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The presentation was divided into two sections concerning J>E medical and pharmaceutical translation.

I. Case Study Translation

A case study is a short medical article in which physicians in clinical practice report on an unusual and unexpected experience in treating an individual patient.

Points to remember in J>E translation of case studies:

1) Do not assume that just because the document is short, it will only take a short time to translate. The writers assume a certain level of expertise and foresight on the part of the reader, but the translator may not have enough medical knowledge to proceed without doing background research to discover what happened in this instance to make it unique and unexpected enough to report to the general medical community.

2) Before starting the translation, look over the document to determine the original complaint or condition of the patient, and then check general internet resources using the name of the condition and "treatment" as key words to see how the physician is likely to respond initially. For example, if a patient presents with signs of anaphylaxis, you will discover that it is common practice for the physician to begin with an injection of epinephrine, followed by treatment with antihistamines and possibly steroids. But what if the patient responds in an unexpected way? That becomes the core issue of the report.

3) Japanese case studies occupy less space than an equivalent report in English. Generally it is a good idea to expand some of the abbreviations such as those used for common antibiotics and to write complete sentences whenever possible to make the document more readable.

4) The tone in English case studies is less formal than in a report concerning a controlled experiment. The authors are reporting an unexpected event, and the report is more likely to assume the form of a narrative.

Sample Translation

抗結核薬の投与により血糖コントロールが悪化した2型糠尿病患者の一例
【症例】71才男性【既往歴】40才左精巣結核（左精巣摘出術後）61才心筋梗塞、咽頭癌【現病歴】63才発症の2型輔尿病患者。最近はグリメピリド１mg投与にて、HbA1c7%前後にて推移していた。平成15年11月に陰嚢の腫脹のため当院泌尿器料受診。MRIで、精巣、精巣上体の腫大を認め、尿より結核菌が検出されたため、12月初旬よりINH、RFP、EBの三者併用治療を開始された。血糖は抗結核薬開始前までは変動なかったが、12月17日にはHbA1c7.3%と程度のよ鼻を認めた。翌年1月には、空腹時血糖227、HbA1c9.3%と著明な上昇を認めたため、インスリン導入となった。52単位/日にてコントロール良好となり、結核剤投与中止後は再びグリメピリド１mgに変更可能となった。【まとめ】抗結核薬には、血糖値上昇の副作用報告がされている。糖尿病患者への抗結薬投与の際には、血糖への影響に十分注意する必警があると考えられた。

A case of type II diabetes with loss of blood glucose control caused by administration of anti-tuberculosis drugs

[Patient] The patient was a 71-year-old male.

[Previous History] Left testicular tuberculosis at age 40 (diagnosed after left orchiectomy). Myocardial infarction and pharyngeal carcinoma at age 61.

[Current Complaint] Type II diabetes mellitus with onset at age 63.

Recently the patient's HbA1c level had been controlled at about 7% with administration of 1 mg of glimepiride. In November 2003, however, the patient was examined by the Dept. of Urology at this hospital for enlargement of the scrotum. MRI revealed swelling of the testis and epididymis, and Mycobacterium tuberculosis was detected in the patient's urine. Therefore, coadministration of INH, RFP, and EB* was started in early December. The blood glucose level was stable before the start of the anti-tuberculosis regimen, but on December 17 a mild elevation of the HbA1c level to 7.3% was seen. In January of the following year, a fasting blood glucose level of 227 and a pronounced elevation in the HbA1c level to 9.3% were seen, so insulin therapy was initiated. Good control was achieved with 52 U/day, and after the discontinuation of the anti-tuberculosis drugs the patient was able to switch back to 1 mg of glimepiride.

[Summary] In the past elevated blood glucose has been associated with anti-tuberculosis drugs as an adverse reaction. We believe the effect on blood glucose levels must be carefully monitored when administering anti-tuberculosis drugs to patients with diabetes.

