针药联合治疗212例妊娠期恶心呕吐患者的临床观察

The Clinical Observation of 212 Patients with Pregnancy Nausea and Vomiting Treated by Acupuncture and Medicine

目的观察针刺联合多西拉敏-维生素B6缓释片治疗妊娠期恶心呕吐(Nausea and vomiting of pregnancy,NVP)临床疗效及安全性,为临床治疗妊娠期恶心呕吐提供一种新思路及新的安全有效的治疗方法。方法选取2017年3月—2019年12月期间就诊于黑龙江中医药大学附属第一和第二医院、哈尔滨医科大学附属第二医院、哈尔滨红十字医院妇科门诊的212例妊娠期恶心呕吐患者,按照随机数字表法分为A组(针刺+多西拉敏);B组(假针刺+多西拉敏);C组(针刺+安慰剂);D组(假针刺+安慰剂),每组各53例。四组均治疗2周后,观察4组患者治疗前后中医证候评分及妊娠恶心呕吐生活质量量表(Quality of life scale for nausea and romiting of during pregnancy,NVPQOL)评分变化情况、尿酮体转阴率以及安全性指标ALT和AST治疗前后的变化。结果治疗后A组、B组、C组中医证候评分均较治疗前降低,差异有统计学意义(P<0.01),D组较治疗前降低不明显,差异无统计学意义(P>0.05);且A组中医证候评分降低水平优于B、C、D组,差异有统计学意义(P<0.05,P<0.01);B、C组与D组比较,差异有统计学意义(P<0.01)。治疗后A组、B组、C组NVPQOL评分均较治疗前降低,差异有统计学意义(P<0.01),D组较治疗前降低不明显,差异无统计学意义(P>0.05);且A组NVPQOL评分降低水平优于B、C、D组,差异有统计学意义(P<0.01);B、C组与D组比较,差异有统计学意义(P<0.01)。4组患者治疗后尿酮体转阴率比较,差异有统计学意义(P<0.05)。4组患者治疗前后安全性指标ALT、AST水平比较,差异无统计学意义(P>0.05)。结论针刺联合多西拉敏维生素B6缓释片可以明显改善妊娠期恶心呕吐患者的中医证候评分及NVPQOL评分,增加尿酮体转阴率,效果优于其他试验组,并且不会影响妊娠女性的肝功能,安全可靠无副作用。

Objective To investigate the mechanism,clinical efficacy and safety of acupuncture combined with doxylamine-vitamin B6 sustained-release tablets in the treatment of pregnancy vomiting,so as to provide a new idea and a new safe and effective treatment method for the clinical treatment of pregnancy vomiting.Methods A total of 212 patients with nausea and vomiting during pregnancy who visited the First and Second Affiliated Hospitals of Heilongjiang University of Traditional Chinese Medicine,the Second Affiliated Hospital of Harbin Medical University,and Harbin Red Cross Hospital Gynecology Clinic from March 2017 to December 2019 were selected.The patients were divided into group A(acupuncture+doxylamine);group B(sham acupuncture+doxylamine);group C(acupuncture+placebo);group D(sham acupuncture+placebo),with 53 cases in each group.After 2 weeks of treatment in all four groups,the changes of TCM syndrome scores,Quality of life scale for nausea and romiting of during pregnancy(NVPQOL)scores,the rate of negative urine ketone bodies,and the safety indicators ALT and AST were observed before and after treatment in the four groups.Results After treatment,theTCM syndrome scores of group A,group B and group C were all lower than those before treatment,and the difference was statistically significant(P<0.01);and the reduction level of TCM syndrome scores in group A was better than that in groups B,C,and D,and the difference was statistically significant(P<0.05,P<0.01).After treatment,the NVPQOL scores of group A,group B,and group C were all lower than those before treatment,and the difference was statistically significant(P<0.01).The reduction level of NVPQOL score in group A was better than that in groups B,C,and D,and the difference was statistically significant(P<0.01).There was a statistically significant difference in the urinary ketone body negative rate among the 4 groups after treatment(P<0.05).There was no significant difference in the levels of ALT and AST in the 4 groups of patients before and after treatment(P>0.05).Conclusion Acupuncture combined with Doxylamine Vitamin B6 Sustained-Release Tablets can significantly improve the TCM syndrome score and NVPQOL score of patients with pregnancy vomiting,increase the negative conversion rate of urine acetone body,and the effect is better than other experimental groups,and will not affect the liver function of pregnant women.It is safe and reliable without side effects.