益气温阳通脉方对化疗致周围神经病变患者的临床疗效

Clinical effect of Yiqi Wenyang Tongmai Formula on patients with chemotherapy induced peripheral neuropathy

目的:观察益气温阳通脉方对化疗致周围神经病变(CIPN)患者的临床疗效。方法:采用随机对照研究方法,纳入135例CIPN患者,随机分为观察组69例、对照组66例。观察组患者给予益气温阳通脉方口服,对照组患者给予甲钴胺片口服,疗程均为2个月。治疗前后,比较两组患者的中医症状积分;评价两组患者的中医证候疗效和周围神经病变分级改善疗效;治疗前后,测定并比较两组患者的正中神经和腓肠神经的感觉神经传导速度(SNCV)、运动神经传导速度(MNCV);采用总神经病变评分(TNS)量表评价患者的周围神经损伤情况;采用FACT/GOG-Ntx量表评估患者的生活质量。结果:研究中,观察组和对照组分别剔除2例、5例患者,最终纳入统计分析者观察组67例、对照组61例。(1)治疗后,观察组患者的手足麻木、疼痛、怕冷、乏力神疲症状积分较治疗前均明显降低(P<0.05),对照组患者的手足麻木、疼痛症状积分较治疗前亦降低(P<0.05),且观察组患者的手足麻木、疼痛、怕冷、乏力神疲症状积分均低于对照组(P<0.05)。(2)治疗后,观察组患者的中医证候疗效总有效率为46.27%,对照组为19.67%,观察组的疗效优于对照组(P<0.05)。(3)治疗后,观察组患者的周围神经病变分级改善疗效总有效率为85.07%,对照组为80.33%,观察组的疗效优于对照组(P<0.05)。(4)治疗后,两组患者的正中神经、腓肠神经的SNCV、MNCV较治疗前均明显增快(P<0.05),且观察组患者的正中神经、腓肠神经的SNCV、MNCV较对照组亦明显增快(P<0.05)。(5)治疗后,两组患者的TNS量表评分较治疗前均降低(P<0.05),且观察组患者的评分低于对照组(P<0.05)。(6)治疗后,两组患者的FACT/GOG-Ntx量表评分较治疗前均降低(P<0.05),且观察组患者的评分低于对照组(P<0.05)。结论:与甲钴胺相比,益气温阳通脉方能更好地改善CIPN患者的临床症状及周围神经病变严重程度,提高患者的周围神经传导速度,从而改善患者的生活质量,增加患者抗癌治疗的信心和依从性。

Objective:To observe the clinical effect of Yiqi Wenyang Tongmai Formula on the patients with chemotherapy induced peripheral neuropathy(CIPN).Methods:The randomized controlled trial was carried out. A total of 135 patients with CIPN were selected and randomly divided into the observation group(69 cases)and the control group(66 cases). The patients in the observation group were orally reated with Yiqi Wenyang Tongmai Formula and the patients in the control group were orally treated with mecobalamin tablets,with a course of 2 months. Before and after treatment,the Chinese medical symptom scores of the two groups were compared. The curative effects on Chinese medical syndrome and the improvement of peripheral neuropathy classification in the two groups were evaluated. Before and after treatment,the sensory nerve conduction velocity(SNCV)and motor nerve conduction velocity(MNCV)of median nerve and sural nerve of patients in the two groups were measured and compared. The total neuropathy score(TNS)scale was used to evaluate the peripheral nerve injury. The life quality of the patients was evaluated by FACT/GOG-Ntx scale.Results:During the study,2 cases in the observation group and 5 cases in the control group were excluded,finally 67 cases in the observation group and 61 cases in the control group were included in the statistical analysis.(1)After treatment,the symptom scores of hand and foot numbness,pain,fear of cold and fatigue in the observation group were significantly decreased compared with those before treatment(P<0.05),the symptom scores of hand and foot numbness and pain in the control group were also decreased compared with those before treatment(P<0.05),and the symptom scores of hand and foot numbness,pain,fear of cold and fatigue in the observation group were lower than those in the control group(P<0.05).(2)After treatment,the total effective rate on Chinese medical syndrome was 46.27% in the observation group and 19.67% in the control group,and the effect of the observation group was better than that of the control group(P<0.05).(3)After treatment,the total effective rate on the improvement of peripheral neuropathy classification was 85.07% in the observation group and 80.33% in the control group,and the curative effect of the observation group was better than that of the control group(P<0.05).(4)After treatment,the SNCV and MNCV of median nerve and sural nerve in the two groups were significantly faster than those before treatment(P<0.05),and the SNCV and MNCV of median nerve and sural nerve in the observation group were also significantly faster than those in the control group(P<0.05).(5)After treatment,the scores of TNS scale in the two groups were decreased compared with those before treatment(P<0.05),and the score of the observation group was lower than that of the control group(P<0.05).(6)After treatment,the scores of FACT/GOG-Ntx scale in the two groups were decreased compared with those before treatment(P<0.05),and the score of the observation group was lower than that of the control group(P<0.05).Conclusion:Compared with mecobalamin,Yiqi Wenyang Tongmai Formula can better improve the clinical symptoms and the peripheral neuropathy of the patients with CIPN,increase the peripheral nerve conduction velocity,thus improve the quality of life and enhance the confidence and compliance of the patients in the treatment of cancer.