参一胶囊联合洛铂和吉西他滨治疗复发性卵巢癌的临床研究

目的探讨采用参一胶囊联合洛铂和吉西他滨治疗复发性卵巢癌患者的有效性和安全性。方法选取安徽医科大学附属巢湖医院2013年1月—2014年1月收治的复发性卵巢癌患者150例,随机分成对照组和治疗组,每组各75例。对照组患者在第1、8天分别静脉滴注注射用盐酸吉西他滨,1 g/m~2加入生理盐水500 m L,第2天静脉滴注注射用洛铂,50 mg/m~2加入生理盐水250 m L。治疗组患者在对照组基础上饭前口服参一胶囊,2粒/次,2次/d。21 d为1个疗程,两组患者连续治疗2个疗程。评价两组患者近期和远期疗效,同时比较治疗前后两组患者生活质量(QOL)评分、CA125血清水平和不良反应情况。结果治疗后,对照组客观缓解率和疾病控制率分别为44.00%和69.33%,均分别显著低于治疗组的68.00%和89.33%,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者QOL评分显著升高(P0.05),CA125血清水平显著降低(P0.05);且治疗组患者的QOL评分和CA125血清水平改善更明显(P0.05)。治疗后2个月随访结果表明,治疗组患者疾病进展时间、总生存期和1年生存率均显著优于对照组患者(P0.05)。治疗期间,治疗组患者在白细胞下降,血小板下降及肝肾功能损伤等不良反应方面要显著低于对照组患者,两组比较差异具有统计学意义(P0.05)。结论参一胶囊联合洛铂和吉西他滨治疗复发性卵巢癌效果明显,安全性高,具有一定的临床推广应用价值。

Clinical study on Shenyi Capsules combined with lobaplatin and gemcitabine in treatment of recurrent ovarian cancer

Objective To investigate the efficacy and safety of Shenyi Capsules combined with lobaplatin and gemcitabine in treatment of recurrent ovarian cancer. Methods Patients (150 cases) with recurrent ovarian cancer in Chaohu Hospital of Anhui Medical University from January 2013 to January 2014 were randomly divided into control and treatment group, and each group had 75 cases. Patients in the control group were iv administered with Gemcitabine Hydrochloride for injection at the first and the eighth day, 1 g/m² added into normal saline 500 mL, and they were iv administered with Lobaplatin for injection at the second day, 50 mg/m² added into normal saline 250 mL. Patients in the treatment group were po administered with Shenyi Capsules on the basis of the control group, 2 grains/time, twice daily. 21 d as one treatment course, patients in two groups were treated for two courses. After treatment, the short-term and long-term efficacies were evaluated, and the QOL score, CA125 serum level and adverse reactions in two groups before and after treatment were compared. Results After treatment, the objective remission rate and disease control rate in the control group were 44.00% and 69.33%, which were significantly lower than 68.00% and 89.33% in the treatment group, respectively, and there were differences between two groups (P<0.05). After treatment, the QOL score in two groups was significantly increased (P<0.05), but CA125 serum level was significantly decreased (P<0.05). And the QOL score and CA125 serum level in the treatment group after treatment were significantly better than that in the control group (P<0.05). The follow-up results of 2 months after treatment showed that the time of disease progression, overall survival and 1 year survival rate in the treatment group after treatment was significantly better than those in the control group (P<0.05). During the treatment, the adverse reactions of leukocyte and platelet decline, liver and kidney function damage in the treatment group were significantly lower than those in the control group, with significant difference between two groups (P<0.05). Conclusion Shenyi Capsules combined with lobaplatin and gemcitabine has significant efficacy in treatment of recurrent ovarian cancer with high safety, which has a certain clinical application value.