Objective To investigate the clinical effects of Kangai-Guben-Xiaozheng decoction based on pathogenesis theory of cancerous toxin combined with TP scheme in the treatment of advanced ovarian carcinoma in elderly patients. Methods A total of 218 elderly patients with advanced ovarian carcinoma in our hospital were randomly divided into the observation and control group, 109 in each group. The control group was treated by TP scheme, while the observation group was treated by Kangai-Guben-Xiaozheng decoction based on pathogenesis theory of cancerous toxin combined with TP scheme. Both groups received 1 chemotherapy cycle at 3 weeks, and a total of 4 cycles of chemotherapy were followed up for 2 years. Quality of life was assessed by Functional Assessment of Cancer Therapy- ovarian Cancer v4.0 (FACT-OV4). Enzyme-linked immunosorbent assay (ELISA) was used to detect tumor markers, including Integrin-Linked Kinase (ILK), Hypoxic Inducible Factor-α (HIF-α), Human Epididymal Protein (HE4) and Epithelial-type calcium mucin (E-cadherin). The toxic and side effects of two groups were observed and the clinical efficacy was evaluated. The survival rate, total survival time and disease-free survival time were observed and recorded during follow-up. Results The control rate and effective rate of the observation group were 90.8% (99/109) and 41.3% (45/109), respectively, and those of the control group were 64.2% (70/109) and 28.4% (31/109), respectively. The comparison of control rate and effective rate between the two groups were statistically significant (Z value were 4.002, 3.401, respectively, all Ps<0.05). After treatment, the ILK (12.31 ± 1.15 ng/L vs. 23.57 ± 2.32 ng/L, t=3.245), HIF-α (2.41 ± 0.22 mg/L vs. 6.67 ± 0.67 mg/L, t=3.596), HE4 (0.34 ± 0.03 pg/L vs. 1.24 ± 0.12 pg/L, t=3.621) levels in the observation group are significantly lower than those in the control group (P<0.05), while the E-cadherin (5.25 ± 0.56 ng/L vs. 2.52 ± 0.26 ng/L, t=3.434) was significantly higher than that in the control group (P<0.05). After treatment, the scores of functional status and social/family status in the observation group were significantly higher than those in the control group (t values were 3.282, 3.214, all Ps<0.05), and the scores of additional attention, emotional status and physiological status were significantly lower than those in the control group (t values were 3.121, 3.512, 3.526, all Ps<0.05). During the treatment period, the incidence of cardiac toxicity, liver toxicity, renal toxicity, bone marrow suppression, nausea and vomiting, abdominal pain and diarrhea in the observation group were significantly lower than those in the control group (χ2 value were 4.947, 4.893, 4.525, 4.692, 4.637, 4.905, respectively, all Ps<0.05). During the follow-up, the 1, 2 year survival rate in the observation group was higher than those in the control group (χ2 value were 3.782, 3.893, respectively, all Ps<0.05). Conclusions The Kangai-Guben-Xiaozheng decoction based on the theory of cancer pathogenesis, combined with TP regimen show effectiveness for the Ⅳ stage of ovarian cancer of the elderly patients. Key words: Ovarian neoplasms; Aged; Antineoplastic combined chemotherapy protocols; Kangai-Guben-Xiaozheng decoction; Disease-free survival; Survivorship
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