聚乙二醇干扰素α-2b治疗慢乙肝引起骨髓抑制后应用利可君片和补中益气汤的临床疗效研究

Peginterferon Alfa-2b in the Treatment of Chronic Hepatitis B-Induced Myelosuppression: Clinical Efficacy of Leucogen Tablets and Buzhong Yiqi Decoction

摘要: 目的：系统探讨补中益气汤联合利可君片干预聚乙二醇干扰素α-2b (PegIFN-α-2b)治疗慢性乙型肝炎(CHB)诱发骨髓抑制的临床疗效、血象改善作用及用药安全性，为临床优化干扰素抗病毒治疗的不良反应管理提供中西医结合方案。方法：采用前瞻性随机对照研究设计，选取2025年1月~2025年8月在北京中医药大学东方医院枣庄医院肝胆病科接受PegIFN-α-2b治疗12 ± 2周后出现骨髓抑制，且中医辨证符合脾胃虚弱证的CHB患者60例，按照随机数字表法分为对照组、研究组，各30例。对照组仅给予利可君片口服治疗，研究组在对照组治疗基础上加用补中益气汤水煎剂口服，两组均连续治疗4周。分别于治疗前、治疗4周后检测两组外周血白细胞(WBC)、中性粒细胞(N)、血小板(PLT)水平，参照《中药新药临床研究指导原则》进行中医证候量化评分并判定疗效，记录治疗期间不良反应发生情况，对比两组各项指标差异。结果：治疗前两组外周血常规指标、中医证候总积分、性别、年龄、病程等基线资料比较，差异均无统计学意义(P > 0.05)，具有可比性；治疗4周后，两组WBC、N、PLT水平均较治疗前显著升高(P < 0.05)，且研究组各指标水平显著高于对照组(P < 0.05)；研究组中医证候总有效率为93.33%，对照组为73.33%，研究组疗效显著更优(P < 0.05)；两组治疗期间流感样症状、胃肠道反应、甲状腺功能异常等不良反应发生率比较，差异无统计学意义(P > 0.05)，均未出现严重不良事件。结论：补中益气汤联合利可君片可显著提升PegIFN-α-2b所致慢乙肝骨髓抑制患者的外周血象水平，有效改善脾胃虚弱相关临床症状，且安全性良好，能够提高患者对干扰素治疗的耐受性，保障抗病毒治疗顺利完成，值得在慢性肝病临床中推广应用。

Abstract: Objective: To systematically investigate the clinical efficacy, peripheral blood image improvement effect, and medication safety of Buzhong Yiqi Decoction combined with Leucogen Tablets in the treatment of myelosuppression induced by Peginterferon alfa-2b (PegIFN‑α2b) in patients with chronic hepatitis B (CHB), so as to provide an integrated traditional Chinese and Western medicine plan for optimizing the adverse reaction management of interferon antiviral therapy. Methods: A prospective randomized controlled study was conducted. Sixty CHB patients with myelosuppression after 12 ± 2 weeks of PegIFN‑α2b treatment and syndrome of spleen-stomach deficiency in traditional Chinese medicine (TCM) in the Department of Hepatology, Zaozhuang Hospital, Dongfang Hospital, Beijing University of Chinese Medicine from January 2025 to August 2025 were selected and divided into control group and study group according to random number table method, with 30 cases in each group. The control group was only given oral Leucogen Tablets, and the study group was additionally given oral Buzhong Yiqi Decoction on the basis of the control group. Both groups were treated continuously for 4 weeks. The levels of peripheral blood white blood cells (WBC), neutrophils (N), and platelets (PLT) were detected before and after 4 weeks of treatment. The quantitative score of TCM syndromes was evaluated and the curative effect was judged with reference to the Guiding Principles for Clinical Research of New Chinese Medicines. The adverse reactions during treatment were recorded, and the differences in various indicators between the two groups were compared. Results: There were no significant differences in baseline data such as peripheral blood routine indicators, total score of TCM syndromes, gender, age, and course of disease between the two groups before treatment (P > 0.05), which was comparable. After 4 weeks of treatment, the levels of WBC, N, and PLT in both groups were significantly higher than those before treatment (P < 0.05), and the levels of each indicator in the study group were significantly higher than those in the control group (P < 0.05). The total effective rate of TCM syndromes in the study group was 93.33%, and that in the control group was 73.33%, the curative effect of the study group was significantly better (P < 0.05). There was no significant difference in the incidence of adverse reactions such as influenza-like symptoms, gastrointestinal reactions, and thyroid dysfunction between the two groups during treatment (P > 0.05), and no serious adverse events occurred. Conclusion: Buzhong Yiqi Decoction combined with Leucogen Tablets can significantly improve the peripheral blood image level of CHB patients with myelosuppression induced by PegIFN-α-2b, effectively relieve the clinical symptoms related to spleen-stomach deficiency, with good safety. It can improve patients’ tolerance to interferon treatment and ensure the smooth completion of antiviral therapy, which is worthy of popularization and application in the clinical practice of chronic liver diseases.