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The importance of request and report forms in the interpretation of therapeutic drug monitoring data.

The interpretation of therapeutic drug monitoring data depends not only on the measurements themselves but also on additional data collected on the request forms and the manner in which the results are displayed on the report forms. A study was conducted to learn how presently used request/report forms affect the interpretation of therapeutic drug level measurements. Letters were sent to 232 directors of laboratory services requesting them to forward examples of forms that they use in therapeutic drug monitoring and toxicology. Replies were received from 77 directors of whom 53 enclosed examples of their therapeutic drug monitoring request/report forms. The characteristics of the 53 request/report forms were analyzed, and the results indicate that request/report forms are not optimally configured to facilitate effective therapeutic drug monitoring. Many request forms are not designed to allow entry of even the most basic data essential to the interpretation of therapeutic drug level measurements. Many report forms do little more than provide a drug level measurement and a therapeutic range. Improved request/report forms, as well as systems to ensure their proper use through adequate numbers of qualified personnel are necessary. Data/word processing computers should prove helpful.

Drug Information Services↗

Outcome analysis of cataract surgery following therapeutic keratoplasty.

PURPOSE: To assess the results of cataract surgery, in terms of visual outcome and effect on graft survival, in eyes that have previously undergone therapeutic penetrating keratoplasty for infective keratitis. METHODS: Case records of patients who had undergone cataract surgery alone (group A) or in combination with regrafting (group B) following initial therapeutic penetrating keratoplasty between January 2000 and December 2001 were reviewed retrospectively. Main outcome measures studied were visual acuity, astigmatism, and effect of the cataract surgery on graft survival. Results were compared with eyes undergoing cataract surgery after optical keratoplasty and between eyes in groups A and B. RESULTS: Frequency of cataract surgery after therapeutic keratoplasty was significantly greater than that following optical keratoplasty [68 (52%) versus 47 (21%); P<0.001]. Fifty-eight eyes of 58 patients undergoing cataract surgery after therapeutic penetrating keratoplasty were analyzed in detail. Mean follow-up period was 8.9 months (+/-7.6 months). Thirty eyes underwent cataract surgery alone (group A), and 28 eyes underwent cataract surgery with regrafting (group B). Eyes that had undergone therapeutic keratoplasty were significantly more likely to have opaque grafts requiring regrafting at the time of cataract surgery than eyes that had undergone optical keratoplasty [28 (48.3%) versus 5 (10.6%); P<0.001]. Incidence of graft failure after cataract surgery did not differ significantly in eyes that had undergone therapeutic or optical keratoplasty. Final visual acuity at last follow-up was 6/12 or better in 25 eyes (43%). There were no significant differences between eyes in groups A and B in terms of final visual acuity, astigmatism, or graft failure rates. CONCLUSIONS: Visual results of cataract surgery following therapeutic keratoplasty are comparable to those following optical keratoplasty. Combining a repeat keratoplasty for a failed graft with the cataract surgery does not significantly affect the final outcome.

Adolescent↗

Disparities in use of and unmet need for therapeutic and supportive services among school-age children with functional limitations: a comparison across settings.

OBJECTIVES: To determine whether family resources predict use of therapeutic and supportive services and unmet needs in medical versus educational settings. DATA SOURCE: Children 5-17 years of age with at least one functional limitation (n=3,434) from the 1994 to 1995 Disability Supplement to the U.S. National Health Interview Survey. STUDY DESIGN: Family resources included the child's type of health insurance, household education level, and poverty status. Therapeutic services included audiology; social work; occupational, physical, or speech therapy. Supportive services included special equipment, personal care assistance, respite care, transportation, or environmental modifications. Need was controlled by child health status and the severity and type of functional limitation(s). Age, gender, race/ethnicity, family size, and structure were covariates. DATA ANALYSIS METHODS: Logistic regression provided estimates of associations between-family resources and use of or unmet need for therapeutic and supportive services. Multinomial methods were used to determine therapeutic service outcomes in medical versus educational settings. PRINCIPAL FINDINGS: Children with public insurance were two to three times more likely to use services than children with private or no insurance regardless of type of service. Household education and public insurance were associated with supportive and therapeutic service use, but for therapeutic services only among children receiving services beyond the school setting. Household education predicted unmet need for both types of services and therapeutic services across settings. Findings should be interpreted cautiously, given the survey's dependence on respondent report to define the need for services and the potential for overrepresentation of children with more severe needs in the public insurance category. CONCLUSIONS: Disparities in the use of services by household education level and by type of health insurance across service settings suggests inequitable access among the U.S. policies and programs serving children with functional limitations. Family income and education appear to give families an advantage in obtaining services and in identifying a child's unmet need.

