医学文献翻译(中英对照)
The clinical and cost-effectiveness of Pharmalgen? for the treatment of bee and wasp venom allergy
1 TITLE OF PROJECT
The clinical and cost effectiveness of Pharmalgen? for the treatment of bee and wasp venom allergy
2 TAR TEAM
Liverpool Reviews and Implementation Group (LR i G), University of Liverpool Correspondence to:
Rumona Dickson, Ms
Director, LR i G
University of Liverpool
Room 2.12
Whelan Building
The Quadrangle
Brownlow Hill
Liverpool
L69 3GB
Tel: +44 (0) 151 794 5682
Fax: +44 (0)151 794 5585
Email: R.Dickson@https://www.wendangku.net/doc/fa15158891.html,
For details of expertise within the TAR team, see section 7.
3 PLAIN ENGLISH SUMMARY
Allergic reactions to bee and wasp venom may occur in venom-sensitive patients immediately following a sting, and can vary in severity, with initially mild symptoms sometimes progressing to critical conditions within seconds. The most severe systemic allergic reactions (generalised reactions) are known as anaphylaxis, a reaction characterised by abnormally low blood pressure, fainting or collapse, and in extreme reactions these symptoms can cause death.
Each year in the UK there are between two and nine deaths from anaphylaxis caused by bee and wasp venom. The immediate treatment for severe allergic reactions to bee and wasp venom cons ists of emergency treatment with drugs to decrease the patient’s response to the venom and support breathing, if required.
To avoid further reactions, the use of sensitisation to bee and wasp venom, through a process known as venom immunotherapy (VIT), has been investigated. Venom immunotherapy consists of subcutaneous injections of increasing amounts of venom into patients with a history of anaphylaxis to bee and wasp venom. Pharmalgen? has had UK marketing authorisation for the diagnosis and treatment (using VIT) of allergy to bee venom (using Pharmalgen? Bee Venom) and wasp venom (using Pharmalgen? Wasp Venom) since March 1995, and it is used by more than 40 centres across the UK. This review aims to assess whether using Pharmalgen? in VIT is clinically useful when treating people with a history of severe reaction to bee and wasp stings. The review will compare preventative treatment with Pharmalgen? to other treatment options, including high dose antihistamines, advice on the
avoidance of bee and wasp stings and adrenaline auto-injector prescription and training. If suitable data are available, the review will also consider the cost effectiveness of using Pharmalgen? for VIT and other subgroups including children and people at high risk of future stings or severe allergic reactions to future stings.
4 DECISION PROBLEM
4.1 Clarification of research question and scope
Pharmalgen? is used for the diagnosis and treatment of immunoglobin E (IgE)-mediated allergy to bee and wasp venom. The aim of this report is to assess whether the use of Pharmalgen? is of clinical value when providing VIT to individuals with a history of severe reaction to bee and wasp venom and whether doing so would be considered cost effective compared with alternative treatment options available in the NHS.
4.2 Background
Bees and wasps form part of the order Hymenoptera (which also includes ants), and within this order the species that cause the most frequent allergic reactions are the Vespidae (wasps, yellow jackets and hornets), and the Apinae (honeybees).1
Bee and wasp stings contain allergenic proteins. In wasps, these are predominantly phospholipase A1,2 hyaluronidase2 and antigen 5,3 and in bees are phospholipase A2 and hyaluronidase.4 Following an initial sting, a type 1 hypersensitivity reaction may occur in some individuals which produces the IgE antibody. This sensitises cells to the allergen, and any subsequent exposure to the allergen may cause the allergen to bind to the IgE molecules, which results in an allergic reaction.
These allergens typically produce an intense, burning pain followed by erythema (redness) and a small area of oedema (swelling) at the site of the sting. The symptoms produced following a sting can be classified into non-allergic reactions, such as local reactions, and allergic reactions, such as extensive local reactions, anaphylactic systemic reactions and delayed systemic reactions.5-6 Systemic allergic reactions may occur in venom-sensitive patients immediately following a sting,7 and can vary in severity, with initially mild symptoms sometimes progressing to critical conditions within seconds.1
The most severe systemic allergic reaction is known as anaphylaxis. Anaphylactic reactions are of rapid onset (typically up to 15 minutes post sting) and can manifest in different ways. Initial symptoms are usually cutaneous followed by hypotension, with light-headedness, fainting or collapse. Some people develop respiratory symptoms due to an asthma-like response or laryngeal oedema. In severe reactions, hypotension, circulatory disturbances, and breathing difficulty can progress to fatal cardio-respiratory arrest.
Anaphylaxis occurs more commonly in males and in people under 20 years of age and can be severe and potentially fatal.8
4.3 Epidemiology
It is estimated that the prevalence of wasp and bee sting allergy is between 0.4% and 3.3%.9 The incidence of systemic reactions to wasp and bee venom is not reliably known, but estimates range from 0.15-3.3%,10-11 Systemic allergic reactions are reported by up to 3% of adults, and almost 1% of children have a medical history of severe sting reactions.9, 12 After a large local reaction, 5–15% of people will go on to develop a systemic reaction when next stung.13 In people with a mild systemic reaction, the risk of subsequent systemic reactions is thought to be about 18%.13 Hymenoptera venom are one of the three main causes of fatal
anaphylaxis in the USA and UK.14-15 Insect stings are the second most frequent cause of anaphylaxis outside of medical settings.16 Between two and nine people in the UK die each year as a result of anaphylaxis due to reactions to wasp and bee stings.17 Once an individual has experienced an anaphylactic reaction, the risk of having a recurrent episode has been estimated to be between 60% and 79%.13
In 2000, the register of fatal anaphylactic reactions in the UK from 1992 onwards was reported by Pumphrey to determine the frequency at which classic manifestations of fatal anaphylaxis are present.18 Of the 56 post-mortems carried out, 19 deaths were recorded as reactions to Hymenoptera venom (33.9%). A retrospective study in 2004 examined all deaths from anaphylaxis in the UK between 1992 and 2001, and estimated 22.19% to be reactions to Hymenoptera venom (47/212). This further breaks down into 29/212 (13.68%) as reactions to wasp stings, and 4/212 (1.89%) as reactions to bee stings. The remaining 14/212 were unidentified Hymenoptera stings (6.62%).19
4.4 Current diagnostic options
Currently, individuals can be tested to determine if they are at risk of systemic reactions to bee and wasp venom. The primary diagnostic method for systemic reactions to bee and/or wasp stings is venom skin testing.
