天蟾胶囊治疗晚期或局部晚期结直肠癌癌性疼痛的临床研究

Clinical efficacy of Tianchan capsule on cancer pain in advanced or locally advanced colorectal cancer

目的观察天蟾胶囊联合阿片类药物治疗正在接受化疗(联合或不联合靶向治疗)的晚期或局部晚期结直肠癌中重度癌性疼痛的临床疗效和安全性。方法选择2022年4月—2023年6月在中国中医科学院肿瘤医院门诊和住院部、北京市朝阳区三环肿瘤医院、北京市朝阳区桓兴肿瘤医院住院部、秦皇岛市中医医院住院部治疗的气滞血瘀型结直肠癌癌性疼痛患者70例,随机分为治疗组和对照组,每组35例,最终治疗组32例、对照组35例完成试验。治疗组给予天蟾胶囊联合阿片类药物治疗,对照组给予安慰剂(1/10天蟾胶囊有效成分及中药糊精)联合阿片类药物治疗,2组均治疗14 d。比较2组治疗前后疼痛数字评分法(NRS)评分、简明疼痛评估量表(BPI)评分、体力状况评分(KPS)、QLQ-C30生存质量量表评分、Piper疲乏量表评分、中医证候评分、阿片类药物单日用量及治疗14 d后的中医证候疗效、癌性疼痛疗效和治疗期间不良反应发生情况。结果治疗第7天,2组NRS评分、QLQ-C30生存质量量表疲乏程度部分总评分、Piper疲乏量表评分和治疗组BPI评分均明显低于治疗前(P均<0.05),治疗组KPS评分、2组QLQ-C30生存质量量表健康情况及生命质量部分总评分均明显高于治疗前(P均<0.05),2组中医证候评分与治疗前比较差异均无统计意义(P均>0.05),且2组治疗后上述各指标比较差异均无统计意义(P均>0.05);治疗第14天,2组NRS评分、QLQ-C30生存质量量表疲乏程度部分总评分、BPI评分、Piper疲乏量表评分、中医证候评分均明显低于治疗前(P均<0.05),2组KPS评分、QLQ-C30生存质量量表健康情况及生命质量部分总评分均明显高于治疗前(P均<0.05),且治疗组治疗第14天的NRS评分和中医证候评分均明显低于同期对照组(P均<0.05);治疗14 d后,2组的阿片类药物单日用量均明显低于治疗首日(P均<0.05),但2组治疗后用量比较差异无统计学意义(P>0.05)。治疗14 d后,治疗组和对照组的中医证候治疗总有效率分别为71.9%(23/32)和42.9%(15/35),差异有统计学意义(P<0.05);治疗组和对照组的疼痛缓解率分别为96.9%(31/32)和71.4%(25/35),差异有统计学意义(P<0.05);治疗前后2组血常规、肝肾功能等安全性指标比较差异均无统计学意义(P均>0.05)。结论天蟾胶囊联合阿片类药物对正在接受化疗(联合或不联合靶向治疗)的气滞血瘀型晚期或局部晚期结直肠癌中重度癌性疼痛患者的止痛作用更强,且安全性较高。

Objective It is to observe the clinical efficacy and safety of Tianchan capsule combined with opiates in the treatment of moderate and severe cancer pain in advanced or locally advanced colorectal cancer treating with chemotherapy(with or without targeted therapy).Methods Seventy cases of patients with cancer pain of colorectal cancer of type of Qi stagnation and blood stasis treated in the outpatient and inpatient departments of Cancer Hospital of China Academy of Traditional Chinese Medicine,Sanhuan Cancer Hospital of Chaoyang District,inpatient department of Huanxing Cancer Hospital of Chaoyang District,and inpatient department of Qinhuangdao Hospital of Traditional Chinese Medicine from April 2022 to June 2023 were selected and randomly divided into treatment group and control group,with 35 cases in each group,and finally 32 cases in the treatment group and 35 cases in the control group completed the trial.The treatment group was treated with Tianchan capsule combined with opiates,while the control group was treated with placebo(1/10 active ingredients of Tianchan capsule and dextrin of traditional Chinese medicine)combined with opiates,both groups were treated for 14 days.The NRS score,BPI score,KPS score,QLQ-C30 score,Piper fatigue scale score,TCM syndrome score before and after treatment,daily dosage of opiates,TCM syndrome efficacy,cancer pain efficacy,and the occurrence of adverse reactions during treatment were compared between the two groups.Results On the 7th day of treatment,the NRS scores,total scores of the fatigue part of QLQ-C30 scale,scores of Piper fatigue scale of the two groups and the BPI score of the treatment group were significantly lower than those before treatment(all P<0.05),the KPS score of the treatment group,the total scores of the health condition and quality of life of QLQ-C30 scale of the two groups were significantly higher than those before treatment(all P<0.05),the differences in TCM syndrome scores of the two groups after treatment were not statistically significant compared with those before treatment(both P>0.05),and the difference in the above indicators after treatment were not statistically significant between the two groups(all P>0.05).On the 14th day of treatment,the NRS scores,total scores of the fatigue part of QLQ-C30 scale,BPI scores,scores of Piper fatigue scale,TCM syndrome scores of the two groups were significantly lower than those before treatment(all P<0.05),the KPS scores,total scores of the health condition and quality of life of QLQ-C30 scale of the two groups were significantly higher than those before treatment(all P<0.05),the NRS score and TCM syndrome score of the treatment group were significantly lower than those of the control group in the same period(all P<0.05).After treatment for 14 days,daily dosages of opiates were significantly lower than those on the first day of treatment in the two groups(both P<0.05),but there was no significant difference between the two groups(P>0.05).After 14 days of treatment,the total effective rates of TCM syndrome in the treatment group and control group were 71.9%(23/32)and 42.9%(15/35),respectively,the pain relief rates in the treatment group and control group were 96.9%(31/32)and 71.4%(25/35),respectively,the differences were all significant different between the two groups(all P<0.05).The differences in the safety indexes such as blood routine,liver and kidney functions of the two groups before and after the treatment were not statistically significant(all P>0.05).Conclusion Tianchan capsule combined with opiates can enhance the analgesic effect in the treatment of moderate and severe cancer pain in advanced or locally advanced colorectal cancer treating with chemotherapy(with or without targeted therapy)with good safety.