自研药物益血生精胶囊治疗化疗后血小板 减少症的临床研究

Clinical Study on Self-Developed Drug Yixueshengjing Capsule for Chemotherapy-Induced Thrombocytopenia

摘要: 目的：通过临床试验，验证自研药物益血生精胶囊在治疗化疗后血小板减少症(CIT)中的有效性和安全性，探究益血生精胶囊促进血小板生成过程中的潜在作用机制。方法：选取2024年9月至2025年11月包头市中心医院60例符合标准的CIT患者，按随机数字表法分为实验组和对照组各30例。实验组采用益血生精胶囊联合重组人血小板生成素(rhTPO)治疗，对照组单用rhTPO治疗；停药标准为连续两次血小板计数 ≥ 100 × 10⁹/L或较治疗前升高 > 50 × 10⁹/L。观察两组治疗前后血小板计数、血清粒细胞集落刺激因子(G-CSF)、血小板衍生生长因子-BB (PDGF-BB)、白细胞介素-3 (IL-3)、白细胞介素-11 (IL-11)水平变化，比较血小板恢复时间、临床疗效、卡劳夫斯基评分(KPS)及不良反应发生情况。结果：实验组血小板恢复时间显著短于对照组[(6.9 ± 3.44) d vs (9.13 ± 4.53) d, P = 0.036]；实验组治疗总有效率100.00%，显著高于对照组的80.00% (P = 0.03)；治疗后两组血清G-CSF、PDGF-BB、IL-3、IL-11水平均升高，且实验组显著高于对照组(均P < 0.001)；治疗后两组KPS评分均升高，实验组(84.00 ± 5.48)显著优于对照组(79.83 ± 3.07) (P < 0.01)；两组均未发生明显不良反应，无血小板输注情况。结论：益血生精胶囊联合rhTPO治疗CIT可显著缩短血小板恢复时间，提高临床疗效，改善患者生活质量，其作用机制可能与上调内源性造血因子、改善骨髓造血微环境相关，且安全性良好、患者接受度高，为CIT的中西医结合治疗提供了新方案。

Abstract: Objective: To validate the efficacy and safety of the self-developed drug Yixueshengjing Capsule in the treatment of chemotherapy-induced thrombocytopenia (CIT) through a clinical trial, and to investigate its mechanism of action in promoting platelet production. Method: A total of 60 CIT patients meeting the inclusion criteria at Baotou Central Hospital from September 2024 to November 2025 were selected and randomly divided into an experimental group and a control group using a random number table, with 30 cases in each group. The experimental group was treated with recombinant human thrombopoietin (rhTPO) combined with Yixueshengjing Capsule, while the control group received rhTPO alone. The treatment discontinuation criterion was two consecutive platelet counts ≥ 100 × 10⁹/L or an increase of >50 × 10⁹/L compared to the pre-treatment level. Changes in platelet counts, serum levels of granulocyte colony-stimulating factor (G-CSF), platelet-derived growth factor-BB (PDGF-BB), interleukin-3 (IL-3), and interleukin-11 (IL-11) were observed before and after treatment in both groups. Platelet recovery time, clinical efficacy, Karnofsky Performance Status (KPS) scores, and the occurrence of adverse reactions were compared between the two groups. Results: The platelet recovery time in the experimental group was significantly shorter than that in the control group [(6.9 ± 3.44) d vs (9.13 ± 4.53) d, P = 0.036]. The total effective rate in the experimental group was 100.00%, significantly higher than 80.00% in the control group (P = 0.03). After treatment, serum levels of G-CSF, PDGF-BB, IL-3, and IL-11 increased in both groups, with significantly higher levels observed in the experimental group compared to the control group (all P < 0.001). Post-treatment KPS scores increased in both groups, with the experimental group (84.00 ± 5.48) showing significantly better scores than the control group (79.83 ± 3.07) (P < 0.01). No significant adverse reactions or platelet transfusions occurred in either group. Conclusions: The combination of Yixueshengjing Capsule and rhTPO in treating CIT can significantly shorten platelet recovery time, improve clinical efficacy, and enhance patients’ quality of life. Its mechanism of action may be associated with upregulating endogenous hematopoietic factors and improving the bone marrow hematopoietic microenvironment. This regimen demonstrates good safety and high patient acceptance, offering a new therapeutic approach integrating traditional Chinese and Western medicine for CIT.