纳子法指导下金龙硝黄散择时外敷联合胸腔灌注治疗恶性胸腔积液的临床研究

Clinical Study on the Treatment of Malignant Pleural Effusion by Time-Selected External Application of Jinlong Nituhuang Powder Combined with Pleural Perfusion under the Guidance of Nazi Method

目的评估纳子法指导下金龙硝黄散择时外敷联合胸腔灌注的有效性和安全性。方法本研究为前瞻性、随机、对照试验。研究包括90例符合条件的患者,随机分为治疗组(n=45)和对照组(n=45)。采用胸腔积液疗效评价标准、中医证候积分及EORTCQLQ-C30量表来进行疗效的评估。结果两组总有效率比较,差异有统计学意义(P<0.05)。两组患者中医证候积分在治疗后较治疗前均降低,且治疗组低于对照组,差异有统计学意义(P<0.05)。治疗组患者躯体功能状况、总体健康状况、疲倦及气促症状得到明显改善,与本组治疗前比较,差异有统计学意义(P<0.05)。无患者出现皮肤过敏、胸闷等不良反应。结论纳子法指导下金龙硝黄散择时外敷联合胸腔灌注治疗MPE疗效显著,能够显著改善患者生活质量,并且安全性高。

Objective The aim of this study was to evaluate the efficacy and safety of time-selected external application of Jinlong Nituhuang Powder combined with thoracic perfusion under the guidance of Nazi method.Methods This study was a prospective,randomized,controlled trial.The efficacy was evaluated according to evaluation criteria for the treatment of pleural effusion,the improvement of TCM symptoms and the EORTC QLQ-C30.Results The study included 90 eligible patients.They were randomly divided into treatment group(n=45)and control group(n=45).The difference of total effective rate between the two groups was statistically significant(P<0.05).The scores of TCM symptoms in both groups were lower after treatment than before treatment,and the difference was statistically significant compared with that in this group(P<0.05),and the reduction of treatment group was better than control group(P<0.05).The physical function status,general health status,fatigue and shortness of breath were significantly improved in the treatment group.No patients had skin allergy,chest tightness and other adverse reactions.Conclusion Under the guidance of Nazi method,Jinlong Nituhuang Powder combined with pleural perfusion has significant therapeutic effect on MPE,can significantly improve patients’quality of life and with high safety.