| Objective To assess the efficacy and safety of Heng Li 200 unit dose, for cerebral vascular spasm after stroke treatment, if subjects combining increased tension of the thumb injected 240 units.Methods1. Study design: a multicenter, randomized, double-blind, placebo, parallel controlled clinical trial. The test experiment data were from the center of Tongji hospital.2. Research object: 22 patients with upper limb spasm of cerebral apoplexy from rehabilitation department in wuhan tongji hospital were selected into the group in October 2014 to April 2015, 1 case of the baseline period exited from the group. All subjects randomly divided into two groups according to the time sequence: the Heng Li group and the placebo group, 14 cases in the Heng Li group, 7 cases in the placebo group.3. Treatment: the Heng Li group was injected botulinum toxin A into cramps arm; the placebo group was injected placebo.4. Observation indexes and time points: general demographic data investigation as abaseline period before treatment; Modified Ashworth spasm scale(Modified Ashworth scale, MAS) and Disability rating scale(Disability Assessment scale, DAS), Hmax/Mmax, simple Fugl-Meyer scale and subjects vital signs in the baseline period, 0 days, 1 week, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 16 weeks, 18 weeks were assessed; Overall assessment scale was assessed after treatment in 1 week, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 16 weeks, 18 weeks; Routine urine and blood biochemical and electrocardiogram were tested at baseline, 6 weeks, 12 weeks; Urine pregnancy test(childbearing age women), and hepatitis b surface antigen and anti HCV were tested in the baseline period, 12 weeks, 18 weeks; record adverse events in the two groups after treatment.Results1. The baseline data21 cases in this study, including 14 cases in the Heng Li group, 7 cases in the placebo group; use the comparison group t test to compare age, height, body weight between the two groups, and there was no statistically significant difference(P>0.05).2. Main outcome indicators2.1Modified Ashworth scale 1 week, 4 weeks, 8 weeks, 12 weeks after treatment, the Heng Li group was compared with the placebo group by wrist flexor, four fingers flexor and thumb flexor muscle tone MAS rating, the chi-square test: MAS rating of the Heng Li group was decreased comparing baseline, P<0.05; MAS rating had no difference between the placebo group and baseline, P>0.05.The Heng Li group was better than that of the placebo group, P <0.05.2.2 Disability Assessment Scale 2.2.1 0 day, 1 week, 4 weeks, 8 weeks, 12 weeks, 16 week, 18 weeks after treatment, the chi-square test: DAS rating of the Heng Li group was decreased comparing baseline, P<0.05; Core research period, namely 0 days, 1 week, 4 weeks, 6 weeks, 8weeks, 12 weeks after treatment, DAS rating had no difference between the placebo group and baseline, P>0.05. Extend the research period, 16 weeks, 18 weeks after treatment, the placebo group had statistically significant difference with baseline, P<0.05. 2.2.2 4 weeks, 6 weeks follow-up point group change value of the Heng Li group, had no difference with 8 weeks, 12 weeks follow-up point group change value of the placebo group, P>0.05.2.3Global Assessment Scale2.3.1 Comparison in the group Always use GAS score every time follow-up after the injections, each visit viewpoint of the Heng Li group had statistically significant difference compared to baseline values, P<0.05. GAS score values of Placebo group had no significant statistical difference compared with baseline values in 1 week, 4 weeks, 6 weeks, 12 weeks visit viewpoint, P>0.05; GAS score value of the placebo group had statistically significant difference compared to baseline values in 16 weeks, 18 weeks visit viewpoint, P<0.05.2.3.2 Comparison between groups 0 days, 1 week, 4 weeks, 6 weeks, 12 weeks these five follow-up periods, GAS score of the Heng Li group had statistically significant difference compared to the placebo group, P<0.05. GAS value between the two groups in16 weeks, 18 weeks supervision period had no significant statistical difference, P>0.05.2.4 The same treatment points compared between groups, the placebo group, 12 weeks placebo injection with botulinum toxin A + 6 weeks(Heng Li); Heng Li set is 6 weeks.2.4.1MAS, DAS score of the placebo group at 18 weeks had no significant statistical difference compared with baseline at 6 weeks, P>0.05.2.4.2GAS score of the placebo group at 18 weeks had no significant statisticaldifference compared with baseline at 6 weeks, P>0.05.2.5 Hmax/Mmax2.5.10 day, 1 week, 4 weeks, 8 weeks, 12 weeks, 16 week, 18 weeks after treatment, the chi-square test: Hmax/Mmax of the Heng Li group was decreased comparing baseline, P<0.05; Core research period, namely 0 days, 1 week, 4 weeks, 6 weeks, 8 weeks, 12 weeks after treatment, Hmax/Mmax had no difference between the placebo group and baseline, P>0.05. Extend the research period, 16 weeks, 18 weeks after treatment, the placebo group had statistically significant difference compared to baseline, P<0.05.2.5.24 weeks, 6 weeks follow-up point group change value of the Heng Li group, had no difference with 8 weeks, 12 weeks follow-up point group change value of the placebo group, P >0.05.2.6 Fugl-Meyer assessment scale0 day, 1 week, 4 weeks, 8 weeks, 12 weeks, 16 week, 18 weeks after treatment, the chi-square test: FMA of the Heng Li group was increased comparing baseline, P<0.05; Core research period, namely 0 days, 1 week, 4 weeks, 6 weeks, 8 weeks, 12 weeks after treatment, FMA had no difference between the placebo group and baseline, P>0.05. Extend the research period, 16 weeks, 18 weeks after treatment, the placebo group had statistically significant difference compared to baseline, P<0.05.3. The security of treatment Before and after treatment at the end of 1 weeks, 6 weeks, 12 weeks, 18 weeks, blood and urine routine, liver and kidney function and electrocardiogram of the two groups were not seen obvious abnormity; Two groups of patients were no increase drug combination after into group; 1 week, 4 weeks, 6 weeks, 12 weeks, 16 weeks, 18 weeks after treatment, there were no adverse events seen in the Heng Li group and the placebo group. There were no adverse events and serious adverse events seen in the two groups during the whole process.4. Falls off and eliminate cases In the course of treatment, the total number of cases dropped off in 3 cases, the loss rate was 13.63%, lower than 20%. All the patients met the study requirements.Conclusion Botulinum toxin A(Heng Li) in muscle intraperitoneal injection, small side effects in the upper limb spasm after cerebral apoplexy therapy, treatment effect and good safety, patient compliance was well.Innovation 1. The domestic first Heng Li parallel randomized, double blind, placebo controlled clinical research, to verify its effectiveness in the treatment of upper limb spasm after cerebral apoplexy and security, for Heng Li in the clinical application to provide a safe and effective certificate. 2. Requirements for the first time in accordance with Good Clinical Practice of the top-level design, with a reasonable statistical method for the treatment of Heng Li strict Clinical evaluation on the upper limb spasm after cerebral apoplexy. |
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