复方苦参注射液联合芬太尼透皮贴治疗癌性疼痛的疗效观察

doi:10.11958/20241432

摘要/Abstract

摘要：

目的观察复方苦参注射液联合芬太尼透皮贴治疗晩期癌性疼痛的临床疗效。方法 100例癌性疼痛患者根据随机数字表法均分为2组。对照组仅使用芬太尼透皮贴，观察组采用芬太尼透皮贴联合复方苦参注射液治疗。观察并比较2组疼痛缓解率，治疗前后的卡式功能状态（KPS）评分，数字疼痛评分量表（NRS）评分，炎症因子白细胞介素（IL）-6、IL-8、C反应蛋白（CRP）水平的影响以及不良反应。结果观察组疼痛缓解率优于对照组（P<0.05）；治疗后，观察组患者KPS评分高于对照组，NRS评分、IL-6、IL-8、CRP水平及胃肠道反应发生率均低于对照组（P<0.05）；2组肝肾损害、头晕、嗜睡的发生率差异无统计学意义（P>0.05）。结论复方苦参注射液联合芬太尼透皮贴能有效改善癌痛，减少炎症因子释放，改善患者生活质量，且不良反应发生率低。

关键词: 癌性疼痛, 疼痛测定, 炎症, 疗效比较研究, 复方苦参注射液, 芬太尼透皮贴

Abstract:

Objective To observe the clinical efficacy of compound kushen injection combined with fentanyl transdermal patch for the treatment of final stage cancer pain. Methods A total of 100 patients with cancer pain were divided into 2 groups of 50 patients each according to the randomized numerical table method. The control group was treated with fentanyl transdermal patch only, and the observation group was treated with fentanyl transdermal patch combined with compound kushen injection. The KPS score, NRS score, pain relief rate after treatment, incidence of adverse reactions and effect on levels of inflammatory factors IL-6, IL-8 and CRP were compared between the two groups. Results The pain relief rate of the observation group was significantly better than that of the control group (P<0.05). After treatment, the KPS score of the observation group was higher than that of the control group (P<0.05), and the incidence of NRS score, IL-6, IL-8, CRP levels and gastrointestinal reactions were lower than those of the control group (P<0.05). There were no significant differences in the incidence of hepatic and renal damage, dizziness and somnolence between the two groups (P>0.05). Conclusion Compound kushen injection combined with fentanyl transdermal patch can effectively improve cancer pain, reduce the release of inflammatory factors, improve the patient quality of life, and the incidence of adverse reactions is low.

Key words: cancer pain, pain measurement, inflammation, comparative effectiveness research, compound kushen injection, fentanyl transdermal patch

中图分类号:

