|本期目录/Table of Contents|

[1]景婧,王睿林,朱云,等.基于整合证据链的中草药相关肝损伤诊断方法解读——以何首乌为例[J].传染病信息,2018,02:131-134,144.
 JING Jing,WANG Rui-lin,ZHU Yun,et al.Evaluation of diagnostic method for herb-induced liver injury based on the integrated evidence chain: exemplification by Polygonum multiflorum[J].Infectious Disease Information,2018,02:131-134,144.
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基于整合证据链的中草药相关肝损伤诊断方法解读——以何首乌为例(PDF)

《传染病信息》[ISSN:1007-8134/CN:11-3886/R]

期数:
2018年02期
页码:
131-134,144
栏目:
专题论著
出版日期:
2018-03-20

文章信息/Info

Title:
Evaluation of diagnostic method for herb-induced liver injury based on the integrated evidence chain: exemplification by Polygonum multiflorum
作者:
景婧王睿林朱云牛明宋雪艾何婷婷肖小河王伽伯
100039 北京,解放军第三〇二医院中西医结合 诊疗与研究中心(景婧、王睿林、朱云、宋雪艾、何婷婷); 100039 北京,全军中医药研究所(牛明、肖小河、王伽伯)
Author(s):
JING Jing WANG Rui-lin ZHU Yun NIU Ming SONG Xue-ai HE Ting-ting XIAO Xiao-he WANG Jia-bo*
Integrative Medicine Center, 302 Military Hospital of China, Beijing 100039, China
关键词:
中草药相关肝损伤整合证据链诊断因果关系评价何首乌
Keywords:
herb-induced liver injury integrated evidence chain diagnosis causality assessment Polygonum multiflorum
分类号:
R575;R44
DOI:
10.3969/j.issn.1007-8134.2018.02.009
文献标识码:
A
摘要:
目的 以何首乌为例,解读中草药相关肝损伤(herb-induced liver injury, HILI)客观诊断整合证据链(integrated evidence chain, iEC)法的适用性和优势。方法 以2007 年1 月—2016 年12 月解放军第三〇二医院收治的145 例发病前有 何首乌及其制剂服用史的HILI 患者为研究对象,对比新建立的iEC 法和常规应用的罗素优克福因果关系评估方法(Roussel- Uclaf causality assessment method, RUCAM)的诊断效能和因果关系判断的异同。结果 145 例HILI 患者的RUCAM 相关 性评分以“很可能”为主(n=74, 51.0%)。而这些RUCAM 相关性评分为“很可能”的患者中,经iEC 法构建证据链后, 5 例达到“确定诊断”,54 例达到“临床诊断”,15 例为“疑似诊断”,分别占iEC 法相同诊断级别HILI 患者的71.4%、 53.5% 和40.5%。RUCAM 相关性评分仅为“很可能”(5 例)和“可能”(2 例)级别的7 例患者,通过iEC 法构建证据 链可达到“确定诊断”。经iEC 法客观辨识后,无慢性肝病(chronic liver diseases, CLDs)基础和有CLDs 基础的HILI 患者 的诊断级别变化不大(P > 0.05),而有CLDs 基础HILI 患者的RUCAM 相关性评分级别较无CLDs 基础HILI 患者 明显下降(P < 0.001)。结论 iEC 法与RUCAM 法的总体一致性较好,iEC 法是适用于临床影响因素较为复杂的HILI 诊断和因果关系评价,对有基础肝病的药物性肝损伤患者仍有较好的适用性。 
Abstract:
Objective To evaluate the applicability and advantage of diagnostic method for herb-induced liver injury (HILI) based on the integrated evidence chain (iEC) with an exemplification by Polygonum multiflorum (PM). Methods A total of 145 HILI patients implicated with PM and its preparation before onset were enrolled from 302 Military Hospital of China from January 2007 to December 2016. The diagnostic efficiency for HILI and the reliability of causality were compared between iEC and Roussel-Uclaf causality assessment method (RUCAM). Results Among 145 HILI patients assessed by RUCAM scale, 74 cases were diagnosed as probable population, which was predominant (51.0%). Among patients diagnosed with probable HILI based on RUCAM score, 5 cases were qualified for confirmed diagnosis, 54 cases for clinical diagnosis and 15 cases for suspected diagnosis after evidence chain was constructed by using iEC method, proportions of cases with confirmed diagnosis, clinical diagnosis and suspected diagnosis were 71.4%, 53.5% and 74.1% assessed by iEC, respectively. Seven patients were diagnosed with confirmed HILI by use of iEC method, whereas those were considered probable (n=5) and possible (n=2) based on RUCAM scale. Chronic liver diseases had no effect on the diagnostic efficiency of iEC method in HILI patients (P > 0.05), but it could obviously reduce the scores of RUCAM scale in HILI patients compared with HILI patients without chronic liver diseases (P < 0.001). Conclusions Both iEC method and RUCAM scale have a good consistency. iEC method can be appropriate for the diagnosis and causality assessment of HILI due to clinical complicated factors of herbal medicines, especially in patients with chronic liver diseases.

