Cheng Zhou
202 lines
7.6 KiB
Python
202 lines
7.6 KiB
Python
import uuid
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from fastapi import APIRouter, Depends, HTTPException, status
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from sqlalchemy import select
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from sqlalchemy.ext.asyncio import AsyncSession
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from app.core.deps import get_cra_site_scope, get_current_user, get_db_session, require_study_member, require_study_roles, require_study_not_locked
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from app.crud import audit as audit_crud
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from app.crud import site as site_crud
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from app.crud import subject as subject_crud
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from app.crud import study as study_crud
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from app.models.ae import AdverseEvent
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from app.schemas.subject import SubjectCreate, SubjectRead, SubjectUpdate
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router = APIRouter()
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async def _ensure_study_exists(db: AsyncSession, study_id: uuid.UUID):
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study = await study_crud.get(db, study_id)
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if not study:
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raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="项目不存在")
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return study
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async def _ensure_subject_active(db: AsyncSession, subject) -> None:
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if not subject or not subject.site_id:
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return
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site = await site_crud.get_site(db, subject.site_id)
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if not site or not site.is_active:
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raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="中心已停用")
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@router.post(
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"/",
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response_model=SubjectRead,
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status_code=status.HTTP_201_CREATED,
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dependencies=[Depends(require_study_roles(["PM", "CRA"])), Depends(require_study_not_locked())],
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)
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async def create_subject(
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study_id: uuid.UUID,
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subject_in: SubjectCreate,
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db: AsyncSession = Depends(get_db_session),
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current_user=Depends(get_current_user),
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) -> SubjectRead:
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await _ensure_study_exists(db, study_id)
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cra_scope = await get_cra_site_scope(db, study_id, current_user)
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if cra_scope and subject_in.site_id not in cra_scope[0]:
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raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="权限不足")
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try:
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subject = await subject_crud.create_subject(db, study_id, subject_in)
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except ValueError as exc:
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raise HTTPException(status_code=status.HTTP_400_BAD_REQUEST, detail=str(exc)) from exc
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await audit_crud.log_action(
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db,
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study_id=study_id,
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entity_type="subject",
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entity_id=subject.id,
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action="CREATE_SUBJECT",
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detail=f"参与者 {subject.subject_no} 已创建",
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operator_id=current_user.id,
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operator_role=current_user.role,
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)
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return subject
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@router.get(
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"/",
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response_model=list[SubjectRead],
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dependencies=[Depends(require_study_member())],
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)
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async def list_subjects(
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study_id: uuid.UUID,
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site_id: uuid.UUID | None = None,
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db: AsyncSession = Depends(get_db_session),
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current_user=Depends(get_current_user),
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) -> list[SubjectRead]:
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await _ensure_study_exists(db, study_id)
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cra_scope = await get_cra_site_scope(db, study_id, current_user)
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site_ids = cra_scope[0] if cra_scope else None
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if site_id and site_ids is not None and site_id not in site_ids:
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return []
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subjects = await subject_crud.list_subjects(db, study_id, site_id=site_id, site_ids=site_ids)
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subject_list = list(subjects)
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if not subject_list:
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return []
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subject_ids = [subject.id for subject in subject_list]
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ae_rows = await db.execute(
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select(AdverseEvent.subject_id).where(
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AdverseEvent.study_id == study_id,
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AdverseEvent.subject_id.in_(subject_ids),
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)
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)
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ae_subject_ids = {row[0] for row in ae_rows.all() if row[0]}
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result: list[SubjectRead] = []
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for subject in subject_list:
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data = SubjectRead.model_validate(subject)
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data.has_ae = subject.id in ae_subject_ids
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result.append(data)
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return result
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@router.get(
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"/{subject_id}",
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response_model=SubjectRead,
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dependencies=[Depends(require_study_member())],
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)
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async def get_subject(
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study_id: uuid.UUID,
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subject_id: uuid.UUID,
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db: AsyncSession = Depends(get_db_session),
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current_user=Depends(get_current_user),
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) -> SubjectRead:
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await _ensure_study_exists(db, study_id)
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subject = await subject_crud.get_subject(db, subject_id)
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if not subject or subject.study_id != study_id:
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raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="参与者不存在")
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cra_scope = await get_cra_site_scope(db, study_id, current_user)
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if cra_scope and subject.site_id not in cra_scope[0]:
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raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="权限不足")
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await _ensure_subject_active(db, subject)
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data = SubjectRead.model_validate(subject)
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ae_row = await db.execute(
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select(AdverseEvent.id).where(
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AdverseEvent.study_id == study_id,
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AdverseEvent.subject_id == subject.id,
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).limit(1)
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)
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data.has_ae = ae_row.scalar_one_or_none() is not None
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return data
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@router.patch(
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"/{subject_id}",
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response_model=SubjectRead,
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dependencies=[Depends(require_study_roles(["PM", "CRA"])), Depends(require_study_not_locked())],
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)
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async def update_subject(
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study_id: uuid.UUID,
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subject_id: uuid.UUID,
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subject_in: SubjectUpdate,
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db: AsyncSession = Depends(get_db_session),
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current_user=Depends(get_current_user),
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) -> SubjectRead:
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await _ensure_study_exists(db, study_id)
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subject = await subject_crud.get_subject(db, subject_id)
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if not subject or subject.study_id != study_id:
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raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="参与者不存在")
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cra_scope = await get_cra_site_scope(db, study_id, current_user)
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if cra_scope and subject.site_id not in cra_scope[0]:
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raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="权限不足")
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await _ensure_subject_active(db, subject)
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old_status = subject.status
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updated = await subject_crud.update_subject(db, subject, subject_in)
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# auto-generate visits when enrolled
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if subject_in.status and subject_in.status == "ENROLLED" and (subject_in.enrollment_date or updated.enrollment_date):
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await subject_crud.generate_default_visits(db, updated)
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detail = None
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if subject_in.status and subject_in.status != old_status:
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detail = f"参与者 {updated.subject_no} 状态 {old_status} -> {subject_in.status}"
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await audit_crud.log_action(
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db,
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study_id=study_id,
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entity_type="subject",
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entity_id=subject_id,
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action="SUBJECT_STATUS_CHANGE" if detail else "UPDATE_SUBJECT",
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detail=detail or "参与者已更新",
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operator_id=current_user.id,
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operator_role=current_user.role,
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)
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return updated
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@router.delete(
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"/{subject_id}",
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status_code=status.HTTP_204_NO_CONTENT,
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dependencies=[Depends(require_study_roles(["PM", "CRA"])), Depends(require_study_not_locked())],
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)
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async def delete_subject(
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study_id: uuid.UUID,
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subject_id: uuid.UUID,
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db: AsyncSession = Depends(get_db_session),
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current_user=Depends(get_current_user),
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) -> None:
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await _ensure_study_exists(db, study_id)
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subject = await subject_crud.get_subject(db, subject_id)
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if not subject or subject.study_id != study_id:
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raise HTTPException(status_code=status.HTTP_404_NOT_FOUND, detail="参与者不存在")
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cra_scope = await get_cra_site_scope(db, study_id, current_user)
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if cra_scope and subject.site_id not in cra_scope[0]:
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raise HTTPException(status_code=status.HTTP_403_FORBIDDEN, detail="权限不足")
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await subject_crud.delete_subject(db, subject)
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await audit_crud.log_action(
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db,
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study_id=study_id,
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entity_type="subject",
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entity_id=subject_id,
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action="DELETE_SUBJECT",
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detail=f"参与者 {subject_id} 已删除",
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operator_id=current_user.id,
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operator_role=current_user.role,
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)
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