Tears have antimicrobial, nourishing, mechanical, and optical properties. They contain components such as growth factors, fibronectin, and vitamins to support proliferation, migration, and differentiation of the corneal and conjunctival epithelium. A lack of these epitheliotrophic factors—for example, in dry eye, can result in severe ocular surface disorders such as persistent epithelial defects. Recently, the use of autologous serum in the form of eye drops has been reported as a new treatment for severe ocular surface disorders. Serum eye drops may be produced as an unpreserved blood preparation. They are by nature non-allergenic and their biomechanical and biochemical properties are similar to normal tears. In vitro cell culture experiments showed that corneal epithelial cell morphology and function are better maintained by serum than by pharmaceutical tear substitutes. Clinical cohort studies have reported its successful use for severe dry eyes and persistent epithelial defects. However, the protocols to prepare and use autologous serum eye drops varied considerably between the studies. As this can result in different biochemical properties protocol variations may also influence the epitheliotrophic effect of the product. Before the definitive role of serum eye drops in the management of severe ocular surface disease can be established in a large randomised controlled trial this has to be evaluated in more detail. In view of legislative restrictions and based upon the literature reviewed here a preliminary standard operating procedure for the manufacture of serum eye drops is proposed.

https://bjo.bmj.com/content/bjophthalmol/88/11/1467.full.pdf

Autologous serum eye drops for ocular surface disorders

Background
Theoretically, autologous serum eye drops (AS) offer a potential advantage over traditional therapies on the assumption that AS not only serve as a lacrimal substitute to provide lubrication but contain other biochemical components that allow them to mimic natural tears more closely. Application of AS has gained popularity as second-line therapy for patients with dry eye. Published studies on this subject indicate that autologous serum could be an effective treatment for dry eye.

Objectives
We conducted this review to evaluate the efficacy and safety of AS given alone or in combination with artificial tears as compared with artificial tears alone, saline, placebo, or no treatment for adults with dry eye.

Search methods
We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 5), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to July 2016), Embase (January 1980 to July 2016), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to July 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We also searched the Science Citation Index Expanded database (December 2016) and reference lists of included studies. We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 5 July 2016.

Selection criteria
We included randomized controlled trials (RCTs) that compared AS versus artificial tears for treatment of adults with dry eye.

Data collection and analysis
Two review authors independently screened all titles and abstracts and assessed full-text reports of potentially eligible trials. Two review authors extracted data and assessed risk of bias and characteristics of included trials. We contacted investigators to ask for missing data. For both primary and secondary outcomes, we reported mean differences with corresponding 95% confidence intervals (CIs) for continuous outcomes. We did not perform meta-analysis owing to differences in outcome assessments across trials.

Main results
We identified five eligible RCTs (92 participants) that compared AS versus artificial tears or saline in individuals with dry eye of various origins (Sjogren's syndrome-related dry eye, non-Sjogren's syndrome dry eye, and postoperative dry eye induced by laser-assisted in situ keratomileusis (LASIK)). We assessed the certainty of evidence as low or very low because of lack of reporting of quantitative data for most outcomes and unclear or high risk of bias among trials. We judged most risk of bias domains to have unclear risk in two trials owing to insufficient reporting of trial characteristics, and we considered one trial to have high risk of bias for most domains. We judged the remaining two trials to have low risk of bias; however, these trials used a cross-over design and did not report data in a way that could be used to compare outcomes between treatment groups appropriately. Incomplete outcome reporting and heterogeneity among outcomes and follow-up periods prevented inclusion of these trials in a summary meta-analysis.

Three trials compared AS with artificial tears; however, only one trial reported quantitative data for analysis. Low-certainty evidence from one trial suggested that AS might provide some improvement in participant-reported symptoms compared with artificial tears after two weeks of treatment; the mean difference in mean change in symptom score measured on a visual analogue scale (range 0 to 100, with higher scores representing worse symptoms) was -12.0 (95% confidence interval (CI) -20.16 to -3.84; 20 participants). This same trial found mixed results with respect to ocular surface outcomes; the mean difference in mean change in scores between AS and artificial tears was -0.9 (95% CI -1.47 to -0.33; 20 participants; low-certainty evidence) for fluorescein staining and -2.2 (95% CI -2.73 to -1.67; 20 participants; low-certainty evidence) for Rose Bengal staining. Both staining scales range from 0 to 9, with higher scores indicating worse results. The mean change in tear film break-up time was 2.00 seconds longer (95% CI 0.99 to 3.01; 20 participants; low-certainty evidence) in the AS group than in the artificial tears group. Investigators reported no clinically meaningful differences in Schirmer’s test scores between groups (mean difference -0.40 mm, 95% CI -2.91 to 2.11; 20 participants; low-certainty evidence). None of these three trials reported tear hyperosmolarity and adverse events.

Two trials compared AS versus saline; however, only one trial reported quantitative data for analysis of only one outcome (Rose Bengal staining). Trial investigators of the two studies reported no differences in symptom scores, fluorescein staining scores, tear film break-up times, or Schirmer's test scores between groups at two to four weeks' follow-up. Very low-certainty evidence from one trial suggested that AS might provide some improvement in Rose Bengal staining scores compared with saline after four weeks of treatment; the mean difference in Rose Bengal staining score (range from 0 to 9, with higher scores showing worse results) was -0.60 (95% CI -1.11 to -0.09; 35 participants). Neither trial reported tear hyperosmolarity outcomes. One trial reported adverse events; two of 12 participants had signs of conjunctivitis with negative culture that did resolve.

