Page 110 - 《中国医疗器械杂志》2026年第2期
P. 110

Chinese Journal of Medical Instrumentation                                         2026年 第50卷 第2期

                                                     监   管   与   测   试



                  Evaluation of the SkinEthic RHE model in the SENS-IS  al. Evaluation of an In Vitro human dermal sensitization
                  assay   for   prediction   of   skin   sensitization   of  test for use with medical device extracts[J]. Appl In Vitro
                  chemicals[C]//Society of Toxicology Annual Meeting.  Toxicol, 2015, 1(2): 118-130.
              [25]   COTTREZ F, PELLEVOISIN C, COLEMAN K, et al. In  [36]   COTTREZ F, BOITEL E, OURLIN J C, et al. SENS-IS, a
                  vitro  assessment  of  medical  device  extracts  potential  to  3D  reconstituted  epidermis  based  model  for  quantifying
                  produce skin sensitization[J]. Toxicol Lett, 2018, 295(1):  chemical  sensitization  potency:  reproducibility  and
                  179.                                              predictivity  results  from  an  inter-laboratory  study[J].
              [26]   URUNO A, MOTOHASHI H. The Keap1-Nrf2 system as  Toxicol In Vitro, 2016, 32: 248-260.
                  an in vivo sensor for electrophiles[J]. Nitric Oxide, 2011,  [37]   SAITO K, TAKENOUCHI O, NUKADA Y, et al. An in
                  25(2): 153-160.                                   vitro skin sensitization assay termed EpiSensA for broad
              [27]   COTTREZ F, BOITEL E, BERRADA-GOMEZ M P, et     sets  of  chemicals  including  lipophilic  chemicals  and
                  al.  In  vitro  measurement  of  skin  sensitization  hazard  of  pre/pro-haptens[J]. Toxicol In Vitro, 2017, 40: 11-25.
                  mixtures and finished products: Results obtained with the  [38]   JOHANSSON  H,  GRADIN  R,  JOHANSSON  A,  et  al.
                  SENS-IS assays[J]. Toxicol In Vitro, 2020, 62: 104644.  Validation  of  the  GARD™skin  assay  for  assessment  of
              [28]   BERGAL M, PUGINIER M, GERBEIX C, et al. In vitro  chemical  skin  sensitizers:  ring  trial  results  of  predictive
                  testing strategy for assessing the skin sensitizing potential  performance  and  reproducibility[J].  Toxicol  Sci,  2019,
                  of “difficult to test” cosmetic ingredients[J]. Toxicol In  170(2): 374-381.
                  Vitro, 2020, 65: 104781.                      [39]   JENVERT R M, JOHANSSON A, LARNE O, et al. In
              [29]   SAITO  K,  NUKADA  Y,  TAKENOUCHI  O,  et  al.  vitro skin sensitization testing of Medical Devices using
                                                                          ®
                  Development  of  a  new  in  vitro  skin  sensitization  assay  GARD [J]. Toxicol Lett, 2019, 31(1): 155.
                  (Epidermal  Sensitization  Assay;  EpiSensA)  using  [40]   王国伟, 侯丽, 秦越, 等. 医用重组人源胶原蛋白功能敷
                  reconstructed human epidermis[J]. Toxicol In Vitro, 2013,  料体外免疫原性评价[J]. 食品与药品, 2024, 26(2): 153-
                  27(8): 2213-2224.                                 157.
              [30]   FORRERYD A, JOHANSSON H, ALBREKT A S, et al.  [41]   陈虹, 黄元礼, 王涵, 等. KeratinoSens试验在医疗器械
                  Evaluation of high throughput gene expression platforms  致敏性检测中的应用研究[J]. 癌变·畸变·突变, 2021,
                  using  a  genomic  biomarker  signature  for  prediction  of  33(6): 455-460.
                  skin sensitization[J]. BMC Genomics, 2014, 15(1): 379.  [42]   KOH  D,  NG  V,  LEOW  Y  H,  et  al.  A  study  of  natural
              [31]   FORRERYD  A,  ZELLER  K  S,  LINDBERG  T,  et  al.  rubber  latex  allergens  in  gloves  used  by  healthcare
                  From  genomewide  arrays  to  tailor-made  biomarker  workers  in  Singapore[J].  Br  J  Dermatol,  2005,  153(5):
                  readout  –  progress  towards  routine  analysis  of  skin  954-959.
                  sensitizing  chemicals  with  GARD[J].  Toxicol  In  Vitro,  [43]   SOMMER S, WILKINSON S M, BECK M H, et al. Type
                  2016, 37: 178-188.                                IV  hypersensitivity  reactions  to  natural  rubber  latex:
              [32]   JOHANSSON H, ALBREKT A S, BORREBAECK C A       results  of  a  multicentre  study[J].  Br  J  Dermatol,  2002,
                  K,  et  al.  The  GARD  assay  for  assessment  of  chemical  146(1): 114-117.
                  skin  sensitizers[J].  Toxicol  In  Vitro,  2013,  27(3):  1163-  [44]   ARTIK  S,  VON  VULTÉE  C,  GLEICHMANN  E,  et  al.
                  1169.                                             Nickel allergy in mice: enhanced sensitization capacity of
              [33]   JOHANSSON H, LINDSTEDT M, ALBREKT A S, et al.  nickel  at  higher  oxidation  states[J].  J  Immunol,  1999,
                  A  genomic  biomarker  signature  can  predict  skin  163(3): 1143-1152.
                  sensitizers using a cell-based in vitro alternative to animal  [45]   BAUCH  C,  KOLLE  S  N,  FABIAN  E,  et  al.
                  tests[J]. BMC Genomics, 2011, 12: 399.            Intralaboratory  validation  of  four  in  vitro  assays  for  the
              [34]   ROBERTS D W. Is a combination of assays really needed  prediction  of  the  skin  sensitizing  potential  of
                  for non-animal prediction of skin sensitization potential?  chemicals[J]. Toxicol In Vitro, 2011, 25(6): 1162-1168.
                  Performance  of  the  GARD™  (Genomic  Allergen  Rapid  [46]   中国食品药品检定研究院. 中检院关于发布《皮肤致
                  Detection)  assay  in  comparison  with  OECD  guideline  敏性整合测试与评估策略应用技术指南》的通知
                  assays  alone  and  in  combination[J].  Reg  Toxocol  [EB/OL]. (2024-07-08)[2025-05-21]. https://www.nifdc.
                  Pharmacol, 2018, 98: 155-160.                     org.cn/nifdc/bshff/hzhpbzh/hzhpbzhtzgg/20240708194553
              [35]   COLEMAN K P, MCNAMARA L R, GRAILER T P, et     1149287.html.














                                                             224
   105   106   107   108   109   110   111   112   113   114   115