Skin testing involves intradermal injection with the five Hymenoptera venom protein extracts, with v enom concentrations in the range of 0.001 to 1.0 μg/ml. This establishes the minimum concentration giving a positive result (a reaction occurring in the individual). As venom tests show unexplained variability over time,20 and as negative skin tests can occur following recent anaphylaxis, it is recommended that tests be repeated after 1 to 6 months.21
Other methods of diagnosis in patients following an anaphylactic reaction include radioallergosorbent test (RAST), which detects allergen-specific IgE antibodies in serum. This test is less sensitive than skin testing but is useful when skin tests cannot be done, for example in patients with skin conditions.22-23
4.5 Current treatment options
Preventative treatments include education on how to avoid bee and wasp venom, and prescription of high dose antihistamines. Patients with a history of moderate local reactions should be provided with an emergency kit,24 containing a H1-blocking antihistamine and a topical corticosteroid for immediate use following a sting. Patients with a history of anaphylaxis should be provided with an emergency kit containing a rapid-acting H1-blocking antihistamine, an oral corticosteroid and an auto-injector for self administration, containing epinephrine.
Injected epinephrine (a sympathomimetic drug which acts on both alpha and beta receptors) is regarded as the emergency treatment of choice for cases of acute anaphylaxis as a result of Hymenoptera stings.25 For adults, the recommended dose is between 0.30 mg/ml and 0.50
mg/ml I.M, and 0.01 ml/kg I.M. for children. Individuals with a history of anaphylactic reactions are recommended to carry auto injectors containing epinephrine (commonly known as EpiPen?, Adrenaclick?, Anapen? or Twinject?). These are intended for immediate
self-administration by individuals with a history of hypersensitivity to Hymenoptera stings and other allergens.
Preventive measures following successful treatment of a systemic allergic reaction to Hymenoptera venom consists of either allergen avoidance or specific allergen immunotherapy,
known as VIT. Venom immunotherapy is considered to be a safe and effective treatment.26 Currently, VIT can be used with several regimes, including Pharmalgen? (manufactured by ALK Abello, and licensed in the UK), Aquagen? and Alutard SQ? (both manufactured by ALK Abello and unlicensed in the UK but licensed in some parts of Europe), VENOMENHAL? (HAL Allergy, Leiden, Netherlands, unlicensed in the UK), Alyostal? (Stallergenes, Antony Cedex, France, unlicensed in the UK), and Venomil? (Hollister-Stier Laboratories LLC, unlicensed in the UK). Venom immunotherapy is recommended to prevent future systemic reactions. It is recommended that VIT is considered ‘when positive test results for specific IgE antibodies correlate with suspected triggers and patient exposure’.27 Venom immunotherapy consists of subcutaneous injections of increasing amounts of venom, and treatment is divided into two periods: the build up phase and maintenance phase. Venom immunotherapy is now the standard therapy for Hymenoptera sting allergy,28 and is a model for allergen-specific therapy,29-30 with success rates (patients who will remain anaphylaxis free) being reported as more than 98% in some studies.4, 31 There are now 44 centres across the UK which provide VIT to people for bee and wasp sting allergy. Venom immunotherapy is normally discontinued after 3 to 5 years, but modifications may be necessary when treating people with intense allergen exposure (such as beekeepers) or those with individual risk factors for severe reactions. There is no method of assessing which patients will be at risk of further anaphylactic reactions following administration of VIT and those who will remain anaphylaxis free in the long term following VIT.27
Local or systemic adverse reactions may occur as a result of VIT. They normally develop within 30 minutes of the injection. Each patient is monitored closely following each injection to check for adverse reactions. Progression to an increased dose only occurs if the previous dose is fully tolerated.
4.6 The technology
Pharmalgen? is produced by ALK Abello, and has had UK marketing authorisation for the diagnosis (using skin testing/intracutaneous testing) and treatment (using VIT) of
IgE-mediated allergy to bee venom (Pharmalgen? Bee Venom) and wasp venom (Pharmalgen? Wasp Venom) since March 1995 (marketing authorisation number PL
10085/0004). The active ingredient is partially purified freeze dried Vespula spp. venom in Pharmalgen? Wasp Venom and freeze dried Apis mellifera venom in Pharmalgen? Bee Venom, each provided in powder form for solution for injection.
Before treatment is considered, allergy to bee or wasp venom must be confirmed by case history and diagnosis. Treatment with Pharmalgen? Bee or Wasp Venom is performed by subcutaneous injections. The treatment is carried out in two phases: the initial phase and the maintenance phase.
In the build up phase, the dose is increased stepwise until the maintenance dose (the maximum tolerable dose before an allergic reaction) is achieved. ALK Abello recommends the following dosage proposals: conventional, modified rush (clustered) and rush updosing. In conventional updosing, the patient receives one injection every 3-7 days. In modified rush (clustered) updosing, the patient receives 2-4 injections once a week. If necessary this interval may be extended up to two weeks. The 2-4 injections are given with an interval of 30 minutes. In rush updosing, while being hospitalised the patient receives injections with a 2-hour interval. A maximum of four injections per day may be given in the initial phase.
