Clinical Efficacy of Didangtang Combined with Gemcitabine in Postoperative Patients with Non-muscle-invasive Bladder Cancer / 中国实验方剂学杂志

Objective:To observe the clinical efficacy of Didangtang combined with gemcitabine chemotherapy in postoperative patients with non-muscle invasive bladder ctraditional chinese medicineancer （NMIBC）. Method:A total of 100 patients with NMIBC in Jiangsu Provincial Second Chinese Medicine Hospital and Jiangsu Province Hospital of Chinese Medicine from January 2015 to September 2020 were randomly divided into control group and treatment group. 50 cases in the treatment group received Didangtang combined with intravesical infusion of gemcitabine， and 50 cases in the control group received placebo combined with intravesical infusion of gemcitabine. Before and after the treatment cycle， the blood biochemistry， immune cell subsets（CD3⁺，CD4⁺ and CD4⁺/CD8⁺） were detected to assess the safety and immune function changes in treatment group. Quality of life scale for patients with bladder cancer prepared by European Organization for the Research and Treatment of Cancer （EORTC QLQ-C30） and Specificity scale for patients with superficial bladder cancer （EORTC QLQ-BLS24） were scored to assess the changes in physical， role， emotional and social functioning of the patients， symptomatic conditions such as fatigue， pain， nausea and vomiting， shortness of breath， insomnia， loss of appetite， diarrhea and constipation， as well as bladder cancer-specific symptoms such as treatment-generated problems， future concerns， bowel symptoms and urinary tract symptoms. Result:There were no differences in terms of age， sex， disease duration and tumor states. During the treatment period， both groups had no recurrence or adverse events. The traditional Chinese medicine（TCM） efficacy in the treatment group was significantly better than that in the control group（<italic>χ²</italic>= 7.23，<italic>P </italic>= 0.02）. After treatment， the number of CD3⁺，CD4⁺ ，CD8⁺ cells and the CD4⁺/CD8⁺ ratio in the treatment group were significantly higher than those in control group（<italic>P</italic><0.05）. Both groups showed significant improvements in the domains of role functioning， social functioning， and general health after treatment （<italic>P</italic><0.05）. In addition， fatigue， diarrhea， constipation， intestinal symptoms， and urinary tract symptoms in the treatment group were significantly better than those in the control group after treatment （<italic>P</italic><0.05）. Conclusion:Didangtang can reduce adverse clinical symptoms during postoperative gemcitabine infusion chemotherapy in patients with NMIBC， reduce urethral and intestinal discomfort reactions， improve immune function and enhance quality of life for patients.