Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China.
School of Biomedical Engineering, Capital Medical University, Beijing, China.
Curr Med Res Opin. 2022 May;38(5):803-810. doi: 10.1080/03007995.2022.2047539. Epub 2022 Mar 15.
This study aimed to evaluate the effectiveness of therapeutic lumbar drainage (LD) compared to therapeutic lumbar puncture (LP) for the management of intracranial hypertension (ICH) among HIV-positive patients with cryptococcal meningitis (CM).
The study was a multicenter prospective non-randomized interventional clinical trial. One hundred and sixteen HIV-associated CM patients were identified who presented with ICH (≥250 mmHO). The LP group comprised 76 cases, while the LD group consisted of 40 cases. We compared mortality, intracranial pressure (ICP) normalization rate, and clinical symptom remission at 10 weeks, between the two groups.
The cumulative mortality at week 10 was 22.4% in the LP group and 20% in the LD group ( = .927), without any significant difference in mortality between the two groups. Improvement after treatment at 2-weeks, ICP normalization, and headache reversal event occurrence in the two groups showed no significant difference ( > .05). The incidence of CSF clearance at two weeks in the LD group was significantly higher than in the LP group ( < .05). The frequency of invasive lumbar therapeutic procedures in the LP group during the first week was higher than that of the LD group ( < .05). Localized infection at the puncture site occurred more frequently in the LD group than in the LP group ( < .05).
For HIV-positive CM patients with an elevated ICP, LD and LP are comparably effective and safe options to normalize ICP. LP increases the frequency of invasive lumbar therapeutic procedures but does not incur more risk of infection events at the puncture site, while LD may accelerate CSF clearance but may induce more frequent localized infection.
This study was registered as one of 12 trials under a general project at the Chinese Clinical Trial Registry (ChiCTR1900021195).
本研究旨在评估治疗性腰椎引流（LD）与治疗性腰椎穿刺（LP）在治疗 HIV 阳性隐球菌性脑膜炎（CM）合并颅内高压（ICH）患者中的疗效。
这是一项多中心前瞻性非随机干预性临床试验。共纳入 116 例合并 ICH（≥250mmHO）的 HIV 相关 CM 患者。LP 组 76 例，LD 组 40 例。比较两组患者死亡率、颅内压（ICP）正常化率及 10 周时临床症状缓解率。
LP 组和 LD 组第 10 周的累积死亡率分别为 22.4%和 20%（ = .927），两组死亡率无显著差异。两组治疗后 2 周时的改善情况、ICP 正常化率及头痛缓解事件发生率无显著差异（ > .05）。LD 组在第 2 周时 CSF 清除率明显高于 LP 组（ < .05）。LP 组在第 1 周时进行侵入性腰椎治疗的频率明显高于 LD 组（ < .05）。LD 组穿刺部位局部感染的发生率明显高于 LP 组（ < .05）。
对于合并 ICP 升高的 HIV 阳性 CM 患者，LD 和 LP 均可有效且安全地降低 ICP。LP 增加了侵入性腰椎治疗操作的频率，但不会增加穿刺部位感染事件的风险，而 LD 可能会加速 CSF 清除，但会导致更频繁的局部感染。
本研究在中国临床试验注册中心（ChiCTR1900021195）作为一个一般项目下的 12 项试验之一进行注册。