The build up phase ends when the individual maintenance dose has been attained and the interval between the injections is increased to 2, 3 and 4 weeks. This is called the maintenance phase, and the maintenance dose is then given every 4 weeks for at least 3 years. Contra-indications to VIT treatment are immunological diseases (e. g. immune complex diseases and immune deficiencies); chronic heart/lung diseases; treatment with β-blockers; severe eczema. Side effects include superficial wheal and flare due to shallow injection; local swelling (which may be immediate or delayed up to 48 hours); mild general reactions such as urticaria, erythema, rhinitis or mild asthma; moderate or severe general reactions such as more severe asthma, angioedema or an anaphylactic reaction with hypotension and respiratory embarrassment; anaphylaxis (often starting with erythema and pruritus, followed by urticaria, angioedema, nasal or pharyngial congestion, wheezing, dyspnoea, nausea, hypotension, syncope, tachycardia or diarrhoea). 32
4.7 Objectives of the HTA project
The aim of this review is to assess the clinical and cost effectiveness of Pharmalgen? in providing immunotherapy to individuals with a history of type 1 IgE-mediated systemic allergic reaction to bee and wasp venom. The review will consider the effectiveness of Pharmalgen? when compared to alternative treatment options available in the NHS, including advice on the avoidance of bee and wasp stings, high dose antihistamines and adrenaline auto-injector prescription and training. The review will also examine the existing health economic evidence and identify the key economic issues related to the use of Pharmalgen? in UK clinical practice. If suitable data are available, an economic model will be developed and populated to evaluate if the use of Pharmalgen? for the treatment of bee and wasp venom allergy, within its licensed indication, would be a cost effective use of NHS resources.
5 METHODS FOR SYNTHESISING CLINICAL EFFECTIVENESS EVIDENCE
5.1 Search strategy
The major electronic databases including Medline, Embase and The Cochrane Library will be searched for relevant published literature. Information on studies in progress, unpublished research or research reported in the grey literature will be sought by searching a range of relevant databases including National Research Register and Controlled Clinical Trials. A sample of the search strategy to be used for MEDLINE is presented in
Appendix 1.
Bibliographies of previous systematic reviews, retrieved articles and the submissions provided by manufacturers will be searched for further studies.
A database of published and unpublished literature will be assembled from systematic searches of electronic sources, hand searching, contacting manufacturers and consultation with experts in the field. The database will be held in the Endnote X4 software package.
5.1.1 Inclusion criteria
The inclusion criteria specified in Table 1 will be applied to all studies after screening. The inclusion criteria were selected to reflect the criteria described in the final scope issued by NICE for the review. However, as there is likely to be a limited amount of RCT data, the inclusion criteria of study design may be expanded to include comparative studies and descriptive cohorts. The clinical and cost effectiveness of Pharmalgen? for the treatment of bee and wasp venom allergy Page 11 of 21
Table 1: Inclusion criteria Intervention(s) Pharmalgen? for the treatment of bee and wasp
venom allergy,
Population(s) People with a history of type 1 IgE-mediated
systemic allergic reactions to:
wasp venom and/or bee venom
Comparators Alternative treatment options available in the
NHS, without venom immunotherapy including:
advice on the avoidance of bee and wasp
venom,
high-dose antihistamines,
adrenaline auto-injector prescription and
training
Study design Randomised controlled trials
Systematic reviews
Outcomes Outcome measures to be considered include:
number and severity of type 1 IgE-mediated
systemic allergic reactions
mortality
anxiety related to the possibility of future allergic
reactions
adverse effects of treatment
health-related quality of life
Other considerations If the evidence allows, considerations will be
given to subgroups of people, according to
their:
risk of future stings (as determined, for
example, by occupational exposure)
risk of severe allergic reactions to future stings
(as determined by such factors as baseline
tryptase levels and co-morbidities)
If the evidence allows, the appraisal will
consider separately people who have a
contraindication to adrenaline.
If the evidence allows, the appraisal will
consider children separately.
Two reviewers will independently screen all titles and abstracts of papers identified in the initial search. Discrepancies will be resolved by consensus and where necessary a third reviewer will be consulted. Studies deemed to be relevant will be obtained and assessed for inclusion. Where studies do not meet the inclusion criteria they will be excluded.
5.1.2 Data extraction strategy
Data relating to study design, findings and quality will be extracted by one reviewer and
independently checked for accuracy by a second reviewer. Study details will be extracted using a standardised data extraction form. If time permits, attempts will be made to contact authors for missing data. Data from studies presented in multiple publications will be extracted and reported as a single study with all relevant other publications listed.
5.1.3 Quality assessment strategy
The quality of the clinical-effectiveness studies will be assessed according to criteria based on the CRD’s guidance for undertaking reviews in healthcare.33-34 The quality of the individual clinical-effectiveness studies will be assessed by one reviewer, and independently checked for agreement by a second. Disagreements will be resolved through consensus and if necessary a third reviewer will be consulted.
5.1.4 Methods of analysis/synthesis
The results of the data extraction and quality assessment for each study will be presented in structured tables and as a narrative summary. The possible effects of study quality on the effectiveness data and review findings will be discussed. All summary statistics will be extracted for each outcome and where possible, data will be pooled using a standard meta-analysis.35 Heterogeneity between the studies will be assessed using the I2 test.34 Both fixed and random effects results will be presented as forest plots.
6 METHODS FOR SYNTHESISING COST EFFECTIVENESS EVIDENCE The economic section of the report will be presented in two parts. The first will include a standard review of relevant published economic evaluations. If appropriate and data are available, the second will include the development of an economic model. The model will be designed to estimate the cost effectiveness of Pharmalgen? for VIT in individuals with a history of anaphylaxis to bee and wasp venom. This section of the report will also consider budget impact and will take account of available information on current and anticipated patient numbers and service configuration for the treatment of this condition in the NHS.
6.1 Systematic review of published economic literature
The literature review of economic evidence will identify any relevant published cost-minimisation, cost-effectiveness, cost-utility and/or cost-benefit analyses. Economic evaluations/models included in the manufacturer submission(s) will be included in the review and critiqued as appropriate.