Adolescent↗

Enhancement of the therapeutic index: from nonmyeloablative and myeloablative toward pretargeted radioimmunotherapy for metastatic prostate cancer.

PURPOSE: New strategies that target selected molecular characteristics and result in an effective therapeutic index are needed for metastatic, hormone-refractory prostate cancer. EXPERIMENTAL DESIGN: A series of preclinical and clinical studies were designed to increase the therapeutic index of targeted radiation therapy for prostate cancer. (111)In/90Y-monoclonal antibody (mAb), m170, which targets aberrant sugars on abnormal MUC1, was evaluated in androgen-independent prostate cancer patients to determine the maximum tolerated dose and efficacy of nonmyeloablative radioimmunotherapy and myeloablative combined modality radioimmunotherapy with paclitaxel. To enhance the tumor to liver therapeutic index, a cathepsin degradable mAb linkage ((111)In/90Y-peptide-m170) was used in the myeloablative combined modality radioimmunotherapy protocol. For tumor to marrow therapeutic index improvement in future studies, anti-MUC1 scFvs modules were developed for pretargeted radioimmunotherapy. Anti-MUC1 and anti-DOTA scFvs were conjugated to polyethylene glycol scaffolds tested on DU145 prostate cancer cells and prostate tissue arrays, along with mAbs against MUC1 epitopes. RESULTS: The nonmyeloablative maximum tolerated dose of 90Y-m170 was 0.74 GBq/m2 for patients with not more than 10% axial skeleton involvement. Metastatic prostate cancer was targeted in all 17 patients; mean radiation dose was 10.5 Gy/GBq and pain response occurred in 7 of 13 patients reporting pain. Myeloablative combined modality radioimmunotherapy with 0.4 GBq/m2 of 90Y-peptide-m170 and paclitaxel showed therapeutic effects in 4 of 6 patients and 30% less radiation to the liver per unit of activity. Neutropenia was dose limiting without marrow support and patient eligibility was a major limitation to dose escalation. Hypoglycosylated MUC1 epitopes were shown to be abundant in prostate cancer and to increase with disease grade. Anti-MUC1 scFvs binding to prostate cancer tissue and live cells were developed into di-scFv binding modules. CONCLUSIONS: The therapeutic index enhancement for prostate radioimmunotherapy was achieved in clinical studies by the addition of cathepsin cleavable linkers to 90Y-conjugated mAbs and the use of paclitaxel. However, the need for marrow support in myeloablative combined modality radioimmunotherapy restricted eligible patients. Therefore, modular pretargeted radioimmunotherapy, aiming at improving the tumor to marrow therapeutic index, is being developed.

Antibodies, Monoclonal↗

The concept of the therapeutic alliance.

Certain conceptual aspects of the therapeutic alliance are considered. Although therapeutic alliance, transference, and the real relation are intermingled and intertwined in the actuality of the analytic relationship, they remain distinguishable and open to differentiating analysis. The distinctions between the therapeutic alliance and transference, and between alliance and the real relation, are explored and their differences clarified, including the difference between therapeutic misalliances and transferences. Some of the component dimensions of the therapeutic alliance are explored, including empathy, the therapeutic framework, responsibility, authority, freedom, trust, autonomy, initiative, and ethical considerations including values and confidentiality. Further exploration of these and other dimensions of the therapeutic alliance is called for, especially the extension of these dimensions to their practical clinical application.

Empathy↗

Self-poisoning and therapeutic intoxication with lithium.

