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February 17, 2015

数学は権利を創出するか(3)

数学は医療を支えている。病理変化の数学的解析は医療の現場で大いに役立っている。ただし,Doctor Xが医療現場で微分・積分を行っているわけではない。肉体の疾患はバイタルサインに続くいろんな生体反応の変化として捉えられ数値化されて,医師の治療方針の決定に役立てられる。集められたデータは同じような病変を持つ患者の治療の重要な指針とされる。
 日経新聞の連載小説が,病気腎移植の可否で紛糾する臨床医学の悩みを取り上げている(「禁断のスペルカル」久間十義)。がん患者の腎臓を移植すれば,倫理に反し違法なのか。この問への正しい答えは,最終的には多くの患者の統計値が導き出してくれるのではないか。専門家,大家の大所高所の意見でなく,実績が治療法を決定するのではないか。
 腎移植が刑事事件に問われた
09年以降再開された移植手術ではドナー,レシピエントの健康状態は順調という宇和島徳州会病院で妹から兄への生体腎臓移植が,非親族間の臓器移植にあたり,臓器移植法11条「臓器売買の禁止」違反であるというのである。執刀医は「裸足にサンダル,下着に白衣」という風変わりな人柄として注目され,マスコミの意見は移植の是非で2分された。平成18年12月6日,松山地裁は患者(レシピエント)と仲介者に懲役1年執行猶予3年を言い渡した(確定)。判決は臓器移植は未だ治療法として確立されていないという。本当にそうなのか。
 慢性腎不全患者の95%が血液透析を,4%が腹膜透析を受けている。透析には,長時間続けると合併症を起こすリスクがある。日常生活や食事に制限がある。慢性的な疲労感に加え透析自体の身体的負担も大きい。24年末現在で日本には31万人の透析患者がおり,年1万人のペースで増え続けている。透析の効果であるが,5年生存率は59.6%,10年生存率は36%。ゆえに治療法としての生体腎移植が求められている。
献腎移植に供される腎臓は年間150から200件。希望する患者は1万人以上。多くの患者が移植を待っている。腎移植総数は年間1000例足らず。その大部分が家族からの生体腎移植で,死体腎移植や脳死腎移植は合わせて150例程度に過ぎない。
 生体腎移植を受けた患者の5年生存率は95.9%,10年生存率は91.9%である。生着率は5年で90.7%,1年で72%。移植される腎臓はすべてが健康な腎臓ではない。これが腎移植是非の小説のテーマになっている。
 91年以降の病気腎移植は42例ある。「修復腎」とは病気の腎臓の病変を切除して修復した腎臓である。病気腎の多くは廃棄されている。病気腎を移植するとレシピエントはドナーの病気も貰うのか。この答えはまだ見つかっていない。摘出された腎臓は全国で1万2000個もあり,がんの腎臓も2000個ある。刑事裁判の事案は関係する病院間で治療のため臓器のやりとりがあった。レシピエントの同意を得ずに移植された事もあった。廃棄されるくらいなら,移植を待ち続ける患者に提供するべきではないか。しかし,医師会・学会・官庁の認識は違う。倫理が移植を阻んでいる。厚労省は平成19年,臓器移植のガイドラインを改正した。
 修復された腎でもドナーのがんを移植するおそれがあるか。ドナーのがんが持ち込まれる可能性が43%あるという一方で,がんの伝播リスクは5%までとする医学者の論文があり,帰一しない。ヨーロッパ泌尿器科会は悪性腫瘍の生体腎移植を絶対禁忌としている。
 日本移植学会は判決の翌年,危険であり医学的妥当性がないとの声明を発表し,厚労省は原則禁止を決めた。移植学会幹部は医師の病気腎移植を批判した。腎臓病患者らは治療を受ける権利が侵害されたとして,学会幹部ら5人に損害賠償を求めた。昨年10月28日,松山地裁は患者らの請求を棄却した。いま高松高裁に係属している。
 松山地裁は「厚生労働省自らの判断と責任で禁止にした」という。そして移植学会の発言と禁止との因果関係を認めなかった。裁判所は修復腎移植が妥当かどうかの答を持っているわけではない。行政の判断だから学会の違法行為は認められない,というのである。

腎移植を認めるべきか,誰がそれを決めるのか。患者に移植を求める権利はないのか。
 日本の腎移植総数は年間1000例足らず。その大部分が家族からの生体腎移植である。友人からの生体腎移植は許されていない。死体腎移植は極端に少ない。フィリピンや中国で腎移植を受ける日本人が年間100人を超えている。国や移植学界はこの実情をどう改善しようとしているのか。病気腎移植で症状が悪化した症例がどれくらいあるか調べているはずだが,公表資料にない。
学会はただ,医学的に評価が確立していない病気腎移植は倫理委員会で承認されていない,データがあるから妥当性がないと建前論,医師の共通認識論のみをいい,病気腎移植を否定する明確な論証をしていない。外から見て大変分かりにくい議論をしている。新聞小説の主人公が刑事事件に問われたり,保険医登録取消になったりしない展開が望ましいと思っている。

前立腺がん患者は悩んでいる。前立腺がんの根治手術をしても約35%の患者に10年以内にPSAは上昇すると医師に告げられる。PSAが上昇するということは,体内に前立腺がん細胞が増殖していることを意味する。目に見えなくても,再発を意味しているからである。
統計によれば手術5年後の生存率は93.8%。生きていれば生存者に数えられる。本人にとって生死の問題だが,医療統計上は数値に置き換わる。93.8%といわれても自分がそれに当てはまるか心配だ。
PSAの上昇を認めた時に、その後の経過(死亡のリスク)を予測できれば、治療の選択に役立つ。進行が早いと予測される場合には、多少の副作用のデメリットがあってもがんを抑える治療(ホルモン療法や抗がん剤治療)が必要になる。ただし,副作用があるから,死亡のリスクが低い場合には副作用のリスクを犯してまで強い治療を受ける必要性は無い。研究論文は、前立腺がんの根治手術後にPSAの上昇を認めた379例について、その後の経過(PSAの変化と死亡の有無)を平均約10年間(1~20年間)追跡して、予後に関連する要因を解析した。
 PSAが 2 倍になるまでの期間と生存率との関係が調査の対象となった。Johns Hopkins UniversityのFleedland医師らは,①PSAが2倍②Gleeson値のランク③PSA再上昇までの期間で分類して5年,10年,15年後の生存率を調査報告した。
3つの因子が悪いと,5年生存率は51%,10年生存率は1%,15年生存率は1%以下である。PSAだけをみると,2倍になるまでの期間が15か月以上,術後の再発までの期間が 3 年超であった82例の生存率は,5年後で100%、10年後で98%、15年後で94%という。少なくとも2倍未満を15ヶ月持ちこたえると,生存率は飛躍的に高まる。逆に早く2倍を超えてしまうと生存率は低くなる,といえそうだ。患者や医師が前立腺がん手術後の再発による死亡リスクを評価し,さらに治療が必要かどうかを判断するうえでこの調査は役立つはずだ。
 ただ,統計がいつも正しい結論を示しているとはいえない。カルシウムサプリメントが腰骨骨折の治療に役立つかの調査結果がある。まったく影響せず,かえって腎臓結石のリスクが高まったそうだ。なぜ医師たちは摂取を勧めたのか。「害がないと思ったからだ」そうだ。何が何を引き起こしたかという調査結果は重要だが,統計の目的を正しく設定し統計の手法を検討し,表示された数値の原因を検討しないで,報告だけで治療・薬剤投与すると間違いを犯す。

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