Study On The Standardization Of Traditional Chinese Medicine External Treatment Of Pleural Effusion Caused By Malignant Tumor

Malignant pleural effusion (MPE) is a common complication of malignant tumor. It is characterized as rapid growth, difficult to control, and poor prognosis. According to statistics, the median survival for patients with MPE is only 3-12 months. Therefore, it’s very important to treat MPE effectively, for improving patients’ quality of life (QOL), and prolonging survival. Common treatment for MPE are systemic chemotherapy, intracavitary treatment, hyperthermia treatment, and surgery. Recently, TCM external treatment has been played an important role in treating malignant tumor and its complications.This thesis reviewed the research progresses of TCM external treatment of malignant pleural effusion by literature review as well as clinical study aimed to find an effective, standard and operable TCM external treatment. There are three review articles about common treatment and preparation form of TCM external treatment on malignant tumor and its complications as well as the TCM syndromes of Malignant pleural effusion, common formulas and herbs treating Malignant pleural effusion, and current situation of comprehensive treatment.The second part is a clinical study.Purpose:To observe the clinical efficacy of Kang’ai Xiaoshui Cream (the medicine of TCM external treatment). To evaluate the safety of the cream and improvement of symptoms.Method:This is a multicenter, double blinded, randomized blocks, placebo controlled clinical trial. Select eligible 72 patients with malignant pleural effusion, assign randomly 36 patients to the treatment group and control group. Using Kang’ai Xiaoshui Cream and Symptomatic treatment in treatment group, placebo and symptomatic treatment in control group with a duration of 2 weeks. Accessing efficacy by imageology, symptom scores of TCM, KPS score, etc. accessing safety by Blood Routine Test, blood biochemistry test, skin irritation score, etc.Outcome:The effective rate of observation and control group is seperately 63.89%and 13.89%(FAS),69.7% and 16.1%(PPS). The effective rate of observation group is higher than that of control group. The difference between the two groups is significant(P<0.05), which indicates that Kang’ai Xiaoshui Cream is effective to reduce pleura effusion induced by malignant tumors. In terms of TCM syndromes, syndromes of patients in observation group were relieved except palpitation(P<0.05). Whereas, syndromes of those in control group were not significantly changed(P>0.05). In terms of KPS, there were no different between before and after treatment in both groups. Conclusion:It’s a effective treatment to reduce MPE using Kang’ai Xiaoshui Cream.