A prospective study of adverse reactions of ALA-PDT for acne vulgaris

BackgroundAcne vulgaris is a chronic inflammatory skin disease around pilosebaceous unit. 5-Aminolaevulinic acid photodynamic therapy (ALA-PDT) is an effective therapy for severe acne vulgaris. However, the lack of detailed information of adverse reactions limits the promotion of ALA-PDT in clinic.ObjectiveTo systemically investigate the adverse reactions relating to ALA-PDT for acne vulgaris.MethodsA prospective study was performed at the Shanghai Skin Disease Hospital.ResultsIn the prospective study, 35 patients with acne vulgaris completed the trial. The adverse reactions were first divided into acute-phase adverse reactions, including erythema (94.3%), post-treatment pain (91.4%), burning skin (91.4%), dry skin (91.4%), itching (85.7%), pustule (82.9%), edema (20%) and blister (11.4%), or recovery-phase adverse reactions, which included crust (65.6%), exudation (48.6%) and hyperpigmentation (42.7%). Younger patients were more likely to have pustules (P<0.05). Male patients were represented itching more often than female patients (P<0.05). The efficacy of ALA-PDT for severe acne was positively related to the severity of acute-phase adverse reactions. The duration of pain was shortest. Crusting and hyperpigmentation lasted considerably longer.ConclusionIn the present study, we recorded the relative incidence of various adverse reactions following ALA-PDT for acne vulgaris. The severity of adverse reactions tended to decrease with increased patient age, except for itching and hyperpigmentation. Light-to-moderate adverse reactions might be the inflammatory reactions of ALA-PDT, predicting a good efficacy. A form for evaluation of adverse reactions based on the present study could assist dermatologists in predicting and managing adverse reactions for greater efficacy and higher patient satisfaction.     

A systematic review and meta-analysis of randomized clinical trials of fire needle combined with ALA-PDT for the treatment of moderate-to- severe acne

BackgroundModerate-to-severe acne affects people's health and quality of life. As first-line therapeutic medications, isotretinoin and antibiotics are used to treat moderate-to-severe acne, but outcomes can be improved. The combination of fire needle and ALA-PDT may be one option. This study evaluated the safety and effectiveness in the treatment of moderate-to-severe acne by the combination with fire needle and ALA-PDT.MethodsBy July 2022, search PubMed, the Chinese Biomedical Literature dababase, the Cochrane Library, the Chinese Scientific Journal Database, the China National Knowledge Infrastructure, the Web of Science Datebase, Embase Datebase,VIP Database and WanFang Database. To gather RCTs of the combination of fire needle and ALA-PDT for the treatment of moderate-to-severe acne. A meta-analysis was performed according to the Handbook guidelines of Cochrane. Study selection, data extraction, and risk of bias evaluation were all governed by two reviewers, with the help of a third reviewer if necessary. The meta-analysis was carried out with Review Manager Software 5.4.ResultsThere were a total of 9 RCTs with 862 participants. Clinical efficacy was recorded in nine trials, GAGS score was published in three studies, adverse events were documented in five studies, and the recurrence rate was reported in two studies. Treatment lasted between four and twelve weeks. Combination therapy outperformed monotherapy in terms of clinical efficacy (OR:3.73; 95% CI:2.51, 5.53; p < 0.00001). Additional subgroup analysis revealed that the combination therapy outperformed ALA-PDT alone in terms of clinical effect (OR: 3.20; 95% CI: 2.05, 4.99; p < 0.00001). Additionally, combination therapy outperformed fire needle alone in terms of clinical efficacy (OR:5.66; 95% CI: 2.66, 12.08; p < 0.00001). Studies have also indicated that combination therapy has a stronger benefit in lowering the GAGS score (MD:-3.35; 95% CI:-4.62, -2.09; p < 0.00001). Additionally, there was no discernible difference in the occurrence of adverse events between the combined treatments and monotherapy (OR:1.43; 95% CI: 0.76, 2.69; p = 0.26), and the combined treatment was able to control the recurrence rate (OR:0.18; 95% CI: 0.07, 0.45; P = 0.0002).ConclusionsThe efficacy of fire needle combined with ALA-PDT in the treatment of moderate-to-severe acne appears superior to that of ALA-PDT or fire needle alone. However, the conclusions of this study must be interpreted carefully due to the high risk and ambiguity of bias of the included trials.     