*INH = isoniazid, RFP = rifampicin, EB = ethambutol HCl

Sample for Practice

Dubin Jonson 症候群に合併した胸膜炎の１例

症例は４８歳女性。主訴は胸部異常影、現病歴は胸部異常影で右胸水を指摘され精査のため入院となった。既往歴では以前Dubin Jonson症候群と指摘されていた。現症で胸部右肺では肺胞音の低下を認めた。入院時検査所見では血算WBC 8900、RBC 448万、Hb 13.4 g/dl、Ht 88.9%、plt 37.6万で血液生化学ではTbil 3.34 mg/dl、GOT 15 IU/L、GPT 18 IU/L、ALP 228 IU/L、LDH 154 IU/L、CRP 0.98 mg/dl であった。胸水穿刺ではPAP 2、有意細菌（－）、結核菌（－）、ADA 30 IU/Lであった。膿胸と考え胸水ドレナージを施行し、抗生剤はCEZ とLVFXの投与を施行した。胸水は一部capsulatedされ、CFDN（セファジニル）内服中である。経過中黄疸の遷延化を認め、消化器内科管理となった。Dubin Jonson 症候群に合併した肺感染症の報告例は少なく、文献的考察を含めて報告する。

1. What is Dubin Jonson syndrome? If you search the internet, you will soon realize that it should be spelled Dubin Johnson syndrome.

2. Are the clinical laboratory results within the normal range? Does anything stand out? (Hint: one of them contains a typographical error) What is LDH? (Normal ranges for clinical laboratory test values are widely available.) What does有意細菌（－）mean? (Hint: this term will need to be explained by the translator.)

3. What is CFZ and LVFX? (cefazolin and levofloxacin) It is usually a good idea to look for drug abbreviations on PubMed rather than Google. Just enter the abbreviation and look for papers with Japanese authors.

4. What does the following suggest? 胸水穿刺ではPAP 2、有意細菌（－）、結核菌（－）、ADA 30 IU/Lであった。First, there is the Japanese phrase: 胸水穿刺, which is more commonly 胸腔穿刺 (thoracentesis or pleural tap). In this case the authors mean that thoracentesis was performed for biopsy of the pleural fluid and the biopsy results then follow. Second, what do "PAP 2" and ADA 30 IU/L mean? Candidates for PAP: pulmonary alveolar proteinosis, prostatic acid phosphatase, primary atypical pneumonia, positive airway pressure, pulmonary artery pressure, Papanicolaou smear). ADA is adenosine deaminase. What role would either have in a diagnosis of pleuritis? Only "prostatic acid phosphatase" can be ruled out (female patient), so good luck unless you know why they are performing the test.

5. Is it important that a portion of the pleural fluid was "capsulated" or is this just additional information?

6. How do we interpret the following: 経過中黄疸の遷延化を認め、消化器内科管理となった。This is the first mention of jaundice. Was the jaundice "delayed" or "protracted"?

For your reference, I did not translate this article for a client, but it took me a lot of time to track down the answers to the above questions. Therefore, you can expect to spend much more time on this kind of short article than on a document with familiar content.

An excellent example of a case study report in English can be found at: http://jcm.asm.org/cgi/content/full/42/7/3374. On the right side, click on full text (PDF) to download the article.

II. Hints for Handling Terminology in Pharmaceutical Reports

A. The Rendering Depends on the Context

In many instances the best rendering of a term changes with its context. Therefore, one important question to ask before starting the translation is: What is the phase of development?

In general:

• Preclinical (nonclinical) studies involve tests in cultured cells and animals;
• Phase I studies involve healthy humans and investigate safety and clinical pharmacology;
• Phase II studies involve a small number of humans (<200) with the target disease(s) and investigate efficacy, safety, and sometimes dose. The background factors in the subject population are rather tightly controlled to reduce the number of variables in the analysis. The efficacy and safety evaluation may involve a double blind controlled study using either an existing drug or placebo as the control substance;
• Phase III studies are large scale studies of humans with the target disease. There is less control over the background factors in the subject population, and a greater variation in the results of the efficacy and safety evaluations can be expected because the subjects are less closely monitored. The intention of the phase III trial is to show that the drug is widely applicable to the subset of the general public afflicted with the target disease; and
• Phase IV studies are post-marketing surveillance studies that involve the compilation of safety data after a drug has reached the market.

