Objective

2

To 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.

Methods

2

This 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.

Results

2

There 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.

Conclusion

2

ZPF 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.