Of 68 admissions for lithium overdose over 16 years, 25 were due to therapeutic intoxication and 43 to deliberate self-poisoning. Three patients with therapeutic intoxication had acute diabetes insipidus with hypernatraemia. One of them had acute renal failure requiring dialysis, prolonged Parkinsonism and generalised myopathy. Twenty-two patients with therapeutic intoxication had peak serum lithium concentrations above the therapeutic range. In contrast, of 22 self-poisoned patients with peak serum lithium concentrations above the therapeutic range only 3 developed toxicity. The mean admission plasma urea concentration in patients with therapeutic intoxication was higher than in self-poisoned patients and the mean admission plasma bicarbonate concentration was lower. The mean serum lithium half-life in 8 patients with therapeutic intoxication was considerably longer than in 5 self-poisoned patients. Renal lithium clearance is enhanced by increased sodium excretion and we recommend that lithium toxicity be treated with saline diuresis and frusemide if fluid retention occurs. Haemodialysis is mandatory when renal failure is present, and may be indicated when serum lithium concentrations are very high or rising rapidly.

Adolescent↗

The effect of physician education on knowledge of drug therapeutics and costs.

OBJECTIVE: To determine if a clinical pharmacist-sponsored education program regarding physician knowledge of drug costs and therapeutics would change drug utilization and costs for specific high-cost groups of drugs in a pediatric critical care unit (PCCU). STUDY DESIGN: Prescribers within the PCCU completed a questionnaire addressing drug costs and therapeutic issues. Subsequent to the questionnaire the PCCU liaison pharmacist implemented a visual display of monthly drug costs, an education program that included the presentation of questionnaire results, and drug information lectures discussing controversial therapeutic issues. After the education program participants again completed the questionnaire. SETTING/PARTICIPANTS: The study was conducted in a 13-bed PCCU in a regional children's hospital. The participants were postgraduate trainees in pediatrics and critical care medicine as well as attending staff in the PCCU. OUTCOME MEASURES: The main outcome measure was the score on a test addressing drug costs and therapeutic issues. RESULTS: The mean overall posteducation score (52.5 percent) improved significantly from the preeducation score (46.4 percent). The preeducation questionnaire results indicated increased knowledge of costs by residents and increased knowledge of therapeutics by attending physicians. The number of educational sessions attended appeared to be associated with improvement in overall questionnaire scores. CONCLUSIONS: There was improvement in knowledge of drug costs and therapeutics associated with the educational program. Although this relationship did not reach statistical significance, this may be related to the relatively small sample size of our study. Our results suggest that clinical pharmacists can positively influence physicians' knowledge on drug costs and therapeutics.

Child↗

Therapeutic trials in HIV infection: which benefits for which patients?

PURPOSE: The purpose of our study was to make an assessment of the HIV patients' overall opinion of therapeutic trials, to analyze the motivations and the reasons linked to this perception, and to determine if their involvement in a therapeutic trial is a help or a hindrance to their treatment. METHOD: All the inpatients and outpatients attending the Dijon University Hospital AIDS day care unit during the first 4 months of 1999 were given an anonymous questionnaire designed to record the patients' attitudes toward therapeutic trials, their motivations, and the perceived risks. The questionnaire was often completed in consultation with a psychoanalyst. RESULTS: Two hundred and seven (207) patients were surveyed; 194 of them had a favorable opinion of therapeutic trials. The main motivations to take part in a therapeutic trial were altruistic. In contrast, individualistic considerations and relational motivations (such as to modify the relationship between the caregiver and the patient) were more closely associated with a negative perception. CONCLUSION: Most of the patients will benefit or at least will not be harmed by being involved in a trial. However, the patients' attitudes toward the principle of therapeutic trials have to be determined before these patients are included in a given therapeutic trial. This is necessary to avoid the risk of subsequent medical care being altered because participation was either induced or compelled.

Adult↗

[Studies on the production rate of estradiol in the testis in male infertility--studies of the predictive values on therapeutic efficacy in patients with oligozoospermia].