Once we are aware of the phase, how do we treat certain Japanese terms to make the translation of the document ring true? The following common examples come to mind.

B. The Nature of Pharmaceutical Reports

We can infer that:

1. The document is a report to be used in a new drug application and is subject to regulatory restrictions on its organization and content. It is not a document intended for publication, and the content will not be made available to the general public.
   
   
2. In an attempt to streamline document production and meet regulatory requirements, many pharmaceutical companies now use templates that are filled in as needed with the proper content. They may contain many section headings followed by: 当該なし.

This being the case, it is reasonable to assume that:

1. The document will have more than one author. There will be one or two main authors who handle the summary sections and several minor authors who only report on their specialty.
   
   
2. The document has not been edited for consistency in terminology other than the Definitions of Terms (if there is one).
   
   
3. The document is intended for an audience that is thoroughly familiar with the topic and issues discussed therein, and any inconsistencies can be cleared up during informal discussions.

How to recognize multiple authors:

• Inconsistencies between sections in the use of nouns with rather narrow definitions. For example, different sections of the same document may say that "Condition A" puts the patient at risk for 冠動脈心疾患, 冠状動脈障害 (coronary artery disease) vs. 虚血性心疾患 (ischemic heart disease), or 深部静脈血栓症(deep vein thrombosis) vs. 静脈血栓塞栓症 (venous thromboembolism). In this instance, different authors are using different but essentially synonymous terms.
• Inconsistencies between sections in the use of connecting words and phrases: 又は vs. また, or したがって vs. よって, or しかしながら vs. しかし
• Inconsistencies in sentence length: short, clear sentences vs. the infamous "one sentence paragraph."
• Inconsistencies in tone: であった vs. 考えられた, etc. The difference here is not the words themselves, but the level of certainty or forcefulness the author uses when describing what the researchers found.

When you realize a document has multiple authors, what do you do?

My adventure with: The Saga of the Vanishing Hormones…

Recently, while I was translating a 39-page summary document on the history of development of an estrogen preparation and an estrogen/progestin preparation for menopausal symptoms, the following events occurred.

1. Initial recognition of multiple authors: Mixed usage of ERT, HRT, and ERT/HRT in different sections, and
2. Mixed terminology: 閉経期 vs. 更年期 (both by page 5). My dictionaries gloss both閉経期 and 更年期as "menopause" and "climacteric." (Menopause is more common in the United States, but the client wanted me to use "climacteric" for 更年期症状 (and 更年期障害) because previous translators had used that term in other documents concerning the same drug. Therefore, I decided to use "menopause/menopausal" in most places and "climacteric" for the symptoms/disorder as the client requested.
3. On page 37 of the 39-page document I encountered the following title heading: HRTとERTのリスク・ベネフィット比は比較的若い閉経女性、特に更年期の女性において良好である. Here this author is making a clear distinction between 閉経女性 and 更年期の女性 by indicating that 更年期の女性 is a subset of 閉経女性, although this heading is the first hint in this document that there is any distinction between the two.
4. Further investigation (see abstract from PubMed)* suggests that 更年期 would most likely be called "perimenopause" in American English, and that更年期 is traditional Japanese women's language, whereas 閉経 is a medical term that probably entered Japanese as a translation from a Western language.
5. Countermeasure: I went back through the whole document and made sure that I had used "climacteric" for 更年期 and "menopause/menopausal" for 閉経. (Thank goodness for electronic search-and-replace.)
6. Conclusion: I suspect most of the authors in this document are men who make no distinction between 閉経 and 更年期, but at least one author (the one who wrote the summary section at the end) makes a clear distinction.

* http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15879913&query_hl=1 (If the abstract cannot be retrieved, go to the Entrez PubMed homepage and type in "Vasomotor symptom prevalence and language of menopause in Japan").

Reflection: Maybe I should start translating these documents from back to front in the future.

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