A randomized, double-blind, and placebo-controlled multicenter clinical trial of a novel cytotoxic T-lymphocyte antigen-4 fusion protein, Leining, in Chinese active rheumatoid arthritis patients with an inadequate response to methotrexate.

To assess the clinical efficacy as well as safety profiles of Leining, a novel cytotoxic T-lymphocyte antigen-4 fusion protein, versus placebo in the treatment of Chinese active rheumatoid arthritis (RA) patients with an inadequate clinical response to methotrexate (MTX). In this 24-week, randomized, double-blind, placebo-controlled multicenter study, a total of 440 Chinese patients with active RA with an inadequate response to MTX were randomly assigned to receive Leining (10 mg/kg) or placebo. Clinical response was assessed using the American College of Rheumatology 20 % improvement criteria ACR20, ACR50, and ACR70, with ACR20 as the primary major endpoints. Disease activity scores in 28 joints with erythrocyte sedimentation rate assessment (DAS28-ESR) were used to evaluate disease activity. After 24 weeks of treatment, significantly more patients in Leining group achieved ACR20 response than those in placebo group (70.61 vs. 46.36 %; p < 0.001). Similarly, ACR50 and ACR70 responses of Leining group were significantly higher than those of placebo group (40.30 vs. 22.73 %; p < 0.001 and 16.67 vs. 7.27 %; p < 0.05, respectively). DAS28-ESR in Leining group was significantly reduced compared to that in placebo group, with greater clinically meaningful (>1.2 unit) improvement (54.85 vs. 29.09 %, p < 0.05). Both the rates of remission (DAS28-ESR < 2.6) and low disease activity (DAS28-ESR < 3.2) were greater in the Leining group than those in the placebo group (12.42 vs. 2.73 %; p < 0.05 and 15.45 vs. 2.73 %; p < 0.05 respectively). The overall incidence of adverse events was similar in both Leining and placebo groups. No neutralizing antibodies were detected. Leining demonstrated clinically meaningful efficacy compared with placebo in Chinese patients with active RA despite MTX therapy. Administration of Leining in combination with MTX for 24 weeks was well tolerated.

[Expression levels of Cdc2 and Cdc25A mRNA in cattle, yak, and cattle-yak testis].

The infertility of cattle-yak, which is the hybrid offspring of cattle and yak, is a difficult problem in crossbreeding and improvement of yak. Cdc2 and Cdc25A are the key genes of meiosis. The decline of their expression levels will cause the spermatogenesis failure and lead to infertility. Therefore, this study was conducted to study the relationship between the infertility of cattle-yak and the expression levels of Cdc2/Cdc25A genes. The expression profiles were obtained by RT-PCR. Cdc2 and Cdc25A genes were widely expressed in many tissues, which confirmed their important role in cell division and the progression of cell cycle. Real-time quantitative PCR analysis indicated that the expression levels of Cdc2 and Cdc25A in cattle and yak testis were higher than those in cattle-yak (P<0.05). Therefore, low expression levels of Cdc2 and Cdc25A genes may have a relationship with the infertility of cattle-yak.

Efficacy on dysphagia induced by bulbar palsy treated with acupuncture at Tiantu (CV 22) with different needling techniques / 中国针灸

<p><b>OBJECTIVE</b>To compare the efficacy between elongated needle therapy and regular needle therapy at Tiantu (CV 22) on the basis of xingnao kaiqiao (activiting brain and regaining consciousness) acupuncture therapy so as to explore the effective therapeutic method in treatment of dysphagia induced by bulbar palsy.</p><p><b>METHODS</b>Seventy one cases of dysphagia induced by bulbar palsy were randomized into two groups. The xingnao kaiqiao acupuncture therapy was applied at Shuigou (GV 26), Neiguan (PC 6), Sanyinjiao (SP 6) and the others in the two groups. In the elongated needle therapy group, on the basis of xingnao kaiqiao acupuncture therapy, the elongated needle was used to puncture Tiantu (CV 22). In the regular needle therapy, the regular acupuncture technique was used at Tiantu (CV 22). In both groups, the treatment was given once a day in a week except Sunday and lasted for 4 weeks totally. Before and after treatment, the swallowing condition and the standardized swallowing assessment (SSA) were observed in the patients and the efficacy was compared between the two groups.</p><p><b>RESULTS</b>The total effective rate was 97.2% (35/36) in the elongated needle therapy group, which was better than 77.1% (27/35) in the regular needle therapy group (P<0.05). After treatment, SSA score was reduced significantly as compared with that before treatment in the two groups (both P<0.05). SSA score in the elongated needle therapy group was reduced much more apparently as compared with that in the regular needle therapy group after treatment (P<0.05).</p><p><b>CONCLUSION</b>On the basis of the xingnao kaiqiao acupuncture therapy, the elongated needle therapy at Tiantu (CV 22) achieves the superior effect on bulbar palsy-induced dysphagia as compared with the regular acu- puncture at Tiantu (CV 22).</p>

