参芪十一味颗粒治疗抗结核药物所致白细胞减少症的疗效

doi:10.3969/j.issn.1000-6621.2018.03.012

摘要/Abstract

摘要：

目的评价参芪十一味颗粒治疗抗结核药物引起白细胞减少症的临床效果。方法收集2015年9月至2017年2月河南省许昌市结核病防治所结核内科收治的规范抗结核药物治疗后引起白细胞减少症的初治肺结核患者158例,按照随机数字表法将患者分为单一服用参芪十一味颗粒治疗白细胞减少症组(简称“A组”,79例)和单一服用利可君片治疗组(简称“B组”,79例),疗程均为1个月。观察治疗1个月后两组患者白细胞减少症的改善有效率,以及治疗前后患者外周血白细胞计数(WBC)和白细胞减少症相关主要症状的改善情况,并记录两组患者药物不良反应的发生情况。结果 A组白细胞减少症改善总有效率[94.44%(68/72)]、外周血WBC值[(5.12±0.76)×10 ⁹/L]均明显高于B组[72.97%(54/74)和(4.09±1.02)×10 ⁹/L](χ ²=10.14,P=0.021;t=4.38,P=0.017);治疗后A组和B组外周血WBC值均明显高于治疗前 [(3.26±1.02)×10 ⁹/L和(3.18±0.82)×10 ⁹/L] (t=5.79,P=0.010;t=4.15,P=0.018)。治疗后A组和B组患者的头晕[8.33%(6/72),9.46%(7/74)]、低热[2.78%(2/72),2.70%(2/74)]、乏力[5.56%(4/72),4.05%(3/74)]等主要症状较治疗前[27.78%(20/72),28.38%(21/74); 15.28%(11/72),16.22%(12/74);40.28%(29/72),41.89%(31/74)]均有明显改善 (χ ²=12.34,P=0.008;χ ²=12.09,P=0.008; χ ²=8.83,P=0.011;χ ²=8.16,P=0.010; χ ²=17.26,P=0.020;χ ²=18.09,P=0.020);但两组患者间治疗后的头晕、低热、乏力等主要症状的改善情况,差异均无统计学意义(χ ²=1.43,P=0.437;χ ²=2.62,P=0.406; χ ²=1.95,P=0.410)。A组患者药物不良反应的发生率[83.33%(60/72)]与B组患者[86.49%(64/74)]比较,差异无统计学意义(χ ²=3.03, P=0.382)。结论参芪十一味颗粒可有效改善抗结核药物所致的白细胞减少症,减少白细胞减少引起的症状,安全性较高,有较好的临床效果。

关键词: 抗结核药, 药物毒性, 白细胞减少, 药物评价, 参芪十一味

Abstract:

Objective To evaluate the treatment effect of Shenqi Eleven Granules on treating leukopenia caused by antituberculosis drugs.Methods A total of 158 patients who were complicated by leukopenia after first standard anti-TB drug treatment were collected from Tuberculosis Prevention and Control Agency, Xuchang City, He’nan Province from September 2015 to February 2017. According to the table of random number, patients were divided into two groups: taking Shenqi Eleven Flavor Granule for “A group”(n=79) and taking Leucogen for B group (n=79). Peripheral blood leukocyte count, main symptoms associated with leucopenia, and adverse drug reactions were observed and recorded.Results The total effective rate of leukopenia (94.44% (68/72)) and WBC in peripheral blood (5.12±0.76)×10 ⁹/L) in A group were significantly higher than those in B group (72.97% (54/74), (4.09±1.02)×10 ⁹/L) (χ ²=10.14, P=0.021; t=4.38, P=0.017). The WBC of peripheral blood in group A and B after treatment were significantly higher than that before treatment ((3.26±1.02)×10 ⁹/L and (3.18±0.82)×10 ⁹/L)) (t=5.79, P=0.010; t=4.15, P=0.018). Dizziness (8.33% (6/72), 9.46% (7/74)), low fever (2.78% (2/72), 2.70% (2/74)), weakness (5.56% (4/72), 4.05% (3/74)) in both groups were than those before treatment (27.78% (20/72), 28.38% (21/74); 15.28% (11/72), 16.22% (12/74)); 40.28% (29/72), 41.89% (31/74)) (χ ²=12.34, P=0.008; χ ²=12.09, P=0.008; χ ²=8.83, P=0.011;χ ²=8.16,P=0.010; χ ²=17.26, P=0.020; χ ²=18.09, P=0.020). However, there was no significant difference between the two groups in the improvement of the main symptoms such as dizziness, fever and fatigue (χ ²=1.43, P=0.437; χ ²=2.62, P=0.406; χ ²=1.95, P=0.410). The incidence of ADR in group A was not significantly different from that in group B (83.33% (60/72)) compared with 86.49% (64/74) in group B (χ ²=3.03, P=0.382). Conclusion Shenqi Eleven Flavor Granules has a better clinic effect on leukopenia caused by anti-tuberculosis drugs and higher safety.

