Javid M J, Nordby E J, Ford L T, Hejna W J, Whisler W W, Burton C, Millett D K, Wiltse L L, Widell E H, Boyd R J, Newton S E, Thisted R
JAMA. 1983 May 13;249(18):2489-94.
A double-blind, randomized trial was conducted to compare the efficacy of intradiskal injection of chymopapain (Chymodiactin) with injection of placebo in patients with a herniated lumbar disk. Patients were randomly assigned to either placebo or drug regimens and followed up for six months. The primary measure of performance was agreement by patient and surgeon that further intervention was not necessary. At any time that patient and investigator agreed that treatment had failed, the patient was classified as a failure and the treatment code was broken. Of 53 placebo-treated patients, 31 failed by this criterion. Of 55 drug-treated patients, 15 failed. Placebo-treated patients who failed were allowed to receive drug treatment, and 29 (91%) of 32 were treated successfully. This study demonstrates that chymopapain is more effective than placebo for treatment of patients with a herniated lumbar disk.
进行了一项双盲随机试验,以比较椎间盘内注射木瓜凝乳蛋白酶(Chymodiactin)与注射安慰剂对腰椎间盘突出症患者的疗效。患者被随机分配到安慰剂组或药物治疗组,并随访六个月。主要疗效指标是患者和外科医生一致认为无需进一步干预。在患者和研究者一致认为治疗失败的任何时候,该患者被判定为治疗失败,治疗编码即被破解。在53例接受安慰剂治疗的患者中,有31例按此标准治疗失败。在55例接受药物治疗的患者中,有15例治疗失败。治疗失败的接受安慰剂治疗的患者被允许接受药物治疗,32例中有29例(91%)治疗成功。这项研究表明,木瓜凝乳蛋白酶治疗腰椎间盘突出症患者比安慰剂更有效。