夫西地酸乳膏联合阿达帕林凝胶治疗寻常痤疮的疗效

 目的 探讨夫西地酸乳膏联合阿达帕林凝胶治疗寻常痤疮的疗效。方法 选择武警黑龙江总队医院诊治的寻常痤疮患者110例,随机分为对照组和观察组,每组各55例。对照组单独应用阿达帕林凝胶治疗,观察组联合应用夫西地酸乳膏与阿达帕林凝胶,两组均持续治疗4周。比较两组治疗后皮损数量、不良反应、复发率等。结果 治疗4周后,与对照组相比,观察组炎性皮损、非炎性皮损个数明显减少,差异有统计学意义(P＜0.05),两组治疗后不良反应差异无统计学意义。治疗后6个月,观察组的复发率3.64%(2/55)低于对照组14.55%(8/55),差异有统计学意义(P＜0.05)。结论 夫西地酸乳膏联合阿达帕林凝胶治疗寻常痤疮,可明显改善皮损情况,安全性较高,复发率低。     

Adverse reactions of ALA-PDT for the treatment of cutaneous diseases: A retrospective study

Background5-Aminolaevulinic acid photodynamic therapy (ALA-PDT) is an effective therapy for cutaneous diseases, such as precancers, superficial non melanoma skin cancers and certain inflammatory or viral conditions. However, the absence of a complete picture of adverse reactions limits the promotion of ALA-PDT.ObjectiveTo systemically investigate the detailed evidence of adverse reactions relating to ALA-PDT for skin diseases.MethodsA retrospective study performed at the Shanghai Skin Disease Hospital.ResultsIn the retrospective study, 439 patients were included. Incidences of adverse reactions, including in-treatment pain (98.8%), erythema (92.4%), edema (35.0%), exudation (23.0%), hyperpigmentation (27.3%) were clarified. Edema was more common in female patients (P<0.05). Patients with HPV-related skin diseases were more likely to suffer erythema, edema or exudation (P<0.05). Hyperpigmentation was more likely to occur in skin appendage disorders (P<0.05). Fever (2.4%) and hypopigmentation (1.9%) are two neglected adverse reactions analyzed in detail. Fever is more prevalent in female patients. Hypopigmentation occurred predominantly in elderly with skin cancer or precancerosis lesions.ConclusionThe results outline detailed information about the adverse reactions, including systemic reactions following ALA-PDT, assisting dermatologists in predicting and managing adverse reactions for greater efficacy and higher patient satisfaction.     

The association between treatment reactions and treatment efficiency of Hemoporfin-photodynamic therapy on port wine stains: A prospective double blind randomized controlled trial

BackgroundResearch has focused on treatment efficiency and/or treatment reactions of photodynamic therapy (PDT) on port-wine stain (PWS). But few studies reported the association between them. Hence, here we investigated the association between the treatment efficiency and treatment reactions after Hemoporfin (HMME) mediated photodynamic therapy (PDT) on PWS through a prospective study.MethodsPatients (n = 50) with PWS were randomly assigned to the HMME group or the placebo group. Three quit after the first treatment, and forty-seven received two sessions of treatment at an 8-week interval. They were given the treatment at day 1 and evaluations were performed at day 1, day 4 and week 8 in each session. HMME group was treated with HMME while the placebo group was given normal saline instead in the first session, double-blindly. While in the second session, both groups received HMME-PDT treatment.ResultsAfter a single treatment, swelling was more severe in younger patients (p < 0.05) and the lesion far from centro-facial showed more severe pruritus and scab. Compared with a single treatment, burning sensation had a higher occurrence rate, while burning sensation and scab were less severe in the second treatment. Importantly, severity of scab and pain (5 min after irradiation) were found possibly correlated with the treatment efficiency.ConclusionHMME-PDT on PWS induces several treatment reactions, including pruritus, burning sensation, pain, swelling, blisters and scab. Two sessions of treatments do not have any accumulation effects on treatment reactions. And there might be a positive correlation between treatment efficiency and the severity of scab or pain (at early stage of the therapy), which might help in regulating treatment modalities.     

