The effectiveness and safety of intra-articular injection of actovegin in osteoarthritis of the knee : a phase two clinical trial / Somsak Kuptniratsaikul = ประสิทธิผลและความปลอดภัยของยาฉีด Actovegin เข้าข้อเข่าในการรักษาผู้ป่วยข้อเข่าเสื่อม : การศึกษาทางคลินิกระยะที่ 2 / สมศักดิ์ คุปต์นิรัติศัยกุล
Background: Actovegin is a protein-free hemodialysate derived from calf blood and product essentially by ultra filtration. Clinical use and outcomes of the treatment of Actovegin for osteoarthritis was reported in a recent study which was a case series of intra-articular injection. It did not show any side effects due to small sample size. Objective: To study the effectiveness and side effect of intr-articular injection of Actovegin for the treatment of knee osteoarthritis. Study design: Comparative study design (before and after design). Materials and Methods; Forty-four patients with knee OA failed to conservative treatment were recruited into the study receiving Actovegin for 2 consecutive weeks. Outcome measured: The visual analog scale (VAS) pain, the duration for pain to resolve, global assessment and patient's satisfaction of effect, adverse effects and joint effusion assessment were employed as measurement of the outcomes. Results: There were statistically significant difference between before and after in all dimensions of VAS pain except pain at rest. These results corresponded to the patient's satisfaction and patient's global assessment. There were no statistically significant difference of the patient's satisfaction and patient's global assessment between week 1 and week 2. It might indicate the effect of Actovegin injection could be detected since the first week. These results corresponded to the duration to pain resolve (mean 6.3 days). There were no difference of the knee circumference before and after injection. Although the adverse effects of this present study ranged from 7.5 9.4%, those were minor such as effusion, inflammation or persistent pain. Conclusion: The present study revealed positive results of intra-articular injection of Actovegin. Further study in other perspective such as randomized control trial, cost effectiveness and details of economic study should be performed.