It is surmised that studies on the relationship between the endocrinological milieu and therapeutic efficacy in male infertile patients are essential in elucidating the etiology of this disease and devising effective therapeutic methods. The relation between serum gonadotropin level and therapeutic efficacy has already been reported. In the present study, we investigated the basal levels of two sex steroids, i.e., testosterone and estradiol, and the estradiol:testosterone (E2/T) ratio, and also the increases in these parameters after the administration of hCG to human subjects presenting various degrees of testicular dysfunction, e.g., male infertile patients, aged males, Klinefelter's syndrome and hypogonadotropic hypogonadism. Special attention was given to the characteristics of the reserve capacity for secretion of estradiol in male infertile patients. The hCG test was performed on a total 527 subjects, including 65 normal adult males. The reserve capacity for the secretion of estradiol was investigated on the basis of the increasing rate in the serum E2/T ratio. The increasing rate in the serum E2/T ratio was statistically larger in subfertile males, oligozoospermia and azoospermia in comparison with the normal adult males. On the other hand, the aged males did not show any difference from the normal adult males, whereas the results were significantly lower in the male subjects with Klinefelter's syndrome and hypogonadotropic hypogonadism. It was considered that the increase in the serum E2/T ratio is one characteristic of the gonads of male infertile patients. The results of multiple regression analysis showed that the LH level, the pretreatment sperm concentration and the increasing rate in the serum E2/T ratio were important factors determining the increase in the sperm concentration after treatment. Accordingly, for cases of oligozoospermia characterized by an LH level of 13.7mIU/ml or less and a sperm concentration of 5 x 10(6)/ml or more, the relationship between the increasing rate in the serum E2/T ratio and therapeutic efficacy was investigated. It was found that the increasing rate in the serum E2/T ratio was significantly greater in the therapeutically ineffective cases compared with the therapeutically effective cases. On the basis of this finding, it was surmised that the percentage increase in the serum E2/T ratio is one index reflecting testicular function. In addition, for cases of oligozoospermia characterized by an LH level of 13.7mIU/ml or less, a sperm concentration of 5 x 10(6)/ml or more and the increasing rate in the serum E2/T ratio of 4.01 or less, the relationship between the degree of spermatogenesis and therapeutic efficacy was investigated.(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗

Adverse drug reactions and therapeutic errors in older adults: a hazard factor analysis of poison center data.

PURPOSE: The severity of hazards posed by medications implicated in poisoning in older adults was characterized. METHODS: Toxic Exposure Surveillance System (TESS) cases from 1993 through 2002 involving a single substance in patients age 60 years or older and coded as an adverse drug reaction (ADR) or therapeutic error were analyzed. Hazard factors were determined for each exposure reason by calculating the sum of the major effects and deaths for each substance category and subcategory and dividing this by the total number of exposures for the respective category or subcategory. RESULTS: Hazard factors were calculated for 12,737 ADRs and 51,846 therapeutic errors. The overall rates of major effects and deaths were 7.5% and 1.6% in the ADR and therapeutic error groups, respectively. In the ADR group, five TESS categories had a hazard factor of > or =2.0: anesthetics, anticoagulants, antineoplastics, cardiovascular drugs, and radiopharmaceuticals. In the therapeutic error group, five drug categories also had a hazard factor of > or =2.0: anesthetics, anticoagulants, antineoplastics, asthma therapies, and serums/toxoids/vaccines. Six pharmaceutical categories were associated with hazard factors of > or =2.0 in both the ADR and therapeutic error groups. CONCLUSION: An analysis of ADRs and therapeutic errors involving older adults and reported to poison control centers from 1993 through 2002 revealed overall rates of major effects and death of 7.5% and 1.6% in the ADR and therapeutic error groups, respectively. Antineoplastics, aminophylline or theophylline, cardiac glycosides, heparin, morphine, and warfarin were implicated in more than 50 cases and associated with hazard factors of > or =2.0 for both exposure groups.

Adverse Drug Reaction Reporting Systems↗

Will routine therapeutic drug monitoring have a place in clozapine therapy?

Clozapine is an atypical antipsychotic medication with proven efficacy in the management of refractory schizophrenia. It is also recommended for patients who do not tolerate the extrapyramidal adverse effects of traditional antipsychotic medications. However, the therapeutic promise of clozapine has been limited by a higher incidence of agranulocytosis. Currently, plasma clozapine concentrations are not routinely used in clinical management. Therapeutic effects are monitored empirically during a 6 to 8 week titration period in which the dosage is raised to 300 to 450 mg/day. Clozapine nevertheless fulfils a number of criteria which make it a candidate for therapeutic monitoring. These include an identifiable therapeutic range, an unpredictable dose-concentration relationship between patients, a potential for clinically relevant pharmacokinetic interaction with other drugs and a high probability of patient noncompliance. The therapeutic threshold plasma concentration appears to be about 400 micrograms/L. Concentrations above 1000 micrograms/L increase the risk of adverse effects on the central nervous system (confusion, delirium and generalised seizures). There is no evidence to link increased concentrations of clozapine or its metabolite to the development of agranulocytosis. We conclude that therapeutic drug monitoring can play a useful role in the clinical management of patients treated with clozapine. The clinician is advised to primarily use clinical judgement during dosage escalation, but intermittent monitoring is recommended to quickly optimise a therapeutic dosage for each patient. At steady state, occasional measurements could be made when clinical signs indicate possible toxicity or lack of effect (possibly caused by a lack of compliance or drug interaction). Long term monitoring would, in our view, not be necessary.