不同剂量氢吗啡酮及舒芬太尼用于无痛支气管镜检查的随机对照研究

目的探讨不同剂量氢吗啡酮复合丙泊酚麻醉应用于无痛支气管镜检查术的有效性和安全性。方法选择无痛支气管镜检查患者80例,随机分为舒芬太尼组（SF组）、低剂量氢吗啡酮组（5 μg/kg,H1组）、中剂量氢吗啡酮组（10 μg/kg,H2组）、高剂量氢吗啡酮组（15 μg/kg,H3组）,每组20例。比较4组诱导前(T0)、诱导后1 min(T1)、纤维支气管镜检查操作时(T2)、术毕时(T3)平均动脉压(mean arterial pressure,MAP)、心率（heart rate,HR）、脉搏血氧饱和度（pulse oxygen saturation,SpO2）、呼吸频率（respiratory rate,RR）,记录手术时间、苏醒时间、内镜医生与麻醉医生对麻醉效果的满意评分、苏醒时呼吸道痛视觉模拟评分（visual analogue scale,VAS）,观察术中体动和呛咳、低氧血症、术后呕吐和头晕、皮肤瘙痒不良反应情况。结果T2~T3时H1组MAP、HR明显高于SF组、H2组、H3组（P<0.05）;T1时SF组、H3组RR、SpO2明显低于H1组、H2组（P<0.05）;SF组苏醒时间明显长于H1组、H2组、H3组（P<0.05）,H2组麻醉医生满意评分明显高于SF组、H1组、H3组（P<0.05）,H1组VAS明显高于SF组、H2组、H3组（P<0.05）。H1组术中体动和呛咳发生率明显高于SF组、H2组、H3组（P<0.05）,H1组、H2组术中低氧血症、术后呕吐和头晕发生率明显低于SF组、H3组（P<0.05）,SF组皮肤瘙痒发生率明显高于H1组、H2组、H3组（P<0.05）。结论10 μg/kg氢吗啡酮复合丙泊酚静脉麻醉下行支气管镜检查,术中呼吸循环稳定、术后苏醒快、不良反应发生率低。     

感冒一号汤剂治疗普通感冒的疗效评价:随机平行对照研究

目的评价感冒一号汤剂治疗普通感冒的疗效和安全性。方法设计随机平行对照试验,筛选驻北京郊区某部队患普通感冒的干部和士兵作为研究对象(n=225),用胶体金法快速筛查排除军团菌抗原阳性患者6例,用计算机产生的随机表将符合条件的研究对象分为试验组(n=111,感冒一号汤剂治疗)和对照组(n=108,北京同仁堂感冒清热颗粒治疗),服药1个疗程(3d)并填写每日感冒症状分级量化表,计算并比较两组药物的有效率、显效率及临床痊愈率,观察和记录不良事件。结果试验期间失访3例(试验组2例,对照组1例),资料不完整13例(试验组5例,对照组8例),219例进入全分析集(FAS)和安全数据集(SS),203例进入符合方案(PP)集。FAS人群的试验组的临床痊愈率、显效率和有效率分别为14.41%、36.94%和72.97%,对照组分别为12.96%、43.52%和64.81%,FAS集和PP集中,试验组与对照组的临床疗效指标组间比较差异均无统计学意义(P>0.05),试验组和对照组有效率差值的95%可信区间为-4.06%~20.38%,有效率按照非劣的-10%标准可见试验组非劣于对照组。PP集结论与FAS集相同。结论感冒一号汤剂治疗普通感冒安全有效。     

