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

Treatment effect of Shenqi Eleven Granules on leuccytopenia caused by antituberculosis drugs

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]（x^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），2．70Yo（2／74）]、乏力[5．56％（4／72），4．05％（3／74）]等主要症状较治疗前E27．78％（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（x^2=12．34，P=0．008；x^2=12．09，P=0．008；x^2=8．83，P=0．011；x^2=8．16，P=0．010；x^2=17．26，P=0．020；x^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（x^2=1．43，P=0．437；x^2=2．62，P=0．406；x^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（x^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。

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） （x^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）） （x^2 =12.34, P=0. 008; x^2 =12.09, P=0. 008;x^2=8.83, P=0. 011;x^2=8.16,P= 0. 010;x^2=17.26, P=0. 020; x^2=18.09, P=0. 020）. However, there was no significant difference between thetwo groups in the improvement of the main symptoms such as dizziness, fever and fatigue （x^2=1.43, P= 0. 437; x^2=2.62, P=0. 406; x^2=1.95, P=0. 410）. The incidence of ADR in group A was not significantly different from that in group B （83.33Z% （60/72）） compared with 86.49% （64/74） in group B （x^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.