Key words: Antitubercular agents, Drug toxicity, Leukopenia, Drug evaluation, Shenqi eleven granules

郭存炳,李辉,郑淑兰. 参芪十一味颗粒治疗抗结核药物所致白细胞减少症的疗效[J]. 中国防痨杂志, 2018, 40(3): 274-279. doi: 10.3969/j.issn.1000-6621.2018.03.012

Cun-bing GUO,Hui LI,Shu-lan ZHENG. Treatment effect of Shenqi Eleven Granules on leuccytopenia caused by antituberculosis drugs[J]. Chinese Journal of Antituberculosis, 2018, 40(3): 274-279. doi: 10.3969/j.issn.1000-6621.2018.03.012

图/表 5

表1

两组患者一般资料的比较

组别	年龄 (岁, $x ˉ$ ±s)	性别[例(构成比,%)]		抗结核药物治疗中 [例(服药率,%)]	抗结核药物治疗时间 (d, $x ˉ$ ±s)
组别	年龄 (岁, $x ˉ$ ±s)	男	女	抗结核药物治疗中 [例(服药率,%)]	抗结核药物治疗时间 (d, $x ˉ$ ±s)
A组(79例)	29.86±3.91	46(58.23)	33(41.77)	63(79.75)	52.23±12.77
B组(79例)	30.72±4.25	44(55.70)	35(44.30)	60(75.95)	51.90±10.41
检验值	t=1.02	χ²=0.10		χ²=0.33	t=0.88
P值	0.329	0.748		0.565	0.496

表1

表2

表3

表4

两组患者治疗前后外周血WBC计数的比较

组别	WBC计数( $x ˉ$ ±s,×10⁹/L)		t值	P值
组别	治疗前	治疗后	t值	P值
A组(72例)	3.26±1.02	5.12±0.76	5.79	0.010
B组(74例)	3.18±0.82	4.09±1.02	4.15	0.018
t值	1.21	4.38	-	-
P值	0.632	0.017	-	-

表4

表5

参考文献 17

[1]	唐神结, 高文 . 临床结核病学. 北京: 人民卫生出版社, 2011: 198.
[2]	Lin FS, Wu MY, Tu WJ , et al. A cross-sectional and follow-up study of leukopenia in tuberculosis patients: prevalence,risk factors and impact of anti-tuberculosis treatment. J Thorac Dis, 2015,7(12):2234-2242.
[3]	中华医学会结核病学分会. 肺结核诊断和治疗指南. 中国实用乡村医生杂志, 2013,20(2):7-11. doi: 10.3969/j.issn.1672-7185.2013.02.005 URL
[4]	陈灏珠, 林果为 . 实用内科学. 13 版. 北京: 人民卫生出版社, 2009: 2568.
[5]	唐天弼, 王建萍, 武栋 , 等. 咖啡酸治疗抗结核药物所致白细胞和血小板下降临床观察. 宁夏医科大学学报, 2017,39(1):78-83. doi: 10.16050/j.cnki.issn1674-6309.2017.01.023 URL
[6]	姚梦杰, 吕金朋, 张乔 , 等. 人参化学成分及药理作用研究. 吉林中医药杂志, 2017,37(12):1261-1263.
[7]	王秋红 . 地榆升白片联合利血生在白细胞减少症治疗中的效果观察. 中国社区医师, 2014,30(16):96-98.
[8]	赵丹, 张振凌, 王胜超 , 等. 不同方法炮制的熟地黄补血作用对比. 中国实验方剂学杂志, 2017,23(19):46-49.
[9]	马喜迎, 刘静 . 脾肾双补汤治疗抗结核治疗中的白细胞减少症的疗效观察 . 世界最新医学信息文摘, 2015, 15(20):73,75.
[10]	蔡艳芳, 王华 . 地榆升白片治疗抗结核化疗白细胞减少症临床效果分析. 北方药学, 2017,14(1):179-181.
[11]	刘志, 刘焱, 李丹丹 , 等. 自拟补肾解毒养肝方对肝肾阴虚型系统性红斑狼疮中医证候积分、免疫功能和相关炎症因子的影响. 辽宁中医杂志, 2017,44(10):2037-2039.
[12]	付彦君, 陶小军, 刘晴 , 等. 天麻川芎对自发高血压大鼠肾脏损伤及炎症因子的影响. 辽宁中医杂志, 2016,43(7):1528-1530.
[13]	马庆彤, 李增云, 张峰 . 参芪十一味颗粒治疗慢性血小板减少性紫癜的疗效观察. 医学信息, 2009,1(12):147. doi: 10.3969/j.issn.1008-0104.2010.01.030 URL
[14]	沈泽天, 武新虎, 李兵 , 等. 参芪十一味颗粒联合三维适形放疗治疗食管癌的临床研究. 现代肿瘤医学, 2010,18(11):2145-2147. doi: 10.3969/j.issn.1672-4992.2010.11.22 URL
[15]	魏凯军 . 参芪十一味颗粒联合干扰素软膏治疗扁平疣. 临床和实验医学杂志, 2010,9(21):1650. doi: 10.3969/j.issn.1671-4695.2010.21.036 URL
[16]	魏明禄, 刘建民, 陈南清 , 等. 滋肾益肝方联合多烯磷脂酰胆碱治疗抗结核药物所致急性肝损伤的有效性与安全性研究. 中华中医药学刊, 2018,36(1):45-48.
[17]	刘丁瑗, 罗虎, 周向东 . 抗结核药物不良反应的临床分析及白细胞下降治疗效果评价. 重庆医学, 2017,46(16):2206-2208. doi: 10.3969/j.issn.1671-8348.2017.16.014 URL

组别	治愈	有效	无效	总有效
A组(72例)	52(72.22)	16(22.22)	4(5.56)	68(94.44)
B组(74例)	41(55.41)	13(17.57)	20(27.02)	54(72.97)
χ²值	4.18	2.98	7.13	10.14
P值	0.097	0.229	0.040	0.021

组别	消化系统	转氨酶升高	神经系统	皮肤瘙痒	合计
A组(72例)	55(76.39)	11(15.28)	3(4.17)	1(1.39)	60(83.33)
B组(74例)	56(75.68)	17(22.97)	2(2.70)	0(0.00)	64(86.49)
χ²值	3.08	2.69	1.08	0.93	3.03
P值	0.371	0.401	0.504	0.728	0.382