前列地尔干乳剂联合低分子肝素注射液和地塞米松注射液治疗血栓闭塞性脉管炎患者的临床研究

Clinical trial of alprostadil dried emulsion combined with low molecular weight heparin injection and dexamethasone injection in the treatment of patients with thromboangiitis obliterans

目的观察前列地尔干乳剂联合低分子肝素注射液和地塞米松注射液治疗血栓闭塞性脉管炎(TAO)的临床疗效及安全性。方法将120例TAO患者分为对照组和试验组,每组60例。对照组给予38 U·kg^(-1)低分子肝素,qd,皮下注射+地塞米松每次10 mg,qd,静脉滴注;试验组在对照组治疗的基础上,给予前列地尔干乳剂每次10μg,qd,静脉滴注。2组患者均连续治疗14 d。比较2组患者的临床疗效,血浆纤维蛋白原(FIB),以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为98.28%(57例/58例)和85.96%(49例/57例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的FIB分别为(2.84±0.59)和(3.21±0.67)g·L^(-1),差异有统计学意义(P<0.05)。试验组发生的药物不良反应以牙龈出血为主,对照组发生的药物不良反应以牙龈出血和鼻出血为主。试验组和对照组的总药物不良反应发生率分别为3.45%和7.02%,差异无统计学意义(P>0.05)。结论前列地尔干乳剂联合低分子肝素注射液和地塞米松注射液治疗TAO的临床疗效较好,其能显著降低患者的FIB水平,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of alprostadil dry emulsion combined with low molecular weight heparin injection and dexamethasone injection in the treatment of thromboangiitis obliterans(TAO).Methods A total of 120 TAO patients were divided into control and treatment groups with 60 cases per group.The control group was given 38 U·kg^(-1)low molecular weight heparin,qd,subcutaneous injection+dexamethasone 10 mg per time,qd,intravenous drip.On the basis of control group,the treatment group was given alprostadil dry emulsion 10μg per time,qd,intravenous drip.Two groups were treated for 14 days.The clinical efficacy,plasma fibrinogen(FIB)and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 98.28%(57 cases/58 cases)and 85.96%(49 cases/57 cases)with significant difference(P<0.05).After treatment,the FIB of treatment and control groups were(2.84±0.59)and(3.21±0.67)g·L^(-1),and the difference was statistically significant(P<0.05).The adverse drug reactions of treatment group were gum bleeding,which in the control group were gum bleeding and epistaxis.The total incidences of adverse drug reactions in the treatment and control groups were 3.45%and 7.02%without significant difference(P>0.05).Conclusion Alprostadil dry emulsion combined with low molecular weight heparin injection and dexamethasone injection has a definite clinical efficacy in the treatment of TAO,which can significantly reduce the patient’s FIB level,without increasing the incidence of adverse drug reactions.