Multicenter Randomized Double-Blind Controlled Clinical Study of Huoxue Tongluo Recipe(活血通络方)External Washing in the Treatment of Chemotherapy-Induced Peripheral Neuropathy

Objective: To objectively evaluate the efficacy of Huoxue Tongluo Recipe(活血通络方) in the treatment of chemotherapy-induced peripheral neuropathy(CIPN).Methods: A multicenter, randomized, double-blind, block, and parallel-controlled study was conducted in which 184 subjects who met the inclusion criteria were randomized into a trial group(92 cases), a control group(46 cases), a placebo group(46 cases) at a 2:1:1 ratio, respectively.Huoxue Tongluo Recipe(活血通络方) granules, Huangqi Guizhi Wuwu Decoction(黄芪桂枝五物汤) instant granules, placebo instant granules were given for hand and foot soaking, with water temperature 38 ℃-45 ℃, soaking for 20 minutes and the intervention time was 14 days.Results:(1) The total effective test drug was 41.30%, the control group was 32.61%, and the placebo group was 32.61%.There was no significant difference in the efficiency of the 3 groups by CMH chi-square test(P>0.05);(2) In the statistics of previous chemotherapy regimens including oxaliplatin or paclitaxel as stratification factors, the overall efficiency of the trial group was significantly different from the other 2 groups.Conclusion: Huoxue Tongluo Recipe(活血通络方) external washing can improve the peripheral nerve injury caused by chemotherapy to some extent, especially in patients with previous chemotherapy regimen including oxaliplatin and paclitaxel.

Regulation of C-type Natriuretic Peptides and Natriuretic Peptide Receptor-B Expression in Diabetic Rats Renal Treated by Tongluo Recipe(通络方)

To investigate the expression of C-type natriuretic peptides （CNP） and natriuretic peptide receptor-B （NPR-B） receptor in diabetic rats renal cortex, and the regulation by Tongluo Recipe （通络方, TLR）. Methods： Sixty male SD rats were divided into 3 groups： the normal control group, diabetic model group and diabetic TLR group. Each group was further divided into two subgroups of ten in each, according to 4-week or 12-week observation period. Streptozotocin （STZ）-induced diabetic rats were treated with TLR （1.0 g.kgl＇d1） for 4 and 12 weeks, respectively. （1） The essential information was collected for comparing renal mass, serum creatinine and 24 h urine albumen on each group was calculated. （2） CNP mRNA and NPR-B mRNA were detected by realtime-polymerase chain reaction （PCR） on rats renal cortex. （3） Concentration of CNP on renal cortex or serum were analyzed by enzyme-linked immunosorbent assay （ELISA）. （4） Pathological evaluation and NPR-B immunostaining for renal tissue were also performed. Results： （1） CNP and NPR-B mRNA levels were detected in each treated or untreated group, with slight elevated in untreated diabetes rats administrated with STZ after 4-week and CNP mRNA level remarkable elevated at 39.21 times higher than normal control group after 12 weeks, but NPR-B mRNA level showed a remarkably down-regulation at 98.07% after 12 weeks. CNP mRNA of TLR-treated group was also elevated after 12-week treatment, but less than untreated group. （2） Concentrations of CNP in renal cortex were obviously increased in treated or untreated diabetes rats, within these groups the treatment of TLR was found more significantly on prompting CNP concentration. Comparing to normal group, serum concentrations of CNP were also increased in treated or untreated diabetic groups, but there was no difference between these diabetic groups. （3） Renal lesions like glomerular volume increased are observed mostly in the relative eady stage after 4 weeks. Although TLR treated group had no significant difference in their glomerular volume, the degrees of injury of glomerulus were ameliorated, as well as the NPR-B immunostaining enhanced in glomerulus. Weakly positive immunostaining of NPR-B are observed in glomerulus of normal control, and negative in glomerulus of untreated diabetes rats administrated with STZ after 12 weeks, whereas TLR-treatment groups showed a little enhancement. Conclusion： CNP and NPR-B showed different characteristic on renal cortex at different pathological period in diabetes rats, and TLR regulated their expression.

Sixty-one Patients with Diabetic Peripheral Neuropathy Treated by Tongluo Yangyin Recipe (通络养阴方)

Objective： To observe the therapeutic effect of Tongluo Yangyin Recipe （通络养阴方, TLYYR） in patients with diabetic peripheral neuropathy （DPN）. Methods： Ninety-nine patients with diabetes mellitus type 2 were assigned, according to the order of their visit, to two groups： 61 in the treated group and 38 in the control group. They were given the same information about diabetes mellitus and treated with the same therapy： strict diet control and Western drugs for hypoglycemia. In addition, the treated group received one dose （200 mL） of TLYYR in water decoction every day in two portions, while the control group had vitamin B1 100 mg and vitamin B12 250 μ g administered daily via intramuscular injection. The course for all patients was 28 days. Results： The treated group experienced a therapeutic effect superior to that of the control group, with the difference between the total effective rates and the markedly effective rates （P〈0.05, P〈0.01）. The blood levels of total cholesterol （TC） and triglyceride （TG） fell, the hemorrheological manner improved, the transmission velocity of the median nerve and common peroneal nerve significantly increased in the treated group after treatment （P〈0.05）, although the treatment showed no significant influence on blood glucose level （P〉0.05）. Conclusion： TLYYR could promote blood microcirculation, improve nutritional metabolism of peripheral nerve, and thus accelerating DPN repair.

Effect of modified Dihuang Yinzi recipe and Huatan Tongluo decoction on neurological function of MCAO rats

Objective To observe the effect of Modified Dihuang Yinzi Recipe(MDYR)and Hua-tan Tongluo Decoction(HTD)on neurological function of middle cerebral artery occlusion(MCAO)model rats.Methods Forty SD rats were randomly divided into 5 groups,i.e.,the sham-op-