重组人血管内皮抑制素联合替吉奥胶囊治疗中晚期原发性肝癌的临床观察

Clinical Observation of S-1 Capsules Combined with Recombinant Human Endostatin in the Treatment of Middle and Advanced Primary Liver Carcinoma

目的:观察重组人血管内皮抑制素联合替吉奥胶囊治疗中晚期原发性肝癌的疗效和安全性。方法:将2012年2月-2014年12月三峡大学第一临床医学院收治的94例中晚期原发性肝癌患者按随机数字表法分为联合组(48例)和对照组(46例),对照组患者每天早晚餐后30 min内口服替吉奥胶囊40~60 mg,bid;联合组患者在对照组基础上给予重组人血管内皮抑制素注射液150 mg加入0.9%氯化钠注射液210 m L中,采用便携式微量泵持续泵注120 h。治疗14 d后间隔7 d为1个周期,两组患者均治疗2个周期后评价近期客观疗效、临床受益反应(CBR)及不良反应,并比较病情进展时间和平均生存期。结果:联合组患者客观有效率为14.6%,疾病控制率为66.7%,疾病进展时间为(5.5±1.3)个月,平均生存期为(10.7±3.8)个月;对照组患者客观有效率为8.7%。疾病控制率为45.6%,疾病进展时间为(4.8±1.2)个月,平均生存期为(8.9±3.3)个月,组间比较差异均有统计学意义(P<0.05)。联合组患者总CBR率(79.2%)显著高于对照组(52.2%),差异有统计学意义(P<0.05)。两组患者不良反应发生率比较,差异无统计学意义(P>0.05)。结论:重组人血管内皮抑制素联合替吉奥治疗中晚期原发性肝癌可获得较好的疗效和耐受性,且不会增加不良反应发生率。

OBJECTIVE:To observe therapeutic efficacy and safety of S-1capsules combined with recombinant human endostatin in the treatment of middle and advanced primary liver carcinoma.METHODS:Totally94patients with middle and advanced primary liver carcinoma in the First College of Clinical Medical Science of China Three Gorges university during Feb.2012-Dec.2014were divided into combination group(48cases)and control group(46cases)according to random number table.Both groups were given S-1capsules40-60mg orally within30min after breakfast and supper.Combination group additionally received Recombinant human endostatin injection150mg added into0.9%Sodium chloride injection210mL with portable micro pump for continuous pump of120h.A course involved14d treatment and7d interval.Short-term objective therapeutic efficacy,clinical benefit response(CBR)and ADR were evaluated after2courses.Disease progression time and average survival period were compared between2groups.RESULTS:Objective response rate,disease control rate,disease progression time and average survival period of combination group were14.6%,66.7%,(5.5±1.3)months,(10.7±3.8)months;those of control group were8.7%,45.6%,(4.8±1.2)months,(8.9±3.3)months,with statistical significance between2groups(P<0.05).CBR rate of combination group(79.2%)was significantly higher than control group(52.2%),with statistical significance(P<0.05).There was no statistical significance in the incidence of ADR between2groups(P>0.05).CONCLUSIONS:S-1combined with recombinant human endostatin show good therapeutic efficacy and tolerance for patients with middle and advanced primary liver carcinoma,and do not increase the incidence of ADR.