摘要
目的:通过观察口服自拟清瘀化痰颗粒对缺血性中风恢复期(痰瘀互阻型)的临床疗效,客观评价其有效性和安全性,为该方药的临床推广应用提供依据。
方法:本临床研究采用随机、阳性药物平行对照法观察缺血性中风恢复期(痰瘀互阻型)患者60例。将其随机分为治疗组30例,对照组30例,疗程均为28天。治疗组采用口服自拟清瘀化痰颗粒(由长春中医药大学附属医院颗粒药房提供);阳性对照组采用口服消栓通络胶囊(吉林省东北亚药业股份有限公司,批准文号:国药准字Z10940067)。通过对60例患者的临床研究,经统计学分析,对其有效性及安全性作出科学、客观评价。
结果:实际入组病例60例,脱落0例,剔除0例,统计病例60例。治疗组总有效率为86.67%,对照组总有效率为83.33%,经秩和检验P>0.05,二者无显著差异;改善缺血性中风恢复期患者的中医证候方面,治疗组有效率为90.00%,对照组有效率为76.67%,经秩和检验P<0.05,治疗组较对照组疗效显著。安全性判定:治疗前后两组患者在服药期间均未发生不良反应及不良事件,证明两组药物在安全性方面均安全可靠。
结论:经统计学分析,结果表明自拟清瘀化痰颗粒与消栓通络胶囊在改善缺血性中风恢复期患者的神经功能缺损、日常生活活动能力方面相比较无统计学意义,在改善缺血性中风恢复期患者的中医证候方面比较有统计学意义,自拟清瘀化痰颗粒较消栓通络胶囊疗效显著。采用自拟清瘀化痰颗粒治疗缺血性中风恢复期(痰瘀互阻型)安全有效。
Purpose: Through the observation of oral since fitting to clear stasis expectorant particles ischemic strokes recovery (phlegm and blood stasis mutual resistance type), an objective evaluation of the clinical curative effect, its effectiveness and safety for the herbs provide basis for the clinical application.
Method: This clinical study using random, positive drug parallel contrast method observation ischemic stroke recovery (phlegm and blood stasis mutual resistance type) patients 60 cases. Will the 30 cases were randomly divided into the treatment group and control group, 30 cases, treatment are 28 days. Using oral treatment group since intends to clear stasis phlegm particles (made in Changchun university of traditional Chinese medicine hospital particles provide); pharmacy Positive were treated by oral away bolt, dredging capsule (Jilin province, northeast Asia pharmaceutical Co, LTD. Z10940067 approved by the approval document number: enterprise). Based on the 60 patients with clinical research, by statistical analysis about its effectiveness and safety, make scientific, objective evaluation.
Result: Actual cases, the fall of 60 patients with 0 case, eliminate 0 example, 60 cases statistical cases. The treatment group total effectiveness is intellectual, the comparison group total effectiveness by rank and 83.33% respectively, for > 0.05, both inspection P no significant differences; Improve ischemic stroke monitoring patients, syndromes in treatment group and control 90.00% laseris by rank, laseris intellectual and inspection P < 0.05, the treatment group than controls curative effect is distinct. Safety judgement: two groups patients before and after treatment were not occur during any adverse reactions and adverse events, proof two groups drugs in safety are safe and reliable.
Conclusion: By statistical analysis, the results show that the plans to clear stasis expectorant particles and elimination in improving bolt, dredging capsule ischemic strokes monitoring patients neurologic deficits, life capacity comparison was statistically significant, improvements in ischemic stroke monitoring patients between syndromes are statistically significant, since the qing stasis phlegm to bolt, dredging capsule is away particle curative effect is distinct. Adopting the plans to clear stasis expectorant particles therapy for ischemic stroke recovery (phlegm stasis mutual resistance type) are safe and effective.
引文
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