6.1.1 Search strategy
The search strategies detailed in section 5 will be adapted accordingly to identify studies examining the cost effectiveness of using Pharmalgen? for VIT in patients with a history of allergic reactions to bee or wasp venom. Other searching activities, including electronic searching of online health economic journals and contacting experts in the field will also be undertaken. Full details of the search process will be presented in the final report. The search strategy will be designed to meet the primary objective of identifying economic evaluations for inclusion in the cost-effectiveness literature review. At the same time, the search strategy will be used to identify economic evaluations and other information sources which may include data that can be used to populate a de novo economic model where appropriate. Searching will be undertaken in MEDLINE and EMBASE as well as in the Cochrane Library, which includes the NHS Economic Evaluation Database (NHS EED).
6.1.2 Inclusion and exclusion
In addition to the inclusion criteria outlined in Table 1, specific criteria required for the
cost-effectiveness review are described in Table 2. In particular, only full economic evaluations that compare two or more options and consider both costs and consequences will be included in the review of published literature. Any economic evaluations/models included in the manufacturer submission(s) will be included as appropriate. Studies that do not meet all of the criteria will be excluded and their bibliographic details listed with reasons for exclusion.
Table 2: Additional inclusion criteria (cost effectiveness) Study design Full economic evaluations that consider both costs and consequences
(cost-effectiveness analysis, cost-utility analysis, cost-minimisation analysis and cost benefit analysis)
Outcomes Incremental cost per life year gained
Incremental cost per quality adjusted life
year gained
6.1.3 Data extraction strategy
Data relating to both study design and quality will be extracted by one reviewer and independently checked for accuracy by a second reviewer. Disagreement will be resolved through consensus and, if necessary, a third reviewer will be consulted. If time constraints allow, attempts will be made to contact authors for missing data. Data from multiple publications will be extracted and reported as a single study.
6.1.4 Quality assessment strategy
The quality of the cost-effectiveness studies/models will be assessed according to a checklist updated from that developed by Drummond et al.36 This checklist will reflect the criteria for economic evaluation detailed in the methodological guidance developed by NICE.37 The quality of the individual cost-effectiveness studies/models will be assessed by one reviewer, and independently checked for agreement by a second. Disagreements will be resolved through consensus and, if necessary, a third reviewer will be consulted. The information will be tabulated and summarised within the text of the report.
6.2 Methods of analysis/synthesis
6.2.1 Cost effectiveness review of published literature
Individual study data and quality assessment will be summarised in structured tables and as a narrative description. Potential effects of study quality will be discussed.
To supplement findings from the economic literature review, additional cost and benefit information from other sources, including the manufacturer submission(s) to NICE, will be collated and presented as appropriate.
6.2.2 Development of a de novo economic model by the AG
a. Cost data
The primary perspective for the analysis of cost information will be the NHS. Cost data will therefore focus on the marginal direct health service costs associated with the intervention. Quantities of resources used will be identified from consultation with experts, primary data from relevant sources and the reviewed literature. Where possible, unit cost data will be extracted from the literature or obtained from other relevant sources (drug price lists, NHS reference costs and Chartered Institute of Public Finance and Accounting cost databases).
Where appropriate costs will be discounted at 3.5% per annum, the rate recommended in NICE guidance to manufacturers and sponsors of submissions. 37
b. Assessmentof benefits
A balance sheet will be constructed to list benefits and costs arising from alternative treatment options. LRiG anticipates that the main measures of benefit will be increased QALYs. Where appropriate, effectiveness and other measures of benefit will be discounted at 3.5%, the rate recommended in NICE guidance to manufacturers and sponsors of submissions. 37 b. Modelling
The ability of LRiG to construct an economic model will depend on the data available. Where modelling is appropriate, a summary description of the model and a critical appraisal of key structures, assumptions, resources, data and sensitivity analysis (see Section d) will be presented. In addition, LRiG will provide an assessment of the model’s strengths and weaknesses and discuss the implications of using different assumptions in the model. Reasons for any major discrepancies between the results obtained from assessment group model and the manufacturer model(s) will be explored.
The time horizon will be a patient’s lifetime in order to reflect the chronic natu re of the disease.
A formal combination of costs and benefits will also be performed, although the type of economic evaluation will only be chosen in light of the variations in outcome identified from the clinical- effectiveness review evidence.
If data are available, the results will be presented as incremental cost per QALY ratios for each alternative considered. If sufficient data are not available to construct these measures with reasonable precision, incremental cost-effectiveness analysis or cost-minimisation analysis will be undertaken. Any failure to meet the reference case will be clearly specified and justified, and the likely implications will, as far as possible, be quantified.
d. Sensitivity analysis
If appropriate, sensitivity analysis will be applied to LRiG’s model in order to assess the robustness of the results to realistic variations in the levels of the underlying parameter values and key assumptions. Where the overall results are sensitive to a particular variable, the sensitivity analysis will explore the exact nature of the impact of variations.
Imprecision inthe principal model cost-effectiveness results with respect to key parameter values will be assessed by use of techniques compatible with the modelling methodology deemed appropriate to the research question and to the potential impact on decision making for specific comparisons (e.g. multi-way sensitivity analysis, cost-effectiveness acceptability curves etc).
