人参二醇组皂苷治疗非小细胞肺癌化疗引起的白细胞减少症临床疗效观察

Clinical effect of panaxadiol saponin on non - small cell lung cancer patients with chemotherapy - induced leukopenia

目的探讨应用人参二醇组皂苷治疗非小细胞肺癌（NSCLC）化疗引起的白细胞减少症的临床疗效及安全性。方法选择92例NSCLC患者，化疗后均存在白细胞减少症，采取随机数字表法分为观察组（46例）和对照组（46例）。观察组化疗后第2天给予派能达胶囊，3粒／次，2次／d，口服。对照组给予安慰剂或利血生等，口服，两组均4周为1个疗程，连续治疗两个疗程。评估两组患者临床疗效、白细胞数量、中医症候改善状况及不良反应。结果观察组治疗4周和8周后白细胞计数分别为（4．48±0．77）×10^9／L和（4．92±0．89）×10^9／L，高于对照组（4．02±0．93）×10。／L和（4．57±0．86）×10^9／L，差异均有统计学意义（t=8．24、8．41，均P〈0．05）；观察组治疗4周和8周后中医证候积分分别为（24．02±5．91）分和（21．73±4．14）分，低于对照组（26．33±5．08）分和（23．14±3．90）分，差异均有统计学意义（t=9．68、9．63，均P〈0．05）。观察组4周和8周中医症候临床疗效总有效率分别为76．09％（35／46）和82．61％（38／46），高于对照组63．04％（29／46）和63．04％（29／46），差异均有统计学意义（X2=10．32、8．61，均P〈0．05）。观察组4周和8周白细胞减少改善显效率分别为69．57％（32／46）和78．26％（36／46），高于对照组56．52％（26／46）和65．22％（30／46），差异均有统计学意义（t=9．38、9．51，均P〈0．05）。两组不良反应结果比较，差异无统计学意义（P〉0．05）。结论应用人参二醇组皂苷治疗NSCLC化疗引起的白细胞减少症能够显著提高患者白细胞数量，改善患者临床症状，并具有较好的安全性。

Objective To explore the clinical efficacy and safety of panaxadiol saponins for the treatment of non - small cell lung cancer（NSCLC） with chemotherapy - induced leukopenia. Methods 92 NSCLC patients with leukopenia after chemotherapy were selected and divided into the observation group （46 cases） and the control group （46 cases） by random number table method. On the second day after the chemotherapy,the observation group was given panaxadiol saponins capsules, 3 tablets/time, 2 times/day. The control group was orally given placebo or reserpine,4 weeks for one course of treatment, the two groups were continuously treated for two courses. The clinical efficacy,number of leukocytes,improvement of TCM symptoms and adverse reactions were evaluated. Results After treatment for 4 weeks and 8 weeks,the WBC counts of the observation group were （4.48±0.77） ×10^9/L and （4.92 ± 0.89） × 10^9/L,respectively ,which were significantly higher than those of the control group[ （4.02 ± 0.93 ） × 10^9/L and （4.57± 0.86） × 10^9/L ], the differences were statistically significant （ t = 8.24,8.41, all P 〈 0.05 ）. After treatment for 4 weeks and 8 weeks, the TCM syndrome scores of the observation group were （24.02 ± 5.91 ） points and （21.73 ±4.14） points, respectively, which were lower than those of the control group [ （ 26.33 ± 5.08 ） points and （23.14 ± 3.90） points ], the differences were statistically significant （ t = 9.68,9.63, all P 〈 0.05 ）. After treatment for 4 weeks and 8 weeks,the total effective rates of TCM were 76.09% （35/46） and 82.61% （38/46） ,respectively,which were significantly higher than those of the control group [ 63.04% （29/46） and 63.04% （ 29/46 ） ], the differences were statistically significant（ X2 = 10.32,8.61, all P 〈 0.05 ）. The effective rates of leukopenia improvement of the observation group after treatment for 4 weeks and 8 weeks were 69.57% （32/46） and 78.26% （36/46）, respectively, which were higher than those of the control group [ 56. 52% （ 26/46 ） and 65.22% （ 30/46 ） ], the differences were statistically significant （ t = 9.38,9.51, all P 〈 0.05 ）. There were no significant differences in adverse reactions between the two groups （ P 〉 0. 05 ）. Conclusion Panaxadiol saponins in the treatment of NSCLC chemotherapyinduced leukopenia can significantly improve the number of white blood cells, improve the clinical symptoms, and it has good safety.