R730.5，R441.1

图/表 4

参考文献 19

[1]	MESTDAGH F, STEYAERT A, LAVAND'HOMME P. Cancer pain management:a narrative review of current concepts, strategies, and techniques[J]. Curr Oncol, 2023, 30(7):6838-6858. doi:10.3390/curroncol30070500.
[2]	郑艳芹, 刘坤, 解传奇. 芬太尼透皮贴与盐酸羟考酮缓释片治疗中度癌性疼痛患者疗效比较[J]. 深圳中西医结合杂志, 2023, 33(7):103-106.
	ZHENG Y Q, LIU K, XIE C Q. Comparison of the efficacy of fentanyl transdermal patches and oxycodone hydrochloride extended-release tablets in the treatment of patients with moderate cancer pain[J]. Shenzhen Journal of Integrated Traditional Chinese and Western Medicine, 2023, 33(7):103-106. doi:10.16458/j.cnki.1007-0893.2023.07.032.
[3]	王熙敏, 李为, 李敏, 等. 我国医务人员对芬太尼透皮贴剂治疗癌痛的临床应用和认知现状[J]. 医药导报, 2023, 42(8):1248-1254.
	WANG X M, LI W, LI M, et al. Investigation on the Chinese medical staff for the clinical application and cognitive status of transdermal fentanyl patch in the treatment of cancer pain[J]. Herald of Medicine, 2023, 42(8):1248-1254. doi:10.3870/j.issn.1004-0781.2023.08.028.
[4]	赵永胜, 张娟. 复方苦参注射液辅助化疗治疗消化道肿瘤临床观察[J]. 山西中医, 2024, 40(1):40-42.
	ZHAO Y S, ZHANG J. Clinical observation on adjuvant chemotherapy of digestive tract tumors with compound kushen injection[J]. Shanxi Journal of Traditional Chinese Medicine, 2024, 40(1):40-42. doi:10.20002/j.issn.1000-7156.2024.01.017.
[5]	中华人民共和国国家卫生健康委员会. 癌症疼痛诊疗规范(2018年版)[J]. 临床肿瘤学杂志, 2018, 23(10):937-944.
	National Health Commission of the People's Republic of China. Standard diagnosis and treatment of cancer pain(version 2018)[J]. Chinese Clinical Oncology, 2018, 23(10): 937-944. doi:1009-0460(2018)10-0937-08.
[6]	ATISOOK R, EUASOBHON P, SAENGSANON A, et al. Validity and utility of four pain intensity measures for use in international research[J]. J Pain Res, 2021, 14:1129-1139. doi:10.2147/JPR.S303305.
[7]	刘敏, 张璐, 孙丽华, 等. 辽宁省肿瘤化疗患者KPS评分情况分析[J]. 中国肿瘤, 2013, 22(8):635-637.
	LIU M, ZHANG L, SUN L H, et al. An analysis on KPS score for chemotherapy patients with cancer in liaoning province[J]. China Cancer, 2013, 22(8):635-637. doi:10.11735/j.issn.1004-0242.2013.08.A007.
[8]	HAROUN R, WOOD J N, SIKANDAR S. Mechanisms of cancer pain[J]. Front Pain Res(Lausanne), 2022, 3:1030899. doi:10.3389/fpain.2022.1030899.
[9]	VIRGEN C G, KELKAR N, TRAN A, et al. Pharmacological management of cancer pain:Novel therapeutics[J]. Biomed Pharmacother, 2022, 156:113871. doi:10.1016/j.biopha.2022.113871.
[10]	FALLON M, DIERBERGER K, LENG M, et al. An international, open-label, randomised trial comparing a two-step approach versus the standard three-step approach of the WHO analgesic ladder in patients with cancer[J]. Ann Oncol, 2022, 33(12):1296-1303. doi:10.1016/j.annonc.2022.08.083.
[11]	陆怡, 朱元章, 朱国福, 等. 中药镇痛机理研究概述[J]. 世界中医药, 2015, 10(4):629-632,636.
	LU Y, ZHU Y Z, ZHU G F, et al. Research on Analgesia Mechanism of Traditional Chinese Medicine[J]. World Chinese Medicine, 2015, 10(4):629-632,636. doi:10.3969/j.issn.1673-7202.2015.04.039.
[12]	董俊, 晏菲, 邓洁, 等. 复方苦参注射液抗肿瘤机制及其临床应用进展[J]. 天津药学, 2019, 31(1):71-74.
	DONG J, YAN F, DENG J, et al. Anti-tumor mechanism of compound kushen injection and progress of its clinical application[J]. Tianjin Pharmacy,2019, 31(1): 71-74. doi:1006-5687(2019)01-0071-04.
[13]	范琦琦, 折改梅, 魏静, 等. 复方苦参注射液抗肿瘤、镇痛活性评价及机制研究[J]. 中国中药杂志, 2022, 47(10):2712-2720.
	FAN Q Q, SHE G M, WEI J, et al. Anti-tumor and analgesic activity evaluation and mechanism of compound kushen injection[J]. China Journal of Chinese Materia Medica, 2022, 47(10):2712-2720. doi:10.19540/j.cnki.cjcmm.20211129.701.
[14]	JI J, GUO J, CHI Y, et al. Cancer pain management with traditional chinese medicine:current status and future perspectives[J]. Am J Chin Med, 2024, 52(1):123-135. doi:10.1142/S0192415X24500058.
[15]	李德辉, 孙春霞, 范焕芳. 复方苦参注射液联合盐酸羟考酮缓释片治疗癌痛的系统评价[J]. 中国疼痛医学杂志, 2017, 23(5):384-388.
	LI D H, SUN C X, FAN H F. Systematic evaluation of compound kushen injection combined with oxycodone hydrochloride extended-release tablets for the treatment of cancer pain[J]. Chinese Journal of Pain Medicine, 2017, 23(5):384-388. doi:10.3969/j.issn.1006-9852.2017.05.014.
[16]	肖冰. 复方苦参注射液对宫颈癌患者免疫功能及炎症反应的影响[J]. 内蒙古中医药, 2019, 38(2):91-92,97.
	XIAO B. Effects of compound kushen injection on immune function and inflammatory response in patients with cervical cancer[J]. Inner Mongolia Journal of Traditional Chinese Medicine, 2019, 38(2):91-92,97. doi:10.16040/j.cnki.cn15-1101.2019.02.062.
[17]	湖北省抗癌协会癌症康复与姑息治疗专业委员会. 芬太尼透皮贴剂临床合理用药指南[J]. 医药导报, 2021, 40(11):1463-1474.
	Cancer Rehabilitation and Palliative Care Professional Committee of Hubei Anti-Cancer Association. Guidelines for the rational clinical use of fentanyl transdermal patches[J]. Herald of Medicine, 2021, 40(11):1463-1474. doi:10.3870/j.issn.1004-0781.2021.11.001.
[18]	王若宇, 张宇, 王佳慧, 等. 复方苦参注射液减轻肝癌大鼠5-氟尿嘧啶化疗不良反应的机制研究[J]. 天津医药, 53(1):24-28.
	WANG R Y, ZHANG Y, WANG J H, et al. Study on the mechanism of compound Kushen injection alleviating adverse reactions of 5-fluorouracil chemotherapy in rats with liver cancer[J]. Tianjin Med J, 53(1):24-28. doi:10.11958/20241277.
[19]	张静娴, 易丹, 苏剑飞, 等. 复方苦参注射液联合阿片类镇痛药治疗中重度癌痛的Meta分析[J]. 中医肿瘤学杂志, 2022, 4(4):60-68.
	ZHANG J X, YI D, SU J F, et al. Meta-analysis of Compound Kushen Injection combined with opioid analgesics for the treatment of moderate to severe cancerous pain[J]. Journal of Oncology in Chinese Medicine, 2022, 4(4):60-68. doi:10.19811/j.cnki.ISSN2096-6628.2022.07.012.