相对低剂量甲泼尼龙联合99Tc-MDP治疗老年Graves眼病的疗效观察

目的评价相对低剂量甲泼尼龙短程疗法联合99Tc-亚甲基二膦酸盐（99Tc-MDP）治疗老年活动性中重度Graves眼病（GO）的临床疗效及安全性。方法24例老年活动性中重度GO患者先配对后随机分入对照组及试验组各12例。对照组应用常规大剂量甲泼尼龙问断静脉短程冲击治疗,累积剂量达800．1200mg。试验组应用相对低剂量甲泼尼龙（累积剂量为300-480mg）联合99Tc-MDP的治疗方案。治疗前及开始治疗后每1～4周进行定期随访观察,并根据眼病临床活动性评分及美国甲状腺协会提出的甲状腺相关眼病分度分级标准评定眼部病情变化,同时监测治疗后的不良反应。应用Ridit检验进行统计分析,比较两组疗效。结果试验组10例患者有效,对照组6例患者有效,两组的疗效有统计学差异（t=2．121,P〈0．05）。对照组的不良反应明显增多,主要体现于消化道症状,引起或加重水钠潴留与糖代谢紊乱。结论对于老年活动性中重度GO应用相对低剂量甲泼尼龙短程疗法联合99Tc-MDP是一种临床疗效及安全性较好的治疗方案。     

Photodynamic therapy and Acyclovir in the treatment of recurrent herpes labialis: A controlled randomized clinical trial

BackgroundHerpes Simplex Virus Type 1 (HSV-1) is one of the most widespread infections that can effect the orofacial region. Recurrent infection is considered a life-long oral health problem, leading to pain, discomfort, and social restriction due to esthetic features when active. Effective therapies are needed. This study aimed to compare photodynamic therapy (PDT), Topical Acyclovir (AC), and the association of both in the healing process and self-reported symptomologies of HSV-1 recurrences.MethodsPatients were randomly assigned into 3 groups (n = 25): PDT (low-power laser, 660 nm, 40 mW, 120 J/cm², 4.8 J, 120 s per point) and methylene blue (0.005 %) as photosensitizer; AC (5%); PDT + AC.Data concerning lesion size, healing time, and self-reported healing parameters, such as pain, tingling, and edema were taken every day up to complete healing for all studied groups.ResultsThere was no significant difference in healing time and pain between groups. AC group showed a significant minor reduction of the lesion compared to the AC-PDT group on day 1. Regarding edema and tingling, the comparison of treatments showed a statistical difference only on day 1, where PDT showed better results.ConclusionWith all the limitations of this study, it can be concluded that only on day 1 PDT showed positive effects in the treatment of herpes lesions in comparison to AC.     

A randomized controlled trial of a leg orthosis versus traditional treatment for soldiers with shin splints: a pilot study

Diagnosis and management strategies for shin splints in active duty military populations closely resemble those in civilian athletic populations. There is a paucity of evidence supporting the use of many of these interventions. The purpose of this study was to present data on the Shin Saver orthosis as a treatment for shin splints in an active duty military population and to review current condition management. Twenty-five subjects diagnosed with shin splints by a U.S. Army physical therapist were randomly assigned to a shin orthosis treatment group or a control group. There was no significant difference between treatment and control groups in days to finish a 0.5-mile run pain free. Visual analog scales for pain at intake versus after 1 week of relative rest revealed no significant improvement in symptoms in either group. Current best-practice guidelines support a treatment program of rest, cryotherapy, and a graduated walk-to-run program.     