7 HANDLING THE MANUFACTURER SUBMISSION(S)
All data submitted by the drug manufacturers arriving before 22nd March 2011 and meeting the set inclusion criteria will be considered for inclusion in the review. Data arriving after this date will only be considered if time constraints allow. Any economic evaluations included in the manufacturer submission(s) will be assessed. This will include a detailed analysis of the appropriateness of the parametric and structural assumptions involved in any models in the submission and an assessment of how robust the models are to changes in key assumptions. Clarification on specific aspects of the model may be sought from the relevant manufacturer. Any 'commercial in confidence' data taken from a manufacturer submission will be clearly
marked in the NICE report according to established NICE policy and removed from the subsequent submission to the HTA
8 EXPERTISE IN THIS TAR TEAM AND COMPETING INTERESTS OF AUTHORS
This TAR team will be made up of the following individuals:
Team lead /clinical systematic reviewer Juliet Hockenhull
Senior economic modeller Professor Adrian Bagust
Systematic reviewer (clinical) Gemma Cherry
Systematic reviewer (economics) Dr Angela Boland
Economic modeller Dr Carlos Martin Saborido
Information specialist Dr Yenal Dundar
Medical statistician James Oyee
Director Ms Rumona Dickson
Clinical advisor A team of clinical experts will be
established to address clinical questions
related to the technology and to provide
feedback on drafts of the final report
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endix 1 Details of MEDLINE clinical effectiveness search strategies:
1. exp wasps/ or exp bees/
2. *Hymenoptera/
3. (wasp$ or honeybee$ or bees or yellow hornet$ or yellow jacket$ or white hornet$ or poliste$).tw.
4. *hypersensitivity, delayed/ or *hypersensitivity, immediate/
5. ((wasp$ or bees) adj (venom or sting) adj (hypersensitivit$ or allerg$ or anaphylax$ or systemic reaction$)).tw.
6. or/1-5
7. Pharmalgen.af.
8. *Immunotherapy/ or immunotherap$.ti,ab.
9. *Desensitization, Immunologic/
10. or/7-9
11. 6 and 10
12. limit 11 to (english language and humans)
Pharmalgen?治疗蜜蜂和黄蜂的毒液过敏的临床和成本效益1 课题题目
Pharmalgen?治疗蜜蜂和黄蜂的毒液过敏的临床和成本效益3 纯英文摘要
对毒素敏感的患者可能会在被蜜蜂和黄蜂的毒针刺中
后立即发生毒液的过敏反应，严重程度会有很大差异。最初症状轻微，有时在几秒钟内发展到危急的状况，最严重的全身过敏反应（广义反应）被称为过敏性休克，一个特征性的反应就是异常的低血压，昏厥或跌倒，在极端的反应发生时，这些症状可导致死亡。
在英国，每年有2－9人死于蜜蜂和黄蜂的毒液引起的过敏反应。对蜜蜂和黄蜂的毒液引起的严重的过敏反应应立即采取的治疗措施包括用药物来减轻病人对毒液的反应和必
要情况下的呼吸支持。为了避免更严重的反应，已经开始对蜜蜂和黄蜂毒液导致过敏的免疫过程进行研究。毒液免疫过程包括增加对蜜蜂和黄蜂毒液有过敏史的患者皮下注射的
毒液量。
从1995年3月至今，拥有英国上市许可的用于诊断和治疗蜜蜂（使用Pharmalgen?蜜蜂毒液）和胡蜂（使用
