Department of Obstetrics and Gynecology, Regional Hospital Heilig Hart, Tienen, Belgium.
J Low Genit Tract Dis. 2012 Oct;16(4):427-36. doi: 10.1097/LGT.0b013e31825a2274.
Is treatment of provoked localized vulvodynia with cutaneous lysate skin cream containing human cytokines effective?
This is a double-blind placebo-controlled randomized crossover trial with a study and a placebo cream applied twice daily for 3 months, 1-week washout, followed by a 3-month crossover medication in 30 patients experiencing provoked localized vulvodynia with visible vulvar erythema. Tolerability of the product, sexual functioning, and clinical findings were the main outcomes. A linear model for repeated measures was used for all visits. Effect after 4 weeks of treatment, effect after 12 weeks of treatment, and, finally, carryover effects of first and second order were estimated. A Wilcoxon signed rank test was used to evaluate 4- and 12-week changes within a group, and Mann-Whitney U test was used to evaluate 4- and 12-week changes between groups.
Tolerability of the cream was excellent and not different from that of placebo. During the first 12 weeks, use of the active cream resulted in a significant reduction in pain during sexual activity after 4 and 12 weeks (p < .05); however, use of the placebo cream did not. When analyzing the entire pain data with the statistical model for crossover clinical study design, the active cream resulted in a decrease of 1.1 points (95% confidence interval = -0.6 to 2.8, p = .20) and 1.3 points (95% confidence interval = 0.1 to 2.5, p = .037) in the visual analog scale score compared with that of placebo after 4 and 12 weeks of treatment, respectively. There was evidence for a second-order carryover effect (p = .024). The pain reduction was most evident for women with secondary dyspareunia. Erythema was reduced after use of the cream at 4 (p = .03) and 12 (p = .01) weeks but not after placebo.
As opposed to placebo, use of cutaneous lysate cream was more effective in reducing focal redness and pain while having intercourse in patients with provoked localized vulvodynia with erythema.
治疗伴有可见外阴红斑的诱发性局部外阴痛，使用含有人细胞因子的皮肤裂解物乳膏是否有效？
这是一项双盲安慰剂对照随机交叉试验，共有 30 名患有诱发性局部外阴痛且伴有可见外阴红斑的患者参与，在为期 3 个月的研究期间，患者每日两次使用研究药物和安慰剂乳膏，洗脱期为 1 周，然后交叉使用药物 3 个月。主要观察指标为产品的耐受性、性功能和临床发现。采用重复测量线性模型对所有就诊进行分析。分别估计治疗 4 周后的疗效、治疗 12 周后的疗效，以及一级和二级的持续效应。采用 Wilcoxon 符号秩检验评估组内治疗 4 周和 12 周的变化，采用 Mann-Whitney U 检验评估组间治疗 4 周和 12 周的变化。
乳膏的耐受性极好，与安慰剂无差异。在最初的 12 周内，使用活性乳膏可显著减轻 4 周和 12 周时的性活动疼痛（p <.05）；然而，使用安慰剂乳膏则无此作用。在使用交叉临床试验设计的统计模型分析整个疼痛数据时，与安慰剂相比，活性乳膏在视觉模拟评分上的降幅分别为 1.1 分（95%置信区间= -0.6 至 2.8，p =.20）和 1.3 分（95%置信区间= 0.1 至 2.5，p =.037）。存在二级持续效应的证据（p =.024）。对于伴有继发性性交困难的女性，疼痛缓解最为明显。使用乳膏治疗 4 周（p =.03）和 12 周（p =.01）后，红斑减少，但使用安慰剂后则无此作用。
与安慰剂相比，在伴有红斑的诱发性局部外阴痛患者中，使用皮肤裂解物乳膏治疗可更有效地减轻性交时的局部红斑和疼痛。
