抗辐射损伤药物安多霖胶囊的安全性分析——基于真实世界大数据研究

doi:10.3760/cma.j.issn.1004-4221.2019.07.001

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摘要目的采用真实世界大数据回顾性分析抗辐射损伤药物安多霖的安全性。方法分析2015-2017年间共87053例癌症住院放疗患者,筛选使用安多霖胶囊最多的10所医疗机构。对肺癌、宫颈癌、鼻咽癌、乳腺癌和结直肠癌5种癌症患者,利用PSM方法对使用与未使用安多霖胶囊患者进行匹配分析。通过血生化肝肾功能等检验结果指标,评价安多霖胶囊用于癌症患者放疗辅助用药的安全性。结果肝功能相关指标中,肺癌患者安多霖胶囊使用组AST和TBIL低于未使用组(22.1 U/L︰24.7 U/L,P=0.04和9.8 μmol/L︰11.4 μmol/L,P=0.01),但均在正常范围内;宫颈癌患者多霖胶囊使用组ALT高于未使用组(24.7 U/L︰21.1 U/L,P=0.01),但均在正常范围内。肾功能相关指标中,CRE、UREA在这5类肿瘤中两组均相近(P=0.09~0.86)。宫颈癌和结直肠癌患者安多霖使用组LDH均低于未用组(P=0.04、0.00),但均在正常范围内。营养相关指标中,乳腺癌患者安多霖使用组TB较高于未使用组(69.4 g/L︰67.1 g/L,P=0.03),但均在正常范围内。结论全国首个抗辐射中药安多霖胶囊用于放疗辅助用药无明显肝肾毒性,安全性高。

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	钟秋子
	于宁
	李高峰
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关键词 ：恶性肿瘤/放射疗法, 放射性损伤, 安多霖

Abstract：Objective To retrospectively analyze the safety of anti-radiation injury drug of Andorin using real-world big data. Methods A total of 87 053 hospitalized cancer patients receiving radiotherapy from 2015 to 2017 were analyzed. Ten medical institutions with the largest number of patients treated with Andorin capsules were screened. Patients with 5 types of cancer including lung cancer, cervical cancer, nasopharyngeal carcinoma, breast cancer and colorectal cancer with/without use of Andorin capsule were subject to propensity score matching (PSM). The safety of Andorin capsule as an adjuvant drug in the radiotherapy for cancer patients was evaluated by the Results of blood biochemical detection and liver and kidney function test. Results In the relevant indexes of liver function, the AST and TBIL levels in the lung cancer patients with use of Andorin capsule were significantly lower than those in their counterparts without use of Andorin capsule (22.1 U/L vs.24.7 U/L,P=0.04 and 9.8 mmol/L vs.11.4 μmol/L, P=0.01),but all the Results were within the normal range. In patients with cervical cancer, the ALT level in patients treated with Andorin capsule was considerably higher than that in those without use of Andorin capsule (24.7 U/L vs.21.1 U/L,P=0.01) and both the Results were within the normal range. In terms of the renal function-related indexes, CRE and UREA were similar between patients with and without use of Andorin capsule in 5 types of tumors (P=0.09-0.86). In patients with cervical and colorectal cancer, the LDH in patients with Andorin capsule was significantly lower compared with that in those without use of Andorin capsule (P=0.04,0.00),but both the Results were within the normal range. Regarding the nutrition-related indexes, the TB level in breast cancer patients with use of Andorin capsule was significantly higher than that in those without use of Andorin capsule (69.4 g/L vs.67.1 g/L, P=0.030), but both the Results were within the normal range. Conclusion As the first anti-radiation traditional Chinese medicine in China, Andorin capsule is utilized as an adjuvant drug for radiotherapy, which yields no significant liver and kidney toxicity and possesses high safety.

Key words： Malignant neoplasm/radiotherapy Radiation-induced injury Anduorin

收稿日期: 2019-03-08

引用本文:

钟秋子,于宁,李高峰等. 抗辐射损伤药物安多霖胶囊的安全性分析——基于真实世界大数据研究[J]. 中华放射肿瘤学杂志, 2019, 28(7): 481-485.

Zhong Qiuzi,Yu Ning,Li Gaofeng et al. Safety analysis of anti-radiation-induced injury drug of Andorin capsule——based on real-world big data research[J]. Chinese Journal of Radiation Oncology, 2019, 28(7): 481-485.

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