龙藤通络方外用治疗奥沙利铂诱导的周围神经病变的临床研究

目的观察龙藤通络方外用治疗奥沙利铂诱导的周围神经病变(OIPN)的临床疗效。方法将120例OIPN患者随机分为治疗组、安慰剂组、对照组,每组40例;治疗组予龙藤通络方外用,安慰剂组予龙藤通络方安慰剂外用,对照组予甲钴胺片口服,各组疗程均为28 d。观察临床疗效,比较周围神经毒性分级、生存质量(FACT/GOG-Ntx量表评分、EORTC QOL C30 v3.0量表评分)、中医证候评分、血清神经生长因子(NGF)水平的变化情况,同时进行安全性评价。结果 (1)治疗组、安慰剂组共脱落或剔除4例,对照组脱落1例,最终完成试验者治疗组、安慰剂组各36例,对照组39例。(2)周围神经毒性疗效:治疗组、安慰剂组、对照组总有效率分别为72.22%、16.67%、35.90%,治疗组疗效优于安慰剂组和对照组(P<0.01);安慰剂组、对照组疗效比较,差异无统计学意义(P>0.05)。中医证候疗效:治疗组、安慰剂组、对照组总有效率分别为72.22%、36.11%、33.33%,治疗组疗效优于安慰剂组和对照组(P<0.01);安慰剂组、对照组疗效比较,差异无统计学意义(P>0.0...

Clinical study on the external application of Longteng Tongluo Decoction in the treatment of oxaliplatin-induced peripheral neuropathy

Objective To observe the clinical efficacy of external application of Longteng Tongluo Decoction(LTD)in the treatment of oxaliplatin-induced peripheral neuropathy(OIPN).Methods Totally 120 patients with OIPN were randomly divided into a treatment group,a placebo group and a control group,with 40 cases in each group.The treatment group was administered with LTD for external application,the placebo group was administered with LTD placebo for external application,and the control group was administered with methylcobalt for oral administration.The treatment lasted 28 days in each group.The clinical efficacy was observed,and the changes in peripheral neurotoxicity grading,quality of survival(FACT/GOG-Ntx scale score,EORTC QOL C30 v3.0 scale score),TCM syndrome scores and serum nerve growth factor(NGF)levels were compared,and safety evaluation was also performed.Results (1)In the treatment group and placebo group 4 cases dropped out or were removed,and there was 1 drop-out case in the control group.Finally,36 cases each in the treatment group and placebo group and 39 cases in the control group completed the trial.(2) On peripheral neurotoxicity grading:the total effective rates of the treatment group,placebo group and control group were72.22%,16.67% and 35.90%,respectively.The efficacy of the treatment group was better than that of the placebo group and control group(P<0.01).There was no significant difference in the efficacy between the placebo group and the control group(P>0.05).On TCM syndrome scores:the total effective rates of the treatment group,placebo group and control group were 72.22%,36.11% and 33.33%,respectively,and the efficacy of the treatment group was better than that of the placebo group and control group(P<0.01).There was no significant difference in the efficacy between the placebo group and the control group(P>0.05).(3)The improvement in the peripheral neurotoxicity grading was observed after 7 days of treatment in the treatment group(P<0.05),after 21 days of treatment in the placebo group(P<0.05),and after treatment in the control group(P<0.05).There was no statistically significant difference in peripheral neurotoxicity grading among three groups after 7 days and 14 days of treatment(P>0.05).After21 days of treatment,the peripheral neurotoxicity grading of the treatment group was better than that of the placebo group(P<0.05),but there was no statistically significant difference in the peripheral neurotoxicity grading between the treatment group and the control group,and between the control group and the placebo group(P>0.05).After 28 days of treatment,the peripheral neurotoxicity grading of the treatment group was better than that of the placebo group and the control group(P<0.01),and there was no statistically significant difference in the peripheral neurotoxicity grading between the placebo group and the control group(P>0.05).(4)According to the intra-group comparison before and after treatment,the scores of palpitation and shortness of breath,fatigue,spontaneous sweating,dizziness,insomnia and forgetfulness,and numbness of hands and feet decreased in the treatment group(P<0.05),the scores of palpitation and shortness of breath,insomnia and forgetfulness dropped in the placebo group(P<0.05),the scores of numbness of hands and feet decreased in the control group(P<0.05).According to the inter-group comparison after treatment,no significant differences were found in the scores of dizziness,insomnia and forgetfulness among the three groups(P>0.05);the scores of palpitation and shortness of breath,spontaneous sweating and numbness of hands and feet in the treatment group were lower than those in the control group(P<0.05,P<0.01),and the scores of fatigue and numbness of hands and feet in the treatment group were lower than those in the placebo group(P<0.05,P<0.01);and the scores of palpitation and shortness of breath in the placebo group were lower than those in the control group(P<0.01).(5) The intra-group comparison before and after treatment showed that the FACT/GOG-Ntx scale scores decreased in each group(P<0.05).After treatment,the FACT/GOG-Ntx scale scores in the treatment group were lower than those in the control group and placebo group(P<0.05,P<0.01),and there was no statistically significant difference in the FACT/GOG-Ntx scale scores between the control group and placebo group(P>0.05).(6)According to the intragroup comparison,the scores of the 5 functional scales(physical,role,cognitive,emotional,and social function)and the total health status scores increased in the treatment group(P<0.05),the scores of physical,role and cognitive function and the total health status scores increased in the placebo group(P<0.05),and only the scores of role function and the total health status scores increased in the control group(P<0.05).After treatment,the differences in scores of cognitive function and social function were not statistically significant(P>0.05);the scores of emotional,physical and role function and the total health status scores in the treatment group were higher than those in the placebo group(P<0.05,P<0.01),and the scores of role function and the total health status scores in the treatment group were higher than those in the control group(P<0.05,P<0.01).The differences in the scores of each subscale of the EORTC QOL C30 v3.0 scale were not statistically significant between the control group and the placebo group(P>0.05).(7)The differences in serum NGF levels were not statistically significant when compared within and between groups before and after treatment(P>0.05).Conclusion Longteng Tongluo Decoction can effectively improve the clinical symptoms of OIPN and the quality of survival of patients with better safety.