双黄升白颗粒防治癌症患者化疗所致骨髓抑制的临床观察

Clinical observation of Shuanghuang Shengbai Granule () on prevention and treatment of myelosuppression caused by chemotherapy in cancer patients.

作者信息

Wang Li-Fang, Xu Zhen-Ye, Wang Zhong-Qi, Zhang Ming, Yan Gui-Ying, Hou An-Ji, Deng Hai-Bin, Wu Ji, Zhao Xiao-Zhen, Xiang Yi, Yu Lei

机构信息

Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.

Department of Integrated Medicine, Shanghai Chest Hospital, Shanghai, 200030, China.

出版信息

Chin J Integr Med. 2017 Feb;23(2):105-109. doi: 10.1007/s11655-016-2503-4. Epub 2016 Aug 2.

DOI:10.1007/s11655-016-2503-4

PMID:27484763

Abstract

OBJECTIVE

To study the efficacy and safety of Shuanghuang Shengbai Granule (, SSG), a traditional Chinese herbal medicine, on myelosuppression of cancer patients caused by chemotherapy.

METHODS

A total of 330 patients were randomly assigned to the treatment group (220 cases, analysed 209 cases) and the control group (110 cases, analysed 102 cases) with a 2:1 ratio by envelope method. The patients in the treatment group at the first day of chemotherapy started to take SSG for 14 days, while the patients in the control group took Leucogon Tablets. The changes of the blood routine, clinical symptoms and immune function in both groups were observed for safety and efficacy evaluation.

RESULTS

At the 7th day of chemotherapy, the white blood cells (WBCs) level in the treatment group was significantly higher than that in the control group (P<0.05). After treatment, the WBCs rate in the normal range accounted for 50.2% in the treatment group, the myelosuppression of WBCs and neutrophil were mainly grade I, while 8.1% and 5.7% of patients emerged grade III and grade IV myelosuppression, respectively. The incidence of myelosuppression of the treatment group was significantly lower than that of the control group (P<0.05). The total effective rate of Chinese medicine syndrome in the treatment group was significantly higher than that in the control group (84.2% vs. 72.5%, P<0.05). The immune cell levels in both groups were maintained in the normal range. Compared with that before treatment, the levels of CD3 and CD4 cells were significantly increased in the treatment group after treatment (P<0.05). The discrepancy of CD3 and CD4 cell activity before and after treatment in both groups were significantly different (P<0.05). No obvious adverse event occurred in both groups.

CONCLUSION

SSG had a protection effect on bone marrow suppression, and alleviated the clinical symptoms together with clinical safety.

摘要

目的

研究中药双黄升白颗粒（SSG）对化疗所致癌症患者骨髓抑制的疗效及安全性。

方法

采用信封法将330例患者按2∶1比例随机分为治疗组（220例，分析209例）和对照组（110例，分析102例）。治疗组患者在化疗第1天开始服用SSG，疗程14天，对照组患者服用利血生片。观察两组血常规、临床症状及免疫功能变化，进行安全性及疗效评价。

结果

化疗第7天，治疗组白细胞（WBC）水平显著高于对照组（P<0.05）。治疗后，治疗组WBC正常率为50.2%，WBC及中性粒细胞骨髓抑制以Ⅰ度为主，Ⅲ度及Ⅳ度骨髓抑制患者分别占8.1%和5.7%。治疗组骨髓抑制发生率显著低于对照组（P<0.05）。治疗组中医证候总有效率显著高于对照组（84.2%比72.5%，P<0.05）。两组免疫细胞水平均维持在正常范围。治疗组治疗后CD3、CD4细胞水平较治疗前显著升高（P<0.05）。两组治疗前后CD3、CD4细胞活性差异均有统计学意义（P<0.05）。两组均未发生明显不良事件。