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

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

刘殿龙^{1, 2},
李经蕾^{1, 2},
邸明一³,
张伟⁴,
侯炜^2, ,

1.
北京中医药大学中医学院，北京 100029
2.
中国中医科学院广安门医院肿瘤科，北京 100053
3.
北京协和医院肺病科，北京 100730
4.
北京大学肿瘤医院中西结合肿瘤科，北京 100142

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
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- 被引次数: 0
出版历程
- 收稿日期: 2021-09-01
- 网络出版日期: 2023-04-19

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

LIU Dianlong^{1, 2},
LI Jinglei^{1, 2},
DI Mingyi³,
ZHANG Wei⁴,
HOU Wei^{2
, ,}

1.
College of Traditional Chinese Medicine, Beijing University of Traditional Chinese Medicine, Beijing 100029, China

摘要

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。
- 非小细胞肺癌 /
- 联合治疗 /
- 消癌平注射液 /
- 痰湿瘀阻证
Abstract: Objective This study aims to observe and compare the clinical efficacy of Xiaoaiping Injection combined with TP chemotherapy and chemotherapy alone in patients with non-small cell lung cancer with phlegm dampness stasis syndrome. Methods A prospective cohort study was used to enroll patients with stage ⅢB-Ⅳ non-small cell lung cancer with phlegm dampness stasis syndrome, There were 53 cases in the treatment group and 53 cases in the control group. The control group was treated with TP chemotherapy, while the treatment group was treated with TP regimen combined with Xiaoaiping Injection. The objective response rate (RR), disease control rate (DCR), TCM syndrome scale score, and the European Quality of Life Collaboration Cancer Core (QLQ-C30) scale score were evaluated and compared between the 2 groups after 2 courses of treatment. The levels of tumor markers, coagulation indicators and inflammatory factors before and after treatment were compared, and the adverse events during treatment were evaluated. Results The objective RR and DCR in the treatment group were 41.5% (22/53) and 71.7% (38/53), after 2 courses of treatment, while those in the control group were 35.8% (19/53) and 62.3% (33/53) respectively. The integral of TCM syndrome scale in the treatment group were lower than those in the control group (P < 0.05), and the QLQ-C30 scale had significant advantages in fatigue improvement and overall health sub items (both P < 0.05). The tumor markers CEA and cytokeratin 19 fragment in the treatment group were lower than those in the control group (all P < 0.05). The activated partial thromboplastin time in the treatment group was higher than that in the control group, and D-dimer was lower than that in the control group (all P < 0.05). The inflammatory factor PCT in the treatment group was lower than that in the control group (P < 0.05). The incidence of thrombocytopenia amongst adverse events in the treatment group was lower than that in the control group (P < 0.05). Conclusion Xiaoaiping Injection combined with TP regimen has advantages in improving TCM clinical symptoms and quality of life. It can prevent the occurrence of thrombocytopenia, and comprehensively improve the treatment effect of advanced non-small cell lung cancer with phlegm damp blood stasis syndrome.
- Non small cell lung cancer /
- Combined therapy /
- Xiaoaiping Injection /
- Syndrome of phlegm dampness and blood stasis

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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值
性别(例)			0.854^a	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	-1.964^b	0.052
吸烟史(例)			1.420^a	0.233
吸烟	24	18
不吸烟	29	35
病理类型(例)			0.155^a	0.693
腺癌	32	30
鳞状细胞癌	21	23
肿瘤部位(例)			0.606^a	0.436
中央型	23	27
周围型	30	26
临床分期(例)			0.052^a	0.819
ⅢB	13	12
Ⅳ	40	41
注：^a为χ²值，^b为t值。

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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值						0.358	1.066
P值						0.550	0.302

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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值	P值
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值		-0.408	-2.648
P值		0.683	0.003

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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值	P值
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

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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)
组别	例数	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±1.67^b	9.41±3.47	7.97±3.53^b
治疗组	53	43.59(23.34, 52.13)	22.16(5.43, 15.43)^b	8.28±2.05	5.51±1.45^b	9.68±3.40	6.63±1.70^b
统计量		-1.125^a	-7.977^a	0.847^c	1.823^c	0.439^c	2.488^c
P值		0.261	＜0.001	0.399	0.071	0.509	0.015
注：^a为Z值，^c为t值；与同组治疗前比较，^bP＜0.05。

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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)
组别	例数	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±3.51^a	10.84±0.86	11.94±0.55^a	518.1±113.5	404.5±119.5^a
治疗组	53	29.66±2.84	34.91±2.29^a	10.77±0.84	12.04±0.99^a	517.0±103.1	335.0±91.8^a
t值		1.203	2.002	0.408	0.803	0.052	3.328
P值		0.232	0.048	0.684	0.424	0.959	0.001
注：与同组治疗前比较，^aP＜0.001。

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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)
组别	例数	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±0.53^b
治疗组	53	3.29(2.02, 4.04)	1.24(0.07, 1.87)^b	3.33±0.57	2.53±0.69^b
统计量		-1.365^a	-0.552^a	0.071^c	2.651^c
P值		0.172	0.581	0.944	0.009
注：^a为Z值，^c为t值；与同组治疗前比较，^bP＜0.05。

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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值		2.065	0.815		0.329	5.194	2.536	0.534	1.100	0.376
P值		0.151	0.367		0.566	0.023	0.111	0.465	0.294	0.540

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