherapy combination vs. NBUVB phototherapy in the treatment of chronic plaque psoriasis. Methods Forty patients with chronic plaque‐type psoriasis (body surface area involvement >10%) were randomized to receive either methotrexate/NBUVB phototherapy (group A) or placebo/NBUVB phototherapy (group B). End point of treatment was 75% reduction in Psoriasis Area and Severity Index (PASI) Score or upto 6 months, whichever was earlier. Patients were then followed up for a period of 12 weeks for assessment of relapse. Results Of 40 patients, 37 completed the treatment period and 29 both the treatment period and follow‐up. PASI 75 was achieved in 19/20 patients in group A and 14/20 patients in group B (P < 0.04). The mean number of weeks(P = 0.001), the mean cumulative dose of NBUVB (P = 0.001) and the mean number of phototherapy sessions (P = 0.0001) required to achieve PASI 75 were significantly less in group A compared with group B. There was no significant difference in the number of patients who relapsed during the follow‐up period (P = 0.68). Conclusion Combination of methotrexate and NBUVB phototherapy provides more rapid clinical improvement compared with NBUVB monotherapy in the treatment for chronic plaque‐type psoriasis.     

家庭支持联合微波理疗对宫颈癌患者放疗后下肢淋巴水肿的干预效果及对负性情绪的影响

目的研究家庭支持与微波理疗联合对宫颈癌患者放疗后下肢淋巴水肿的干预效果以及对患者负面情绪的影响。方法选取2017年8月至2018年8月成都市中西医结合医院(成都市第一人民医院)诊治的100例宫颈癌放疗后下肢淋巴水肿患者作为研究对象。随机分为对照组和干预组,每组50例患者。对照组患者通过微波理疗进行单一治疗并进行常规护理,干预组患者在对照组患者基础上通过家庭支持进行干预治疗。对比两组患者的治疗效果,通过汉密尔顿焦虑量表(HAMA)、汉密尔顿抑郁量表(HAMD)评分对比两组患者治疗前后的负面情绪情况,并对比两组患者治疗前后生活质量评分的改善情况以及患者对治疗及护理的满意程度。结果干预组患者治疗的总有效率为92%,显著高于对照组患者的74%(P<0.05);两组患者治疗前的HAMA评分和HAMD评分差异不明显(P>0.05),治疗后的HAMA评分和HAMD评分均有了明显的降低,且干预组患者的降低程度显著高于对照组患者(P<0.05);两组患者治疗前的生活质量评分无显著差异(P>0.05),治疗后均有显著改善,且干预组患者的改善效果显著优于对照组患者(P<0.05);干预组患者对治疗及护理的满意度为94%,显著高于对照组患者的78%(P<0.05)。结论对于宫颈癌患者放疗后下肢淋巴水肿的患者来说,家庭支持与微波理疗联合治疗的方法,不仅比单一微波理疗有着更佳的临床治疗效果,而且可以更加有效改善患者的负面情绪情况,并改善患者的生活质量,提高患者对治疗效果的满意度。因此值得推广。     

Efficacy and safety of preprandial versus postprandial administration of low-dose cyclosporin microemulsion (Neoral) in patients with psoriasis vulgaris

A study of therapeutic drug monitoring indicated that cyclosporin administered before meals produces higher blood concentrations than an equivalent dose administered after meals. Our objective was to compare the efficacy of cyclosporin administered before and after meals, respectively, in psoriasis vulgaris patients. We performed an open trial study. Patients were randomly assigned to receive cyclosporin before (group B, n = 20) or after meals (group A, n = 17), and were followed up in 10 dermatology clinics. The difference between groups was evaluated in severity. The percent reduction in psoriasis area and severity index score from baseline was 29.8% in group A and 75.4% in group B (A vs B, P = 0.00005). Two patients in each group withdrew due to abnormality of laboratory data. Short-term, low-dose treatment with cyclosporin before rather than after meals is suggested as a new effective treatment regimen for psoriasis, with the added advantage of lowering costs.     