Authors' conclusions
Overall, investigators reported inconsistency in possible benefits of AS for improving participant-reported symptoms and other objective clinical measures. There might be some benefit in symptoms with AS compared with artificial tears in the short-term, but we found no evidence of an effect after two weeks of treatment. Well-planned, large, high-quality RCTs are warranted to examine participants with dry eye of different severities by using standardized questionnaires to measure participant-reported outcomes, as well as objective clinical tests and objective biomarkers to assess the benefit of AS therapy for dry eye.

Autologous serum eye drops for dry eye

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Autologous serum has been used to treat dry eye syndrome for many years. It contains several growth factors, vitamins, fibronectin and other components that have been considered important for corneal and conjunctival integrity. Serum eye drops are usually prepared as an unpreserved blood solution. The serum is by nature well tolerated and its biochemical properties are somewhat similar to natural tears. Autologous serum eye drops have been reported to be effective for the treatment of severe dry eye-related ocular surface disorders (Sjogren's syndrome), and also other entities such as superior limbic keratoconjunctivitis, graft-versus-host disease, Stevens-Johnson syndrome, ocular cicatricial pemphigoid, recurrent or persistent corneal erosions, neurotrophic keratopathy, Mooren's ulcer, aniridic keratopathy, filtering blebs after trabeculectomy, and post-keratorefractive surgery. The purpose of this study is to review the recently published literature on ocular surface diseases treated with human autologous serum eye drops.

/pdf/autologous-serum-for-ocular-surface-diseases-143d7x4wbr.pdf

Autologous serum for ocular surface diseases

espanolObjetivo: Estudiar la influencia del tratamiento topico con suero autologo en la evolucion clinica de los defectos epiteliales persistentes (DEP). Observar el efecto de este tratamiento en las variaciones histologicas de la metaplasia escamosa en 7 casos de ojo seco. Pacientes y metodos: Estudiamos un total de 17 ojos (14 pacientes). Analizamos la evolucion clinica (test fluoresceina, Schirmer I y II y control fotografico) de los DEP en estos pacientes a los que se les aplico suero autologo al 20% durante 28 dias. Cuantificamos histologicamente con citologia de impresion y mediante el metodo de Tseng, la regresion de la metaplasia escamosa en 7 ojos de cuatro pacientes diagnosticados de penfigoide ocular cicatricial con ojo seco severo, tratados con autosuero. Se trata de un estudio clinico prospectivo no comparativo de series de casos. En el tratamiento estadistico de los datos utilizamos el test de Wilconxon. Resultados: En el 35,2% de casos (6 ojos) los DEP cicatrizaron a las 2 semanas (grupo efectivo), en el 47% (8 ojos) entre las 2 y 4 semanas (grupo parcialmente efectivo) y en el 17,6% (3 ojos) de casos la curacion fue posterior a la 4.a semana. La duracion de los DEP previo al tratamiento fue de 36 dias. En 6 de los 7 ojos en los que se estudio la metaplasia escamosa, se observo una regresion de la misma a los 28 dias de tratamiento. Conclusiones: El tratamiento con suero autologo acelera la cicatrizacion de los DEP. En la mayoria de casos, el tratamiento con suero autologo provoca una involucion de la metaplasia escamosa. EnglishPurpose: To study the impact of topical treatment with autologous serum on the clinical evolution of persistent corneal epithelial defects (PED) and to observe its effect on squamous metaplasia in 7 cases of dry eye. Patients and methods: In this prospective, clinical, non-comparative case series study we evaluated a total of 17 eyes (14 patients). We analized the clinical evolution (fluorescein staining, Schirmer's I and II tests and photographic control) of PED in these patients, to whom 20% autologous serum eyedrops were applied for 28 days. Using impression cytology technique (Tseng's method) we evaluated the involution of squamous metaplasia in 7 eyes of 4 patients with ocular cicatricial pemphigoid and dry eye who were treated with autologous serum. The Wilconxon test was used for the statistical treatment of the data. Results: The epithelial defect healed within 2 weeks in 6 eyes (35.2%). Eight eyes (47%) healed within 2-4 weeks and 3 eyes (17.6%) did not heal after week 4. The duration of PED, before serum therapy was 36 days. Six of seven eyes treated with autologous serum presented an involution of squamous metaplasia 28 days after initiation of the serum drops. Conclusions: Autologous serum treatment accelerates PED healing. Autologous serum application causes an involution of squamous metaplasia.

Tratamiento de defectos epiteliales persistentes mediante suero autólogo

https://revistafarmaciahospitalaria.sefh.es/gdcr/index.php/fh/article/download/1042/1042

Evaluación de la calidad percibida por los usuarios de una unidad de atención farmacéutica a pacientes externos

http://scielo.isciii.es/pdf/fh/v37n4/03original02.pdf

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http://www.grupoaran.com/mrmUpdate/lecturaPDFfromXML.asp?IdArt=457370&TO=RVN&Eng=0

J. Borrás Blasco

Papers

Tratamiento de defectos epiteliales persistentes mediante suero autólogo

Evaluación de la calidad percibida por los usuarios de una unidad de atención farmacéutica a pacientes externos

Adalimumab versus etanercept en el tratamiento de la artritis reumatoide: análisis coste-efectividad

Tratamiento farmacológico de la neoplasia corneal y conjuntival

Atención farmacéutica a pacientes con artritis reumatoide y psoriásica en tratamiento con etanercept