RESUMO
ObjectiveTo evaluate the clinical efficacy and safety of Zisheng Pill Formula （资生丸方， ZPF） in the treatment of malignant tumor targeted drugs-related diarrhea with spleen-stomach weakness syndrome. MethodsThis was an randomized controlled study， involving 34 cases in the treatment group and 33 cases in the control group. The treatment group was given ZPF decoction， one dose daily by twice， 200 ml each time， while the control group was given montmorillonite powder， three times per day， 3 g each time， with the first dose doubled， both groups for two weeks. The diarrhea frequency， stool characteristics， common terminology criteria for adverse events （CTCAE） for diarrhea， traditional Chinese medicine （TCM） syndrome score， the European organization for research on treatment of cancer （EORTC） quality of life questionnaire （EORTC QOL-C30） score， levels of serum intestinal functional indicators including diamine oxidase （DAO）， D-lactic acid （D-LA）， endotoxin （ET） levels were evaluated before and after treatment， and the safety was assessed. ResultsThere were 33 cases in the treatment group and 32 cases in the control group in terms of the per-protocol set （PPS）. The total effective rate of diarrhea of the treatment group and control group was 84.85% and 37.50%， respectively， and the total effective rate of TCM syndromes was 93.94% and 34.38%， with statistically significant differences between the groups （P＜0.01）. After treatment， the frequency of diarrhea and CTCAE grade decreased in both groups， with improved stool characteristics， increased overall health score， and decreased DAO， D-LA and ET levels； in the treatment group， the frequency of diarrhea， the TCM symptom scores in terms of stool characteristics， fear of cold and cold limbs， fatigue， numbness， nausea and vomiting， abdominal distension and abdominal pain were reduced， while the physical function score increased； in the control group， the frequency of diarrhea， stool characteristics and abdominal pain score decreased （P＜0.05 or P＜0.01）. The results favored the treatment group than the control group in all the outcomes except for the nausea and vomiting score， abdominal pain score， overall health score， physical function score， and ET level （P＜0.05 or P＜0.01）. During the treatment， one case of gastrointestinal infection and one case of constipation occurred in the treatment group， while one case of tumor progression in the control group. ConclusionZPF can effectively improve the clinical symptoms， increase quality of life， decrease serum DAO， D-LA and ET levels， and is safe when treating malignant tumor targeted drug-related diarrhea with spleen-stomach weakness syndrome. The possible mechanism may be related to the repair of intestinal mucosa barrier function.
RESUMO
ObjectiveTo investigate the clinical efficacy of Zisheng pills in the treatment of adverse reactions in patients with primary hepatocellular carcinoma (HCC) after transcatheter arterial chemoembolization (TACE). MethodsThis study included 72 patients with liver cancer hospitalized in the Department of Liver Diseases and Department of Oncology, Wenzhou Hospital of Traditional Chinese Medicine, from June 2011 to May 2014. These cases were randomly divided into treatment group (n=37) and control group (n=35). All the patients were treated with TACE, as well as conventional symptomatic and supportive treatment. In addition, the treatment group was given Zisheng pills (one bag) three times a day for at least three consecutive months. Comparison of categorical data was made by chi-square test, while comparison of continuous data (expressed as mean±SD) was made by t test. Survival comparison was made by Kaplan-Meier method and log-rank test. ResultsAfter the first TACE, there were significant differences in poor appetite and abdominal distension between the treatment group and the control group (P＜0.05); significant differences were also observed in CD3+ and CD4+ T lymphocytes between the two groups (P＜0.05). After the second TACE, there were significant differences in postoperative fatigue, poor appetite, and abdominal distension, as well as postoperative Karnofsky score, between the treatment group and the control group (P＜0.05); significant differences were also found in CD3+, CD4+, and CD8+ T lymphocytes and CD4+/CD8+ ratio between the two groups (P＜0.05). The median survival time showed no significant differences between the treatment group and the control group (82 vs 74 weeks, P＞0.05), but the 2-year overall survival rate was significantly higher in the treatment group than in the control group (43.2% vs 20%, P＜0.05). ConclusionZisheng pills have good clinical efficacy in the treatment of adverse reactions in liver cancer patients after TACE, and it can improve the symptoms and quality of life, regulate peripheral blood T lymphocyte subsets, and increase the 2-year overall survival rate.