组别	n	无缓解	轻度缓解	中度缓解	完全缓解	疼痛缓解
对照组	50	8（16.0）	22（44.0）	17（34.0）	3（6.0）	20（40.0）
观察组	50	2（4.0）	6（12.0）	20（40.0）	22（44.0）	42（84.0）
Z或χ²		5.121^＊＊				20.543^＊＊

组别	n	无缓解	轻度缓解	中度缓解	完全缓解	疼痛缓解
对照组	50	8（16.0）	22（44.0）	17（34.0）	3（6.0）	20（40.0）
观察组	50	2（4.0）	6（12.0）	20（40.0）	22（44.0）	42（84.0）
Z或χ²		5.121^＊＊				20.543^＊＊

组别	n		KPS/分
组别	n		治疗前		治疗后		Z
对照组	50		80.00（70.00，90.00）		90.00（80.00，90.50）		5.369^＊＊
观察组	50		80.00（70.00，90.00）		95.00（94.75，100.00）		6.178^＊＊
Z			0.853		6.366^＊＊
组别		NRS/分
组别		治疗前		治疗后		Z
对照组		5.00（5.00，6.00）		3.00（2.00，4.25）		5.687^＊＊
观察组		5.50（4.00，6.00）		1.00（0.00，3.00）		6.153^＊＊
Z		0.496		4.743^＊＊

组别	n		KPS/分
组别	n		治疗前		治疗后		Z
对照组	50		80.00（70.00，90.00）		90.00（80.00，90.50）		5.369^＊＊
观察组	50		80.00（70.00，90.00）		95.00（94.75，100.00）		6.178^＊＊
Z			0.853		6.366^＊＊
组别		NRS/分
组别		治疗前		治疗后		Z
对照组		5.00（5.00，6.00）		3.00（2.00，4.25）		5.687^＊＊
观察组		5.50（4.00，6.00）		1.00（0.00，3.00）		6.153^＊＊
Z		0.496		4.743^＊＊

组别	n		IL-6/（ng/L）
组别	n		治疗前		治疗后		t
对照组	50		92.65±8.67		51.20±5.93		25.497^＊＊
观察组	50		88.87±13.82		41.70±9.51		24.021^＊＊
t			1.638		5.997^＊＊
组别		IL-8/（ng/L）
组别		治疗前		治疗后		t
对照组		259.13±32.11		152.65±8.89		22.842^＊＊
观察组		271.15±52.60		122.43±14.18		19.470^＊＊
t		1.379		12.768^＊＊
组别		CRP/（mg/L）
组别		治疗前		治疗后		t
对照组		17.94±3.19		11.12±2.48		11.860^＊＊
观察组		16.76±4.87		8.52±2.90		15.314^＊＊
t		1.425		4.806^＊＊