定期随访对出院患者应用华法林抗凝治疗效果与安全性的影响

The influence of regular follow-up on efficacy and safety of anticoagulant therapy with warfarin used in patients discharged from hospital

目的:探讨定期随访对出院患者华法林抗凝治疗效果和安全性的影响。方法:研究对象为2009年1月至2010年1月在解放军总医院心血管中心住院期间应用华法林抗凝治疗未达到稳定剂量、出院3个月内仍需持续服用该药的患者。按随机数字表法将患者分为随访组和对照组。随访调查采用电话访问,对随访组患者每周访问1次,对照组患者仅在出院后3个月时访问1次。主要了解患者华法林剂量调整、国际标准化比值(INR)监测、合并用药、饮食情况以及出血或血栓等不良反应发生情况;另外,根据随访结果敦促患者定期测定INR和调节华法林剂量。结果:总共200例患者纳入本研究并分为2组,每组100例患者。随访组男62例,女38例,平均年龄(57.0±16.2)岁;对照组男47例,女53例,平均年龄(59.6±13.4)岁。出院后3个月内,随访组坚持服用华法林并达到稳定剂量者比例高于对照组(75%比53%,P=0.00);随访组失访和非医源性停药者比例低于对照组(11%比22%,6%比15%,均P=0.04);随访组未监测INR者比例与对照组相近(8%比10%,P=0.62)。随访组患者出院至达稳定剂量所需时间短于对照组[(38.7±19.0)d比(54.5±45.6)d,P=0.03];随访组INR>3但<4和INR≥4者比例[分别为14.7%(11/75)和10.7%(8/75)]均少于对照组[分别为30.2%(16/53)和24.6%(13/53)],差异有统计学意义(均P=0.04);随访组发生出血事件者比例低于对照组[4.0%(3/75)比11.3%(6/53)],但差异无统计学意义(P=0.21)。随访期间,2组患者均未出现血栓性事件。结论:定期随访可提高出院患者华法林抗凝治疗依从性和疗效,并可能有助于减少出血等不良反应的发生。

Objective：To explore the influence of regular follow-up on efficacy and safety of anticoagulant therapy with warfarin used in patients discharged from hospital.Methods：From January 2009 to January 2010,the patients,who received warfarin therapy for anticoagulation during hospitalization in Center of Cardiology of Chinese PLA General Hospital but did not reach a stable dose and should continue to receive warfarin therapy for 3 months after discharge,were enrolled in this study.The patients were divided into the follow-up group and the control group by random-digit table method.All the patients were followed-up with telephone interviews.The patients in the follow-up and control groups were followed-up once a week and only once 3 months after discharge,respectively.In telephone interview,the patients were asked about warfarin dosage adjustment,international normalized ratio（INR）value monitoring,combination therapy,dietary habits,and the adverse reactions,such as haemorrhage or thrombosis.In addition,the patients were demanded to regularly determine INR and adjust the warfarin dosage according to the follow-up results.Results：A total of 200 patients entered this study.They were divided into two groups and each group consisted of 100 patients.The follow-up group comprised 62 male and 38 female with average age of（57.0±16.2）years.The control group comprised 47 male and 53 female with average age of（59.6±13.4）years.The proportion of patients who continued to receive warfarin and reached a stable dose within 3 months of discharge was significantly higher in the follow-up group than in the control group（75% vs 53%,P=0.00）.The proportion of patients who were loss to follow-up and discontinued warfarin therapy due to non-iatrogenic disease was significantly lower in the follow-up group than in the control group（11% vs 22%,6% vs 15%,all P=0.04）.The proportion of patients who did not received regular monitoring of INR values in the follow-up group was similar to that found in the control group（8% vs 10%,P=0.62）.The time from discharge to reach a stable dose was shorter in the fellow-up group than in the control group [（38.7±19.0）d vs（54.5 ± 45.6）d,P=0.03].The proportion of patients with INR3 but 4 and INR≥ 4 was significantly lower in the follow-up group [14.7%（11/75）] and 10.7%（8/75）,respectively] than in the control group [30.2%（16/53）and 24.6%（13/53）,respectively].The difference was significant（P= 0.04）.The proportion of hemorrhage events was lower in the follow-up group [4.0%（3/75）] than in the control group [11.3%（6/53）],but there was no significant difference（P=0.21）.No thrombosis event was observed in both groups during follow-up.Conclusion：Regular follow-up can enhance the compliance and efficacy of warfarin therapy and might decrease the occurrence of hemorrhage events in patients discharged from hospital.