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

目的观察龙藤通络方外用联合阿片类止痛药治疗中重度肺癌癌痛的临床疗效。方法采用多中心、开放标签的随机对照试验设计,收集中重度肺癌癌痛患者117例(治疗组57例,对照组60例),治疗组采用阿片类药物联合龙藤通络方外用,对照组采用单纯阿片类药物,连续给药8天,分别观察两组患者疼痛治疗前后数字疼痛评分法(numerical rating scale,NRS)评分、日均吗啡消耗量、爆发痛次数、止痛起效时间及不良反应,评价镇痛疗效。并运用UPLC-QQQ-MS/MS质谱技术对龙藤通络方含测指标进行检测,预估止痛有效成分。结果治疗组疼痛缓解率97.37%,显效率为50.88%,均高于对照组(P<0.05),治疗组治疗前后NRS评分差值为(2.07±1.02)分,与对照组比较差异有统计学意义(P<0.05)。分层分析显示在不同疼痛程度及类型人群中,龙藤通络方联合阿片类药物对中度疼痛(NRS评分4分~7分)、骨转移性癌痛以及副肿瘤综合征、恶病质等引起的癌痛人群中治疗疗效更有优势,治疗前后NRS差值与同类型对照组有明显差异(P<0.05)。治疗组中度疼痛亚组患者的等效吗啡日均消耗量为(61.57±51.69)mg,少于中度疼痛对照组(P<0.05)。龙藤通络方联合治疗后与外治相关的不良反应以皮肤瘙痒和局部红肿为主,其余发生率超过10%的不良反应主要为恶心呕吐、便秘、头晕、肝肾功能及心电图异常。质谱分析检测出龙藤通络方中野漆树苷、络石苷等7个活性指标性化合物,这些有效成分可能在肺癌癌痛治疗中起着一定作用。结论龙藤通络方联合阿片类止痛方案有协同、增效的作用,尤其在中度疼痛中效果显著,可减少中度疼痛患者阿片类药物日均消耗量,且安全性好。

Patient-Reported Outcomes of Postoperative NSCLC Patients with or without Staged Chinese Herb Medicine Therapy during Adjuvant Chemotherapy (NALLC 2): A Randomized, Double-Blind, Placebo-Controlled Trial

Objective:To investigate whether the combination of chemotherapy with staged Chinese herbal medicine(CHM) therapy could enhance health-related quality of life(QoL) in non-small-cell lung cancer(NSCLC)patients and prolong the time before deterioration of lung cancer symptoms,in comparison to chemotherapy alone.Methods:A prospective,double-blind,randomized,controlled trial was conducted from December 14,2017 to August 28,2020.A total of 180 patients with stage ⅠB-ⅢA NSCLC from 5 hospitals in Shanghai were randomly divided into chemotherapy combined with CHM(chemo+CHM) group(120 cases) or chemotherapy combined with placebo(chemo+placebo) group(60 cases) using stratified blocking randomization.The European Organization for Research and Treatment of Cancer(EORTC) Quality-of-Life-Core 30 Scale(QLQ-C30) was used to evaluate the patient-reported outcomes(PROs) during postoperative adjuvant chemotherapy in patients with early-stage NSCLC.Adverse events(AEs) were assessed in the safety analysis.Results:Out of the total 180 patients,173 patients(116in the chemo+CHM group and 57 in the chemo+placebo group) were included in the PRO analyses.The initial mean QLQ-C30 Global Health Status(GHS)/QoL scores at baseline were 57.16±1.64 and 57.67±2.25 for the two respective groups(P>0.05).Compared with baseline,the chemo+CHM group had an improvement in QLQ-C30GHS/QoL score at week 18 [least squares mean(LSM) change 17.83,95% confidence interval(CI) 14.29 to 21.38].Conversely,the chemo+placebo group had a decrease in the score(LSM change-13.67,95% CI-22.70 to-4.63).A significant between-group difference in the LSM GHS/QoL score was observed,amounting to 31.63 points(95% CI25.61 to 37.64,P<0.001).The similar trends were observed in physical functioning,fatigue and appetite loss.At week 18,patients in the chemo+CHM group had a higher proportion of improvement or stabilization in GHS/QoL functional and symptom scores compared to chemo+placebo group(P<0.001).The median time to deterioration was longer in the chemo+CHM group for GHS/QoL score [hazard ratio(HR)=0.33,95% CI 0.23 to 0.48,P<0.0010],physical functioning(HR=0.43,95% CI 0.25 to 0.75,P=0.0005),fatigue(HR=0.47,95% CI 0.30 to 0.72,P<0.0001) and appetite loss(HR=0.65,95% CI 0.42to 1.00,P=0.0215).The incidence of AEs was lower in the chemo+CHM group than in the chemo+placebo group(9.83% vs.15.79%,P=0.52).Conclusion:The staged CHM therapy could help improve the PROs of postoperative patients with early-stage NSCLC during adjuvant chemotherapy,which is worthy of further clinical research.(Registry No.NCT03372694)

特定耳穴贴压法治疗胃癌患者术后疼痛的临床疗效

目的探讨特定耳穴贴压法治疗胃癌患者术后疼痛的临床疗效。方法选取2016年1月至2017年1月间第二军医大学长海医院收治的104例胃癌术后患者,采用随机数表法分为治疗组(51例)和对照组(53例)。选定耳廓中的心、神门、交感、皮质下和胃5个穴位贴压,治疗组患者每日按压4次,对照组患者仅贴不按压。采用视觉模拟评分法评估两组患者术后疼痛程度,比较两组患者的γ-氨基丁酸(GABA)和β-内啡肽(β-EP)等血清学指标。结果治疗组患者术后2~5d的疼痛评分均低于对照组,差异均有统计学意义(均P<0.05);治疗组患者治疗后的GABA和β-EP均高于对照组患者,差异均有统计学意义(均P<0.05)。结论特定耳穴贴压法可有效缓解胃癌患者的术后疼痛,机制可能与上调GABA和β-EP表达有关。