Pharmalgen?胡蜂毒液）蜂毒过敏的药物Pharmalgen?（使用毒液免疫），已经在英国的40多个医疗中心中使用。
这次回顾分析的目的是评估Pharmalgen?在治疗蜜蜂和胡蜂蜇伤严重反应史的人的蜂毒过敏方面的临床作用。这次回顾分析将对比使用Pharmalgen?进行预防性治疗的方案和其它治疗方案，包括稿剂量的抗组胺药，避免被蜜蜂和黄蜂蜇伤的建议，肾上腺素药自动注射的处方和训练。如果有合适的数据可用，这次回顾性分析也将考虑在蜂毒过敏者和遭到蜂蜇风险较高或被蜂蜇会发生严重过敏反应的儿童和其他人群中使用Pharmalgen?的成本效益。
4 决策问题
4.1 关于研究的问题及范围的说明
Pharmalgen?是用于诊断和治疗免疫球蛋白E（IgE）介导的蜜蜂和黄蜂的毒液过敏的药物。本报告的目的是评估对有蜜蜂和黄蜂的毒液严重反应史的个人使用Pharmalgen以提供毒液免疫是否具有临床应用价值，这样做和NHS提供的替代治疗方案相比是否更符合成本效益，更划算。
4.2 背景
蜜蜂和黄蜂是膜翅目昆虫的一部分（同样也包括蚂蚁），在这一类昆虫中最常见的导致过敏反应的是黄蜂和蜜蜂。
蜜蜂和马蜂刺含有过敏的蛋白质。黄蜂的致过敏蛋白主要是
磷脂酶A1，透明质酸酶和抗原5，而蜜蜂的致过敏蛋白主要是磷脂酶A2和透明质酸。在被某个蜂刺蜇了后，某些个体可能会发生1型过敏反应并产生IgE抗体。这类对过敏原敏感的细胞和任何对过敏原的再次接触都可能导致IgE抗体分子和过敏原结合，这会导致过敏性反应。这些过敏原通常会产生强烈的烧灼样疼痛，在刺痛部位会有小面积的红斑（发红）和水肿（肿胀）。
这些被蜇后产生的症状可以分为非过敏性反应如局部反应，还有过敏反应，如广泛的局部反应，全身过敏性反应和迟发性全身反应。对毒液敏感的患者在被蜂刺蜇了之后可能会立即发生系统性的过敏反应，在严重的程度上会有所差异，最初症状轻微，有时在几秒钟内发展到危急的状况。最严重的全身过敏性症状被称为过敏反应。过敏反应起效迅速（通常在被蜂刺蜇后15分钟），并能以不同的方式体现。最初的症状通常是皮肤其次是低血压，头晕，昏厥或晕倒。有些人发展致哮喘样反应如喉头水肿，呼吸道症状。严重的低血压，循环系统障碍，呼吸困难等反应，可以进展到致命的心跳呼吸骤停。过敏反应较为普遍发生在男性和未满20岁的人，可以是严重和潜在致命的。
4.3 流行病学
据估计，黄蜂和蜜蜂蜇伤后过敏的发生率是0.4％和
3.3％之间。黄蜂和蜜蜂毒液的全身性反应的发生率是不可靠的，但估计范围从0.15-3.3％。据报道，有严重的刺痛反应的病史的患者，会导致成年人的全身性过敏反应升高达3％，儿童的全身性过敏反应升高达1％。经过大量的局部反应，有5-15％的人会在下次被蜂蜇时的发生一种全身反应。发生温和的全身性反应的人，随后的全身性反应的风险被认为是18％左右。蜂毒液是在美国和英国的三个主要的致命过敏反应的原因之一。昆虫叮咬的医疗环境以外的第二个最常见的过敏的原因
在英国，每年有两到九人死于由于黄蜂和蜜蜂蜇刺引起的过敏反应。一个人一旦经历了过敏反应，经常性发作过敏反应的风险大约是60％和79％之间。在2000年，由庞弗里报道的从1992年起在英国的致命的过敏性反应的记录确定致命过敏反应的典型表现的频率。根据56份过敏反应者的验尸报告，我们知道，有19人死于蜂毒液的反应（33.9％）。回顾2004年的研究在英国1992年和2001年之间的所有过敏死亡，估计22.19％是蜂毒液的反应（47/212）。进一步分析发现29/212（13.68％）是马蜂蜇伤，4/212（1.89％）是蜜蜂蜇伤。余下的14/212（6.62％）是被不明蜂蜇伤
4.4 目前的诊断方法
目前，个人可以进行测试，以确定他们是否处于易发蜜蜂和黄蜂毒液的全身性反应的风险中。蜜蜂和/或马蜂蜇伤的
全身反应诊断的主要方法是毒液的皮肤测试。
皮肤测试的方法是在皮内注射五种蜂毒液的蛋白提取物，其的浓度范围在0.001到1.0微克/毫升。这是可以得出阳性的结果（在个体发生的反应）的规定的最低浓度。当毒液测试表现为不明原因的变异超时，或阴性的皮肤测试结果可能会发生以下最近的过敏反应，建议1到6个月后重复测试。过敏反应的病人其他的诊断方法，包括放射变应性吸附法（RAST），一种检测血清中的过敏原特异性IgE抗体的方法。这个测试方法没有皮肤测试敏感，但在皮肤测试不能进行时可以使用该方法，比如被测试者有皮肤病时。
4.5目前的治疗方法
预防性治疗包括如何避免蜜蜂和黄蜂的毒液，高剂量抗组胺药处方的教育。应该为有温和的局部反应病史的患者应提供急救包，包内含有抗组胺药H1阻断剂和外用皮质类固醇，可以在被蜇后立即使用。应为过敏症病史的患者提供包含快速长效抗组胺药H1阻断剂，口服皮质类固醇和自我管理的自动注射器，含肾上腺素套件。注射肾上腺素（一种交感神经药物，作用于α和β受体）被视为例急性过敏反应，如蜂蜇紧急治疗的首选。
对于成年人来说，推荐剂量为0.30毫克/毫升和0.50毫克/毫升的I.M, 儿童的推荐剂量为0.01毫升/千克I.M。有过敏反应史的个体应该带着含有肾上腺素的自动注射器。（常见的
有EpiPen?, Adrenaclick?, Anapen? or Twinject?）。这些都是用于有蜂蜇伤和其他过敏原过敏史的个体的及时的自我
治疗。继成功治疗蜂毒液的全身过敏性反应的预防措施，包括避免过敏原或特定的过敏原免疫疗法，比如众所周知的VIT。毒液免疫治疗被认为是一种安全有效的治疗。
目前，VIT可以在多个国家使用，包括Pharmalgen ?（由ALK Abello生产，在英国获得许可）Aquagen? and Alutard SQ? (都是由ALK Abello生产，未在英国获得许可，但在欧洲的部分国家获得许可) VENOMENHAL? (由新西兰的
HAL Allergy, Leiden, 生产，未在英国获得许可)Alyostal ?（法国Stallergenes, Antony Cedex生产，未在英国获得许可），and Venomil? (霍利斯特的公牛实验室有限责任公司, 未在
英国获得许可).
