CAJ | 학술논문

目的：观察和比较艾迪注射液联合化疗(多西紫杉醇+草酸铂)与单纯化疗(多西紫杉醇+草酸铂)治疗转移性或复发性晚期非小细胞肺癌的疗效、毒副反应及免疫调节作用。方法71例经病理组织学及影像学确诊为转移性或复发性晚期非小细胞肺癌患者，随机分入三组：高剂量艾迪注射液联合化疗组(治疗A组)25例、低剂量艾迪注射液联合化疗组(治疗B组)20例及单纯化疗组(对照组)26例(A组+B组为治疗组，C组为对照组)。每例患者至少治疗两个周期以上后进行疗效评价。结果所有患者均可评价疗效。A组、B组、C组的总有效率(CR+PR)分别为52.00%、45.00%、38.46%；三组疗效比较组间差异均无统计学意义(P>0.05)。治疗后各组患者生活质量均有所改善，三组生活质量Karnofsky评分提高率分别为76.00%、45.00%、15.38%；与对照组比较，治疗组患者生活质量有了显著改善(P<0.05)，且高剂量组优于低剂量组(P<0.05)。三组白细胞减少的发生率分别为32.00%、35.00%、65.38%；恶心呕吐发生率分别为20.00%、45.00%、46.15%；治疗组发生率显著少于对照组(P<0.05)。治疗组化疗后外周血中细胞免疫指标(CD4、CD8值)较化疗前显著提高(P<0.05)，而对照组则差异无统计学意义(P>0.05)，化疗后治疗组的外周血中细胞免疫指标较对照组提高(P<0.05)。结论艾迪注射液能够减少化疗的毒副作用，增加患者化疗耐受性，提高患者免疫功能，改善生活质量，且艾迪改善生活质量的程度与剂量正相关。
목적：관찰화비교애적주사액연합화료(다서자삼순+초산박)여단순화료(다서자삼순+초산박)치료전이성혹복발성만기비소세포폐암적료효、독부반응급면역조절작용。방법71례경병리조직학급영상학학진위전이성혹복발성만기비소세포폐암환자，수궤분입삼조：고제량애적주사액연합화료조(치료A조)25례、저제량애적주사액연합화료조(치료B조)20례급단순화료조(대조조)26례(A조+B조위치료조，C조위대조조)。매례환자지소치료량개주기이상후진행료효평개。결과소유환자균가평개료효。A조、B조、C조적총유효솔(CR+PR)분별위52.00%、45.00%、38.46%；삼조료효비교조간차이균무통계학의의(P>0.05)。치료후각조환자생활질량균유소개선，삼조생활질량Karnofsky평분제고솔분별위76.00%、45.00%、15.38%；여대조조비교，치료조환자생활질량유료현저개선(P<0.05)，차고제량조우우저제량조(P<0.05)。삼조백세포감소적발생솔분별위32.00%、35.00%、65.38%；악심구토발생솔분별위20.00%、45.00%、46.15%；치료조발생솔현저소우대조조(P<0.05)。치료조화료후외주혈중세포면역지표(CD4、CD8치)교화료전현저제고(P<0.05)，이대조조칙차이무통계학의의(P>0.05)，화료후치료조적외주혈중세포면역지표교대조조제고(P<0.05)。결론애적주사액능구감소화료적독부작용，증가환자화료내수성，제고환자면역공능，개선생활질량，차애적개선생활질량적정도여제량정상관。
Objective To observe and compare the curative effects, side effects and immunomodulatory ef-fects of Aidi injection combined with chemotherapy (DP) and chemotherapy only in the treatment of metastatic or re-current advanced non-small cell lung cancer (NSCLC). Methods Seventy-one metastatic or recurrent advanced NSCLC patients were randomly divided into three groups: 25 patients received high dose Aidi injection combined with DP treatment (group A), 20 patients received low dose Aidi injection combined with DP treatment (group B), and 26 patients received DP only treatment (group C). Group A and B was the experimental group and group C was the control group. Their curative effects were evaluated after at least two therapy sessions. The curative effects, adverse reactions and impact on quality of life (QOL) were compared. Results The total effective rate (CR+PR) in group A, B and C was 52%, 45% and 38.46% respectively, with no statistically significant differences between the three groups. There were improvement of QOL in all groups after the treatments. Accorrding to Karnofsky performanee status (KPS), the QOL improvement rate of group A, B and C was respectively 76%, 45% and 15.38%; QOL was significantly improved in the experimental group, compared with that of the control group (P<0.05); and QOL of group A was better than that of group B (P<0.05). The incidence rate of leucopenia in group A, B and C was respectively 32%, 35% and 65.38% ; and incidence rate of gastrointestinal reaction in group A, B and C was respectively 20% , 45% and 46.15%; the incident rate in experimental group was significantly lower than that in the control group (P<0.05). The cellular immunological indices of peripheral blood (CD4 and CD8) in experimental group were significantly increased after the treatment (P<0.05), while there was no statistically significant difference between the control group (P>0.05). After the treatment, the cellular immunological indices of peripheral blood (CD4 and CD8) in experimental group were higher than that in the control group (P<0.05). Conclusion Aidi injection could be able to reduce the toxic effects of DP, improve patients' tolerance to chemotherapy, patients' immune function and patients' QOL. And the improvement of patients' QOL is positively related to Aidi dosage.