天蟾胶囊治疗化疗所致周围神经病理性疼痛的临床观察

doi:10.3760/cma.j.cn371439-20240820-00049

摘要/Abstract

摘要：

目的观察天蟾胶囊对化疗所致周围神经病理性疼痛（CIPNP）的有效性及安全性。方法选取2023年4月至2024年4月江苏省南通市肿瘤医院、苏州市中医院收治的120例Karnofsky功能状态（KPS）评分>60分的CIPNP患者作为研究对象，按随机数字表法分为对照组（顺铂/紫杉醇）和观察组（顺铂/紫杉醇+天蟾胶囊），每组各60例。治疗28 d后，观察比较两组患者临床疗效、不良反应情况及治疗前后数字疼痛分级法（NRS）评分、生命质量评分、中医证候积分、神经毒分级评分。结果治疗28 d后，对照组、观察组总有效率分别为0（0/60）、83.33%（50/60），差异有统计学意义（χ²=85.71，P<0.001）。对照组治疗前，治疗7、14、28 d后的NRS评分分别为（6.18±1.71）、（6.17±1.72）、（6.20±1.70）、（6.22±1.70）分，差异无统计学意义（F=-1.43， P=0.160）；观察组治疗前，治疗7、14、28 d后的NRS评分分别为（6.05±1.76）、（5.17±1.42）、（3.76±1.16）、（2.00±0.80）分，差异有统计学意义（F=22.89， P<0.001）；观察组治疗7、14、28 d后的NRS评分均低于对照组，差异均有统计学意义（均P<0.001）。进一步两两比较发现，观察组治疗前，治疗7、14、28 d后的NRS评分逐渐降低（均P<0.05）。对照组治疗前，治疗7、14、28 d后的KPS评分分别为（67.33±6.43）、（67.25±6.29）、（67.08±6.14）、（66.75±5.80）分，差异无统计学意义（F=2.18， P=0.340）；观察组治疗前，治疗7、14、28 d后的KPS评分分别为（67.17±6.49）、（68.33±6.32）、（71.25±7.68）、（79.42±5.30）分，差异有统计学意义（F=-19.33， P<0.001）；观察组治疗14、28 d后的KPS评分均高于对照组，差异均有统计学意义（t=-3.33，P<0.001；t=-12.66，P<0.001）。进一步两两比较发现，观察组治疗28 d后的KPS评分均高于治疗前，治疗7、14 d后的KPS评分（均P<0.05）。中医证候积分比较显示，倦怠乏力积分：治疗前、治疗28 d后对照组分别为（3.03±0.66）、（3.03±0.66）分，差异无统计学意义（t<0.01，P>0.999）；观察组分别为（3.02±0.60）、（1.97±0.52）分，差异有统计学意义（t=21.00，P<0.001）。胁肋胀痛积分：治疗前、治疗28 d后对照组分别为（3.05±0.68）、（3.07±0.63）分，差异无统计学意义（t=-0.57，P=0.568）；观察组分别为（3.03±0.66）、（2.02±0.57）分，差异有统计学意义（t=18.25，P<0.001）。面色萎黄积分：治疗前、治疗28 d后对照组分别为（2.87±0.50）、（2.85±0.48）分，差异无统计学意义（t=-0.57，P=0.568）；观察组分别为（2.93±0.55）、（1.93±0.55）分，差异有统计学意义（t=24.29，P<0.001）。食欲缺乏积分：治疗前、治疗28 d后对照组分别为（2.90±0.60）、（2.90±0.63）分，差异无统计学意义（t<0.01，P>0.999）；观察组分别为（2.95±0.57）、（1.98±0.60）分，差异有统计学意义（t=20.42，P<0.001）。治疗28 d后，观察组倦怠乏力、胁肋胀痛、面色萎黄、食欲缺乏积分均低于对照组（均P<0.001）。神经毒性分级比较显示，外周感觉神经障碍评分：治疗前、治疗28 d后对照组分别为（2.54±0.50）、（2.58±0.49）分，差异无统计学意义（t=-0.40，P=0.690）；观察组分别为（2.52±0.50）、（2.00±0.00）分，差异有统计学意义（t=7.29，P<0.001）。外周运动神经障碍评分：治疗前、治疗28 d后对照组分别为（2.44±0.51）、（2.36±0.48）分，差异无统计学意义（t=0.81，P=0.419）；观察组分别为（2.46±0.50）、（2.00±0.10）分，差异有统计学意义（t=6.49，P<0.001）。神经痛评分：治疗前、治疗28 d后对照组分别为（2.14±0.49）、（2.18±0.48）分，差异无统计学意义（t=-0.41，P=0.683）；观察组分别为（2.16±0.51）、（1.72±0.46）分，差异有统计学意义（t=4.56，P<0.001）；观察组治疗28 d后外周感觉神经障碍、外周运动神经障碍、神经痛评分均低于对照组（均P<0.001）。对照组与观察组患者均出现了不同程度的腹泻、恶心呕吐，但两组间总不良反应发生率差异无统计学意义（χ²=0.22，P=0.637）。结论天蟾胶囊能够有效减轻CIPNP患者的疼痛程度，提高患者的生命质量，安全性良好。

