中医肿瘤学杂志2024，Vol.6Issue(2)：24-32,9.DOI:10.19811/j.cnki.ISSN2096-6628.2024.03.004
龙藤通络方联合阿片类止痛药治疗中重度肺癌癌痛的前瞻性临床研究
A Prospective Clinical Trial of Longteng Tongluo Formula Combined with Opioid Analgesics for the Treatment of Moderate to Severe Cancer Pain of Lung Cancer
摘要
Abstract
Objective To observe the clinical efficacy of Longteng Tongluo Formula combined with opioid analgesics for the treatment of moderate to severe cancer pain of lung cancer.Methods A multicenter,open-label randomized controlled trial was designed to collect 117 lung cancer patients with moderate to severe pain,with 57 cases in the treatment group and 60 cases in the control group.The treatment group was treated with opioids combined with Longten Tongluo Formula for external use,while the control group was given opioids alone,for successive 8 days.Numerical rating scale(NRS)scores,daily morphine consumption,frequency of pain outbreak,analgesic onset time,and adverse reactions of the two groups were observed before and after treatment to evaluate analgesic efficacy.Furthermore,UPLC-QQQ-MS/MS mass spectrometry was used to detect the content of Longteng Tongluo Formula and estimated the effective analgesic ingredients.Results The pain relief rate of the treatment group was 97.37%and the significant efficiency was 50.88%,which were higher than those of the control group(P＜0.05).The difference of NRS scores before and after treatment in the treatment group was(2.07±1.02)points,with statistical significance compared with the control group(P＜0.05).Stratified analysis showed that in different pain levels and types of populations,Longteng Tongluo Formula combined with opioids was more effective in treating moderate pain(NRS score of 4 to 7 points)as well as patients with cancer pain caused by bone metastases,paraneoplastic syndromes,cachexia,etc.There was a significant difference in NRS scores before and after treatment compared with the same type of control group(P＜0.05).The daily equivalent morphine consumption in the subgroup with moderate pain was(61.57±51.69)mg,which was lower than that in control group with moderate pain(P＜0.05).The main adverse reactions related to external treatment of the combination therapy of Longteng Tongluo Formula were skin itching,local redness,and swelling.The other adverse reactions with an incidence rate of over 10%were mainly nausea,vomiting,constipation,dizziness,and abnormality of liver and kidney function as well as electrocardiogram.UPLC-QQQ-MS/MS mass spectrometry analysis showed that 7 active indicator compounds including rhoifolin and tracheloside were detected,which might play a role in the treatment of lung cancer pain.Conclusion The combination of Longteng Tongluo Formula and opioid analgesic has synergistic effect,especially in moderate pain,which can reduce the average daily consumption of opioids in patients with moderate pain,and has good safety.关键词
肺癌癌痛/龙藤通络方/阿片类止痛药/中医外治/UPLC-QQQ-MS/MSKey words
lung cancer pain/Longteng Tongluo Formula/opioid analgesics/tradition Chinese medicine external treatment/UPLC-QQQ-MS/MS分类
医药卫生引用本文复制引用
周迪,陈洁,许玲,黄虞枫,董昌盛,陈建茹,苏羚子,林丹,姚嘉麟,龚亚斌..龙藤通络方联合阿片类止痛药治疗中重度肺癌癌痛的前瞻性临床研究[J].中医肿瘤学杂志,2024,6(2):24-32,9.基金项目
国家科技重大专项(编号:2019ZX09201004-002-001) （编号:2019ZX09201004-002-001）
上海市科学技术委员会科技计划项目(编号:20S31904100). （编号:20S31904100）
