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消癌平注射液联合TP方案治疗晚期非小细胞肺癌痰湿瘀阻证的疗效观察

刘殿龙 李经蕾 邸明一 张伟 侯炜

刘殿龙, 李经蕾, 邸明一, 张伟, 侯炜. 消癌平注射液联合TP方案治疗晚期非小细胞肺癌痰湿瘀阻证的疗效观察[J]. 中华全科医学, 2023, 21(3): 389-392. doi: 10.16766/j.cnki.issn.1674-4152.002890
引用本文: 刘殿龙, 李经蕾, 邸明一, 张伟, 侯炜. 消癌平注射液联合TP方案治疗晚期非小细胞肺癌痰湿瘀阻证的疗效观察[J]. 中华全科医学, 2023, 21(3): 389-392. doi: 10.16766/j.cnki.issn.1674-4152.002890
LIU Dianlong, LI Jinglei, DI Mingyi, ZHANG Wei, HOU Wei. Clinical observation of Xiaoaiping Injection combined with TP regimen in the treatment of advanced non-small cell lung cancer with phlegm-damp-stasis syndrome[J]. Chinese Journal of General Practice, 2023, 21(3): 389-392. doi: 10.16766/j.cnki.issn.1674-4152.002890
Citation: LIU Dianlong, LI Jinglei, DI Mingyi, ZHANG Wei, HOU Wei. Clinical observation of Xiaoaiping Injection combined with TP regimen in the treatment of advanced non-small cell lung cancer with phlegm-damp-stasis syndrome[J]. Chinese Journal of General Practice, 2023, 21(3): 389-392. doi: 10.16766/j.cnki.issn.1674-4152.002890

消癌平注射液联合TP方案治疗晚期非小细胞肺癌痰湿瘀阻证的疗效观察

doi: 10.16766/j.cnki.issn.1674-4152.002890
基金项目: 

北京市科学技术委员会计划资助项目 D161100005116001

国家中医临床研究基地业务建设科研专项课题资助项目 2015ZSB01

详细信息
    通讯作者:

    侯炜, E-mail: houwei1964@163.com

  • 中图分类号: R734.2 R730.58

Clinical observation of Xiaoaiping Injection combined with TP regimen in the treatment of advanced non-small cell lung cancer with phlegm-damp-stasis syndrome

  • 摘要:   目的  观察比较消癌平注射液联合TP化疗及单纯化疗两种治疗方式对ⅢB~ Ⅳ期非小细胞肺癌患者的临床疗效。  方法  采用前瞻性队列研究方法, 纳入ⅢB~Ⅳ期非小细胞肺癌痰湿瘀阻证患者,治疗组及对照组各53例。对照组给予TP化疗, 治疗组为TP方案联合消癌平注射液治疗。比较2组治疗2个疗程后的客观有效率(RR)和疾病控制率(DCR)、中医证候量表积分、欧洲生活质量协作组癌症核心(QLQ-C30)量表积分。比较治疗前后肿瘤标记物、凝血指标及炎症因子水平,并评估治疗过程中不良事件的发生情况。  结果  2个疗程后治疗组RR为41.5%(22/53),DCR为71.7%(38/53),对照组分别为35.8%(19/53)和62.3%(33/53)。治疗组患者中医证候量表积分低于对照组(P<0.05),QLQ-C30量表疲乏和总体健康状况改善明显(均P<0.05)。治疗组肿瘤标记物CEA、细胞角蛋白19片段低于对照组(均P<0.05);治疗组活化部分凝血活酶时间高于对照组、D-二聚体低于对照组(均P<0.05);治疗组炎症因子PCT低于对照组(P<0.05)。治疗组不良事件中血小板降低发生率低于对照组(P<0.05)。  结论  消癌平注射液联合TP方案在改善中医临床症状、提高生命质量方面有优势,能预防血小板下降的发生,综合提高晚期非小细胞肺癌痰湿瘀阻证的疗效。

     

  • 表  1  2组非小细胞肺癌患者人口学及临床基线资料比较

    Table  1.   Comparison of demographic and clinical baseline data between the two groups of patients with non-small cell lung cancer

    项目 对照组(53例) 治疗组(53例) 统计量 P
    性别(例) 0.854a 0.356
        男性 39 43
        女性 14 10
    入组年龄(x±s,岁) 60.07±5.84 63.73±5.43 -1.964b 0.052
    吸烟史(例) 1.420a 0.233
        吸烟 24 18
        不吸烟 29 35
    病理类型(例) 0.155a 0.693
        腺癌 32 30
        鳞状细胞癌 21 23
    肿瘤部位(例) 0.606a 0.436
        中央型 23 27
        周围型 30 26
    临床分期(例) 0.052a 0.819
        ⅢB 13 12
      Ⅳ 40 41
    注:a为χ2值,bt值。
    下载: 导出CSV

    表  2  2组非小细胞肺癌患者治疗2个周期后疗效比较[例(%)]

    Table  2.   Comparison of efficacy between the two groups of patients with non-small cell lung cancer after 2 cycles of treatment [cases (%)]

    组别 例数 CR PR SD PD RR DCR
    治疗组 53 3(5.7) 19(35.8) 16(30.2) 15(28.3) 22(41.5) 38(71.7)
    对照组 53 1(1.8) 18(34.0) 14(26.4) 20(37.7) 19(35.8) 33(62.3)
    χ2 0.358 1.066
    P 0.550 0.302
    下载: 导出CSV

    表  3  2组非小细胞肺癌患者治疗2个周期后中医临床症状积分比较[M(P25, P75),分]