Systematic evaluation of acupuncture for treatment of post-stroke spastic paralysis / 中国针灸

<p><b>OBJECTIVE</b>To evaluate the effects of acupuncture on post-stroke spastic paralysis.</p><p><b>METHODS</b>A systematic evaluation including all the relavant randomized controlled trials (RCTs) or quasi-RCTs of acupuncture and moxibustion for treatment of post-stroke spastic paralysis were carried out according to the method recommended by the Cochrane Collaboration.</p><p><b>RESULTS</b>Nine hundred and seventy-eight patients being included in fourteen papers met the enrolled criteria. However, their methodological quality was relatively poor. Meta-analysis of nine trials indicated that there was no significant difference between the treatment groups and the control groups in Ashworth scores, Carr-Shepherd scores, nerve defect scores and hip adductor tension scores. Whereas the Fugel-Meyer scores in one trial and the Barthel scores in three trials were better in the treatment groups than those of the control group.</p><p><b>CONCLUSION</b>A reliable conclusion can not be drawn from the present data because of the defects in methodological quality and insufficient numbers of trials, especially lack the long-term terminal outcomes, although it appears a tedency that acupuncture can improve the conditions of post-stroke spastic paralysis. Therefore, it is necessary to perform more multi-central RCTs of high quality in future.</p>

Study on electroacupuncture at shuigou (GV 26) for treatment of mild and moderate shock: a multicentral and randomized controlled trial / 中国针灸

<p><b>OBJECTIVE</b>To probe into the effect of electroacupuncture (EA) at Shuigou (GV 26) on mild and moderate shock.</p><p><b>METHODS</b>With 3-center randomized control study method, 276 cases were assigned to an EA plus medicine group and a medication group, 138 cases in each group. They were treated respectively with western medicine plus EA at Shuigou (GV 26), and simple western medicine. Their curative effects were observed after treatment for 6 hours.</p><p><b>RESULTS</b>The blood pressure was immediately increased in the EA plus medicine group and the increase of blood pressure was earlier than that in the medication group (P<0.001). The markedly effective rate of 52.9% in the EA plus medicine group was significantly higher than 18.1% in the medication group (P<0.001).</p><p><b>CONCLUSION</b>The therapeutic effect of EA at Shuigou (GV 26) plus western medicine on mild and moderate shock is better than that of simple western medicine.</p>

Effects of acupuncture on ET mRNA expressions in different brain regions of the rat of experimental cerebral bleeding / 中国针灸

<p><b>OBJECTIVE</b>To probe into the mechanism of acupuncture for treatment of cerebro-cardiac syndrome.</p><p><b>METHODS</b>The rats were randomly divided into a normal group, a sham operation group, a cerebral bleeding group, an acupuncture group and an acupuncture control group. The acupuncture group were treated with acupuncture at "Neiguan" (PC 6), "Shuigou" (GV 26), "Renying" (ST 19), and the acupuncture control group with acupuncture at "Shenmen" (HT 7) and "Danzhong" (CV 17). The tissue in situ hybridization technique was used to detect dynamic changes of endothelin (ET) mRNA expression in both the central cardiovascular special regulative area and the myocardium, and imaging quantitative analysis on the positive response materials was carried out.</p><p><b>RESULTS</b>The experimental cerebral bleeding could rapidly induce abnormal expression of ET gene in the cerebral bleeding surrounding area, hypothalamus, brain stem, hippocampus and myocardium. Up-regulation of FT mRNA expression could be found at 6 h of cerebral bleeding, and it reached to the peak at 24 h, and slightly reduced at 72 h, still being higher than the normal level. At the same time, ET expression in the myocardium increased. Acupuncture could block the increase of FT gene expression induced by cerebral bleeding.</p><p><b>CONCLUSION</b>Acupuncture exerts protective action on injuries of neurons and myocardium induced by cerebral bleeding via blocking the increase of FT gene expression induced by cerebral bleeding.</p>