A comparative clinico-pathological study of single dose ROM in paucibacillary leprosy patients with 1-3 skin lesions

A controlled clinical and histopathological study was carried out to compare the efficacy of a combination of rifampicin 600 mg plus ofloxacin 400 mg plus minocycline 100 mg (ROM) administered as a single dose with that of standard WHO/MDT-PB six months' regimen with regard to resolution of lesion clinically and histopathologically. Skin biopsy was performed at the intake and at 6 months. The study subjects were 32 previously untreated, smear-negative patients, without nerve trunk involvement and having 1-3 skin lesions. The results were analyzed for mean clinical score for marked, moderate and no improvement and mean histopathological score was graded as active, resolving and complete resolution, according to granuloma fraction at the end of 6 months. Marked clinical improvement was seen in 25% and 12%, moderate improvement in 50% and 56% patients treated with ROM and standard regimens respectively. Histopathologically, activity was seen in 62.5% and 43.7% and resolution of granuloma in 25% and 31.2% in the ROM and standard regimens respectively. Both the regimens were equally efficacious in the reduction of clinical score and granuloma fraction. No adverse drug reactions or reversal reactions were seen during the study period in both the groups.     

Comparison of efficacy and side‐effect profile of oral PUVA vs. oral PUVA sol in the treatment of vitiligo: a 36‐week prospective study

Background Both Oral PUVA and PUVA sol have been successfully used in vitiligo treatment. However, there is paucity of studies comparing the two therapies, especially under subtropical conditions of abundant sunlight where PUVA sol is more feasible. Objectives To compare the efficacy and side effects of oral PUVA versus oral PUVA sol therapy in generalized vitiligo. Methods Comparative prospective clinical trial conducted on consecutive patients of generalized vitiligo. Response to treatment was assessed using change in Lund & Browder (L & B) score for assessment of reduction in body surface area of involvement, patient global assessment (PGA) of improvement in vitiligo, investigator’s global assessment (IGA) of extent of repigmentation, and quality of life (QOL) assessment using Tjioe et al questionnaire. Results Thirty five patients were recruited‐ 18 in PUVA and 17 in PUVA sol group. Mean percentage change in L & B score at 36 weeks was 46.4% in PUVA and 26.1% in PUVA sol group (P = 0.06), mean PGA score in PUVA was 4.58 ± 2.23 and in PUVA sol group was 6 ± 2.08 (P = 0.13), mean IGA score was 3.08 ± 1.68 in PUVA and 1.79 ± 0.57 in PUVA sol group (P = 0.11). QOL scores were significantly higher in PUVA group as compared to the PUVA sol group (P = 0.04). Side effects were comparable in two groups except for phototoxic side effects which were significantly more in PUVA group. Conclusions PUVA is more efficacious than PUVA sol and also provides greater psychological benefit in treatment of generalized vitiligo but is associated with more phototoxic adverse effects.     

Treatment of chronic urticaria with narrowband ultraviolet B phototherapy: a randomized controlled trial

Data regarding narrowband ultraviolet B (NB-UVB) phototherapy in patients with chronic urticaria is limited. The aim of this open, controlled study was to determine whether NB-UVB is effective in treating urticaria in combination with antihistamin. A total of 81 patients with chronic urticaria were recruited, 48 of whom were randomized into the NB-UVB plus antihistamine group. The control group (n = 33) received only antihistamine. Patients were assessed using the urticaria activity score and a visual analogue score (VAS). The 2 groups were evaluated at the same time-points: at treatment sessions 10 and 20 and at follow-up 3 months post-treatment. The reduction in urticaria activity score and VAS was statistically significant (p < 0.05 for both groups). When comparing the groups, the mean urticaria activity score was significantly lower in the NB-UVB group at session 10 (22.6 vs. 27.3) and session 20 (17.4 vs. 20.7). Statistically significant differences were also noted in VAS between the 2 groups (p < 0.01) at 3 months post-treatment. We conclude that NB-UVB may be an effective complementary treatment for patients with chronic urticaria.     