    Table  3.   Comparison of TCM clinical symptom scores between the two groups of patients with non-small cell lung cancer after 2 cycles of treatment[M(P25, P75), points]

    组别 例数 治疗前 治疗后 Z P
    治疗组 53 6(4, 7) 4(2, 5) -0.889 0.374
    对照组 53 6(4, 7) 5(4, 6) -3.427 0.001
    Z -0.408 -2.648
    P 0.683 0.003
    下载: 导出CSV

    表  4  2组非小细胞肺癌患者治疗2个周期后QLQ-C30量表积分差值比较[M(P25, P75),分]

    Table  4.   Comparison of QLQ-C30 scale score differences between the two groups of patients with non-small cell lung cancer after 2 cycles of treatment[M(P25, P75), points]

    子项 对照组(53例) 治疗组(53例) Z P
    躯体功能 0(0, 1) 1(0, 2) -1.889 0.059
    角色功能 0(0, 0) 0(0, 0) -1.025 0.305
    认知功能 0(0, 0) 1(0, 1) -1.658 0.097
    情绪功能 0(0, 1) 0(0, 1) -1.005 0.315
    社会功能 0(0, 1) 0(0, 0) -1.546 0.122
    疲乏 1(0, 1) 1(0, 2) -2.280 0.023
    疼痛 0(0, 1) 0(0, 0) -1.375 0.169
    恶心、呕吐 1(0, 1) 0(0, 1) -0.337 0.736
    呼吸困难 0(0, 0) 0(0, 0) -1.393 0.163
    失眠 0(0, 0) 0(0, 0) -0.109 0.913
    食欲不振 0(0, 0) 0(0, 0) -0.918 0.359
    便秘 0(0, 0) 0(0, 0) -1.297 0.195
    腹泻 0(0, 0) 0(0, 0) -0.228 0.820
    经济困难 0(0, 0) 0(0, 0) -0.186 0.852
    总体健康状况 0(0, 1) 1(0, 2) -2.213 0.027
    下载: 导出CSV

    表  5  2组非小细胞肺癌患者治疗前后CEA、SCC、CYFRA21-1比较(ρ/μg·L-1)

    Table  5.   Comparison of CEA, SCC and CYFRA21-1 before and after treatment in the two groups of patients with non-small cell lung cancer(ρ/μg·L-1)

    组别 例数 CEA[M(P25, P75)] SCC(x±s) CYFRA21-1(x±s)
    治疗前 治疗后 治疗前 治疗后 治疗前 治疗后
    对照组 53 46.75(26.53, 55.43) 31.89(21.97, 35.50)b 8.61±1.95 6.06±1.67b 9.41±3.47 7.97±3.53b
    治疗组 53 43.59(23.34, 52.13) 22.16(5.43, 15.43)b 8.28±2.05 5.51±1.45b 9.68±3.40 6.63±1.70b
    统计量 -1.125a -7.977a 0.847c 1.823c 0.439c 2.488c
    P 0.261 <0.001 0.399 0.071 0.509 0.015
    注:aZ值,ct值;与同组治疗前比较,bP<0.05。
    下载: 导出CSV

    表  6  2组非小细胞肺癌患者治疗前后APTT、PT、D-二聚体比较(x±s)

    Table  6.   Comparison of APTT, PT and D-dimer before and after treatment in patients with non-small cell lung cancer in the two groups(x±s)

    组别 例数 APTT(s) PT(s) D-二聚体(μg/L)
    治疗前 治疗后 治疗前 治疗后 治疗前 治疗后
    对照组 53 29.01±2.67 33.76±3.51a 10.84±0.86 11.94±0.55a 518.1±113.5 404.5±119.5a
    治疗组 53 29.66±2.84 34.91±2.29a 10.77±0.84 12.04±0.99a 517.0±103.1 335.0±91.8a
    t 1.203 2.002 0.408 0.803 0.052 3.328
    P 0.232 0.048 0.684 0.424 0.959 0.001
    注:与同组治疗前比较,aP<0.001。
    下载: 导出CSV

    表  7  2组非小细胞肺癌患者治疗前后CRP、PCT比较

    Table  7.   Comparison of CRP and PCT before and after treatment in the two groups of patients with non-small cell lung cancer

    组别 例数 CRP[M(P25, P75),mg/L] PCT(x±s, μg/L)
    治疗前 治疗后 治疗前 治疗后
    对照组 53 3.06(1.09, 4.60) 1.56(0.09, 2.54)b 3.34±0.52 2.85±0.53b
    治疗组 53 3.29(2.02, 4.04) 1.24(0.07, 1.87)b 3.33±0.57 2.53±0.69b
    统计量 -1.365a -0.552a 0.071c 2.651c
    P 0.172 0.581 0.944 0.009
    注:aZ值,ct值;与同组治疗前比较,bP<0.05。
    下载: 导出CSV

    表  8  2组非小细胞肺癌患者不良事件发生情况比较(例)

    Table  8.   Comparison of adverse events between the two groups of patients with non-small cell lung cancer (cases)

    组别 例数 谷氨酰转肽酶升高 消化道不良反应 肺栓塞 骨髓抑制 血小板减少 贫血 消瘦 心律失常 血压不稳
    对照组 53 14 15 0 8 14 8 12 19 7
    治疗组 53 8 11 0 6 5 3 9 14 5
    χ2 2.065 0.815 0.329 5.194 2.536 0.534 1.100 0.376
    P 0.151 0.367 0.566 0.023 0.111 0.465 0.294 0.540
    下载: 导出CSV
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出版历程
  • 收稿日期:  2021-09-01
  • 网络出版日期:  2023-04-19

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