Romics Imre, Siller György, Kohnen Ralf, Mavrogenis Stelios, Varga József, Holman Endre
Department of Urology, Semmelweis University, Budapest, Hungary.
Urol Int. 2011;86(1):102-9. doi: 10.1159/000320999. Epub 2010 Dec 7.
To investigate the safety and efficacy of a special terpene combination in the treatment of patients with urolithiasis after extracorporeal shockwave lithotripsy (ESWL).
222 patients with clinically stable kidney or ureter stones of 0.3-2.0 cm undergoing complication-free ESWL were randomised to receive a special terpene combination (Rowatinex®; 3 × 2 capsules/day) or placebo. The study consisted of a 12-week active treatment phase and a 2-week follow-up phase. All patients had a physical examination, and diagnosis of kidney stones was made by X-ray, intravenous pyelogram or ultrasound at weeks 1, 4, 8 and 12 as well as after 2 weeks of follow-up. Stone-free status was defined as obviously successful expulsion of calculi/fragments, being without any stone.
In all, when compared to placebo, significantly more patients receiving the terpene combination treatment in the intent-to-treat (ITT) group [72 (67.9%) vs. 49 (50.0%); p = 0.0009] and the per-protocol (PP) group [69 (78.4%) vs. 48 (52.2%); p = 0.0004] were stone-free at the end of the study. Treatment with the terpene combination was also more effective when analysed with respect to the size of the treated stone. In addition, treatment with the terpene combination significantly reduced the median time to stone-free status from 85.0 to 56.0 days (p = 0.0061) and from 85.0 to 49.5 days (p = 0.0028) in the ITT and PP populations, respectively. Nine mild-to-moderate adverse events (AE; terpene combination group: 7 AE in 4 patients; placebo group: 2 AE in 2 patients) were assessed as drug-related.
Treatment with the terpene combination is well tolerated and safe. The terpene combination was found to be an efficacious treatment in eliminating calculi fragments generated by ESWL as compared to placebo. The pharmacodynamic properties of the terpene combination (antilithogenic, antibacterial, antiinflammatory, spasmolytic and analgesic effects), which have been also confirmed in preclinical studies, represent a valuable alternative to the different drugs used in the treatment of urolithiasis.
探讨一种特殊萜烯组合在体外冲击波碎石术（ESWL）后治疗尿石症患者中的安全性和有效性。
222例临床症状稳定、肾结石或输尿管结石大小为0.3 - 2.0 cm且ESWL术后无并发症的患者被随机分为两组，分别接受一种特殊萜烯组合（消石素®；每日3次，每次2粒胶囊）或安慰剂治疗。该研究包括一个为期12周的积极治疗阶段和一个为期2周的随访阶段。所有患者均接受体格检查，并在第1、4、8和12周以及随访2周后通过X线、静脉肾盂造影或超声检查来诊断肾结石。结石清除状态定义为结石/碎片明显成功排出，即无任何结石残留。
总体而言，在意向性治疗（ITT）组中，与安慰剂组相比，接受萜烯组合治疗的患者在研究结束时结石清除的比例显著更高[72例（67.9%） vs. 49例（50.0%）；p = 0.0009]；在符合方案（PP）组中也是如此[69例（78.4%） vs. 48例（52.2%）；p = 0.0004]。从所治疗结石的大小分析，萜烯组合治疗也更有效。此外，在ITT人群和PP人群中，萜烯组合治疗分别显著缩短了达到结石清除状态的中位时间，从85.0天降至56.0天（p = 0.0061）和从85.0天降至49.5天（p = 0.0028）。评估有9例轻度至中度不良事件（AE；萜烯组合组：4例患者出现7例AE；安慰剂组：2例患者出现2例AE）与药物相关。
萜烯组合治疗耐受性良好且安全。与安慰剂相比，发现萜烯组合在消除ESWL产生的结石碎片方面是一种有效的治疗方法。萜烯组合的药效学特性（抗结石形成、抗菌、抗炎、解痉和镇痛作用）在临床前研究中也得到了证实，是治疗尿石症所用不同药物的一种有价值的替代方法。