Saline spa water or combined water and UV-B for psoriasis vs conventional UV-B: lessons from the Salies de Béarn randomized study

OBJECTIVE: To study the effects of UV-B therapy and saline spa water given alone or in combination for the treatment of psoriasis. DESIGN: Randomized, controlled, comparative study with blinded observers. SETTING: Salies de Béarn, saline spa water center located in the southwest of France. PARTICIPANTS: Seventy-one adult patients with psoriasis with a Psoriasis Area and Severity Index (PASI) score greater than 10. INTERVENTION: Patients were randomly assigned to 1 of 3 treatments: spa water alone (group A); UV-B 311-nm phototherapy alone (group B); and a combination of the 2 therapies (group C). The 3 groups were treated on a daily basis 5 days a week for a total of 21 days. MAIN OUTCOME MEASURES: Change in PASI score from baseline as determined by an investigator blinded to randomization; variation in quality of life, adverse effects, and long-term effects (1 year after treatment). RESULTS: Four patients dropped out because of secondary effects. Efficacy was similar in groups B and C, with changes in PASI of -64% and -55%, respectively at 3 weeks. For group A, change in PASI was -29%, thus showing a minor therapeutic effect of saline spa water alone and poor efficacy compared with groups B and C (P<.001). More adverse effects were reported in groups A and C but did not reach significance. Combined saline spa water and UV-B therapy had no sparing effect on UV-B dosages. One year after treatment, no long-term benefit could be attributed specifically to a given regimen, but the patients had overall significantly better PASI scores than at baseline. CONCLUSIONS: Saline spa water alone had a minor therapeutic effect in psoriasis, and the beneficial effect of bathing to enhance phototherapy was not demonstrated.     

A comparative study on the use of fractional CO2 laser with tacrolimus or calcipotriol or narrow band ultraviolet‐B in treatment of stable nonsegmental vitiligo

Conventional methods of treatment for vitiligo are often unsatisfactory to the patients and time consuming, new treatment modalities are needed. This study was conducted to evaluate the efficacy and safety of fractional carbon dioxide (CO₂) laser therapy followed by narrow band ultraviolet‐B (NB‐UVB) phototherapy, topical tacrolimus or topical calcipotriol on stable nonsegmental vitiligo. Thirty patients with stable nonsegmental vitiligo were evaluated. All patients were subjected to three sessions of fractional CO₂ laser 1 month apart. Patients were divided into three groups (each group 10 patients). Group (A) treated with tacrolimus ointment twice daily for 3 months, group (B) treated with calcipotriol ointment twice daily for 3 months, and group (C) treated with NB‐UVB twice weekly for 3 months. Outcomes were evaluated by calculating vitiligo area scoring index (VASI) score change, percentage of repigmentation, patient satisfaction, and adverse effects. There was a statistical significant decrease in VASI score after treatment in the three groups. The VASI change and % of regimentation was higher in group (C) treated by laser and NB‐UVB and this was significantly higher than group (B) treated with laser and calcipotriol. Otherwise, there was no statistical significant difference between other treatment groups. In concluion, NB‐UVB phototherapy, topical tacrolimus, or topical calcipotriol in combination with fractional CO₂ laser could be used effectively and safely as an alternative modality for treatment of vitiligo. The combination of fractional CO₂ laser and NB‐UVB was found to be more effective.     

Efficacy and safety of systemic methotrexate vs. acitretin in psoriasis patients with significant palmoplantar involvement: a prospective,randomized study

Background Palmoplantar psoriasis (PP) is a chronic, inflammatory and proliferative dermatosis of the palms and/or soles with significant morbidity. It is notoriously difficult to treat and unresponsive to traditional topical agents. Material and methods This was a prospective, randomized study involving 111 patients of psoriasis with significant palmoplantar disease. Patients meeting the eligibility criteria were randomly assigned to one of the two treatment groups. Patients in Group I received methotrexate in doses of 0.4 mg/kg weekly, and patients in Group II received acitretin in doses of 0.5 mg/kg daily. Patients were evaluated by modified PPPASI (m‐PPPASI) score for palm and sole involvement at baseline, at two weekly intervals for the first 4 weeks and then four weekly for next 8 weeks. Treatment protocol was continued for a period till patient achieved 75% reduction in m‐PPPASI from baseline or 12 weeks whichever was earlier. Results There was a statistically significant difference in reduction of m‐PPPASI of patients on methotrexate at weeks 8 and 12. The mean m‐PPPASI at week 8 was 15.38 ± 6.08 in methotrexate group and 17.23 ± 5.25 in acitretin group (P = 0.04). The mean m‐PPPASI at week 12 was 10.30 ± 5.97 in methotrexate group and 12.40 ± 5.31 in acitretin group (P = 0.03). Marked improvement (m‐PPPASI 75) was achieved in 12 (24%) patients in methotrexate group compared with 4 (8%) in acitretin group which was statistically significant (P = 0.029). Adverse events were generally mild and were seen in 14 patients in methotrexate group and 15 patients in acitretin group (P = 0.080). Conclusion Methotrexate is relatively inexpensive, safe and efficacious drug for the treatment of psoriasis patients with significant palmoplantar involvement. Acitretin can be used as an alternative therapy and with a good safety profile.     

