复方苦参注射液治疗轻中度癌性疼痛的临床研究

Fufang Kushen Injection in treatment of mild or moderate cancer pain

目的探讨复方苦参注射液治疗轻中度癌性疼痛的疗效和不良反应。方法采用随机对照方法,将50例轻度的癌痛患者分为治疗组和意施丁(Indometacin)组;将54例中度癌痛患者分为治疗组和奇曼丁(Hydrochloride)组。分别给予相应药物,复方苦参注射液12～15 mL加入250 mL生理盐水静脉滴注,每日1次,连用10 d;意施丁每次25 mg,2次/d,进食后整片吞服,连用10 d;奇曼丁每次100 mg,2次/d,连用10 d。观察两组的镇痛效果,药物的起效时间、最佳缓解时间和持续时间,以及不良反应。结果复方苦参注射液对于轻度癌性疼痛的总有效率为84.6%,与意施丁组比较,无统计学差异(P>0.05);复方苦参注射液在疼痛缓解率方面差于意施丁,在微效率方面优于意施丁(P<0.05);复方苦参注射液对于中度癌性疼痛的总有效率为75.0%,与奇曼丁组比较,无统计学差异(P>0.05)。复方苦参注射液在疼痛缓解率方面差于奇曼丁,在微效率方面则优于奇曼丁(P<0.05)。复方苦参注射液的中位起效时间、最佳缓解时间以及持续时间分别为3、3、4d,不良反应轻微。结论复方苦参注射液对于轻度和中度的癌性疼痛具有较好的疗效,但在疼痛缓解率方面不及对应的西药,在微效率方面则优于对应的西药。复方苦参注射液的止痛起效时间缓慢,但是止痛的缓解时间长,并且不良反应轻微。

Objective To probe into the curative effect and adverse actions of Fufang Kushen Injection in the treatment of mild or moderate cancer pain. Methods With randomized and controlled method, the patients with mild cancer pain （n = 50） were divided into treatment group and Indocontin group, and patients with moderate cancer pain （n = 54）, into treatment group and Tramadol Hydrochloride group. All groups were given relevant medications. Fufang Kushen Injection （ 12 mL-15 mL） was added into 250 mL normal saline solution for intravenous drip once a day for 10 days. Indocontin （25 mg each time） was administrated after eating two times a day for 10 days. Tramadol Hydrochloride （ 100 mg each time） was administrated two times a day for 10 days. The analgesic effect, and initial time, best pain relief time, duration and adverse actions of medications were observed in two groups. Results The total effective rate on mild cancer pain was 84.6% in treatment group and it was not statistically different compared with Indocontin group （P 〉 0.05 ）. The pain rehef rate was lower but micro efficiency was higher in treatment group than those in Indocontin group （P 〈 0.05 ）. The total effective rate on moderate cancer pain was 75.0% in treatment group and it was not statistically different compared with Tramadol Hydrochloride group （ P 〉 0.05 ）. The pain relief rate was lower but micro efficiency was higher in treatment group than those in Tramadol Hydrochloride group （ P 〈 0.05 ）. The initial time, best remission duration and relieving pain duration of Fufang Kushen Injection were respectively 3 days, 3 days and 4 days, while relevant Western medications were respectively 1 hour, 2 hours and 6 hours. Fufang Kushen Injection had slight adverse actions. Conclusion Fufang Kushen Injection has a good curative effect on mild and moderate cancer pain. In pain relieve rate it is not as good as relevant Western medications but better in micro efficiency. Its initial time of analgesic effect is slow, but the duration is long and adverse actions are slight.