< 血色素異常症に関する遺伝子分析と研究的側面の説明 > <Explanation for gene analysis and research aspects of abnormal hemoglobinopathies> この説明文は血色素異常症 ( 異常血色素症 サラセミア ) の遺伝子診断に
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1 < 血色素異常症に関する遺伝子分析と研究的側面の説明 > <Explanation for gene analysis and research aspects of abnormal hemoglobinopathies> この説明文は血色素異常症 ( 異常血色素症 サラセミア ) の遺伝子診断に関するものです 担当医師の説明を補い 患者様の理解を助けるために書かれています 担当医師の説明を聞かれるとともに この説明文をお読みいただいた上で ご自身の自由な意志で この分析を受けられるかどうかをお決め下さい この分析を受けないということが理由で 日常診療において不利益や差別を受けることはありません This manuscript explains the gene analysis of abnormal hemoglobinopathies (abnormal hemoglobin and thalassemia) to a relevant patient and/or to the patient s family. We ask that you make a determination as to whether you should have your samples analyzed based on your attending doctor s advice. 1. この検査の根拠と意義血色素異常症は日本人には比較的少ないのですが 世界的には頻度の高い疾患です 遺伝性ですので 基本的には治癒は望めませんが その存在を知ることによって一過性の増悪に対処したり 不必要な治療を避けることができます また場合によっては 重篤な症状を持つ子孫の出現を回避することが可能です 特に劣性遺伝の場合は その因子を持っていても日常生活への障害は少ないので 知っているだけで十分なことが少なくありません そのためにも 確定診断が求められます 最近は遺伝子分析によって より正しい診断が得られるようになってきています Reason for and significance of this analysis: Hemoglobinopathy is relatively uncommon among Japanese, but it is common around the world. Since it is an inherited disorder, a cure can basically be not expected. However, knowledge of its presence may help cope with the transient exacerbation of anemia or avoid unnecessary iron treatments. In addition, it may be practical in preventing conception of a fetus with severe symptoms (hemolytic anemia) for a couple at risk, although ethical issues must also be considered. Autosomal recessive individuals (carriers) have almost no problems in daily life, and only the knowledge of being a carrier may be sufficient in coping with hemoglobinopathy, which is the reason why a definitive (or accurate) diagnosis is recommended for a carrier. With the advancements in recent gene analysis, a more accurate and detailed diagnosis can be obtained. 2. 検査の内容と限界 ここでは患者様からお預かりした血液で 先天性溶血性貧血の一種である血色素異常 ( 異 1 / 4
2 常血色素症 サラセミア ) の検索を行います 1 先ずスクリーニングで異常の有無を調べます 2さらに ご希望により遺伝子異常の検索 ( 遺伝子検査 ) を行います 遺伝子検査の内容は -globin についての GAP-PCR による広範囲欠失解析 (SEA 型 FIL 型 -3.7 型 ) anti3.7 型解析 β-globin, α-globin 遺伝子の疾患に関連する主要な領域のシーケンシングによる変異解析です ( これらのうちどの検査を実施するかは患者様によって異なります ) ただし これらの検査をすべて行っても異常が決定できない あるいは病態を完全には解明できない症例もありますのでその節はご容赦下さい 3この遺伝子異常で患者様の病態の説明が付かない場合 あるいは血色素異常が強く疑われながら当該遺伝子異常が発見されない場合は 山口大学医学部保健学科山城安啓先生の研究室にて 血色素異常の病態を修飾する可能性のある遺伝子 ( -globin, β-globin 以外のグロビン遺伝子など ) を付加的に検索することがあります Details and limitations of this examination (analysis): Here performed are 1The presence or absence of an abnormality by a screening program, 2 In addition, gene analysis as an option is conducted in accordance with a patient s or his/her parent s request. It is composed of GAP-PCR for large deletion of the -globin gene (SEA-type, FIL-type, type), the anti 3.7 -type, and sequencing analysis for the β- and α-globin genes. However, there are some cases in which the cause cannot be determined by the above methods or the patient s clinical manifestation cannot be fully explained. 3For these cases, samples may be referred to the research laboratory of the Yamaguchi University School of Medicine (Yamashiro lab) for further analysis at the research level. 3. この検査により期待される効果患者様がご自分の血色素異常の遺伝子異常を知られますと これは原則として最終判定となります 世界中どこへいかれてもこれで通ります 意義の項で述べましたように 自分の状態を的確に把握し 理解されると自ら対処法も分かり むやみと恐れる必要がないことが分かります また 血色素異常症の症状の修飾に荷担する異常が分かれば より患者様の病態を詳細に把握でき 一段と役に立ちます ただ 検索してもそれらしき答えが得られないこともありますので その時はご容赦下さい Expected effect from this analysis: In principle, this is a conclusive diagnosis for a hemoglobinopathy, and wherever the patient may travel around the world the results are available. As mentioned above, if the patient correctly understands the disease that he/she has, the patient will be able to cope with it appropriately and will not have to feel anxious about the disease unnecessarily. If the modifying factors that worsen the hemogobinopathy are disclosed, this may be beneficial in understanding the disease and coping with it. However, there 2 / 4