Antipsychotic Agents↗

Respirable microspheres for inhalation: the potential of manipulating pulmonary disposition for improved therapeutic efficacy.

Several particle engineering technologies have recently emerged, which have enabled inhaled microspheres to seek to manipulate pulmonary biopharmaceuticals, and to improve therapeutic efficacy for both local and systemic treatments. These microspheres may be designed to sustain drug release, to prolong lung retention, to achieve drug targeting and/or to enhance drug absorption and thereby, to seek the potentials of reducing dosing frequency and/or drug dose, while maintaining therapeutic efficacy and/or reducing adverse effects. While product development is still in process, in many cases, considerable therapeutic benefits and/or new therapeutic opportunities can be envisaged. 'Proof-of-concept' results are now available for various drug classes including beta(2)-adrenoceptor agonists, corticosteroids, antimycobacterial antibacterials, estradiol and therapeutic macromolecules such as insulin. Nevertheless, their development success must overcome several critical and unique challenges including toxicological evaluations of microsphere materials, and, clearly, successful products should meet the needs of the patient and the market place. Unfortunately, such issues have not always been addressed or examined adequately in the current studies, and thus we may anticipate paradigm shifts in the research of several groups seeking to develop products with improved therapeutic profiles. Nevertheless, it seems likely that improved inhalation products, with greater therapeutic efficacy and reduced adverse effects, will result from next-generation respirable microspheres. These may be expected to contain drugs intended for both local and systemic activity.

Administration, Inhalation↗

FGF-4 gene therapy GENERX--Collateral Therapeutics.

Collateral Therapeutics and Schering AG in Germany are developing a gene therapy product, GENERX for coronary artery disease. Based on the terms of the agreement, Schering or its affliates will be responsible for conducting and financing phase II/III clinical trials which are currently underway in the US and Europe. In particular, Berlex Labs (the US subsidiary of Schering AG), is involved in developing the gene therapy in the US. GENERX is an angiogenic gene therapy which triggers the production of a protein that stimulates new blood vessel growth providing an alternative route for blood to bypass clogged and blocked arteries in the heart. GENERX involves a one-time, non-surgical delivery of an adenovirus vector containing the human fibroblast growth factor-4 (FGF-4) into coronary arteries via a standard catheter. The FGF-4 gene was licensed from New York University. Collateral Therapeutics has been granted a US patent for "gene transfer-mediated angiogenesis therapy" for the nonsurgical administration of angiogenic genes for coronary and peripheral vascular disease. The patented technology has been licensed from the University of California. Collateral and Berlex have initiated pivotal phase IIb/III trials with GENERX in the US and Europe. The US-based study will evaluate the safety and efficacy of GENERX in patients with stable exertional angina due to coronary artery disease. The European-based study will evaluate patients with advanced coronary artery disease who are not considered candidates for interventions such as angioplasty and bypass surgery and/or patients who are unlikely to have positive outcomes from such interventions. Both studies, of a multicentre, randomised, double-blind and placebo-controlled design, will evaluate 2 dose levels of GENERX which will be non-surgically administered to the heart via intracoronary infusion through a standard cardiac catheter. Collateral also plans to develop a non-surgical gene therapy product using the FGF-4 gene for the treatment of patients with heart failure. In a blinded placebo-controlled study in a pig model of pacing-induced heart failure, intracoronary delivery of human FGF-4 expressed in an adenovirus vector showed significant improvement in regional cardiac function and a reduction in the size of the heart over a 3-week study period. If these results translated favourably to humans, FGF-4 gene therapy may be a therapeutic option for patients with dilated heart failure. Collateral Therapeutics has also announced a research collaboration with Targeted Genetics on the use of viral vectors to deliver therapeutic genes in cardiovascular disease. Under the terms of the agreement, Targeted Genetics and Collateral Therapeutics each have the option to collaborate further to use Targeted Genetics' recombinant adeno-associated viral vector to treat congestive heart failure. In such an event, Targeted Genetics would be responsible for constructing and manufacturing the vector, and Collateral Therapeutics will fund the costs of future collaboration. Either party may terminate this agreement at any time upon 30 days prior written notice.

