甘氨双唑钠注射剂联合同期放化疗治疗原发性晚期宫颈癌的临床研究

Clinical research of sodium glycididazole injection combined with concurrent chemoradiotherapy in treatment of primary advanced cervical cancer

目的观察甘氨双唑钠注射剂联合同期放化疗治疗原发性晚期宫颈癌的临床疗效及安全性。方法选择2010年11月至2016年11月青海省人民医院收治的84例原发性晚期宫颈癌患者,按随机数字表法分为对照组(42例)和试验组(42例)。对照组予以常规放化疗,试验组基于对照组加以甘氨双唑钠治疗。比较两组患者的临床疗效,血清肿瘤标志物如鳞状细胞癌相关抗原(SCC)、组织多肽特异性抗原(TPS)、可溶性人类组织相容性复合物-Ⅰ类分子链相关基因A蛋白(sMICA)、缺氧诱导因子-1α(HIF-1α)和人表皮生长因子受体-2(Her-2)水平,以及不良反应的发生情况。结果治疗后4个月,试验组和对照组的总有效率分别为73.81%(31/42)和50.00%(21/42),试验组总有效率优于对照组,差异有统计学意义(χ^2=5.048,P=0.025)。治疗后4个月,试验组SCC[(2.67±0.76)ng/ml∶(4.10±0.94)ng/ml]、TPS[(56.85±6.39)U/L∶(86.69±12.62)U/L]、sMICA[(90.31±11.25)ng/L∶(129.46±16.60)ng/L]、HIF-1α[(55.47±7.04)ng/L∶(68.07±7.97)ng/L]和Her-2[(44.64±4.96)U/L∶(53.07±6.56)U/L]均低于对照组,差异均有统计学意义(t=7.667,P<0.001;t=13.671,P<0.001;t=12.653,P<0.001;t=7.679,P<0.001;t=6.643,P<0.001)。试验组和对照组的骨髓抑制发生率分别为23.81%(10/42)、21.43%(9/42),胃肠道反应发生率分别为19.05%(8/42)、14.29%(6/42),心电图异常发生率分别为4.76%(2/42)、2.38%(1/42),总不良反应发生率分别为47.62%(20/42)和38.10%(16/42),两组总不良反应发生率差异无统计学意义(χ^2=0.778,P=0.378)。结论甘氨双唑钠注射剂联合同期放化疗治疗原发性晚期宫颈癌的临床疗效确切,其能够显著降低SCC、TPS、sMICA、HIF-1α及Her-2水平,且不增加不良反应的发生率。

Objective To observe the clinical efficacy and safety of sodium glycididazole injection combined with concurrent chemoradiotherapy in treatment of primary advanced cervical cancer. MethodsA total of 84 patients with primary advanced cervical cancer were selected from November 2010 to November 2016 in Qinghai Provincial People′s Hospital. All the patients were divided into the control group (n=42) and the experimental group (n=42) according to random number table method. The control group was treated with routine chemoradiotherapy, and the experimental group was treated with sodium glycididazole injection based on the control group. The curative effects, levels of serum tumor markers such as squamous cell carcinoma associated antigen (SCC), tissue polypeptide specific antigen (TPS), soluble human major histocompatibility complex-Ⅰ molecular chain related gene A protein (sMICA), hypoxia inducible factor-1α(HIF-1α), human epidermal growth factor receptor 2 (Her-2) and adverse reactions of the two groups were compared. ResultsFour months after treatment, the total effective rates of the experimental group and the control group were 73.81%(31/42) and 50.00%(21/42). The total effective rate in the experimental group was higher than that in the control group, and the difference was statistically significant (χ^2=5.048, P=0.025). Four months after treatment, the levels of SCC [(2.67±0.76 ) ng/ml vs.(4.10±0.94) ng/ml], TPS [(56.85±6.39) U/L vs.(86.69±12.62) U/L], sMICA [(90.31±11.25) ng/L vs.(129.46±16.60) ng/L], HIF-1α[(55.47±7.04) ng/L vs.(68.07±7.97) ng/L] and Her-2 [(44.64±4.96) U/L vs.(53.07±6.56) U/L] in the experimental group were lower than those in the control group, with statistically significant differences (t=7.667, P<0.001;t=13.671, P<0.001;t=12.653, P<0.001;t=7.679, P<0.001;t=6.643, P<0.001). The occurrence rates of bone marrow suppression of the experimental group and the control group were 23.81%(10/42) and 21.43%(9/42), the occurrence rates of gastrointestinal reaction were 19.05%(8/42) and 14.29%(6/42), the occurrence rates of abnormal electrocardiogram were 4.76%(2/42) and 2.38%(1/42), and the tatal adverse reaction rates were 47.62%(20/42) and 38.10%(16/42). The difference of the total adverse reaction rates between the experimental group and the control group was not statistically significant (χ^2=0.778, P=0.378). ConclusionThe clinical efficacy of sodium glycididazole injection combined with concurrent chemoradiotherapy is definite for primary advanced cervical cancer. This treatment regimen can reduce serum levels of SCC, TPS, sMICA, HIF-1α and Her-2, and not increase the incidence of adverse reactions.