A randomized controlled clinical study on the prevention and treatment of adverse bleeding events caused by chemotherapy in patients with advanced lung cancer with Yiqi Yangxue Shengsui (益气养血生髓方) Formula
10.3760/cma.j.cn114015-20241126-00169
- VernacularTitle:益气养血生髓方防治晚期肺癌患者化疗所致出血不良事件的随机对照临床研究
- Author:
Yu LIAO
1
;
Fangfang LIU
;
Cheng LI
;
Surui YUAN
;
Lingshuang LIU
Author Information
1. 上海中医药大学附属龙华医院肿瘤科，上海 200030
- Publication Type:Journal Article
- Keywords:
Carcinoma, non-small cell lung;
Bleeding;
Drugs, Chinese herbal;
Yiqi Yangxue;
Platinum-based doublet chemotherapy;
Bevacizumab;
Integrated traditional Chin
- From:
Adverse Drug Reactions Journal
2025;27(10):577-583
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To observe the clinical effect of the Yiqi Yangxue Shengsui Formula in the prevention and treatment of adverse bleeding events caused by platinum-based dual drugs combined with bevacizumab chemotherapy in patients with advanced non-small cell lung cancer (NSCLC). Methods:A prospective, single-center, randomized controlled trial design was adopted. The research subjects were patients with stage Ⅲb-Ⅳb non-squamous NSCLC who were hospitalized at Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from December 2022 to March 2024. Patients who met the inclusion criteria were randomly assigned to the experimental group and the control group in a 1∶1 ratio. The control group received a platinum-based doublet regimen [pemetrexed disodium for injection+cisplatin/carboplatin, or paclitaxel protein-bound for injection+cisplatin/carboplatin] combined with bevacizumab for 4 courses of treatment; the experimental group was treated with the same regimen plus the traditional Chinese medicine Yiqi Yangxue Shengsui Formula, nourishing blood and generating bone marrow. The primary observation index was the incidence and grade of adverse bleeding events during the 4 courses of treatment. The secondary observation indices were the occurrence time and duration of bleeding, the grade of the lowest platelet count during treatment, the platelet count grade at the time of bleeding, and coagulation function indicators. Results:A total of 77 patients were included, with 39 in the experimental group and 38 in the control group. Among them, 29 were male (37.7%) and 48 were female (62.3%); 35 were aged 65 years or older and 42 were younger than 65 years. There were no statistically significant differences between the 2 groups in terms of gender, age, lung cancer stage, pathological type, and chemotherapy drug selection ( P> 0.05). The incidence of adverse bleeding events in the experimental group was significantly lower than that in the control group [17.9%(7/39) vs. 39.5%(15/38), P=0.037]. There was no statistically significant difference in the grading of adverse bleeding events between the 2 groups ( P>0.05). The duration of bleeding in the experimental group was shorter than that in the control group [(2.57±1.13) days vs. (5.67±1.80) days, P<0.001]. The minimum platelet count classification during the treatment period, and the platelet count classification at the time of bleeding in the experimental group were both better than those in the control group ( P<0.05). The prothrombin time and international normalized ratio when bleeding occurred in the experimental group were both lower than those in the control group [(10.96±0.39) s vs. (11.49±0.50) s and 0.97±0.04 vs. 1.02±0.06, P<0.05]. There were no statistically significant differences between the 2 groups of patients in terms of activated partial thromboplastin time, fibrinogen degradation products and D-dimer ( P>0.05). Conclusion:The Yiqi Yangxue Shengsui formula can effectively prevent and treat bleeding adverse events related to platinum-based dual-drug chemotherapy combined with bevacizumab in patients with advanced NSCLC. The mechanism may be related to the increase of platelet count and the improvement of exogenous coagulation function indicators.
