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A Randomized Controlled Study to Observe the Efficacy of External Treatment With a Traditional Chinese Medicine Herbal Ointment on Malignant Plural Effusion: Outcome Report and Design Review

机译:观察中药外用药对恶性多发性积液外部疗效的随机对照研究:结果报告及设计回顾

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Background. Malignant pleural effusion (MPE) is a common complication in most malignancies. Despite its frequent occurrence, current knowledge of MPE remains limited and the effect of the management is still unsatisfying. Traditional Chinese medicine (TCM) external treatment has unique advantages, such as quicker efficacy and fewer side effects. Objective. To observe the effects and safety of Kang’ai Xiaoshui ointment (TCM herbal ointment) in MPE. Design. This was a placebo-controlled double-blinded randomized study. A total of 80 patients were enrolled, of which 72 were randomized to receive Kang’ai Xiaoshui ointment or placebo at an allocation ratio of 1:1. Kang’ai Xiaoshui ointment or placebo was applied on the thorax wall for 8 hours daily. The intervention lasted 2 weeks. Kang’ai Xiaoshui ointment consisted of Astragalus membranaces (黄芪), Semen pharbitidis (牵牛子), Cassia twig (桂枝), Pericarpium arecae (大腹皮), Curcuma zedoary (莪术), Borneol (冰片), and other substances. In both groups, diuresis and drainages were used as needed. Outcomes covered the quantity of pleural effusion evaluation, TCM Symptom Scale, Karnofsky Performance Scale, and safety indicators such as routine blood test, blood biochemistry test, and response table of skin irritation. Results. Of 72 patients randomized to receive Kang’ai Xiaoshui ointment or placebo along with symptomatic treatment, the response rate was documented as 42.4% for the treatment group and 25.0% for the placebo group (P = .138). As for the TCM symptom scale, the treatment group showed improvement in chest distress (P = .003), fullness and distention (P = .042), shortness of breath (P P = .237), and pain (P = .063), whereas the placebo group did not show statistical significance in any of the 5 symptoms. Major adverse events related to the treatment, mainly skin irritation, were distributed equally. Conclusions. Kang’ai Xiaoshui ointment showed a potential of reducing MPE, and it could alleviate symptoms of dyspnea. Thus, it may be appropriate as a supplementary intervention for MPE. There were some flaws in the study design. A larger scale and better designed trial is advocated.
机译:背景。恶性胸腔积液(MPE)是大多数恶性肿瘤的常见并发症。尽管经常发生MPE,但目前对MPE的了解仍然有限,并且管理效果仍不令人满意。中药(TCM)外用疗法具有独特的优势,例如疗效更快,副作用更少。目的。观察康爱小水软膏(TCM草药软膏)在MPE中的作用和安全性。设计。这是安慰剂对照的双盲随机研究。总共招募了80位患者,其中72位被随机分配为分配比例为1:1的康爱小水软膏或安慰剂。每天将8个小时的抗凝软膏或安慰剂涂在胸腔壁上。干预持续了2周。康爱小水软膏由黄芪,黄精,牵牛子,桂枝,大果皮,大黄姜皮,姜黄,冰片等组成。两组均根据需要使用利尿和引流。结果涵盖了胸腔积液评估的数量,中医症状量表,卡诺夫斯基表现量表以及安全指标,如常规血液检查,血液生化检查和皮肤刺激反应表。结果。在随机分配接受康爱小水软膏或安慰剂对症治疗的72例患者中,治疗组的缓解率为42.4%,安慰剂组为25.0%(P = .138)。至于中医症状量表,治疗组的胸痛(P = .003),饱腹和胀气(P = .042),呼吸急促(PP = .237)和疼痛(P = .063)有所改善。 ,而安慰剂组在这5种症状中均未显示出统计学意义。与治疗相关的主要不良事件(主要是皮肤刺激)平均分布。结论。康爱小水软膏具有降低MPE的潜力,可以缓解呼吸困难的症状。因此,它可能适合作为MPE的补充干预措施。研究设计中存在一些缺陷。提倡更大范围和更好设计的试验。

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