研究背景與目的
　　目前台灣中文藥品仿單之適應症與禁忌症並未有統一的醫學中文詞彙。因此常遇到治療相同疾病的藥品，仿單敘述卻不相同的現象。就健保署的角度而言，在評估藥品適應症與給付之相關性時，則須依據國際疾病分類代碼（International Classification of Disease，簡稱ICD）。台灣於2015年全面採用國際疾病分類標準第十修訂版（ICD-10-CM/PCS），對於病患的詳盡醫療紀錄、流行病學的研究數據等面向都有大幅品質的提升。然而，我國並未有建立藥品適應症及禁忌症與國際疾病分類代碼之間的轉換模式，健保署無法依據申報資料評估健保處方用藥是否符合其適應症及禁忌症。Systematized Nomenclature of Medicine - Clinical Terms（SNOMED CT）為國際間常用的標準化臨床術語，可以使醫學術語一致化，使不同醫療環境之間具一致性並減少解讀與紀錄的差異。此外，SNOMED CT也提供臨床術語對應至ICD-10-CM之參考。
因此本研究之目的是期望藉由SNOMED CT的標準化系統建立藥品適應症和禁忌症之中文敘述與ICD-10-CM轉換模式，並進一步評估醫師處方時的疾病代碼與本研究模式疾病代碼的一致性結果。本研究以抗精神病藥物為主要研究藥品，由於此類藥品之適應症涵蓋範圍廣泛，因此適合於本研究驗證。

研究方法
　　運用系統性回顧蒐集國內外關於藥品適應症和禁忌症與疾病代碼對應方式之文獻與報告。適應症和禁忌症與ICD-10-CM轉換模式建立，是經由ATC藥品分類系統篩選抗精神病藥品（N05A）後，統整其中文仿單的適應症與禁忌症之中文敘述，藉由DSM-5中文版和英文仿單，經兩位研究人員進行中英詞彙轉換，並確認適應症和禁忌症之英文醫學術語，再與SNOMED CT系統進行連結，對應出ICD-10-CM。ICD-10-CM一致性驗證分析，是以2018年單一醫學中心的電子病歷資料為研究資料庫，篩選抗精神病藥品成分risperidone進行驗證，比較醫師處方時的疾病代碼與本研究模式疾病代碼的一致性，並計算其敏感性和陽性預測值結果。

研究結果
　　經由系統性文獻回顧，發現符合研究目的的文獻共有6篇。其中有三篇是來自美國的研究，其文獻中有提及到將適應症對應至ICD-10-CM是使用SNOMED CT系統進行轉換。截至2018年衛生福利部食品藥物管理署（TFDA）核准之抗精神病藥品之許可證共784張，其中以quetiapine為成分之許可證張數最多（15.2 %）。另外，抗精神病藥品仿單中適應症及禁忌症統整後共有492筆適應症及禁忌症之敘述。經由SNOMED CT對照後的ICD-10-CM代碼中屬於精神（心智）行為疾患（代碼開頭為F）佔47.6 %，屬於神經與感官系統疾病（代碼開頭為G）佔3.7 %，屬於影響健康狀態與醫療保健服務因素（代碼開頭為Z）佔8.5 %，屬於症狀、徵候與臨床發現者（代碼開頭為R）佔6.2 %，而其他分類則佔34.0 %。ICD-10-CM一致性驗證分析結果發現，醫師處方時的疾病代碼與本研究模式疾病代碼的一致性，其敏感性為94.6 %及陽性預測值為80.8 %。

結論
經文獻回顧得知SNOMED CT是適用於適應症和禁忌症與ICD-10-CM轉換的系統。本研究是以抗精神病藥物仿單為例，未來若要應用在其他種類藥品上，此轉換模式流程可以做為其參考依據，提供健保署用藥型態之分析。

關鍵詞：適應症、禁忌症、ICD-10-CM/PCS、SNOMED CT

SUMMARY

Objective:
The objective of this study was to establish a model for mapping indications and contraindications with ICD-10-CM for TFDA approved antipsychotics, and evaluate the agreement of our model with reviewing electronic medical records.
Methods:
To establish a model for mapping indication and contraindication with ICD-10-CM, the terminology in Chinese drug labels were translated into English with dictionary-based approach. Then, they were linked to SNOMED CT, and further mapped to ICD-10-CM. The sensitivity and positive predictive value (PPV) were estimated by reviewing the electronic medical records sampled in National Cheng Kung University Hospital.
Results:
There were 784 pharmaceutical licenses of antipsychotic medications approved by TDFA and the terms were linked to SNOMED CT then matched to ICD-10-CM. The mapping rate was 96.5 %. Finally, the sensitivity and PPV of this model we established were 94.59 % and 80.77 %, respectively.
Conclusion:
The mapping model we established had satisfactory sensitivity and PPV; thus, this mapping strategy we developed can be applied to other pharmaceutical products, and further used could evaluate pharmaceutical reimbursement in Taiwan.

Keywords: Indication, Contraindication, ICD-10-CM/PCS, SNOMED CT

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