Efficacy and safety of ALA-PDT in treatment of diabetic foot ulcer with infection

BackgroundDiabetic foot ulcers (DFUs) with infection is a major clinical issue, as the infection not only potentially devastate the wound healing, but also is the factor that most often leads to amputation. Nevertheless, traditional antibiotic treatment is often insufficient to clear the infection, which could lead to side effects. Photodynamic therapy (PDT) has broad-spectral antibacterial activity. Meanwhile, it is difficult to induce antibiotic resistance. Here, we aim to evaluate the safety and efficacy of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) in the treatment of DFUs with infection.MethodsIn our study, 5 diabetic patients with infectious DFUs were diagnosed by pathological examination and the depth of wound was examined by X-Ray. All patients’ wounds were firstly irradiated with 20% ALA-PDT (635 nm, 100 J/cm², 80 mW/cm²) using the red LED to control the infection. Treatment will be combined with debridement if there is granulation necrosis or secretion on the wound surface. PDT sessions were performed weekly in all patients until healing was achieved. All patients were followed up for 0.6–1.2 years after treatment.ResultsIn 5 patients, the DFUs with infection was completely controlled by ALA-PDT. There was no recurrence of DFUs in the follow-up of 0.9 years (range, 0.6–1.2 years) after the treatment.ConclusionsALA-PDT treatment for DFUs with infection show successful outcomes and might ultimately avoid amputation.     

A strategy of symptom-limited exercise with regadenoson-as-needed for stress myocardial perfusion imaging: A randomized controlled trial

Background

Ambulatory patients with uncertain functional capacity may benefit from combined exercise and vasodilator stress protocols for myocardial perfusion imaging (MPI). The safety and MPI image quality with regadenoson administered during symptom-limited exercise have not been prospectively evaluated.

Methods and Results

A total of 140 patients (mean age 61 years, 48% female) referred for exercise with vasodilator stress MPI were randomized 2:1 to a strategy of exercise with regadenoson-as-necessary (Ex-Reg, n = 96) or dipyridamole with exercise (Dip-Ex, n = 44) after Duke Activity Status Index (DASI) scoring (median score 28 vs 24, P = .09). Ex-Reg subjects commenced treadmill exercise and regadenoson was administered only if the subject was unable to reach standard endpoints. Dip-Ex subjects received dipyridamole prior to symptom-limited exercise. Hemodynamics were recorded throughout. Subjects completed symptom questionnaires and MPI image quality was assessed by blinded read. Ex-Reg subjects were more likely to achieve ≥85% age-predicted maximum heart rate than Dip-Ex subjects (57% vs 32%, P < .01). Only 50% of subjects meeting inclusion criteria and randomized to Ex-Reg required regadenoson and none had symptomatic hemodynamic changes. Severe side effects or adverse events occurred in 16% of Ex-Reg and 24% of Dip-Ex subjects (P = .12). MPI image quality was “good” or “excellent” in 88% of Ex-Reg subjects and 86% of Dip-Ex subjects (P = .33).

Conclusion

A strategy of exercise with regadenoson-as-needed for MPI offers similar safety and side effect profile with similar image quality compared to dipyridamole with exercise, with reduced pharmaceutical use.     

One-year aerobic interval training in outpatients with schizophrenia: A randomized controlled trial