为防止未来的系统免疫反应，毒液免疫是必需的。据建议，VIT被认为是“特异性IgE抗体的检测结果呈阳性和可以触发器及病人的暴露是相关的”。毒液免疫包括皮下注射剂量逐渐增加的毒液，治疗将分为两个阶段：建立阶段和维护阶段。毒液免疫治疗是目前治疗蜂蜇过敏的标准，也是过敏原特异性治疗模式，在一些研究报告中治疗成功率98％以上（患者仍然是无过敏性的）。目前有44个英国中心为被蜜蜂和马蜂蜇过敏者提供VIT。
毒液免疫通常持续3到5年，但当处理强烈的过敏原接触
者（如养蜂人）或有严重反应的风险因素的个体时要作出改变。现在还无法评估在使用VIT后哪些患者处于进一步的过敏反应的风险中，哪些患者在长期使用VIT后仍然处于无过敏性状态。在使用VIT后，可能出现局部或系统性的不良反应。它们通常在注射后30分钟内发生。每个病人在每次注射后都进行严密的监测以检查不良反应。逐步增加剂量的方法仅用于完全不能接受以前的剂量的情况。
4.6技术
Pharmalgen?是由ALK Abello生产，并有英国上市许可，自1995年3月起用于诊断（使用皮肤测试/皮内测试）和治疗（VIT）IgE介导的蜂毒（Pharmalgen蜂毒）和黄蜂毒液（Pharmalgen?胡蜂毒液）（营销授权证号码PL10085/0004）的过敏。活性成分是部分的Pharmalgen?的胡蜂毒液冻干粉和部分的Pharmalgen?的蜜蜂毒液冻干粉，都是粉末状以方便注射。治疗前必须通过病历和诊断确认是蜜蜂或黄蜂的毒液过敏。使用Pharmalgen?的蜜蜂或胡蜂毒液治疗的方法是皮下注射。
治疗分两个阶段：初始阶敌和维护阶段。在建设阶段，增加剂量逐步直到达到维持剂量（在发生过敏性反应前的最大耐受剂量）。ALK Abello 有如下的用量建议：常规量，改良冲击量（集群量）和冲击治疗量。常规治疗量是指病人每3－7天接受一次注射。改良冲击量（集群量）是指病人每
周接受2－4次注射。在必要的情况下这个剂量的应用间隔可延长至2周。这2－4次的注射应每30min注射一次。冲击量治疗，住院病人接受注射时应间隔2小时。在初始阶段，最多可给予每天四次注射。当个人维持剂量已达到，注射之间的间隔增加至2，3和4周时，建立阶段结束。这就是所谓的维护阶段，然后每4周给予一次维持剂量，至少3年。
VIT治疗的禁忌症有：免疫性疾病（如免疫复合物性疾病和免疫缺陷）；β-受体阻滞剂治疗的慢性心脏/肺疾病；严重的湿疹。副作用包括：由于浅层注射导致的浅表水疱和红斑;局部红肿（可能是即时或延迟至48小时）;轻度全身反应如荨麻疹，红斑，过敏性鼻炎或轻度哮喘，中度或严重的全身反应，如更严重的哮喘，血管神经性水肿或过敏反应与低血压和呼吸窘迫过敏反应（开始常表现为红斑和瘙痒，然后发展为荨麻疹，血管神经性水肿，鼻腔或咽部充血，气喘，呼吸困难，恶心，低血压，晕厥，心动过速或腹泻）。
4.7 HTA项目的目标
本次审查的目的是评估Pharmalgen?对于防止有1型IgE介导的全身过敏反应史的个人对蜜蜂和黄蜂的毒液全身过敏反应的临床和成本效益。该审查将考虑相对于NHS的替代治疗方案，其中包括避免蜜蜂和马蜂蜇伤的建议，高剂量的抗组胺药和肾上腺素自动注射处方药和培训，Pharmalgen?的成本效益。审查还将审查现有卫生经济证据，
学术英语医学Unit1-3-7-9课文翻译
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血糖好点了。胆固醇不是很好。可能需要考虑开始服用他汀类药物。 她的肝酶正常吗？ 她的体重有点增加。我需要和她谈谈每天吃五种蔬果、每天步行 30 分钟的事。 糖尿病：她早上的血糖水平和晚上的比对结果如何？她最近是否和营养师谈过？她是否看过眼科医生？足科医生呢？ 她的血压还好，但不是很好。我是不是应该再加一种降血压的药？药片多了是否让她困惑？更好地控制血压的益处和她可能什么药都不吃带来的风险孰重孰轻？ 骨密度 DEXA 扫描显示她的骨质有点疏松。我是否应该让她服用二磷酸盐，因为这可以预防骨质疏松症？而我现在又要给她加一种药丸，而这种药需要详细说明。也许留到下一次再说吧？ 她家里的情况怎么样呢？她现在是否有常见的生活压力？亦或她有可能有抑郁症或焦虑症？有没有时间让她做个抑郁问卷调查呢？ 健康保养：她最后一次乳房 X 光检查是什么时候做的？子宫颈抹片呢？ 50 岁之后是否做过结肠镜检查？过去 10 年间她是否注射过破伤风加强疫苗？她是否符合接种肺炎疫苗的条件？ 奥索里奥夫人打断了我的思路，告诉我过去的几个月里她一直背痛。从她的角度来看，这可能是她此次就诊最要紧的事。但事实是，她让我如火如荼的思绪戛然而止（当时我正在考虑她的血糖问题，继而又有了一个念头，准备和她讨论饮食和锻炼的事，这时又跳出了另一个想法，要和她探讨是否开始服用他汀类药物）。我的本能反应是举手，阻止她打断我的思路。这并不是说我不想听她一定要说的话，而是我千头万绪，在到点前需要解决所这些问题，这种感
中英文文献翻译
毕业设计（论文）外文参考文献及译文 英文题目Component-based Safety Computer of Railway Signal Interlocking System 中文题目模块化安全铁路信号计算机联锁系统 学院自动化与电气工程学院 专业自动控制 姓名葛彦宁 学号 200808746 指导教师贺清 2012年5月30日
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1.POMR (Problem-Oriented Medical Records)表格式住院病历 2.Biographical data:一般项目： https://www.wendangku.net/doc/fa15158891.html, Age Sex Marital status Nativity Race 姓名年龄性别婚否籍贯民族 4.Occupation Date of admission Informant History 职业入院日期病史叙述者病史 5.Chief complaint主诉 6.History of present illness现病史 Past history既往史： 7.Previous health status: well ordinary bad Infectious diseases 平素健康状况：良好一般较差传染病史8.Immunizations Allergies: N Y clinical manifestation 预防接种史过敏史无有临床表现 9.allergen: Trauma: Surgery: 过敏原外伤史手术史 10.Review of systems: (Tick if positive, cross out if negative. If postive, you should write down your disease history and brief course of diagnose and therapy) 系统回顾：(有打√无打×阳性病史应在下面空间内填写发病时间及扼要诊疗经过) 