Clinical efficacy observation of Jidesheng snake medicine in the treatment of patients with middle and advanced liver cancer of damp-heat and stasis toxin syndrome and correlation study of its influence on serum miR-335
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摘要: 目的 观察季德胜蛇药治疗中晚期湿热瘀毒型肝癌患者的临床疗效以及对患者血清miR-335的影响。方法 选取2019年1月—2021年9月在南通大学附属南通第三医院住院部准备接受治疗的62例符合研究条件的中晚期湿热瘀毒型肝癌患者,将他们随机分为观察组和对照组各31例,在西医对症药物治疗的基础上观察组给予季德胜蛇药口服治疗3个月,而对照组不予中药治疗,3个月后进行复诊。对比2组肝癌患者治疗前后的谷草转氨酶(AST)、谷丙转氨酶(ALT)、白蛋白(ALB)、总胆红素(TBIL)情况,治疗前后T淋巴细胞水平变化情况,加用季德胜蛇药治疗后的临床有效率以及患者生活质量改变情况,对比分析不良反应的发生率。比较治疗时、治疗后1个月、治疗后3个月患者外周血中miR-335表达水平。结果 治疗后,2组患者AST、ALT、TBIL均低于治疗前(P< 0.05),同时观察组这3项指标均显著低于对照组(P< 0.05);2组治疗前后ALB指标无明显变化(P>0.05)。治疗后,2组患者T淋巴细胞检测CD4+、CD4+/CD8+指标均较治疗前升高(P< 0.05),且观察组均高于对照组(P< 0.05);2组治疗前后CD8+表达水平无明显改变(P>0.05)。加用季德胜蛇药治疗后的肝癌患者临床治疗有效率为74.19%,高于对照组的61.29%(P< 0.05);生活质量提高率为67.74%,高于对照组的48.39%(P< 0.05);生活质量下降率为12.90%,低于对照组的25.81%(P< 0.05);加用季德胜蛇药治疗后没有提高药物不良反应发生率(P>0.05)。2组患者治疗时外周血miR-335表达差异无统计学意义(P>0.05),治疗后1个月观察组外周血miR-335表达较治疗时有所升高,治疗后3个月明显高于治疗时(P< 0.05),而对照组基本持平(P=0.969)。结论 应用季德胜蛇药对中晚期湿热瘀毒型肝癌患者可以提高患者临床疗效,改善患者生活质量,并且能提高患者外周血miR-335表达水平,具有一定的抗癌临床应用意义。Abstract: Objective To observe the clinical effect of Jidesheng snake medicine on patients with middle and advanced liver cancer of damp-heat and stasis toxin syndrome and study its effect on serum miR-335.Methods Sixty-two patients with middle and advanced liver cancer of damp-heat and stasis toxin syndrome who were prepared for basic treatment in the inpatient department of Nantong Third Hospital were selected from January 2019 to September 2021. They were randomly divided into observation group and control group(n=31), on the basis of western medicine symptomatic drug treatment, the observation group was given Jidesheng snake medicine oral treatment for 3 months, while the control group was not given Traditional Chinese Medicine treatment. A follow-up visit was made after 3 months. The levels of AST, ALT, ALB, TBIL and the changes of T lymphocyte level were compared between the two groups of liver cancer patients before and after treatment. To compare the clinical effective rate and life quality of patients treated with Jidesheng snake medicine. The incidence of adverse reactions was analyzed. The expression levels of miR-335 in peripheral blood of patients were compared at the time of treatment, one month and three months after treatment.Results AST, ALT and TBIL after treatment in two groups were lower than before treatment(P< 0.05), and the above three indexes in observation group were significantly lower than those in control group(P< 0.05). There was no significant change in ALB before and after treatment in both groups(P>0.05). CD4+ and CD4+/CD8+ indexes of T lymphocytes after treatment in two groups were increased compared with those before treatment(P< 0.05), and the two indexes in observation group were higher than those in control group(P< 0.05). There was no significant change in CD8+ expression before and after treatment(P>0.05). The effective rate of liver cancer patients treated with Jidesheng snake medicine was 74.19%, which was higher than that of 61.29% in the control group(P< 0.05), the improvement rate of life quality was 67.74%, which was higher than that of 48.39% in control group(P< 0.05), the reduction rate of quality of life was 12.90%, which was lower than that of 25.81% in the control group(P< 0.05). No increase in the incidence of adverse drug reactions after the addition of Jidesheng snake medicine treatment(P>0.05). There was no significant difference in the expression of miR-335 in peripheral blood between two groups(P>0.05), the expression of miR-335 in peripheral blood of the observation group was little increased after one month, and significantly higher after three months(P< 0.05), the control group was basically flat(P=0.969).Conclusion Jidesheng snake medicine can improve the clinical efficacy, improve the life quality of patients, and improve the expression level of miR-335 in peripheral blood in patients with middle and advanced liver cancer of damp-heat and stasis toxin syndrome, which has certain anticancer clinical application significance.