Adenoviridae↗

Effectiveness of diabetic therapeutic footwear in preventing reulceration.

OBJECTIVE: To review the evidence for the effectiveness of therapeutic footwear in preventing foot reulceration in individuals with diabetes and foot risk factors. RESEARCH DESIGN AND METHODS: We conducted a structured literature review based on a Medline search for studies of therapeutic footwear that examined prevention of reulceration. Nine published articles were identified. Characteristics of the study population, components of the intervention, and level of adherence were evaluated. U.S. Preventive Services Task Force criteria for evaluating research were applied to rate each study on study design and internal validity. RESULTS: Risk ratios in all studies assessing the association between therapeutic footwear and reulceration were below 1.0, suggesting some protective footwear benefit. However, in the most rigorous experimental study, no statistically significant benefit was observed between control patients wearing their own footwear and intervention patients wearing study footwear. Annual reulceration in these studies' control groups ranged from 8.4 to 59.3%. In patients with severe foot deformity or prior toe or ray amputation, observational studies suggested a significant protective benefit from therapeutic footwear. CONCLUSIONS: Therapeutic footwear has been used for decades as one of many strategies to prevent reulceration in patients with diabetes and foot risk factors. The findings of several studies reporting statistically significant protective effects from therapeutic footwear may have been influenced by several design issues. When considering the appropriateness of therapeutic footwear recommendations for moderate-risk patients, clinicians and patients should jointly explore individual strategies to decrease events that lead to foot ulcers.

Diabetic Foot↗

CD28, TNF receptor, and IL-12 are critical for CD4-independent cross-priming of therapeutic antitumor CD8+ T cells.

Previously, we have shown that priming of therapeutic CD8(+) T cells in tumor vaccine-draining lymph nodes of mice vaccinated with GM-CSF secreting B16BL6 melanoma cells occurs independent of CD4 T cell help. In this study, we examined the contribution of the major costimulatory molecules, CD40 ligand (CD40L), CD80, and CD86, in the priming of CD8(+) T cells. Priming of therapeutic CD8(+) T cells by a GM-CSF-transduced tumor vaccine did not require CD40 and CD40L interactions, as therapeutic T cells could be generated from mice injected with anti-CD40L Ab and from CD40L knockout mice. However, costimulation via either CD80 or CD86 was required, as therapeutic T cells could be generated from mice injected with either anti-CD80 or anti-CD86 Ab alone, but administration of both Abs completely inhibited the priming of therapeutic T cells. Blocking experiments also identified that priming of therapeutic T cells in MHC class II-deficient mice required TNFR and IL-12 signaling, but signaling through CD40, lymphotoxin-betaR, or receptor activator of NF-kappaB was not essential. Thus, cross-priming of therapeutic CD8(+) T cells by a tumor vaccine transduced with GM-CSF requires TNFR, IL-12, and CD28 signaling.

Animals↗

Therapeutic use of Bausch & Lomb PureVision contact lenses.

