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目的观察人自体原发性肝癌(以下简称“肝癌”)组织提取的热休克蛋白70-肽复合物致敏的树突状细胞(HSP70-PC/DCs)瘤苗的免疫效应及其安全性。方法回顾性分析2010年2月至2015年2月期间我院和南通大学附属第三医院肝胆胰外科手术治疗的30例肝癌患者的临床病例资料,根据术后治疗方法分为HSP70-PC/DCs治疗组(免疫治疗组)和化疗组,每组15例。检测2组患者的外周血T淋巴细胞亚群、血清甲胎蛋白(AFP)及CA19-9水平,观察其毒副反应、复发、生存及KPS评分情况。结果 1 CD3+、CD4+、CD4+/CD8+及CD3CD56指标在治疗前的2组间比较差异无统计学意义(P>0.05);治疗后,以上指标在免疫治疗组均明显高于化疗组(P<0.05),且免疫治疗组治疗后较治疗前均有不同程度的升高且差异有统计学意义(P<0.05),而化疗组在治疗前、后比较差异无统计学意义(P>0.05)。2 AFP及CA19-9水平在治疗前的2组间比较差异无统计学意义(P>0.05);治疗后,以上指标在免疫治疗组均明显低于化疗组(P<0.05),且免疫治疗组治疗后以上指标均明显低于治疗前(t=2.564,P=0.021;t=2.011,P=0.041),化疗组以上指标治疗后较治疗前也有不同程度降低(t=2.221,P=0.036;t=2.487,P=0.066)。3免疫治疗后,有3例患者出现发热(体温38.0~38.5℃),未给予特殊处理,体温均在5~24 h内恢复正常。有2例患者瘤苗注射局部出现直径1.0~1.5 cm的皮肤红肿,患者均可耐受,未予特殊处理,72 h后皮肤红晕消散。瘤苗接种期间,患者均未出现恶心、呕吐、头痛等症状,1例患者出现肌肉痛,给予吲哚美辛后疼痛消失,部分患者出现不同程度的食欲改善,疼痛缓解,生存质量得到明显改善,血常规及肝功能检测也未发现明显异常,所有患者耐受性良好。4 30例患者随访时间5~19个月,中位随访时间9个月。免疫治疗组共死亡4例,中位生存时间为560 d,化疗组中位生存时间为436 d。治疗后,免疫治疗组的KPS评分明显高于化疗组(t=2.421,P=0.045),免疫治疗组的复发率明显低于化疗组(χ~2=0.651,P=0.048),免疫治疗组和化疗组的总生存率比较差异无统计学意义(χ~2=0.476,P=0.579)。结论从本组有限的数据初步可见,应用HSP70-PC/DCs瘤苗对肝癌的治疗是安全、有效的,对激活T淋巴细胞抑制肿瘤生长可能有效,可提高免疫力及预防术后复发。
Objective To observe the immune effect and safety of heat shock protein 70-peptide complex sensitized dendritic cells (HSP70-PC / DCs) isolated from human primary hepatocellular carcinoma (HCC) Sex. Methods The clinical data of 30 patients with hepatocellular carcinoma treated by hepatobiliary and pancreatic surgery in our hospital and the Third Affiliated Hospital of Nantong University from February 2010 to February 2015 were retrospectively analyzed. According to the postoperative treatment, HSP70-PC / DCs Treatment group (immunotherapy group) and chemotherapy group, 15 cases in each group. Peripheral blood T lymphocyte subsets, serum AFP and CA19-9 levels were detected in two groups of patients, and their toxicity, relapse, survival and KPS scores were observed. Results 1 There was no significant difference in the indexes of CD3 +, CD4 +, CD4 + / CD8 + and CD3CD56 between the two groups before treatment (P> 0.05). After treatment, the above indexes in immunotherapy group were significantly higher than those in chemotherapy group ), And immunotherapy group after treatment than before treatment were increased to varying degrees and the difference was statistically significant (P <0.05), while the chemotherapy group before and after treatment was no significant difference (P> 0.05). The levels of AFP and CA19-9 were not significantly different between the two groups before treatment (P> 0.05). After treatment, the above indexes in immunotherapy group were significantly lower than those in chemotherapy group (P <0.05), and immunotherapy The above indexes in the treatment group were significantly lower than those before treatment (t = 2.564, P = 0.021; t = 2.011, P = 0.041) ; t = 2.487, P = 0.066). 3 After immunotherapy, 3 patients had fever (body temperature 38.0 ~ 38.5 ℃), did not give special treatment, body temperature returned to normal within 5 ~ 24 h. In 2 cases, the skin tumor of 1.0-1.5 cm in diameter was locally infiltrated by the tumor vaccine. All the patients were tolerant without any special treatment. After 72 hours, the skin flush disappeared. There was no nausea, vomiting, headache and other symptoms during the inoculation of the tumor vaccine. One patient developed muscle pain. After the indomethacin treatment, the pain disappeared. Some patients showed different degree of appetite improvement, pain relief and quality of life improved significantly , Blood tests and liver function tests did not find significant abnormalities, all patients were well tolerated. 4,30 patients were followed up for 5 to 19 months, with a median follow-up of 9 months. Four patients died in the immunotherapy group, with a median survival time of 560 days and a median survival time of 436 days in the chemotherapy group. After treatment, the KPS score of immunotherapy group was significantly higher than that of chemotherapy group (t = 2.421, P = 0.045). The relapse rate of immunotherapy group was significantly lower than that of chemotherapy group (χ ~ 2 = 0.651, P = 0.048) There was no significant difference in the overall survival rate between chemotherapy and chemotherapy (χ ~ 2 = 0.476, P = 0.579). Conclusions From the limited data in this group, we can see that the application of HSP70-PC / DCs vaccine is safe and effective for the treatment of liver cancer. It may be effective in inhibiting the growth of T lymphocytes and promoting the immunity and preventing postoperative recurrence.