Department of Traditional Chinese Medicine, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Department of Comprehensive Therapy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Chin J Integr Med. 2020 Apr;26(4):263-269. doi: 10.1007/s11655-019-3167-7. Epub 2019 Aug 24.
To evaluate whether low-frequency ultrasound-facilitated transdermal delivery of a Chinese medicine (CM) formula could improve the efficacy of intrapleural administration of interleukin-2 (IL-2) in treatment of malignant pleural effusion (MPE).
A total of 110 eligible participants were randomized into the low-frequency sonophoresis (LFS) of CM (LSF/CM) group (55 cases) and the control group (55 cases) by simple randomization using a random number table. The control group was treated with an intrapleural administration of IL-2; and the LFS/CM group was treated with LFS of a CM gel formulation, combined with the same IL-2 injection as in the control group. The CM formula consisted of Semen Lepidii, Semen Sinapis, Ramulus Cinnamomi, Poriacocos, Herba Lycopi, and Radix Paeoniae Rubra. After 2-week treatment, the therapeutic outcome was determined by the change of the amount of MPE, which was evaluated by B-scan ultrasound and/or chest X-ray, and the change of quality of life (QOL) scores, which were evaluated by the Eastern Cooperative Oncology Group (ECOG) performance status.
A significantly higher objective remission rate (ORR) was obtained with intrapleural IL-2 plus LFS/CM than IL-2 treatment alone (P=0.049). In addition, more patients in the LFS/CM group than in the control group had an improved QOL score (P=0.048), and no patients in the LFS/CM group had a reduced QOL.
LFS of CM formulation could effectively alleviate MPE and improve the QOL of cancer patients.
评估低频超声透皮给药的中药(CM)配方是否可以提高白细胞介素-2(IL-2)腔内给药治疗恶性胸腔积液(MPE)的疗效。
采用简单随机数字表法将 110 例符合条件的患者随机分为低频超声透皮给药(LFS)的 CM(LSF/CM)组(55 例)和对照组(55 例)。对照组采用 IL-2 腔内给药治疗;LSF/CM 组采用 CM 凝胶制剂的 LFS,联合对照组相同的 IL-2 注射。CM 配方由葶苈子、白芥子、肉桂、茯苓、番茄叶和赤芍组成。经过 2 周的治疗,通过 B 超和/或胸部 X 线检查胸腔积液量的变化以及东部合作肿瘤学组(ECOG)体力状况评分评估生活质量(QOL)评分的变化来确定治疗效果。
与单独使用 IL-2 相比,胸腔内 IL-2 加 LFS/CM 治疗的客观缓解率(ORR)显著更高(P=0.049)。此外,与对照组相比,LSF/CM 组有更多的患者 QOL 评分得到改善(P=0.048),并且 LSF/CM 组没有患者的 QOL 评分降低。
CM 配方的 LFS 可以有效缓解 MPE 并提高癌症患者的 QOL。