参考文献/References

[1] 中华中医药学会肝胆病分会,中华中医药学会中成药分会. 中草药相关肝损伤临床诊疗指南[J]. 临床肝胆病杂志, 2016,32(5):835-843.
[2] 朱云,刘树红,王伽伯,等. 何首乌及其制剂导致药物性 肝损伤的临床分析[J]. 中国中西医结合杂志,2015, 35(12):1442-1447.
[3] But PP, Tomlinson B, Lee KL. Hepatitis related to the Chinese medicine Shou-wu-pian manufactured from Polygonum multiflorum[J].Vet Hum Toxicol, 1996, 38(4):280-282.
[4] Park GJ, Mann SP, Ngu MC. Acute hepatitis induced by Shou-Wu- Pian, a herbal product derived from Polygonum multiflorum[J]. J Gastroenterol Hepatol, 2001, 16(1):115-117.
[5] Mazzanti G, Battinelli L, Daniele C, et al. New case of acute hepatitis following the consumption of Shou Wu Pian, a Chinese herbal product derived from Polygonum multiflorum[J]. Ann Intern Med, 2004, 140(7):W30.
[6] Cárdenas A, Restrepo JC, Sierra F, et al. Acute hepatitis due to shen-min: a herbal product derived from Polygonum multiflorum [J]. J Clin Gastroenterol, 2006, 40(7):629-632.
[7] Dong H, Slain D, Cheng J, et al. Eighteen cases of liver injury following ingestion of Polygonum multiflorum[J]. Complement Ther Med, 2014, 22(1):70-74.
[8] Aithal GP, Watkins PB, Andrade RJ, et al. Case definition and phenotype standardization in drug-induced liver injury[J]. Clin Pharmacol Ther, 2011, 89(6):806-815.
[9] Chalasani NP, Hayashi PH, Bonkovsky HL, et al. ACG Clinical Guideline: the diagnosis and management of idiosyncratic druginduced liver injury[J]. Am J Gastroenterol, 2014, 109(7):950- 967.
[10] Teschke R, Danan G. Diagnosis and management of drug-induced liver injury (DILI) in patients with pre-existing liver disease[J]. Drug Saf, 2016, 39(8): 729-744.
[11] Chalasani N, Bonkovsky HL, Fontana R, et al. Features and Outcomes of 899 patients with drug-induced liver injury: the DILIN prospective study[J]. Gastroenterology, 2015, 148(7):1340- 1352.
[12] Chalasani N, Regev A. Drug-Induced liver injury in patients with preexisting chronic liver disease in drug development: how to identify and manage? [J]. Gastroenterology, 2016, 151(6):1046- 1051.
[13] 急性酒精中毒诊治共识专家组. 急性酒精中毒诊治共识[J]. 中华急诊医学杂志,2014,23(2):135-138.
[14] Danan G, Teschke R. RUCAM in drug and herb induced liver injury: the update[J]. Int J Mol Sci, 2015, 17(1):1-33.
[15] Danan G, Benichou C. Causality assessment of adverse reactions to drugs-I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries[J]. J Clin Epidemiol, 1993, 46(11):1323-1330.
[16] Benichou C1, Danan G, Flahault A. Causality assessment of adverse reactions to drugs-II. An original model for validation of drug causality assessment methods: case reports with positive rechallenge[J]. J Clin Epidemiol, 1993, 46(11):1331-1336.
[17] 孙颖, 谢欢,王春红, 等. 特异质型药物性肝损伤病因 评估及生物标志物的研究进展[J]. 传染病信息,2017, 30(4):203-208.
[18] Teschke R, Frenzel C, Schulze J, et al. Herbal hepatotoxicity: challenges and pitfalls of causality assessment methods[J]. World J Gastroenterol, 2013, 19(19):2864-2882.
[19] Zhu Y, Niu M, Chen J, et al. Comparison between Chinese herbal medicine and Western medicine-induced liver injury of 1985 patients[J]. J Gastroenterol Hepatol, 2016, 31(8):1476-1482.
[20] Teschke R, Schulze J, Schwarzenboeck A, et al. Herbal hepatotoxicity: suspected cases assessed for alternative causes[J]. Eur J Gastroenterol Hepatol, 2013, 25(9):1093-1098.

备注/Memo

备注/Memo:
[基金项目] 国家重大新药创制重大专项(2015ZX09501-004- 001-008);国家中医药行业科研专项(201507004-04);国 家自然科学基金(81630100,81403126);北京科技新星项目 (Z16111000490000);北京自然科学基金(7152142)
[通信作者] 王伽伯,E-mail: pharm_sci@126.com
更新日期/Last Update: 2018-03-20