薯蓣丸联合聚乙二醇化重组人粒细胞刺激因子注射液治疗恶性肿瘤患者放化疗后白细胞减少症的疗效研究

Clinical Study on Shuyu Wan in Combination with Pegylated Recombinant Human Granulocyte Stimulating Factor Injection in the Treatment of Leukopenia in Patients with Malignant Tumors After Radiotherapy and Chemotherapy

目的:探讨薯蓣丸联合聚乙二醇化重组人粒细胞刺激因子注射液治疗恶性肿瘤患者放化疗后白细胞减少症的临床疗效。方法:选取2020年1月~2022年3月期间该院收治的70例经放化疗后伴有白细胞减少症的恶性肿瘤患者作为研究对象,采用随机数字表法分为对照组和试验组,每组35例。两组患者均根据相应的恶性肿瘤及分期行对应的放化疗,对照组患者于放化疗结束后24h皮下注射聚乙二醇化重组人粒细胞刺激因子注射液,每个放化疗周期结束后给药1次,共2次。试验组在对照组基础上于每个放化疗周期期间服用薯蓣丸,一个放化疗周期内连续服用15天,共服用2个放化疗周期。比较两组患者中医证候积分、临床疗效、白细胞计数(WBC)、T淋巴细胞水平、卡诺夫斯凯计分(KPS)评分及不良反应发生情况。结果:治疗后,两组气短、神疲、乏力、面色淡白、头晕眼花、自汗、懒言等中医症状和体征积分较治疗前均降低(P<0.05),且试验组低于对照组(P<0.05);试验组治疗总有效率(94.29%)高于对照组(77.14%,P<0.05);两组WBC均升高(P<0.05),且试验组高于对照组(P<0.05);两组CD3^(+)、CD4^(+)、CD4^(+)/CD8^(+)较治疗前均升高(P<0.05),且试验组高于对照组(P<0.05);两组KPS评分较治疗前均升高(P<0.05),且试验组高于对照组(P<0.05),两组不良反应发生率比较无统计学差异(P>0.05)。结论:薯蓣丸联合聚乙二醇化重组人粒细胞刺激因子注射液治疗有助于提高恶性肿瘤患者放化疗后WBC水平,改善机体细胞免疫水平,并提高患者的生活质量。

Objective:To investigate the clinical efficacy of Shuyu Wan combined with pegylated recombinant human granulocyte stimulating factor injection in the treatment of leukopenia in patients with malignant tumors after radiotherapy and chemotherapy.Methods:A total of 70 patients with malignant tumors and leukopenia after radiotherapy and chemotherapy admitted to a our hospital from January 2020 to March 2022 were included and divided into control group and experimental group according to random number table method,with 35patients in each group.Patients in both groups received the radiotherapy and chemotherapy treatment regimen based on their specific malignant tumor and stage.The control group was given subcutaneous injection of pegylated recombinant human granulocyte stimulating factor injection 24 hours after the end of radiotherapy.One treatment would be adminitrated by the end of each cycle of radiotherapy,with a total of 2 treatments.The experimental group received Shuyu Wan during each cycle of chemoradiotherapy,in addition to the treatment received by the control group.They took Shuyu Wan continuously for 15 days within one cycle of chemoradiotherapy,and underwent 2 cycles of chemoradiotherapy.The traditional Chinese medicine(TCM)syndrome score,clinical efficacy,white blood cell count(WBC),T lymphocyte level,Kanofsky performance score(KPS) score and occurrence of adverse reactions were compared between the two groups.Results:After treatment,the scores of TCM symptoms and vital signs,such as shortness of breath,fatigue,tiredness,pale face,dizziness,spontaneous sweating and lazy speech,were lower in both groups compared to before treatment(P<0.05).The experimental group had lower scores than the control group(P<0.05).The total efficacy rate in the treatment group(94.29%) was higher than that in the control group(77.14%,P<0.05).The WBC increased in both groups(P<0.05),with the experimental group showing a higher increase than the control group(P<0.05).The levels of CD3^(+),CD4^(+) and CD4^(+)/CD8^(+) in both groups significantly increased after treatment(P<0.05).Moreover,the experimental group showed higher levels compared to the control group(P<0.05).The KPS scores significantly improved in both groups after treatment(P<0.05).Additionally,the experimental group had higher scores compared to the control group(P<0.05),and there were no significant differences in adverse reactions between the two groups(P>0.05).Conclusion:The combination of Shuyu Wan and pegylated recombinant human granulocyte stimulating factor injection can effectively increase the WBC,enhance the cellular immunity and improve the quality of life in patients with malignant tumor after radiotherapy and chemotherapy.