目的 探讨康莱特注射液联合TP方案（紫杉类联合顺铂）治疗晚期鼻咽癌的临床疗效。方法 将2022年3月—2025年12月在唐山市人民医院就诊的晚期鼻咽癌患者92例作为研究对象，所有患者按随机数字表法分为对照组和治疗组，每组46例。对照组给予TP方案，第1天静滴紫杉醇注射液150 mg/m²，第1～3天静滴顺铂注射液75 mg/m²。治疗组在对照组基础上第1～10天静脉滴注康莱特注射液10 mg/m²。3周为1个疗程，两组患者连续治疗3个疗程。统计近期疗效和药物不良反应，比较两组患者的生活质量、血清肿瘤标志物。结果 治疗后，对照组的疾病控制率为78.26%，治疗组的疾病控制率为93.48%，组间比较差异具有显著性（P＜0.05）；对照组的客观缓解率为50.00%，治疗组的客观缓解率为60.87%，组间客观缓解率无明显差异。两组治疗后的卡氏（KPS）评分明显升高（P＜0.05），且治疗组治疗后KPS评分明显高于对照组（P＜0.05）。两组治疗后的血清鳞状细胞癌抗原（SCCAg）、组织多肽特异性抗原（TPS）、癌胚抗原（CEA）水平显著降低（P＜0.05），且治疗组治疗后的血清SCCAg、TPS、CEA水平均低于对照组（P＜0.05）。治疗组骨髓抑制、消化道反应、肝肾功能损害的发生率明显低于对照组（P＜0.05），两组神经毒性、过敏反应的发生率无明显差异。结论 康莱特注射液联合TP方案可提高晚期鼻咽癌的疾病控制率，降低肿瘤标志物水平，改善生活质量，减轻药物不良反应。

Objective To investigate the clinical efficacy of Kanglaite Injection combined with TP regimen (paclitaxel combined with cisplatin) in treatment of advanced nasopharyngeal carcinoma. Methods 92 Patients with advanced nasopharyngeal carcinoma who visited Tangshan People’s Hospital from March 2022 to December 2025 were selected as the study subjects. All patients were divided into control group and treatment group using a random number table method, with 46 patients in each group. The control group was given a TP regimen, with intravenous infusion of Paclitaxel Injection at 150 mg/m² on day 1 and intravenous infusion of Cisplatin Injection at 75 mg/m² on days 1—3. The treatment group received intravenous infusion of 10 mg/m² of Kanglaite injection on the basis of the control group from day 1 to day 10. One course of treatment was three weeks, and two groups of patients received three consecutive courses of treatment. The recent efficacy and adverse drug reactions of two groups of patients were calculated, and their quality of life and serum tumor markers were compared. Results After treatment, the disease control rate of the control group was 78.26%, while the disease control rate of the treatment group was 93.48%, and the difference between the groups was significant (P < 0.05). The objective remission rate of the control group was 50.00%, while the objective remission rate of the treatment group was 60.87%, and there was no significant difference in the objective remission rate between two groups. After treatment, the KPS (Karnofsky Performance Status) scores of two groups significantly increased (P < 0.05), and the KPS scores of the treatment group were significantly higher than those of the control group (P < 0.05). After treatment, the serum levels of squamous cell carcinoma antigen (SCCAg), tissue polypeptide specific antigen (TPS), and carcinoembryonic antigen (CEA) in two groups were significantly reduced (P < 0.05), and the serum levels of SCCAg, TPS, and CEA in the treatment group were lower than those in the control group (P < 0.05). The incidence of bone marrow suppression, gastrointestinal reactions, and liver and kidney dysfunction in the treatment group was significantly lower than that in the control group (P < 0.05), while there was no significant difference in the incidence of neurotoxicity and allergic reactions between two groups. Conclusion The combination of Kanglaite injection and TP regimen can improve the disease control rate of advanced nasopharyngeal carcinoma, reduce tumor marker levels, improve quality of life, and alleviate drug adverse reactions.

R979.1

河北省医学科学研究课题计划(20191601)