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