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Key words:
- Jidesheng snake medicine /
- liver cancer /
- clinical efficacy /
- miR-335
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表 1 2组患者的基线特征
项目 对照组
(n=31)观察组
(n=31)χ2/t P 年龄/岁 63.68±9.38 59.10±9.11 0.328 0.576 性别/例 0.075 0.785 男 20 19 女 11 12 肝癌病程/年 5.23±2.34 4.98±1.79 0.228 0.626 乙肝患者/例 27 29 0.127 0.814 Child-Pugh分级/例 0.042 0.839 A级 20 18 B级 11 13 治疗史/例 0.321 0.643 TACE术治疗 7 8 TACE术+系统治疗 24 23 表 2 2组患者治疗前后的肝功能指标变化
X±S 指标 对照组(n=31) 观察组(n=31) t P AST/(U·L-1) 治疗前 79.10±22.66 74.43±17.80 0.141 0.761 治疗后 53.00±14.06 42.33±2.78 2.782 0.044 t 2.987 5.231 P 0.034 <0.001 ALT/(U·L-1) 治疗前 104.50±19.41 100.31±20.26 0.113 0.921 治疗后 82.32±11.23 71.21±23.45 2.953 0.035 t 3.253 5.341 P 0.021 0.000 ALB/(g·L-1) 治疗前 31.34±3.23 30.23±2.35 0.063 0.872 治疗后 32.12±3.21 29.11±2.45 0.952 0.292 t 0.354 0.328 P 0.431 0.576 TBIL/(μmol·L-1) 治疗前 26.12±6.12 27.13±4.43 0.021 0.882 治疗后 22.15±4.23 19.21±4.23 4.132 0.023 t 3.185 5.968 P 0.025 0.000 表 3 2组患者治疗前后T淋巴细胞水平变化
X±S 指标 对照组(n=31) 观察组(n=31) t P CD4+/% 治疗前 27.32±4.31 27.53±4.32 0.124 0.821 治疗后 35.24±3.51 37.69±4.57 3.782 0.036 t 3.429 5.325 P 0.032 <0.001 CD8+/% 治疗前 34.23±2.81 32.70±2.96 0.073 0.091 治疗后 32.94±2.46 31.85±2.52 1.953 0.435 t 1.376 1.967 P 0.265 0.324 CD4+/CD8+ 治疗前 1.22±0.16 1.32±0.14 1.163 0.222 治疗后 1.52±0.39 1.78±0.54 3.153 0.032 t 3.448 3.476 P 0.032 0.026 表 4 2组患者临床治疗效果比较
例 组别 例数 疾病进展 疾病稳定 部分缓解 完全缓解 临床有效率/% 对照组 31 12 11 8 0 61.29 观察组 31 8 12 11 0 74.19 χ2 4.324 P 0.033 表 5 2组生活质量改善情况比较
例(%) 组别 例数 改善 稳定 下降 对照组 31 15(48.39) 8(25.81) 8(25.81) 观察组 31 21(67.74) 6(19.35) 4(12.90) χ2 5.034 0.884 4.592 P 0.025 0.347 0.033 表 6 2组患者治疗后的不良反应比较
例(%) 组别 例数 过敏 肾功能受损 胃肠道不适 神经受损 发生率/% 对照组 31 1(3.2) 2(6.5) 2(6.5) 0 16.1 观察组 31 0 1(3.2) 3(9.7) 1(3.2) 16.1 χ2 1.40 2.01 0.17 2.24 0.01 P 0.54 0.44 0.65 0.35 0.91 表 7 不同时间点2组患者外周血中miR-335的表达水平
X±S 时间点 对照组 观察组 t P 治疗时 1.23±0.18 1.27±0.26 0.145 0.885 治疗1个月后 1.28±0.25 1.45±0.16 0.561 0.576 治疗3个月后 1.31±0.21 2.11±0.28 2.258 0.028 F 0.032 3.302 P 0.969 0.041 -
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