关键词: 天蟾胶囊, 神经痛, 药物疗法

Abstract:

Objective To observe the efficacy and safety of Tianchan capsule on chemotherapy-induced peripheral neuropathic pain（CIPNP）. Methods A total of 120 CIPNP patients with Karnofsky performance status （KPS） score higher than 60 admitted to the Nantong Tumor Hospital， Jiangsu Province and Suzhou Hospital of Traditional Chinese Medicine from April 2023 to April 2024 were selected as study objects. Patients were divided into control group （cisplatin/paclitaxel） and observation group （cisplatin/paclitaxel+Tianchan capsule） according to random number table method， with 60 cases in each group. After 28 days of treatment， the clinical efficacy， adverse reactions， numberical rating scale （NRS） score， quality of life score， Traditional Chinese Medicine （TCM） syndrome score and neurotoxicity grading score before and after treatment were observed and compared between the two groups. Results Twenty-eight days after treatment， the total effective rate of the control group was 0 （0/60）， while the total effective rate of the observation group was 83.33% （50/60）， with a statistically significant difference （χ²=85.71， P<0.001）. The NRS scores of the control group before treatment and at 7， 14， and 28 days after treatment were 6.18±1.71， 6.17±1.72， 6.20±1.70 and 6.22±1.70， respectively， with no statistically significant difference （F=-1.43， P=0.160）. The NRS scores of the observation group before treatment and at 7， 14， and 28 days after treatment were 6.05±1.76， 5.17±1.42， 3.76±1.16， and 2.00±0.80， respectively， with a statistically significant difference （F=22.89， P<0.001）. The NRS scores of the observation group at 7， 14， and 28 days after treatment were all lower than those of the control group， with statistically significant differences （all P<0.001）. Further pairwise comparison showed that， NRS scores in the observation group gradually decreased from before treatment to after 7， 14 and 28 days of treatment （all P<0.05）. Before treatment and 7， 14， and 28 days after treatment in the control group， the KPS scores were 67.33±6.43， 67.25±6.29， 67.08±6.14 and 66.75±5.80， respectively， with no statistically significant difference （F=2.18， P=0.340）. Before treatment and 7， 14， and 28 days after treatment in the observation group， the KPS scores were 67.17±6.49， 68.33±6.32， 71.25±7.68 and 79.42±5.30， respectively， with a statistically significant difference （F=-19.33， P<0.001）. The KPS scores of the observation group at 14 and 28 days after treatment were both higher than those of the control group， with statistically significant differences （t=-3.33， P<0.001； t=-12.66， P<0.001）. Further pairwise comparison showed that， the KPS scores of the observation group were higher at 28 days after treatment compared to pre-treatment levels， as well as to those at 7 and 14 days after treatment （all P<0.05）. The scores of TCM syndrome showed that the scores of burnout and fatigue were 3.03±0.66 before treatment and 3.03±0.66 after 28 days of treatment in the control group， respectively， with no statistically significant difference （t<0.01， P>0.999）. In the observation group， the scores were 3.02±0.60 and 1.97±0.52， respectively， with a statistically significant difference （t=21.00， P<0.001）. The scores of hypochondriac pain were 3.05±0.68 before treatment and 3.07±0.63 after 28 days of treatment in the control group， respectively， with no statistically significant difference （t=-0.57， P=0.568）. In the observation group， the scores were 3.03±0.66 and 2.02±0.57， respectively， with a statistically significant difference （t=18.25， P<0.001）. The scores of pale complexion were 2.87±0.50 and 2.85±0.48 in the control group before treatment and 28 days after treatment， respectively， with no statistically significant difference （t=-0.57， P=0.568）. In the observation group， the scores were 2.93±0.55 and 1.93±0.55， respectively， with a statistically significant difference （t=24.29， P<0.001）. The scores of loss of appetite were 2.90±0.60 and 2.90±0.63 in the control group before treatment and after 28 days of treatment， respectively， with no statistically significant difference （t<0.01， P>0.999）. In the observation group， the scores were 2.95±0.57 and 1.98±0.60， respectively， with a statistically significant difference （t=20.42， P<0.001）. After 28 days of treatment， the scores of burnout and fatigue， hypochondriac pain， pale complexion and loss of appetite in the observation group were lower than those in the control group （all P<0.001）. Comparison of neurotoxicity grading showed that the scores of peripheral sensory nerve disorder were 2.54±0.50 before treatment and 2.58±0.49 after 28 days of treatment in the control group， respectively， with no statistically significant difference （t=-0.40， P=0.690）. The scores in the observation group were 2.52±0.50 and 2.00±0.00， respectively， with a statistically significant difference （t=7.29， P<0.001）. The scores of peripheral motor nerve disorder were 2.44±0.51 before treatment and 2.36±0.48 after 28 days of treatment， respectively， with no statistically significant difference （t=0.81， P=0.419）. In the observation group， the scores were 2.46±0.50 and 2.00±0.10， respectively， with a statistically significant difference （t=6.49， P<0.001）. Neuralgia score： Before treatment and after 28 days of treatment， the scores in the control group were 2.14±0.49 and 2.18±0.48， respectively， with no statistically significant difference （t=-0.41， P=0.683）. The scores in the observation group were 2.16±0.51 and 1.72±0.46， respectively， with a statistically significant difference （t=4.56， P<0.001）. After 28 days of treatment， the scores of peripheral sensory nerve disorder， peripheral motor nerve disorder and neuralgia in the observation group were lower than those in the control group （all P<0.001）. Patients in both control group and observation group had different degrees of diarrhea， nausea and vomiting， but there was no statistically significant difference in total incidence of adverse reactions between the two groups （χ²=0.22，P=0.637）. Conclusions Tianchan capsule can effectively reduce the pain degree of patients with CIPNP， improve the quality of life of patients and has good safety.

