硝西泮对RigiScan检测夜间阴茎肿胀和硬度结果的影响

Effect of nitrazepam on nocturnal penile tumescence and rigidity measurement by RigiScan

目的 探究硝西泮能否通过改善患者的睡眠质量,增加RigiScan夜间阴茎肿胀和硬度(NPTR)检测结果的准确性。方法 所有参与者均连续监测两晚NPTR。在试验1中,125名正常志愿者被随机分至对照组(n=68)和试验组(n=57),于第2晚NPTR检测睡前分别予口服安慰剂或10 mg硝西泮,观察硝西泮对正常人群NPTR检测结果的影响。在试验2中,128例勃起功能障碍患者被随机分至对照组(n=64)和试验组(n=64),在NPTR检测前分别服用安慰剂或10 mg硝西泮,观察硝西泮对NPTR检测参数值[包括尖端冠状沟(tip)和阴茎底部(base)的有效勃起次数(EEE)、总勃起时间(TED)、勃起硬度≥60%的勃起持续时间(D60)、平均勃起硬度(AER)、平均勃起胀大周长(AET)、勃起硬度活动单位(RAU)和勃起胀大活动单位(TAU)]和检测结果正常率的影响。结果 在试验1中,对照组和试验组第2晚的NPTR所有参数检测结果及正常率比较差异均无统计学意义(P> 0.05);试验组的理查兹-坎贝尔睡眠问卷(RCSQ)评分高于对照组(P <0.001)。在试验2中,对照组第1晚的NPTR参数值(D60tip、D60base、AERbase、RAUtip、TAUtip)均低于第2晚(P <0.05),组内两晚检测结果正常率比较差异无统计学意义(67.2%vs.78.1%,P=0.065);试验组除了AETtip值[7.85(6.83,8.98) cm vs. 8.10(7.50,8.90) cm,P=0.014],两晚的其他参数检测结果及检测正常率比较差异均无统计学意义(P均>0.05)。组间比较显示,试验组第1晚参数值(EEE、D60tip、RAUtip以及TAUtip)及第2晚参数值(EEE、D60tip、D60base、TED、RAUtip、RAUbase、TAUtip以及TAUbase)均低于对照组(P均<0.05),2组第1晚的NPTR检测结果正常率比较差异无统计学意义(67.2%vs. 65.6%,P=0.852),而第2晚试验组的NPTR检测结果正常率低于对照组(78.1%vs. 57.8%,P=0.014);试验组两晚的RCSQ评分均高于对照组,且试验组和对照组的第1晚评分均低于第2晚评分(P均<0.05)。结论 NPTR检测存在“首夜效应”。硝西泮会明显抑制夜间阴茎勃起,不能通过改善睡眠质量消除“首夜效应”的影响,反而增加NPTR检测的假阴性率。对于睡眠正常者行NPTR检测时应避免使用硝西泮;而对于睡眠障碍或者难以入眠的患者,可权衡对患者的利弊后使用硝西泮。

Objective To investigate whether nitrazepam can increase the accuracy of RigiScan measurement of nocturnal penile tumescence and rigidity(NPTR)by improving the sleep quality of patients.Methods All participants received NPTR measurement for two consecutive nights.In Trial 1,125 normal volunteers were randomly assigned into the control group(n=68)and experimental group(n=57).They took either a placebo or 10 mg of nitrazepam before NPTR testing on the second night to observe the effect of nitrazepam on nocturnal penile erections in the normal population.In Trial 2,128 patients with erectile dysfunction were randomly assigned into the control group(n=64)and experimental group(n=64).They took either a placebo or 10 mg of nitrazepam before NPTR testing to observe the effect of nitrazepam on NPTR detection parameters including effective erection times(EEE),total erection duration(TED),erection duration with erection rigidity≥60%(D60),average erection rigidity(AER),average erection tumescence circumference(AET),rigidity activity unit(RAU)and tumescence activity unit(TAU)at the tip and base of the penis and the normal erection rates.Results In Trial 1,there were no statistically significant differences in NPTR parameters and normal rates between two groups on the second night(all P>0.05).The Richards-Campbell Sleep Questionnaire(RCSQ)score in the experimental group was higher than that in the control group(P<0.001).In Trial 2,NPTR parameters(D60tip,D60base,AERbase,RAUtip,TAUtip)on the first night were lower compared to those on the second night in the control group(all P<0.05),and there were no significant differences in normal erection rates(67.2%vs.78.1%,P=0.065).Except for AETtip(7.85(6.83,8.98)cm vs.8.10(7.50,8.90)cm,P=0.014),there were no statistically significant differences in NPTR parameters and normal erection rates between two nights in the experimental group(all P>0.05).In comparison between two groups,the parameters on the first night(EEE,D60tip,RAUtip and TAUtip)and those on the second night(EEE,D60tip,D60base,TED,RAUtip,RAUbase,TAUtip and TAUbase)in the experimental group were lower than those in the control group(all P<0.05).No significant difference was observed in the normal erection rates on the first night between two groups(67.2%vs.65.6%,P=0.852),and the normal erection rate on the second night in the experimental group was lower than that in the control group(78.1%vs.57.8%,P=0.014).In the experimental group,the RCSQ scores on two nights were higher compared to those in the control group,and the RCSQ scores on the first night were lower than those on the second night in both groups(both P<0.05).Conclusions NPTR measurement yields the first night effect.Nitrazepam can significantly inhibit the nocturnal penile erection.Improving sleep quality cannot eliminate the first night effect,whereas increase the false negative rate of NPTR measurement.Nitrazepam should be avoided in the NPTR measurement for patients with normal sleep,whereas it can be given for patients with sleep disorders or sleep difficulty after full consideration of the advantages and disadvantages.