The effect of corticosteroid usage on the bacterial killing, clearance and nerve damage in leprosy: a prospective cohort study: part 1--study design and baseline findings of 400 untreated multibacillary patients

OBJECTIVE: To investigate possible adverse effects of therapeutic usage of corticosteroids on the killing and clearance of M. leprae and the clearance of granuloma, in patients with multibacillary (MB) leprosy. DESIGN: A cohort of 400 untreated MB patients were sub-grouped into those to be treated with corticosteroids (prednisolone 40 mg daily tapered to 5 mg over 12 weeks) along with MB-MDT for reaction and/or neuritis or silent neuropathy (SN) of <6 months duration (group A), and those with no reaction and to be treated with MDT only (group B). Clinical, bacteriological, histopathological and neurological test findings at fixed time points were compared. Analysis was performed using SPSS version 10.0. The significance of association was tested using Chi-square test. In the current report, we describe the study design and baseline findings of 400 untreated MB patients, with special emphasis on differences between patients in groups A and B. RESULTS: At baseline, applying Ridley-Jopling classification, 39% patients were BT, 20% BB, 24% BL, 12% sub-polar LL and 5% pure neural (PN). Overall, 60% patients were slit skin smear (SSS) negative and 33% presented with disability either grades 1 or 2. Overall 140/400 (35%) patients presented with reaction and/or neuritis and 11/400 (3%) presented with SN of <6 months duration. Comparing groups A and B, the percentage of patients presenting with DG2 was significantly higher in group A (43%). By clinical tests, monofilaments (MF) and voluntary muscle testing (VMT), the percentage of patients and nerves showing functional impairment was also significantly higher in group A. However, in the more sensitive nerve conduction velocity (NCV) test, the percentage of patients that showed nerve abnormalities was closely comparable; 94% and 91% in groups A and B respectively while number of affected nerves was higher in group A. CONCLUSION: At baseline, as recorded by NCV, peripheral nerve function abnormality was observed in almost all the MB patients regardless of reaction; but among those presenting with reaction or neuritis, the nerve damage was more severe and extensive.     

Amorolfine and itraconazole combination for severe toenail onychomycosis; results of an open randomized trial in Spain

Objective In an open, randomized, clinical study of toenail onychomycosis with matrix area involvement, two alternative regimens of topical amorolfine/oral itraconazole therapy were compared with itraconazole monotherapy.
Patients/Methods A total of 131 patients were randomized to treatment. Patients in the combination groups were treated with amorolfine 5% nail lacquer (Loceryl®, Galderma Laboratories) once weekly for 24 weeks and 200 mg itraconazole once daily for 6 weeks (Group AI-6) or 12 weeks (Group AI-12). A control group received itraconazole monotherapy for 12 weeks (Group I-12). Strict inclusion criteria specified that subjects had to have onychomycosis of the toenails with matrix area involvement and/or > 80% total nail surface involvement. Mycological evaluations using both microscopic examination and culture of nail samples were performed at weeks 12 and 24. A stringent assessment of outcome at study end combined the results of mycological and clinical outcomes into a global cure rate. Safety was also assessed.
Results At week 12, mycological cure was attained in 42 of 45 patients (93·3%) in group AI-6, 29 of 35 patients (82·9%) in group AI-12, and 14 of 34 patients in group I-12. The difference between both combination groups and the control group were significant ( P  < 0·001). The global cure rate at week 24 was 83·7% (36 patients) in group AI-6, 93·9% (31 patients) in group AI-12, and 68·8% (22 patients) in group I-12. The difference between the AI-12 group and itraconazole monotherapy was significant ( P  < 0·05).
Conclusions These results indicate that amorolfine combination therapy represents an improved treatment strategy for patients with severe onychomycosis.