鼠神经生长因子治疗中重度颅脑损伤的有效性和安全性

doi:10.3877/cma.j.issn.2095-9141.2016.03.002

目的

观察注射用鼠神经生长因子治疗中重度颅脑损伤的临床疗效及安全性。

方法

选取自2012年2月至2015年12月陆军总医院附属八一脑科医院一病区接诊的60例中重度颅脑损伤患者作为研究对象，按随机数字表分为观察组30例和对照组30例，对照组进行常规方法治疗，观察组在对照组的基础上再肌内注射鼠神经生长因子，30 μg/次，每日1次，治疗时间为3周，所有患者随访3个月。治疗前、治疗3周、随访3个月进行格拉斯哥昏迷（GCS）评分、格拉斯哥结果（GOS）评分、日常生活能力（ADL）评分、蒙特利尔认知评估量表（MoCA）评分，记录ICU住院天数，统计死亡率，评判两组临床疗效。

结果

观察组和对照组治疗3周、随访3个月的GCS、ADL、MoCA评分较治疗前明显升高，F=3.664、11.827、9.667和3.028、9.808、8.623，P<0.05或P<0.01，且观察组治疗3周GCS、ADL、MoCA、GOS评分高于对照组，且差异均有统计学意义（t=3.526、3.665、3.862、3.448，P<0.05），随访3个月ADL评分高于对照组，且差异有统计学意义（t=3.472，P<0.05）。观察组的临床总有效率为86.7%，高于对照组的60.0%，且差异有统计学意义（χ²=6.393，P<0.05），两组患者ICU停留时间差异无统计学意义（t=0.339，P>0.05）。

结论

注射用鼠神经生长因子治疗中重度颅脑损伤疗效确切且安全性良好，能够快速促进神经功能缺损恢复，且对合并颅神经损伤也有积极影响，值得临床推广使用。

关键词: 颅脑损伤, 颅神经损伤, 鼠神经生长因子, 治疗结果, 安全性

Objective

To observe the clinical study of the safety and efficacy of mouse nerve growth factor for injection in treatment of moderate and severe head trauma.

Methods

Totally 60 patients with moderate and severe head trauma in The Affiliated Bayi Brain Hospital, PLA Army General Hospital from February 2012 to December 2015 were included as research subjects. All patients were randomly divided into 30 cases of the observation group and 30 cases of the control group. The control group were received conventional treatment. The observation group were additionally received 30 μg mouse nerve growth factor for injection, once a day, for 3 week, all patients were followed up for 3 months, the GCS, GOS, ADL, MoCA score were recorded before treatment, after 3 weeks treatment and 3 months follow-up, the ICU length of stay, mortality rate were recorded, total clinical efficiency were evaluated.

Results

the GCS, ADL, MoCA score of the observation group and the control group after 3 weeks treatment and follow-up three months were significantly higher than before treatment, F=3.664, 11.827, 9.667 and 3.028, 9.808, 8.623, P<0.05 or P<0.01, and the GCS, ADL, MoCA, GOS score of the observation group after 3 weeks were significantly higher than the control group, t=3.526, 3.665, 3.862, 3.448, all P<0.05, ADL score 3-month follow-up were significantly higher than the control group, t=3.472, P<0.05. the clinical effective rate of the observation group were 86.67%, and the control group were 60%,the difference was significant, χ²=6.393, P<0.05, the ICU stay was not significantly different between both group, t=0.339, P>0.05.

Conclusion

The mouse nerve growth factor for inject have exact efficacy and good security, can quickly promote the recovery of neurological deficit, and also has a positive effect on the consolidated cranial nerve injury, worthy of clinical use.

Key words: Head trauma, Cranial nerve injury, Mouse nerve growth factor, Treatment outcome, Safety

表1 两组患者治疗前后各量表评分结果（分，±s）

组别	n	?	GCS	ADL	MoCA	GOS
观察组	30	治疗前	8.75±2.55	4.85±13.84	2.05±6.46	-
?	?	治疗3周	13.55±3.43^a	68.32±35.64^b	24.43±11.55^c	4.33±0.95^e
?	?	随访3个月	14.35±2.26	93.58±30.66^d	25.58±9.18	4.67±0.86
?	?	组内F值或t值	3.664	11.827	9.667	1.228
?	?	组内P值	<0.05	<0.01	<0.01	>0.05
对照组	30	治疗前	8.69±2.58	4.78±15.92	2.00±6.68	-
?	?	治疗3周	11.96±3.72	54.55±40.21	17.50±12.97	3.68±1.04
?	?	随访3个月	13.91±2.37	79.09±35.04	24.45±10.09	4.18±1.10
?	?	组内F值或t值	3.028	9.808	8.623	3.007
?	?	组内P值	<0.05	<0.01	<0.01	<0.05

表1 两组患者治疗前后各量表评分结果（分，±s）

组别	n	?	GCS	ADL	MoCA	GOS
观察组	30	治疗前	8.75±2.55	4.85±13.84	2.05±6.46	-
?	?	治疗3周	13.55±3.43^a	68.32±35.64^b	24.43±11.55^c	4.33±0.95^e
?	?	随访3个月	14.35±2.26	93.58±30.66^d	25.58±9.18	4.67±0.86
?	?	组内F值或t值	3.664	11.827	9.667	1.228
?	?	组内P值	<0.05	<0.01	<0.01	>0.05
对照组	30	治疗前	8.69±2.58	4.78±15.92	2.00±6.68	-
?	?	治疗3周	11.96±3.72	54.55±40.21	17.50±12.97	3.68±1.04
?	?	随访3个月	13.91±2.37	79.09±35.04	24.45±10.09	4.18±1.10
?	?	组内F值或t值	3.028	9.808	8.623	3.007
?	?	组内P值	<0.05	<0.01	<0.01	<0.05

表2 两组患者临床疗效比较

组别	例数	痊愈[例(%)]	好转[例(%)]	好转[例(%)]	总有效率(%)	ICU停留时间（d，±s）
观察组	30	11(36.67)	15(50.00)	4(13.33)	86.7	4.22±2.08
对照组	30	5(16.67)	13(43.33)	12(40.00)	60.0	4.57±2.13
检验值	?	-	-	-	χ²=6.393	t=0.339
P值	?	-	-	-	<0.05	>0.05

表2 两组患者临床疗效比较

组别	例数	痊愈[例(%)]	好转[例(%)]	好转[例(%)]	总有效率(%)	ICU停留时间（d，±s）
观察组	30	11(36.67)	15(50.00)	4(13.33)	86.7	4.22±2.08
对照组	30	5(16.67)	13(43.33)	12(40.00)	60.0	4.57±2.13
检验值	?	-	-	-	χ²=6.393	t=0.339
P值	?	-	-	-	<0.05	>0.05

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The clinical study of the safety and efficacy of mouse nerve growth factor in treatment of moderate and severe head trauma

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The clinical study of the safety and efficacy of mouse nerve growth factor in treatment of moderate and severe head trauma