Background: Chemotherapy has become the main means to prolong the life of patients with advanced digestive tract cancer; however, it is associated with serious toxicity and side effects. Compound Ku Shen Injection is a pure Chinese herbal preparation, which can assist chemotherapy, inhibit tumor cell proliferation, and reduce adverse reactions of chemotherapy. In this study, we systematically evaluated reports of Ku Shen injection as an adjuvant to chemotherapeutic treatment of digestive tract cancer in recent years and provided evidence for clinical diagnosis and treatment.
Methods: The databases of PubMed, Chinese Biomedical Literature (CBM), China National Knowledge Infrastructure (CNKI) and Web Of Science were searched for clinical randomized controlled trials (RCTs) related to adjuvant chemotherapy with Ku Shen injection in the treatment of advanced gastrointestinal tumors published from January 2000 to September 2021. After screening the qualified literatures, RevMan 5.4 software was used to evaluate the bias of the included literatures and perform meta-analysis.
Results: A total of 12 articles were included in the selection, incorporating 1080 study participants in all; meta-analysis results showed that application of the Ku Shen injection in the process of chemotherapy for digestive tract tumors could improve the efficacy [odds ratio (OR) =3.11; 95% confidence interval (CI): 2.26 to 4.47, Z=7.00, P<0.00001], increase the patients’ median survival time (months) (OR =3.00; 95% CI: 1.47 to 4.52, Z=3.84, P=0.0001), increase the level of CD3+ [mean difference (MD) =4.11; 95% CI: 3.24 to 4.98], CD4+ level (MD =8.24; 95% CI: 3.72 to 12.76), reduce the CD8+ level (MD =-5.42; 95% CI: -8.09 to -2.76), reduce the tumor markers carcinoembryonic antigen (CEA; MD =-14.26; 95% CI: -14.81 to -13.71), CA199 (MD =-138.87; 95% CI: -143.21 to -132.52), and reduce the adverse reactions of chemotherapy: leukopenia (OR =0.28; 95% CI: 0.19 to 0.43), thrombocytopenia (OR =0.38; 95% CI: 0.24 to 061), decreased hemoglobin (OR =0.55; 95% CI: 0.31 to 0.98), and nausea and vomiting symptoms (OR =0.35; 95% CI: 0.24 to 0.53).
Discussion: Adjuvant chemotherapy with Ku Shen injection in the treatment of digestive tract tumors can effectively improve the symptoms of patients, improve immunity, reduce the level of serum tumor markers, improve efficacy, and reduce toxic and side effects.