3 may be cases where a disease cannot be completely elucidated by the current research technology. 4. プライバシーの保護この検査に同意された場合 常に患者様のプライバシーは厳重に保護されます Privacy protection: Patient s privacy is completely protected, and it is strictly kept. 5. 本検査終了後の試料の取扱についてこの血色素異常症の診断や治療に非常に有効な遺伝子が見つかった場合は さらなる検討が必要になります その時 今回の検体は大変貴重な資料となりますので 同意戴ければ 山口大学医学部保健学科にて使い切るまで厳重に保存させて戴きたいと思います 保存した検体を使って新たな検討を行う際には 山口大学医学部にて研究計画書を倫理審査委員会に提出し 承認を受けた上で行います Management of samples after analysis is completed: When additional factors that may be important for diagnosis and/or treatment are discovered, further analysis for research may be necessary. Samples in such cases are very important, and with your approval, samples will be stored until completely utilized. When a new research project using these samples is instituted, it will be forwarded in advance to the ethical committee of the medical department of Yamaguchi University to obtain approval for the project. 6. 検査 ( 研究 ) 結果の公表血色素異常の症例が蓄積するごとに定期的に 遺伝子異常と臨床データとの関係の見直しや日本における最近の遺伝子異常の動向を集計し これらを公表します また 新変異や新しい科学的知見は学会や学術誌などで公表されます このとき 患者様ご本人やその家族の情報が明らかにならないよう厳重に注意して行います Publication of results (research): With accumulation of the analysis of samples, the data of hemoglobinopathies and their figures in Japan are re-evaluated periodically and published. New mutations and new scientific findings will be published on academic conferences or in academic journals under careful protection of each patient s privacy. 7. 臨床データの提供について 血色素異常症の検査では 患者様のこの検査を受ける以前の臨床 ( 検査 ) データの専門 医師への提供をお願いしています これは今回の血色素異常症の検査データ分析に重要な 3 / 4
4 情報となるためです また これ以外の目的に使用することはありません Providing clinical data from a doctor to us: Clinical data before application of a sample analysis is requested to a doctor who refers a patient s samples, because such data is important in the process of making an accurate diagnosis. Data will not be used for other purposes than analyses related to hemoglobinopathies. 8. 遺伝カウンセリングについて血色素異常症は先天的な疾患で 子孫に遺伝されます しかし 一部を除き大部分は先に述べましたように著しい異常は出ず 軽い貧血程度です もし 不安に感じられるようでしたら 主治医にいつでもご相談下さい Genetic counseling: Hemoglobinopathy is a genetic disorder and passed on to offspring. However, the majority of cases fall under less severe symptoms and are typically diagnosed with a mild degree of anemia. Should you have any concerns, please consult your attending doctor. 4 / 4
5 同意書 Written informed consent 担当医師殿 Dear doctor この度 血色素異常症検査 の検査にあたり 説明文書に記載されている下記項目について 担当医師により詳細な説明を受け十分に理解し 検査の必要性を認めたので同意します I received a detailed explanation for the items described below from the attending doctor and understand the importance of the examination. チェック欄 ( レ ) Check column( レ ) 1) この検査の根拠と意義 reason for and significance of this analysis 2) 検査の内容 details and limitations of this examination (analysis) 3) 検査結果により期待される効果 expected effect from this analysis 4) プライバシーの保護 privacy protection 5) 本検査終了後の試料の取り扱いについて management of samples after analysis is completed 6) 検査 ( 研究 ) 結果の公表 publication of results (research) 7) 臨床データの提供 providing clinical data from a doctor to us 8) 遺伝カウンセリングについて genetic counseling 氏名 (Name) 1 / (D-1)
6 本検査についての説明は 被検者ご本人に私が直接説明し同意されましたことを確認します I acknowledge that I have directly explained the examination for the hemoglobinopathy to the patient or to his/her parent(s) and they have consented. 担当医師所属 氏名 (Attending doctor s affiliation name) この検査の結果 血色素異常症の診断や治療に有効な遺伝子診断が見つかった場合は 自分の試料を用いてさらなる検討に同意します If new findings that may be effective in diagnosis and/or treatment related to the hemoglobinopathy are discovered, I agree to allow use of the samples for further detailed analysis related to hemoglobinopathy or hemolytic anemia. はい yes いいえ no( チェック ( レ ) を入れて下さい )(Check column( レ )) 氏名 (Name) 本検査についての説明は 被検者ご本人に私が直接説明し同意されましたことを確認します I acknowledge that I have directly explained the examination for the hemoglobinopathy to the patient or to his/her parent(s) and they have consented. 担当医師所属 氏名 (Attending doctor s affiliation name) 2 / (D-1)
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