Fu Biqian, Zhai Xiangyang, Xi Shengyan, Yue Lifeng, Wang Yanan, Qiu Yingkun, Gong Yuewen, Xu Yangxinzi, Qian Linchao, Huang Jingru, Lu Dawei, Huang Shuqiong, Wang Jing, Zhou Jing, Wu Di, Wang Yanhui
Department of Traditional Chinese Medicine, School of Medicine, Xiamen University, Xiamen 361102, Fujian, China.
Cancer Research Center of Xiamen University, Xiamen 361102, Fujian, China.
Evid Based Complement Alternat Med. 2019 Jan 14;2019:3659890. doi: 10.1155/2019/3659890. eCollection 2019.
Ciji-Hua'ai-Baosheng II Formula (CHB-II-F) is a new traditional Chinese medical formula that has been shown to reduce toxicity and side effects of chemotherapy and increase the probability of cancer patient survival. Whether CHB-II-F is safe as an adjunctive therapy for cancer patients receiving chemotherapy has yet to be determined.
To evaluate the acute and subchronic toxic effects of CHB-II-F in rodent models.
In acute toxicity test, 24 Kunming mice were divided into 2 groups: untreated control and CHB-II-F 1.05 g/mL (31.44 g/kg) treated group. Treatment was administered to the treated group 3 times a day for 14 days. The overall health, adverse reactions, and mortality rate were documented. In subchronic toxicity test, 96 Sprague-Dawley rats were divided into 4 groups: untreated control, high dose CHB-II-F (H) (26.20 g/kg), medium dose CHB-II-F (M) (13. 10 g/kg), and low dose CHB-II-F (L) (6.55 g/kg) [equal to 24.375 g (dried medicinal herb)/kg] treated groups. Treated groups were given the treatments once a day for 4 weeks. The overall health and mortality rate were recorded every day. Body weight and food consumption were measured once a week. Hematologic and biochemical parameters, organ weights, and histopathologic markers were analyzed after 4 weeks. An additional 2 weeks were given as the treatment recovery period before end-point euthanization, and biochemical analyses were performed.
The maximum tolerated dose (MTD) of CHB-II-F on mice was found to be 94.31 g/kg [equal to 351 g (dried medicinal herb)/kg], which is 108 times the human adult dose. In the acute toxicity test, administration of CHB-II-F 31.44 g/kg showed no adverse effect and did not cause mortality. In the subchronic toxicity test, after 4 weeks of treatment, compared to the controls, total cholesterol (TCHO) level, cardiac and splenic indexes, body weights of female rats, and mean corpuscular hemoglobin concentration (MCHC) in the CHB-II-F (H) group were significantly increased; triglyceride (TG) in the CHB-II-F (M) group and liver and splenic indexes in the CHB-II-F (L) group were increased. After the two-week recovery period, biofluid analyses, food consumption, and histopathologic examinations showed no abnormalities.
Administration of CHB-II-F had no obvious adverse effect on the overall health of rodent models. A daily maximum dose of less than 94.31 g/kg or 6.55 g/kg CHB-II-F for 4 continuous weeks was considered safe.
慈济化癌保生二号方（CHB-II-F）是一种新型中药方剂，已被证明可降低化疗的毒性和副作用，并提高癌症患者的生存几率。CHB-II-F作为接受化疗的癌症患者的辅助治疗是否安全尚未确定。
评估CHB-II-F在啮齿动物模型中的急性和亚慢性毒性作用。
在急性毒性试验中，将24只昆明小鼠分为2组：未处理对照组和CHB-II-F 1.05 g/mL（31.44 g/kg）处理组。处理组每天给药3次，共14天。记录整体健康状况、不良反应和死亡率。在亚慢性毒性试验中，将96只Sprague-Dawley大鼠分为4组：未处理对照组、高剂量CHB-II-F（H）（26.20 g/kg）、中剂量CHB-II-F（M）（13.10 g/kg）和低剂量CHB-II-F（L）（6.55 g/kg）[相当于24.375 g（干药材）/kg]处理组。处理组每天给药1次，共4周。每天记录整体健康状况和死亡率。每周测量一次体重和食物摄入量。4周后分析血液学和生化参数、器官重量和组织病理学指标。在终点安乐死前提2周作为治疗恢复期，并进行生化分析。
发现CHB-II-F对小鼠的最大耐受剂量（MTD）为94.31 g/kg[相当于351 g（干药材）/kg]，是成人剂量的108倍。在急性毒性试验中，给予31.44 g/kg的CHB-II-F未显示出不良反应，也未导致死亡。在亚慢性毒性试验中，治疗4周后，与对照组相比，CHB-II-F（H）组的总胆固醇（TCHO）水平、心脏和脾脏指数、雌性大鼠体重以及平均红细胞血红蛋白浓度（MCHC）显著升高；CHB-II-F（M）组的甘油三酯（TG）以及CHB-II-F（L）组的肝脏和脾脏指数升高。在两周的恢复期后，生物流体分析、食物摄入量和组织病理学检查均未显示异常。
给予CHB-II-F对啮齿动物模型的整体健康没有明显不良影响。连续4周每天给予小于94.31 g/kg或6.55 g/kg的CHB-II-F被认为是安全的。