11.Respiratory system:呼吸系统 12.Sore throat chronic cough sputum hemoptysis wheezing 咽痛慢性咳嗽咳痰咯血哮喘 13.dyspnea chest pain 呼吸困难胸痛 14.cadiovascular system: 循环系统 15.Palpitation dyspnea on exertion hemoptysis syncope 心悸活动后气促咯血晕厥 16.edema of lower limbs precordial pain hypertention3 m4 G: a6 ] h 下肢水肿心前区疼痛高血压 Digestive system: 消化系统 Anorexia sour regurgitation belching nausea vomitting; L. N) o# e w! A$ H* W 食欲减退反酸嗳气恶心呕吐abdominal distention abdominal pain constipation diarrhea 8 G1 d; G# P$ `( ] 腹胀腹痛便秘腹泻8 t) }/ q7 i' v# ]6 V hematemesis melena hematochezia jaundice% c2 h& ^) w% r/ G% s# i9 c- h 呕血黑便便血黄疸 Urinary system: 泌尿系统 Lumbago frequent micturition urgent micturition urodynia 腰痛尿频尿急尿痛7 D) {2 U/ K# ?5 L9 L V9 G dysuria hematuria nocturia polyuria oliguria facial edema 排尿困难血尿夜尿多尿少尿面部水肿Hematopoietic system 造血系统 Fatigue dizziness blurred vision gingival bleedig 乏力头昏牙龈出血" j9 w, N. P5 j m! C subcutaneous hemorrhage ostealgia epistaxis ' z$ {% i; V4 r7 {- S 皮下出血骨痛鼻衄0 b* ?5 ] ~ R* a# b( A" g e* H Metabolic and endocrine system: 代谢及内分泌系统 Excessive appetite anorexia sweats cold intolerance 食欲亢进食欲减退多汗畏寒" f8 X: \! j |4 A r6 z polydipsia tremor hands change of character obvious obesity 0 [: z) L! A& M/ {+ y$ l 多饮双手震颤性格改变显著肥胖* D* N. t& S& i# | p- _& ] - E. ^% k" v5 ]6 A* g emaciation hirsutism hair losing pigmentation 消瘦多毛毛发脱落色素沉着: N d4 x! B5 R chang of sexual function amenorrhea 性功能改变闭经. T' J. A; Y, Z# ]2 f Musculoskeletal system - \+ }/ L6 H8 e8 A9 H; {# G
医学英语课文翻译
Unit One Text A： Hippocratic Oath, The Medical Ideal 或许在医学史上最持久的,被引用最多次的誓言就是”希波克拉底誓言”.这个以古希腊著名医师希波克拉底命名的誓言,被作为医师道德伦理的指导纲领.虽然随着时代的变迁,准确的文字已不可考,但誓言的主旨却始终如一——尊敬那些将毕生知识奉献于医学科学的人，尊重病人，尊重医师尽己所能治愈病人的承诺。 作为被大家公认的”医学之父”,我们对希波克拉底知之甚少.他生活于约公元前460-380年,作为一名职业医师,与苏格拉底是同代人.在他的时代,他被推举为当时最著名的医师和医学教育者.收录了超过60篇论文的专著——希波克拉底文集,被归于他的名下;但是其中有些论文的内容主旨相冲突,并成文于公元前510-300年,所以不可能都是出自他之手. 这个宣言是以希波克拉底命名的，虽然它的作者依然存在疑问。根据医学历史权威的看法，这个宣言的内容是在公元前四世纪起草的，这使希波克拉底自己起草这个宣言成为可能。无论如何，不管是否是希波克拉底自己起草的（希波克拉底宣言），这个宣言的内容都反映了他在医学伦理上的看法。 作为代表当时希腊观点的唯一一小部分，希波克拉底誓言首次被写时并没有受到很好的欢迎。然而,在那远古时代结束时,医生们开始遵循誓言的条款。当科学医学在罗马帝国衰亡后遭受一显而易见的衰退时，这个誓言,连同希波克拉底医学的指示命令，在西方都几乎被遗忘是有可能的。正是通过东方坚持不懈的探索精神，使得希波克拉底医学信念和希波克拉底宣言得以在这一恶化的时期幸存下来，尤其是通过阿拉伯当局在医学上的著作。希腊医学知识而后在西方基督教复活是通过了阿拉伯文论著和原始希腊文的拉丁文翻译。 到17世纪后期，专业行为标准已经在西方世界建立。被专业组织通过的第一部医学伦理学的法典是由英国内科医生托马斯·珀西瓦尔(1740 - 1804)1794年编写的, 并在1846年被改编和通过了美国医学协会(AMA)。Thomas Percival提出的道德规范为职业医师提供了金标准，主宰着医生们服务他人时的道德权威和独立性以及医生对病人的责任，还有医生的个人荣誉。 种子已经被希波克拉底或者他的代笔者们所播种。 二战之后，由于在罪犯身上进行骇人听闻的医学实验而违反了医学伦理准则，23位来自行德国纳粹集中营的医生被判有罪。这一事件导致了纽伦堡宣言的诞生（1947），这意味着关于人类受试者的道德治疗的讨论的开启，概述了在医学研究中关于这些受试者权益的道德问题。这反过来导致1948年世界医学协会通过了维也纳宣言的宣誓。 誓言的重申一直是个问题。医学伦理相当复杂。他们必须平衡病人的期望、社会需求和禁忌、经济和政治现实以及并不断发展的医学和科学知识之间的关系。例如，当初的誓言要求无论在任何情况下患者都应得到治愈。然而，在双盲试验中使用安慰剂是在药物开发必不可少的，但却意味着医生没有试图进行治疗。而当初的誓言，也将禁止病人分流治疗。病人分流治疗用于战争或灾害时根据病人的生存机会优先进行治疗。对有或没有医疗保险的病人进行不同的医疗保健是不可能的。使用高剂量毒性药物进行化疗的某些危险形式将被禁止。最后，能够减轻身处无法治愈境地的病人痛苦的安乐死被当初的誓言所禁止。 因此，人们争辩自希波克拉底的时代以后,原始的希波克拉底誓言在一个发生了翻天覆地的社会经济、政治和道德变革的社会是无效的。这指引我们对誓言进行修改，使其更适合我们的时代。四个当今使用最广泛的版本是:日内瓦宣言（前文已提及）；迈蒙尼德的祷告；Lasagna宣言；修复后的希波克拉底宣言.虽然他们的措辞和内容不同,主要原则是一样的