| Background:Malignant ascites (MA) is one of common complications of the late malignant tumor, mostly secondary to ovarian cancer, gastric cancer, breast cancer and other malignant tumors, the overall prognosis is poor, become one of the difficult problem of tumor palliative care. And the quality of life of patients with severely affected. So the palliative care for cancer patients with malignant ascites to improve quality of life, improve the prognosis is still important. Currently the treatment of malignant ascites mainly include the basic nutritional support treatment and symptomatic treatment abdominal puncture drainag, intraperitoneal chemotherapy, immune therapy, molecular targeted therapy, Chinese medicine treatment and surgical treatment, ect., the Chinese medicine treatment of malignant ascites in recent years, it achieved good clinical efficacy, especially the Chinese medicine external treatment of malignant ascites. Shipi Xiaoshui Extract is the China-Japan Friendship Hospital of traditional Chinese medicine and Western medicine combined with tumor medicine developed in the treatment of malignant peritoneal effusion an external preparation of Chinese traditional medicine. Early clinical observation and experimental study confirmed that Shipi Xiaoshui Extract can pass diuresis and inhibit cancer cell control ascites, and can improve the clinical symptoms of the patients with carcinomatous ascites and improve the quality of life. This study is under the "Beijing Municipal Science and technology project" of major projects funded。Objective:To observe the clinical efficacy and safety of Shipi Xiaoshui Extract in external treatment of malignant ascites, and its influence on the clinical symptoms, quality of life (QOL) of patients, in order to find an effective, standard, is advantageous for the clinical operation methods of TCM External Treatment of malignant peritoneal effusion.Methods:A multicenter, double-blind, randomized, controlled method, consists of 5 units of multi-center research team, enrolled 108 cases of malignant ascites in patients, experimental group and control group (n=54). Experimental group received the Shipi Xiaoshui Extract, in malignant peritoneal effusion corresponding in body surface, each 20 g,1 time/day,2 weeks for a cycle. The control group was placebo intervention, before the same amount of usage. The primary outcome was the volume of ascites, TCM symptom score, KPS changes, minor view Observation index is ascites drainage/total body surface area, abdominal circumference, quality of life evaluation. Safety evaluation indicators are mainly blood routine, liver and kidney function, skin irritation and allergic reaction.Results:The total effective rate of malignant ascites, FAS analysis of the experimental group complete remission in 6 cases (11.1%), partial remission in 19 cases (35.2%), unchanged in 29 cases (53.7%), the total effective rate was 46.3%; control group 0 cases of complete remission, partial remission in 7 cases (13.0%), unchanged in 47 cases (87.0%), the total efficiency of 13.0%, the χ2 test, total effective rate difference was statistically significant (P <0.05). PPS analysis, test group and the control group, the total efficiency of 52.1% and 15.2%, respectively, by the χ2 test, total effective rate difference was statistically significant (P<0.05). TCM symptoms, the test group patients with abdominal, shortness of breath, loss of appetite, vomiting, fullness after eating before, compared with medication to alleviate pain; the control group had no significant changes in clinical symptoms, the test group was statistically significant difference compared with the control group (p<0.05). And test group 7 ± 1 days after treatment, significant improvement when compared with the group of the above symptoms; KPS score regard, the experimental group after treatment KPS score was significantly improved, compared with the control group, the difference was statistically significant (P<0.05). After the two-sample t-test, test and control groups in terms of improving the quality of life, compared to the two groups was statistically significant difference (P<0.05). Better patient satisfaction experimental group, a significant difference (P <0.05) compared with the control group. Two skin incidence of adverse reactions, blood, liver and kidney function was no significant difference (P> 0.05).Conclusions:The Shipi Xiaoshui Extract in external treatment of malignant ascites can effectively reduce the amount of fluid, and can relieve abdominal distention and fullness, shortness of breath, dyspnea and other symptoms, improve the quality of life of patients. The results indicated that TCM External Treatment of malignant ascites, curative effect, safe and reliable, convenient for clinical Operation, should be widely applied. |
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