Although aerobic interval training (AIT) is recognized to attenuate the risk of cardiovascular disease (CVD) and premature mortality, it appears that it rarely arrives at patients’ doorsteps. Thus, this study investigated 1-year effects and feasibility of AIT delivered with adherence support in collaborative care of outpatients with schizophrenia. Forty-eight outpatients (28 men, 35 [31-38] (mean [95% confidence intervals]) years; 20 women, 36 [30-41] years) with schizophrenia spectrum disorders (ICD-10) were randomized to either a collaborative care group provided with municipal transportation service and training supervision (walking/running 4 × 4 minutes at ~90% of peak heart rate; HR_peak) 2 d wk⁻¹ at the clinic (TG) or a control group (CG) given 2 introductory AIT sessions and advised to continue training. Directly assessed peak oxygen uptake () increased in the TG after 3 months (2.3 [0.6-4.4] mL kg⁻¹ min⁻¹, Cohen's d = 0.33[−4.63 to 4.30], P = 0.04), 6 months (2.7 [0.5-4.8] mL kg⁻¹ min⁻¹, Cohen's d = 0.42[−4.73 to 4.11], P = 0.02) and 1 year (4.6 [2.3-6.8] mL kg⁻¹ min⁻¹, Cohen's d = 0.70[−4.31 to 4.10], P < 0.001) compared to the CG. One-year cardiac effects revealed higher HR_peak (7 [2-11] b min⁻¹, Cohen's d = 0.34[−8.48 to 8.65], P = 0.01), while peak stroke volume tended to be higher (0.9 [−0.2 to 2.0] mL b⁻¹, Cohen's d = 0.35[−1.62 to 2.01], P = 0.11) in the TG compared to the CG. Conventional risk factors (body weight, waist circumference, blood pressure, and lipids/glucose) remained unaltered in both groups. One-year AIT adherence rates were 15/25 (TG; different from CG: P < 0.001) and 0/23 (CG). AIT was successfully included in long-term collaborative care of outpatients with schizophrenia and yielded improved , advocating this model for aerobic capacity improvement and CVD risk reduction in future treatment.     

Efficacy of antimicrobial photodynamic therapy versus antiviral therapy in the treatment of herpetic gingivostomatitis among children: Aa randomized controlled clinical trial

AimThe aim of the present study was to evaluate the effect of antimicrobial photodynamic therapy (aPDT) as an adjunctive treatment to topical antiviral therapy for the treatment of children having herpetic gingivostomatitis.Materials and methods45 individuals (age group 12–18 years) with herpetic gingivostomatitis (HG) were divided into three groups on the basis of provision of treatment. (a) Group A: topical anti-viral therapy (TAT) (n = 14, mean age = 17.0 years) (b) Group B: antimicrobial photodynamic therapy (aPDT) (n = 15, mean age =17.7 years) and (c) Group C: topical anti-viral therapy + adjunctive aPDT (n = 16, mean age = 18.0 years) respectively. Pain scores [visual analogue scale (VAS) and McGill Pain Questionnaire (MPQ)] were assessed and HSV-1 was quantified. ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) was used to compute the pro-inflammatory cytokine including interleukin 6 (IL-6) and tumor necrosis factor-alpha (TNF-α). The analysis of the mean values and inter group comparisons were evaluated with the Mann-Whitney test. The Friedman test was used to establish the comparison of the changes observed in HSV quantification, pain scores, and pro-inflammatory cytokines. ANOVA tests were employed for the quantification of differences observed at follow-ups. The assessments for the clinical trial were done at baseline, immediate after post-op, two, and four weeks, and three and six months respectively.ResultsAccording to the analysis of the data obtained after the clinical assessment, the three groups reported a decrease in the pain scores, HSV-1 quantification and levels of the pro-inflammatory cytokines. However, Group C (TAT + aPDT) reported improvement in the observed parameters which was statistically significant in comparison to Group A (TAT) and Group B (aPDT) respectively.ConclusionAntimicrobial photodynamic therapy (aPDT) in conjunction with topical antiviral therapy (TAT) helped in reducing the pain scores and pro-inflammatory cytokine levels in herpetic gingivostomatitis among children.     

Misonidazole combined with radiotherapy in the treatment of non-small cell lung cancer. A randomized double-blind trial

Forty-one patients with inoperable non-small cell lung cancer were randomized to receive irradiation therapy 45 Gy in ten fractions over eight weeks, plus either placebo or misonidazole 1.2 g/m2 orally on treatment day. The irradiated area was the primary tumour. Twenty-one patients received misonidazole and 20 received placebo. Minimal observation time for the study was 36 months. No clear difference was observed in the pattern of relapse between the groups. 43% of the patients in the misonidazole group attained a complete response (CR) or partial response (PR) as compared with 65% in the placebo group. Median survival time was twelve months in the misonidazole group and 14 months in the placebo group.