目的 探究低劑量聚乙二醇化重組人粒細(xì)胞刺激因子（PEG-rhG-CSF）治療食管癌化療后中性粒細(xì)胞減少癥的臨床療效。方法 前瞻性選取哈勵遜國際和平醫(yī)院胸外科2019年5月-2021年10月收治的食管癌術(shù)后化療患者200例為研究對象，采用隨機數(shù)字表法，將所有患者均分為對照組和試驗組，每組100例。兩組患者均采用氟尿嘧啶聯(lián)合順鉑3周療法進行化療，3周為1個周期。對照組患者化療1個周期結(jié)束后24～48 h開始，給予5 μg·kg^-1·d^-1的人粒細(xì)胞刺激因子注射液進行sc用藥，每天1次，直至外周血中性粒細(xì)胞絕對值（ANC）降至最低值后連續(xù)兩次≥5.0×10⁹·L^-1或1次≥10.0×10⁹·L^-1，或連續(xù)用藥14 d。試驗組患者給藥開始時間同對照組，給予3 mg的聚乙二醇化重組人粒細(xì)胞刺激因子注射液進行sc用藥，1個化療周期用藥1次。兩組患者均進行1個化療周期的治療。對兩組患者中性粒細(xì)胞變化情況、Ⅲ/Ⅳ度中性粒細(xì)胞減少癥發(fā)生率及持續(xù)時間、中性粒細(xì)胞缺乏伴發(fā)熱（FN）發(fā)生率及再次返院情況、不良反應(yīng)及并發(fā)癥發(fā)生率、患者給藥前后生活質(zhì)量評分進行比較。結(jié)果 試驗組患者化療結(jié)束后第6、9、12、15、18天時的外周血ANC顯著高于對照組（P＜0.05），第1、3、21天時的ANC與對照組相比，均無統(tǒng)計學(xué)差異（P＞0.05）。與對照組相比，試驗組患者中性粒細(xì)胞減少癥發(fā)生率及其持續(xù)時間顯著降低（P＜0.05），F(xiàn)N發(fā)生率及再次返院率顯著減少（P＜0.05），不良反應(yīng)及并發(fā)癥發(fā)生率顯著減少（P＜0.05）。給藥前，兩組癌癥治療功能評價量表（FACT-G）中身體狀況、社會/家庭狀況、功能狀況、情緒狀況4個方面內(nèi)容評分比較無統(tǒng)計學(xué)差異（P＞0.05），給藥后，兩組FACT-G量表各項內(nèi)容評分均較給藥前升高，試驗組給藥后FACT-G評分顯著高于對照組（P＜0.05）。結(jié)論 低劑量PEG-rhG-CSF用于食管癌化療后中性粒細(xì)胞減少癥治療，能顯著預(yù)防中性粒細(xì)胞減少癥及FN的發(fā)生，同時還能有效縮短中性粒細(xì)胞減少癥持續(xù)時間，降低因FN再住院率，減少患者不良反應(yīng)及并發(fā)癥，有效改善患者生活質(zhì)量。

Objective To investigate the clinical efficacy of low-dose polyethylene glycol-recombinant human granulocyte stimulating factor (PEG-rhG-CSF) in treatment of neutropenia after chemotherapy in esophageal cancer. Methods A total of 200 patients with esophageal cancer undergoing postoperative chemotherapy in the Department of Thoracic Surgery of Harrison International Peace Hospital from May 2019 to October 2021 were prospectively selected as the research objects. The patients were equally grouped into two groups by random number table method, 100 cases in each group. Both groups of patients were treated with fluorouracil combined with cisplatin for three weeks, with three weeks as a cycle. Patients in the control group were given 5 μg·kg^-1·d^-1 human granulocyte stimulating factor injection was administered with sc once a day from 24 to 48 h after one cycle of chemotherapy until the absolute value of neutrophils (ANC) in peripheral blood dropped to the lowest value for two consecutive times ≥ 5.0×10⁹·L^-1 or once ≥ 10.0×10⁹·L^-1, or continuous administration for 14 days. The patients in the experimental group were given 3 mg of Polyethylene Glycol-Recombinant Human Granulocyte Stimulating Factor Injection for sc at the same time as those in the control group, once in every chemotherapy cycle. Both groups were treated with one chemotherapy cycle. The changes of neutrophils, the incidence and duration of grade III/IV neutropenia, the incidence of neutropenia with fever (FN), rehospitalization, adverse reactions, complications, and the quality of life before and after treatment were compared between two groups. Results The ANC in peripheral blood in the experimental group at 6th, 9th, 12th, 15th, and 18th day after chemotherapy was obviously higher than that in the control group (P< 0.05), and there was no significant difference in ANC on the 3rd, and 21st day (P> 0.05). Compared with the control group, the incidence and duration of neutropenia in the experimental group were obviously reduced (P< 0.05), the incidence of FN and the rate of hospital rehospitalization were obviously reduced (P< 0.05), the incidences of adverse reactions and complications were obviously reduced (P< 0.05. Before treatment, there was no significant difference in the scores of physical status, social/family status, functional status, and emotional status in Functional Assessment of Cancer Therapy (FACT-G) between two groups (P> 0.05), after treatment, the scores of FACT-G scale in both groups were higher than those before treatment, and the FACT-G scores in the experimental group after treatment were obviously higher than those in the control group after treatment (P< 0.05). Conclusion Low-dose PEG-rhG-CSF for the treatment of neutropenia after esophageal cancer chemotherapy can obviously prevent the occurrences of neutropenia and FN, and can effectively shorten the duration of neutropenia, reduce the rate of rehospitalization due to FN, reduce the adverse reactions and complications of patients, and effectively ameliorate the quality of life of patients.

R973

衡水市重點研發(fā)計劃項目（2021014030Z）