Key words: Tianchan capsule, Neuralgia, Drug therapy

王青, 陈婷, 高静东, 彭春雷. 天蟾胶囊治疗化疗所致周围神经病理性疼痛的临床观察[J]. 国际肿瘤学杂志, 2025, 52(5): 288-294.

Wang Qing, Chen Ting, Gao Jingdong, Peng Chunlei. Clinical observation on the treatment of chemotherapy-induced peripheral neuropathic pain with Tianchan capsule[J]. Journal of International Oncology, 2025, 52(5): 288-294.

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组别	显效	有效	无效	总有效	χ²值	P值
对照组（n=60）	0（0）	0（0）	60（100）	0（0）	85.71	<0.001
观察组（n=60）	31（51.67）	19（31.67）	10（16.67）	50（83.33）	85.71	<0.001

组别	治疗前	治疗7 d后	治疗14 d后	治疗28 d后	F值	P值
对照组（n=60）	6.18±1.71	6.17±1.72	6.20±1.70	6.22±1.70	-1.43	0.160
观察组（n=60）	6.05±1.76	5.17±1.42^a	3.76±1.16^ab	2.00±0.80^abc	22.89	<0.001
t值	0.42	3.48	9.28	17.39
P值	0.675	<0.001	<0.001	<0.001

组别	腹泻	恶心呕吐	总不良反应	χ²值	P值
对照组（n=60）	7（11.67）	5（8.33）	12（20.00）	0.22	0.637
观察组（n=60）	6（10.00）	4（6.67）	10（16.67）	0.22	0.637