解毒化瘀通腑颗粒治疗湿热瘀毒型中晚期胰腺癌的疗效观察

Evaluation of efficacy of Jiedu Huayu Tongfu granule on advanced pancreatic cancer patients with dampheat and stasis-toxic syndrome

[目的]观察解毒化瘀通腑颗粒治疗湿热瘀毒型中晚期胰腺癌的临床疗效。[方法]将50例患者按随机数字表法随机分为2组,治疗组25例患者在吉西他滨化疗的前提下,加服解毒化瘀通腑颗粒,对照组25例患者用化疗加安慰剂治疗。两组均治疗4个疗程,21 d为1个疗程,观察其近期疗效和中医症状改善,T细胞亚群CD3+、CD4+、CD4+/CD8+及自然杀伤细胞(NK细胞)等免疫功能指标,肿瘤标志物癌胚抗原(CEA)、糖类抗原19-9(CA199)和凝血系列中凝血酶原时间(PT-T)、活化部分凝血活酶时间(APTT-T)、D-二聚体及血小板计数(PLT)指标。[结果]治疗组近期疗效中完全缓解(CR)0例,部分缓解(PR)18例,总有效率为72%;对照组CR 0例,PR 15例,总有效率为60%,差异无统计学意义(P>0.05)。治疗组临床症状显著改善率为24%,总有效率为84%;对照组显著改善率为8%,总有效率为56%,差异有统计学意义(P<0.05)。治疗组CD3+、CD4+、CD4+/CD8+及NK细胞较治疗前增加,且均高于对照组,差异有统计学意义(P<0.05)。两组治疗前后CEA、CA199变化差异无统计学意义(P>0.05)。治疗组PT-T、APTT-T、D-二聚体及PLT均较治疗前降低,且低于对照组,差异有统计学意义(P<0.05)。治疗组不良反应发生率低于对照组。[结论]解毒化瘀通腑颗粒治疗湿热瘀毒型中晚期胰腺癌疗效确切,安全可靠。

[Objective] To observe the clinical curative effect of Jiedu Huayu Tongfu granule in the treatment of the Damp-heat and Stasis-toxic advanced pancreatic cancer. [Methods] The 50 patients were randomly divided into 2 groups, 25 patients in treatment group were based on gemcitabine, and Jiedu Huayu Tongfu granule, control plus placebo group of 25 patients treated with chemotherapy. The two groups were treated for 4 courses, 21 days are 1 treatment course, observe its curative effect and TCM symptom improvement, index function of T cell subsets of CD3＋, CD4＋, CD4＋/CD8＋ and NK cell immunity, tumor markers CEA, CA199, and coagulation series （PT-T, APTT-T, D2 dimer and platelet （PLT） index. [Results] In the treatment group, curative effect in complete remission （CR） was 0 cases, and partial remission （PR） was 18 cases, the total efficiency of 72%. In control group, CR was 0 cases; PR was 15 cases, and the total effective rate was 60%, no significant difference （P〉0.05）. In treatment group, the clinical symptoms improved rate was 24%, total efficiency of 84%. In control group significantly improved rate was 8%, the total efficiency of 56%, and the difference was statistically significant （P〈0.05）. CD3＋, CD4＋, CD4＋/ CD8 ＋ and NK cells of the treatment group were in creased, compared with that before treatment, and were higher than that in the control group, and the difference was statistically significant （P〈0.05）. In the two groups before and after treatment, CEA, CA199 were no statistically significant difference （P〉0.05）. PT, APTT,D2 dimer and PLT in treatment group were lower than those before therapy, and lower than that of control group. The difference was statistically significant （P〈0.05）. The incidence of adverse reaction was lower than that control group. [Conclusion] Jiedu Huayu Tongfu Granule has better effect and safety on the patients with advanced pancreatic cancer.