活血散结方与GEMOX化疗方案联用治疗湿热瘀毒型晚期胰腺癌临床研究

目的：评价活血散结方联合GEMOX化疗方案治疗湿热瘀毒型晚期胰腺癌疗效。方法将符合入选标准的湿热瘀毒型晚期胰腺癌患者90例按随机数字表法分为2组各45例，对照组单纯给予GEMOX化疗方案治疗，联合治疗组在此基础上联用活血散结方。以21 d为1个周期，共治疗3个周期。比较2组治疗前后免疫功能指标和凝血指标变化，评价临床疗效、1年生存率及毒副作用的发生情况。结果联合治疗组总有效率为73.33%(33/45)、对照组为66.67%(30/45)，2组比较差异无统计学意义(χ2＝1.708，P＝0.135)；对照组1年生存率为28.89%(13/45)、联合治疗组为55.56%(25/45)，2组比较差异有统计学意义(χ2＝10.406， P＜0.01)；联合治疗组毒副作用发生率为15.56%(7/45)、对照组为35.56%(16/45)，2组比较差异有统计学意义(χ2＝8.728，P＝0.002)。与对照组治疗后比较，联合治疗组CD3＋(65.20±5.21)个/ml比(62.94±4.73)个/ml，t＝2.106]、CD4＋(36.86±3.70)个/ml比(33.88±3.04)个/ml， t＝2.482]、CD4＋/CD8＋(1.46±0.30)比(1.36±0.24)，t＝2.972]水平明显升高(P＜0.05或 P＜0.01)；联合治疗组凝血酶原时间(13.76±1.70)s 比(14.73±2.12)s，t＝2.842]、活化部分凝血活酶时间(31.84±2.53)s比(36.97±3.40)s，t＝2.713]、D-二聚体(291.68±25.15)mg/L比(486.21±44.32)mg/L，t＝2.845]、PLT(298.91±20.75)×109/L比(329.44±24.07)×109/L，t＝2.693]水平明显降低(P＜0.01)。结论活血散结方与GEMOX化疗方案联用可有效提高湿热瘀毒型晚期胰腺癌患者的生活质量，改善免疫功能和凝血指标，延长生存时间并降低毒副作用。

Clinical observation of Huoxue-Sanjie decoction combined with GEMOX chemotherapy regimen in the treatment of advanced pancreatic cancer for shireyudu syndrome

Objective To evaluate the clinical effects ofHuoxue-Sanjie decoction combined with GEMOX chemotherapy regimen in the treatment of advanced pancreatic cancer with dampness-heat and stasis pattern.MethodsA total of 90 patients with advanced pancreatic cancer and TCM pattern of dampness-heat and stasis were enrolled from January 2012 to May 2014 in our hospital and randomly divided into control group (45 patients) and TCM group (45 patients). The control group was treated with GEMOX chemotherapy regimen used alone, while the TCM group was treated withHuoxue-Sanjie decoction assisted treatment based on control group. The clinical effects, quality improvement rate, immune function index and coagulation index before and after treatment and survival rate in 1 year after treatment and adverse events were compared between two groups.Results The total effective rate (73.33%vs. 66.67%,χ2=1.708,P=0.135) in TCM group was not significantly different from the control group. The survival rate in 1 year was (28.89%vs. 55.56%,χ2=10.406, P<0.01) in TCM group was significantly lower than that in control group. The adverse events (15.56% vs. 35.56%,χ2=8.728,P=0.002) in TCM group was significantly lower than that in control group. Compared with the control group, the CD3+ (65.20 ± 5.21 ratio/mlvs.62.94 ± 4.73 ratio/ml,t=2.106), CD4+ (36.86 ± 3.70 ratio/mlvs. 33.88 ± 3.04 ratio/ml,t=2.482), CD4+/CD8+(1.46 ± 0.30vs.1.36 ± 0.24,t=2.972) levels in TCM group increased significantly (P<0.05 orP<0.01). The PT (13.76 ± 1.70 svs. 14.73 ± 2.12 s,t=2.842), APTT (31.84 ± 2.53 svs. 36.97 ± 3.40 s,t=2.713), D-dimer (291.68 ± 25.15 mg/Lvs. 486.21 ± 44.32 mg/L,t=2.845), PLT (298.91×109/L ± 20.75×109/Lvs. 329.44×109/L ± 24.07×109/L,t=2.693) levels in TCM group significantly decreased (P<0.01).ConclusionHuoxue- Sanjie decoction combined with GEMOX chemotherapy regimen in the treatment of advanced pancreatic cancer for Shieryudu syndrome can improve the quality of life, prolong the survival time and helpreduce the risk of adverse events.