枸橼酸氯米酚和宫腔内人工授精作为不明原因不孕的一线治疗方法：它们具有成本效益吗？
Clomifene citrate and intrauterine insemination as first-line treatments for unexplained infertility: are they cost-effective?
机构信息
Health Economics Research Centre, University of Oxford, Old Road Campus, Oxford OX3 7LF, UK.
出版信息
Hum Reprod. 2011 Feb;26(2):369-75. doi: 10.1093/humrep/deq315. Epub 2010 Dec 2.
BACKGROUND
First-line treatments for unexplained infertility traditionally include clomifene citrate (CC) or unstimulated intrauterine insemination (IUI). A recently published randomized controlled trial considered the effectiveness of CC and IUI in patients with unexplained infertility and found that neither treatment offered a superior live birth rate when compared with expectant management (EM). This paper reports the economic evaluation conducted alongside this trial in order to assess whether health care providers are gaining value for money in this clinical area.
METHODS
Five hundred and eighty women across five Scottish hospitals were randomized to either EM, CC or IUI for 6 months. The primary outcome measure was live births. Resource-use data were collected during the trial and costs were calculated from a UK National Health Service (NHS) perspective. Incremental cost-effectiveness ratios were calculated, expressed as cost per live birth, in order to compare the cost-effectiveness of CC and IUI with that of EM to treat unexplained infertility.
RESULTS
Live birth rates in the three randomized groups were: EM = 32/193 (17%), CC = 26/194 (13%) and IUI = 43/193 (22%). The mean (standard deviation) costs per treatment cycle were £0 for EM, £83 (£17) for CC and £98 (£31) for IUI. The mean treatment costs per patient for EM, CC and IUI were £12 (£117), £350 (£220) and £331 (£222), respectively. The cost per live birth for EM, CC and IUI was £72 (95% confidence interval £0-£206), £2611 (£1870-£4166) and £1487 (£1116-£2155), respectively. The incremental cost-effectiveness ratio for IUI versus EM was £5604 (-£12204 to £2227), with CC dominated by IUI.
CONCLUSIONS
Despite being more expensive, existing treatments such as empirical CC and unstimulated IUI do not offer superior live birth rates compared with EM of unexplained infertility. They are unlikely to be a cost-effective use of limited NHS resources. The study's main limitation is that it did not consider the psychological effects on couples. ISRCT Number: 71762042.
背景
不明原因不孕的一线治疗方法传统上包括枸橼酸氯米芬（CC）或未刺激宫腔内人工授精（IUI）。最近发表的一项随机对照试验考虑了 CC 和 IUI 在不明原因不孕患者中的疗效，结果发现与期待治疗（EM）相比，这两种治疗方法都没有提供更高的活产率。本文报告了该试验的伴随经济评估，以评估在这一临床领域，医疗保健提供者是否获得了物有所值。
方法
580 名女性在苏格兰的五家医院被随机分配到 EM、CC 或 IUI 组，治疗时间为 6 个月。主要结局指标是活产。在试验期间收集了资源使用数据，并从英国国家医疗服务体系（NHS）的角度计算了成本。计算了增量成本效益比，以每活产成本表示，以比较 CC 和 IUI 与 EM 治疗不明原因不孕的成本效益。
结果
三组随机分组的活产率分别为：EM = 32/193（17%），CC = 26/194（13%），IUI = 43/193（22%）。每个治疗周期的平均（标准差）成本分别为 EM = 0，CC = 83（17）英镑，IUI = 98（31）英镑。EM、CC 和 IUI 的每位患者平均治疗费用分别为 12 英镑（117 英镑）、350 英镑（220 英镑）和 331 英镑（222 英镑）。EM、CC 和 IUI 的每活产成本分别为 72 英镑（95%置信区间 0-206 英镑）、2611 英镑（1870-4166 英镑）和 1487 英镑（1116-2155 英镑）。IUI 与 EM 的增量成本效益比为 5604 英镑（-12204 至 2227 英镑），CC 被 IUI 所主导。
结论
尽管更昂贵，但现有的治疗方法，如经验性 CC 和未刺激 IUI，与 EM 相比并不能提供更高的活产率。它们不太可能是对有限的 NHS 资源的具有成本效益的利用。该研究的主要局限性是它没有考虑对夫妇的心理影响。ISRCTN 编号：71762042。
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