Clinical And Experimental Study Of Jian Pi Li Qi Chinese Medicine In The Treatment Of Postembolization Syndrome In Patients With Primary Liver Canter Following Transcatheter Arterial Chemoembolization

Primary liver cancer (PLC) is one of the most common cancers with poor prognosis in China. Unfortunely, the majority of PLCs are diagnosed at an intermediate or later stage when curative treatments are less effective. Transcatheter arterial chemoembolization (TACE) is widely considered as an effective treatment for most patients with unresectable PLC. This treatment option usually leads to adverse events and complications called postembolization syndrome (PES), such as nausea, vomiting, fever, pain, astriction and so on. Although PES is widely considered as self-limited, it however, reduces the quality of life (QOL), interferes with compliance or may cause treatment delays, which all will lead to a potential loss of control over tumor and only with effective management will this be resolved. Traditional Chinese Medicine (TCM) has received widely acception in the treatment of PLC. "Jian Pi Li Qi" (JPLQ) Chinese medicine is one of the most commonly used prescriptions, which was designed by Fudan University Shanghai Cancer Center. However, the relatively poor designs of many clinical reports result in the difficulties for evaluating the effects of herbal medicine for cancer treatment. So far, no well-designed randomized study has evaluated the potential benefit of JPLQ in improving QOL of PLC patients after TACE. With this in mind, we undertook a randomized, double-blind, placebo-controlled trial. Moreover, we conducted a randomized, placebo-controlled trial in mice.Part Ⅰ. Clinical Study of Jian Pi Li Qi Chinese Medicine in the Treatment of Postembolization Syndrome in Patients with Primary Liver Cancer following Transcatheter Arterial ChemoembolizationObjective:To evaluate the effectiveness of JPLQ Chinese medicine in improving quality of life of patients with PLC following TACE.Methods:A randomized, double-blinded, placebo-controlled trial was conducted in patients with PLC.150 patients were randomly assigned into three groups. Groups were designed as none herbal medicine nor placebo administration (Group 1), placebo treatment (Group 2), and JPLQ Chinese medicine treatment (Group 3). The measurement methods of the observed outcomes include M. D. Anderson Symptom Inventory (MDASI) and laboratory tests.Results:The incidence of abdominal pain, drowsiness and xerostomia in Group 3 was lower than that in Group 1 and Group 2 (P<0.05). There was no difference between Group 1 and Group 2. The incidence of symptoms of astriction, loss of appetite and tiredness in Group 3 was lower than Group 1 and Group 2 without statistical significance. There was no significance among three groups in the incidence of nausea and fever. The incidence of vomting in Group 2 was significantly higher than the other groups. Levels of total bilirubin (TB) and lactate dehydrogenase (LDH) were significantly different among three groups after TACE (p=0.032 and p=0.001, respectively).Conclusion:JPLQ Chinese medicine is a new way of improving quality of life, relieving PES, and protecting liver function in patients with PLC after TACE.Part Ⅱ. the Empirical Study of Jian Pi Li Qi Docoction in Regulating Gastrointestinal Function in Spleen Asthenia Type Constipated MiceObjective:To study the effects of JPLQ Docoction in in regulating gastrointestinal function in spleen asthenia type constipated mice.Methods:The mice models of spleen asthenia type constipation were induced by splenasthenic diarrhea, irregular diet and fluid-consuming constipation. Then the model mice were divided into three groups, treated with nothing, placebo saline solution and JPLQ Docoction, respectively. The percentage of pushing carbonic powder was observed in small intestine. The level of D-xylose was tested in blood plasma. The expression of SP and VIP in the colon was tested by immunohistochemical staining.Results:After treatment, the intestinal propulsion rate was faster markly in JPLQ Docoction group than unhandled control group and saline group (p< 0.05). Compared with unhandled control group and saline group, the level of D-xylose and the expression of SP and VIP was significant higher in JPLQ Docoction group (p< 0.01).Conclusion:The function of intestinal movement and absorption was obviously improved by JPLQ Docoction, which may be related to the regulation of SP and VIP levels.