PURPOSE: To evaluate the Bausch & Lomb PureVision contact lens as a continuous wear contact lens for therapeutic indications in a prospective open-ended non-randomized clinical trial. METHODS: Patients with a variety of corneal and ocular surface disease conditions presenting at the Singapore National Eye Centre who required therapeutic continuous contact lens wear were enrolled. Therapeutic indications included pain relief, corneal protection, and enhancement of corneal wound healing. Success or failure of specific treatment indications was assessed in all cases, with evaluation of lens performance and fit characteristics, and the presence of ocular complications or lens-related complications was noted. RESULTS: There were 54 patients (54 eyes), and the mean duration of continuous contact lens wear was 1.1 months. Conditions treated included post-surgical indications (n = 36) (post-keratoplasty or ocular surface transplantation, post-LASIK or PRK surgery) bullous keratopathy (n = 7), chemical burns (n = 3), epithelial abrasions or recurrent corneal erosion syndromes (n = 3), corneal perforations (n = 3), neurotrophic ulcer (n = 1), and corneal laceration (n = 1). For the indication of corneal healing (40 eyes), improved healing was noted in 38 eyes (96%), with full healing occurring in 33 eyes (83%). For pain relief (28 eyes), 27 patients (96%) had considerable or complete pain relief, and the remaining patient reported partial pain relief. For corneal protection (21 eyes), lens wear was fully protective in all cases. The lens performance and fitting characteristics surpassed any previous therapeutic lenses used by the investigators. Complications related to contact lens wear were limited to one case of a culture-negative corneal infiltrate requiring cessation of therapeutic lens wear and one case of a loosely fit lens. CONCLUSIONS: Our results show that the PureVision contact lens exhibits good safety and efficacy when utilized as a continuous wear therapeutic lens. With the theoretical advantage of increased oxygen transmissibility reducing the risk of hypoxia-related complications, this new lens may be one step closer to the ideal therapeutic contact lens. The PureVision contact lens is now our primary bandage lens of choice in our corneal, external disease, and refractive surgery services.

Adolescent↗

Balloon occlusion test and therapeutic occlusion on traumatic carotid cavernous fistulas.

OBJECTIVE: To evaluate the safety of the balloon occlusion test(BOT) and therapeutic occlusion of the internal carotid artery(ICA). METHODS: The data of 43 patients hospitalized consecutively with traumatic intractable carotid cavernous fistulas (TICCF) were analyzed. Therapeutic occlusion of ICA was performed on 39 cases and BOT was only performed on the remaining 4 cases. Our assessment consisted of: (1) angiographic evaluation of collateral circulation with or without BOT of ICA, and (2) evaluation of clinical tolerance to therapeutic occlusion of ICA with hypotensive challenge for 30 minutes. Complications of BOT and therapeutic occlusion of ICA were also analyzed retrospectively. RESULTS: Complications related to BOT occurred in 1 case (2.3%) without causing permanent deficits. Complications related to therapeutic occlusion of ICA occurred in 4 cases (10%), including 1 technical (2.5%), 2 temporary (5%) and 1 permanent (2.5%) deficit. There was no fistula recurrence or mortality. CONCLUSIONS: BOT of ICA is safe and economical. The reliability of the results is almost the same compared with that of other more complicated methods of assessing therapeutic occlusion of ICA. And it is easy to treat TICCF with therapeutic occlusion of ICA.

Journal Article↗

Therapeutic keratoplasty for infectious keratitis: a review of the literature.

PURPOSE: This article provides a review of the literature on various aspects of therapeutic keratoplasty, including indications, techniques, complications and outcome, and its application in cases of infectious keratitis. METHODS: Various articles on therapeutic keratoplasty (including English- and non-English-language publications) were analyzed. Selection of the articles was based on a Medline search for articles using the key words therapeutic keratoplasty, penetrating keratoplasty, therapeutic keratoplasty for infectious keratitis, non-healing corneal ulcer, microbial keratitis, and perforated corneal ulcer. Abstracts in English were used for non-English articles. RESULTS: Therapeutic keratoplasty has a definitive role in the management of progressive bacterial, fungal, Acanthamoeba, and viral keratitis refractory to medical treatment. Management of bacterial keratitis has higher functional success and anatomic cure rate compared with fungal, viral and Acanthamoeba keratitis. Therapeutic keratoplasty offers a cure rate of up to 100% in bacterial and fungal keratitis, whereas the recurrence of infection after Acanthamoeba keratitis is frequent. Visual outcome depends on various factors such as the causative agent, timing of surgery, degree of inflammation, type of donor material used, and size of the graft used. For example, larger grafts have a higher incidence of graft rejection and failure compared to smaller grafts. The primary aim of the procedure is to reestablish the integrity of the globe and to eliminate the infectious disease process. Visual rehabilitation is a secondary outcome. CONCLUSIONS: This review helps to elucidate the various aspects of therapeutic keratoplasty, including indications, preoperative assessment, surgical techniques, postoperative management, complications, and anatomic and functional outcome.

Corneal Ulcer↗