目的 探討采用參一膠囊聯(lián)合洛鉑和吉西他濱治療復(fù)發(fā)性卵巢癌患者的有效性和安全性。方法 選取安徽醫(yī)科大學(xué)附屬巢湖醫(yī)院2013年1月-2014年1月收治的復(fù)發(fā)性卵巢癌患者150例，隨機(jī)分成對(duì)照組和治療組，每組各75例。對(duì)照組患者在第1、8天分別靜脈滴注注射用鹽酸吉西他濱，1 g/m²加入生理鹽水500 mL，第2天靜脈滴注注射用洛鉑，50 mg/m²加入生理鹽水250 mL。治療組患者在對(duì)照組基礎(chǔ)上飯前口服參一膠囊，2粒/次，2次/d。21 d為1個(gè)療程，兩組患者連續(xù)治療2個(gè)療程。評(píng)價(jià)兩組患者近期和遠(yuǎn)期療效，同時(shí)比較治療前后兩組患者生活質(zhì)量（QOL）評(píng)分、CA125血清水平和不良反應(yīng)情況。結(jié)果 治療后，對(duì)照組客觀緩解率和疾病控制率分別為44.00%和69.33%，均分別顯著低于治療組的68.00%和89.33%，兩組比較差異具有統(tǒng)計(jì)學(xué)意義（P<0.05）。治療后，兩組患者QOL評(píng)分顯著升高（P<0.05），CA125血清水平顯著降低（P<0.05）；且治療組患者的QOL評(píng)分和CA125血清水平改善更明顯（P<0.05）。治療后2個(gè)月隨訪結(jié)果表明，治療組患者疾病進(jìn)展時(shí)間、總生存期和1年生存率均顯著優(yōu)于對(duì)照組患者（P<0.05）。治療期間，治療組患者在白細(xì)胞下降，血小板下降及肝腎功能損傷等不良反應(yīng)方面要顯著低于對(duì)照組患者，兩組比較差異具有統(tǒng)計(jì)學(xué)意義（P<0.05）。結(jié)論 參一膠囊聯(lián)合洛鉑和吉西他濱治療復(fù)發(fā)性卵巢癌效果明顯，安全性高，具有一定的臨床推廣應(yīng)用價(jià)值。

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.