藤黄健骨片联合骨肽注射液治疗腰椎骨质增生症临床研究

Clinical study on the treatment of lumbar hyperosteogenywith Tenghuang-Jiangu tablet and osteopeptide injection

目的 评价藤黄健骨片联合骨肽注射液治疗腰椎骨质增生症的疗效.方法 将符合入选标准的106例腰椎骨质增生症患者采用随机数字表法分为2组,每组53例.对照组给予骨肽注射液治疗,研究组在对照组基础上口服藤黄健骨片.2组均治疗45 d.分别于治疗前后从疼痛、麻木、肿胀、屈展方面进行中医症状评分,采用 ELISA 法检测血清血栓素 B2(thromboxane B2, TXB2)、6-酮前列腺素 Flα (6-ketone prostaglandin Flα, 6-Keto-PGFlα)水平,记录不良反应,评价临床疗效.结果 研究组总有效率为86.8%(46/53)、对照组为64.2%(34/53),2组比较差异有统计学意义(χ2=7.338,P=0.007).治疗后,研究组血清TXB2[(128.01±23.68)pg/ml比(172.26±19.33)pg/ml,t=10.539]水平低于对照组(P<0.01);6-Keto-PGFlα[(36.84±4.96)pg/ml 比(25.44±4.21)pg/ml,t=12.757]水平高于对照组(P<0.01).研究组治疗后疼痛、麻木、肿胀、屈展评分均低于对照组(t值分别为10.061、11.449、14.921、15.527,P值均<0.01).治疗期间,对照组不良反应发生率为17.0%(9/53)、研究组为22.6%(12/53),2组比较差异无统计学意义(χ2=0.534,P=0.465).结论 藤黄健骨片联合骨肽注射液可改善腰椎骨质增生症患者的临床症状,调节血清TXB2、6-Keto-PGFlα水平,提高临床疗效.

Objective To evaluate the efficacy of Tenghuang-Jiangu tablet combined with osteopeptide injection in the treatment of lumbar hyperosteogeny. Methods A total of 106 patients with lumbar hyperosteogeny were randomly divided into two groups, 53 in each group by digital table method. The control group was treated with osteopeptide injection, and the study group was treated with Tenghuang-Jiangu tablet on the basis of the control group. Both groups were treated for 45 days. The traditional Chinese medcine (TCM) symptoms were scored from pain, numbness, swelling, flexion and extension before and after treatment. The levels of thromboxane B2 (TXB2) and 6-ketone prostaglandin Flα ( 6-Keto-PGFlα ) in serum were detected by ELISA. Adverse reactions during treatment were recorded. Results The total effective rate was 86.8% (46/53) in the study group and 64.2% (34/53) in the control group. There were significant differences between the two groups (χ2=7.338, P=0.007). After treatment, the serum TXB2 (128.01 ± 23.68 pg/ml vs. 172.26 ± 19.33 pg/ml, t=10.539) level in the study group was significantly lower than control group (P<0.01);the serum 6-Keto-PGFlα (36.84 ± 4.96 pg/ml vs. 25.44 ± 4.21 pg/ml, t=12.757) level was significantly higher than control group (P<0.01). After treatment, the scores of pain, numbness, swelling, flexion and extension in the study group were significantly lower than those in the control group (t=10.061, 11.449, 14.921, 15.527, P<0.01). During the treatment period, the incidence of adverse reactions was 17.0% (9/53) in the control group and 22.6% (12/53) in the study group. There was no significant difference between the two groups (χ2=0.534, P=0.465). Conclusions The Tenghuang-Jiangu tablet combined with osteopeptide injection can improve the clinical symptoms of patients with lumbar hyperosteogeny, and regulate the serum levels of TXB2 and 6-Keto-PGFlα.