氨酚曲马多片治疗中重度骨科门急诊急性疼痛的疗效及安全性临床研究

Efficacy and safety of Paracetamol tramadol in the treatment of moderate to severe acute pain in out-patient and emergency of orthopedic

目的观察氨酚曲马多片治疗骨科门急诊常见急性疼痛的疗效和安全性。方法在全国23家医院开放性临床试验，对正在经历中至重度急性疼痛的骨科门急诊患者，给予氨酚曲马多片1片治疗，观察8h，在0．5、1、2、4、6、8h分别评价疼痛缓解度及疼痛强度。结果本次研究共纳入病例3325例，平均年龄（39．53±14．67）岁（7．00～89．00岁），患者就诊时疼痛平均评分（7．28±1．37）分（5～10．00分），8h后评分（2．21±1．83）分（0～10．00分）。在用药后1h、8h分别有77．48％、88．39％患者的疼痛缓解程度在中等程度以上。高达83．88％的患者和85．41％的医生的的整体满意度为“满意”或“非常满意”。有6．05％的患者发生一般不良事件。结论氨酚曲马多融合了对乙酰氨基酚和曲马多的优点，起效快，作用时间长，耐受性好，医患满意度高，是骨科急性疼痛临床治疗的理想选择。

Objective To observe the efficacy and safety of Paracetamoland Tramadol Hydrochloride Tablets in patients with moderate or severe acute pain in out - patient and emergency of orthopedics. Methods The present study was an open clinical trial at 23 hospitals in China. All patients who were experiencing moderate or severe acute pain in orthopedics were received Paracetamoland Tramadol Hydrochloride tablets （ 1 tablet） for treatment. The pain relief and pain intensity were evaluated 0.5, 1,2, 4, 6 and 8h after treatment respectively. Results Of 3325 patients who were enrolled into the study, average age was 39. 53：1： 14. 67 years （ range 7 - 89 years）. Average PPS was （ 7.28±1.37 ） （ range 5 - 10. 00 ） when the patients were diagnosed. After 8 hour treatment, average PPS was （2.21±1.83） （ range 0 - 10. 00）. After 1 hour treatment and 8 hour with Paraeetamoland Tramadol Hydrochloride tablets, pain relief scores was relieved of 77.48% and 88. 39% respectively. Overall satisfaction rate was 83. 88% in patients and 85.41% in doctors. In all patients, the incidence of adverse events （AEs） was 6.05%. Most of adverse events were typically mild to moderate and were manageable with routine support . Conclusion Conclusions In this study, Paracetamoland Tramadol Hydrochloride tablets possess of the advantages of paracetamol and Tramadol hydrochloride ,with significant improvement in pain relief and a significant reduction in pain intensity. Patients and doctors get satisfaction from the drug. The drug is well tolerate and longer faction, and use of the drug may be considered a good choice in subjects with acute pain in orthopaedics.