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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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.

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	Articles by authors
	Zhong Qiuzi
	Yu Ning
	Li Gaofeng
	Xiu Xia
	Ma Wenping

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

Received: 08 March 2019

Cite this article:

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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http://journal12.magtechjournal.com/Jweb_fszlx/EN/10.3760/cma.j.issn.1004-4221.2019.07.001 OR http://journal12.magtechjournal.com/Jweb_fszlx/EN/Y2019/V28/I7/481

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